[Autonomy and informed consent in surgical care-patients' and staff perceptions].

PubMed

Schopp, Anja; Dassen, Theo; Välimäki, Maritta; Leino-Kilpi, Helena; Gasull, Maria; Lemonidou, Chryssoula; Scott, Anne P; Arndt, Marianne

2004-06-01

The aim of this study was to describe autonomy and informed consent in surgical care. The study is a part of the international BIOMED 2 project "Patients' Autonomy and Privacy in Nursing Interventions" (BIOMED2, BMH4-CT98-3555; 1998-2001) supported by the European Commission. For this study, data of patients (n = 254) and nurses (n = 205) in eleven Berlin hospitals and three hospitals outside Berlin were collected by means of a structured questionnaire. The findings of the study indicate, that information-giving was more positive than decision-making. Patients perceived they were more frequently informed about their surgery than about their care. According to the perceptions of nurses the case was reversed. The perceptions of both groups differed, since from the point of view of nurses, patients' autonomy was more frequently heeded and their consent was sought more often than from the point of view of the patients. Patients admitted as emergencies and in multi-bed rooms perceived their autonomy more negatively than those with a planned surgery or in single rooms. Elderly nurses were more frequently than younger nurses of the opinion to grant patients autonomy. Nurses with a longer working experience in nursing care perceived that patients were more frequently asked their consent. Further, nurses with a higher educational qualification and with a higher occupational status perceived decision-making more negatively. The findings of the present study give implications for clinical practice, nursing education, and for further research.

Legal protection of informed consent of minors.

PubMed

Osuna, Eduardo

2010-06-01

One of the pillars of healthcare provision is respect for the autonomy of the patient's wishes, which is given substance by the process of obtaining informed consent. Minors deserve special protection, entitled to basic rights and increasingly autonomous as they develop. In certain situations, minors are deemed matures and able to consent to treatment without the involvement of a parent or guardian. The assessment of competence would be based on the child's functional ability, not on age or outcome of the decision. This manuscript includes a brief analysis of legal perspectives on informed consent of minors, and minors' capacities to make medical decisions. Remaining questions of how to evaluate capacity and balance parental and minor autonomy are explored. Considerations on informed consent in different situations as refusing treatment and termination of pregnancy by female children are analyzed.

A half century of electronic fetal monitoring and bioethics: silence speaks louder than words.

PubMed

Sartwelle, Thomas P; Johnston, James C; Arda, Berna

2017-01-01

Bioethics abolished the prevailing Hippocratic tenet instructing physicians to make treatment decisions, replacing it with autonomy through informed consent. Informed consent allows the patient to choose treatment after options are explained by the physician. The appearance of bioethics in 1970 coincided with the introduction of electronic fetal monitoring (EFM), which evolved to become the fetal surveillance modality of choice for virtually all women in labor. Autonomy rapidly pervaded all medical procedures, but there was a clear exemption for EFM. Even today, EFM remains immune to the doctrine of informed consent despite continually mounting evidence which proves the procedure is nothing more than myth, illusion and junk science that subjects mothers and babies alike to increased risks of morbidity and mortality. And ethicists have remained utterly silent through a half century of EFM misuse. Our article explores this egregious ethical failure by reviewing EFM's lack of clinical efficacy, discussing the EFM related harm to mothers and babies, and focusing on the reasons that this obstetrical procedure eluded the revolutionary change from the Hippocratic tradition to autonomy through informed consent.

The new genetics and informed consent: differentiating choice to preserve autonomy.

PubMed

Bunnik, Eline M; de Jong, Antina; Nijsingh, Niels; de Wert, Guido M W R

2013-07-01

The advent of new genetic and genomic technologies may cause friction with the principle of respect for autonomy and demands a rethinking of traditional interpretations of the concept of informed consent. Technologies such as whole-genome sequencing and micro-array based analysis enable genome-wide testing for many heterogeneous abnormalities and predispositions simultaneously. This may challenge the feasibility of providing adequate pre-test information and achieving autonomous decision-making. At a symposium held at the 11th World Congress of Bioethics in June 2012 (Rotterdam), organized by the International Association of Bioethics, these challenges were presented for three different areas in which these so-called 'new genetics' technologies are increasingly being applied: newborn screening, prenatal screening strategies and commercial personal genome testing. In this article, we build upon the existing ethical framework for a responsible set-up of testing and screening offers and reinterpret some of its criteria in the light of the new genetics. As we will argue, the scope of a responsible testing or screening offer should align with the purpose(s) of testing and with the principle of respect for autonomy for all stakeholders involved, including (future) children. Informed consent is a prerequisite but requires a new approach. We present preliminary and general directions for an individualized or differentiated set-up of the testing offer and for the informed consent process. With this article we wish to contribute to the formation of new ideas on how to tackle the issues of autonomy and informed consent for (public) healthcare and direct-to-consumer applications of the new genetics. © 2013 John Wiley & Sons Ltd.

Addiction, Autonomy, and Informed Consent: On and Off the Garden Path

PubMed Central

Levy, Neil

2016-01-01

Several ethicists have argued that research trials and treatment programs that involve the provision of drugs to addicts are prima facie unethical, because addicts can’t refuse the offer of drugs and therefore can’t give informed consent to participation. In response, several people have pointed out that addiction does not cause a compulsion to use drugs. However, since we know that addiction impairs autonomy, this response is inadequate. In this paper, I advance a stronger defense of the capacity of addicts to participate in the programs envisaged. I argue that it is only in certain circumstances that addicts find themselves choosing in ways that conflict with their genuine preferences. Research and treatment programs have none of the features that characterize choices in these autonomy-undermining circumstances, and there is therefore no reason to think that addicts lack the capacity to give informed consent to these programs. PMID:26668167

Paternalism and partial autonomy.

PubMed Central

O'Neill, O

1984-01-01

A contrast is often drawn between standard adult capacities for autonomy, which allow informed consent to be given or withheld, and patients' reduced capacities, which demand paternalistic treatment. But patients may not be radically different from the rest of us, in that all human capacities for autonomous action are limited. An adequate account of paternalism and the role that consent and respect for persons can play in medical and other practice has to be developed within an ethical theory that does not impose an idealised picture of unlimited autonomy but allows for the variable and partial character of actual human autonomy. PMID:6520849

Voices of people who have received ECT.

PubMed

Rajkumar, A P; Saravanan, B; Jacob, K S

2007-01-01

Electroconvulsive therapy (ECT) is controversial but widely practised in India. We elicited perspectives, using qualitative interviews, from patients who received ECT and their relatives. Ethical issues related to personal autonomy, right to information, competence, informed consent and consent by proxy are discussed. We suggest strategies to ensure a basic minimum standard for obtaining informed consent for ECT in India.

The myth of informed consent: in daily practice and in clinical trials.

PubMed

Silverman, W A

1989-03-01

Until about thirty years ago, the extent of disclosure about and consent-seeking for medical interventions was influenced by a beneficence model of professional behaviour. Informed consent shifted attention to a duty to respect the autonomy of patients. The new requirement arrived on the American scene in two separate contexts: for daily practice in 1957, and for clinical study in 1966. A confusing double standard has been established. 'Daily consent' is reviewed, if at all, only in retrospect. Doctors are merely exhorted to obtain informed consent; they often minimise uncertainties about 'best' treatment and they feel duty-bound to provide patients with an unequivocal recommendation for action. 'Study consent' in a clinical trial is reviewed prospectively, and doctors are compelled by regulation to point out that there is insufficient evidence to make a rational choice between two compared treatments. It has been impossible to devise informed consent practices that satisfy, in full, the competing moral imperatives of respect for autonomy, concern for beneficence with emphasis on the value of health, and a vigil for justice. A way must be found to experiment with various discretionary approaches that would strike a realistic balance among competing interests.

Framing patient consent for student involvement in pelvic examination: a dual model of autonomy.

PubMed

Carson-Stevens, Andrew; Davies, Myfanwy M; Jones, Rhiain; Chik, Aiman D Pawan; Robbé, Iain J; Fiander, Alison N

2013-11-01

Patient consent has been formulated in terms of radical individualism rather than shared benefits. Medical education relies on the provision of patient consent to provide medical students with the training and experience to become competent doctors. Pelvic examination represents an extreme case in which patients may legitimately seek to avoid contact with inexperienced medical students particularly where these are male. However, using this extreme case, this paper will examine practices of framing and obtaining consent as perceived by medical students. This paper reports findings of an exploratory qualitative study of medical students and junior doctors. Participants described a number of barriers to obtaining informed consent. These related to misunderstandings concerning student roles and experiences and insufficient information on the nature of the examination. Participants reported perceptions of the negative framing of decisions on consent by nursing staff where the student was male. Potentially coercive practices of framing of the decision by senior doctors were also reported. Participants outlined strategies they adopted to circumvent patients' reasons for refusal. Practices of framing the information used by students, nurses and senior doctors to enable patients to decide about consent are discussed in the context of good ethical practice. In the absence of a clear ethical model, coercion appears likely. We argue for an expanded model of autonomy in which the potential tension between respecting patients' autonomy and ensuring the societal benefit of well-trained doctors is recognised. Practical recommendations are made concerning information provision and clear delineations of student and patient roles and expectations.

Informed consent: what does it mean?

PubMed Central

Kirby, M D

1983-01-01

The editorial in the September 1982 issue of this journal and many articles before and since have addressed the problem of informed consent. Is it possible? Is it a useful concept? Is there anything new to be said about it? In this article the basic rationale of the rule (patient autonomy) is explained and the extent of the rule explored. Various exceptions have been offered by the law and an attempt is made to catalogue the chief of these. A number of specially vulnerable groups are then identified, the most important, and vexed, being children. How can informed consent be secured in the case of young patients? Finally, a few problems are mentioned in an attempt to get this subject back to reality. The appeal to the principle primum non nocere may be medical paternalism in disguise. Informed consent is the competing principle that reminds us of the primacy of human autonomy. A pointer is given to the future: even the use of sound recordings to explain medical procedures and to activate informed consent so that it may become a reality and not just a lawyer's myth, should be considered. PMID:6876100

Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: an empirical study.

PubMed

Chima, Sylvester C

2013-01-01

Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent. The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa. The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists scoring lowest, while internists, GPs and obstetricians/gynaecologists scored highest. Comparative ICAS scores showed that professional nurses scored significantly lower than doctors (p ≤ 0.001). This study shows that though doctors had general knowledge of informed consent requirements, execution in practice was inadequate, with deficiency in knowledge of basic local laws and regulations. Remedying identified deficiencies may require a 'corps' of interpreters in local hospitals to assist doctors in dealing with language difficulties, and continuing education in medical law and ethics to improve informed consent practices and overall quality of healthcare service delivery.

Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: An empirical study

PubMed Central

2013-01-01

Background Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent. Methods The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa. Results The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists scoring lowest, while internists, GPs and obstetricians/gynaecologists scored highest. Comparative ICAS scores showed that professional nurses scored significantly lower than doctors (p ≤ 0.001). Conclusions This study shows that though doctors had general knowledge of informed consent requirements, execution in practice was inadequate, with deficiency in knowledge of basic local laws and regulations. Remedying identified deficiencies may require a 'corps' of interpreters in local hospitals to assist doctors in dealing with language difficulties, and continuing education in medical law and ethics to improve informed consent practices and overall quality of healthcare service delivery. PMID:24564932

Is Consent Based on Trust Morally Inferior to Consent Based on Information?

PubMed

Kongsholm, Nana Cecilie Halmsted; Kappel, Klemens

2017-07-01

Informed consent is considered by many to be a moral imperative in medical research. However, it is increasingly acknowledged that in many actual instances of consent to participation in medical research, participants do not employ the provided information in their decision to consent, but rather consent based on the trust they hold in the researcher or research enterprise. In this article we explore whether trust-based consent is morally inferior to information-based consent. We analyse the moral values essential to valid consent - autonomy, voluntariness, non-manipulation, and non-exploitation - and assess whether these values are less protected and promoted by consent based on trust than they are by consent based on information. We find that this is not the case, and thus conclude that trust-based consent if not morally inferior to information-based consent. © 2017 John Wiley & Sons Ltd.

Educational pelvic exams on anesthetized women: Why consent matters.

PubMed

Friesen, Phoebe

2018-06-01

It is argued here that the practice of medical students performing pelvic exams on women who are under anesthetic and have not consented is immoral and indefensible. This argument begins by laying out the ethical justification for the practice of informed consent, which can be found in autonomy and basic rights. Foregoing the process of consent within medicine can result in violations of both autonomy and basic rights, as well as trust, forming the basis of the wrong of unauthorized pelvic examinations. Several objections to this argument are considered, all of which stem from the idea that this practice constitutes an exception to the general requirement of informed consent. These objections suggest that nonconsensual pelvic examinations on women under anesthetic are ethically acceptable on utilitarian grounds, in that they offer benefits either to the patient or to society, or on the grounds of triviality, in that consent is already presumed, or the practice is insignificant. Each of these objections is rejected and the practice is deemed indefensible. © 2018 John Wiley & Sons Ltd.

Informed Consent to Treatment in Psychiatry

PubMed Central

Neilson, Grainne; Chaimowitz, Gary

2015-01-01

Summary Patients have a right to be informed and actively involved in their health care. Fundamental to a person’s dignity and autonomy is the right to make decisions about their psychiatric treatment, including their right to refuse unwanted treatments, providing that the refusal is a capable one. It is important that psychiatrists have an awareness of the ethical underpinnings of consent and the legislated requirements related to consent, including precedent cases. Consent may change over time and for different conditions and circumstances. Consent must be an ongoing process.

Autonomy is a Right, Not a Feat: How Theoretical Misconceptions have Muddled the Debate on Dynamic Consent to Biobank Research.

PubMed

Johnsson, Linus; Eriksson, Stefan

2016-09-01

Should people be involved as active participants in longitudinal medical research, as opposed to remaining passive providers of data and material? We argue in this article that misconceptions of 'autonomy' as a kind of feat rather than a right are to blame for much of the confusion surrounding the debate of dynamic versus broad consent. Keeping in mind two foundational facts of human life, freedom and dignity, we elaborate three moral principles - those of autonomy, integrity and authority - to better see what is at stake. Respect for autonomy is to recognize the other's right to decide in matters that are important to them. Respect for integrity is to meet, in one's relationship with the other, their need to navigate the intersection between private and social life. Respect for authority is to empower the other - to help them to cultivate their responsibility as citizens. On our account, to force information onto someone who does not want it is not to respect that person's autonomy, but to violate integrity in the name of empowerment. Empowerment, not respect for autonomy, is the aim that sets patient-centred initiatives employing a dynamic consent model apart from other consent models. Whether this is ultimately morally justified depends on whether empowerment ought to be a goal of medical research, which is questionable. © 2016 John Wiley & Sons Ltd.

Addiction, Autonomy, and Informed Consent: On and Off the Garden Path.

PubMed

Levy, Neil

2016-02-01

Several ethicists have argued that research trials and treatment programs that involve the provision of drugs to addicts are prima facie unethical, because addicts can't refuse the offer of drugs and therefore can't give informed consent to participation. In response, several people have pointed out that addiction does not cause a compulsion to use drugs. However, since we know that addiction impairs autonomy, this response is inadequate. In this paper, I advance a stronger defense of the capacity of addicts to participate in the programs envisaged. I argue that it is only in certain circumstances that addicts find themselves choosing in ways that conflict with their genuine preferences. Research and treatment programs have none of the features that characterize choices in these autonomy-undermining circumstances, and there is therefore no reason to think that addicts lack the capacity to give informed consent to these programs. © The Author 2015. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights.

PubMed

Ekmekci, Perihan Elif; Arda, Berna

2017-01-01

Interventions in medicine require multicenter clinical trials on a large rather than limited number of subjects from various genetic and cultural backgrounds. International guidelines to protect the rights and well-being of human subjects involved in clinical trials are criticized for the priority they place on Western cultural values. These discussions become manifest especially with regard to the content and methodology of the informed consent procedure. The ethical dilemma emerges from the argument that there are fundamental differences about the concept of respect for the autonomy of individuals in different cultures and religions. Some communities prioritize the consent of community leaders or the head of family - usually men - over the voluntary and free consent of the individual. The aim of this work is to discuss this ethical dilemma to determine a base for a consensus that satisfies the sensibilities of different cultures without damaging the rights and autonomy of human subjects.

Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights

PubMed Central

Ekmekci, Perihan Elif; Arda, Berna

2018-01-01

Interventions in medicine require multicenter clinical trials on a large rather than limited number of subjects from various genetic and cultural backgrounds. International guidelines to protect the rights and well-being of human subjects involved in clinical trials are criticized for the priority they place on Western cultural values. These discussions become manifest especially with regard to the content and methodology of the informed consent procedure. The ethical dilemma emerges from the argument that there are fundamental differences about the concept of respect for the autonomy of individuals in different cultures and religions. Some communities prioritize the consent of community leaders or the head of family – usually men – over the voluntary and free consent of the individual. The aim of this work is to discuss this ethical dilemma to determine a base for a consensus that satisfies the sensibilities of different cultures without damaging the rights and autonomy of human subjects. PMID:29645014

Autonomy, privacy and informed consent 3: elderly care perspective.

PubMed

Scott, P A; Välimäki, M; Leino-Kilpi, H; Dassen, T; Gasull, M; Lemonidou, C; Arndt, M

Despite the growing interest in clinical healthcare ethics, there is a dearth of empirical studies investigating the ethical elements of day-to-day clinical practice from the perspective of either patients or staff. This article, the third in a four-part series, reports the results of a Scottish Study that formed part of a multi-site comparative study funded by the European Commission. It explores patient autonomy, privacy and informed consent in the care of elderly people in long-stay care facilities (i.e. nursing homes and continuing care units). A convenience sample of 101 elderly residents and their nurses (n = 160) participated in the study. Data were collected by means of a self-completion questionnaire for staff and a structured interview schedule for elderly residents. Results indicate marked differences between staff's and residents' responses on three of the four dimensions explored: information-giving, and opportunity to participate in decision-making about care and consent. There was much closer agreement between staff's and residents' responses regarding protection of patient privacy. From the results of this study there is indication of a clear need for further empirical studies exploring issues of patient autonomy, privacy and informed consent in the day-to-day nursing care of older people. Findings to date suggest there is still a significant need to educate staff concerning ethical awareness and sensitivity to the dignity and rights of patients.

The ethics of managing affective and emotional states to improve informed consent: autonomy, comprehension, and voluntariness.

PubMed

Braude, Hillel; Kimmelman, Jonathan

2012-03-01

Over the past several decades the 'affective revolution' in cognitive psychology has emphasized the critical role affect and emotion play in human decision-making. Drawing on this affective literature, various commentators have recently proposed strategies for managing therapeutic expectation that use contextual, symbolic, or emotive interventions in the consent process to convey information or enhance comprehension. In this paper, we examine whether affective consent interventions that target affect and emotion can be reconciled with widely accepted standards for autonomous action. More specifically, the ethics of affective consent interventions is assessed in terms of key elements of autonomy, comprehension and voluntariness. While there may appear to be a moral obligation to manage the affective environment to ensure valid informed consent, in circumstances where volunteers may be prone to problematic therapeutic expectancy, this moral obligation needs to be weighed against the potential risks of human instrumentalization. At this point in time we do not have enough information to be able to justify clearly the programmatic manipulation of human subjects' affective states. The lack of knowledge about affective interventions requires corresponding caution in its ethical justification. © 2010 Blackwell Publishing Ltd.

Informed consent process: A step further towards making it meaningful!

PubMed Central

Kadam, Rashmi Ashish

2017-01-01

Informed consent process is the cornerstone of ethics in clinical research. Obtaining informed consent from patients participating in clinical research is an important legal and ethical imperative for clinical trial researchers. Although informed consent is an important process in clinical research, its effectiveness and validity are always a concern. Issues related to understanding, comprehension, competence, and voluntariness of clinical trial participants may adversely affect the informed consent process. Communication of highly technical, complex, and specialized clinical trial information to participants with limited literacy, diverse sociocultural background, diminished autonomy, and debilitating diseases is a difficult task for clinical researchers. It is therefore essential to investigate and adopt innovative communication strategies to enhance understanding of clinical trial information among participants. This review article visits the challenges that affect the informed consent process and explores various innovative strategies to enhance the consent process. PMID:28828304

Nudging and informed consent.

PubMed

Cohen, Shlomo

2013-01-01

Libertarian paternalism's notion of "nudging" refers to steering individual decision making so as to make choosers better off without breaching their free choice. If successful, this may offer an ideal synthesis between the duty to respect patient autonomy and that of beneficence, which at times favors paternalistic influence. A growing body of literature attempts to assess the merits of nudging in health care. However, this literature deals almost exclusively with health policy, while the question of the potential benefit of nudging for the practice of informed consent has escaped systematic analysis. This article focuses on this question. While it concedes that nudging could amount to improper exploitation of cognitive weaknesses, it defends the practice of nudging in a wide range of other conditions. The conclusion is that, when ethically legitimate, nudging offers an important new paradigm for informed consent, with a special potential to overcome the classical dilemma between paternalistic beneficence and respect for autonomy.

Should informed consent be based on rational beliefs?

PubMed Central

Savulescu, J; Momeyer, R W

1997-01-01

Our aim is to expand the regulative ideal governing consent. We argue that consent should not only be informed but also based on rational beliefs. We argue that holding true beliefs promotes autonomy. Information is important insofar as it helps a person to hold the relevant true beliefs. But in order to hold the relevant true beliefs, competent people must also think rationally. Insofar as information is important, rational deliberation is important. Just as physicians should aim to provide relevant information regarding the medical procedures prior to patients consenting to have those procedures, they should also assist patients to think more rationally. We distinguish between rational choice/action and rational belief. While autonomous choice need not necessarily be rational, it should be based on rational belief. The implication for the doctrine of informed consent and the practice of medicine is that, if physicians are to respect patient autonomy and help patients to choose and act more rationally, not only must they provide information, but they should care more about the theoretical rationality of their patients. They should not abandon their patients to irrationality. They should help their patients to deliberate more effectively and to care more about thinking rationally. We illustrate these arguments in the context of Jehovah's Witnesses refusing life-saving blood transfusions. Insofar as Jehovah's Witnesses should be informed of the consequences of their actions, they should also deliberate rationally about these consequences. PMID:9358347

Should informed consent be based on rational beliefs?

PubMed

Savulescu, J; Momeyer, R W

1997-10-01

Our aim is to expand the regulative ideal governing consent. We argue that consent should not only be informed but also based on rational beliefs. We argue that holding true beliefs promotes autonomy. Information is important insofar as it helps a person to hold the relevant true beliefs. But in order to hold the relevant true beliefs, competent people must also think rationally. Insofar as information is important, rational deliberation is important. Just as physicians should aim to provide relevant information regarding the medical procedures prior to patients consenting to have those procedures, they should also assist patients to think more rationally. We distinguish between rational choice/action and rational belief. While autonomous choice need not necessarily be rational, it should be based on rational belief. The implication for the doctrine of informed consent and the practice of medicine is that, if physicians are to respect patient autonomy and help patients to choose and act more rationally, not only must they provide information, but they should care more about the theoretical rationality of their patients. They should not abandon their patients to irrationality. They should help their patients to deliberate more effectively and to care more about thinking rationally. We illustrate these arguments in the context of Jehovah's Witnesses refusing life-saving blood transfusions. Insofar as Jehovah's Witnesses should be informed of the consequences of their actions, they should also deliberate rationally about these consequences.

Autonomy and Privacy in Clinical Laboratory Science Policy and Practice.

PubMed

Leibach, Elizabeth Kenimer

2014-01-01

Rapid advancements in diagnostic technologies coupled with growth in testing options and choices mandate the development of evidence-based testing algorithms linked to the care paths of the major chronic diseases and health challenges encountered most frequently. As care paths are evaluated, patient/consumers become partners in healthcare delivery. Clinical laboratory scientists find themselves firmly embedded in both quality improvement and clinical research with an urgent need to translate clinical laboratory information into knowledge required by practitioners and patient/consumers alike. To implement this patient-centered care approach in clinical laboratory science, practitioners must understand their roles in (1) protecting patient/consumer autonomy in the healthcare informed consent process and (2) assuring patient/consumer privacy and confidentiality while blending quality improvement study findings with protected health information. A literature review, describing the current ethical environment, supports a consultative role for clinical laboratory scientists in the clinical decision-making process and suggests guidance for policy and practice regarding the principle of autonomy and its associated operational characteristics: informed consent and privacy.

The ethical use of existing samples for genome research.

PubMed

Bathe, Oliver F; McGuire, Amy L

2009-10-01

Modern biobanking efforts consist of prospective collections of tissues linked to clinical data for patients who have given informed consent for the research use of their specimens and data, including their DNA. In such efforts, patient autonomy and privacy are well respected because of the prospective nature of the informed consent process. However, one of the richest sources of tissue for research continues to be the millions of archived samples collected by pathology departments during normal clinical care or for research purposes without specific consent for future research or genetic analysis. Because specific consent was not obtained a priori, issues related to individual privacy and autonomy are much more complicated. A framework for accessing these existing samples and related clinical data for research is presented. Archival tissues may be accessed only when there is a reasonable likelihood of generating beneficial and scientifically valid information. To minimize risks, databases containing information related to the tissue and to clinical data should be coded, no personally identifying phenotypic information should be included, and access should be restricted to bona fide researchers for legitimate research purposes. These precautions, if implemented appropriately, should ensure that the research use of archival tissue and data are no more than minimal risk. A waiver of the requirement for informed consent would then be justified if reconsent is shown to be impracticable. A waiver of consent should not be granted, however, if there is a significant risk to privacy, if the proposed research use is inconsistent with the original consent (where there is one), or if the potential harm from a privacy breach is considerable.

A semi-qualitative study of attitudes to vaccinating adolescents against human papillomavirus without parental consent.

PubMed

Brabin, Loretta; Roberts, Stephen A; Kitchener, Henry C

2007-02-09

The first vaccine to prevent human papillomavirus (HPV) and cervical cancer has been licensed, and in future, vaccination may be routinely offered to 10-14 year old girls. HPV is a sexually transmitted virus and some parents may refuse consent for vaccination. Under-16s in the UK have a right to confidential sexual health care without parental consent. We investigated parents' views on making available HPV vaccination to adolescent minors at sexual health clinics without parental consent. This was a semi-qualitative analysis of views of parents of 11-12 year old school children collected as part of a population-based survey of parental attitudes to HPV vaccination in Manchester. Parents were firstly asked if they agreed that a well-informed child should be able to request vaccination at a sexual health clinic without parental consent, and secondly, to provide a reason for this answer. Ethical perspectives on adolescent autonomy provided the framework for descriptive analysis. 307 parents answered the question, and of these, 244 (80%) explained their views. Parents with views consistent with support for adolescent autonomy (n = 99) wanted to encourage responsible behaviour, protect children from ill-informed or bigoted parents, and respected confidentiality and individual rights. In contrast, 97 parents insisted on being involved in decision-making. They emphasised adult responsibility for a child's health and guidance, erosion of parental rights, and respect for cultural and moral values. Other parents (n = 48) wanted clearer legal definitions governing parental rights and responsibilities or hoped for joint decision-making. Parents resistant to adolescent autonomy would be less likely to consent to future HPV vaccination, (67%) than parents supporting this principle (89%; p < 0.001). In the UK, the principle of adolescent autonomy is recognised and logically should include the right to HPV vaccination, but this may concern parents who would otherwise approve vaccination.

Informed consent in otolaryngologic surgery: case scenario from a nigerian specialist hospital.

PubMed

Afolabi, O A; Fadare, J O; Ajiboye, O T

2014-01-01

Informed consent is a foundational concept necessary for ethical conduct of clinical research and practice. It is a technical tool that shifts the autonomy to decide whether a medical procedure should be performed-from the doctor to the patient. However there is an ongoing discussion in bioethical circles on the level of comprehension of the informed consent process by the patients and research participants. We present this case vignette and the discussion afterwards to explore the question of to what extent a patient comprehends the information given to him/her before a surgical procedure is carried out. In other words, the question being asked here is how informed is informed consent in the context of oto-laryngological practice.

"Sign here": nursing value and the process of informed consent.

PubMed

Cook, Wesley E

2014-01-01

Protecting patient autonomy is a key nursing role. The Code of Ethics (American Nurses Association, 2010), contextualizes the nurse's call to advocacy within the doctrine of informed consent. This article offers a primer on the legal, ethical, and practical aspects of procedural informed consent and examines the value of nursing's role within the process. The theory of nursing's value is sound, but the literature lacks data. Higher levels of evidence are necessary to make sound decisions about best practice for the process of informed consent. As such, this article concludes that adding nursing research to the current discourse should prove most valuable to patients, providers, and the nursing profession as a whole.

Culturally Competent Informed-Consent Process to Evaluate a Social Policy for Older Persons With Low Literacy: The Mexican Case

PubMed Central

Aguila, Emma; Weidmer, Beverly A.; Illingworth, Alfonso Rivera; Martinez, Homero

2017-01-01

The informed-consent process seeks to provide complete information to participants about a research project and to protect personal information they may disclose. In this article, we present an informed-consent process that we piloted and improved to obtain consent from older adults in Yucatan, Mexico. Respondents had limited fluency in Spanish, spoke the local Mayan language, and had some physical limitations due to their age. We describe how we adapted the informed-consent process to comply with U.S. and Mexican regulations, while simplifying the forms and providing them in Spanish and Mayan. We present the challenges and lessons learned when dealing with low-literacy older populations, some with diminished autonomy, in a bilingual context and a binational approach to the legal framework. PMID:28824826

Refusal of treatment, leading to death: towards optimization of informed consent.

PubMed

Trevor-Deutsch, B; Nelson, R F

1996-12-01

Few medical decisions create more anguish than ones involving cessation of treatment, resulting in the death of a patient. In this article, the ethical and legal aspects of the withdrawal of treatment are examined with respect to a case of a 67-year-old man who fell and sustained a fracture of his second cervical vertebra, rendering him paralysed and respirator-dependent. He immediately requested the withdrawal of treatment, but his family baulked. Ethics consultation recommended delaying the decision, to give the patient enough time to foster optimal comprehension and synthesis of information related to his condition and the consequences; we refer to this process as "optimization of informed consent." When the patient was informed of the delay and the reasons for it, he was assured (and subsequently repeatedly reassured) of his ultimate right to refuse treatment at a future date. On balance, optimization of informed consent promotes patients' autonomy, even though it involves suspending this autonomy for a time. It is also consistent with physicians' responsibility to promote life and avoid premature death.

Perpetuating Myths, Fables, and Fairy Tales: A Half Century of Electronic Fetal Monitoring

PubMed Central

Sartwelle, Thomas P.; Johnston, James C.; Arda, Berna

2015-01-01

Electronic fetal monitoring (EFM) entered clinical medical practice at the same time bioethics became reality. Bioethics changed the medical ethics landscape by replacing the traditional Hippocratic benign paternalism with patient autonomy, informed consent, beneficence, and nonmaleficence. But EFM use represents the polar opposite of bioethics' revered principles—it has been documented for half a century to be completely ineffectual, used without informed consent, and harmful to mothers and newborns alike. Despite EFM's ethical misuse, there has been no outcry from the bioethical world. Why? This article answers that question, discussing EFM's history and the reasons it was issued an ethics pass. And it explores the reason that even today mothers are still treated with blatant medical paternalism, deprived of autonomy and informed consent, and subjected to real medical risks under the guise that EFM is an essential safety device when in fact it is used almost solely to protect physicians and hospitals from cerebral palsy lawsuits. PMID:28824967

Can Broad Consent be Informed Consent?

PubMed Central

Sheehan, Mark

2011-01-01

In biobanks, a broader model of consent is often used and justified by a range of different strategies that make reference to the potential benefits brought by the research it will facilitate combined with the low level of risk involved (provided adequate measures are in place to protect privacy and confidentiality) or a questioning of the centrality of the notion of informed consent. Against this, it has been suggested that the lack of specific information about particular uses of the samples means that such consent cannot be fully autonomous and so is unethical. My answer to the title question is a definite ‘yes’. Broad consent can be informed consent and is justified by appeal to the principle of respect for autonomy. Indeed, I will suggest that the distinction between the various kinds of consent is not a distinction between kinds of consent but between the kinds of choice a person makes. When an individual makes a choice (of any kind) it is important that they do so according to the standards of informed consent and consistent with the choice that they are making. PMID:22102849

Informed consent in psychiatry clinical research: A conceptual review of issues, challenges, and recommendations

PubMed Central

Gupta, Umesh Chandra; Kharawala, Saifuddin

2012-01-01

Obtaining informed consent in psychiatry clinical research involving subjects with diminished mental abilities and impaired consent capacity has been a challenge for researchers, posing many ethical concerns and procedural hurdles due to participants’ cognitive deficits and impaired ability to judge reality. Regulations seem inadequate and provide limited guidance, not sufficient to address all the ethical issues inherent in different situations related to obtaining consent from decisionally impaired persons. Researchers are struggling to find a balance between risk-benefit ratio, research advancement, and autonomy of study subjects. Inspired to improve the consent process in psychiatry clinical research, many studies have been conducted focusing on various informed consent-related ethical concerns, with the aim of developing appropriate strategies and optimizing the informed consent procedure in psychiatry clinical research, overcoming the ethical concerns. This article critically reviews the various ethical issues and consent challenges, their underlying reasons, and investigates the appropriate strategies and practices needed to be adopted while obtaining informed consent from subjects with impaired consent capacity, participating in psychiatry clinical research. PMID:22347696

Information, consent and treatment of patients with Morgellons disease: an ethical perspective.

PubMed

Söderfeldt, Ylva; Groß, Dominik

2014-04-01

Morgellons is a medically contested diagnosis with foremost dermatological symptoms. Patients experience fibers emerging from the skin, together with a range of other somatic, psychiatric, and neurological complaints. Within the medical community, it is generally held to be a variation of delusional parasitosis/delusional infestation, which is usually treated with antipsychotics. Little attention has been paid in the literature to the ethical aspects of treating patients with Morgellons disease. The communicative strategies suggested in the literature display significant ethical issues, primarily the use of therapeutic privilege, i.e. withholding information from the patient. Since this limits patient autonomy, that approach is ethically problematic. Instead, the physician has an ethical obligation to respect the patient's autonomy, provide full information, and seek consent before initiating a psychiatric referral.

Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?

PubMed Central

Steinsbekk, Kristin Solum; Kåre Myskja, Bjørn; Solberg, Berge

2013-01-01

In the endeavour of biobank research there is dispute concerning what type of consent and which form of donor–biobank relationship meet high ethical standards. Up until now, a ‘broad consent' model has been used in many present-day biobank projects. However it has been, by some scholars, deemed as a pragmatic, and not an acceptable ethical solution. Calls for change have been made on the basis of avoidance of paternalism, intentions to fulfil the principle of autonomy, wish for increased user participation, a questioning of the role of experts and ideas advocating reduction of top–down governance. Recently, an approach termed ‘dynamic consent' has been proposed to meet such challenges. Dynamic consent uses modern communication strategies to inform, involve, offer choices and last but not the least obtain consent for every research projects based on biobank resources. At first glance dynamic consent seems appealing, and we have identified six claims of superiority of this model; claims pertaining to autonomy, information, increased engagement, control, social robustness and reciprocity. However, after closer examination, there seems to be several weaknesses with a dynamic consent approach; among others the risk of inviting people into the therapeutic misconception as well as individualizing the ethical review of research projects. When comparing the two models, broad consent still holds and can be deemed a good ethical solution for longitudinal biobank research. Nevertheless, there is potential for improvement in the broad model, and criticism can be met by adapting some of the modern communication strategies proposed in the dynamic consent approach. PMID:23299918

[Knowledge and willingness to participate in research: a descriptive study of volunteers in a clinical trial].

PubMed

Lobato, Lucas; Gazzinelli, Maria Flávia; Gazzinelli, Andréa; Soares, Amanda Nathale

2014-06-01

The aim of this study was to evaluate volunteers' knowledge of the information on the free informed consent form and their willingness to participate in a clinical trial. This was a quantitative, descriptive, cross-sectional study conducted in November 2011 with subjects from a clinical trial in Americaninhas, northeast Minas Gerais State, Brazil. A convenience sample included 143 adults of both sexes, 18 to 45 years of age. A structured questionnaire was applied one week after signing the free informed consent form. Most participants signed the free informed consent without sufficient knowledge of the research information and were influenced in their decision to participate in the trial. The authors conclude that signing the free informed consent form fails to express all participants' autonomy in clinical trials.

The Influence of Education and Depression on Autonomy of Women with Chronic Pelvic Pain: A Cross-sectional Study.

PubMed

Barbosa, Hermes de Freitas; Nogueira, Antonio Alberto; e Silva, Júlio César Rosa; Poli Neto, Omero Benedicto; dos Reis, Francisco José Candido

2016-01-01

Patient autonomy has great importance for a valid informed consent in clinical practice. Our objectives were to quantify the domains of patient autonomy and to evaluate the variables that can affect patient autonomy in women with chronic pelvic pain. This study is a cross sectional survey performed in a tertiary care University Hospital. Fifty-two consecutive women scheduled for laparoscopic management of chronic pelvic were included. Three major components of autonomy (competence, information or freedom) were evaluated using a Likert scale with 24 validated affirmatives. Competence scores (0.85 vs 0.92; p = 0.006) and information scores (0.90 vs 0.93; p = 0.02) were low for women with less than eight years of school attendance. Information scores were low in the presence of anxiety (0.91 vs 0.93; p = 0.05) or depression (0.90 vs 0.93; p = 0.01). Our data show that systematic evaluation of patient autonomy can provide clinical relevant information in gynecology. Low educational level, anxiety and depression might reduce the patient autonomy in women with chronic pelvic pain.

Futility, autonomy, and informed consent.

PubMed

Trau, J M

1994-03-01

If clinicians deem a treatment medically futile, is it appropriate to mention such a treatment to patients? Do healthcare professionals violate informed consent if they do not offer patients an opportunity to decline futile treatments? The notion of futility involves an assessment of patient best interest--both short-term and long-term therapeutic benefit for a patient and the community in which he or she intends to survive and flourish. Although survival interests may be construed as long term, a treatment that offers survival without any promise of flourishing is not the goal of medicine and is futile. Flourishing requires some cognitive and affective function. The goal of informed consent practices is to ensure that patients accept the benefits of treatment with cognizance of the burdens and risks. Given the impact of illness on the emotional and psychological states of patients and their families and their resultant vulnerability, the omission of futile options from treatment plans is logical and exemplifies the best of paternalistic behavior. The claim that requests for futile treatment must be honored is based on a perverse understanding of patient autonomy. Rational medicine demands that patients' requests be reasonable from a clinical perspective, as well as from a subjective one. The practice of informed consent can be implemented as a balance between these two interests.

Informed consent: not just for procedures anymore.

PubMed

Feld, Andrew D

2004-06-01

The ethical and legal requirement to obtain informed consent prior to performing a procedure or administering a treatment derives from the concept of personal (patient) autonomy. The competent patient, after receiving appropriate disclosure of the material risks of the procedure or treatment, understanding those risks, the benefits, and the alternative approaches, makes a voluntary and uncoerced informed decision to proceed. This article will present a general overview of the modern concept of informed consent as a process (mutual communication) rather than an event (document signing). The historical evolution of this concept and the legal rulings that have shaped the requirements of informed consent will be cited. The benefits of informed decision making as a communication and risk management tool are presented. This review is intended as general information, and not as legal advice, which should be sought from a health-care attorney.

Ethical issues with informed consent from potential living kidney donors.

PubMed

Petrini, C

2010-05-01

Living organ donation and participation in clinical research trials have several features in common from an ethical perspective. The primary similarity is risk justification: the risk of harm to living organ donors and clinical research participants is justified by a resulting benefit to one or more other individuals. Some authors hold that organ donation and clinical trial participation are full-fledged duties. Such an implicit likening of the two leads to several considerations regarding informed consent in each situation. Informed consent raises ethical concerns in every medical context, and some of those concerns, such as competence, understanding, autonomy, and free or voluntary choice, are uniquely relevant to living organ donation and clinical trial participation. Most countries regulate informed consent procedures for living organ donation in great detail, and although informed consent procedures for clinical trial participation are somewhat less detailed, their rules are subject to review by ethics committees. It would be constructive for research participation informed consent procedures and living organ donation informed consent procedures to learn from one another. Copyright (c) 2009 Elsevier Inc. All rights reserved.

Disclosure of information and informed consent: ethical and practical considerations.

PubMed

Steinberg, Avraham

2009-12-01

Disclosure of information and informed consent are relatively new concepts in the patient-physician relationship. They are based primarily on the principle of autonomy and they have many favorable practical advantages. However, the practical implementation of these requirements is fraught with difficulties, some of which can cause harm to the patient or be obstacles in fulfilling the moral obligation of beneficence. This is particularly true when disclosure of information and informed consent are done by physicians in a defensive way for fear of malpractice suits. The most ethically defensible approach is to tailor and navigate the information according to the needs and desires of each individual patient in a sensitive and empathic manner. The informed consent should be a process of mutually shared responsibility by the patient and the physician, ensuring adequate and relevant information that is well comprehended by the individual patient, and is used correctly for his or her decision making.

[The doctrine of free and informed consent: its ethical and legal foundations and its applications in research and practice of psychiatry].

PubMed

Grunberg, F

1990-06-01

This article briefly examines the ethical and legal foundations for the doctrine of informed consent in medical research and practice. The doctrine is based upon the importance of respecting the individual's autonomy and his right to self-determination. The article also reviews the development of the doctrine of informed consent based on its recent application. The authors cite the Nuremburg Code and the Helsinki Declarations and particularly the media denunication of several scandals in the United States during the late 1960s, when Henri Beecher's name figured prominently. The effects of informed consent in psychiatry are examined specifically, as well as the consequences for psychiatric research, on subjects who are able to give their consent, as well as those who are unable to do so. As for its effects on clinical practice, the paper discusses the right of the hospitalized patient to refuse treatment, and informed consent and the risks for patients treated with neuroleptics of developing tardive dyskinesia. The authors conclude that in psychotherapy the concept of informed consent cannot be taken for granted.

Intention, autonomy, and brain events.

PubMed

Gillett, Grant

2009-07-01

Informed consent is the practical expression of the doctrine of autonomy. But the very idea of autonomy and conscious free choice is undercut by the view that human beings react as their unconscious brain centres dictate, depending on factors that may or may not be under rational control and reflection. This worry is, however, based on a faulty model of human autonomy and consciousness and needs close neurophilosophical scrutiny. A critique of the ethics implied by the model takes us towards a 'care of the self' view of autonomy and the subject's attunement to the truth as the crux of reasoning rather than the inner mental/neural state views of autonomy and human choice on offer at present.

Informed consent and the law--an English legal perspective.

PubMed

Hassan, Majid

2008-01-01

'Informed consent' is a widely used term, but its application in a legal perspective can be varied. American and Commonwealth jurisdictions have developed a 'patient-based' true informed consent approach, whereas in the English legal system a 'doctor-based' approach has traditionally been applied in relation to disclosure of risk. This article will seek to compare these approaches and give a brief overview of some of the key legal rulings which have shaped the requirement of consent. The decision in the English case of Chester vs. Afshar is considered as showing the significance the court attached to the principle of autonomy and using ethical and policy considerations to depart from established principles of English law relating to consent to treatment and disclosure of risk. This review is intended as general information and not as legal advice which should be sought from defence organisation and specialist health care lawyers. Copyright 2008 S. Karger AG, Basel.

Cardiac imaging modalities with ionizing radiation: the role of informed consent.

PubMed

Paterick, Timothy E; Jan, M Fuad; Paterick, Zachary R; Tajik, A Jamil; Gerber, Thomas C

2012-06-01

Informed consent ideally results in patient autonomy and rational health care decisions. Frequently, patients face complex medical decisions that require a delicate balancing of anticipated benefits and potential risks, which is the concept of informed consent. This balancing process requires an understanding of available medical evidence and alternative medical options, and input from experienced physicians. The informed consent doctrine places a positive obligation on physicians to partner with patients as they try to make the best decision for their specific medical situation. The high prevalence and mortality related to heart disease in our society has led to increased cardiac imaging with modalities that use ionizing radiation. This paper reviews how physicians can meet the ideals of informed consent when considering cardiac imaging with ionizing radiation, given the limited evidence for risks and benefits. The goal is an informed patient making rational choices based on available medical information. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Legal issues surrounding consent and capacity: the key to autonomy.

PubMed

Griffith, Richard; Tengnah, Cassam

2011-12-01

With campaigns from the RCN, Nursing Times and Patients' Association promoting dignity and choice in healthcare district nurses need to be aware of the legal principle that lie at the heart of autonomy, consent. In the first of a series of articles on the principles of patient consent Richard Griffith and Cassam Tengnah outline the elements of a valid consent and how important obtaining consent is to the propriety of a district nurse's practice.

Jehovah's Witnesses and autonomy: honouring the refusal of blood transfusions.

PubMed

Bock, Gregory L

2012-11-01

This paper explores the scriptural and theological reasons given by Jehovah's Witnesses (JWs) to refuse blood transfusions. Julian Savulescu and Richard W Momeyer argue that informed consent should be based on rational beliefs and that the refusal of blood transfusions by JWs is irrational, but after examining the reasons given by JWs, I challenge the claim that JW beliefs are irrational. I also question whether we should give up the traditional notion of informed consent.

Negligence in securing informed consent and medical malpractice.

PubMed

Perry, C

1988-01-01

The doctrine of informed consent requires that the patient must act voluntarily and in the light of adequate information in order to give legally valid consent to medical care. Different models have been developed by various courts to determine whether the informational requirement, what the physician must disclose to the patient about the potential risks of the proposed treatment, has been met under the tort theory of negligence. To prevail, the patient plaintiff must show that a particular jurisdiction's disclosure standard has been breached, that harm has resulted, and that the defendant physician's negligent failure to discuss certain risks was causally responsible for the patient's failure to withhold consent. Perry discusses possible problems of redundancy or inconsistency concerning the relationship between different models for disclosure and causality, and notes that these problems may have serious implications for patient autonomy.

Obstetrics and gynaecology residents' knowledge of the informed consent process and its practice in their training institutions.

PubMed

Okonta, P I

2015-01-01

The ethical principle of autonomy as expressed in the practice of informed consent is a core tenet of clinical practice and good patient physician relationship. The aim was to identify specific gaps in the knowledge of trainee obstetricians and gynecologists in Nigeria about the informed consent process and its content. It also sought to describe the practice of informed consent in their respective institutions. A survey of Residents in obstetrics and gynecology attending the revision course of the Faculty of obstetrics and gynecology of the national postgraduate medical college was done to determine their knowledge of the informed consent process and its practice in their institutions. None of the residents was able to give responses that contained all five conditions for informed consent to be valid. Furthermore, only 3 (2.22%) Residents mentioned that the name of the surgeon to perform the surgery should be part of the information provided to patients during the informed consent process. Similarly, only 8 (5.93%) mentioned that consequences of not having the surgery should be part of the informed consent process. The concept of the 'emancipated minor' being competent to give consent was known by 38% of the residents. Although Residents in obstetrics and gynecology in Nigeria have some knowledge of the informed consent process, this knowledge is deficient in key areas such as competence to give consent, content and scope of information to be disclosed to patients for surgery. There is a need to teach residents the rudiments of informed consent and bioethics in general.

Respecting the autonomy of cancer patients when talking with their families: qualitative analysis of semistructured interviews with patients.

PubMed Central

Benson, J.; Britten, N.

1996-01-01

OBJECTIVE: To discover cancer patients' views about disclosure of information to their family, their family's influence over the information given them, and their preferences for doctors' behaviour if they and their family disagree, as a complement to applied ethical theory. DESIGN: Semistructured interviews followed by qualitative content analysis. SETTING: Mainly urban British general practice. SUBJECTS: 30 patients in whom cancer, excluding basal and squamous cell skin carcinomas, was diagnosed 1-7 years earlier. RESULTS: All subjects wished doctors to respect their views rather than those of their family, should they differ. With their consent, subjects favoured close family receiving information about their illness, all but one mentioning advantage to their family. Without such consent, six unconditionally favoured disclosure of information to their family while seven unconditionally opposed disclosure. Seventeen participants restricted their approval for such disclosure to specific circumstances. Only two participants approved of their family influencing the information that they received about their illness; all but seven wished to receive full information, the exceptions relating to information about bad prognosis. CONCLUSIONS: Subjects favoured openness with their family but most rejected unconditional disclosure of information without their consent and their family influencing what information they would be given. They valued respect for their autonomy more highly than beneficence and considered that their own needs took priority over those of their family. PMID:8819445

Perception on Informed Consent Regarding Nursing Care Practices in a Tertiary Care Center.

PubMed

Paudel, B; Shrestha, G K

Background Consent for care procedures is mandatory after receipt of adequate information. It maintains patient's rights and autonomy to make thoughtful decisions. Poor communication often leads to poor health quality. Objective To assess hospitalized patients' perception on informed consent regarding nursing care practices in a tertiary care center. Method This is a descriptive cross-sectional study among 113 admitted patients conducted in February 2012 at Dhulikhel Hospital, Nepal. Patients of various wards were selected using purposive non-probability sampling with at least 3 days of hospitalization. Close ended structured questionnaire was used to assess patients' perception on three different areas of informed consent (information giving, opportunity to make decision and taking prior consent). Result Among the participants 71.6% perceived positively regarding informed consent towards nursing care practices with a mean score of 3.32 ± 1.28. Patients' perception on various areas of informed consent viz. information giving, opportunities to make specific decision and taking prior consent were all positive with mean values of 3.43±1.12, 2.88±1.23, 3.65±1.49 respectively. Comparison of mean perception of informed consent with various variables revealed insignificant correlation (p-value >0.05) for age, educational level and previous hospitalization while it was significant (p-value < 0.05) for communication skills of nurses. Conclusion Majority of patients have positive perception on informed consent towards nursing care practices. Communication skills of nurses affect the perception of patients' regardless of age, education level and past experiences.

Closing the evidence gap in infectious disease: point-of-care randomization and informed consent.

PubMed

Huttner, A; Leibovici, L; Theuretzbacher, U; Huttner, B; Paul, M

2017-02-01

The informed consent document is intended to provide basic rights to patients but often fails to do so. Patients' autonomy may be diminished by virtue of their illness; evidence shows that even patients who appear to be ideal candidates for understanding and granting informed consent rarely are, particularly those with acute infections. We argue that for low-risk trials whose purpose is to evaluate nonexperimental therapies or other measures towards which the medical community is in a state of equipoise, ethics committees should play a more active role in a more standardized fashion. Patients in the clinic are continually subject to spontaneous 'pseudo-randomizations' based on local dogma and the anecdotal experience of their physicians. Stronger ethics oversight would allow point-of-care trials to structure these spontaneous randomizations, using widely available informatics tools, in combination with opt-out informed consent where deemed appropriate. Copyright © 2016. Published by Elsevier Ltd.

THE PARAMETERS OF INFORMED CONSENT

PubMed Central

Raab, Edward L

2004-01-01

ABSTRACT Purpose To describe the components of a proper informed consent; which risks must be disclosed and which need not; additional safeguards for incapacitated persons, minors, and research subjects; and where the law will imply consent that is not otherwise obtained. Methods Summarization of current law obtained from legal treatises, reports of recent cases, and personal experience as a reviewer and expert. Results Lack of informed consent can reinforce a claim of medical malpractice or serve as an alternative point of attack when the case is otherwise weak. Special requirements must be met when patients are the subjects of clinical research. Conclusion Demonstration of a well-conducted process, not merely of a paper, not only protects the physician from exposure to liability, but increases the patient’s autonomy in decisions concerning health and encourages compliance with treatment. PMID:15747761

Do we need informed consent?

PubMed

Baum, M

1986-10-18

A British surgeon contends that the requirement of informed consent for randomized, controlled clinical trials of alternative therapies would result in a double standard, because physicians are free to conduct informal, unreliable comparisons of different treatments without such a requirement. He asserts that patients' rights are not seriously endangered in trials that are scrutinized by award-granting bodies and local ethics committees to ensure that their aims are to improve quality of care and to increase knowledge. Baum argues that, while informed consent promotes respect for patient autonomy and increases understanding of the illness and treatment, it is chiefly a legalistic device to shift unpleasant physician responsibilities onto the patient and will result in fewer patients entering clinical trials because of negative attitudes induced by uncertainty of treatment and diminished confidence in the physician.

[Physicians and professionalism. Patients and information].

PubMed

Carvallo, Aurelio

2005-02-01

In the present time, the advances in sciences brought by technology are worshiped. This contributes to dehumanize human relationships. Medical profession is a commitment to oneself, society and social justice. Scientific and humanist formation must coexist during the training of new physicians. The main objective of medical profession is the relationship with patients. Patients have acquired increasing autonomy and a deliberative relationship is the closest to the ideal medical action. The relationship must be based in autonomy, beneficence, lack of maleficence and justice. The patient must receive all the information about his ailment and the diagnostic and therapeutic alternatives in a clear and intelligible language. This will allow to obtain a fully conscious informed consent from the patient. Asking for this consent, gives the patient the opportunity to practice his responsibility and to decide the best for him in a friendly and confident environment. In the middle of science and technology, a close contact with ethics and humanism will allow a better understanding of the integrity of subjects, specially when they are ill.

Autonomy in Depressive Patients Undergoing DBS-Treatment: Informed Consent, Freedom of Will and DBS' Potential to Restore It.

PubMed

Beeker, Timo; Schlaepfer, Thomas E; Coenen, Volker A

2017-01-01

According to the World Health Organization, depression is one of the most common and most disabling psychiatric disorders, affecting at any given time approximately 325 million people worldwide. As there is strong evidence that depressive disorders are associated with a dynamic dysregulation of neural circuits involved in emotional processing, recently several attempts have been made to intervene directly in these circuits via deep brain stimulation (DBS) in patients with treatment-resistant major depressive disorder (MDD). Given the promising results of most of these studies, the rising medical interest in this new treatment correlates with a growing sensitivity to ethical questions. One of the most crucial concerns is that DBS might interfere with patients' ability to make autonomous decisions. Thus, the goal of this article is to evaluate the impact DBS presumably has on the capacity to decide and act autonomously in patients with MDD in the light of the autonomy-undermining effects depression has itself. Following the chronological order of the procedure, special attention will first be paid to depression's effects on patients' capacity to make use of their free will in giving valid Informed Consent. We suggest that while the majority of patients with MDD appear capable of autonomous choices, as it is required for Informed Consent, they might still be unable to effectively act according to their own will whenever acting includes significant personal effort. In reducing disabling depressive symptoms like anhedonia and decrease of energy, DBS for treatment resistant MDD thus rather seems to be an opportunity to substantially increase autonomy than a threat to it.

Abortion and informed consent requirements.

PubMed

Kapp, M B

1982-09-01

Supreme Court decisions have liberalized a woman's right to decide whether to obtain an abortion. Some state and local governments have tried to circumvent these decisions by enacting requirements designed to discourage abortions by, among other things, dictating to physicians an elaborate litany of specific information that must be communicated to a patient as a necessary precondition of her informed consent for an abortion. This article discusses the legal status of such requirements, their implications for the professional autonomy of physicians, and the role of the medical profession in challenging these restrictions, on its own behalf and in concert with its patients.

WASP (Write a Scientific Paper): Informed consent in research.

PubMed

Mallia, Pierre

2018-05-03

The autonomy of patients participating in research means that a proper informed consent process must take place. This means that information must be given according to a reasonable person standard implying what legally and ethical a reasonable person participating in the research would want to know. The research must assure that the patient has understood all the information given and that a voluntary choice has been made. This means that no form of coercion must take place and that information must not be manipulated in such a way as to influence the participant. No undue pressure or persuasion must either occur. Particular attention must be paid to vulnerable groups and participants must be competent and have the capacity to consent. Where necessary the use of a proxy to act on behalf of a patient who does not have legal capacity must be used and the best interests of the patient must be asserted. In research consent must always include a signed consent form which again is duly explained and authorized by the research ethics committee. Copyright © 2018. Published by Elsevier B.V.

Informed decision making and abortion: crisis pregnancy centers, informed consent, and the first amendment.

PubMed

Ahmed, Aziza

2015-01-01

Shifting laws and regulations increasingly displace the centrality of women's health concerns in the provision of abortion services. This is exemplified by the growing presence of deceptive Crisis Pregnancy Centers alongside new informed consent laws designed to dissuade women from seeking abortions. Litigation on informed consent is further complicated in the clinical context due to the increased mobilization of facts - such as the gestational age or sonogram of the fetus - delivered with the intent to dissuade women from accessing abortion. In other words, factual information utilized for ideological purpose. To preserve a woman's autonomy and decision-making capacity, there must be a concerted effort on the part of legislators and courts to place a woman's health at the center of abortion law and policy. © 2015 American Society of Law, Medicine & Ethics, Inc.

Avoiding malpractice suits through the use of informed consent.

PubMed

Annas, G J

1976-03-01

The doctrine of informed consent is based on a long tradition of promoting self-autonomy and rational decision-making. The amount of information required to be disclosed by the doctor to the patient is that which permits the patient to decide for himself whether or not to undergo the recommended treatment. It includes information about risks of death or serious bodily harm, probability of success, problems of recuperation, and alternative modes of treatment. Disclosing such information contributes to the doctor-patient relationship and therefore makes recourse to malpractice litigation in the face of an unsatisfactory or untoward result less likely. Attempts to abolish the doctrine are potentially counterproductive and could lead to widespread mistrust of the medical profession on the part of a society that increasingly demands more information in all areas. Physicians will best serve both themselves and their patients by fully disclosing all relevant information before asking patients to consent to specific therapies.

Using a Multimedia Presentation to Enhance Informed Consent in a Pediatric Emergency Department.

PubMed

Spencer, Sandra P; Stoner, Michael J; Kelleher, Kelly; Cohen, Daniel M

2015-08-01

Informed consent is an ethical process for ensuring patient autonomy. Multimedia presentations (MMPs) often aid the informed consent process for research studies. Thus, it follows that MMPs would improve informed consent in clinical settings. The aim of this study was to determine if an MMP for the informed consent process for ketamine sedation improves parental satisfaction and comprehension as compared with standard practice. This 2-phase study compared 2 methods of informed consent for ketamine sedation of pediatric patients. Phase 1 was a randomized, prospective study that compared the standard verbal consent to an MMP. Phase 2 implemented the MMP into daily work flow to validate the previous year's results. Parents completed a survey evaluating their satisfaction of the informed consent process and assessing their knowledge of ketamine sedation. Primary outcome measures were parental overall satisfaction with the informed consent process and knowledge of ketamine sedation. One hundred eighty-four families from a free-standing, urban, tertiary pediatric emergency department with over 85,000 annual visits were enrolled. Different demographics were not associated with a preference for the MMP or improved scores on the content quiz. Intervention families were more likely "to feel involved in the decision to use ketamine" and to understand that "they had the right to refuse the ketamine" as compared with control families. The intervention group scored significantly higher overall on the content section than the control group. Implementation and intervention families responded similarly to all survey sections. Multimedia presentation improves parental understanding of ketamine sedation, whereas parental satisfaction with the informed consent process remains unchanged. Use of MMP in the emergency department for informed consent shows potential for both patients and providers.

Ethical issues in research.

PubMed

Artal, Raul; Rubenfeld, Sheldon

2017-08-01

Biomedical research is currently guided by ethical standards that have evolved over many centuries. Historical and political events, social and legal considerations, and continuous medical and technological advances have led to the prevailing research ethics and practice. Currently, patients and research subjects have complete autonomy while under medical care or when volunteering as research subjects. Enrolling volunteers in human subjects research includes a detailed and meaningful informed consent process that follows the cardinal principles of ethics: autonomy, beneficence, nonmaleficence, and justice. These principles were gradually adopted after World War II, primarily in response to the unethical behavior of German physicians and scientists during the Third Reich. This review emphasizes the importance of historical milestones and the essential role that ethics has in contemporary medical research. Research protocols should achieve maximum benefits for the society, have clinical and scientific value, be subject to independent review, respect human dignity, and follow the principles of informed consent, and most importantly, subjects should have complete autonomy. However, current principles and regulations cannot cover every conceivable situation, particularly in view of the new advances in science and technology. New and evolving medical technology, genetic research, therapeutic interventions, and innovations challenge society to maintain the highest moral and ethical principles. Copyright © 2017. Published by Elsevier Ltd.

Informed consent in psychotherapy.

PubMed

Beahrs, J O; Gutheil, T G

2001-01-01

The authors sought a rational approach to implementing informed consent within the practice of psychotherapy. The history of informed consent in psychotherapy was reviewed to define a common synthesis that maximizes the potential benefits and minimizes the potential hazards. The benefits of informed consent in psychotherapy include fostering a positive treatment outcome through enhancing patient autonomy, responsibility, and self-therapeutic activity; lessening the risks of regressive effects and therapist liability; and helping the practice of psychotherapy extend beyond particular parochialisms by providing checks and balances on therapist judgments. The hazards include the unpredictability of interactional outcomes and the possibilities of replacing positive expectancy with negative suggestion, replacing a therapeutic alliance with a legalistic stance, and misimplying that patients are passive recipients. Practical implementation of informed consent in psychotherapy must balance such tensions in service of optimal treatment. As a guiding principle, the authors recommend that psychotherapists convey to a prospective patient information that is material to the particular patient's decision. The level of detail needed in informed consent discussions varies directly with the cost and risks of the proposed treatment, the presence of viable alternatives and their relative grounding in scientific data and professional acceptance, and the presence of significant controversy. Unresolved is the question of how to address problematic or controversial psychotherapeutic trends that temporarily enjoy wide professional support.

Youth "At Risk"? Young People, Sexual Health and Consent

ERIC Educational Resources Information Center

Powell, Anastasia

2007-01-01

In Australia, there is a growing expectation that sexuality education should reduce the risks associated with youth sex by providing young people with information on protecting their sexual health. However, this information may be insufficient to ensure that young people make choices that support their sexual safety and autonomy. This paper…

A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group

PubMed Central

Bleiberg, H.; Decoster, G.; de Gramont, A.; Rougier, P.; Sobrero, A.; Benson, A.; Chibaudel, B.; Douillard, J. Y.; Eng, C.; Fuchs, C.; Fujii, M.; Labianca, R.; Larsen, A. K.; Mitchell, E.; Schmoll, H. J.; Sprumont, D.; Zalcberg, J.

2017-01-01

Background In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. Methods The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. Results A simplified form of informed consent with the leading part of 1200–1800 words containing all of the key information necessary to meet ethical and regulatory requirements and ‘relevant supportive information appendix’ of 2000–3000 words is provided. Conclusions This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content. PMID:28453700

Cultural aspects related to informed consent in health research: A systematic review.

PubMed

Halkoaho, Arja; Pietilä, Anna-Maija; Ebbesen, Mette; Karki, Suyen; Kangasniemi, Mari

2016-09-01

In order to protect the autonomy of human subjects, we need to take their culture into account when we are obtaining informed consent. This study describes the cultural aspects related to informed consent in health research and is based on electronic searches that were conducted using the Scopus, PubMed, CINAHL, and Cochrane databases published between 2000 and 2013. A total of 25 articles were selected. Our findings indicate that cultural perspectives relating to the informed consent process are essential during the whole research process and particularly crucial in the planning phase of a study. Our study indicates that appropriate communication between different stakeholders plays a vital role in cultural understanding. The researchers' awareness of cultural differences and their ability to work in a culturally sensitive way are key factors in improving study participation and retention in a multicultural context. Taking cultural aspects into account during the whole research process improves the quality of research. © The Author(s) 2015.

The moral agency of institutions: effectively using expert nurses to support patient autonomy.

PubMed

Charles, Sonya

2017-08-01

Patient autonomy-with an emphasis on informed consent and the right to refuse treatment-is a cornerstone of modern bioethics. Within discussions about patient autonomy, feminist bioethicists have argued for a relational approach to autonomy. Under a relational framework, we must look beyond the individual moment of choice to include the role relationships and specific contexts can play in supporting or undermining autonomy. Given the day-to-day interactions they have with patients, nurses play a significant role in helping patients understand the nature of their illnesses and make truly informed decisions. However, the skills of expert nurses also support patient autonomy in more subtle ways. Specifically, nurses develop skills of attunement that help them to find subtle ways to support patient autonomy. However, in order to effectively do this, nurses need institutions that support their professional autonomy. In this paper, I look at the ways nurses have been inhibited in their professional autonomy both as a profession and as individual practitioners. I argue that turning our attention to institutions and the role they play in supporting or undermining nurses' autonomy can help promote nurses' professional autonomy and thereby enhance patient autonomy. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Focusing on relationships, not information, respects autonomy during antenatal consultations.

PubMed

Gaucher, Nathalie; Payot, Antoine

2017-01-01

Policy statements regarding antenatal consultations for preterm labour are guided by physicians' concerns for upholding the legal doctrine of informed consent, through the provision of standardised homogeneous medical information. This approach, led by classical in-control conceptions of patient autonomy, conceives moral agents as rational, independent, self-sufficient decision-makers. Recent studies on these antenatal consultations have explored patients' perspectives, and these differ from guidelines' suggestions. Relational autonomy - which understands moral agents as rational, emotional, creative and interdependent - resonates impressively with these new data. A model for antenatal consultations is proposed. This approach encourages clinicians to explore individual patients' lived experiences and engage in trusting empowering relationships. Moreover, it calls on physicians to enhance patients' relational autonomy by becoming advocates for their patients within healthcare institutions and professional organisations, while calling for broadscale policy changes to encourage further funding and support in investigations of the patient's voice. ©2016 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

Market liberalism in health care: a dysfunctional view of respecting "consumer" autonomy.

PubMed

Kekewich, Michael A

2014-03-01

The unfortunately vast history of paternalism in both medicine and clinical research has resulted in perpetually increasing respect for patient autonomy and free choice in Western health care systems. Beginning with the negative right to informed consent, the principle of respect for autonomy has for many patients evolved into a positive right to request treatments and expect accommodation. This evolution of patient autonomy has mirrored a more general social attitude of market liberalism where increasing numbers of patients have come to embody the role of the "consumer." This paper explores this transformation and critiques the current way in which respect for patient autonomy is put into practice. Ultimately, this paper concludes that the consumer view of patient autonomy is dysfunctional. Moreover, this paper argues that, based on the inherent goals of medicine, some form of paternalism is required in any meaningfully therapeutic relationship.

Autonomy in Depressive Patients Undergoing DBS-Treatment: Informed Consent, Freedom of Will and DBS’ Potential to Restore It

PubMed Central

Beeker, Timo; Schlaepfer, Thomas E.; Coenen, Volker A.

2017-01-01

According to the World Health Organization, depression is one of the most common and most disabling psychiatric disorders, affecting at any given time approximately 325 million people worldwide. As there is strong evidence that depressive disorders are associated with a dynamic dysregulation of neural circuits involved in emotional processing, recently several attempts have been made to intervene directly in these circuits via deep brain stimulation (DBS) in patients with treatment-resistant major depressive disorder (MDD). Given the promising results of most of these studies, the rising medical interest in this new treatment correlates with a growing sensitivity to ethical questions. One of the most crucial concerns is that DBS might interfere with patients’ ability to make autonomous decisions. Thus, the goal of this article is to evaluate the impact DBS presumably has on the capacity to decide and act autonomously in patients with MDD in the light of the autonomy-undermining effects depression has itself. Following the chronological order of the procedure, special attention will first be paid to depression’s effects on patients’ capacity to make use of their free will in giving valid Informed Consent. We suggest that while the majority of patients with MDD appear capable of autonomous choices, as it is required for Informed Consent, they might still be unable to effectively act according to their own will whenever acting includes significant personal effort. In reducing disabling depressive symptoms like anhedonia and decrease of energy, DBS for treatment resistant MDD thus rather seems to be an opportunity to substantially increase autonomy than a threat to it. PMID:28642690

Access to special care dentistry, part 3. Consent and capacity.

PubMed

Dougall, A; Fiske, J

2008-07-26

This article considers what is meant by informed consent and the implications of the Mental Capacity Act in obtaining consent from vulnerable adults. It explores a number of conditions which impact on this task, namely dyslexia, literacy problems and learning disability. The focus on encouraging and facilitating autonomy and the use of the appropriate level of language in the consent giving process ensures that consent is valid. The use of appropriate methods to facilitate communication with individuals in order to be able to assess capacity and ensure that any treatment options that are chosen on their behalf are in their best interests are outlined. The use of physical intervention in special care dentistry in order to provide dental care safely for both the patient and the dental team is also considered.

Patients as Rights Holders.

PubMed

Brännmark, Johan

2017-07-01

Autonomy and consent have been central values in Western moral and political thought for centuries. One way of understanding the bioethical models that started to develop, especially in the 1970s, is that they were about the fusion of a long-standing professional ethics with the core values underpinning modern political institutions. That there was a need for this kind of fusion is difficult to dispute, especially since the provision of health care has in most developed countries become an ever more important concern of our political institutions, with governments playing a significant role in regulating and facilitating the provision of health care and in many countries even largely organizing it. There is, nevertheless, still room for dispute about how best to achieve this fusion and how to best think about autonomy and consent in a biomedical context. The simplest model we can have is probably about how being a person is largely about having the capacity of autonomous choice and that the main mode through which we exercise autonomy is by providing informed consent. Yet, liberal democracy's core idea that human beings have a high and equal value is also found in other accounts of the person. The human-rights framework provides an alternative model for thinking about personhood and about patient care. The human-rights approach is grounded, not in an account of autonomy (although it has something to say about autonomy), but in an account of the moral and political personhood that people possess merely by being human beings. In this approach, values like dignity and integrity, both highly relevant in a bioethical context, are identified as distinct values rather than being derived from and therefore reduced to respect for autonomous choice. The human-rights approach can supplement the problematic notion of autonomy that has been central to bioethics by placing this notion in a broader, strongly pluralistic framework. © 2017 The Hastings Center.

77 FR 70440 - Hertz Global Holdings, Inc.; Analysis of Agreement Containing Consent Orders To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-26

... state identification number or foreign country equivalent, passport number, financial account number, or... information. In addition, do not include any ``[t]rade secret or any commercial or financial information which... convenience, autonomy, or cost efficiency of renting a car, and, as a practical matter, customers are unlikely...

Ethical principles of informed consent: exploring nurses' dual role of care provider and researcher.

PubMed

Judkins-Cohn, Tanya M; Kielwasser-Withrow, Kiersten; Owen, Melissa; Ward, Jessica

2014-01-01

This article describes the ethical principles of autonomy, beneficence, and justice within the nurse researcher-participant relationship as these principles relate to the informed consent process for research. Within this process, the nurse is confronted with a dual role. This article describes how nurses, who are in the dual role of care provider and researcher, can apply these ethical principles to their practice in conjunction with the American Nurses Association's code of ethics for nurses. This article also describes, as an element of ethical practice, the importance of using participant-centered quality measures to aid informed decision making of participants in research. In addition, the article provides strategies for improving the informed consent process in nursing research. Finally, case scenarios are discussed, along with the application of ethical principles within the awareness of the dual role of the nurse as care provider and researcher. Copyright 2014, SLACK Incorporated.

Considerations of informed consent and decision-making competence in older adults with cognitive impairment.

PubMed

Mayo, Ann M; Wallhagen, Margaret I

2009-04-01

Including older adults with cognitive impairment in research studies is necessary to ensure that interventions designed to improve care are effective for all older adults. However, issues related to capacity to consent raise many difficult questions that nurse researchers must address. Protecting vulnerable participants while simultaneously maintaining autonomy and moving important research forward can be challenging. Assessing the decision-making abilities of understanding, appreciation, reasoning, and expressing a choice is an important aspect of determining decision-making capacity. Yet although this is the prominent rational method for judging decision-making competence, it does not take into consideration the importance of culture, values, and emotions. This article focuses on the assessment of decision-making capacity to consent, recommendations for obtaining informed consent in older adults with cognitive impairment, the use of surrogate decision makers, strategies to maximize research participation, and directions for future research. Copyright 2009, SLACK Incorporated.

How do clinical genetics consent forms address the familial approach to confidentiality and incidental findings? A mixed-methods study.

PubMed

Dheensa, Sandi; Crawford, Gillian; Salter, Claire; Parker, Michael; Fenwick, Angela; Lucassen, Anneke

2018-01-01

Genetic test results can be relevant to patients and their relatives. Questions thus arise around whether clinicians regard genetic information as confidential to individuals or to families, and about how they broach this and other issues, including the potential for incidental findings, in consent (forms) for genetic testing. We conducted a content analysis of UK-wide genetic testing consent forms and interviewed 128 clinicians/laboratory scientists. We found that almost all genetic services offered patients multiple, sometimes unworkable, choices on forms, including an option to veto the use of familial genetic information to benefit relatives. Participants worried that documented choices were overriding professional judgement and cautioned against any future forms dictating practice around incidental findings. We conclude that 'tick-box' forms, which do little to enhance autonomy, are masking valid consent processes in clinical practice. As genome-wide testing becomes commonplace, we must re-consider consent processes, so that they protects patients'-and relatives'-interests.

Cultural competency, autonomy, and spiritual conflicts related to Reiki/CAM therapies: Should patients be informed?

PubMed Central

Arvonio, Maria Marra

2014-01-01

The use of complementary and alternative medicines (CAM) such as Reiki is on the rise in healthcare centers. Reiki is associated with a spirituality that conflicts with some belief systems. Catholic healthcare facilities are restricted from offering this therapy because it conflicts with the teachings of the Catholic Church. However, hospitals are offering it without disclosing the spiritual aspects of it to patients. This article will address the ethical concerns and possible legal implications associated with the present process of offering Reiki. It will address these concerns based on the Joint Commission's Standard of Cultural Competency and the ethical principles of autonomy and informed consent. A proposal will also be introduced identifying specific information which Reiki/CAM practitioners should offer to their patients out of respect of their autonomy as well as their cultural, spiritual, and religious beliefs. PMID:24899738

[Consent and confidentiality in occupational health practice: balance between legal requirements and ethical values].

PubMed

Mora, Erika; Franco, G

2010-01-01

The recently introduced Italian law on the protection of workers' health states that the occupational health physician (competent physician) is required to act according to the Code of Ethics of the International Commission on Occupational Health (ICOH). This paper aims at examining the articles of legislative decree 81/2008 dealing with informed consent and confidentiality compared with the corresponding points of the ICOH Ethics Code. Analysis of the relationship between articles 25 and 39 (informed consent) and 18, 20 and 39 (confidentiality) of the decree shows that there are some points of disagreement between the legal requirements and the Code of Ethics, in particular concerning prescribed health surveillance, consent based on appropriate information (points 8, 10 and 12 of the Code) and some aspects of confidentiality (points 10, 20, 21, 22 and 23 of the Code). Although the competent physician is required to act according to the law, the decisional process could lead to a violation of workers' autonomy.

A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group.

PubMed

Bleiberg, H; Decoster, G; de Gramont, A; Rougier, P; Sobrero, A; Benson, A; Chibaudel, B; Douillard, J Y; Eng, C; Fuchs, C; Fujii, M; Labianca, R; Larsen, A K; Mitchell, E; Schmoll, H J; Sprumont, D; Zalcberg, J

2017-05-01

In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. A simplified form of informed consent with the leading part of 1200-1800 words containing all of the key information necessary to meet ethical and regulatory requirements and 'relevant supportive information appendix' of 2000-3000 words is provided. This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Informed consent needed for sterilization or research.

PubMed

Barnett, B

1998-01-01

Informed choice involves enabling family planning clients to base their decisions about contraceptive use upon adequate information. It is a process in which clients give their permission to undergo a procedure, take a medication, or participate in a study after being fully informed. Informed consent protects an individual's freedom of choice, respects his or her autonomy, is important in both family planning programs and reproductive health research, and should always be available to clients seeking health services. Although written informed consent is not needed for most reproductive health services, it should be obtained from men and women who undergo sterilization, since that involves surgery and is considered permanent. In addition, people who volunteer to participate in contraceptive studies need to be fully informed of the risks and benefits of any new drugs or devices they receive. Volunteers should understand the potential effects of methods upon their physical health and other aspects of their lives. Ethical reviews need to be conducted before research begins.

Do Research Intermediaries Reduce Perceived Coercion to Enter Research Trials Among Criminally Involved Substance Abusers?

PubMed

Festinger, David S; Dugosh, Karen L; Croft, Jason R; Arabia, Patricia L; Marlowe, Douglas B

2011-01-01

We examined the efficacy of including a research intermediary (RI) during the consent process in reducing participants' perceptions of coercion to enroll in a research study. Eighty-four drug court clients being recruited into an ongoing study were randomized to receive a standard informed consent process alone (standard condition) or with an RI (intermediary condition). Before obtaining consent, RIs met with clients individually to discuss remaining concerns. Findings provided preliminary evidence that RIs reduced client perceptions that their participation might influence how clinical and judicial staff view them. This suggests that using RIs may improve participant autonomy in clinical studies.

Do Research Intermediaries Reduce Perceived Coercion to Enter Research Trials Among Criminally Involved Substance Abusers?

PubMed Central

Festinger, David S.; Dugosh, Karen L.; Croft, Jason R.; Arabia, Patricia L.; Marlowe, Douglas B.

2011-01-01

We examined the efficacy of including a research intermediary (RI) during the consent process in reducing participants’ perceptions of coercion to enroll in a research study. Eighty-four drug court clients being recruited into an ongoing study were randomized to receive a standard informed consent process alone (standard condition) or with an RI (intermediary condition). Before obtaining consent, RIs met with clients individually to discuss remaining concerns. Findings provided preliminary evidence that RIs reduced client perceptions that their participation might influence how clinical and judicial staff view them. This suggests that using RIs may improve participant autonomy in clinical studies. PMID:22081751

Autism, intellectual disability, and a challenge to our understanding of proxy consent.

PubMed

Graber, Abraham

2017-06-01

This paper focuses on a hypothetical case that represents an intervention request familiar to those who work with individuals with intellectual disability. Stacy has autism and moderate intellectual disability. Her parents have requested treatment for her hand flapping. Stacy is not competent to make her own treatment decisions; proxy consent is required. There are three primary justifications for proxy consent: the right to an open future, substituted judgment, and the best interest standard. The right to an open future justifies proxy consent on the assumption of future autonomy whereas substituted judgment justifies proxy consent via reference to past autonomy. Neither applies. Stacy has not been, nor will she be, competent to make her own treatment decisions. The best interest standard justifies proxy consent on the grounds of beneficence. It is unlikely that hand flapping harms Stacy. None of the three primary means of justifying proxy consent apply to Stacy's case.

Informed consent and decision-making about adult-to-adult living donor liver transplantation: a systematic review of empirical research.

PubMed

Gordon, Elisa J; Daud, Amna; Caicedo, Juan Carlos; Cameron, Kenzie A; Jay, Colleen; Fryer, Jonathan; Beauvais, Nicole; Skaro, Anton; Baker, Talia

2011-12-27

Adult-to-adult living donor liver transplantation (LDLT) is a complex procedure that poses serious health risks to and provides no direct health benefit for the donor. Because of this uneven risk-benefit ratio, ensuring donor autonomy through informed consent is critical. To assess the current knowledge pertaining to informed consent for LDLT, we conducted a systematic review of the empirical literature on donors' decision-making process, comprehension about risks and outcomes, and information needs for LDLT. Of the 1423 identified articles, 24 met final review criteria, representing the perspective of approximately 2789 potential and actual donors. As donors' decisions to donate often occur before evaluation, they often make uninformed decisions. The review found that 88% to 95% of donors reported understanding information clinicians disclosed about risks and benefits. However, donors reported unmet information needs, knowledge gaps regarding risks, and unanticipated complications. Few donors reported feeling pressure to donate. Most studies were limited by cultural differences, small sample sizes, inconsistent measures, and poor methodological approaches. This systematic review suggests that informed consent for LDLT is sub-optimal as donors do not adequately appreciate disclosed information during the informed consent process, despite United Network for Organ Sharing/CMS regulations requiring formal psychological evaluation of donor candidates. Interventions are needed to improve donor-clinician communication during the LDLT informed consent process such as through the use of comprehension assessment tools and e-health educational tools that leverage adult learning theory to effectively convey LDLT outcome data.

Is ‘informed consent’ an ‘understood consent’ in hematopoietic cell transplantation?

PubMed Central

D'Souza, A; Pasquini, M; Spellecy, R

2015-01-01

Hematopoietic cell transplantation (HCT) is a complex and highly specialized medical treatment that is associated with significant risks, including death. Furthermore, transplantation is offered to patients who often have no other curative treatment alternatives. The routine-consent process for HCT typically occurs before HCT and is influenced by many factors related to patients, physicians and the transplant per se. These factors can impede the consent process and subsequently result in a failure of proper engagement in and an understanding of the procedure with resultant adverse consequences influencing patients and even the patient–physician relationship. We contend that informed consent is a dynamic and ongoing process and that better patient education can assist in the decision making, fulfill the ethical principle of respect for autonomy and engage the patient to maximize compliance and adherence to therapy. This manuscript reviews the key literature pertaining to the decision-making and consent process in HCT and proposes guidelines for improving the consent process. Strategies for improving patient comprehension, engagement and enhancing consent forms are discussed. PMID:25243618

Patient Autonomy in Talmudic Context: The Patient's "I Must Eat" on Yom Kippur in the Light of Contemporary Bioethics.

PubMed

Berger, Zackary; Cahan, Rabbi Joshua

2016-10-01

In contemporary bioethics, the autonomy of the patient has assumed considerable importance. Progressing from a more limited notion of informed consent, shared decision making calls upon patients to voice the desires and preferences of their authentic self, engaging in choice among alternatives as a way to exercise deeply held values. One influential opinion in Jewish bioethics holds that Jewish law, in contradistinction to secular bioethics, limits the patient's exercise of autonomy only in those instances in which treatment choices are sensitive to preferences. Here, we analyze a discussion in the Mishna, a foundational text of rabbinic Judaism, regarding patient autonomy in the setting of religiously mandated fasting, and commentaries in the Babylonian and Palestinian Talmuds, finding both a more expansive notion of such autonomy and a potential metaphysical grounding for it in the importance of patient self-knowledge.

ACOG Committee Opinion No. 306. Informed refusal.

PubMed

2004-12-01

Informed refusal is a fundamental component of the informed consent process. Informed consent laws have evolved to the "materiality or patient viewpoint" standard. A physician must disclose to the patient the risks, benefits, and alternatives that a reasonable person in the patient's position would want to know to make an informed decision. Throughout this process, the patient's autonomy, level of health literacy, and cultural background should be respected. The subsequent election by the patient to forgo an intervention that has been recommended by the physician constitutes informed refusal. Documentation of the informed refusal process is essential. It should include a notation that the need for the intervention, as well as risks, benefits, and alternatives to the intervention, and possible consequences of refusal, have been explained. The patient's reason for refusal also should be documented.

Healthcare professionals' and patients' perspectives on consent to clinical genetic testing: moving towards a more relational approach.

PubMed

Samuel, Gabrielle Natalie; Dheensa, Sandi; Farsides, Bobbie; Fenwick, Angela; Lucassen, Anneke

2017-08-08

This paper proposes a refocusing of consent for clinical genetic testing, moving away from an emphasis on autonomy and information provision, towards an emphasis on the virtues of healthcare professionals seeking consent, and the relationships they construct with their patients. We draw on focus groups with UK healthcare professionals working in the field of clinical genetics, as well as in-depth interviews with patients who have sought genetic testing in the UK's National Health Service (data collected 2013-2015). We explore two aspects of consent: first, how healthcare professionals consider the act of 'consenting' patients; and second how these professional accounts, along with the accounts of patients, deepen our understanding of the consent process. Our findings suggest that while healthcare professionals working in genetic medicine put much effort into ensuring patients' understanding about their impending genetic test, they acknowledge, and we show, that patients can still leave genetic consultations relatively uninformed. Moreover, we show how placing emphasis on the informational aspect of genetic testing is not always reflective of, or valuable to, patients' decision-making. Rather, decision-making is socially contextualised - also based on factors outside of information provision. A more collaborative on-going consent process, grounded in virtue ethics and values of honesty, openness and trustworthiness, is proposed.

Patient and Physician Views about Protocolized Dialysis Treatment in Randomized Trials and Clinical Care

PubMed Central

Kraybill, Ashley; Dember, Laura M.; Joffe, Steven; Karlawish, Jason; Ellenberg, Susan S.; Madden, Vanessa; Halpern, Scott D.

2016-01-01

Background Pragmatic trials comparing standard-of-care interventions may improve the quality of care for future patients, but raise ethical questions about limitations on decisional autonomy. We sought to understand how patients and physicians view and respond to these questions in the contexts of pragmatic trials and of usual clinical care. Methods We conducted scenario-based, semi-structured interviews with 32 patients with end-stage renal disease (ESRD) receiving maintenance hemodialysis in outpatient dialysis units and with 24 nephrologists. Each participant was presented with two hypothetical scenarios in which a protocolized approach to hemodialysis treatment time was adopted for the entire dialysis unit as part of a clinical trial or a new clinical practice. Results A modified grounded theory analysis revealed three major themes: 1) the value of research, 2) the effect of protocolized care on patient and physician autonomy, and 3) information exchange between patients and physicians, including the mechanism of consent. Most patients and physicians were willing to relinquish decisional autonomy and were more willing to relinquish autonomy for research purposes than in clinical care. Patients’ concerns towards clinical trials were tempered by their desires for certainty for a positive outcome and for physician validation. Patients tended to believe that being informed about research was more important than the actual mechanism of consent, and most were content with being able to opt out from participating. Conclusions This qualitative study suggests the general acceptability of a pragmatic clinical trial comparing standard-of-care interventions that limits decisional autonomy for nephrologists and patients receiving hemodialysis. Future studies are needed to determine whether similar findings would emerge among other patients and providers considering other standard-of-care trials. PMID:27833931

Patient and Physician Views about Protocolized Dialysis Treatment in Randomized Trials and Clinical Care.

PubMed

Kraybill, Ashley; Dember, Laura M; Joffe, Steven; Karlawish, Jason; Ellenberg, Susan S; Madden, Vanessa; Halpern, Scott D

2016-01-01

Pragmatic trials comparing standard-of-care interventions may improve the quality of care for future patients, but raise ethical questions about limitations on decisional autonomy. We sought to understand how patients and physicians view and respond to these questions in the contexts of pragmatic trials and of usual clinical care. We conducted scenario-based, semi-structured interviews with 32 patients with end-stage renal disease (ESRD) receiving maintenance hemodialysis in outpatient dialysis units and with 24 nephrologists. Each participant was presented with two hypothetical scenarios in which a protocolized approach to hemodialysis treatment time was adopted for the entire dialysis unit as part of a clinical trial or a new clinical practice. A modified grounded theory analysis revealed three major themes: 1) the value of research, 2) the effect of protocolized care on patient and physician autonomy, and 3) information exchange between patients and physicians, including the mechanism of consent. Most patients and physicians were willing to relinquish decisional autonomy and were more willing to relinquish autonomy for research purposes than in clinical care. Patients' concerns towards clinical trials were tempered by their desires for certainty for a positive outcome and for physician validation. Patients tended to believe that being informed about research was more important than the actual mechanism of consent, and most were content with being able to opt out from participating. This qualitative study suggests the general acceptability of a pragmatic clinical trial comparing standard-of-care interventions that limits decisional autonomy for nephrologists and patients receiving hemodialysis. Future studies are needed to determine whether similar findings would emerge among other patients and providers considering other standard-of-care trials.

Challenges of Obtaining Informed Consent in Emergency Ward: A Qualitative Study in One Iranian Hospital

PubMed Central

Davoudi, Nayyereh; Nayeri, Nahid Dehghan; Zokaei, Mohammad Saeed; Fazeli, Nematallah

2017-01-01

Background and Objective: Regarding the fact that emergency ward has unique characteristics, whose uniqueness affects informed consent processes by creating specific challenges. Hence, it seems necessary to identify the process and challenges of informed consent in the emergency ward through a qualitative study to understand actual patients’ and health care providers’ experiences, beliefs, values, and feelings about the informed consent in the emergency ward. Through such studies, new insight can be gained on the process of informed consent and its challenges with the hope that the resulting knowledge will enable the promotion of ethical, legal as well as effective health services to the patients in the emergency ward. Method: In this qualitative study, research field was one of the emergency wards of educational and public hospitals in Iran. Field work and participant observation were carried out for 515 hours from June 2014 to March 2016. Also, conversations and semi-structured interviews based on the observations were conducted. The participants of the study were nurses and physicians working in the emergency ward, as well as patients and their attendants who were involved in the process of obtaining informed consent. Results: Three main categories were extracted from the data: a sense of frustration; reverse protection; and culture of paternalism in consent process. Conclusion: Findings of this study can be utilized in correcting the structures and processes of obtaining informed consent together with promotion of patients' ethical and legal care in emergency ward. In this way, the approaches in consent process will be changed from paternalistic approach to patient-centered care which concomitantly protects patient’s autonomy. PMID:29399235

Patient decision making competence: outlines of a conceptual analysis.

PubMed

Welie, J V; Welie, S P

2001-01-01

In order to protect patients against medical paternalism, patients have been granted the right to respect of their autonomy. This right is operationalized first and foremost through the phenomenon of informed consent. If the patient withholds consent, medical treatment, including life-saving treatment, may not be provided. However, there is one proviso: The patient must be competent to realize his autonomy and reach a decision about his own care that reflects that autonomy. Since one of the most important patient rights hinges on the patient's competence, it is crucially important that patient decision making incompetence is clearly defined and can be diagnosed with the greatest possible degree of sensitivity and, even more important, specificity. Unfortunately, the reality is quite different. There is little consensus in the scientific literature and even less among clinicians and in the law as to what competence exactly means, let alone how it can be diagnosed reliably. And yet, patients are deemed incompetent on a daily basis, losing the right to respect of their autonomy. In this article, we set out to fill that hiatus by beginning at the very beginning, the literal meaning of the term competence. We suggest a generic definition of competence and derive four necessary conditions of competence. We then transpose this definition to the health care context and discuss patient decision making competence.

[The law of March 5, 2007 and the care of persons placed under guardianship].

PubMed

Modot, Matthieu; Rougé-Maillart, Clotilde

2018-04-01

The care of persons placed under guardianship has changed considerably since the law of March 5, 2007, as greater autonomy is granted to them. By advocating greater autonomy of protected adults, the French Civil Code is in opposition with the French Public Health Code since the latter states that the systematic consent of the guardian is required in addition to that of the protected adult for so-called general care. In cases of serious injury to bodily integrity, the guardianship judge's opinion must be sought by the guardian. For some specific medical procedures (medically assisted procreation, abortion, etc.), the consent of the guardian does not seem necessary. A protected adult can now, if he/she is able to understand the information, with the agreement of the guardianship judge or the family council, appoint a trusted person and draft advance directives without possible representation by the guardian. The legislator promotes greater autonomy while not neglecting their protection. It also helps relieve the guardian, who is generally trained in asset management, of sometimes difficult medical decisions. Harmony between the Civil Code and the Public Health Code seems essential so as to move towards greater autonomy of the person under guardianship in the care relationship. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

[Informed consent process in clinical trials: Insights of researchers, patients and general practitioners].

PubMed

Giménez, Nuria; Pedrazas, David; Redondo, Susana; Quintana, Salvador

2016-10-01

Adequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP. A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports. GPs, researchers and patients involved in clinical trials. Included, 504 GPs, 108 researchers, and 71 patients. Consulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection. GPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

Informed consent in human experimentation before the Nuremberg code.

PubMed

Vollmann, J; Winau, R

1996-12-07

The issue of ethics with respect to medical experimentation in Germany during the 1930s and 1940s was crucial at the Nuremberg trials and related trials of doctors and public health officials. Those involved in horrible crimes attempted to excuse themselves by arguing that there were no explicit rules governing medical research on human beings in Germany during the period and that research practices in Germany were not different from those in allied countries. In this context the Nuremberg code of 1947 is generally regarded as the first document to set out ethical regulations in human experimentation based on informed consent. New research, however, indicates that ethical issues of informed consent in guidelines for human experimentation were recognised as early as the nineteenth century. These guidelines shed light on the still contentious issue of when the concepts of autonomy, informed consent, and therapeutic and non-therapeutic research first emerged. This issue assumes renewed importance in the context of current attempts to assess liability and responsibility for the abuse of people in various experiments conducted since the second world war in the United States, Canada, Russia, and other nations.

Coercion, incarceration, and chemical castration: an argument from autonomy.

PubMed

Douglas, Thomas; Bonte, Pieter; Focquaert, Farah; Devolder, Katrien; Sterckx, Sigrid

2013-10-01

In several jurisdictions, sex offenders may be offered chemical castration as an alternative to further incarceration. In some, agreement to chemical castration may be made a formal condition of parole or release. In others, refusal to undergo chemical castration can increase the likelihood of further incarceration though no formal link is made between the two. Offering chemical castration as an alternative to further incarceration is often said to be partially coercive, thus rendering the offender's consent invalid. The dominant response to this objection has been to argue that any coercion present in such cases is compatible with valid consent. In this article, we take a different tack, arguing that, even if consent would not be valid, offering chemical castration will often be supported by the very considerations that underpin concerns about consent: considerations of autonomy. This is because offering chemical castration will often increase the offender's autonomy, both at the time the offer is made and in the future.

Patients’ perceived purpose of clinical informed consent: Mill’s individual autonomy model is preferred

PubMed Central

2014-01-01

Background Although informed consent is an integral part of clinical practice, its current doctrine remains mostly a matter of law and mainstream ethics rather than empirical research. There are scarce empirical data on patients’ perceived purpose of informed consent, which may include administrative routine/courtesy gesture, simple honest permission, informed permission, patient-clinician shared decision-making, and enabling patient’s self decision-making. Different purposes require different processes. Methods We surveyed 488 adults who were planning to undergo or had recently undergone written informed consent-requiring procedures. Perceptions of informed consent purpose (from norm and current practice perspectives) were explored by asking respondents to rank (1 = most reflective) 10 randomly-presented statements: “meaningless routine”, “courtesy gesture” “litigation protection”, “take away compensation rights”, “inform patient’, “make sure patient understand”, “document patient’s decision”, “discover patient’s preferences”, “have shared decision”, and “help patient decide”. Results Respondents’ mean (SD) age was 38.3 (12.5); 50.4% were males, 56.8% had ≥ college education, and 37.3% had undergone a procedure. From the norm perspective, the least reflective statement was “meaningless routine” (ranked 1–3 by 2.6% of respondents) and the most reflective statements were “help patient decide”, “make sure patient understand”, and “inform patient” (ranked 1–3 by 65%, 60%, and 48% of respondents with median [25%,75%] ranking scores of 2 [1,5], 3 [2,4], and 4 [2,5], respectively). Compared to their counterparts, males and pre-procedure respondents ranked “help patient decide” better, whereas females and post-procedure respondents ranked “inform patient” better (p = 0.007 to p < 0.001). Age was associated with better ranking of “help patient decide” and “make sure patient understand” statements (p < 0.001 and p = 0.002, respectively), which were ranked 1–3 by only 46% and 42% of respondents from the current practice perspective (median ranking score 4 [2,6], p < 0.001 vs. norm perspective for both). Conclusions 1) the informed consent process is important to patients, however, patients vary in their views of its purpose with the dominant view being enabling patients’ self decision-making, 2) males, pre-procedure, and older patients more favor a self decision-making purpose, whereas females and post-procedure patients more favor an information disclosure purpose, and 3) more self decision-making and more effective information disclosure than is currently practiced are desired. An informed consent process consistent with Mill’s individual autonomy model may be suitable for most patients. PMID:24406020

Placebo Effects and Informed Consent.

PubMed

Alfano, Mark

2015-01-01

The concepts of placebos and placebo effects refer to extremely diverse phenomena. I recommend dissolving the concepts of placebos and placebo effects into loosely related groups of specific mechanisms, including (potentially among others) expectation-fulfillment, classical conditioning, and attentional-somatic feedback loops. If this approach is on the right track, it has three main implications for the ethics of informed consent. First, because of the expectation-fulfillment mechanism, the process of informing cannot be considered independently from the potential effects of treatment. Obtaining informed consent influences the effects of treatment. This provides support for the authorized concealment and authorized deception paradigms, and perhaps even for outright deceptive placebo use. Second, doctors may easily fail to consider the potential benefits of conditioning, leading them to misjudge the trade-off between beneficence and autonomy. Third, how attentional-somatic feedback loops play out depends not only on the content of the informing process but also on its framing. This suggests a role for libertarian paternalism in clinical practice.

Informed consent for blood tests in people with a learning disability.

PubMed

Goldsmith, Lesley; Woodward, Val; Jackson, Leigh; Skirton, Heather

2013-09-01

This article is a report of a study of informed consent in people with a learning disability. The aims of the study were to explore the information needs of people with mild-to-moderate learning disabilities with respect to consent for blood tests and to identify ways of facilitating informed consent. The recent political agenda for social change in the UK has emphasized the right of people with a learning disability to have more autonomy and make their own decisions. As in other countries, there has also been a shift towards shared decision-making in healthcare practice. Qualitative study using an ethnographic approach. An ethnographic approach was used for this qualitative study. Phase 1 involved observation of six participants with a learning disability having a routine blood test in general practice, followed by semi-structured interviews with 14 participants with a learning disability in Phase 2. Data were collected between February 2009-February 2010. The data showed that consent procedures were often inadequate and provision of information to patients prior to a blood test was variable. People with a learning disability expressed clearly their information requirements when having a routine blood test; this included not wanting any information in some cases. Healthcare practitioners and people with a learning disability need to be familiar with current consent law in their own country to facilitate valid consent in the healthcare context. This study demonstrated the value of qualitative research in exploring the knowledge and attitudes of people with learning disability. © 2012 Blackwell Publishing Ltd.

Notes on patients with disabilities autonomy in Spanish law.

PubMed

Arcos, María Luisa

2013-12-01

The U.N. Convention on the Rights of Persons with Disabilities recognizes as the first of its general principles the "Respect for inherent dignity, individual autonomy including the freedom to make one's own choice, and independence of persons" (Art.3.a). With regard to health, States Parties recognize that persons with disabilities have the right to the enjoyment of the highest attainable standard of health without being discriminated on the basis of disability (Article 25), which includes requiring health professionals to provide care of the same quality to persons with disabilities as to others, including on the basis of free and informed consent (subsection d).These guidelines must enlighten the interpretation of the Spanish legal system as for the scope of autonomy of people with disabilities. Nevertheless, they still bear some handicaps in order to preserve their autonomy from third-party interferences.

The Ethics of Information: Absolute Risk Reduction and Patient Understanding of Screening

PubMed Central

Meslin, Eric M.

2008-01-01

Some experts have argued that patients should routinely be told the specific magnitude and absolute probability of potential risks and benefits of screening tests. This position is motivated by the idea that framing risk information in ways that are less precise violates the ethical principle of respect for autonomy and its application in informed consent or shared decision-making. In this Perspective, we consider a number of problems with this view that have not been adequately addressed. The most important challenges stem from the danger that patients will misunderstand the information or have irrational responses to it. Any initiative in this area should take such factors into account and should consider carefully how to apply the ethical principles of respect for autonomy and beneficence. PMID:18421509

Montgomery, informed consent and causation of harm: lessons from Australia or a uniquely English approach to patient autonomy?

PubMed

Smith, Malcolm K; Carver, Tracey

2018-06-01

The UK Supreme Court in Montgomery v Lanarkshire Health Board adopts an approach to information disclosure in connection with clinical treatment that moves away from medical paternalism towards a more patient-centred approach. In doing so, it reinforces the protection afforded to informed consent and autonomous patient decision making under the law of negligence. However, some commentators have expressed a concern that the widening of the healthcare providers' duty of disclosure may provide impetus, in future cases, for courts to adopt a more rigorous approach to the application of causation principles. The aim would be to limit liability but, in turn, it would also limit autonomy protection. Such a restrictive approach has recently been adopted in Australia as a result of the High Court decision in Wallace v Kam This paper considers whether such an approach is likely under English negligence law and discusses case law from both jurisdictions in order to provide a point of comparison from which to scope the post- Montgomery future. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Pediatric Issues in Return of Results and Incidental Findings: Weighing Autonomy and Best Interests.

PubMed

Holm, Ingrid A

2017-03-01

Nowhere are the ethical issues in genomic research more complex than in pediatrics. Balancing the sometime conflicting autonomy of the parent and the child, and the best interest of the family and the child, brings up many challenging issues. Addressing this balance, especially in the context of the child's developing maturity and comprehension, requires deep analysis and discussion. Issues discussed include the impact of genetic information on the family, parental versus the child's autonomy, the best interests of the child versus the family, potential limitations on the parents' right to know or not know information about their child, and changing role of the developing child in return of research results. Finally, a dynamic model will be proposed that takes into consideration the child's evolving role in consenting and return of results that can be adapted in different national contexts.

Local attitudes, moral obligation, customary obedience and other cultural practices: their influence on the process of gaining informed consent for surgery in a tertiary institution in a developing country.

PubMed

Irabor, David O; Omonzejele, Peter

2009-04-01

The process of obtaining informed consent in a teaching hospital in a developing country (e.g. Nigeria) is shaped by factors which, to the Western world, may be seen to be anti-autonomous: autonomy being one of the pillars of an ideal informed consent. However, the mix of cultural bioethics and local moral obligation in the face of communal tradition ensures a mutually acceptable informed consent process. Paternalism is indeed encouraged by the patients who prefer to see the doctor as all-powerful and all-knowing, and this is buttressed by the cultural practice of customary obedience to those 'above you': either in age or social rank. The local moral obligation reassures the patients that those in authority will always look after others placed in their care without recourse to lengthy discussions or signed documentation, while the communal traditions ensure that the designated head of a family unit has the honor and sole responsibility of assenting and consenting to an operation to be carried out on a younger, or female, member of the family. Indeed it is to only a few educated patients that the informed consent process is deemed a shield against litigation by the doctors. This paper later addresses the need for physicians to update their knowledge on the process of informed consent through the attendance of biomedical ethics courses, which should highlight socio-cultural practices that may make this process different from the Western concept, but perfectly acceptable in this setting.

[Deferred consent for inclusion of patients unable to give their consent in studies in the field of emergency medicine].

PubMed

Kompanje, E J O; Jansen, T C; Le Noble, J L M L; de Geus, H R; Bakker, J

2008-09-20

Respect for individual autonomy, expressed in the concept of informed consent, is a basic principle in research with humans. Many patients in intensive care are unable to give consent because of mental incapacity, and this can be further complicated in emergency research, in which the treatment or experiment needs to be initiated without delay. In those situations consent can be deferred. Randomization is done without prior consent, followed by patients' or relatives' consent at a later stage. Butwhat should one do with the data if the patient dies at an early stage after randomization before consent could be obtained? Should the data be used or not? Should the relatives be asked for consent for using the data? The Dutch Central Committee on Research involving Human Subjects (CCMO) states that asking for consent after the patient has died makes no sense, because with the death of the patient the research has ended. Relatives do not have the authority to give consent for the use of medical data after the patient has died. Data can be used anonymously in the final analysis of the trial. We propose a flowchart for this procedure.

Informed consent in paediatric critical care research--a South African perspective.

PubMed

Morrow, Brenda M; Argent, Andrew C; Kling, Sharon

2015-09-09

Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources. Ethical oversight is essential for safe, appropriate research conduct. Informed consent by the parent or legal guardian is usually required for child research participation, but obtaining consent may be challenging in paediatric critical care research. Local regulations may also impede important research if overly restrictive. By narratively synthesising and contextualising the results of a comprehensive literature review, this paper describes ethical principles and regulations; potential barriers to obtaining prospective informed consent; and consent options in the context of paediatric critical care research in South Africa. Voluntary prospective informed consent from a parent or legal guardian is a statutory requirement for child research participation in South Africa. However, parents of critically ill or injured children might be incapable of or unwilling to provide the level of consent required to uphold the ethical principle of autonomy. In emergency care research it may not be practical to obtain consent when urgent action is required. Therapeutic misconceptions and sociocultural and language issues are also barriers to obtaining valid consent. Alternative consent options for paediatric critical care research include a waiver or deferred consent for minimal risk and/or emergency research, whilst prospective informed consent is appropriate for randomised trials of novel therapies or devices. We propose that parents or legal guardians of critically ill or injured children should only be approached to consent for their child's participation in clinical research when it is ethically justifiable and in the best interests of both child participant and parent. Where appropriate, alternatives to prospective informed consent should be considered to ensure that important paediatric critical care research can be undertaken in South Africa, whilst being cognisant of research risk. This document could provide a basis for debate on consent options in paediatric critical care research and contribute to efforts to advocate for South African law reform.

Research participation registers can increase opportunities for patients and the public to participate in health services research.

PubMed

Leach, Verity; Redwood, Sabi; Lasseter, Gemma; Walther, Axel; Reid, Colette; Blazeby, Jane; Martin, Richard; Donovan, Jenny

2016-07-01

Members of the public and patients repeatedly indicate their willingness to take part in research, but current United Kingdom research governance involves complex rules about gaining consent. Research participation registers that seek consent from participants to be approached about future studies have several potential benefits, including: increased research participation across clinical and healthy populations; simplified recruitment to health care research; support for people's autonomy in decision making; and improved efficiency and generalizability of research. These potential benefits have to be balanced against ethical and governance considerations. With appropriate processes in place, seeking prospective consent from patients and members of the public to be approached about future studies could potentially increase public participation in health research without compromising informed consent and other ethical principles. © The Author(s) 2016.

Recovery of transplantable organs after cardiac or circulatory death: Transforming the paradigm for the ethics of organ donation

PubMed Central

Verheijde, Joseph L; Rady, Mohamed Y; McGregor, Joan

2007-01-01

Organ donation after cardiac or circulatory death (DCD) has been introduced to increase the supply of transplantable organs. In this paper, we argue that the recovery of viable organs useful for transplantation in DCD is not compatible with the dead donor rule and we explain the consequential ethical and legal ramifications. We also outline serious deficiencies in the current consent process for DCD with respect to disclosure of necessary elements for voluntary informed decision making and respect for the donor's autonomy. We compare two alternative proposals for increasing organ donation consent in society: presumed consent and mandated choice. We conclude that proceeding with the recovery of transplantable organs from decedents requires a paradigm change in the ethics of organ donation. The paradigm change to ensure the legitimacy of DCD practice must include: (1) societal agreement on abandonment of the dead donor rule, (2) legislative revisions reflecting abandonment of the dead donor rule, and (3) requirement of mandated choice to facilitate individual participation in organ donation and to ensure that decisions to participate are made in compliance with the societal values of respect for autonomy and self-determination. PMID:17519030

[Issues related to consent to healthcare decisions in children and adolescents].

PubMed

Bailly, D

2010-02-01

The process of consent to healthcare decisions in children and adolescents often set physicians difficult problems. From what age is a child able to understand the information given to him or her about illness and treatment? Is an ill child indeed in the capacity to give his or her voluntary consent to treatment? How to define and to assess the capacity of an ill child to take part in treatment decisions? More than the age of the child, it is his or her level of cognitive, emotional and social development and its interactions with illness that will determine his or her degree of involvement in the decision-making process. There is a moral and ethical need to respect the rights and autonomy of every individual, regardless of age. This does not mean viewing children and adolescents as rational and autonomous decision-makers. This implies that we must promote their developmentally appropriate participation in shared decision-making with parents and physicians. Therefore, instead of asking, "should children and adolescents be granted absolute autonomy in decision making?" we ought to ask, "should we treat children and adolescents like people?" Copyright (c) 2010 Elsevier Masson SAS. All rights reserved.

Patient autonomy: a view from the kitchen.

PubMed

Struhkamp, Rita M

2005-01-01

In contemporary liberal ethics patient autonomy is often interpreted as the right to self-determination: when it comes to treatment decisions, the patient is given the right to give or withhold informed consent. This paper joins in the philosophical and ethical criticism of the liberal interpretation as it does not regard patient autonomy as a right, rule or principle, but rather as a practice. Patient autonomy, or so I will argue, is realised in the concrete activities of day-to-day health care, in the material and technological context of care, in arrangements of health care institutions, in the physical training of people with disabilities, as well as in the concrete activities of care-giving. This move from conversations in the consultation room to other sites and situations in the practice of care takes seriously the empirical reality of medical care and intends to show that patient autonomy is practically realised in a much richer and more creative way than most ethical theory seems to assume.

Awareness, knowledge and attitude toward informed consent among doctors in two different cultures in Asia: a cross-sectional comparative study in Malaysia and Kashmir, India.

PubMed

Yousuf, R M; Fauzi, A R M; How, S H; Rasool, A G; Rehana, K

2007-06-01

Informed consent is now accepted as the cornerstone of medical practice, with reasonable patient standards typically considered to be appropriate in the developed countries; however it is still challenged in many developing countries. The objective of this descriptive study was to evaluate the perceptions and practices among attending medical professionals in matters relating to informed consent in selected hospitals. A questionnaire-based cross sectional survey among doctors in the two tertiary care hospitals, one in Malaysia and the other in Kashmir, was performed. Awareness on informed consent was universal with "reasonable physician standard" as the most popular choice. As compared to doctors in Malaysia, doctors from Kashmir showed a tendency to reservedly disclose medical information (p-value equals 0.051) and withhold it, if it was deemed potentially harmful (p-value is less than 0.001) or requested so by relatives (p-value is less than 0.023). They also withheld some information from female patients (p-value is less than 0.001). When consent was refused despite needing lifesaving intervention, the majority of both respondents (73 percent versus 80 percent) considered intervention without consent to be justified. Respondents from Malaysia felt that parents could refuse treatment on their children's behalf on the basis of their beliefs (p-value is less than 0.001). Despite a very high awareness of informed consent, the model chosen reflected age-old medical paternalism. Doctors' opinions are accorded a larger role in clinical decision-making in Kashmir. The results emphasise the need for doctors to change their attitude and acknowledge the patient's autonomy, which is the basis of modern medical ethics, and yet still be aware of the cultural and religious views of the local population.

Time to Improve Informed Consent for Dialysis: An International Perspective.

PubMed

Brennan, Frank; Stewart, Cameron; Burgess, Hannah; Davison, Sara N; Moss, Alvin H; Murtagh, Fliss E M; Germain, Michael; Tranter, Shelley; Brown, Mark

2017-06-07

The literature reveals that current nephrology practice in obtaining informed consent for dialysis falls short of ethical and legal requirements. Meeting these requirements represents a significant challenge, especially because the benefits and risks of dialysis have shifted significantly with the growing number of older, comorbid patients. The importance of informed consent for dialysis is heightened by several concerns, including: ( 1 ) the proportion of predialysis patients and patients on dialysis who lack capacity in decision making and ( 2 ) whether older, comorbid, and frail patients understand their poor prognosis and the full implications to their independence and functional status of being on dialysis. This article outlines the ethical and legal requirements for a valid informed consent to dialysis: ( 1 ) the patient was competent, ( 2 ) the consent was made voluntarily, and ( 3 ) the patient was given sufficient information in an understandable manner to make the decision. It then considers the application of these requirements to practice across different countries. In the process of informed consent, the law requires a discussion by the physician of the material risks associated with dialysis and alternative options. We argue that, legally and ethically, this discussion should include both the anticipated trajectory of the illness and the effect on the life of the patient with particular regard to the outcomes most important to the individual. In addition, a discussion should occur about the option of a conservative, nondialysis pathway. These requirements ensure that the ethical principle of respect for patient autonomy is honored in the context of dialysis. Nephrologists need to be open to, comfortable with, and skillful in communicating this information. From these clear, open, ethically, and legally valid consent discussions, a significant dividend will hopefully flow for patients, families, and nephrologists alike. Copyright © 2017 by the American Society of Nephrology.

[Inappropriateness in ionizing imaging. The central node of the informed consent: from "event" model to "process" model].

PubMed

Dodaro, Antonio; Recchia, Virginia

2011-11-01

The phenomenon of inappropriateness in ionizing imaging and medical interventions is large-scale and increasing. This tendency causes noteworthy damages to health and to patient's autonomy. Moreover, this trend causes a huge increment of health expenditures, waiting lists, organizational conflicts, judicial disputes, insurance compensations. The actual passive signature on unreadable templates of informed consent in the Italian hospital context constitutes, by a matter of facts, a central node of inappropriateness problem. This way to manage informed consent - "event" model - mortifies the patient's right to decide freely and deliberately, being him unaware of biological consequences of clinical-therapeutical interventions on himself and his progeny's health. Physician himself can generate arbitrary clinical acts, with heavy deontological and legal consequences. Hence, informed consent in ionizing imaging necessitates a particular "process" management, useful to convey a series of other clinical and organisational processes towards a full realisation of therapeutic alliance among physician and patient. This review aims at highlighting - in a juridical and communicative key - a range of tools which are applicable to contrasting the hospital abuse of ionizing radiations, for defending both patients' health and patients' dignity, being them primarily persons and citizens of a rule-of-law State.

Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries.

PubMed

Mystakidou, Kyriaki; Panagiotou, Irene; Katsaragakis, Stelios; Tsilika, Eleni; Parpa, Efi

2009-09-01

Ethical issues regarding HIV/AIDS human research in the developing world remain under continuous evaluation; a critical area of concern includes informed consent. This paper reviews several of the most important ethical and practical aspects of informed consent in HIV research in developing countries. Enhancement of overall understanding of such key issues might promote higher ethical standards of future research. The major objective was to address informed consent in human research in non-Western societies, and specifically in HIV clinical trials of affected adults. Secondary end-points included the consent complexities in HIV research involving vulnerable patient populations in resource-limited nations, such as children, adolescents and women. A systematic review of the published literature using MEDLINE and EMBASE from 1998 until December 2008 was performed, using the search terms 'HIV/AIDS', 'informed consent', 'clinical trials', 'developing world'. Ethical complexities such as participants' diminished autonomy, coercion or monetary inducement, language difficulties, illiteracy or lack of true understanding of the entire study, cultural barriers mainly due to communitarianism and social diversities were identified in the 44 studies reviewed. Informed consent of vulnerable patient populations must be tailored to their sex and developmental age, while counselling is fundamental. Children and adolescents' assent must be ensured. Local language is to be used, while trusted community leaders and local cultural representatives may convey information. Despite the heterogeneity of studies, similarities were identified. Providing adequate and comprehensive information and assessing the true understanding of the research represent fundamental prerequisites. Potential solutions to the critical areas of concern include peer counselling and meetings with local community leaders or local cultural representatives. International investigators of HIV human research should bear in mind these ethical issues and their potential solutions, when trying to ensure ethical research conduct, based on a truly informed and culturally relevant consent.

"Ultimately, mom has the call": Viewing clinical trial decision making among patients with ovarian cancer through the lens of relational autonomy.

PubMed

Asiedu, Gladys B; Ridgeway, Jennifer L; Carroll, Katherine; Jatoi, Aminah; Radecki Breitkopf, Carmen

2018-04-14

This study employs the concept of relational autonomy to understand how relational encounters with family members (FMs) and care providers may shape decisions around ovarian cancer patients' clinical trial (CT) participation. The study also offers unique insights into how FMs view patients' decision making. In-depth interviews were conducted with 33 patients with ovarian cancer who had been offered a CT and 39 FMs. Data were inductively analysed using a thematic approach and deductively informed by constructs derived from the theory of relational autonomy (RA). Patients' relationships, experiences and social status were significant resources that shaped their decisions. Patients did not give equal weight to all relationships and created boundaries around whom to include in decision making. Doctors' recommendations and perceived enthusiasm were described as influential in CT decisions. Both patients with ovarian cancer and their FMs maintained that patients have the "final say," indicating an individualistic autonomy. However, maintaining the "final say" in the decision-making process is constitutive of patients' relationships, emphasizing a relational approach to autonomy. FMs support patients' autonomy and they do so particularly when they believe the patient is capable of making the right choices. Although ethical principles underlying informed consent for CT participation emphasize individual autonomy, greater attention to relational autonomy is warranted for a more comprehensive understanding of CT decision making. © 2018 Mayo Clinic. Health Expectations published by John Wiley & Sons Ltd.

Population attitudes towards research use of health care registries: a population-based survey in Finland.

PubMed

Eloranta, Katariina; Auvinen, Anssi

2015-07-17

Register-based research can provide important and valuable contributions to public health research, but involves ethical issues concerning the balance of public health benefits and individual autonomy. This study aimed to describe the opinions of the Finnish public about these issues. Mail survey questionnaire sent to a random sample of 1000 Finns. Participation proportion was 42%, with 258 women and 160 men. The majority of the participants (61%) were willing to provide their identifiable health information for research. Almost half of the participants (48%) would, nevertheless, like to be informed when their information is used. A third (30%) indicated no need for informed consent in register-based research, a similar proportion felt it should be obtained for every study, and 40% thought it necessary in some situations, such as studies addressing a sensitive study topic. As for the best policy for obtaining consent, the majority (86%) favoured broader consent methods: one consent covering a certain register or a research topic. Half of the participants (55%) desired a required ethical evaluation from register-based research addressing a sensitive issue. Privacy protection was the most common concern for register-based research. More than half of the participants were either content with the current Finnish laws concerning register-based research or wanted to liberalize them to advance research. The Finnish public is supportive of register-based research, but the requirement for informed consent divides opinions and many would at least like to be informed of the research use of their information.

[In the beginning was a relationship].

PubMed

Vanbelle, Guido

2008-01-01

Judgment and actions based on scientific evidence are modified by the unique caregiver-patient relationship. Caregivers relying exclusively upon "rational" decisions in line with evidence-based clinical recommendations avoid their relational responsibility. The "noble" purpose illustrates that decisions to treat can be at the same time pointless and valuable. Dia (through) - logue (knowledge) makes it possible to go beyond informed consent, which holds caregivers responsible for providing information and patients for the decision to treat. Finally, where healing is no longer achievable and autonomy dies away, compassion rather than therapeutic tenacity might be the answer. These examples are explained corresponding to the philosophical ideas of respectively Emmanuel Levinas en Roger Burgraeve (noble purpose), Martin Buber (dialogical thinking) and Daniel C. Dennett (autonomy loss).

Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach.

PubMed

Courtright, Katherine R; Halpern, Scott D; Joffe, Steven; Ellenberg, Susan S; Karlawish, Jason; Madden, Vanessa; Gabler, Nicole B; Szymanski, Stephanie; Yadav, Kuldeep N; Dember, Laura M

2017-10-11

Pragmatic clinical trials embedded in routine delivery of clinical care can lead to improvements in quality of care, but often have design features that raise ethical concerns. We performed a discrete choice experiment and used conjoint analysis to assess how specific attributes of pragmatic dialysis trials influenced patients' and physicians' willingness to have their dialysis facility participate in a hypothetical trial of hypertension management. Electronic survey data were collected from 200 patients enrolled from 11 outpatient hemodialysis units and from 203 nephrologists. The three attributes studied were physicians' treatment autonomy, participants' research burden, and the approach to consent. The influence of each attribute was quantified using mixed-effects logistic regression. Similar proportions of patients were willing to have their facilities participate in a trial with high vs. low physician autonomy (77% vs. 79%; p = 0.13) and research burden (76% vs. 80%; p = 0.06). Opt-in, opt-out, and notification-only consent approaches were acceptable to most patients (84%, 82%, and 81%, respectively), but compared to each of these consent approaches, fewer patients (66%) were willing to have their facility participate in a trial that used no notification (p < 0.001 for each 2-way comparison). Among the physicians, similar proportions were willing to participate in trials with high and low physician autonomy (61% and 61%, respectively, p = 0.96) or with low and high burden (60 and 61%, respectively, p = 0.79). However, as for the patients, the consent approach influenced trial acceptability with 77%, 69%, and 62% willing to participate using opt-in, opt-out, and notification-only, respectively, compared to no notification (36%) (p < 0.001 for each 2-way comparison). Curtailing physician's treatment autonomy and increasing the burden associated with participation did not influence patients' or physicians' willingness to participate in the hypothetical research, suggesting that pragmatic dialysis trials are generally acceptable to patients and physicians. Both patients and physicians preferred consent approaches that include at least some level of patient notification, but the majority of patients were still willing to participate in trials that did not notify patients of the research.

The Mental Capacity Act--a balance between protection and liberty.

PubMed

Walters, Thomas Paul

The stated aim of the Mental Capacity Act is to provide greater protection to those who may lose their mental capacities, particularly in terms of informed consent, patient affairs, advanced decisions and research. This article attempts to explore this new statute by way of examining the scope to which the Act departs from the previous Common Law. Three key themes are identified within this new Act, which differentiate it from Common Law: patients' best interests, which is paramount to any care or treatment; proxy consent, whereby donees can now be appointed to take charge of medical decisions; and advanced directives, where so-called living wills can be enforced provided that they are specific, written, signed and witnessed. However, upon examining the statute it appears that rather than increasing patient autonomy and self-determination, evidence suggests that power is still being held by the medical profession. Whether patients have full autonomy or not, the main issue could be how to strike an effective and workable balance between protection and liberty.

Patient autonomy in home care: Nurses' relational practices of responsibility.

PubMed

Jacobs, Gaby

2018-01-01

Over the last decade, new healthcare policies are transforming healthcare practices towards independent living and self-care of older people and people with a chronic disease or disability within the community. For professional caregivers in home care, such as nurses, this requires a shift from a caring attitude towards the promotion of patient autonomy. To explore how nurses in home care deal with the transformation towards fostering patient autonomy and self-care. Research design and context: A case study was conducted in a professional development course ('learning circle') for home care nurses, including participant observations and focus groups. The theoretical notion of 'relational agency' and the moral concept of 'practices of responsibility' were used to conduct a narrative analysis on the nurses' stories about autonomy. Eight nurses, two coaches and two university lecturers who participated in the learning circle. Ethical considerations: Informed consent was sought at the start of the course and again, at specific moments during the course of the learning circle. Three main themes were found that expressed the moral demands experienced and negotiated by the nurses: adapting to the person, activating patients' strengths and collaboration with patients and informal caregivers. On a policy and organisational level, the moral discourse on patient autonomy gets intertwined with the instrumental discourse on healthcare budget savings. This is manifested in the ambiguities the nurses face in fostering patient autonomy in their daily home care practice. To support nurses, critical thinking, moral sensitivity and trans-professional working should be part of their professional development. The turn towards autonomy in healthcare raises moral questions about responsibilities for care. Promoting patient autonomy should be a collaborative endeavour and deliberation of patients, professional and informal caregivers together.

Le consentement libre et éclairé aux soins en psychiatrie

PubMed Central

Neilson, Grainne; Chaimowitz, Gary

2015-01-01

Résumé Le patient a le droit d’être informé sur les soins de santé qui lui sont proposés et de participer activement à la prise de décisions relativement à ces soins. Le respect de la dignité et de l’autonomie de la personne passe par le respect de son droit de prendre des décisions à propos de ses soins psychiatriques, notamment de refuser un traitement, pour autant qu’elle soit apte à prendre des décisions. Il importe que le psychiatre connaisse les fondements éthiques du consentement libre et éclairé et les exigences prévues par le droit en cette matière, y compris la jurisprudence. Le consentement n’est pas immuable, pouvant changer avec le temps, au fil de l’évolution des conditions et des circonstances. Par conséquent, le consentement doit être un processus continu.

Reconciling the principle of patient autonomy with the practice of informed consent: decision-making about prognostication in uveal melanoma.

PubMed

Cook, Sharon A; Damato, Bertil; Marshall, Ernie; Salmon, Peter

2011-12-01

Influential views on how to protect patient autonomy in clinical care have been greatly shaped by rational and deliberative models of decision-making. Our aim was to understand how the general principle of respecting autonomy can be reconciled with the local reality of obtaining consent in a clinical situation that precludes extended deliberation. We interviewed 22 patients with intraocular melanoma who had been offered cytogenetic tumour typing to indicate whether the tumour was likely to shorten life considerably. They were interviewed before and/or up to 36 months after receiving cytogenetic results. Patients described their decision-making about the test and how they anticipated and used the results. Their accounts were analysed qualitatively, using inconsistencies at a descriptive level to guide interpretative analysis. Patients did not see a decision to be made. For those who accepted testing, their choice reflected trust of what the clinicians offered them. Patients anticipated that a good prognosis would be reassuring, but this response was not evident. Although they anticipated that a poor prognosis would enable end-of-life planning, adverse results were interpreted hopefully. In general, the meaning of the test for patients was not separable from ongoing care. Models of decision-making and associated consent procedures that emphasize patients' active consideration of isolated decision-making opportunities are invalid for clinical situations such as this. Hence, responsibility for ensuring that a procedure protects patients' interests rests with practitioners who offer it and cannot be delegated to patients. © 2010 Blackwell Publishing Ltd.

Shared Mind: Communication, Decision Making, and Autonomy in Serious Illness

PubMed Central

Epstein, Ronald M.; Street, Richard L.

2011-01-01

In the context of serious illness, individuals usually rely on others to help them think and feel their way through difficult decisions. To help us to understand why, when, and how individuals involve trusted others in sharing information, deliberation, and decision making, we offer the concept of shared mind—ways in which new ideas and perspectives can emerge through the sharing of thoughts, feelings, perceptions, meanings, and intentions among 2 or more people. We consider how shared mind manifests in relationships and organizations in general, building on studies of collaborative cognition, attunement, and sensemaking. Then, we explore how shared mind might be promoted through communication, when appropriate, and the implications of shared mind for decision making and patient autonomy. Next, we consider a continuum of patient-centered approaches to patient-clinician interactions. At one end of the continuum, an interactional approach promotes knowing the patient as a person, tailoring information, constructing preferences, achieving consensus, and promoting relational autonomy. At the other end, a transactional approach focuses on knowledge about the patient, information-as-commodity, negotiation, consent, and individual autonomy. Finally, we propose that autonomy and decision making should consider not only the individual perspectives of patients, their families, and members of the health care team, but also the perspectives that emerge from the interactions among them. By drawing attention to shared mind, clinicians can observe in what ways they can promote it through bidirectional sharing of information and engaging in shared deliberation. PMID:21911765

Shared mind: communication, decision making, and autonomy in serious illness.

PubMed

Epstein, Ronald M; Street, Richard L

2011-01-01

In the context of serious illness, individuals usually rely on others to help them think and feel their way through difficult decisions. To help us to understand why, when, and how individuals involve trusted others in sharing information, deliberation, and decision making, we offer the concept of shared mind-ways in which new ideas and perspectives can emerge through the sharing of thoughts, feelings, perceptions, meanings, and intentions among 2 or more people. We consider how shared mind manifests in relationships and organizations in general, building on studies of collaborative cognition, attunement, and sensemaking. Then, we explore how shared mind might be promoted through communication, when appropriate, and the implications of shared mind for decision making and patient autonomy. Next, we consider a continuum of patient-centered approaches to patient-clinician interactions. At one end of the continuum, an interactional approach promotes knowing the patient as a person, tailoring information, constructing preferences, achieving consensus, and promoting relational autonomy. At the other end, a transactional approach focuses on knowledge about the patient, information-as-commodity, negotiation, consent, and individual autonomy. Finally, we propose that autonomy and decision making should consider not only the individual perspectives of patients, their families, and members of the health care team, but also the perspectives that emerge from the interactions among them. By drawing attention to shared mind, clinicians can observe in what ways they can promote it through bidirectional sharing of information and engaging in shared deliberation.

Informed consent to medical treatment--the Israeli experience.

PubMed

Weil, Z

1998-01-01

The ideological foundation of the doctrine of "informed consent" is rooted in the concept of personal freedom and freedom of choice. The concept of individual autonomy is represented by the "reasonable patient" standard which requires the disclosure of all information which a reasonable person in the position of the patient would need in order to make a rational decision regarding a proposed medical treatment. This attitude, however, conflicts with the traditional paternalism which is reflected in the "reasonable physician" standard, that is that a doctor must disclose that medical information which a rational doctor would relate to a patient in order to receive his consent. The enactment of the Patients' Rights Law in Israel in 1996 was an essential turning point in Israeli medical law. Section 13 of the new law explicitly establishes the requirement of informed consent and the details which a doctor must relate to a patient in order to reach the said agreement. Nevertheless, the law does not state the standard according to which it should be assessed whether the disclosure was proper. In a recent decision (C.A. 434/94 Shai Berman et al. v. Mor--the Institute for Medical Information, Ltd.) the Israeli Supreme Court took a step forward and determined that the duty to inform a patient will be judged by recognised criteria of negligence as they apply to the merits of each case.

Consent: a Cartesian ideal? Human neural transplantation in Parkinson's disease.

PubMed

Lopes, Manuel; Meningaud, Jean-Paul; Behin, Anthony; Hervé, Christian

2003-01-01

The grafting of human embryonic cells in Parkinson's disease is an innovative and hopefully useful therapeutic approach. However, it still concerns a very small number of patients and is only suggested as a research protocol. We present here a study of the problems of information and consent to research within the framework of this disease in which the efficacy of medical treatment is shortlived. The only French center to use this treatment (Hôpital H. Mondor in Créteil) has received authorization from the Comité Consultatif National d'Ethique (Consultative National Committee on Ethics). Eleven patients were treated between 1991 and 1998. The study of the results of a questionnaire sent to those patients showed the difficulties met in evaluating the perception of information despite intact intellectual capacities in people "prepared to risk everything." In France, the duty to inform patients during research procedures is regulated by the Huriet Act. However, it is not easy to guarantee genuine consent when preliminary information is given to patients psychologically impaired by the slow and ineluctable course of their disease. In these borderline cases, a valid consent seems to be a myth in terms of pure autonomy when considered with the Cartesian aim of elimination of uncertainty. The relevance of this concept of genuine consent probably makes more sense as aiming at a Cartesian ideal which is perhaps more in the spirit rather than in the letter. It is in that same spirit that, from the outset, we propose to define t he practical ways of answering the patients' request for information, even sometimes after consent has been given.

Autonomy of the child in the South African context: is a 12 year old of sufficient maturity to consent to medical treatment?

PubMed

Ganya, Wandile; Kling, Sharon; Moodley, Keymanthri

2016-11-02

A child is a developing person with evolving capacities that include autonomy, mental (decisional) capacity and capacity to assume responsibility. Hence, children are entitled to participatory (autonomy) rights in South Africa as observed in the Children's Act 38 of 2005. According to section 129 of the Act a child may consent to his or her own medical treatment provided that he or she is over the age of 12 years and is of sufficient maturity and decisional capacity to understand the various implications of the treatment including the risks and benefits thereof. However, the Act does not provide a definition for what qualifies as 'sufficient maturity' nor does it stipulate how health professionals ought to assess the decisional capacity of a child. In addition, South Africa is a culturally diverse country. The Western liberal notion of autonomy may not necessarily find equal prominence in the mores of people with a different worldview. Hence we demonstrate a few salient comparisons between legal liberal moral theory and African communitarianism as pertinent to the autonomy of the child. Children are rights-holders by virtue of their humanity. Their dignity as individual human persons affords them the entitlement to human rights as contemplated under the Constitution of the Republic of South Africa. However, contrary to the traditional Western notion of individual autonomous persons African societies hold a communalistic notion of person hence there is less regard for individual autonomy and rights with more emphasis on the communal good and maintaining the continuity of relationships and interdependencies shared within a community. A child considered in this view is not regarded as a full person. This implies that decisions concerning the child, including consent to medical treatment are discussed and determined by the community to which the child belongs. Lastly, in this article, we draw on the notion of capacity for responsibility to produce a pragmatic definition of sufficient maturity. It seems reasonable to suggest a move away from a general legal age of consent for medical treatment toward more individualised, context-specific approaches in determining the maturity of a child patient to consent to medical treatment. Perhaps, decision-making with respect to consent to the medical treatment of a child belonging to a traditional African community where the notion of a person is embedded in communitarianism ought to involve the child's parents/guardians/caregivers where possible provided that the best interests of the child are awarded priority.

Informed Consent in the Changing Landscape of Research.

PubMed

Hammer, Marilyn J

2016-09-01

The history of informed consent dates back as early as the 16th century (Selek, 2010). The current tenets of informed consent pertaining to the ethical conduct of research on human participants predominately stems from the 1947 Nuremberg Code (National Institutes of Health, 2016), which was created following the Nuremberg trials at the end of World War II. The unethical conduct of research on human participants during the Holocaust, coupled with experiments (e.g., the Tuskegee syphilis study), prompted a more formalized structure for ensuring the well-being and autonomy of human participants in research studies. The World Medical Association (2013) created the Declaration of Geneva in 1948 (Fischer, 2006), followed by the Declaration of Helsinki in 1964, to apply ethical principles to medical research involving human participants (Fischer, 2006; Rickham, 1964). A decade later, on July 12, 1974, the National Research Act was signed into law (U.S. Department of Health and Human Services [HHS], 1979). Through this act, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed and charged with developing guidelines for the conduct of biomedical and behavioral research. The guidelines were established in the Belmont Report (HHS, 1979; U.S. Department of Health, Education, and Welfare, 1979), which continues to be periodically updated. The Belmont Report describes the general principles of respect for persons, beneficence, and justice, and it outlines the process of obtaining informed consent to ensure that these principles are followed (HHS, 1979). In 1998, an informed consent checklist was instituted (HHS, 1998). Although clearly outlined, defined, and described in consent forms, it is beneficial to revisit how informed participants are when they enter research studies, particularly for patients undergoing treatment for cancer. This article will provide an overview of several areas for consideration. 
.

Perceptions of potential donors in the Swedish public towards information and consent procedures in relation to use of human tissue samples in biobanks: a population-based study.

PubMed

Kettis-Lindblad, Asa; Ring, Lena; Viberth, Eva; Hansson, Mats G

2007-01-01

To assess the Swedish public's preferences for information and consent procedures when being asked for permission to use previously collected tissue samples for new research studies. Cross-sectional study employing postal questionnaires to a random sample of the Swedish general public (n = 6,000) in October 2002-February 2003. The response rate was 49% (n = 2,928). This paper includes only respondents who reportedly would approve of samples being taken and stored (n = 2,122). When potential tissue sample donors in the general public have to strike a balance between the values at stake, i.e. the autonomy of the donor versus the research value, most (72%) prefer general consent, i.e. where consent is asked for at the outset only. They want the research ethics committee (REC) alone to decide on the use of stored samples, and they would allow storage as long as the sample is useful for research. The minority of respondents who were in favour of specific consent were more likely to be young, well educated, have negative experiences of healthcare and low trust in healthcare authorities. The majority of the Swedish general public prefer general consent, and are thus willing to delegate some decisions to the RECs. However, preferences for information and consent procedures depend on the context, e.g. the risks for the donor and the purpose of the research. If feasible, procedures should be differentiated according to the preferences of individual donors, thus protecting the interests of both the minority and the majority.

“Ready-to-Recruit” or “Ready-to-Consent” Populations?: Informed Consent and the Limits of Subject Autonomy

PubMed Central

Fisher, Jill A.

2011-01-01

This paper queries the pharmaceutical industry’s concept of “ready-to-recruit” populations by examining its recruitment strategies for clinical trials and the types of human subjects who participate in these drug studies. The argument is that the pharmaceutical industry has profited from a system comprised of what can more aptly be characterized as ready-to-consent populations, meaning populations who do not have better alternatives than participation in clinical trials. Further, through qualitative research, this paper aims to highlight some of the limitations of current U.S. federal regulation and to show how these limits signal problems that are not normally discussed in the medical ethics literature about research on human subjects. It does this by examining the impotence of informed consent – both as a concept and as a practice – in light of recruitment strategies and the structural reasons motivating individuals to participate in clinical trials. PMID:21359125

Medical care in minors and incompetent patients: the patient's will and third party intervention in Spanish law.

PubMed

Arcos Vieira, Luisa

2009-03-01

Health care in minors and incompetent patients implies problems with regard to the extent of the impact that those circumstances must have on their right to be informed and on their capacity for giving informed consent and, consequently, on a greater or lesser importance of third party intervention. This article aims to contribute some considerations about the approach of Spanish law to these questions, in order to show the extent to which those patients' autonomy has been recognized.

How US institutional review boards decide when researchers need to translate studies

PubMed Central

Klitzman, Robert

2013-01-01

Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards (IRBs) and research ethics committees’ (RECs) about the need for researchers to translate consent forms and other study materials. Sixty US IRBs (every fourth one in the list of the top 240 institutions by The National Institutes of Health funding) were contacted, and leaders (eg, chairs) from 34 (response rate=57%) and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals—what, when and how to translate (eg, for how many or what proportion of potential subjects), why to do so and how to decide. Difficulties can arise about translation of specific words and of broader cultural concepts regarding processes of informed consent and research, especially in the developing world. In these decisions, IRBs weigh the need for autonomy (through informed consent) and justice (to ensure fair distribution of benefits and burdens of research) against practical concerns about costs to researchers. At times IRBs may have to compromise between these competing goals. These data, the first to examine when and how IRBs/RECs require researchers to translate materials, thus highlight a range of problems with which these committees struggle, suggesting a need for further normative and empirical investigation of these domains, and consideration of guidelines to help IRBs deal with these tensions. PMID:23475805

How US institutional review boards decide when researchers need to translate studies.

PubMed

Klitzman, Robert

2014-03-01

Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards (IRBs) and research ethics committees' (RECs) about the need for researchers to translate consent forms and other study materials. Sixty US IRBs (every fourth one in the list of the top 240 institutions by The National Institutes of Health funding) were contacted, and leaders (eg, chairs) from 34 (response rate=57%) and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals-what, when and how to translate (eg, for how many or what proportion of potential subjects), why to do so and how to decide. Difficulties can arise about translation of specific words and of broader cultural concepts regarding processes of informed consent and research, especially in the developing world. In these decisions, IRBs weigh the need for autonomy (through informed consent) and justice (to ensure fair distribution of benefits and burdens of research) against practical concerns about costs to researchers. At times IRBs may have to compromise between these competing goals. These data, the first to examine when and how IRBs/RECs require researchers to translate materials, thus highlight a range of problems with which these committees struggle, suggesting a need for further normative and empirical investigation of these domains, and consideration of guidelines to help IRBs deal with these tensions.

Autonomy and reason: treatment choice in breast cancer.

PubMed

Twomey, Mary

2012-10-01

The practice of offering choice to those women with breast cancer for whom either breast conserving surgery or mastectomy would be equally beneficial has come to be seen as an important aspect of medical care. As well as improving satisfaction with treatment, this is seen as satisfying the ethical principle of respect for autonomy. A number of studies, however, show that women are not always comfortable with such choice, preferring to leave treatment decisions to their surgeons. A question then arises as to the extent that these women can be seen as autonomous or as exercising autonomy. This paper argues, however, that the understanding of autonomy which is applied in current approaches to breast cancer care does not adequately support the exercise of autonomy, and that the clinical context of care means that women are not able to engage in the kind of reasoning that might promote the exercise of autonomy. Where respect for autonomy is limited to informed consent and choice, there is a danger that women's interests are overlooked in those aspects of their care where choice is not appropriate, with very real, long-term consequences for some women. Promoting the exercise of autonomy, it is argued, needs to go beyond the conception of autonomy as rational individuals making their own decisions, and clinicians need to work with an understanding of autonomy as relational in order to better involve women in their care. © 2012 Blackwell Publishing Ltd.

[Autonomy, Trust and Medical Ethics in Onora O'Neill's Work].

PubMed

Jaramillo, Carlos Alberto López; Lew, Jorge Carlos Holguín

2013-03-01

Autonomy has become a key concept in bioethics. Onora O'neill is perhaps the most representative author and researcher in the philosophical and bioethical fields regrding the concept of autonomy. To review the concept of autonomy in Onora O'Neill's work so as to understand its relevance in current bioethics. The concept of bioethics is reviewed in relation to three fundamental quesions: 1) Which are the main limitations of the individualistic conception of autonomy? 2) How to understand the relations between trust and autonomy together with their implications? and 3) Which are the implications of principled autonomy for aspects such as doctor-patient relationship and informed consent. The main works by O'Neill are reviewed, specifically regarding medical bioethics. O'neill's approach is original and relates Kantian autonomy to her own conceptions about trust, and both the individual and social levels of bioethics. The author has developed a Kantian non indvidualistic view of autonomy. Her conceptulization of trust and the crises this concept is currently undergoing complement and strengthen the concept of principled autonomy. The implications of O'Neill's concepts go beyond theoretical discussions and in her work she uses examples and analyzes circumstances which demonstrate the applicability of her proposals. O'Neill's work contributes to dealing with the challenges posed by the socio-political context of cost-efficiency oriented health systems and of the so-called defensive medicine. Copyright © 2013 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

(Why) should we require consent to participation in research?

PubMed Central

Wertheimer, Alan

2014-01-01

It is widely accepted that informed consent is a requirement of ethical biomedical research. It is less clear why this is so. As an argumentative strategy the article asks whether it would be legitimate for the state to require people to participate in research. This article argues that the consent requirement cannot be defended by appeal to any simple principle, such as not treating people merely as a means, bodily integrity, and autonomy. As an argumentative strategy the article asks whether it would be legitimate for the state to require people to participate in research. I argue that while it would be legitimate and potentially justifiable to coerce people to participate in research as a matter of first-order moral principles, there are good reasons to adopt a general prohibition on coercive participation as a matter of second-order morality. PMID:25937932

Disclosure of incidental constituents of psychotherapy as a moral obligation for psychiatrists and psychotherapists.

PubMed

Trachsel, Manuel; Gaab, Jens

2016-08-01

Informed consent to medical intervention reflects the moral principle of respect for autonomy and the patient's right to self-determination. In psychotherapy, this includes a requirement to inform the patient about those components of treatment purported to cause the therapeutic effect. This information must encompass positive expectancies of change and placebo-related or incidental constituent therapy effects, which are as important as specific intervention techniques for the efficacy of psychotherapy. There is a risk that informing the patient about possible incidental constituents of therapy may reduce or even completely impede these effects, with negative consequences for overall outcome. However, withholding information about incidental constituents of psychotherapy would effectively represent a paternalistic action at the expense of patient autonomy; whether such paternalism might in certain circumstances be justified forms part of the present discussion. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

The radiology informed consent form: recommendations from the European Society of Cardiology position paper.

PubMed

Carpeggiani, Clara; Picano, Eugenio

2016-06-01

Every radiological and nuclear medicine examination confers a definite long-term risk of cancer, but most patients undergoing such examinations receive no or inaccurate information about radiation dose and corresponding risk related to the dose received. Informed consent is a procedure to support (not substitute) the physician/patient dialogue and relationship, facilitating a free, informed and aware expression of the patient's will in the principle of patient autonomy. Physicians are responsible for providing patients with all the information on risks, benefits and alternatives useful to the patient to make the decision. In current radiological practice the information on the radiation dose and long-term cancer risks is difficult to find and not easy to understand. The form using plain language should spell-out the type of examination, the effective dose (mSv), the effective dose expressed in number of chest radiographs and the risk of cancer. The current practice clashes against the guidelines and the law.

Obtaining waivers of parental consent: A strategy endorsed by gay, bisexual, and queer adolescent males for health prevention research.

PubMed

Flores, Dalmacio; McKinney, Ross; Arscott, Joyell; Barroso, Julie

Requiring parental consent in studies with sexual minority youth (SMY) can sometimes be problematic as participants may have yet to disclose their sexual orientation, may not feel comfortable asking parents' permission, and may promote a self-selection bias. We discuss rationale for waiving parental consent, strategies to secure waivers from review boards, and present participants' feedback on research without parents' permission. We share our institutional review board proposal in which we made a case that excluding SMY from research violates ethical research principles, does not recognize their autonomy, and limits collection of sexuality data. Standard consent policies may inadvertently exclude youth who are at high risk for negative health outcomes or may potentially put them at risk because of forced disclosure of sexual orientation. Securing a waiver addresses these concerns and allows for rich data, which is critical for providers to have a deeper understanding of their unique sexual health needs. To properly safeguard and encourage research informed by SMY, parental consent waivers may be necessary. Copyright © 2017 Elsevier Inc. All rights reserved.

Consent and consensus-ethical perspectives on obtaining bodies for anatomical dissection.

PubMed

Winkelmann, Andreas

2016-01-01

Biomedical research and education benefit from the use of human cadavers. These are usually acquired from donors who have willed their body to science during their lifetime. This concept of donation through "informed consent" respects the personal autonomy of the donor and the dignity of the dead body (extended from the dignity of the living person). The concept of informed consent is taken from research on living human subjects regulated in the Helsinki Declaration. This transfer to the domain of anatomical donation, however, has several problems. For example, the dead cannot speak for themselves and the ethical status of the human cadaver remains ambiguous. It is therefore suggested that an element of consensus is added to the concept of consent, a consensus between donors, relatives, anatomists, and the wider community. A consensus can give difficult decisions surrounding body donation and dissection a broader basis and can help bridge the gap between donors and families on the one side and anatomists, researchers and students on the other side. This approach can help to establish relationships of trust with local communities, on which body donation programs depend. © 2015 Wiley Periodicals, Inc.

"Negotiorum Gestio" in Family Medicine, Informed Consent Obtainment, and Disciplinary Responsibility.

PubMed

Birkeland, Søren

2016-01-01

Introduction. Negotiorum gestio (NG) denotes an action where a person well intendedly acts on behalf of another without obtaining the latter's prior consent. In broad terms, NG-like actions have played a considerable role in health care provision. In some settings, health care delivery with only little or presumed patients' consent has been the rule rather than the exception. However, bioethical principles regarding patient autonomy and obtainment of the patient's informed consent (IC) before intervention are now increasingly materialized in the law of many countries. Aim. To study legal consequences of NG in family medicine and IC handling options. Methods. Case law examination. Results. A disciplinary board case is described concerning a family doctor conducting unlawful NG by not coming up to legal IC requirements. Discussion and Conclusion. The practical and legal implications of IC and possible role of novel Shared Decision-Making approaches in coming up to regulation and bioethical demands are discussed. It is concluded that a doctor may run an unnecessary legal risk when conducting NG in decision-competent patients and furthermore it is suggested that novel Shared Decision-Making approaches could help in obtaining a rightful and practicable IC.

Correlation Between Insight and Capacity to Consent to Research in Subjects With Bipolar Disorder Type I and Schizophrenia.

PubMed

López-Jaramillo, Carlos; Tobler, Chantal Aristizábal; Gómez, Constanza Ovalle; Triana, Jaime Escobar

2016-01-01

Schizophrenia and bipolar disorder type I (BD-I) can affect patient autonomy and capacity to consent to participate in research. Other variables associated with the autonomy of patients must be explored in order to improve the quality of the currently available tools. To evaluate the relationship between insight and the capacity to consent to participate in research in patients with BD-I and schizophrenia. A cross-sectional and longitudinal study was conducted with 120 subjects (40 subjects with schizophrenia, 40 with BD-I, and 40 healthy controls). The tools used were the Scale Assessment Insight-Expanded (SAI-E) and the MacArthur Competence Assessment Tool-Treatment (MacCAT-CR), which was first adapted culturally, and its validity and reliability assessed. The results obtained on each scale were compared and the association between them were evaluated. There is a direct correlation between the capacity to consent to research, measured using the MacCAT-CR tool, and the degree of insight, measured using the SAI-E scale, with an effect size of 1.3 for BD-I and 2.03 for schizophrenia. The results suggest that there is a correlation between the degree of insight and the capacity to consent to research in subjects with schizophrenia and BD-I. Insight should therefore be included as a relevant variable to assess the capacity to consent, and future studies should include it when researching on or designing new tools which aim at a greater respect of patient autonomy. Copyright © 2016 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

"She made up a choice for me": 22 HIV-positive women's experiences of involuntary sterilization in two South African provinces.

PubMed

Strode, Ann; Mthembu, Sethembiso; Essack, Zaynab

2012-12-01

Since 1998 South African law has provided that adults should have access to sterilization but only with their informed consent. However, the right to sterilization and other sexual and reproductive rights have not been fully realized as women struggle to access limited services, and there are allegations of discrimination and sterilization abuses. This qualitative study explores the experiences of 22 HIV-positive women in two provinces who reported being sterilized between 1996 and 2010 without their informed consent (n=18) or without their knowledge (n=4). Key issues reported by participants included failure to respect their autonomy, lack of information given about what sterilization entailed, and subtle or overt pressure to sign the consent form. Although the legal framework was intended to ensure informed decision-making regarding sterilization, these protections appear to have failed the HIV-positive women in this study. The findings suggest that some health professionals may consider a signature on a consent form as sufficient regardless of how it was obtained. Furthermore the women's perceptions that they were singled out as needing to be sterilized simply because they were HIV-positive warrants further investigation. More research is required on the nature of the problem and on other stakeholders' perceptions. Copyright © 2012 Reproductive Health Matters. Published by Elsevier Ltd. All rights reserved.

Sterilizing the mentally-handicapped: who can give consent?

PubMed

1980-01-26

Due to the vulnerable position of the mentally handicapped individual, the question of whether the state or any other interested 3rd party should intervene in procreative rights even with consent will depend to a great extent on the ability and autonomy of the individual to make the decision. There are 3 elements to consent: 1) it must be voluntary; 2) it requires that the individual has sufficient information to make a decision; and 3) it is imperative that the person providing the consent have the mental competence to appreciate exactly what is being consented to and the implication of the consent. Consent can be either personal consent or it may be "3rd party" consent. The 3rd party consent is used when an individual is incapable of providing personal consent. It is crucially important that those mentally handicapped individuals who are capable of making a decision do make such a decision when they agree to undergo sterilization. There is nothing inherent in mental handicap that prevents an individual from providing competent consent to a sterilization. The situation when someone other than the individual to be sterilized consents to the procedure poses more problems. Some glaring problems that arise when 3rd party consent on behalf of full-time residents in state institutions is allowed are the following: 1) state coercion behind such decisions is too easily concealed; 2) persuasion can be brought to bear on parents who already bear the stigma of a mentally handicapped child; and 3) administrative convenience may too easily be substituted for the benefit to the individual.

Simulated Patient Studies: An Ethical Analysis

PubMed Central

Rhodes, Karin V; Miller, Franklin G

2012-01-01

Context In connection with health care reform, the U.S. Department of Health and Human Services commissioned a “mystery shopper,” or simulated patient study, to measure access to primary care. But the study was shelved because of public controversy over “government spying” on doctors. Opponents of the study also raised ethical concerns about the use of deception with human subjects without soliciting their informed consent. Methods We undertook an ethical analysis of the use of simulated patient techniques in health services research, with a particular focus on research measuring access to care. Using a case study, we explored relevant methodological considerations and ethical principles relating to deceptive research without informed consent, as well as U.S. federal regulations permitting exceptions to consent. Findings Several relevant considerations both favor and oppose soliciting consent for simulated patient studies. Making research participation conditional on informed consent protects the autonomy of research subjects and shields them from unreasonable exposure to research risks. However, scientific validity is also an important ethical principle of human subjects research, as the net risks to subjects must be justified by the value to society of the knowledge to be gained. The use of simulated patients to monitor access is a naturalistic and scientifically sound experimental design that can answer important policy-relevant questions, with minimal risks to human subjects. As interaction between researchers and subjects increases, however, so does the need for consent. Conclusions As long as adequate protections of confidentiality of research data are in place, minimally intrusive simulated patient research that gathers policy-relevant data on the health system without the consent of individuals working in that system can be ethically justified when the risks and burdens to research subjects are minimal and the research has the potential to generate socially valuable knowledge. PMID:23216428

"The angel of the house" in the realm of ART: feminist approach to oocyte and spare embryo donation for research.

PubMed

Alichniewicz, Anna; Michalowska, Monika

2014-02-01

The spectacular progress in assisted reproduction technology that has been witnessed for the past thirty years resulted in emerging new ethical dilemmas as well as the revision of some perennial ones. The paper aims at a feminist approach to oocyte and spare embryo donation for research. First, referring to different concepts of autonomy and informed consent, we discuss whether the decision to donate oocyte/embryo can truly be an autonomous choice of a female patient. Secondly, we argue the commonly adopted language of gift is misleading and that calling for altruism could put female patients at risk of exploitation. Finally, we point out that the presence of gender stereotypes in the procreative area casts doubt whether even a more robust notion of informed consent manages to overcome this risk.

Addiction and autonomy: can addicted people consent to the prescription of their drug of addiction?

PubMed

Foddy, Bennett; Savulescu, Julian

2006-02-01

It is often claimed that the autonomy of heroin addicts is compromised when they are choosing between taking their drug of addiction and abstaining. This is the basis of claims that they are incompetent to give consent to be prescribed heroin. We reject these claims on a number of empirical and theoretical grounds. First we argue that addicts are likely to be sober, and thus capable of rational thought, when approaching researchers to participate in research. We reject behavioural evidence purported to establish that addicts lack autonomy. We present an argument that extrinsic forces must be irresistible in order to make a choice non-autonomous. We argue that heroin does not present such an irresistible force. We make a case that drug-oriented desires are strong regular appetitive desires, which do not compromise consent. Finally we argue that an addict's apparent desire to engage in a harmful act cannot be construed as evidence of irrational or compulsive thought. On these arguments, a sober heroin addict must be considered competent, autonomous and capable of giving consent. More generally, any argument against legalisation of drugs or supporting infringement of the liberty of those desiring to take drugs of addiction must be based on considerations of harm and paternalism, and not on false claims that addicts lack freedom of the will.

Should consent be required for organ procurement?

PubMed

Zambrano, Alexander

2018-06-08

Must we obtain a patient's consent before posthumously removing her organs? According to the consent requirement, in order to permissibly remove organs from a deceased person, it is necessary that her prior consent be obtained. If the consent requirement is true, then this seems to rule out policies that do not seek and obtain a patient's prior consent to organ donation, while at the same time vindicating policies that do seek and obtain patient consent. In this paper, however, I argue that once we recognize the difference between consent, on the one hand, and wishing or desiring, on the other, we will see that obtaining consent before organ removal is neither necessary nor sufficient to respect patient autonomy in organ procurement. © 2018 John Wiley & Sons Ltd.

Problems in deceptive medical procedures: an ethical and legal analysis of the administration of placebos

PubMed Central

Simmons, Beth

1978-01-01

The use of placebos in therapy or research poses ethical questions. What are the benefits and the costs in ethical terms of condoning deception of the patient or subject? What does the deception mean for the patient's or subject's right to give informed consent to his treatment? Doctors are rightly expected to disclose to their patient facts which would in their judgement best enable him to give informed consent to treatment. On occasion, the degree of this disclosure may be limited by the need to avoid hazarding the success of treatment of an unstable patient whose condition threatens his life, but doctors should have no right to withhold information just to prevent a patient refusing consent to therapy. No such limitation should apply in experiments where full disclosure must operate to enable the subject to give his informed consent. The potential medical benefits for the patient of placebo therapy have to be weighed against all the ethical costs of the deception and dishonesty involved, including the longer term repercussions on doctor/patient trust: similar ethical costs may arise in experiments involving the use of placebos without disclosure of this as a possibility to the subject. Deception is ethically degrading to both parties not only being a breach of trust, but denying the moral autonomy of the patient or subject to make his own choice. The writer concludes that placebos should be used only with full disclosure and consent whether in therapy or in research, and that this need not impede the success of either. PMID:739513

The Effects of Closed-Loop Medical Devices on the Autonomy and Accountability of Persons and Systems.

PubMed

Kellmeyer, Philipp; Cochrane, Thomas; Müller, Oliver; Mitchell, Christine; Ball, Tonio; Fins, Joseph J; Biller-Andorno, Nikola

2016-10-01

Closed-loop medical devices such as brain-computer interfaces are an emerging and rapidly advancing neurotechnology. The target patients for brain-computer interfaces (BCIs) are often severely paralyzed, and thus particularly vulnerable in terms of personal autonomy, decisionmaking capacity, and agency. Here we analyze the effects of closed-loop medical devices on the autonomy and accountability of both persons (as patients or research participants) and neurotechnological closed-loop medical systems. We show that although BCIs can strengthen patient autonomy by preserving or restoring communicative abilities and/or motor control, closed-loop devices may also create challenges for moral and legal accountability. We advocate the development of a comprehensive ethical and legal framework to address the challenges of emerging closed-loop neurotechnologies like BCIs and stress the centrality of informed consent and refusal as a means to foster accountability. We propose the creation of an international neuroethics task force with members from medical neuroscience, neuroengineering, computer science, medical law, and medical ethics, as well as representatives of patient advocacy groups and the public.

Challenges of mediated communication, disclosure and patient autonomy in cross-cultural cancer care

PubMed Central

Kai, J; Beavan, J; Faull, C

2011-01-01

Background: Evidence concerning the influence of ethnic diversity on clinical encounters in cancer care is sparse. We explored health providers' experiences in this context. Methods: Focus groups were conducted with a purposeful sample of 106 health professionals of differing disciplines, in 18 UK primary and secondary care settings. Qualitative data were analysed using constant comparison and processes for validation. Results: Communication and the quality of information exchanged with patients about cancer and their treatment was commonly frustrated within interpreter-mediated consultations, particularly those involving a family member. Relatives' approach to ownership of information and decision making could hinder assessment, informed consent and discussion of care with patients. This magnified the complexity of disclosing information sensitively and appropriately at the end of life. Professionals' concern to be patient-centred, and regard for patient choice and autonomy, were tested in these circumstances. Conclusion: Health professionals require better preparation to work effectively not only with trained interpreters, but also with the common reality of patients' families interpreting for patients, to improve quality of cancer care. Greater understanding of cultural and individual variations in concepts of disclosure, patient autonomy and patient-centredness is needed. The extent to which these concepts may be ethnocentric and lack universality deserves wider consideration. PMID:21863029

[Decision making in the elderly: which tools for its evaluation by the clinician?].

PubMed

Hommet, Caroline; Constans, Thierry; Atanasova, Boriana; Mondon, Karl

2010-09-01

Numerous decision-making situations occur in the activities of daily living. The consequences of the decision-making capacity disturbances may have a great impact on the patient's autonomy, financial management, and his or her reaction to a diagnosis as well as the ability to accept a therapeutic option or give informed consent. Decision-making is a complex and multi-dimensional process and brings into play attention, memory and executive functions, which are processed in the prefrontal cortex, particularly vulnerable in aging. A better comprehension of the mechanisms of decision-making, and of the resulting social consequences of their dysfunction may improve autonomy of the elderly. Unfortunately, we still lack appropriate tools to explore decision-making in routine practice.

What about the dentist-patient relationship in dental tourism?

PubMed

Conti, Adelaide; Delbon, Paola; Laffranchi, Laura; Paganelli, Corrado

2014-03-01

Dental tourism is patients travelling across international borders with the intention of receiving dental care. It is a growing phenomenon that raises many ethical issues, particularly regarding the dentist-patient relationship. We discuss various issues related to this phenomenon, including patient autonomy over practitioner choice, patient safety, continuity of care, informed consent and doctor-patient communication, among other factors. In particular, patients partaking in medical tourism should be informed of its potential problems and the importance of proper planning and post-treatment care to guarantee high-quality treatment outcomes.

Disclosure of Individual Surgeon's Performance Rates During Informed Consent

PubMed Central

Burger, Ingrid; Schill, Kathryn; Goodman, Steven

2007-01-01

Objective: The purpose of the paper is to examine the ethical arguments for and against disclosing surgeon-specific performance rates to patients during informed consent, and to examine the challenges that generating and using performance rates entail. Methods: Ethical, legal, and statistical theory is explored to approach the question of whether, when, and how surgeons should disclosure their personal performance rates to patients. The main ethical question addressed is what type of information surgeons owe their patients during informed consent. This question comprises 3 related, ethically relevant considerations that are explored in detail: 1) Does surgeon-specific performance information enhance patient decision-making? 2) Do patients want this type of information? 3) How do the potential benefits of disclosure balance against the risks? Results: Calculating individual performance measures requires tradeoffs and involves inherent uncertainty. There is a lack of evidence regarding whether patients want this information, whether it facilitates their decision-making for surgery, and how it is best communicated to them. Disclosure of personal performance rates during informed consent has the potential benefits of enhancing patient autonomy, improving patient decision-making, and improving quality of care. The major risks of disclosure include inaccurate and misleading performance rates, avoidance of high-risk cases, unjust damage to surgeon's reputations, and jeopardized patient trust. Conclusion: At this time, we think that, for most conditions, surgical procedures, and outcomes, the accuracy of surgeon- and patient-specific performance rates is illusory, obviating the ethical obligation to communicate them as part of the informed consent process. Nonetheless, the surgical profession has the duty to develop information systems that allow for performance to be evaluated to a high degree of accuracy. In the meantime, patients should be informed of the quantity of procedures their surgeons have performed, providing an idea of the surgeon's experience and qualitative idea of potential risk. PMID:17414595

Dignity and informed consent in the treatment of mature minors.

PubMed

Bello, Bidemi Ademola

2010-12-01

In today's world, as evinced in various human rights provisions, emphasis is placed on the assertion and protection of the entrenched rights of every human and particularly the dignity of humans and respect of human autonomy. Medical/health workers are concerned about protecting every patient's right to the dignity of his or her person. This led to the formulation of the concept of self determination and informed consent in medical diagnosis and treatments. However, serious concern is placed on these principles especially as it affects mature minors, a group of individuals who by conduct demand a level of respect but may at the same time be viewed as not capable of making the "best" informed decisions, especially about health. The following issues may arise as a result of the aforementioned concerns: --are mature young ones entitled to right of self determination and informed consent despite the alleged fear that they may lack capacity to make informed decisions? --if no, who should decide on their behalf--their parents, their medical/health provider or the society/government (especially since the 3 (three) interested groups may have different and conflicting stands on what is best for the child); --if the answer to the initial question is yes, to what extent should mature minors be informed of their medical choices and be allowed to exercise their right of self determination? --should they be guided? --and who should so guide them? In resolving the above issue, due consideration has been given not only to legal and bio-ethical provisions of some countries but also to international conventions which several countries are party to. Thereafter, it became clear that most authorities are of the view that mature minors should be fully informed and be allowed to have a say in health decisions, coaching them with few exceptions. Ultimately, because of the importance of respect for human dignity, autonomy and self determination along with medical disclosure in today's world, it will be recommended that laws in a number of jurisdictions need to be reviewed to reflect the current international trend and amended or replaced as the need might be.

“At our age, we would like to do things the way we want:” a qualitative study of adolescent HIV testing services in Kenya

PubMed Central

Wilson, Kate S.; Beima-Sofie, Kristin M.; Moraa, Helen; Wagner, Anjuli D.; Mugo, Cyrus; Mutiti, Peter M.; Wamalwa, Dalton; Bukusi, David; John-Stewart, Grace C.; Slyker, Jennifer A.; Kohler, Pamela K.; O’Malley, Gabrielle

2017-01-01

Objectives: Adolescents in Africa have low HIV testing rates. Better understanding of adolescent, provider, and caregiver experiences in high-burden countries such as Kenya could improve adolescent HIV testing programs. Design: We conducted 16 qualitative interviews with HIV-positive and HIV-negative adolescents (13–18 years) and six focus group discussions with Healthcare workers (HCWs) and caregivers of adolescents in Nairobi, Kenya. Methods: Semi-structured interviews and focus groups were recorded and transcribed. Analysis employed a modified constant comparative approach to triangulate findings and identify themes influencing testing experiences and practices. Results: All groups identified that supportive interactions during testing were essential to the adolescent's positive testing experience. HCWs were a primary source of support during testing. HCWs who acted respectful and informed helped adolescents accept results, link to care, or return for repeat testing, whereas HCWs who acted dismissive or judgmental discouraged adolescent testing. Caregivers universally supported adolescent testing, including testing with the adolescent to demonstrate support. Caregivers relied on HCWs to inform and encourage adolescents. Although peers played less significant roles during testing, all groups agreed that school-based outreach could increase peer demand and counteract stigma. All groups recognized tensions around adolescent autonomy in the absence of clear consent guidelines. Adolescents valued support people during testing but wanted autonomy over testing and disclosure decisions. HCWs felt pressured to defer consent to caregivers. Caregivers wanted to know results regardless of adolescents’ wishes. Conclusion: Findings indicate that strengthening HCW, caregiver, and peer capacities to support adolescents while respecting their autonomy may facilitate attaining ‘90-90-90’ targets for adolescents. PMID:28665879

A dialectical perspective on informed consent to treatment: an examination of radiologists' dilemmas and negotiations.

PubMed

Olufowote, James Olumide

2011-06-01

Informed consent to treatment (ICT), designed to honor patient autonomy, has been an important subject of inquiry in many disciplines. To foreground the dynamic and dilemmatic tendencies of ICT practice implied by previous inquiries, I advanced relational dialectics theory into the realm of physicians' experiences with ICT. On performing a dialectical analysis of transcripts from focus group discussions with radiologists, I found them experiencing four primary tensions: (a) between simple and complex ICT; (b) between radiologist and patient control; (c) between standardized and idiosyncratic practice (involving struggles between documentation and conversational process, and between vague and detailed language use); and (d) between withholding and disclosing alternatives. Moreover, I drew on concepts from relational dialectics theory to capture the various ways radiologists negotiate these dialectics. I conclude with practical applications for physician and patient training and interprofessional coordination.

Lessons from HeLa Cells: The Ethics and Policy of Biospecimens.

PubMed

Beskow, Laura M

2016-08-31

Human biospecimens have played a crucial role in scientific and medical advances. Although the ethical and policy issues associated with biospecimen research have long been the subject of scholarly debate, the story of Henrietta Lacks, her family, and the creation of HeLa cells captured the attention of a much broader audience. The story has been a catalyst for policy change, including major regulatory changes proposed in the United States surrounding informed consent. These proposals are premised in part on public opinion data, necessitating a closer look at what such data tell us. The development of biospecimen policy should be informed by many considerations-one of which is public input, robustly gathered, on acceptable approaches that optimize shared interests, including access for all to the benefits of research. There is a need for consent approaches that are guided by realistic aspirations and a balanced view of autonomy within an expanded ethical framework.

[Clinical trials in developing countries: who should define ethics?].

PubMed

Béréterbide, F; Hirsch, F

2008-04-01

Many clinical trials have proved much more difficult to implement in developing countries than in the Northern countries if not totally impossible. Should we therefore just observe this situation and approve a "double ethical standard"? Clinical trials in developing countries are also a means for volunteers to have access to medical care, therefore how could the process of informed consent keep its significance? In this context, should the participation in clinical trials be restricted or even stopped? If so, we would thus justify the superiority of an international duty of charity compared with the right of autonomy of these populations. This theoretical analysis cannot be precisely justified. On the contrary, it reveals that while informed consent, international organisations and guidelines have the tendency to play a major role in this debate, local ethics committee are too absent although they represent the more relevant and legitimate discussion partners in this dilemma.

Lessons from HeLa Cells: The Ethics and Policy of Biospecimens

PubMed Central

Beskow, Laura M.

2016-01-01

Human biospecimens have played a crucial role in scientific and medical advances. Although the ethical and policy issues associated with biospecimen research have long been the subject of scholarly debate, the story of attention of a much broader audience. The story has been a catalyst for policy change, including major regulatory changes proposed in the United States surrounding informed consent. These proposals are premised in part on public opinion data, necessitating a closer look at what such data tell us. The development of biospecimen policy should be informed by many considerations—one of which is public input, robustly gathered, on acceptable approaches that optimize shared interests, including access for all to the benefits of research. There is a need for consent approaches that are guided by realistic aspirations and a balanced view of autonomy within an expanded ethical framework. PMID:26979405

A Republican Argument Against Nudging and Informed Consent.

PubMed

Hamilton, Paul

2017-12-30

I argue that it is impermissible to use nudges as a tool to influence patients in the context of informed consent. The motivation for such nudges is that their use can help reconcile potential conflicts between a physician's duty of beneficence and duty to respect patient autonomy. I argue that their use places physicians in a position of domination over patients. That is, it violates the republican freedom of patients because it grants physicians the power to arbitrarily interfere. I also argue that if one tries to adjust the duty of beneficence to avoid this conclusion, then the republican freedom of patients is still threatened under conditions of clinical equipoise. As ways to avoid the inevitability of nudging, I suggest the alternative of boosting or the pairing of patients with physicians who share their deep values. This latter option achieves the benefits nudging patients is supposed to provide without violating the republican freedom of those patients.

Global ethics and principlism.

PubMed

Gordon, John-Stewart

2011-09-01

This article examines the special relation between common morality and particular moralities in the four-principles approach and its use for global ethics. It is argued that the special dialectical relation between common morality and particular moralities is the key to bridging the gap between ethical universalism and relativism. The four-principles approach is a good model for a global bioethics by virtue of its ability to mediate successfully between universal demands and cultural diversity. The principle of autonomy (i.e., the idea of individual informed consent), however, does need to be revised so as to make it compatible with alternatives such as family- or community-informed consent. The upshot is that the contribution of the four-principles approach to global ethics lies in the so-called dialectical process and its power to deal with cross-cultural issues against the background of universal demands by joining them together.

Equity under the knife: justice and evidence in surgery.

PubMed

Rogers, Wendy; Degeling, Christopher; Townley, Cynthia

2014-03-01

Surgery is an increasingly common and expensive mode of medical intervention. The ethical dimensions of the surgeon-patient relationship, including respect for personal autonomy and informed consent, are much discussed; but broader equity issues have not received the same attention. This paper extends the understanding of surgical ethics by considering the nature of evidence in surgery and its relationship to a just provision of healthcare for individuals and their populations. © 2012 John Wiley & Sons Ltd.

Biomedical Big Data: New Models of Control Over Access, Use and Governance.

PubMed

Vayena, Effy; Blasimme, Alessandro

2017-12-01

Empirical evidence suggests that while people hold the capacity to control their data in high regard, they increasingly experience a loss of control over their data in the online world. The capacity to exert control over the generation and flow of personal information is a fundamental premise to important values such as autonomy, privacy, and trust. In healthcare and clinical research this capacity is generally achieved indirectly, by agreeing to specific conditions of informational exposure. Such conditions can be openly stated in informed consent documents or be implicit in the norms of confidentiality that govern the relationships of patients and healthcare professionals. However, with medicine becoming a data-intense enterprise, informed consent and medical confidentiality, as mechanisms of control, are put under pressure. In this paper we explore emerging models of informational control in data-intense healthcare and clinical research, which can compensate for the limitations of currently available instruments. More specifically, we discuss three approaches that hold promise in increasing individual control: the emergence of data portability rights as means to control data access, new mechanisms of informed consent as tools to control data use, and finally, new participatory governance schemes that allow individuals to control their data through direct involvement in data governance. We conclude by suggesting that, despite the impression that biomedical big data diminish individual control, the synergistic effect of new data management models can in fact improve it.

Toward a gender-sensitive assisted reproduction policy.

PubMed

Donchin, Anne

2009-01-01

The recent case of the UK woman who lost her legal struggle to be impregnated with her own frozen embryos, raises critical issues about the meaning of reproductive autonomy and the scope of regulatory practices. I revisit this case within the context of contemporary debate about the moral and legal dimensions of assisted reproduction. I argue that the gender neutral context that frames discussion of regulatory practices is unjust unless it gives appropriate consideration to the different positions women and men occupy in relation to reproductive processes and their options for autonomous choice. First, I consider relevant legal rulings, media debate, and scholarly commentary. Then I discuss the concept of reproductive autonomy imbedded in this debate. I argue that this concept conflates informed consent and reproductive autonomy, thereby providing an excessively narrow reading of autonomy that fails to give due regard to relations among individuals or the social, political and economic environment that shapes their options. I contrast this notion of autonomy with feminist formulations that seek to preserve respect for the agency of individuals without severing them from the conditions of their embodiment, their surrounding social relationships, or the political contexts that shape their options. Taking these considerations into account I weigh the advantages of regulation over the commercial market arrangement that prevails in some countries and suggest general guidelines for a regulatory policy that would more equitably resolve conflicting claims to reproductive autonomy.

A survey of patient perspectives on the research use of health information and biospecimens.

PubMed

Page, Stacey A; Manhas, Kiran Pohar; Muruve, Daniel A

2016-08-15

Personal health information and biospecimens are valuable research resources essential for the advancement of medicine and protected by national standards and provincial statutes. Research ethics and privacy standards attempt to balance individual interests with societal interests. However these standards may not reflect public opinion or preferences. The purpose of this study was to assess the opinions and preferences of patients with kidney disease about the use of their health information and biospecimens for medical research. A 45-item survey was distributed to a convenience sample of patients at an outpatient clinic in a large urban centre. The survey briefly addressed sociodemographic and illness characteristics. Opinions were sought on the research use of health information and biospecimens including consent preferences. Two hundred eleven of 400 distributed surveys were completed (response rate 52.8 %). Respondents were generally supportive of medical research and trusting of researchers. Many respondents supported the use of their information and biospecimens for health research and also preferred consent be sought for use of health information and biospecimens. Some supported the use of their information and biospecimens for research without consent. There were significant differences in the opinions people offered regarding the research use of biospecimens compared to health information. Some respondent perspectives about consent were at odds with current regulatory and legal standards. Clinical health data and biospecimens are valuable research resources, critical to the advancement of medicine. Use of these data for research requires balancing respect for individual autonomy, privacy and the societal interest in the greater good. Incongruence between some respondent perspectives and the regulatory standards suggest both a need for public education and review of legislation to increase understanding and ensure the public's trust is maintained.

Patient's autonomy of will in Polish law.

PubMed

Swiderska, Małgorzata

2012-09-01

A principle of Polish legislation is that the evidence of legality for any medical intervention is the patient's consent. The issue is directly referred to by both the Patient's Rights Act from 2008 and the Medical Profession Act from 1996. The patient's consent may be given after obtaining reliable, accessible and thorough information about all stages of medical intervention: diagnosis, therapy prospects or rehabilitation. The extent of information about the potential risk of medical treatment should include the typically foreseeable results, which usually brings the matter down to typical risk. However, there are interventions, which bear greater risk, and even though it can't be considered typical, it should also be mentioned, despite the fact that the postulate of tactfulness should be respected here. The burden of proof that appropriate information has been given lies upon the doctor. Thus default consent, especially one given on being admitted to hospital, to all medical actions isn't valid in legal terms. The role of forms including standard information for giving consent is limited. Polish law doesn't regulate this issue, and other forms of indirect communication are used as auxiliary and cannot replace direct contact between a patient and a doctor. According to the Patient's Rights Act, in case of deliberate breach of those rights, the court can grant the aggrieved party with an appropriate sum as financial compensation for the harm sustained or an appropriate sum of money for the charity chosen by the aggrieved party. It is a legal basis for claiming compensation for non-material harm in case of a breach of the patient's right to give consent. It is possible both in case of liability in tort, as well as contractual claims.

A discussion supporting presumed consent for posthumous sperm procurement and conception.

PubMed

Tremellen, Kelton; Savulescu, Julian

2015-01-01

Conception of a child using cryopreserved sperm from a deceased man is generally considered ethically sound provided explicit consent for its use has been made, thereby protecting the man's autonomy. When death is sudden (trauma, unexpected illness), explicit consent is not possible, thereby preventing posthumous sperm procurement (PSP) and conception according to current European Society of Human Reproduction and Embryology and the American Society for Reproductive Medicine guidelines. Here, we argue that autonomy of a deceased person should not be considered the paramount ethical concern, but rather consideration of the welfare of the living (widow and prospective child) should be the primary focus. Posthumous conception can bring significant advantages to the widow and her resulting child, with most men supporting such practice. We suggest that a deceased man can benefit from posthumous conception (continuation of his 'bloodline', allowing his widow's wishes for a child to be satisfied), and has a moral duty to allow his widow access to his sperm, if she so wishes, unless he clearly indicated that he did not want children when alive. We outline the arguments favouring presumed consent over implied or proxy consent, plus practical considerations for recording men's wishes to opt-out of posthumous conception. Copyright © 2014 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Consent, competence and lies to children: veracity in paediatric care.

PubMed

McMurdo, Maeve; Gillett, Grant

2013-12-01

Principles of consent and autonomy based on adult-oriented bioethics must be modified to take account of the cognitive development occurring in childhood. That development differentially affects executive and more theoretical intelligence and is greatly influenced by experience. Thus, a judgment about a matter of degree is required by clinicians dealing with children, particularly when children diverge from the choices that would be endorsed by the adults and clinicians surrounding them. If we accept that partnership and the evolution of consent away from a formal procedure are both indicative of current ethical and medico-legal thinking, then it follows that the involvement of a child in an open-ended conversation taking account of the realistic prospects and the subjective experiences associated with treatment is the right way to proceed and that it should reflect the ability of the child to understand what is at stake and how it will affect her or him. That carries implications for the child's access to adequate information about the condition, the treatment, and the decisions being made.

Participation of Adolescent Girls in a Study of Sexual Behaviors: Balancing Autonomy and Parental Involvement

PubMed Central

Short, Mary B.; Wiemann, Constance; Rosenthal, Susan L.

2009-01-01

Study Objective The process of research with adolescents should balance parental involvement and adolescent autonomy. The attendance of parents and peers at research study visits of girls participating in a 6-month study of topical microbicide acceptability is described, as well as the participants’ conversations with their parents. Methods Girls, 14 through 21 years, were recruited from previous studies (3%), advertisements (14%), clinics (17%), and recommendations by friends (66%) to participate. Girls under 18 years were required to have parental consent, but parents could provide verbal phone consent as long as a signed consent form was returned before participation. Results The 208 participants were 41% African-American, 30% Hispanic, and 29% Caucasian. Girls averaged 18 years of age, and 95 (46%) were under 18. Seventeen percent of parents attended the first visit; all but one was with a daughter of less than 18 years. The mothers of older adolescents were less likely to attend the appointment with them. More Caucasian than African-American girls came with a mother. Parental attendance decreased at follow-up visits. Thirty-seven percent of girls brought a peer to the first visit; there were no age or race/ethnic differences. There was no relationship between attending with a parent or peer and talking to a parent about the study. Some adolescents obtained parental consent to participate in the study while keeping their sexual behaviors private. Conclusions Parental attendance at study visits may not be marker of parental involvement with the study. Creative ways for balancing concerns about confidentiality, promotion of autonomy, and adult involvement should be considered. PMID:19345916

Can patients be sure they are fully informed when representatives of surgical equipment manufacturers attend their operations?

PubMed Central

Sillender, M

2006-01-01

Objective To determine the practice in UK hospitals regarding the level of patient involvement and consent when representatives of commercial surgical device manufacturers attend and advise during operations. Methods An anonymous postal questionnaire was sent to the senior nurse in charge in all 236 UK gynaecology theatres in 2004. 79/236 (33%) replies were received. Results Operating departments were visited every 2 weeks on average by a representative of the surgical device manufacturer. Actual operations were attended every 10 weeks, although there was much variation. 33/79 (42%) units consistently obtained patient consent for visits, usually orally, whereas 40/79 (51%) units did not. 65/79 (82%) units had no guidelines for surgical device representative visits. 91% of nurses in charge believed that there should be guidelines to protect both patients and staff. 6/79 (8%) units were preparing local guidelines at the time of the survey. Conclusions Currently, patient safety, confidentiality and autonomy are being protected by a minority of NHS operating theatres when surgical device representatives attend surgery. National guidelines would hopefully ensure that fully informed patient consent is obtained and that representatives are fully trained and supervised. PMID:16816038

Procreative torts: enhancing the common-law protection for reproductive autonomy.

PubMed

Northern, K S

1998-01-01

Roe v. Wade's twenty-fifth anniversary is likely to herald widespread scholarly commentary on the decision's continued vitality and the future of abortion in the United States. However, if such commentary focuses solely upon the constitutional dimensions and political aspects of a woman's right to privacy, an important dimension of this right will be overlooked. Few commentators have considered the extent to which tort law safeguards a woman's interest in reproductive autonomy. In this article, Professor Northern argues that the interest in reproductive autonomy has not yet received the full protection to which it is entitled and that tort law is poised to evolve distinct causes of action for the interference with procreative autonomy interests. Professor Northern begins with an overview of the medical and psychological literature on abortion-related risks. She goes on to discuss current trends in abortion malpractice litigation. The author then reviews the three basic types of malpractice causes of action--battery, negligence, and lack of informed consent--and explores their application to abortion malpractice claims. The focus of the article then shifts to the development of specialized procreative torts, and Professor Northern contends that courts should go beyond previous decisions to redress any substantial interference with procreative autonomy. Finally, the author asserts that legislative alternatives to the common-law development of procreative torts, such as right-to-know statutes, are less protective of women's interests. Professor Northern concludes that tort law could and should be used to more fully protect women's interests in procreative autonomy.

The perspectives of researchers on obtaining informed consent in developing countries.

PubMed

Newton, Sam K; Appiah-Poku, John

2007-04-01

The doctrine of informed consent (IC) exists to protect individuals from exploitation or harm. This study into IC was carried out to investigate how different researchers perceived the process whereby researchers obtained consent. It also examined researchers' perspectives on what constituted IC, and how different settings influenced the process. The study recorded in-depth interviews with 12 lecturers and five doctoral students, who had carried out research in developing countries, at a leading school of public health in the United Kingdom. A purposive, snowballing approach was used to identify interviewees. Although the concept and application of the doctrine of IC should have been the same, irrespective of where the research was carried out, the process of obtaining it had to be different. The setting had to be taken into consideration and the autonomy of the subject had to be respected at all times. In areas of high illiteracy, and where understanding of the subject was likely to be a problem, there was an added responsibility placed on the researcher to devise innovative ways of carrying out the study, taking into consideration the peculiarities of the environment. The ethical issues for IC were the same, irrespective of where the research was conducted. However, because the backgrounds, setting, and knowledge of populations differed, there was the need to be similarly sensitive in obtaining consent. The problems of obtaining genuine IC were not limited to developing countries.

Emergency research without consent under Polish law.

PubMed

Rózyńska, Joanna; Czarkowski, Marek

2007-09-01

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject's life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject's participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject's consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject's autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible.

'Vague Oviedo': autonomy, culture and the case of previously competent patients.

PubMed

Pascalev, Assya; Vidalis, Takis

2010-03-01

The paper examines the ethical and legal challenges of making decisions for previously competent patients and the role of advance directives and legal representatives in light of the Oviedo Convention. The paper identifies gaps in the Convention that result in conflicting instructions in cases of a disagreement between the expressed prior wishes of a patient, and the legal representative. The authors also examine the legal and moral status of informally expressed prior wishes of patients unable to consent. The authors argue that positivist legal reasoning is insufficient for a consistent interpretation of the relevant provisions of the Convention and argue that ethical argumentation is needed to provide guidance in such cases. Based on the ethical arguments, the authors propose a way of reconciling the apparent inconsistencies in the Oviedo Convention. They advance a culturally sensitive approach to the application of the Convention at the national level. This approach understands autonomy as a broader, relational consent and emphasizes the social and cultural embeddedness of the individual. Based on their approach, the authors argue that there exists a moral obligation to respect the prior wishes of the patient even in countries without advance directives. Yet it should be left to the national legislations to determine the extent of this obligation and its concrete forms.

The ethics of neuromodulation for anorexia nervosa: a focus on rTMS

PubMed Central

2014-01-01

Objective Recently there has been emerging clinical and research interest in the application of deep brain stimulation (DBS) and repetitive transcranial magnetic stimulation (rTMS) to the treatment of anorexia nervosa (AN). To our knowledge, few studies have discussed ethical aspects associated with the increased use of neuromodulation in AN, some of which are quite specific to AN, despite the rapid development and dissemination of these new technologies. Method We provide a brief overview of three published rTMS studies for AN and discuss ethical issues involved in the use of neuromodulation for AN. Results In contrast to neurosurgery or DBS, rTMS is a less invasive technique, with less associated risk, and thus has greater potential to become a more widespread augmentation or add-on therapy for AN. New therapeutic procedures are promising, yet they raise ethical questions regarding informed consent and patient selection. Illness-specific issues surrounding authenticity and autonomy are important to consider, ensuring an ethical approach to treatment for patients with AN. Discussion We argue that ethical investigations for neuromodulation techniques are timely and important, and discussions should go beyond the immediate goals of patient safety, consent, and risk and benefit, to consider broader ethical concepts such as authenticity and autonomy. PMID:24690315

Healthcare justice and human rights in perinatal medicine.

PubMed

Chervenak, Frank A; McCullough, Laurence B

2016-06-01

This article describes an approach to ethics of perinatal medicine in which "women and children first" plays a central role, based on the concept of healthcare justice. Healthcare justice requires that all patients receive clinical management based on their clinical needs, which are defined by deliberative (evidence-based, rigorous, transparent, and accountable) clinical judgment. All patients in perinatal medicine includes pregnant, fetal, and neonatal patients. Healthcare justice also protects the informed consent process, which is intended to empower the exercise of patient autonomy in the decision-making process about patient care. In the context of healthcare justice, the informed consent process should not be influenced by ethically irrelevant factors. Healthcare justice should be understood as a basis for the human rights to healthcare and to participate in decisions about one's healthcare. Healthcare justice in perinatal medicine creates an essential role for the perinatologist to be an effective advocate for pregnant, fetal, and neonatal patients, i.e., for "women and children first." Copyright © 2016 Elsevier Inc. All rights reserved.

An economic theory of patient decision-making.

PubMed

Stewart, Douglas O; DeMarco, Joseph P

2005-01-01

Patient autonomy, as exercised in the informed consent process, is a central concern in bioethics. The typical bioethicist's analysis of autonomy centers on decisional capacity--finding the line between autonomy and its absence. This approach leaves unexplored the structure of reasoning behind patient treatment decisions. To counter that approach, we present a microeconomic theory of patient decision-making regarding the acceptable level of medical treatment from the patient's perspective. We show that a rational patient's desired treatment level typically departs from the level yielding an absence of symptoms, the level we call ideal. This microeconomic theory demonstrates why patients have good reason not to pursue treatment to the point of absence of physical symptoms. We defend our view against possible objections that it is unrealistic and that it fails to adequately consider harm a patient may suffer by curtailing treatment. Our analysis is fruitful in various ways. It shows why decisions often considered unreasonable might be fully reasonable. It offers a theoretical account of how physician misinformation may adversely affect a patient's decision. It shows how billing costs influence patient decision-making. It indicates that health care professionals' beliefs about the 'unreasonable' attitudes of patients might often be wrong. It provides a better understanding of patient rationality that should help to ensure fuller information as well as increased respect for patient decision-making.

THE ETHICS OF OCCUPATIONAL HEALTH AND SAFETY IN TURKEY: RESPONSIBILITY AND CONSENT TO RISK.

PubMed

Artvinli, Fatih

2016-06-01

Work-related diseases, injuries, risks and deaths are the issues that have been recently gaining importance especially in developing countries. The ethical dimensions of occupational health and safety have remained as relatively understudied areas. Concepts such as responsibility, consent, autonomy, paternalism, choice, and certain values or justifications that are used in medical ethics and bioethics are also applicable to occupational health and safety. This article examines the ethical issues of responsibility and consent to occupational risk. It will first define the concepts of consent and risk, and then different views on responsibility and consent to risk will be discussed. The article will also examine the responsibility of the society and government regarding these concepts.

Informed consent for inclusion into clinical trials: a serious subject to note in the developing world.

PubMed

Izadi, Morteza; Fazel, Mozhgan; Nasiri-Vanashi, Taha; Saadat, Seyed Hasan; Taheri, Saeed

2012-05-01

Informed consent is a critical issue especially in conducting clinical trials that expose human life to medical or surgical interventions. It necessitates a long and complex process through which the participant is presented with all potential favorable and non-favorable consequences upon getting enrolled in the study. The process of taking informed consent is well-understood in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of whether to participate or not. This may not be the case in the developing world.The information given to patients before the trial might not be properly developed and presented, an issue that can result in serious threat to the decision-making process. On the other hand, investigators should remember that enrolling people into a trial with no potential benefit for themselves cannot be considered ethical. In the current debate, we aim to address the issue of how respectfully and ethically clinical research trials can be done on human subjects and what we can do to enhance the practice in an ethical context. Development of a system through which we could warrant all rights of study participants in all cases around the world seems far from view. However, if we are in doubt about the ethics of a clinical trial, we can ask ourselves: "what would we do, if we were in the same position our patients are in now?"

Informed consent for clinical trials of deep brain stimulation in psychiatric disease: challenges and implications for trial design.

PubMed

Lipsman, Nir; Giacobbe, Peter; Bernstein, Mark; Lozano, Andres M

2012-02-01

Advances in neuromodulation and an improved understanding of the anatomy and circuitry of psychopathology have led to a resurgence of interest in surgery for psychiatric disease. Clinical trials exploring deep brain stimulation (DBS), a focally targeted, adjustable and reversible form of neurosurgery, are being developed to address the use of this technology in highly selected patient populations. Psychiatric patients deemed eligible for surgical intervention, such as DBS, typically meet stringent inclusion criteria, including demonstrated severity, chronicity and a failure of conventional therapy. Although a humanitarian device exemption by the US Food and Drug Administration exists for its use in obsessive-compulsive disorder, DBS remains a largely experimental treatment in the psychiatric context, with its use currently limited to clinical trials and investigative studies. The combination of a patient population at the limits of conventional therapy and a novel technology in a new indication poses interesting challenges to the informed consent process as it relates to clinical trial enrollment. These challenges can be divided into those that relate to the patient, their disease and the technology, with each illustrating how traditional conceptualisations of research consent may be inadequate in the surgical psychiatry context. With specific reference to risk analysis, patient autonomy, voluntariness and the duty of the clinician-researcher, this paper will discuss the unique challenges that clinical trials of surgery for refractory psychiatric disease present to the consent process. Recommendations are also made for an ethical approach to clinical trial consent acquisition in this unique patient population.

Facilitating the ethical use of health data for the benefit of society: electronic health records, consent and the duty of easy rescue

PubMed Central

Porsdam Mann, Sebastian; Sahakian, Barbara J.

2016-01-01

Advances in data science allow for sophisticated analysis of increasingly large datasets. In the medical context, large volumes of data collected for healthcare purposes are contained in electronic health records (EHRs). The real-life character and sheer amount of data contained in them make EHRs an attractive resource for public health and biomedical research. However, medical records contain sensitive information that could be misused by third parties. Medical confidentiality and respect for patients' privacy and autonomy protect patient data, barring access to health records unless consent is given by the data subject. This creates a situation in which much of the beneficial records-based research is prevented from being used or is seriously undermined, because the refusal of consent by some patients introduces a systematic deviation, known as selection bias, from a representative sample of the general population, thus distorting research findings. Although research exemptions for the requirement of informed consent exist, they are rarely used in practice due to concerns over liability and a general culture of caution. In this paper, we argue that the problem of research access to sensitive data can be understood as a tension between the medical duties of confidentiality and beneficence. We attempt to show that the requirement of informed consent is not appropriate for all kinds of records-based research by distinguishing studies involving minimal risk from those that feature moderate or greater risks. We argue that the duty of easy rescue—the principle that persons should benefit others when this can be done at no or minimal risk to themselves—grounds the removal of consent requirements for minimally risky records-based research. Drawing on this discussion, we propose a risk-adapted framework for the facilitation of ethical uses of health data for the benefit of society. This article is part of the themed issue ‘The ethical impact of data science’. PMID:28336803

Facilitating the ethical use of health data for the benefit of society: electronic health records, consent and the duty of easy rescue.

PubMed

Porsdam Mann, Sebastian; Savulescu, Julian; Sahakian, Barbara J

2016-12-28

Advances in data science allow for sophisticated analysis of increasingly large datasets. In the medical context, large volumes of data collected for healthcare purposes are contained in electronic health records (EHRs). The real-life character and sheer amount of data contained in them make EHRs an attractive resource for public health and biomedical research. However, medical records contain sensitive information that could be misused by third parties. Medical confidentiality and respect for patients' privacy and autonomy protect patient data, barring access to health records unless consent is given by the data subject. This creates a situation in which much of the beneficial records-based research is prevented from being used or is seriously undermined, because the refusal of consent by some patients introduces a systematic deviation, known as selection bias, from a representative sample of the general population, thus distorting research findings. Although research exemptions for the requirement of informed consent exist, they are rarely used in practice due to concerns over liability and a general culture of caution. In this paper, we argue that the problem of research access to sensitive data can be understood as a tension between the medical duties of confidentiality and beneficence. We attempt to show that the requirement of informed consent is not appropriate for all kinds of records-based research by distinguishing studies involving minimal risk from those that feature moderate or greater risks. We argue that the duty of easy rescue-the principle that persons should benefit others when this can be done at no or minimal risk to themselves-grounds the removal of consent requirements for minimally risky records-based research. Drawing on this discussion, we propose a risk-adapted framework for the facilitation of ethical uses of health data for the benefit of society.This article is part of the themed issue 'The ethical impact of data science'. © 2015 The Authors.

Rethinking HIV exceptionalism: the ethics of opt-out HIV testing in sub-Saharan Africa

PubMed Central

2010-01-01

Abstract Opt-out testing for the human immunodeficiency virus (HIV) incorporates testing as a routine part of health care for all patients unless they refuse. The ethics of this approach to testing in sub-Saharan Africa is a source of controversy. Opt-out HIV testing is expected to improve survival by increasing case detection and thus linking more HIV-infected people to earlier treatment, provided there is effective patient follow-up and programme sustainability. At the population level, these benefits will likely outweigh the potential negative consequences of individuals experiencing HIV-related stigma. These justifications appeal to consequentialist moral theories that the acceptability of an action depends upon its outcomes. On the other hand, liberal moral theories state that the autonomy of individuals should always be protected unless restricting autonomy is necessary to protect the welfare of others. Opt-out consent may restrict autonomy and it is unclear whether it would benefit people other than those being tested. Yet, the doctrine of libertarian paternalism proposes that it is justifiable and desirable to use unobtrusive mechanisms to help individuals make choices to maximize their own welfare. Central to this idea are the premises featured by supporters of opt-out consent that individuals will not always make the best choices for their own welfare but they may be influenced to do so in ways that will not compromise their freedom of choice. Also important is the premise that all policies inevitably exert some such influence: opt-in consent encourages test refusal just as opt-out consent encourages acceptance. Based on these premises, opt-out testing may be an effective and ethically acceptable policy response to Africa’s HIV epidemic. PMID:20865076

Rethinking HIV exceptionalism: the ethics of opt-out HIV testing in sub-Saharan Africa.

PubMed

April, Michael D

2010-09-01

Opt-out testing for the human immunodeficiency virus (HIV) incorporates testing as a routine part of health care for all patients unless they refuse. The ethics of this approach to testing in sub-Saharan Africa is a source of controversy. Opt-out HIV testing is expected to improve survival by increasing case detection and thus linking more HIV-infected people to earlier treatment, provided there is effective patient follow-up and programme sustainability. At the population level, these benefits will likely outweigh the potential negative consequences of individuals experiencing HIV-related stigma. These justifications appeal to consequentialist moral theories that the acceptability of an action depends upon its outcomes. On the other hand, liberal moral theories state that the autonomy of individuals should always be protected unless restricting autonomy is necessary to protect the welfare of others. Opt-out consent may restrict autonomy and it is unclear whether it would benefit people other than those being tested. Yet, the doctrine of libertarian paternalism proposes that it is justifiable and desirable to use unobtrusive mechanisms to help individuals make choices to maximize their own welfare. Central to this idea are the premises featured by supporters of opt-out consent that individuals will not always make the best choices for their own welfare but they may be influenced to do so in ways that will not compromise their freedom of choice. Also important is the premise that all policies inevitably exert some such influence: opt-in consent encourages test refusal just as opt-out consent encourages acceptance. Based on these premises, opt-out testing may be an effective and ethically acceptable policy response to Africa's HIV epidemic.

A clinician's understanding of ethics in palliative care: an American perspective.

PubMed

Cimino, James E

2003-04-01

I believe the standard for making ethical decisions should be the same for all patients: appropriate medical interventions, carefully weighing their benefits and burdens, and trying to honor the wishes of the patients. When cure is not possible, the balance between benefits and burdens should shift to greater consideration of the burden side of the equation. The ascendancy of autonomy over other medical ethical principles is the center for most of the ethical dilemmas encountered in palliative care. This paper discusses the issues of autonomy, informed consent, patient capacity, advance directives, futility, "do-not-resuscitate" orders, withholding or withdrawing interventions, euthanasia, and sedation therapy. After 41 years of my personally caring for over 4000 terminally ill patients, primarily at Calvary Hospital, the most practical approach has been to establish trust with patients and families, determining their goals, and diligently applying the principles of beneficence (benefits) and nonmaleficence (burdens) in everyday practice.

Compensating Injury to Autonomy in English Negligence Law: Inconsistent Recognition.

PubMed

Keren-Paz, Tsachi

2018-04-10

Recently in Shaw v Kovac, the Court of Appeal seemed to have rejected a standalone injury to autonomy (ITA) as actionable in negligence, in an informed consent case. In this article, I argue that Shaw can be explained away, and that English law recognizes ITA as actionable in a series of cases, some of which-Bhamra, Tracey, and Yearworth-were not hitherto understood to do so. However, the under-theorization in the cases leads to inconsistencies. Like cases (Rees/Yearworth; Chester/Tracey) are not treated alike; ITA is misunderstood to be about 'religious offence' (Bhamra) and property loss (Yearworth) and worse still, the more serious type 2 ITA (Rees) gives rise to a weaker remedy (of exceptional nature aside) than the less serious type 1 injury (Chester). A better understanding of the different manifestations of ITA will lead to results which are both more consistent and more justified on the merit.

Observing principles of medical ethics during family planning services at Tehran urban healthcare centers in 2007.

PubMed

Motevallizadeh, Saeed; Malek Afzali, Hossein; Larijani, Bagher

2011-01-01

Family planning has been defined in the framework of mothers and children plan as one of Primary Healthcare (PHC) details. Besides quantity, the quality of services, particularly in terms of ethics, such as observing individuals' privacy, is of great importance in offering family planning services. A preliminary study to gather information about the degree of medical ethics offered during family planning services at Tehran urban healthcare centers. A questionnaire was designed for study. In the first question regarding informed consent, 47 clients who were advised about various contraception methods were asked whether advantages and disadvantages of the contraceptive methods have been discussed by the service provider. Then a certain rank was measured for either client or method in 2007. Finally, average value of advantage and disadvantage for each method was measured. In questions about autonomy, justice and beneficence, yes/no answers have been expected and measured accordingly. Health care providers have stressed more on the advantages of pills and disadvantages of tubectomy and have paid less attention to advantages of injection ampoules and disadvantages of pills in first time clients. While they have stressed more on the advantages and disadvantages of tubectomy and less attention to advantages of condom and disadvantages of vasectomy in second time clients. Clients divulged their 100% satisfaction in terms of observing turns and free charges services. Observance degree of autonomy was 64.7% and 77.3% for first time and second- time clients respectively. Applying the consultant's personal viewpoint for selecting a method will breach an informed consent for first and second time clients. System has good consideration to justice and no malfeasance.

Caring in nursing homes to promote autonomy and participation.

PubMed

Hedman, Maria; Häggström, Elisabeth; Mamhidir, Anna-Greta; Pöder, Ulrika

2017-01-01

Autonomy and participation are threatened within the group of older people living in nursing homes. Evidence suggests that healthcare personnel act on behalf of older people but are still excluding them from decision-making in everyday care. The purpose was to describe registered nurses' experience of caring for older people in nursing homes to promote autonomy and participation. A descriptive design with a phenomenological approach was used. Data were collected by semi-structured individual interviews. Analysis was inspired by Giorgi's method. Participants and research context: A total of 13 registered nurses from 10 nursing homes participated. Ethical considerations: Ethical approval was obtained from the Regional Research Ethics Committee. Informed consent was achieved and confidentiality guaranteed. The essence of caring for older people in nursing homes to promote autonomy and participation consisted of registered nurses' awareness of older people's frailty and the impact of illness to support health and well-being, and awareness of acknowledgement in everyday life and trusting relationships. Paying attention to older people by being open to the persons' wishes were aspects that relied on registered nurses' trusting relationships with older people, their relatives and surrounding healthcare personnel. The awareness reflected challenges in caring to promote older people's right to autonomy and participation in nursing homes. Registered nurses' strategies, hopes for and/or concerns about development of everyday life in nursing homes were revealed and mirrored their engagement in caring for older people. Awareness of older people's frailty in nursing homes and the importance of maintained health and well-being were described as the main source for promoting autonomy and participation. Everyday life and care in nursing homes needs to be addressed from both older people's and healthcare personnel's perspectives, to promote autonomy and participation for residents in nursing homes.

Why is it hard to make progress in assessing children's decision-making competence?

PubMed

Hein, Irma M; Troost, Pieter W; Broersma, Alice; de Vries, Martine C; Daams, Joost G; Lindauer, Ramón J L

2015-01-10

For decades, the discussion on children's competence to consent to medical issues has concentrated around normative concerns, with little progress in clinical practices. Decision-making competence is an important condition in the informed consent model. In pediatrics, clinicians need to strike a proper balance in order to both protect children's interests when they are not fully able to do so themselves and to respect their autonomy when they are. Children's competence to consent, however, is currently not assessed in a standardized way. Moreover, the correlation between competence to give informed consent and age in children has never been systematically investigated, nor do we know which factors exactly contribute to children's competence.This article aims at identifying these gaps in knowledge and suggests options for dealing with the obstacles in empirical research in order to advance policies and practices regarding children's medical decision-making competence. Understanding children's competency is hampered by the law. Legislative regulations concerning competency are established on a strong presumption that persons older than a certain age are competent, whereas younger persons are not. Furthermore, a number of contextual factors are believed to be of influence on a child's decision-making competence: the developmental stage of children, the influence of parents and peers, the quality of information provision, life experience, the type of medical decision, and so on. Ostensibly, these diverse and extensive barriers hinder any form of advancement in this conflicted area. Addressing these obstacles encourages the discussion on children's competency, in which the most prominent question concerns the lack of a clear operationalization of children's competence to consent. Empirical data are needed to substantiate the discussion. The empirical approach offers an opportunity to give direction to the debate. Recommendations for future research include: studying a standardized assessment instrument covering all four relevant dimensions of competence (understanding, reasoning, appreciation, expressing a choice), including a study population of children covering the full age range of 7 to 18 years, improving information provision, and assessing relevant contextual data.

Live donor transplantation--the incompetent donor: comparative law.

PubMed

Wolfman, Samuel; Shaked, Tali

2008-12-01

Informed consent of the patient to medical treatment is an essential prerequisite for any invasive medical procedure. However in emergency cases, when the patient is unable to sign a consent form due to unconsciousness or to psychotic state, than the primary medical consideration shall take place. In such a case, in order to save life or even prevent a major medical hazard to the patient, doctors are allowed, in certain cases and in accordance with well accepted medical practice, to perform invasive procedures, major surgery or risky pharmacological treatment, without the explicit consent of the patient. All the above refers to the cases when avoidance of such non-consented treatment may harm severely the health and wellbeing of the patient and there is no doubt that such treatment is for the ultimate benefit of the patient. The question, however, shall arise when such a medical procedure is not necessarily for the benefit of the patient, but rather for the benefit of somebody else. Such is the case in the transplantation area and the question of living donor-donee relationship. This paper shall analyze the legal situation in cases of non competent donors whose consent cannot be considered legal consent given in full understanding and out of free will. It will also compare three legal systems, the Israeli, the American and the traditional Jewish law, with regard to the different approaches to this human problem, where the autonomy of the donor may be sacrificed for the purpose of saving life of another person.

Controversies in oncologist-patient communication: a nuanced approach to autonomy, culture, and paternalism.

PubMed

Cherny, Nathan I

2012-01-01

Difficult dialogues with patients facing life-changing decisions are an intrinsic part of oncologic practice and a major source of stress. Having a sophisticated approach to the concepts of autonomy, paternalism, and culture can help in addressing difficult dilemmas that arise around the issues of disclosure and decision making. This article addresses some of the most common major challenges in oncologist-patient communication with a nuanced approach to the concepts of autonomy, paternalism, and culture. It introduces the new concept of"voluntary diminished autonomy" and describes the implications this concept has for the consent process. It also attempts to bring clarity to common problems and misconceptions relating to culture, paternalism, and therapeutic privilege as these pertain to the communication practices of oncologists.

Ethical Justification for Conducting Public Health Surveillance Without Patient Consent

PubMed Central

Heilig, Charles M.; White, Angela

2012-01-01

Public health surveillance by necessity occurs without explicit patient consent. There is strong legal and scientific support for maintaining name-based reporting of infectious diseases and other types of public health surveillance. We present conditions under which surveillance without explicit patient consent is ethically justifiable using principles of contemporary clinical and public health ethics. Overriding individual autonomy must be justified in terms of the obligation of public health to improve population health, reduce inequities, attend to the health of vulnerable and systematically disadvantaged persons, and prevent harm. In addition, data elements collected without consent must represent the minimal necessary interference, lead to effective public health action, and be maintained securely. PMID:22095338

Some comments on the substituted judgement standard.

PubMed

Egonsson, Dan

2010-02-01

On a traditional interpretation of the substituted judgement standard (SJS) a person who makes treatment decisions on behalf of a non-competent patient (e.g. concerning euthanasia) ought to decide as the patient would have decided had she been competent. I propose an alternative interpretation of SJS in which the surrogate is required to infer what the patient actually thought about these end-of-life decisions. In clarifying SJS it is also important to differentiate the patient's consent and preference. If SJS is part of an autonomy ideal of the sort found in Kantian ethics, consent seems more important than preference. From a utilitarian perspective a preference-based reading of SJS seems natural. I argue that the justification of SJS within a utilitarian framework will boil down to the question whether a non-competent patient can be said to have any surviving preferences. If we give a virtue-ethical justification of SJS the relative importance of consent and preferences depends on which virtue one stresses--respect or care. I argue that SJS might be an independent normative method for extending the patient's autonomy, both from a Kantian and a virtue ethical perspective.

Ionising radiation risk disclosure: When should radiographers assume a duty to inform?

PubMed

Younger, C W E; Douglas, C; Warren-Forward, H

2018-05-01

Autonomy is a fundamental patient right for ethical practice, and informed consent is the mechanism by which health care professionals ensure this right has been respected. The ethical notion of informed consent has evolved alongside legal developments. Under Australian law, a provider who fails to disclose risk may be found to be in breach of a duty of disclosure, potentially facing legal consequences if the patient experiences harm that is attributable to an undisclosed risk. These consequences may include the common law tort of negligence. Ionising radiation, in the form of a medical imaging examination, has the potential to cause harm. However, stochastic effects cannot be attributable to a specific ionising radiation event. What then is the role of the Australian medical imaging service provider in disclosing ionising radiation risk? The ethical and legal principles of informed consent, and the duty of information provision to the patient are investigated. These general principles are then applied to the specific and unusual case of ionising radiation, and what responsibilities apply to the medical imaging provider. Finally, the legal, professional and ethical duties of the radiographer to disclose information to their patients are investigated. Australian law is unclear as to whether a radiographer has a common law responsibility to disclose radiation risk. There is ambiguity as to whether stochastic ionising radiation risk could be considered a legal disclosure responsibility. While it is unlikely that not disclosing risk will have medicolegal consequences, doing so represents sound ethical practice. Copyright © 2017 The College of Radiographers. Published by Elsevier Ltd. All rights reserved.

The principle of respect for autonomy--concordant with the experience of oncology physicians and molecular biologists in their daily work?

PubMed

Ebbesen, Mette; Pedersen, Birthe D

2008-03-26

This article presents results from a qualitative empirical investigation of how Danish oncology physicians and Danish molecular biologists experience the principle of respect for autonomy in their daily work. This study is based on 12 semi-structured interviews with three groups of respondents: a group of oncology physicians working in a clinic at a public hospital and two groups of molecular biologists conducting basic research, one group employed at a public university and the other in a private biopharmaceutical company. We found that that molecular biologists consider the principle of respect for autonomy as a negative obligation, where the informed consent of patients or research subjects should be respected. Furthermore, molecular biologists believe that very sick patients are constraint by the circumstances to a certain choice. However, in contrast to molecular biologists, oncology physicians experience the principle of respect for autonomy as a positive obligation, where the physician in dialogue with the patient performs a medical prognosis based on the patient's wishes and ideas, mutual understanding and respect. Oncology physicians believe that they have a positive obligation to adjust to the level of the patient when providing information making sure that the patient understands. Oncology physicians experience situations where the principle of respect for autonomy does not apply because the patient is in a difficult situation. In this study we explore the moral views and attitudes of oncology physicians and molecular biologists and compare these views with bioethical theories of the American bioethicists Tom L. Beauchamp & James F. Childress and the Danish philosophers Jakob Rendtorff & Peter Kemp. This study shows that essential parts of the two bioethical theories are reflected in the daily work of Danish oncology physicians and Danish molecular biologists. However, the study also explores dimensions where the theories can be developed further to be concordant with biomedical practice. The hope is that this study enhances the understanding of the principle of respect for autonomy and the way it is practiced.

The Noncompliant Patient in Psychiatry: The Case For and Against Covert/Surreptitious Medication

PubMed Central

Latha, K. S.

2010-01-01

Nonadherence to treatment continues to be one of psychiatry’s greatest challenges. To improve adherence and thus improve the care of patients, clinicians and patients’ family members sometimes resort to hiding medication in food or drink, a practice referred to as covert/ surreptitious medication. The practice of covert drug administration in food and beverages is well known in the treatment of psychiatrically ill world-wide but no prevalence rates exist. Covert medication may seem like a minor matter, but it touches on legal and ethical issues of a patient’s competence, autonomy, and insight. Medicating patients without their knowledge is not justifiable solely as a shortcut for institutions or families wishing to calm a troublesome patient and thus alleviate some of the burdens of care giving. The paramount principle is ensuring the well-being of a patient who lacks the competence to give informed consent. Ethically, covert/surreptitious administration can be seen as a breach of trust by the doctor or by family members who administer the drugs. Covert medication contravenes contemporary ethical practice. Legally, treatment without consent is permissible only where common law or statute provides such authority. The practice of covert administration of medication is not specifically covered in the mental health legislation in developing countries. Many of the current dilemmas in this area have come to public attention because of two important developments in medical ethics and the law - the increasing importance accorded to respect for autonomy and loss of the parens patriae jurisdiction of the courts [parens patriae means ‘parent of the country’; it permitted a court to consent or refuse treatment on behalf of an ‘incapacity’, or alternatively to appoint a guardian with such powers]. PMID:21327173

Forensic psychiatry, one subspecialty with two ethics? A systematic review.

PubMed

Niveau, Gérard; Welle, Ida

2018-04-10

Forensic psychiatry is a particular subspecialty within psychiatry, dedicated in applying psychiatric knowledge and psychiatric training for particular legal purposes. Given that within the scope of forensic psychiatry, a third party usually intervenes in the patient-doctor relationship, an amendment of the traditional ethical principles seems justified. Thus, 47 articles, two book chapters and the guidelines produced by the World Psychiatric Association, the American Association of Psychiatry and the Law, as well as by the Royal Australian and New Zealand College of psychiatrists, were analyzed. The review revealed that the ethics of correctional forensic psychiatry and those of legal forensic psychiatry do not markedly differ from each other, but they are incongruent in terms of implementation. In an effort to better understand which ethical principles apply to forensic psychiatry, a chronological review of the literature published from 1950 to 2015 was carried out. The ethics of correctional forensic psychiatry are primarily deontological. The principle of justice translates into the principle of health care equivalence, the principle of beneficence into providing the best possible care to patients, and the principle of respect of autonomy into ensuring confidentiality and informed consent. The ethics of legal forensic psychiatry are rather consequentialist. In this latter setting, the principle of justice is mainly characterized by professionalism, the principle of beneficence by objectivity and impartiality, and the principle of respect of autonomy by informed consent. However, these two distinct fields of forensic psychiatry share in common the principle of non maleficence, defined as the non collaboration of the psychiatrist in any activity leading to inhuman and degrading treatment or to the death penalty.

Decision-making and motivation to participate in biomedical research in southwest Nigeria.

PubMed

Osamor, Pauline E; Kass, Nancy

2012-08-01

Motivations and decision-making styles that influence participation in biomedical research vary across study types, cultures, and countries. While there is a small amount of literature on informed consent in non-western cultures, few studies have examined how participants make the decision to join research. This study was designed to identify the factors motivating people to participate in biomedical research in a traditional Nigerian community, assess the degree to which participants involve others in the decision-making process, and examine issues of autonomy in decision-making for research. A descriptive cross-sectional study was conducted with 100 adults (50 men, 50 women) in an urban Nigerian community who had participated in a biomedical research study. Subjects were interviewed using a survey instrument. Two-thirds of the respondents reported participating in the biomedical study to learn more about their illness, while 30% hoped to get some medical care. Over three-quarters (78%) of participants discussed the enrollment decision with someone else and 39% reported obtaining permission from a spouse or family member to participate in the study. Women were more than twice as likely as men to report obtaining permission from someone else before participating. More specifically, half of the female participants reported seeking permission from a spouse before enrolling. The findings suggest that informed consent in this community is understood and practised as a relational activity that involves others in the decision making process. Further studies are needed in non-Western countries concerning autonomy, decision-making, and motivation to participate in research studies. © 2012 Blackwell Publishing Ltd.

Huntington's disease predictive testing: the case for an assessment approach to requests from adolescents.

PubMed Central

Binedell, J; Soldan, J R; Scourfield, J; Harper, P S

1996-01-01

Adolescents who are actively requesting Huntington's predictive testing of their own accord pose a dilemma to those providing testing. In the absence of empirical evidence as regards the impact of genetic testing on minors, current policy and guidelines, based on the ethical principles of non-maleficence and respect for individual autonomy and confidentiality, generally exclude the testing of minors. It is argued that adherence to an age based exclusion criterion in Huntington's disease predictive testing protocols is out of step with trends in UK case law concerning minors' consent to medical treatment. Furthermore, contributions from developmental psychology and research into adolescents' decision making competence suggest that adolescents can make informed choices about their health and personal lives. Criteria for developing an assessment approach to such requests are put forward and the implications of a case by case evaluation of competence to consent in terms of clinicians' tolerance for uncertainty are discussed. PMID:8950670

Exploring the Readability of Consent Forms in Human Research in the United States Army

DTIC Science & Technology

2005-03-01

subjects: autonomy (respect for persons), beneficence, and justice. Readability of consent forms 12 The report also defined how these principles apply to...Regional Medical Command, Fort Sam Houston, Texas CPT Heidi P. Mon) U.S. Army-Baylor University Graduate Program in Health Care Administration March...United States v. Karl Brandt, 1947). The opinion in that case included 10 basic principles for human research, called the Nuremberg Code

Law, ethics, and the clinical neurologist.

PubMed

Nora, Lois Margaret

2013-01-01

There is dynamic interplay between the disciplines of law and ethics, and the result is often laws and regulation that impact the practice of clinical neurology. This chapter explores how the disciplines of law and ethics inform and intersect with each other, and how resulting law impacts the everyday work of the clinical neurologist. Examples of how the core bioethical principles of nonmaleficence, beneficence, respect for autonomy, and justice are manifest in legislative, common, and administrative laws are presented. Examples of how these laws, in turn, impact the practice of neurology through protection of patient privacy, the avoidance of conflict of interest, and informed consent and other issues are offered. © 2013 Elsevier B.V. All rights reserved.

Shared decision-making: is it time to obtain informed consent before radiologic examinations utilizing ionizing radiation? Legal and ethical implications.

PubMed

Berlin, Leonard

2014-03-01

Concerns about the possibility of developing cancer due to diagnostic imaging examinations utilizing ionizing radiation exposure are increasing. Research studies of survivors of atomic bomb explosions, nuclear reactor accidents, and other unanticipated exposures to similar radiation have led to varying conclusions regarding the stochastic effects of radiation exposure. That high doses of ionizing radiation cause cancer in humans is generally accepted, but the question of whether diagnostic levels of radiation cause cancer continues to be hotly debated. It cannot be denied that overexposure to ionizing radiation beyond a certain threshold, which has not been exactly determined, does generate cancer. This causes a dilemma: what should patients be informed about the possibility that a CT or similar examination might cause cancer later in life? At present, there is no consensus in the radiology community as to whether informed consent must be obtained from a patient before the patient undergoes a CT or similar examination. The author analyzes whether there is a legal duty mandating radiologists to obtain such informed consent but also, irrespective of the law, whether there an ethical duty that compels radiologists to inform patients of potential adverse effects of ionizing radiation. Over the past decade, there has been a noticeable shift from a benevolent, paternalistic approach to medical care to an autonomy-based, shared-decision-making approach, whereby patient and physician work as partners in determining what is medically best for the patient. Radiologists should discuss the benefits and hazards of imaging with their patients. Copyright © 2014. Published by Elsevier Inc.

Genetic screening and testing in an episode-based payment model: preserving patient autonomy.

PubMed

Sutherland, Sharon; Farrell, Ruth M; Lockwood, Charles

2014-11-01

The State of Ohio is implementing an episode-based payment model for perinatal care. All costs of care will be tabulated for each live birth and assigned to the delivering provider, creating a three-tiered model for reimbursement for care. Providers will be reimbursed as usual for care that is average in cost and quality, while instituting rewards or penalties for those outside the expected range in either domain. There are few exclusions, and all methods of genetic screening and diagnostic testing are included in the episode cost calculation as proposed. Prenatal ultrasonography, genetic screening, and diagnostic testing are critical components of the delivery of high-quality, evidence-based prenatal care. These tests provide pregnant women with key information about the pregnancy, which, in turn, allows them to work closely with their health care provider to determine optimal prenatal care. The concepts of informed consent and decision-making, cornerstones of the ethical practice of medicine, are founded on the principles of autonomy and respect for persons. These principles recognize that patients' rights to make choices and take actions are based on their personal beliefs and values. Given the personal nature of such decisions, it is critical that patients have unbarred access to prenatal genetic tests if they elect to use them as part of their prenatal care. The proposed restructuring of reimbursement creates a clear conflict between patient autonomy and physician financial incentives.

Nurses' autonomy in end-of-life situations in intensive care units.

PubMed

Paganini, Maria Cristina; Bousso, Regina Szylit

2015-11-01

The intensive care unit environment focuses on interventions and support therapies that prolong life. The exercise by nurses of their autonomy impacts on perception of the role they assume in the multidisciplinary team and on their function in the intensive care unit context. There is much international research relating to nurses' involvement in end-of-life situations; however, there is a paucity of research in this area in Brazil. In the Brazilian medical scenario, life support limitation generated a certain reluctance of a legal nature, which has now become unjustifiable with the publication of a resolution by the Federal Medical Council. In Brazil, the lack of medical commitments to end-of-life care is evident. To understand the process by which nurses exercise autonomy in making end-of-life decisions in intensive care units. Symbolic Interactionism and Corbin and Strauss theory methodology were used for this study. Data were collected through single audio-recorded qualitative interviews with 14 critical care nurses. The comparative analysis of the data has permitted the understanding of the meaning of nurse's experience in exercising autonomy relating to end-of-life decision-making. Institutional ethics approval was obtained for data collection. Participants gave informed consent. All data were anonymized. The results revealed that nurses experience the need to exercise autonomy in intensive care units on a daily basis. Their experience expressed by the process of increase opportunities to exercise autonomy is conditioned by the pressure of the intensive care unit environment, in which nurses can grow, feel empowered, and exercise their autonomy or else can continuously depend on the decisions made by other professionals. Nurses exercise their autonomy through care. They work to create new spaces at the same time that they acquire new knowledge and make decisions. Because of the complexity of the end-of-life situation, nurses must adopt a proactive attitude that inserts them into the decision-making process. © The Author(s) 2014.

Marginal capacity: the dilemmas faced in assessment and declaration.

PubMed Central

Ho, V

1995-01-01

Ontario is adopting informed-consent legislation that reflects increasing emphasis on patient autonomy and self-determination. Capacity assessment and declaration by physicians and other health care professionals are pivotal under the new legislation. While grossly capable or incapable patients provide few management difficulties, marginally capable patients provide a challenge for physicians who must assess capacity, and decisions concerning them emphasize the ethical dilemma involved in any declaration of incapacity. Our 1994 Logie Medical Ethics Essay first-prize winner, Vincent Ho, examines the issues that clinicians must consider when assessing marginally capable patients. Images p260-a PMID:7820810

Ethics of placebo-controlled clinical trials in multiple sclerosis: a reassessment.

PubMed

Polman, C H; Reingold, S C; Barkhof, F; Calabresi, P A; Clanet, M; Cohen, J A; Cutter, G R; Freedman, M S; Kappos, L; Lublin, F D; McFarland, H F; Metz, L M; Miller, A E; Montalban, X; O'Connor, P W; Panitch, H; Richert, J R; Petkau, J; Schwid, S R; Sormani, M P; Thompson, A J; Weinshenker, B G; Wolinsky, J S

2008-03-25

The increasing number of established effective therapies for relapsing multiple sclerosis (MS) and emerging consensus for early treatment raise practical concerns and ethical dilemmas for placebo-controlled clinical trials in this disease. An international group of clinicians, ethicists, statisticians, regulators, and representatives from the pharmaceutical industry convened to reconsider prior recommendations regarding the ethics of placebo-controlled trials in MS. The group concluded that placebo-controlled trials can still be done ethically, with restrictions. For patients with relapsing MS for which established effective therapies exist, placebo-controlled trials should only be offered with rigorous informed consent if the subjects refuse to use these treatments, have not responded to them, or if these treatments are not available to them for other reasons (e.g., economics). Suggestions are provided to protect subject autonomy and improve informed consent procedures. Recommendations are tighter than previously suggested for placebo-controlled trials in "resource-restricted" environments where established therapies may not be available. Guidance is also provided on the ethics of alternative trial designs and the balance between study subject burden and risk, scientific rationale and interpretability of trial outcomes.

[Bioethics and research into mental health].

PubMed

Braz, Marlene; Schramm, Fermin Roland

2011-04-01

This article discusses research in the field of mental health, examining the ethical is sues involved and the use of Informed Consent. In order to achieve these objectives two main approaches were used: (1) a brief history of the different treatments and research with patients with mental illness or disability; (2) theoretical and conceptual analysis of the main problems concerning the mental health field, namely the notion of vulnerability, responsibility and autonomy and the use of placebo control groups. Two main questions prompted the reflection on whether the patient with a mental disorder can sign an Informed Consent, and whether the use of a placebo is acceptable. The existence of antagonistic and contradictory positions indicates that mental health research is hampered by biases that are difficult to overcome. Ethical investigation that may contribute to the healing of mental disorders should not however be overlooked merely because of the difficulties involved in its implementation. It must be borne in mind that changes occurring in the context of Psychiatric Reform in Brazil are gradually altering archaic concepts about what constitutes mental illness and how this group should be understood and treated.

Perspective: The case for research justice: inclusion of patients with limited English proficiency in clinical research.

PubMed

Glickman, Seth W; Ndubuizu, Adanma; Weinfurt, Kevin P; Hamilton, Carol D; Glickman, Lawrence T; Schulman, Kevin A; Cairns, Charles B

2011-03-01

Persons with limited English proficiency (LEP) constitute a growing portion of the U.S. population, yet they are underrepresented in clinical research. This inherently limits the societal benefits of the research and its generalizability to ethnic populations living in the United States. To illustrate the complexity associated with including LEP participants in clinical research, the authors critically evaluated LEP consent requirements posted on the Web sites of 134 academic health centers in March 2008. They found wide variability with regard to consent policies and striking interinstitutional differences in posted IRB policies and attitudes toward consent of LEP patients in research. The authors argue this variation highlights competing concerns between autonomy and justice. Outcomes-based justice requires inclusion of LEP patients in the research, yet the consent process is often resource-intensive and complex. The authors suggest that more uniform and specific guidance from federal agencies for enrollment of LEP patients in clinical research be established and that this guidance explicitly recalibrate the current balance between autonomy and justice. Investigators and institutional review boards should also develop streamlined best practices to reduce unnecessary effort and expense associated with recruitment of LEP individuals. LEP individuals should have fair access to clinical research in order to fully realize individual and societal benefits of their participation and to ensure the generalizability of scientific discovery.

A problem with inclusion in learning disability research.

PubMed

McClimens, Alex; Allmark, Peter

2011-09-01

People with severe learning disability are particularly difficult to include in the research process. As a result, researchers may be tempted to focus on those with learning disability who can be included. The problem is exacerbated in this field as the political agenda of inclusion and involvement is driven by those people with learning disability who are the higher functioning. To overcome this we should first detach the notion of consent from ideas about autonomy and think instead of it as a way to avoid wronging others; this fits the original historical use of consent in research. This allows us to think in terms of including participants to the best of their abilities rather than in terms of a threshold of autonomy. Researchers could then use imaginative ways to include the least able and to ensure they are not wronged in research or by exclusion from it.

Informed consent: a socio-legal study.

PubMed

Rathor, M Y; Rani, Mohammad Fauzi Abdul; Shah, Azarisman Mohammad; Akter, Sheikh Fariuddin

2011-12-01

Informed consent [IC] is a recognized socio-legal obligation for the medical profession. The doctrine of IC involves the law, which aims to ensure the lawfulness of health assistance and tends to reflect the concept of autonomy of the person requiring and requesting medical and/or surgical treatment. Recent changes in the health care delivery system and the complex sociological settings, in which it is practiced, have resulted in an increase in judicial activity and medical negligence lawsuits for physicians. While IC is a well-established practice, it often fails to meet its stated purpose. In the common law, the standard of medical care to disclose risks has been laid down by the Bolam test- a familiar concept to most physicians, but it has been challenged recently in many jurisdictions. This paper aims to discuss some important judgments in cases of alleged medical negligence so as to familiarize doctors regarding their socio-legal obligations. We also propose to discuss some factors that influence the quality of IC in clinical practice. Literature review. The law of medical consent has been undergoing changes in recent years. Case law appears to be evolving towards a more patient centered standard of disclosure. Patient's expectations are higher and they are aware of the power of exercising their rights. Failure to obtain IC is one of the common allegations in medical malpractice suits. The medical professionals need to change their mindset and avoid claims of negligence by providing information that is "reasonable" in the eyes of the court.

Evolution of European Union legislation on emergency research.

PubMed

Mentzelopoulos, Spyros D; Mantzanas, Michail; van Belle, Gerald; Nichol, Graham

2015-06-01

Emergency research is necessary to prevent exposure of patients to unvalidated clinical practice (nonmaleficence), and to improve the dismal prognosis of disorders requiring emergent treatment such as cardiac arrest (beneficence). Regulations that govern clinical research should conform to bioethical principles of respect for nonmaleficence, beneficence, autonomy, and justice. Our objectives are to review the evolution of European Union (EU) legislation on emergency research, and to identify potentially remaining problems. EU legislative sources on clinical research and medical literature describing the impact of EU Regulations on emergency research. Article 5 of EU Directive 2001/20/EC required consent before enrolment in a research study to ensure the autonomy of potentially incapacitated research subjects. However, obtaining such consent is often impossible in emergency situations. Directive 2001/20/EC was criticized for potentially preventing emergency research. Several EU Member States addressed this problem by permitting deferred consent. International ethical guidelines supporting deferred consent were also cited by Good Clinical Practice Directive 2005/28/EC. However, Directive 2001/20/EC was not revised to achieve harmonization of EU emergency research, thus resulting in ongoing "ambiguity" as regards to emergency research legitimacy. This will be definitively addressed by applying EU Regulation No. 536/2014 and repealing Directive 2001/20/EC. The new EU Regulation permits using deferred consent under clearly specified conditions, and may foster emergency research that evaluates interventions posing minimal risk relative to standard practice. Legislation related to emergency research in Europe has evolved to increase concordance with bioethical principles so as to increase evidence-based improvements in emergency care. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Informed consent in medical decision-making in commercial gestational surrogacy: a mixed methods study in New Delhi, India.

PubMed

Tanderup, Malene; Reddy, Sunita; Patel, Tulsi; Nielsen, Birgitte Bruun

2015-05-01

To investigate ethical issues in informed consent for decisions regarding embryo transfer and fetal reduction in commercial gestational surrogacy. Mixed methods study employing observations, an interview-guide and semi-structured interviews. Fertility clinics and agencies in Delhi, India, between December 2011 and December 2012. Doctors providing conceptive technologies to commissioning couples and carrying out surrogacy procedures; surrogate mothers; agents functioning as links for surrogacy. Interviews using semi-structured interview guides were carried out among 20 doctors in 18 fertility clinics, five agents from four agencies and 14 surrogate mothers. Surrogate mothers were interviewed both individually and in the presence of doctors and agents. Data on socio-economic context and experiences among and between various actors in the surrogacy process were coded to identify categories of ethical concern. Numerical and grounded theory-oriented analyses were used. Informed consent, number of embryos transferred, fetal reduction, conflict of interest among the involved parties. None of the 14 surrogate mothers were able to explain the risks involved in embryo transfer and fetal reduction. The majority of the doctors took unilateral decisions about embryo transfer and fetal reduction. The commissioning parents were usually only indirectly involved. In the qualitative analysis, difficulties in explaining procedures, autonomy, self-payment of fertility treatment and conflicts of interest were the main themes. Clinical procedural decisions were primarily made by the doctors. Surrogate mothers were not adequately informed. There is a need for regulation on decision-making procedures to safeguard the interests of surrogate mothers. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

Biases and Heuristics in Decision Making and Their Impact on Autonomy.

PubMed

Blumenthal-Barby, J S

2016-05-01

Cognitive scientists have identified a wide range of biases and heuristics in human decision making over the past few decades. Only recently have bioethicists begun to think seriously about the implications of these findings for topics such as agency, autonomy, and consent. This article aims to provide an overview of biases and heuristics that have been identified and a framework in which to think comprehensively about the impact of them on the exercise of autonomous decision making. I analyze the impact that these biases and heuristics have on the following dimensions of autonomy: understanding, intentionality, absence of alienating or controlling influence, and match between formally autonomous preferences or decisions and actual choices or actions.

The metaphysical basis of a liberal organ procurement policy.

PubMed

Hershenov, David B; Delaney, James J

2010-08-01

There remains a need to properly analyze the metaphysical assumptions underlying two organ procurement policies: presumed consent and organ sales. Our contention is that if one correctly understands the metaphysics of both the human body and material property, then it will turn out that while organ sales are illiberal, presumed consent is not. What we mean by illiberal includes violating rights of bodily integrity, property, or autonomy, as well as arguing for or against a policy in a manner that runs afoul of Rawlsian public reason.

Is consent in medicine a concept only of modern times?

PubMed Central

Dalla-Vorgia, P; Lascaratos, J; Skiadas, P; Garanis-Papadatos, T

2001-01-01

Although the issue of consent in medical practice has grown immensely in recent years, and it is generally believed that historical cases are unknown, our research amongst original ancient Greek and Byzantine historical sources reveals that it is a very old subject which ancient philosophers and physicians have addressed. Plato, in ancient Greece, connected consent with the quality of a free person and even before him, Hippocrates had advocated seeking the patient's cooperation in order to combat the disease. In Alexander the Great's era and later on in Byzantine times, not only was the consent of the patient necessary but physicians were asking for even more safeguards before undertaking a difficult operation. Our study has shown that from ancient times physicians have at least on occasion been driven to seek the consent of their patient either because of respect for the patient's autonomy or from fear of the consequences of their failure. Key Words: Consent • history of medicine • medical ethics PMID:11233382

Legal issues concerning electronic health information: privacy, quality, and liability.

PubMed

Hodge, J G; Gostin, L O; Jacobson, P D

1999-10-20

Personally identifiable health information about individuals and general medical information is increasingly available in electronic form in health databases and through online networks. The proliferation of electronic data within the modern health information infrastructure presents significant benefits for medical providers and patients, including enhanced patient autonomy, improved clinical treatment, advances in health research and public health surveillance, and modern security techniques. However, it also presents new legal challenges in 3 interconnected areas: privacy of identifiable health information, reliability and quality of health data, and tortbased liability. Protecting health information privacy (by giving individuals control over health data without severely restricting warranted communal uses) directly improves the quality and reliability of health data (by encouraging individual uses of health services and communal uses of data), which diminishes tort-based liabilities (by reducing instances of medical malpractice or privacy invasions through improvements in the delivery of health care services resulting in part from better quality and reliability of clinical and research data). Following an analysis of the interconnectivity of these 3 areas and discussing existing and proposed health information privacy laws, recommendations for legal reform concerning health information privacy are presented. These include (1) recognizing identifiable health information as highly sensitive, (2) providing privacy safeguards based on fair information practices, (3) empowering patients with information and rights to consent to disclosure (4) limiting disclosures of health data absent consent, (5) incorporating industry-wide security protections, (6) establishing a national data protection authority, and (7) providing a national minimal level of privacy protections.

[Psychiatry with open doors. Part 1: Rational for an open door for acute psychiatry].

PubMed

Sollberger, D; Lang, U E

2014-03-01

Despite the reform efforts of the last decades modern acute psychiatry still stands between conflicting priorities in everyday practice. The protection of patient autonomy might conflict with a regulatory mandate of psychiatry in societal contexts and the necessity of coercive measures and involuntary treatment might become problematic with respect to presumed but contentious interests of the patient. The conflicts particularly concern questions of involuntary commitment, door closing, coercive and isolation measures. Research on the topic of therapeutic effectiveness of these practices is rare. Accordingly, the practice depends on the federal state, hospital and ward and is very heterogeneous. Epidemiological prognosis predicts an increase of psychiatric disorders; however, simultaneously in terms of medical ethics the warranty of patient autonomy, shared decision-making and informed consent in psychiatry become increasingly more important. This challenges structural and practical changes in psychiatry, particularly in situations of self and third party endangerment which are outlined and a rationale for an opening of the doors in acute psychiatric wards is provided.

Ethics in studies on children and environmental health.

PubMed

Merlo, D F; Knudsen, L E; Matusiewicz, K; Niebrój, L; Vähäkangas, K H

2007-07-01

Children, because of age-related reasons, are a vulnerable population, and protecting their health is a social, scientific and emotional priority. The increased susceptibility of children and fetuses to environmental (including genotoxic) agents has been widely discussed by the scientific community. Children may experience different levels of chemical exposure than adults, and their sensitivity to chemical toxicities may be increased or decreased in comparison with adults. Such considerations also apply to unborn (fetal exposure) and newborn (neonatal exposure) children. Therefore, research on children is necessary in both clinical and environmental fields, to provide age-specific relevant data regarding the efficacy and safety of medical treatments, and regarding the assessment of risk from unintended environmental exposure. In this context, the stakeholders are many, including children and their parents, physicians and public health researchers, and the society as a whole, with its ethical, regulatory, administrative and political components. The important ethical issues are information of participants and consent to participate. Follow-up and protection of data (samples and information derived from samples) should be discussed in the context of biobanks, where children obtain individual rights when they become adults. It is important to realise that there are highly variable practices within European countries, which may have, in the past, led to differences in practical aspects of research in children. A number of recommendations are provided for research with children and environmental health. Environmental research with children should be scientifically justified, with sound research questions and valid study protocols of sufficient statistical power, ensuring the autonomy of the child and his/her family at the time of the study and later in life, if data and samples are used for follow-up studies. When children are enrolled, we recommend a consent dyad, including (1) parental (or legal guardian) informed consent and (2) the child's assent and/or informed consent from older minors. For evaluation of the studies including children, a paediatrician should always be involved in the research ethics committee.

Ethics in studies on children and environmental health

PubMed Central

Merlo, D F; Knudsen, L E; Matusiewicz, K; Niebrój, L; Vähäkangas, K H

2007-01-01

Children, because of age‐related reasons, are a vulnerable population, and protecting their health is a social, scientific and emotional priority. The increased susceptibility of children and fetuses to environmental (including genotoxic) agents has been widely discussed by the scientific community. Children may experience different levels of chemical exposure than adults, and their sensitivity to chemical toxicities may be increased or decreased in comparison with adults. Such considerations also apply to unborn (fetal exposure) and newborn (neonatal exposure) children. Therefore, research on children is necessary in both clinical and environmental fields, to provide age‐specific relevant data regarding the efficacy and safety of medical treatments, and regarding the assessment of risk from unintended environmental exposure. In this context, the stakeholders are many, including children and their parents, physicians and public health researchers, and the society as a whole, with its ethical, regulatory, administrative and political components. The important ethical issues are information of participants and consent to participate. Follow‐up and protection of data (samples and information derived from samples) should be discussed in the context of biobanks, where children obtain individual rights when they become adults. It is important to realise that there are highly variable practices within European countries, which may have, in the past, led to differences in practical aspects of research in children. A number of recommendations are provided for research with children and environmental health. Environmental research with children should be scientifically justified, with sound research questions and valid study protocols of sufficient statistical power, ensuring the autonomy of the child and his/her family at the time of the study and later in life, if data and samples are used for follow‐up studies. When children are enrolled, we recommend a consent dyad, including (1) parental (or legal guardian) informed consent and (2) the child's assent and/or informed consent from older minors. For evaluation of the studies including children, a paediatrician should always be involved in the research ethics committee. PMID:17601869

The principle of respect for autonomy – Concordant with the experience of oncology physicians and molecular biologists in their daily work?

PubMed Central

Ebbesen, Mette; Pedersen, Birthe D

2008-01-01

Background This article presents results from a qualitative empirical investigation of how Danish oncology physicians and Danish molecular biologists experience the principle of respect for autonomy in their daily work. Methods This study is based on 12 semi-structured interviews with three groups of respondents: a group of oncology physicians working in a clinic at a public hospital and two groups of molecular biologists conducting basic research, one group employed at a public university and the other in a private biopharmaceutical company. Results We found that that molecular biologists consider the principle of respect for autonomy as a negative obligation, where the informed consent of patients or research subjects should be respected. Furthermore, molecular biologists believe that very sick patients are constraint by the circumstances to a certain choice. However, in contrast to molecular biologists, oncology physicians experience the principle of respect for autonomy as a positive obligation, where the physician in dialogue with the patient performs a medical prognosis based on the patient's wishes and ideas, mutual understanding and respect. Oncology physicians believe that they have a positive obligation to adjust to the level of the patient when providing information making sure that the patient understands. Oncology physicians experience situations where the principle of respect for autonomy does not apply because the patient is in a difficult situation. Conclusion In this study we explore the moral views and attitudes of oncology physicians and molecular biologists and compare these views with bioethical theories of the American bioethicists Tom L. Beauchamp & James F. Childress and the Danish philosophers Jakob Rendtorff & Peter Kemp. This study shows that essential parts of the two bioethical theories are reflected in the daily work of Danish oncology physicians and Danish molecular biologists. However, the study also explores dimensions where the theories can be developed further to be concordant with biomedical practice. The hope is that this study enhances the understanding of the principle of respect for autonomy and the way it is practiced. PMID:18366749

Joint reproductive autonomy: does Evans v Amicus Healthcare Ltd provide for a gender-neutral approach to assisted reproductive rights?

PubMed

Allin, Michael J

2015-06-01

Assisted reproductive technology encompasses methods of achieving pregnancy by artificial or partially artificial means. Whilst these methods are more commonly used by couples suffering from problems of infertility, some forms of assistance are employed by fertile couples, for example pre-implantation genetic diagnosis. The overall regulatory framework in the UK is predominantly found in the Human Fertilisation and Embryology Act 1990. The usual rules relating to consent and autonomy apply and were discussed in depth in Evans v Amicus Healthcare Ltd and later in Evans v United Kingdom. This paper considers whether the Evans litigation envisages the possibility of further encouraging joint autonomy in the use of zygotes and whether there is a continuing right to autonomy by the party not bearing the pregnancy. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

T.D. v. New York State Office of Mental Health.

PubMed

1995-02-28

The New York Supreme Court for New York County determined that a state regulation allowing substituted consent to research on mentally ill individuals by a spouse, parent, adult child or sibling, guardian, or authorized committee did not apply to nonfederally funded research. The court was asked by a group of involuntary state mental patients to decide on the validity of state regulations concerning participation in potentially high risk experimentation without consent. The patients, who were incapable of giving informed consent, claimed that their right to refuse treatment based on autonomy, privacy, due process, and equal protection was violated by provisions allowing substituted consent by third party decision makers. The court interpreted federal regulations on research and state regulations on public health and mental health as they applied to both federally funded and nonfederally funded, possibly therapeutic and nontherapeutic, research using non-FDA approved psychotropic drugs that could cause stroke, heart attack, convulsions, hallucinations, or death. The court found first, that the state mental health regulations covered the care, treatment, and rehabilitation of the mentally ill generally; second, that the state public health regulations specifically governed research on human subjects; and third, that the federal regulations controlled federally funded research unless state or local law provides additional protection. But in this case the state public health regulations did not apply to the federally funded research due to an exemption by the state legislature, but did apply to the nonfederally funded research, because not all the federal requirements had been met. The state mental health regulation on substituted consent was enacted without authority and thus was found to be invalid.

Ethical issues in neurogenetics.

PubMed

Uhlmann, Wendy R; Roberts, J Scott

2018-01-01

Many neurogenetic conditions are inherited and therefore diagnosis of a patient will have implications for the patient's relatives and can raise ethical issues. Predictive genetic testing offers asymptomatic relatives the opportunity to determine their risk status for a neurogenetic condition, and professional guidelines emphasize patients' autonomy and informed, voluntary decision making. Beneficence and nonmaleficence both need to be considered when making decisions about disclosure and nondisclosure of genetic information and test results. There can be disclosure concerns and challenges in determining whose autonomy to prioritize when a patient makes a genetic testing decision that can reveal the genetic status of a relative (e.g., testing an adult child when the at-risk parent has not been tested). Ethical issues are prominent when genetic testing for neurogenetic conditions is requested prenatally, on minors, adoptees, adult children at 25% risk, and for individuals with psychiatric issues or cognitive impairment. Neurogenetic conditions can result in cognitive decline which can affect decisional capacity and lead to ethical challenges with decision making, informed consent, and determining the patient's ability to comprehend test results. The ethical implications of genetic testing and emerging issues, including direct-to-consumer genetic testing, disclosure of secondary findings from genomic sequencing, and use of apolipoprotein E testing in clinical and research settings, are also discussed. Resources for information about genetic testing practice guidelines, insurance laws, and directories of genetics clinics are included. Copyright © 2018 Elsevier B.V. All rights reserved.

Ethical Issues in Neurogenetics

PubMed Central

Uhlmann, Wendy R.; Roberts, J. Scott

2018-01-01

Many neurogenetic conditions are inherited and therefore diagnosis of a patient will have implications for their relatives and can raise ethical issues. Predictive genetic testing offers asymptomatic relatives the opportunity to determine their risk status for a neurogenetic condition, and professional guidelines emphasize patients’ autonomy and informed, voluntary decision-making. Beneficence and non-maleficence both need to be considered when making decisions about disclosure and nondisclosure of genetic information and test results. There can be disclosure concerns and issues of determining whose autonomy to prioritize when a patient makes a genetic testing decision that can reveal the genetic status of a relative (e.g. testing an adult child when the at-risk parent has not been tested). Ethical issues are prominent when genetic testing for neurogenetic conditions is requested prenatally, on minors, adoptees, adult children at 25% risk, and for individuals with psychiatric issues or cognitive impairment. Neurogenetic conditions can result in cognitive decline which can affect decisional capacity and lead to ethical challenges with decision-making, informed consent and determining the patient’s ability to comprehend test results. The ethical implications of genetic testing and emerging issues, including direct-to-consumer genetic testing, disclosure of secondary findings from genomic sequencing, and use of APOE testing in clinical and research settings, are also discussed. Resources for information about genetic testing practice guidelines, insurance laws and directories of genetics clinics are included. PMID:29325614

Relational autonomy or undue pressure? Family's role in medical decision-making.

PubMed

Ho, Anita

2008-03-01

The intertwining ideas of self-determination and well-being have received tremendous support in western bioethics. They have been used to reject medical paternalism and to justify patients' rights to give informed consent (or refusal) and execute advanced directives. It is frequently argued that everyone is thoroughly unique, and as patients are most knowledgeable of and invested in their own interests, they should be the ones to make voluntary decisions regarding their care. Two results of the strong focus on autonomy are the rejection of the image of patients as passive care recipients and the suspicion against paternalistic influence anyone may have on patients' decision-making process. Although the initial focus in western bioethics was on minimizing professional coercion, there has been a steady concern of family's involvement in adult patients' medical decision-making. Many worry that family members may have divergent values and priorities from those of the patients, such that their involvement could counter patients' autonomy. Those who are heavily involved in competent patients' decision-making are often met with suspicion. Patients who defer to their families are sometimes presumed to be acting out of undue pressure. This essay argues for a re-examination of the notions of autonomy and undue pressure in the contexts of patienthood and relational identity. In particular, it examines the characteristics of families and their role in adult patients' decision-making. Building on the feminist conception of the relational self and examining the context of contemporary institutional medicine, this paper argues that family involvement and consideration of family interests can be integral in promoting patients' overall agency. It argues that, in the absence of abuse and neglect, respect for autonomy and agency requires clinicians to abide by patients' expressed wishes.

Transforming Scientific Inquiry: Tapping Into Digital Data by Building a Culture of Transparency and Consent

PubMed Central

Smith, Robert J.; Grande, David; Merchant, Raina M.

2015-01-01

With over 1.7 billion individuals engaged in social media, patients and consumers share more about their lives than ever before through wearable devices, smart phone applications, and social media outlets. This cornucopia of data offers significant opportunity for health researchers and clinicians to track and explore how digital presence contributes to patients’ health outcomes and use of health care resources. While patients readily share their information with online communities, it is imperative that they maintain a sense of autonomy over who has access to such data. Recent data breaches of major insurance companies and retailers illustrate the challenges and vulnerabilities related to information safety and privacy. Many Websites and mobile apps require users to agree to data policies, but how those data are mined, protected, utilized, and externally shared is frequently non-transparent, resulting in a climate of fear and distrust around all forums of digital information sharing. While such skepticism is perhaps justified, it should not deter health researchers from attempting to collect and analyze these novel data for the purpose of designing unique health interventions. By clarifying intent around digital data acquisition, simplifying consent procedures, and affirming a commitment to privacy, the authors contend that health researchers can partner with patients to transform the boundaries of scientific inquiry. PMID:26630607

Transforming Scientific Inquiry: Tapping Into Digital Data by Building a Culture of Transparency and Consent.

PubMed

Smith, Robert J; Grande, David; Merchant, Raina M

2016-04-01

With over 1.7 billion individuals engaged in social media, patients and consumers share more about their lives than ever before through wearable devices, smartphone applications, and social media outlets. This cornucopia of data offers significant opportunity for health researchers and clinicians to track and explore how digital presence contributes to patients' health outcomes and use of health care resources. While patients readily share their information with online communities, it is imperative that they maintain a sense of autonomy over who has access to such data. Recent data breaches of major insurance companies and retailers illustrate the challenges and vulnerabilities related to information safety and privacy. Many Web sites and mobile apps require users to agree to data policies, but how those data are mined, protected, used, and externally shared is frequently nontransparent, resulting in a climate of fear and distrust around all forums of digital information sharing. Although such skepticism is perhaps justified, it should not deter health researchers from attempting to collect and analyze these novel data for the purpose of designing unique health interventions. By clarifying intent around digital data acquisition, simplifying consent procedures, and affirming a commitment to privacy, the authors contend that health researchers can partner with patients to transform the boundaries of scientific inquiry.

Melissa Rowland and the rights of pregnant women.

PubMed

Minkoff, Howard; Paltrow, Lynn M

2004-12-01

On March 11, 2004, the State of Utah charged Melissa Rowland with the murder of her stillborn fetus, claiming that the death resulted from her rejection of the advice of her physicians to have a cesarean delivery. Although Ms. Rowland avoided the homicide charge by pleading guilty to lesser child endangerment charges, the approach taken by the State raises important and troubling issues regarding the autonomy rights of pregnant women, as well as their right to speak on behalf their unborn children. We use this case to review relevant ethical principals and legal precedents. We conclude that if Ms. Rowland is to be judged legally culpable for the death of her fetus, then the courts must first create a new and significant exception to the doctrine of informed consent and the common law and constitutional principles upon which it is based. Such a precedent could introduce a substantial disparity between the rights of pregnant women and those of all other persons. We would argue that a better means of assuring the health interests of the pregnant woman and the fetus in similar circumstances is through advocacy by obstetricians for pregnant women's fully realized rights, including the right to informed consent.

[Involuntary treatment of mental patients in the community: legal and ethical dilemmas].

PubMed

Mitrossili, M

2014-01-01

This article focuses on the measure of involuntary treatment of mental patients in the community, not only with regard to human rights and more specifically those of persons with mental disorders, but also with regard to ethics and deontology in mental healthcare delivery service. In this light, the important role of informed consent in psychiatry with regard to the psychiatric act is examined. Informed consent of mental patients in treatment when they are in need of voluntary or involuntary hospitalization is further examined, while emphasis is being put on the case of involuntary treatment. The Convention for Human Rights and Biomedicine (Convention of Οviedo), the European Convention of Human Rights, other documents of International Organizations (UN) and specialized national legislation (A. 2071/1992, Chapter vi, Greek law) constitute basic reference and interpretation points. The examination of consent and the demarcation of the exceptions are important issues that need to be approached. More particularly, our interest lies with the article 7 of the Convention for Human Rights and Biomedicine, which specifically refers to the protection of person who suffers from a mental disorder. The opinion that informed consent in psychiatric treatment and involuntary treatment are concepts and processes which are distinct but not always mutually exclusive is enhanced. In any case, involuntary treatment causes major dilemmas as far as informed consent in the psychiatric act is concerned, as it raises issues that affect the autonomy of the person. Today, however, there are many factors which influence public politics towards the adoption of the measure of involuntary treatment within the community. How is it that this paradoxical link is legitimized and justified: involuntary treatment and community? The enactment of the above mentioned measure in many European and North American countries has created new paths in the practice of contemporary psychiatry. Nonetheless, it continues to divide the psychiatric and legal word for it causes intense questioning from a legal, ethical, deontological and clinical aspect, as it offends fundamental rights of the individual. In a legal civilization, in which the principle of informed consent or refusal constitutes a basic rule of the lawfulness of the medical and psychiatric act, any divergence from this rule has consequences for the patients and affects a well-tempered therapeutic treatment. The above mentioned measure could be counterbalanced by the legal regulation of advance directives and the provision for the appointment of a proxy person by the mental patient.

Intimacy and Family Consent: A Confucian Ideal.

PubMed

Lee, Shui Chuen

2015-08-01

In the West, mainstream bioethicists tend to appreciate intimate relationships as a hindrance to individual autonomy. Scholars have even argued against approaching a mother to donate a kidney to save the life of her child; the request, they claim, is too manipulative and, thereby, violates her autonomy. For Chinese bioethicists, such a moral analysis is absurd. The intimate relationship between mother and child establishes strong mutual obligations. It creates mutual moral responsibilities that often require sacrifices for each other. This paper argues that while aiding others is a moral duty, helping one's family is a much stronger duty and poses no threat to one's autonomy. For Confucianism, empathetic intimate feelings, the heart and mind of ren, rest at the root of morality. It requires that we, as moral beings, assume duties to relieve the suffering of others. The more intimate the relationship the stronger the obligation to assist. The family is a closely knitted moral community. Family members often share living resources, mutual experiences, and a sense of identity. Family members act as a social unit, and, ordinarily, mutual obligations among members have priority over duties to those outside of the family. For Confucian bioethics, family-based consent to medical treatment is regarded as natural and reasonable. Family-based decision making is a taken-for-granted norm of social life. While close family members have priority, Confucianism extends such obligations outward toward members of the extended family and the society at large. There is a general principle of gradation of love, which reflects different degrees of personal intimacy and, therefore, of moral obligation. In this fashion, Confucianism seeks to treat the whole of society as one extended family. Hence, in bioethics, mutual responsibility and family-based consent are regarded as basic principles. Through a series of case discussions, this paper illustrates that atomistic individual-based autonomy offers but a poor response to bioethical issues. © The Author 2015. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

State generic substitution laws can lower drug outlays under Medicaid.

PubMed

Shrank, William H; Choudhry, Niteesh K; Agnew-Blais, Jessica; Federman, Alex D; Liberman, Joshua N; Liu, Jun; Kesselheim, Aaron S; Brookhart, M Alan; Fischer, Michael A

2010-07-01

To stem the rising costs of medications provided to patients enrolled in Medicaid, states have implemented varying policies about generic substitution. These policies differ in the extent to which pharmacists or patients can influence which medications they choose. Using national Medicaid data, we evaluated the relationship between different generic substitution policies and the use of generic simvastatin, a cholesterol-lowering drug, after the patent for the brand-name equivalent, Zocor, expired. States that implemented policies requiring patients' consent prior to generic substitution experienced rates of substitution that were 25 percent lower than those of states that did not require patient consent. By eliminating patient consent requirements, state Medicaid programs could expect to save more than $100 million in coverage for three top-selling medications that are nearing patent expiration. Although these consent requirements are probably intended to increase patient autonomy, policy makers should consider the sizable opportunity costs.

Constraint, consent, and well-being in human kidney sales.

PubMed

Hughes, Paul M

2009-12-01

This paper canvasses recent arguments in favor of commercial markets in human transplant kidneys, raising objections to those arguments on grounds of the role of injustice, exploitation, and coercion in compromising the autonomy of those most likely to sell a kidney, namely, the least well off members of society.

Communicating with Muslim parents: "the four principles" are not as culturally neutral as suggested.

PubMed

Westra, Anna E; Willems, Dick L; Smit, Bert J

2009-11-01

The "four principles approach" has been popularly accepted as a set of universal guidelines for biomedical ethics. Based on four allegedly trans-cultural principles (respect for autonomy, nonmaleficence, beneficence and justice), it is supposed to fulfil the need of a 'culturally neutral approach to thinking about ethical issues in health care'. On the basis of a case-history, this paper challenges the appropriateness of communicating in terms of these four principles with patients with a different background. The case describes the situation in which Muslim parents bring forward that their religion keeps them from consenting to end-of-life decisions by non-religious paediatricians. In a literature analysis, the different meanings and roles of the relevant principles in non-religious and Islamic ethics are compared. In non-religious ethics, the principle of nonmaleficence may be used to justify withholding or withdrawing futile or damaging treatments, whereas Islamic ethics applies this principle to forbid all actions that may harm life. And while the non-religious version of the principle of respect for autonomy emphasises the need for informed consent, the Islamic version focuses on "respect for the patient". We conclude that the parties involved in the described disagreement may feel committed to seemingly similar, but actually quite different principles. In such cases, communication in terms of these principles may create a conflict within an apparently common conceptual framework. The four principles approach may be very helpful in analysing ethical dilemmas, but when communicating with patients with different backgrounds, an alternative approach is needed that pays genuine attention to the different backgrounds.

Children, biobanks and the scope of parental consent

PubMed Central

Hens, Kristien; Cassiman, Jean-Jacques; Nys, Herman; Dierickx, Kris

2011-01-01

The use of stored tissue samples from children for genetic research raises specific ethical questions that are not all analogous to those raised when adult participants are concerned. These include issues with regard to consent, as it is typically a parent who consents to the use of samples from children. In this paper, we discuss the scope of parental consent. This scope has a temporal dimension and one related to the content of consent. It is not questioned that the temporal scope of parental consent is limited and that young adults have the right to decide on the fate of their samples when they reach the age of maturity. With regard to the content of consent, the question remains whether parents are allowed to give full broad consent to any possible future research on the samples of their children. We argue that they should not be allowed to do so, based on two premises. First, it is generally acknowledged that children have a right to express their own values and that they should be given the opportunity to develop their own autonomy as they grow older. Second, research and science are not completely value-free and some types of research may be more sensitive than other types. Children should be given the opportunity to express their values also in this respect. PMID:21386873

The Future of Reproductive Autonomy.

PubMed

Johnston, Josephine; Zacharias, Rachel L

2017-12-01

In a project The Hastings Center is now running on the future of prenatal testing, we are encountering clear examples, both in established law and in the practices of individual providers, of failures to respect women's reproductive autonomy: when testing is not offered to certain demographics of women, for instance, or when the choices of women to terminate or continue pregnancies are prohibited or otherwise not supported. But this project also raises puzzles for reproductive autonomy. We have learned that some clinicians and patients do not discuss the fact that prenatal testing can lead to a decision about whether to terminate a pregnancy-they just don't talk about it. And while the decision whether to agree to prenatal screening and diagnostic testing is to be made with women's free and informed consent, many screening tests have been routinized in such a way that some women do not even recall agreeing to testing, while others feel that agreeing to testing is what their clinicians expect of them or that the testing is necessary to protect themselves and their families from the significant financial hardship of raising a child with a disability. In the face of these pressures, can one really say that women are freely choosing to undergo testing or are freely choosing to continue or terminate a pregnancy following receipt of test results? The reality of these pressures is requiring us to consider expanding the scope of our investigation beyond the clinical encounter to the broader context-to think harder about what reproductive autonomy means and how best to enhance it. © 2017 The Hastings Center.

RECONCEPTUALIZING CONSENT FOR DIRECT-TO-CONSUMER HEALTH SERVICES.

PubMed

Spector-Bagdady, Kayte

2015-01-01

The market for direct-to-consumer (DTC) health services continues to grow rapidly with former patients converting to customers for the opportunity to purchase varied diagnostic tests without the involvement of their clinician. For the first time a DTC genetic testing company is advertising health-related reports "that meet [Food and Drug Administration] standards for being clinically and scientifically valid." Ethicists and regulatory agencies alike have recognized the need for a more informed transaction in the DTC context, but how should we classify a commercial transaction for something normally protected by a duty of care? How can we assure informed agreements in an industry with terms and conditions as varied as the services performed? The doctrine of "informed consent" began as an ethical construct building on the promise of beneficence in the clinical relationship and elevating the principle of autonomy--but in the DTC context should we hold providers to legal standards of informed consent and associated medical malpractice liability, or contractual obligations where consumers would seek remedy for breach? This Article analyzes the fine balance that must be struck in an industry where companies are selling services for entertainment or non-medical purposes that possess the capacity to produce serious and disquieting medical information. It begins by reviewing current standards of consent in the clinical setting from both a legal and ethical perspective and then lays forth current standards for DTC consent using two currently controversial case studies: that of keepsake fetal ultrasound and genetic testing. DTC keepsake ultrasound and genetic testing providers attempt to de-medicalize the devices used for these procedures from their intended medical uses to non-medical uses. But while keepsake ultrasound is marketed as "intended for entertainment purposes only," it can provide medical information as an incidental finding. 23andMe currently purports to be the only DTC genetics service that "includes" reports that meet FDA qualifications, despite disclaimers of intent to "provide medical advice." The attempted de-medicalization of these devices, therefore, has not been fully transformative, and DTC providers should have more robust ethical and legal duties than the average goods and services seller. This Article delineates these responsibilities, beginning with ethical duties surrounding marketing, entering into, and providing DTC services. It then turns to the legal paradigms necessary to enable, or at least allow for, DTC providers to meet these ethical obligations. While it argues that contractual, as opposed to fiduciary, requirements are most appropriate and that waivers of liability will likely be upheld, it also advocates for a heightened expectation of disclosure during contracting.

[The law of rights and duties of persons in health care from the viewpoint of bioethics].

PubMed

León, Francisco Javier

2012-11-01

The enactment of Law 20.584 in April of 2012 promotes a change in the physician-patient relationship, with recognition of people's rights and duties in healthcare by all the health professional and entities. The legal obligation, and not only the ethical one, as it currently happens, for humane treatment and regard for the dignity of the sick, informed consent, medical data confidentiality, the possibility to reject treatments, etc., is established. This review analyzes the contents of this law, especially those parts affecting physicians. It exposes its limitations, especially those related to minors' consent, living wills and research in people with mental disabilities. It also highlights positive aspects such as the promotion of a humane healthcare. This Law begins to consider patients' autonomy shyly. However, from a bioethical viewpoint, there are still many issues to be perfected such as healthcare humanization, excellence of patient care, healthcare quality and medical professionalism, considering competence, social service, charity and solidarity. It is a first step that must be supplemented with a greater development of medical deontology, and the development of clinical and institutional bioethics.

Beyond the Absence of Disease or Infirmity: The Case for Sexual Wellness

ERIC Educational Resources Information Center

Daugherty, Timothy K.; Julian, Hannah M.; Lynch, Nicole M.; Chen, Stephanie J.; Whipple, Tanya L.; Ginsburg, Austin F.

2016-01-01

Examined a version of the Substance Abuse and Mental Health Services Administration (SAMHSA) wellness model that was revised to include a ninth factor, sexual wellness: "understanding the human body, choosing the type and size of one's family, and experiencing satisfaction (alone or with consenting others) while maintaining autonomy,…

Impact of gender on the decision to participate in a clinical trial: a cross-sectional study.

PubMed

Lobato, Lucas; Bethony, Jeffrey Michael; Pereira, Fernanda Bicalho; Grahek, Shannon Lee; Diemert, David; Gazzinelli, Maria Flávia

2014-11-06

In order for Informed Consent to be ethical and valid each clinical trial participant must be able to make a voluntary decision to participate, free from pressure or coercion. Nonetheless, many factors may influence the decision reached, and such influences may be different for male and female volunteers. Being aware of these differences may help researches develop better processes for obtaining consent that safeguard the right of autonomy for all participants. The goal of this study was to evaluate potential gender-based differences in the factors influencing clinical trial participation. This cross-sectional study was conducted in the Northeast region of Minas Gerais, Brazil, in October 2011. A structured questionnaire was administered to 143 volunteers (48 male, 95 female) screened for participation in a clinical study of an investigational functional food with potential anthelminthic properties. Answers regarding their decision to participate in the study were compared, by gender, using chi-square and Mann Whitney tests. Odds ratios (OR) was used to measure association. A majority of subjects (58% of males, 59% of females) listed the desire to collaborate with the development of a product against parasitic worms as their main reason for participation. Females were significantly more likely to report a decision influenced by friends, family, or researchers (OR 3.14, 3.45, and 3.46 respectively, p < 0.005). Females were also significantly more likely to report a decision influenced by general altruistic considerations (OR 8.45, p < 0.005). There was no difference, by gender, in the report of decisions influenced by informational meetings, understanding of the disease, or the availability of medical treatments or exams. There was also no difference in knowledge of the rights of research participants. Study results indicate that there is a strong difference between male and female participants regarding social influences on the decision to participate in clinical research. Further research into the impact this may have on autonomy is warranted.

Consent to medical research of vulnerable subjects from the French point of view: the example of consent in research in the case of Alzheimer disease.

PubMed

Duguet, Anne-Marie; Boyer-Beviere, Bénédicte

2011-12-01

The consent to research is the expression of autonomy. Some groups are vulnerable and cannot give free consent because their conditions limit their decision making or because they are unable to consent themselves (minor, incompetent adults). International standards and recommendations for medical research protect vulnerable subjects (article 17 of the Helsinki declaration, guidelines 9 and 13 of the CIOMS, article 17 of the Oviedo Convention). French Law protects mostly three categories of vulnerable people: minors, adults with a legal representative, and the people living in sanitary and social establishments. Specific protection is given as well to pregnant women, detainees and persons with psychiatric disorders in involuntary commitment. From the example of research with Alzheimer patients the authors show the original provisions of French legislation to involve in medical research incompetent patients with or without legal protection. Clinical research on Alzheimer's disease poses challenges as never before to research ethics. In fact, the development of the disease progressively reduces the patient's ability to make choices: the latter is no longer capable, but is not totally incapacitated. Several solutions are offered for a "proxy" consent or authorisation.

[The notion of decision making capacity in medical and legal practice].

PubMed

Bórquez E, Gladys; Raineri B, Gina; Horwitz C, Nina; Huepe O, Gabriela

2007-09-01

The relationship between patients and health professionals emphasizes deliberation and joint decision making, that derives in the informed consent. To evaluate decision making of patients in health care and to identify the notion of capacity for decision making, according to lawyers and physicians. A semi-structured interview about procedures to assess decision making capacity was applied to 27 selected physicians and lawyers, considering their experience in this area. A qualitative analysis of answers was performed. Several differences were observed between physicians and lawyers, probably originated in their respective disciplines as well as the context of their professional practice. For physicians the notion of capacity is associated to comprehension of the information, it is not absolute, and it must consider the intellectual maturity of the teenager and the autonomy of the elderly. This evaluation is frequently performed in the clinical interview and standardized protocols do not exist. For lawyers, capacity is established by age and is associated to rights and obligations, as determined by law. When it is assessed by experts, including physicians, it becomes evidence. These professionals assume that experts will use standardized assessment instruments. Capacity has significance in the legal system. Since there are substantial consequences when a person is deemed incompetent, it is necessary to distinguish between health capacity and legal capacity, and to inverted exclamation markink the informed consent with the fundamental rights of citizens, such as taking decisions about our own health.

Influencing relatives to respect donor autonomy: Should we nudge families to consent to organ donation?

PubMed

Sharif, Adnan; Moorlock, Greg

2018-03-01

Refusing consent to organ donation remains unacceptably high, and improving consent rates from family or next-of-kin is an important step to procuring more organs for solid organ transplantation in countries where this approval is sought. We have thus far failed to translate fully our limited understanding of why families refuse permission into successful strategies targeting consent in the setting of deceased organ donation, primarily because our interventions fail to target underlying cognitive obstacles. Novel interventions to overcome these hurdles, incorporating an understanding of cognitive psychology and behavioral change therapy, may be beneficial. One potential intervention is to use the concept of nudge theory, where decision-making is influenced by encouraging positive reinforcement and indirect suggestion. Purposefully nudging families to given consent for organ donation by understanding, and then overcoming, their inherent cognitive biases is novel but also controversial. This article explores the roles of relatives in decisions about organ donation, how nudge theory translates to organ donation and discusses the arguments for and against its application. © 2018 John Wiley & Sons Ltd.

Bariatric surgery for obese children and adolescents: a review of the moral challenges.

PubMed

Hofmann, Bjørn

2013-04-30

Bariatric surgery for children and adolescents is becoming widespread. However, the evidence is still scarce and of poor quality, and many of the patients are too young to consent. This poses a series of moral challenges, which have to be addressed both when considering bariatric surgery introduced as a health care service and when deciding for treatment for young individuals. A question based (Socratic) approach is applied to reveal underlying moral issues that can be relevant to an open and transparent decision making process. A wide range of moral issues with bariatric surgery for children and adolescents is identified in the literature. There is a moral imperative to help obese minors avoiding serious health problems, but there is little high quality evidence on safety, outcomes, and cost-effectiveness for bariatric surgery in this group. Lack of maturity and family relations poses a series of challenges with autonomy, informed consent, assent, and assessing the best interest of children and adolescents. Social aspects of obesity, such as medicalization, prejudice, and discrimination, raise problems with justice and trust in health professionals. Conceptual issues, such as definition of obesity and treatment end-points, present moral problems. Hidden interests of patients, parents, professionals, industry, and society need to be revealed. Performing bariatric surgery for obese children and adolescents in order to discipline their behavior warrants reflection and caution. More evidence on outcomes is needed to be able to balance benefits and risks, to provide information for a valid consent or assent, and to advise minors and parents.

Bariatric surgery for obese children and adolescents: a review of the moral challenges

PubMed Central

2013-01-01

Background Bariatric surgery for children and adolescents is becoming widespread. However, the evidence is still scarce and of poor quality, and many of the patients are too young to consent. This poses a series of moral challenges, which have to be addressed both when considering bariatric surgery introduced as a health care service and when deciding for treatment for young individuals. A question based (Socratic) approach is applied to reveal underlying moral issues that can be relevant to an open and transparent decision making process. Discussion A wide range of moral issues with bariatric surgery for children and adolescents is identified in the literature. There is a moral imperative to help obese minors avoiding serious health problems, but there is little high quality evidence on safety, outcomes, and cost-effectiveness for bariatric surgery in this group. Lack of maturity and family relations poses a series of challenges with autonomy, informed consent, assent, and assessing the best interest of children and adolescents. Social aspects of obesity, such as medicalization, prejudice, and discrimination, raise problems with justice and trust in health professionals. Conceptual issues, such as definition of obesity and treatment end-points, present moral problems. Hidden interests of patients, parents, professionals, industry, and society need to be revealed. Summary Performing bariatric surgery for obese children and adolescents in order to discipline their behavior warrants reflection and caution. More evidence on outcomes is needed to be able to balance benefits and risks, to provide information for a valid consent or assent, and to advise minors and parents. PMID:23631445

Advance Directives as Support of Autonomy for Persons with Dementia? A Pilot Study among Persons with Dementia and Their Informal Caregivers.

PubMed

Schmidhuber, Martina; Haeupler, Sandra; Marinova-Schmidt, Velislava; Frewer, Andreas; Kolominsky-Rabas, Peter L

2017-01-01

Advance directives could be an important instrument to support a person's will once he/she is not able to consent anymore - if composed competently. A survey was conducted to identify the level of knowledge concerning possibilities and limits of advance directives. The study was conducted as part of the Bavarian Dementia Survey (BayDem). Data were collected from January 2014 to December 2015 by structured face-to-face interviews. Study participants were persons with dementia and their informal caregivers ( n = 74). In total, 66% reported having written an advance directive. Concerning the participants' knowledge about possibilities and limitations of advance directives, a lack of knowledge was noted about the possibility to revoke an advance directive. Furthermore, 70% of informal caregivers and 56% of persons with dementia were not aware of the possibility to include dementia-specific terms in the advance directive. It is necessary to optimize structures for public information and education concerning the topic of advance directives for persons with dementia.

Informed consent for innovative surgery: A survey of patients and surgeons

PubMed Central

Lee Char, Susan J.; Hills, Nancy K.; Lo, Bernard; Kirkwood, Kimberly S.

2012-01-01

Background Unlike new drugs and medical devices, most surgical procedures are developed outside clinical trials, without regulatory oversight. Surgical professional organizations have discussed how new procedures should be introduced into practice, without agreement on what topics informed consent discussions must include. To provide surgeons with more specific guidance, we wanted to determine what information patients and surgeons consider essential to disclose before an innovative surgical procedure. Methods 85 attending surgeons and 383 adult postoperative patients completed surveys. Using a 6-point Likert scale, participants rated the importance of discussing 16 types of information preoperatively for 3 techniques (standard open, laparoscopic, robotic) offered for a hypothetical partial hepatectomy. Results Compared with surgeons, patients placed more importance on nearly all types of information, particularly volumes and outcomes. For all 3 techniques, around 80% of patients indicated that they could not decide on surgery without being told whether it would be the surgeon’s first time doing the procedure. When considering an innovative robotic surgery, a clear majority of both patients and surgeons agreed that it was essential to disclose the procedure’s novel nature, potentially unknown risks and benefits, and whether it would be the surgeon’s first time performing the procedure. Conclusions To promote informed decision making and autonomy among patients considering innovative surgery, surgeons should disclose the procedure’s novel nature, potentially unknown risks and benefits, and whether the surgeon would be performing the procedure for the first time. When accurate volumes and outcomes data are available, surgeons should also discuss these with patients. PMID:23218878

An ethical dilemma: when the family wants the withdrawal of care.

PubMed

Wagle, Rinata K; Ede, Kekoa; Craig, Jana; Bottum, Kathleen

2004-09-01

The ethical principles of beneficence, nonmaleficence, and respect for the dignity and autonomy of the patient provide the moral-ethical foundation for the doctor-patient relationship. However, inability to obtain informed consent in the absence of advance directives as well as conflicting family sentiments can give rise to ethical dilemmas. We present a case of a 59-year-old man who survived a near fatal suicide attempt by shooting himself in the face and whose family communicated their desire for the patient to have medical care withheld. The ethical issues that emerged from this suicide attempt, including the family's perspective on the patient's right to die, are discussed in the context of a consultation-liaison psychiatrist's recommendations to a multi-specialty treatment team.

Divergent Views on Abortion and the Period of Ensoulment

PubMed Central

Khitamy, Badawy A. B.

2013-01-01

A Muslim woman in her sixteenth week of pregnancy was informed that her ultrasound scan showed spina bifida, and laboratory results confirmed the diagnosis. The child would have various complications and, most probably, would need medical care for life. With the consent of her husband she decided to terminate the pregnancy. Her decision sparked controversy among Muslim clerics in her community, sparking debate between those who would allow abortion for medical reasons and those who oppose abortion for any reason. This paper will review the philosophical and theological arguments of the pro-life and pro-choice groups as well as the Islamic perspective concerning a woman’s autonomy over her reproductive system, the sanctity of the fetus and the embryo, therapeutic abortion, and ensoulment. PMID:23573379

Noninvasive Brain Stimulation and Personal Identity: Ethical Considerations

PubMed Central

Iwry, Jonathan; Yaden, David B.; Newberg, Andrew B.

2017-01-01

As noninvasive brain stimulation (NIBS) technology advances, these methods may become increasingly capable of influencing complex networks of mental functioning. We suggest that these might include cognitive and affective processes underlying personality and belief systems, which would raise important questions concerning personal identity and autonomy. We give particular attention to the relationship between personal identity and belief, emphasizing the importance of respecting users' personal values. We posit that research participants and patients should be encouraged to take an active approach to considering the personal implications of altering their own cognition, particularly in cases of neurocognitive “enhancement.” We suggest that efforts to encourage careful consideration through the informed consent process would contribute usefully to studies and treatments that use NIBS. PMID:28638327

Beyond a Western Bioethics in Asia and Its Implication on Autonomy.

PubMed

Tan Kiak Min, Mark

2017-07-01

Despite flourishing as a multidisciplinary subject, the predominant view in bioethics today is based on Anglo-American thought. This has serious implications for a global bioethics that needs to be contextualized to local cultures and circumstances in order to be relevant. Being the largest continent on the earth, Asia is home to a variety of cultures, religions and countries of different economic statuses. While the practice of medicine in the East and West may be similar, its ethical practices do differ. Thus, the Western understanding of autonomy may not be wholly applicable in the Asian setting, especially in the setting of breaking bad news, giving consent, determining best interests and deciding on end-of-life care. This article explores these topics in depth, attempting to find shared integrating factors, but at the same time arguing for a modified ethical application of autonomy, based on Asian beliefs.

Preferences for autonomy in end-of-life decision making in modern Korean society.

PubMed

Kim, Su Hyun

2015-03-01

The demand for autonomy in medical decision making is increasing among Korean people, but it is not well known why some people prefer autonomy in decision making but others do not. The aim of this study was to determine the extent to which Korean adults wished to exercise autonomy in the process of decision making regarding end-of-life treatment and to determine whether economic issues and family functioning, in particular, were associated with preferences for participation in decision making in Korean people. This study was a cross-sectional correlational study using a survey. Data were collected using structured questionnaires from 354 patients or their families who visited ambulatory departments at two general hospitals in South Korea, recruited by the proportionate quota sampling method. Data analysis was performed using multinomial logistic regression analyses. The study was approved by the hospitals' directors and the ethics committee of Kyungpook National University Hospital. Written informed consent was given by all participants. A majority of Korean people wanted to make autonomous decisions regarding treatment at the end of life. Preferences for autonomous decision making regarding end-of-life treatment, rather than relying on family, showed a significant increase in association with poor family functioning and low income. Results of this study suggested the necessity for development of alternatives to a dominant traditional "family-centered" approach in Korean people, in order to enhance end-of-life decision making for people who wish to take an active role in the decision-making process. Healthcare providers need to examine not only patients' preferred decision-making style but also any reasons for their choice, in particular, family conflict and financial burden. © The Author(s) 2014.

Minor Birth Mothers and Consent to Adoption: An Anomaly in Youth Law.

ERIC Educational Resources Information Center

Durcan, Jennifer; Appell, Annette R.

2001-01-01

Explores different treatment of pregnant minors under adoption and abortion law. Asserts rules governing autonomy of minor decision-making in adoption and abortion are not predicated on any unified theory of child development, protection of pregnant teenagers, or nature and long-term effects of decisions, but rather are motivated by the state's…

Engineering practice variation through provider agreement: a cluster-randomized feasibility trial.

PubMed

McCarren, Madeline; Twedt, Elaine L; Mansuri, Faizmohamed M; Nelson, Philip R; Peek, Brian T

2014-01-01

Minimal-risk randomized trials that can be embedded in practice could facilitate learning health-care systems. A cluster-randomized design was proposed to compare treatment strategies by assigning clusters (eg, providers) to "favor" a particular drug, with providers retaining autonomy for specific patients. Patient informed consent might be waived, broadening inclusion. However, it is not known if providers will adhere to the assignment or whether institutional review boards will waive consent. We evaluated the feasibility of this trial design. Agreeable providers were randomized to "favor" either hydrochlorothiazide or chlorthalidone when starting patients on thiazide-type therapy for hypertension. The assignment applied when the provider had already decided to start a thiazide, and providers could deviate from the strategy as needed. Prescriptions were aggregated to produce a provider strategy-adherence rate. All four institutional review boards waived documentation of patient consent. Providers (n=18) followed their assigned strategy for most of their new thiazide prescriptions (n=138 patients). In the "favor hydrochlorothiazide" group, there was 99% adherence to that strategy. In the "favor chlorthalidone" group, chlorthalidone comprised 77% of new thiazide starts, up from 1% in the pre-study period. When the assigned strategy was followed, dosing in the recommended range was 48% for hydrochlorothiazide (25-50 mg/day) and 100% for chlorthalidone (12.5-25.0 mg/day). Providers were motivated to participate by a desire to contribute to a comparative effectiveness study. A study promotional mug, provider information letter, and interactions with the site investigator were identified as most helpful in reminding providers of their study drug strategy. Providers prescribed according to an assigned drug-choice strategy most of the time for the purpose of a comparative effectiveness study. This simple design could facilitate research participation and behavior change in non-research clinicians. Waiver of patient consent can broaden the representation of patients, providers, and settings.

Selected aspects of health literacy among seniors.

PubMed

Šedová, Lenka; Doskočil, Ondřej; Brabcová, Iva; Hajduchová, Hana; Bártlová, Sylva

2016-12-01

This study aimed to map the selected indicators of health literacy in the senior population via a qualitative survey that focused specifically on its relationship with autonomy in the context of health literacy among seniors. A qualitative survey focused on the selected indicators of health literacy of seniors living in the South Bohemian Region of the Czech Republic (R1-19). The snowball sampling method was intentionally selected. Completed interviews were transcribed and data was reduced, analyzed, and categorized. The identified categories were 1) information comprehension, 2) decision-making in healthcare, and 3) compliance with nonpharmacologic treatment. The 'information comprehension' category clearly shows that the seniors involved in this study rated the comprehensibility of information provided by medical professionals as being good. An especially positive finding was that seniors do seek information through the internet, print sources, or other media, even though, as one senior (80-year-old woman) said, comprehension of medical information is becoming "more and more complex". The 'decision-making in healthcare' category touched upon opinions regarding informed consent and opinions regarding seniors' own involvement in healthcare. Results from this category suggest that seniors accept informed consent as a routine necessity. Inhibition regarding personal involvement in healthcare was also apparent: "... I come from a family accustomed to not bothering the doctor unnecessarily, so I just stick out my arm..." The last category of 'compliance with nonpharmacologic treatment' clearly shows that respondents are informed regarding lifestyle modifications that would benefit their treatment, although, few respondents had achieved the desired lifestyle changes. Results of this qualitative research show clear health literacy limits among seniors. As shown in this study, age itself could also be a limiting factor of health literacy.

Rhetoric or reality: what is the legal status of the consent form in health-related research?

PubMed

Laurie, Graeme; Postan, Emily

2013-01-01

This article addresses the unresolved conundrum of the legal status of consent forms used in research involving tissue samples or personal data. It identifies which rights participants might have by virtue of any consent form they have signed and which legal remedies might be available to them should the research depart from the terms of the original consent. The paper demonstrates that, although the legal status of consent forms is not clear in the UK, the landscape is evolving. We suggest that the growing legal protection afforded to autonomy and judicial recognition of individual property rights in tissues may offer opportunities for remedies in law where the regulatory regimes controlling uses of human tissue and personal data do not. However, we argue that in the governance of research relationships-which depend crucially on trust-resort to legal remedy may be undesirable. We suggest that treating consent as a one-off event that can be effectively captured in a written document-as the law tends to do-is an inappropriate and counter-productive approach. The aims of ethical research governance will be better served by seeing consent as continuing relational process, requiring on-going mutual respect, opportunity for communication, and accommodation of changing circumstances. The consent form is merely a framing instrument and only the starting point for a partnership that will evolve over time. Crucially, the limits of consent must be recognised in the design and governance of modern research practices. The article concludes with recommendations to reconceive consent in these terms.

RHETORIC OR REALITY: WHAT IS THE LEGAL STATUS OF THE CONSENT FORM IN HEALTH-RELATED RESEARCH?*

PubMed Central

Laurie, Graeme; Postan, Emily

2013-01-01

This article addresses the unresolved conundrum of the legal status of consent forms used in research involving tissue samples or personal data. It identifies which rights participants might have by virtue of any consent form they have signed and which legal remedies might be available to them should the research depart from the terms of the original consent. The paper demonstrates that, although the legal status of consent forms is not clear in the UK, the landscape is evolving. We suggest that the growing legal protection afforded to autonomy and judicial recognition of individual property rights in tissues may offer opportunities for remedies in law where the regulatory regimes controlling uses of human tissue and personal data do not. However, we argue that in the governance of research relationships—which depend crucially on trust—resort to legal remedy may be undesirable. We suggest that treating consent as a one-off event that can be effectively captured in a written document—as the law tends to do—is an inappropriate and counter-productive approach. The aims of ethical research governance will be better served by seeing consent as continuing relational process, requiring on-going mutual respect, opportunity for communication, and accommodation of changing circumstances. The consent form is merely a framing instrument and only the starting point for a partnership that will evolve over time. Crucially, the limits of consent must be recognised in the design and governance of modern research practices. The article concludes with recommendations to reconceive consent in these terms. PMID:23055572

Loss of possession: concussions, informed consent, and autonomy.

PubMed

Robeson, Richard; King, Nancy M P

2014-01-01

The recent explosion of publicity about the dangers of concussion in contact sports - particularly in football - represents the unraveling of a disinformation campaign by the NFL amid growing public and professional concern about the game's long-term risks of harm. The persistence of controversy and denial reflects a cultural view of football players as serving the needs of the team, a resulting evidentiary skepticism, and resistance to rule changes as excessive or unenforceable. This article considers the cultural context of informed decision making by parents of youth football players and suggests that policy changes designed to lower (although they cannot eliminate) risks of brain injury have the potential to change both the culture of football and the way the benefits and harms of the game are regarded for its players, without loss of its essential excitement and appeal. © 2014 American Society of Law, Medicine & Ethics, Inc.

Nontherapeutic Circumcision of Minors as an Ethically Problematic Form of Iatrogenic Injury.

PubMed

Svoboda, J Steven

2017-08-01

Nontherapeutic circumcision (NTC) of male infants and boys is a common but misunderstood form of iatrogenic injury that causes harm by removing functional tissue that has known erogenous, protective, and immunological properties, regardless of whether the surgery generates complications. I argue that the loss of the foreskin itself should be counted, clinically and morally, as a harm in evaluating NTC; that a comparison of benefits and risks is not ethically sufficient in an analysis of a nontherapeutic procedure performed on patients unable to provide informed consent; and that circumcision violates clinicians' imperatives to respect patients' autonomy, to do good, to do no harm, and to be just. When due consideration is given to these values, the balance of factors suggests that NTC should be deferred until the affected person can perform his own cost-benefit analysis, applying his mature, informed preferences and values. © 2017 American Medical Association. All Rights Reserved.

Legal process, litigation, and judicial decisions.

PubMed

Beresford, H Richard

2013-01-01

Ethically salient issues in neurologic care may have important legal overtones. This chapter considers some of these, emphasizing how law may influence the outcome of controversies over how best to promote autonomy, beneficence, and justice in the care of individuals with neurologic disorders. Constitutional, statutory, and judicial dimensions are addressed. With respect to autonomy, discussion emphasizes legal dimensions of the doctrine of informed consent and the obligations of medical professionals to protect the privacy and confidentiality of their patients. The discussion of beneficence focuses on issues relating to actual or potential conflicts of interest in the care of patients and on the conduct of research involving human subjects. The section on justice considers how law aims to define protectable rights and interests of individuals and to provide a fair and efficient process for resolving disputes. Applications of legal principles and doctrines are illustrated primarily through the examples afforded by judicial decisions. These cases demonstrate how law both promotes ethical decision-making and protects the rights and interests of those affected. The cases also highlight some of the ethical quandaries that evoke resort to litigation and the limits of law in advancing ethically appropriate outcomes. © 2013 Elsevier B.V. All rights reserved.

Extensively drug-resistant bacteria: Which ethical issues?

PubMed

Vassal, P; Berthelot, P; Chaussinand, J P; Jay, S; de Filippis, J P; Auboyer, C; Renoux, F; Bedoin, D

2017-09-01

The increased bacterial resistance to antibiotics has now become a public health concern. How can we preserve the well-being of patients presenting with infections caused by extensively drug-resistant bacteria (EDRBs) and that of their contacts without inducing any loss of chance of survival, all the while living together and controlling the spread of these EDRBs? Terre d'éthique, a French territorial ethics committee, was asked to reflect on this topic by the infection control unit of a French University Hospital as it raises many ethical issues. Patients are at the core of any ethical approach, and respecting their autonomy is fundamental. Patients should be adequately informed to be able to give consent. Indeed, the creation and dissemination of a register (list of names of contacts or infected patients) entails responsibility of the infected person and that of the community. This responsibility leads to an ethical dilemma as protecting the group (the whole population) necessarily means limiting individual freedom. The principle of autonomy should thus be compared with that of solidarity. Is medical confidentiality an obstacle to the sharing of information or lists of names? We did not aim to answer our problematic but merely wanted to show the complexity of EDRB spread in a broader societal and economic context, all the while respecting the rights of patients. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Why consent may not be needed for organ procurement.

PubMed

Delaney, James; Hershenov, David B

2009-08-01

Most people think it is wrong to take organs from the dead if the potential donors had previously expressed a wish not to donate. Yet people respond differently to a thought experiment that seems analogous in terms of moral relevance to taking organs without consent. We argue that our reaction to the thought experiment is most representative of our deepest moral convictions. We realize not everyone will be convinced by the conclusions we draw from our thought experiment. Therefore, we point out that the state ignores consent in performing mandatory autopsies in some cases. If readers are willing to give up the permissibility of mandatory autopsies, we then offer some metaphysical arguments against posthumous harm. Drawing upon claims about bodies ceasing to exist at death and Epicurean-inspired arguments against posthumous interests, we make a case for an organ conscription policy which respects fundamental liberal principles of autonomy, bodily integrity, and property.

The family v. the family court: sterilisation issues.

PubMed

Petersen, K

1992-06-01

Parents as guardians of minor children have the right and duty to give and withhold consent to medical treatment when the treatment is neither routine nor urgent. Parental authority, however, is not absolute and dwindles as the child gradually matures. In general, teenagers can give consent to medical treatment if they understand the nature and consequences of the proposed treatment. The diminution of parental authority is based on the premise that the child will eventually become autonomous. In cases where a sterilisation or hysterectomy procedure is being considered for a severely intellectually disabled teenager the question of consent is most contentious. Should this power belong to parents or the state? This paper examines some recent Family Court cases concerning this issue and also addresses questions about human rights, medical autonomy and the role of the Family Court. Finally, a proposal for an alternative means of decision-making in these cases is briefly outlined.

21 CFR 50.25 - Elements of informed consent.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Elements of informed consent. 50.25 Section 50.25... OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to...

21 CFR 50.25 - Elements of informed consent.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Elements of informed consent. 50.25 Section 50.25... OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to...

21 CFR 50.25 - Elements of informed consent.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Elements of informed consent. 50.25 Section 50.25... OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to...

Electroconvulsive therapy, the placebo effect and informed consent.

PubMed

Blease, Charlotte Rosalind

2013-03-01

Major depressive disorder is not only the most widespread mental disorder in the world, it is a disorder on the rise. In cases of particularly severe forms of depression, when all other treatment options have failed, the use of electroconvulsive therapy (ECT) is a recommended treatment option for patients. ECT has been in use in psychiatric practice for over 70 years and is now undergoing something of a restricted renaissance following a sharp decline in its use in the 1970s. Despite its success in treating severe depression there is continued debate as to the effectiveness of ECT: in some studies, it is argued that ECT is marginally more effective than sham ECT. In addition, there is still no clear explanation of how ECT works; among the range of hypotheses proposed it is claimed that ECT may work by harnessing placebo effects. In light of the uncertainties over the mechanism of action of ECT and given the risk of serious side effects that ECT may produce, I contend that the process of informed consent must include comprehensive accounts of these uncertainties. I examine the possible consequences of providing adequate information to potential ECT patients, including the consideration that ECT may still prove to be effective even if physicians are open about the possibility of it working as a placebo. I conclude that if we value patient autonomy as well as the professional reputation of medical practitioners, a fuller description of ECT must be provided to patients and their carers.

Allocating health care: cost-utility analysis, informed democratic decision making, or the veil of ignorance?

PubMed

Goold, S D

1996-01-01

Assuming that rationing health care is unavoidable, and that it requires moral reasoning, how should we allocate limited health care resources? This question is difficult because our pluralistic, liberal society has no consensus on a conception of distributive justice. In this article I focus on an alternative: Who shall decide how to ration health care, and how shall this be done to respect autonomy, pluralism, liberalism, and fairness? I explore three processes for making rationing decisions: cost-utility analysis, informed democratic decision making, and applications of the veil of ignorance. I evaluate these processes as examples of procedural justice, assuming that there is no outcome considered the most just. I use consent as a criterion to judge competing processes so that rationing decisions are, to some extent, self-imposed. I also examine the processes' feasibility in our current health care system. Cost-utility analysis does not meet criteria for actual or presumed consent, even if costs and health-related utility could be measured perfectly. Existing structures of government cannot creditably assimilate the information required for sound rationing decisions, and grassroots efforts are not representative. Applications of the veil of ignorance are more useful for identifying principles relevant to health care rationing than for making concrete rationing decisions. I outline a process of decision making, specifically for health care, that relies on substantive, selected representation, respects pluralism, liberalism, and deliberative democracy, and could be implemented at the community or organizational level.

[New italian law about end of life: self-determination and shared care pathway.

PubMed

Ciliberti, Rosagemma; Gulino, Matteo; Gorini, Ilaria

2018-05-01

The Italian Parliament has recently approved the Law n. 219/2017 concerning "Rules on informed consent and advance directives". The manuscript points out the main key points of the new law, in order to clarify the role of the advance directives and to provide clear operational guidelines for healthcare personnel. Taking into consideration the Italian deontological and juridical context, along with the main jurisprudential judgements, the law has been analysed. The Authors discussed the new rules and the bioethical issues also in relation to the provisions stated by the Convention on Human Rights and Biomedicine (Convention of Oviedo). The new law deals with relevant issues that were confined to jurisprudential rulings so far, such as the informed consent, the withdrawal/withholding of medical treatment (including artificial nutrition and hydration), the content of medical information, including the modalities, the medical responsibility and, finally, the value of advance directives. In the Authors' opinion this law provides essential rules to expressly strengthen the patients' autonomy, eliminating the juridical uncertainty on many central issues (such us, for example, the refusal of life-sustainment treatments) that have been the subject of contradictory judgments ruled by the Italian Courts. Nevertheless, advance directives should be regarded as a dynamic tools of relationship between physicians and assisted person and, thus, as an essential integrant part of the advance care planning. The education of health professionals and citizens about end of life issues is the basis for the successful implementation of this legislation.

Assessing patient capacity to consent to treatment: an integrative review of instruments and tools.

PubMed

Lamont, Scott; Jeon, Yun-Hee; Chiarella, Mary

2013-09-01

To provide a narrative synthesis of research findings on instruments or tools designed to aid assessment of patient capacity to consent to treatment. Capacity assessment is of significant priority within health care as a finding of incapacity is a vehicle for the removal of many of an individual's fundamental rights. Despite there being many instruments and tools available to aid health professionals in the assessment of patient capacity, there are no standardised guidelines from professional bodies that inform the assessment of mental capacity. Integrative review. Primary studies of instruments or tools concerning assessment of patient capacity to consent to treatment, published in English in peer-reviewed journals between January 2005-December 2010, were included in the review. Review papers of capacity assessment instruments were included for years including and prior to 2006. Nineteen instruments were found which assess patient capacity to consent. Key themes were identified in terms of capacity domains assessed, psychometric properties, instrument implementation, patient populations studied and instrument versus clinician judgement. Despite a plethora of capacity assessment instruments and tools available, only a small number of instruments were found to have demonstrated both reliability and validity. Further research is required to improve the validity of existing capacity assessment instruments. Increased attention to patient rights and autonomy arguably places a considerable burden on healthcare professionals to facilitate capacity assessments across a continuum of health care. Despite a plethora of capacity assessment instruments and tools being available to healthcare professionals, a comprehensive assessment requires time and is often difficult in the acute care setting. A strictly formulaic approach to the assessment of capacity is unlikely to capture specific individual nuances; therefore, capacity assessment instruments should support, but not replace, experienced clinical judgement. © 2013 John Wiley & Sons Ltd.

Informed consent for innovative surgery: a survey of patients and surgeons.

PubMed

Lee Char, Susan J; Hills, Nancy K; Lo, Bernard; Kirkwood, Kimberly S

2013-04-01

Unlike new drugs and medical devices, most surgical procedures are developed outside clinical trials and without regulatory oversight. Surgical professional organizations have discussed how new procedures should be introduced into practice without agreement on what topics informed consent discussions must include. To provide surgeons with more specific guidance, we wanted to determine what information patients and surgeons consider essential to disclose before an innovative surgical procedure. Of those approached, 85 of 113 attending surgeons and 383 of 541 adult postoperative patients completed surveys; responses to the surveys were 75% and 71%, respectively. Using a 6-point Likert scale, participants rated the importance of discussing 16 types of information preoperatively for 3 techniques (standard open, laparoscopic, robotic) offered for a hypothetic partial hepatectomy. Compared with surgeons, patients placed more importance on nearly all types of information, particularly volumes and outcomes. For all 3 techniques, approximately 80% of patients indicated that they could not decide on surgery without being told whether it would be the surgeon's first time doing the procedure. When considering an innovative robotic surgery, a clear majority of both patients and surgeons agreed that it was essential to disclose the novel nature of the procedure, potentially unknown risks and benefits, and whether it would be the surgeon's first time performing the procedure. To promote informed decision-making and autonomy among patients considering innovative surgery, surgeons should disclose the novel nature of the procedure, potentially unknown risks and benefits, and whether the surgeon would be performing the procedure for the first time. When accurate volumes and outcomes data are available, surgeons should also discuss these with patients. Copyright © 2013 Mosby, Inc. All rights reserved.

Parental and youth understanding of the informed consent process for pediatric endoscopy.

PubMed

Jubbal, Kevin; Chun, Stanford; Chang, Jeremy; Zhang, Sherry; Terrones, Laura; Huang, Jeannie S

2015-06-01

Informed consent (IC) is an essential communication between patient/representative and physician that acknowledges patient autonomy; assent is the equivalent process performed between youth and physician. For clinical procedures involving youth, only the IC process between guardian/parent and physician is required to be performed. Nevertheless, experts recommend that youth undergo assent whenever possible. In the present study, we explored both parental and youth understanding of required IC elements in IC discussions before pediatric endoscopy. Following signing of IC documents on the day of endoscopy at a tertiary care academic medical center, youth and their parents underwent structured interviews to assess comprehension of key elements of the IC process. A total of 88 children and adolescents and their parents were evaluated. Two youth and 12 parents demonstrated comprehensive understanding of key IC elements for pediatric endoscopy. Suboptimal youth understanding was demonstrated for nature of the procedure (25% with adequate understanding) and related risks (17%), and alternatives (14%) to the procedure. Suboptimal parental understanding was demonstrated for procedure alternatives (24%). Youth overall understanding of IC varied by age, whereas parental global understanding of IC varied by physician. Understanding of IC performed for pediatric endoscopy could be improved in both parents and youth. Our findings suggest that interventions targeting parents, youth, and physicians may be helpful. Further study is needed to determine whether our findings are representative of IC understanding at other pediatric endoscopy centers.

Moral implications of obstetric technologies for pregnancy and motherhood.

PubMed

Brauer, Susanne

2016-03-01

Drawing on sociological and anthropological studies, the aim of this article is to reconstruct how obstetric technologies contribute to a moral conception of pregnancy and motherhood, and to evaluate that conception from a normative point of view. Obstetrics and midwifery, so the assumption, are value-laden, value-producing and value-reproducing practices, values that shape the social perception of what it means to be a "good" pregnant woman and to be a "good" (future) mother. Activities in the medical field of reproduction contribute to "kinning", that is the making of particular social relationships marked by closeness and special moral obligations. Three technologies, which belong to standard procedures in prenatal care in postmodern societies, are presently investigated: (1) informed consent in prenatal care, (2) obstetric sonogram, and (3) birth plan. Their widespread application is supposed to serve the moral (and legal) goal of effecting patient autonomy (and patient right). A reconstruction of the actual moral implications of these technologies, however, reveals that this goal is missed in multiple ways. Informed consent situations are marked by involuntariness and blindness to social dimensions of decision-making; obstetric sonograms construct moral subjectivity and agency in a way that attribute inconsistent and unreasonable moral responsibilities to the pregnant woman; and birth plans obscure the need for a healthcare environment that reflects a shared-decision-making model, rather than a rational-choice-framework.

Stakeholders' views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs.

PubMed

Kalkman, Shona; van Thiel, Ghislaine J M W; Grobbee, Diederick E; Meinecke, Anna-Katharina; Zuidgeest, Mira G P; van Delden, Johannes J M

2016-08-22

We explored the views of key stakeholders to identify the ethical challenges of pragmatic trials investigating pharmaceutical drugs. A secondary aim was to capture stakeholders' attitudes towards the implementation of pragmatic trials in the drug development process. We conducted semistructured, in-depth interviews among individuals from different key stakeholder groups (academia and independent research institutions, the pharmaceutical industry, regulators, Health Technology Assessment (HTA) agencies and patients' organizations) through telephone or face-to-face sessions. Interviews were structured around the question "what challenges were experienced or perceived during the design, conduct and/or review of pragmatic trials." Respondents were additionally asked about their views on implementation of pragmatic trials in the drug development process. Thematic analysis was used to identify the ethically relevant features across data sets. We interviewed 34 stakeholders in 25 individual sessions and four group sessions. The four perceived challenges of ethical relevance were: (1) less controlled conditions creating safety concerns, (2) comparison with usual care potentially compromising clinical equipoise, (3) tailored or waivers of informed consent affecting patient autonomy, and (4) minimal interference with "real-world" practice reducing the knowledge value of trial results. We identified stakeholder concerns regarding risk assessment, use of suboptimal usual care as a comparator, tailoring of informed consent procedures and ensuring the social value of pragmatic trials. These concerns increased when respondents were asked about pragmatic trials conducted before market authorization.

The bioethics of separating conjoined twins in plastic surgery.

PubMed

Lee, Michelle; Gosain, Arun K; Becker, Devra

2011-10-01

The incidence of craniopagus twins approximates four to six per 10 million births. Although rare, surgical separation of conjoined twins poses significant technical and ethical challenges. The present report uses the case of craniopagus twins AD and TD to examine the bioethical issues faced by a multidisciplinary medical team in planning the separation of craniopagus twins. AD and TD are craniopagus twins conjoined at the head. TD's head is conjoined to the back of AD's head. Neurologically, AD has the dominant cerebral circulation. TD has two normal kidneys, whereas AD has none. AD depends on TD's renal function and, on separation, will require either a kidney transplant or lifelong dialysis. This case report reviews one approach to analyzing and solving complex ethical dilemmas in pediatric plastic surgery. The principles reviewed are (1) autonomy and informed consent, focusing especially on the role of children in the informed consent process; (2) beneficence and nonmaleficence, two intricately intertwined principles because separation could potentially cause irreversible harm to one twin while improving the quality of life for the other (as separation is not a life-saving procedure, is it ethical to perform a procedure with unknown surgical risk to improve children's quality of life?); and (3) justice (is it fair to allocate excessive medical resources for the twins' separation?). The present report explores the ethics behind such decisions with respect to the separation of conjoined twins.

Health-related biotechnology transfer to Africa: principal-agency relationship issues.

PubMed

Kirigia, J M; Muthuri, L K; Kirigia, D G

2007-01-01

The aim of this paper is to stimulate debate on the agency (principal-agent) in health-related biotechnology research. It attempts to answer the following questions: What is health-related biotechnology and biotechnology research? What is an agency? What factors are likely to undermine the principal's capacity to exercise informed consent? When might the principal-agency problem arise? How could the agency in biotechnology transfer be strengthened in Sub-Saharan Africa (SSA)? The transfer of health-related biotechnology to SSA ought to be preceded by research to ascertain the effectiveness of such technologies on population health. In that process, the national ethical review committee (REC), as an agent of every human research subject (principal), ought to ensure that international principles (e.g. beneficence, non-malfeasance, autonomy, justice, dignity, truthfulness and honesty) for human experimentation are observed by biotechnology researchers in order to satisfy moral, ethical and legal requirements. The key factors that undermine principals' sovereignty in exercising their right to informed consent to participate in biotechnology trials are discussed. The paper ends with a list of activities that can strengthen the agency, e.g. legislative requirement that all health-related biotechnology transfer should be preceded by rigorous evaluation; continuous update of the agents knowledge of the contents of the international ethical guidelines; and education of potential and actual principals on their human rights; among others.

Ethics in sports medicine.

PubMed

Dunn, Warren R; George, Michael S; Churchill, Larry; Spindler, Kurt P

2007-05-01

Physicians have struggled with the medical ramifications of athletic competition since ancient Greece, where rational medicine and organized athletics originated. Historically, the relationship between sport and medicine was adversarial because of conflicts between health and sport. However, modern sports medicine has emerged with the goal of improving performance and preventing injury, and the concept of the "team physician" has become an integral part of athletic culture. With this distinction come unique ethical challenges because the customary ethical norms for most forms of clinical practice, such as confidentiality and patient autonomy, cannot be translated easily into sports medicine. The particular areas of medical ethics that present unique challenges in sports medicine are informed consent, third parties, advertising, confidentiality, drug use, and innovative technology. Unfortunately, there is no widely accepted code of sports medicine ethics that adequately addresses these issues.

Ethical Challenges and Solutions Regarding Delirium Studies in Palliative Care

PubMed Central

Sweet, Lisa; Adamis, Dimitrios; Meagher, David; Davis, Daniel; Currow, David; Bush, Shirley H.; Barnes, Christopher; Hartwick, Michael; Agar, Meera; Simon, Jessica; Breitbart, William; MacDonald, Neil; Lawlor, Peter G.

2014-01-01

Context Delirium occurs commonly in settings of palliative care (PC), in which patient vulnerability in the unique context of end-of-life care and delirium-associated impairment of decision-making capacity may together present many ethical challenges. Objectives Based on deliberations at the Studies to Understand Delirium in Palliative Care Settings (SUNDIPS) meeting and an associated literature review, this article discusses ethical issues central to the conduct of research on delirious PC patients. Methods Together with an analysis of the ethical deliberations at the SUNDIPS meeting, we conducted a narrative literature review by key words searching of relevant databases and a subsequent hand search of initially identified articles. We also reviewed statements of relevance to delirium research in major national and international ethics guidelines. Results Key issues identified include the inclusion of PC patients in delirium research, capacity determination, and the mandate to respect patient autonomy and ensure maintenance of patient dignity. Proposed solutions include designing informed consent statements that are clear, concise, and free of complex phraseology; use of concise, yet accurate, capacity assessment instruments with a minimally burdensome schedule; and use of PC friendly consent models, such as facilitated, deferred, experienced, advance, and proxy models. Conclusion Delirium research in PC patients must meet the common standards for such research in any setting. Certain features unique to PC establish a need for extra diligence in meeting these standards and the employment of assessments, consent procedures, and patient-family interactions that are clearly grounded on the tenets of PC. PMID:24388124

Audit of the informed consent process as a part of a clinical research quality assurance program.

PubMed

Lad, Pramod M; Dahl, Rebecca

2014-06-01

Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process.

Presumed consent for organ preservation in uncontrolled donation after cardiac death in the United States: a public policy with serious consequences

PubMed Central

Verheijde, Joseph L; Rady, Mohamed Y; McGregor, Joan

2009-01-01

Organ donation after cessation of circulation and respiration, both controlled and uncontrolled, has been proposed by the Institute of Medicine as a way to increase opportunities for organ procurement. Despite claims to the contrary, both forms of controlled and uncontrolled donation after cardiac death raise significant ethical and legal issues. Identified causes for concern include absence of agreement on criteria for the declaration of death, nonexistence of universal guidelines for duration before stopping resuscitation efforts and techniques, and assumption of presumed intent to donate for the purpose of initiating temporary organ-preservation interventions when no expressed consent to donate is present. From a legal point of view, not having scientifically valid criteria of cessation of circulation and respiration for declaring death could lead to a conclusion that organ procurement itself is the proximate cause of death. Although the revised Uniform Anatomical Gift Act of 2006 provides broad immunity to those involved in organ-procurement activities, courts have yet to provide an opinion on whether persons can be held liable for injuries arising from the determination of death itself. Preserving organs in uncontrolled donation after cardiac death requires the administration of life-support systems such as extracorporeal membrane oxygenation. These life-support systems can lead to return of signs of life that, in turn, have to be deliberately suppressed by the administration of pharmacological agents. Finally, allowing temporary organ-preservation interventions without expressed consent is inherently a violation of the principle of respect for a person's autonomy. Proponents of organ donation from uncontrolled donation after cardiac death, on the other hand, claim that these nonconsensual interventions enhance respect for autonomy by allowing people, through surrogate decision making, to execute their right to donate organs. However, the lack of transparency and the absence of protection of individual autonomy, for the sake of maximizing procurement opportunities, have placed the current organ-donation system of opting-in in great jeopardy. Equally as important, current policies enabling and enhancing organ procurement practices, pose challenges to the constitutional rights of individuals in a pluralistic society as these policies are founded on flawed medical standards for declaring death. PMID:19772617

Presumed consent for organ preservation in uncontrolled donation after cardiac death in the United States: a public policy with serious consequences.

PubMed

Verheijde, Joseph L; Rady, Mohamed Y; McGregor, Joan

2009-09-22

Organ donation after cessation of circulation and respiration, both controlled and uncontrolled, has been proposed by the Institute of Medicine as a way to increase opportunities for organ procurement. Despite claims to the contrary, both forms of controlled and uncontrolled donation after cardiac death raise significant ethical and legal issues. Identified causes for concern include absence of agreement on criteria for the declaration of death, nonexistence of universal guidelines for duration before stopping resuscitation efforts and techniques, and assumption of presumed intent to donate for the purpose of initiating temporary organ-preservation interventions when no expressed consent to donate is present. From a legal point of view, not having scientifically valid criteria of cessation of circulation and respiration for declaring death could lead to a conclusion that organ procurement itself is the proximate cause of death. Although the revised Uniform Anatomical Gift Act of 2006 provides broad immunity to those involved in organ-procurement activities, courts have yet to provide an opinion on whether persons can be held liable for injuries arising from the determination of death itself. Preserving organs in uncontrolled donation after cardiac death requires the administration of life-support systems such as extracorporeal membrane oxygenation. These life-support systems can lead to return of signs of life that, in turn, have to be deliberately suppressed by the administration of pharmacological agents. Finally, allowing temporary organ-preservation interventions without expressed consent is inherently a violation of the principle of respect for a person's autonomy. Proponents of organ donation from uncontrolled donation after cardiac death, on the other hand, claim that these nonconsensual interventions enhance respect for autonomy by allowing people, through surrogate decision making, to execute their right to donate organs. However, the lack of transparency and the absence of protection of individual autonomy, for the sake of maximizing procurement opportunities, have placed the current organ-donation system of opting-in in great jeopardy. Equally as important, current policies enabling and enhancing organ procurement practices, pose challenges to the constitutional rights of individuals in a pluralistic society as these policies are founded on flawed medical standards for declaring death.

A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy.

PubMed

Friedlander, Joel A; Loeben, Greg S; Finnegan, Patricia K; Puma, Anita E; Zhang, Xuemei; de Zoeten, Edwin F; Piccoli, David A; Mamula, Petar

2011-04-01

To evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy. The Consent-20 instrument was developed and piloted on 47 subjects. Subsequently, parents of 101 children undergoing first-time, diagnostic upper endoscopy performed under moderate IV sedation were prospectively and consecutively, blinded, randomised and enrolled into two groups that received either standard form-based informed consent or standard form-based informed consent plus a commercial (Emmi Solutions, Inc, Chicago, Il), sixth grade level, interactive learning module (electronic assisted consent). Anonymously and electronically, the subjects' anxiety (State Trait Anxiety Inventory), satisfaction (Modified Group Health Association of America), number of questions asked, and attainment of informed consent were assessed (Consent-20). Statistics were calculated using t test, paired t test, and Mann Whitney tests. The ability to achieve informed consent, as measured by the new instrument, was 10% in the control form-based consent group and 33% in the electronic assisted consent group (p<0.0001). Electronically assisting form-based informed consent did not alter secondary outcome measures of subject satisfaction, anxiety or number of questions asked in a paediatric endoscopy unit. This study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy. It also shows that even when necessary information was repeated electronically in a comprehensive and standardised video, informed consent as measured by our instrument was incompletely achieved. The supplemental information did, however, significantly improve understanding in a manner that did not negatively impact workflow, subject anxiety or subject satisfaction. Additional study of informed consent is required.

[The informed consent in international clinical trials including developing countries].

PubMed

Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

2008-01-01

The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

Advance Directives as Support of Autonomy for Persons with Dementia? A Pilot Study among Persons with Dementia and Their Informal Caregivers

PubMed Central

Schmidhuber, Martina; Haeupler, Sandra; Marinova-Schmidt, Velislava; Frewer, Andreas; Kolominsky-Rabas, Peter L.

2017-01-01

Background Advance directives could be an important instrument to support a person's will once he/she is not able to consent anymore – if composed competently. A survey was conducted to identify the level of knowledge concerning possibilities and limits of advance directives. Methods The study was conducted as part of the Bavarian Dementia Survey (BayDem). Data were collected from January 2014 to December 2015 by structured face-to-face interviews. Study participants were persons with dementia and their informal caregivers (n = 74). Results In total, 66% reported having written an advance directive. Concerning the participants' knowledge about possibilities and limitations of advance directives, a lack of knowledge was noted about the possibility to revoke an advance directive. Furthermore, 70% of informal caregivers and 56% of persons with dementia were not aware of the possibility to include dementia-specific terms in the advance directive. Conclusion It is necessary to optimize structures for public information and education concerning the topic of advance directives for persons with dementia. PMID:29118785

Description of a Mobile-based Electronic Informed Consent System Development.

PubMed

Hwang, Min-A; Kwak, In Ja

2015-01-01

Seoul National University Hospital constructed and implemented a computer-based informed consent system in December 2011. As of 2013, 30% of the informed consents were still filled out manually on paper. Patients and medical staff continuously suggested the implementation of a system for electronic informed consent using portable devices. Therefore, a mobile-based system for electronic informed consent was developed in 2013 to prevent the issues that arise with computer-based systems and paper informed consent. The rate of filling out electronic informed consent increased from 69% to 95% following the implementation of the mobile-based electronic informed consent. This construction of a mobile-based electronic informed consent system would be a good reference point for the development of a mobile-based Electronic Medical Record and for various mobile system environments in medical institutions.

Contemporary issues concerning informed consent in Japan based on a review of court decisions and characteristics of Japanese culture

PubMed Central

2014-01-01

Background Since Japan adopted the concept of informed consent from the West, its inappropriate acquisition from patients in the Japanese clinical setting has continued, due in part to cultural aspects. Here, we discuss the current status of and contemporary issues surrounding informed consent in Japan, and how these are influenced by Japanese culture. Discussion Current legal norms towards informed consent and information disclosure are obscure in Japan. For instance, physicians in Japan do not have a legal duty to inform patients of a cancer diagnosis. To gain a better understanding of these issues, we present five court decisions related to informed consent and information disclosure. We then discuss Japanese culture through reviews of published opinions and commentaries regarding how culture affects decision making and obtaining informed consent. We focus on two contemporary problems involving informed consent and relevant issues in clinical settings: the misuse of informed consent and persistence in obtaining consent. For the former issue, the phrase "informed consent" is often used to express an opportunity to disclose medical conditions and recommended treatment choices. The casual use of the expression "informed consent" likely reflects deep-rooted cultural influences. For the latter issue, physicians may try to obtain a signature by doing whatever it takes, lacking a deep understanding of important ethical principles, such as protecting human dignity, serving the patient’s best interest, and doing no harm in decision-making for patients. There is clearly a misunderstanding of the concept of informed consent and a lack of complete understanding of ethical principles among Japanese healthcare professionals. Although similar in some respects to informed consent as it originated in the United States, our review makes it clear that informed consent in Japan has clear distinguishing features. Summary Japanese healthcare professionals should aim to understand the basic nature of informed consent, irrespective of their attitudes about individualism, liberalism, and patient self-determination. If they believe that the concept of informed consent is important and essential in Japanese clinical settings, efforts should be made to obtain informed consent in an appropriate manner. PMID:24495473

Contemporary issues concerning informed consent in Japan based on a review of court decisions and characteristics of Japanese culture.

PubMed

Masaki, Sakiko; Ishimoto, Hiroko; Asai, Atsushi

2014-02-04

Since Japan adopted the concept of informed consent from the West, its inappropriate acquisition from patients in the Japanese clinical setting has continued, due in part to cultural aspects. Here, we discuss the current status of and contemporary issues surrounding informed consent in Japan, and how these are influenced by Japanese culture. Current legal norms towards informed consent and information disclosure are obscure in Japan. For instance, physicians in Japan do not have a legal duty to inform patients of a cancer diagnosis. To gain a better understanding of these issues, we present five court decisions related to informed consent and information disclosure. We then discuss Japanese culture through reviews of published opinions and commentaries regarding how culture affects decision making and obtaining informed consent. We focus on two contemporary problems involving informed consent and relevant issues in clinical settings: the misuse of informed consent and persistence in obtaining consent. For the former issue, the phrase "informed consent" is often used to express an opportunity to disclose medical conditions and recommended treatment choices. The casual use of the expression "informed consent" likely reflects deep-rooted cultural influences. For the latter issue, physicians may try to obtain a signature by doing whatever it takes, lacking a deep understanding of important ethical principles, such as protecting human dignity, serving the patient's best interest, and doing no harm in decision-making for patients.There is clearly a misunderstanding of the concept of informed consent and a lack of complete understanding of ethical principles among Japanese healthcare professionals. Although similar in some respects to informed consent as it originated in the United States, our review makes it clear that informed consent in Japan has clear distinguishing features. Japanese healthcare professionals should aim to understand the basic nature of informed consent, irrespective of their attitudes about individualism, liberalism, and patient self-determination. If they believe that the concept of informed consent is important and essential in Japanese clinical settings, efforts should be made to obtain informed consent in an appropriate manner.

Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level.

PubMed

Kim, Eun Jin; Kim, Su Hyun

2015-06-01

This study evaluated the effect of a simplified informed consent form for clinical trials on the understanding and efficacy of informed consent information across health literacy levels. A total of 150 participants were randomly assigned to one of two groups and provided with either standard or simplified consent forms for a cancer clinical trial. The features of the simplified informed consent form included plain language, short sentences, diagrams, pictures, and bullet points. Levels of objective and subjective understanding were significantly higher in participants provided with simplified informed consent forms relative to those provided with standard informed consent forms. The interaction effects between type of consent form and health literacy level on objective and subjective understanding were nonsignificant. Simplified informed consent was effective in enhancing participant's subjective and objective understanding regardless of health literacy. © The Author(s) 2015.

Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment trial

PubMed Central

Denning, Eileen; Sharma, Shweta; Smolskis, Mary; Touloumi, Giota; Walker, Sarah; Babiker, Abdel; Clewett, Megan; Emanuel, Ezekiel; Florence, Eric; Papadopoulos, Antonios; Sánchez, Adriana; Tavel, Jorge; Grady, Christine

2014-01-01

Objectives Efforts are needed to improve informed consent of participants in research. The Strategic Timing of AntiRetroviral Therapy (START) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants. Methods Interested START sites were randomised to use either the standard consent form or the concise consent form for all of the site’s participants. Results A total of 4473 HIV-positive participants at 154 sites worldwide took part in the Informed Consent Substudy, with consent given in 11 primary languages. Most sites sent written information to potential participants in advance of clinic visits, usually including the consent form. At about half the sites, staff reported spending less than an hour per participant in the consent process. The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment. Conclusions These data reflect the interest of START research staff in evaluating the consent process and improving informed consent. The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted. Its results have the potential to impact how consent forms are written around the world. PMID:25711320

Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial.

PubMed

Denning, E; Sharma, S; Smolskis, M; Touloumi, G; Walker, S; Babiker, A; Clewett, M; Emanuel, E; Florence, E; Papadopoulos, A; Sánchez, A; Tavel, J; Grady, C

2015-04-01

Efforts are needed to improve informed consent of participants in research. The Strategic Timing of AntiRetroviral Therapy (START) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants. Interested START sites were randomized to use either the standard consent form or the concise consent form for all of the site's participants. A total of 4473 HIV-positive participants at 154 sites world-wide took part in the Informed Consent Substudy, with consent given in 11 primary languages. Most sites sent written information to potential participants in advance of clinic visits, usually including the consent form. At about half the sites, staff reported spending less than an hour per participant in the consent process. The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment. These data reflect the interest of START research staff in evaluating the consent process and improving informed consent. The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted. Its results have the potential to impact how consent forms are written around the world. © 2015 British HIV Association.

Getting meaningful informed consent from older adults: a structured literature review of empirical research.

PubMed

Sugarman, J; McCrory, D C; Hubal, R C

1998-04-01

To perform a structured literature review of the published empirical research on informed consent with older adults in order to make recommendations to improve the informed consent process and to highlight areas needing further examination. Relevant literature was identified by searching electronic databases (AGELINE, BIOETHICSLINE, CancerLit, Ethics Index, Health, LegalTrac, MEDLINE, PAIS International, PsycInfo, and Sociofile). Studies were included if they were reports of primary research data about informed consent and, if patients or other subjects were used, older subjects were included in the sample. Data related to the aspect of informed consent under study (recruitment, decision-making capacity, voluntariness, disclosure of information, understanding of information, consent forms, authorization, and policies and procedures) were abstracted and entered into a specially designed database. Characterization of the population, age of subjects, setting, whether informed consent was being studied in the context of research or treatment, study design, the nature of outcome or dependent variables, independent variables (e.g., experimental conditions in a randomized controlled trial or patient/subject characteristics in a nonrandomized comparison), and results according to the aspect of informed consent under study. A total of 99 articles met all the inclusion criteria and posed 289 unique research questions covering a wide range of aspects of informed consent: recruitment (60); decision making capacity (21); voluntariness (6); disclosure (30); understanding (139); consent forms (7); authorization (11); policies (13); and other (2). In the secondary analyses of numerous studies, diminished understanding of informed consent information was associated with older age and fewer years of education. Older age was also sometimes associated with decreased participation in research. Studies of disclosure of informed consent information suggest strategies to improve understanding and include a variety of novel formats (e.g., simplified, storybook, video) and procedures (e.g., use of health educators, quizzing subjects, multiple disclosure sessions). A systematic review of the published literature on informed consent reveals evidence for impaired understanding of informed consent information in older subjects and those with less formal education. Effective strategies to improve the understanding of informed consent information should be considered when designing materials, forms, policies, and procedures for obtaining informed consent. Other than empirical research that has investigated disclosure and understanding of informed consent information, little systematic research has examined other aspects of the informed consent process. This deficit should be rectified to ensure that the rights and interests of patients and of human subjects who participate in research are adequately protected.

Improving readability of informed consents for research at an academic medical institution.

PubMed

Hadden, Kristie B; Prince, Latrina Y; Moore, Tina D; James, Laura P; Holland, Jennifer R; Trudeau, Christopher R

2017-12-01

The final rule for the protection of human subjects requires that informed consent be "in language understandable to the subject" and mandates that "the informed consent must be organized in such a way that facilitates comprehension." This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention. Readability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year. The mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade. Providing investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.

Toward Optimal Decision Making among Vulnerable Patients Referred for Cardiac Surgery: A Qualitative Analysis of Patient and Provider Perspectives.

PubMed

Gainer, Ryan A; Curran, Janet; Buth, Karen J; David, Jennie G; Légaré, Jean-Francois; Hirsch, Gregory M

2017-07-01

Comprehension of risks, benefits, and alternative treatment options has been shown to be poor among patients referred for cardiac interventions. Patients' values and preferences are rarely explicitly sought. An increasing proportion of frail and older patients are undergoing complex cardiac surgical procedures with increased risk of both mortality and prolonged institutional care. We sought input from patients and caregivers to determine the optimal approach to decision making in this vulnerable patient population. Focus groups were held with both providers and former patients. Three focus groups were convened for Coronary Artery Bypass Graft (CABG), Valve, or CABG +Valve patients ≥ 70 y old (2-y post-op, ≤ 8-wk post-op, complicated post-op course) (n = 15). Three focus groups were convened for Intermediate Medical Care Unit (IMCU) nurses, Intensive Care Unit (ICU) nurses, surgeons, anesthesiologists and cardiac intensivists (n = 20). We used a semi-structured interview format to ask questions surrounding the informed consent process. Transcribed audio data was analyzed to develop consistent and comprehensive themes. We identified 5 main themes that influence the decision making process: educational barriers, educational facilitators, patient autonomy and perceived autonomy, patient and family expectations of care, and decision making advocates. All themes were influenced by time constraints experienced in the current consent process. Patient groups expressed a desire to receive information earlier in their care to allow time to identify personal values and preferences in developing plans for treatment. Both groups strongly supported a formal approach for shared decision making with a decisional coach to provide information and facilitate communication with the care team. Identifying the barriers and facilitators to patient and caretaker engagement in decision making is a key step in the development of a structured, patient-centered SDM approach. Intervention early in the decision process, the use of individualized decision aids that employ graphic risk presentations, and a dedicated decisional coach were identified by patients and providers as approaches with a high potential for success. The impact of such a formalized shared decision making process in cardiac surgery on decisional quality will need to be formally assessed. Given the trend toward older and frail patients referred for complex cardiac procedures, the need for an effective shared decision making process is compelling.

Nurses' and patients' perceptions of privacy protection behaviours and information provision.

PubMed

Kim, Kyunghee; Han, Yonghee; Kim, Ji-Su

2017-08-01

With increased attention to patient privacy and autonomy, privacy protection and information provision for patients are becoming increasingly important. The aim of this study was to identify and analyse nurses' and patients' perceptions of the importance and performance of protecting patients' privacy and providing them with relevant information. This study is a descriptive cross-sectional investigation. Participants and research context: Participants were 168 patients hospitalised in medical and surgical wards and 176 nurses who cared for them. Ethical consideration: This study was approved by the Chung-Ang University Bioethics Committee, and informed written consent was collected from all participants. Nurses' recognition of the importance of protecting patients' privacy and providing adequate information was higher compared to their actual performance, and the nurses' level of performance was higher in comparison with the patients' recognition of its importance. Although a holistic approach to patient privacy protection and information provision is needed, the medical field has not embraced this model of care. These findings provide empirical data to create an ethical environment for the future, as considerable attention has been devoted to patients' rights and medical institutions' liability for providing explanations to patients.

Improving informed consent: Stakeholder views.

PubMed

Anderson, Emily E; Newman, Susan B; Matthews, Alicia K

2017-01-01

Innovation will be required to improve the informed consent process in research. We aimed to obtain input from key stakeholders-research participants and those responsible for obtaining informed consent-to inform potential development of a multimedia informed consent "app." This descriptive study used a mixed-methods approach. Five 90-minute focus groups were conducted with volunteer samples of former research participants and researchers/research staff responsible for obtaining informed consent. Participants also completed a brief survey that measured background information and knowledge and attitudes regarding research and the use of technology. Established qualitative methods were used to conduct the focus groups and data analysis. We conducted five focus groups with 41 total participants: three groups with former research participants (total n = 22), and two groups with researchers and research coordinators (total n = 19). Overall, individuals who had previously participated in research had positive views regarding their experiences. However, further discussion elicited that the informed consent process often did not meet its intended objectives. Findings from both groups are presented according to three primary themes: content of consent forms, experience of the informed consent process, and the potential of technology to improve the informed consent process. A fourth theme, need for lay input on informed consent, emerged from the researcher groups. Our findings add to previous research that suggests that the use of interactive technology has the potential to improve the process of informed consent. However, our focus-group findings provide additional insight that technology cannot replace the human connection that is central to the informed consent process. More research that incorporates the views of key stakeholders is needed to ensure that multimedia consent processes do not repeat the mistakes of paper-based consent forms.

The Voluntary Nature of Decision-Making in Addiction: Static Metaphysical Views Versus Epistemologically Dynamic Views.

PubMed

Racine, Eric; Rousseau-Lesage, Simon

2017-06-01

The degree of autonomy present in the choices made by individuals with an addiction, notably in the context of research, is unclear and debated. Some have argued that addiction, as it is commonly understood, prevents people from having sufficient decision-making capacity or self-control to engage in choices involving substances to which they have an addiction. Others have criticized this position for being too radical and have counter-argued in favour of the full autonomy of people with an addiction. Aligning ourselves with middle-ground positions between these two extremes, we flesh out an account of voluntary action that makes room for finer-grained analyses than the proposed all-or-nothing stances, which rely on a rather static metaphysical understanding of the nature of the voluntariness of action. In contrast, a dynamic concept of voluntary action better accounts for varying levels of voluntariness of the person with an addiction which takes into consideration internal (e.g. cravings) and external (e.g. perceptions of degrees of freedom related to different options) determinants of choice. Accordingly, like other components of autonomous choices such as level of information, voluntariness can fluctuate. Therefore, there are important implications for research and clinical ethics in matters of consent, recruitment, and therapeutic approaches. Overall, our proposal is inspired by a pragmatist understanding of voluntary action, notably with respect to how voluntariness is both informed by actions and experiences that shape one's view of the world. © 2017 John Wiley & Sons Ltd.

Regulation of advance directives in Italy: a bad law in the making.

PubMed

Gristina, Giuseppe Renato; Martin, Erica; Ranieri, Vito Marco

2012-11-01

The Advance Directives (ADs) have been adopted in many countries to defend patients' autonomy. In Italy, the role of ADs has recently been the subject of heated debate involving political parties and the Roman Catholic Church. In February 2009, the conservative government coalition presented a bill of law on this issue. It has been passed by the Low Chamber and is now being discussed in the Senate. The purpose of the article is to highlight any possible bill's contradiction with Italian Constitution, Italian Code of Medical Ethics (ICME), and Oviedo Convention contents, relevant for intensivists. Analysis of bill's content in the light of Italian Constitution, ICME, Oviedo Convention articles and in comparison with French legislation regarding end of life (Leonetti law). In the Authors' point of view the bill's articles -limit the moral and judicial importance of four main issues as informed consent, permanent incapacity, artificial nutrition/hydration, and withdraw/withhold treatments. In the Authors' opinion the ADs must represent informed preferences made freely by patients within the relationship with their physicians, as part of an advance care planning. When this relationship develops in accordance with the ICME rules, it contains all of the ethical/professional dimensions to legitimate right choices in each case. The law should draw inspiration from ICME principles, assigning them a juridical power, acknowledging their validity in legitimating end-of-life decisions, and defining a framework of juridical legitimacy for these decisions without infringing on patients' right to autonomy with prescriptions on the care.

Research participation and the right to withdraw.

PubMed

Edwards, Sarah J L

2005-04-01

Most ethics committees which review research protocols insist that potential research participants reserve unconditional or absolute 'right' of withdrawal at any time and without giving any reason. In this paper, I examine what consent means for research participation and a sense of commitment in relation to this right to withdraw. I suggest that, once consent has been given (and here I am excluding incompetent minors and adults), participants should not necessarily have unconditional or absolute rights to withdraw. This does not imply that there should be a complete absence of rights, or, indeed, an abandonment of the right to withdraw. The point of this paper is to show that the supposed unconditional or absolute nature of these rights may be self-defeating and so fail to respect the autonomy of participants. In addition, and on a more positive note, I suggest that, attaching certain conditions on the right to withdraw, may better respect the autonomy of these participants by underlining the idea that autonomy is more than mere whim or indifference to the fate of others. On the contrary, research staff are currently unable to 'push' participants, who may merely have logistical difficulties unrelated to the research itself, but who really want to stay the course, for fear of coercing them. Furthermore, researchers now try to 'screen out' people they think may be unreliable to protect the science of the study and so groups at risk of dropping out may be unfairly denied access to research treatments. I conclude that on-going negotiation between the relevant parties could be on balance the only truly acceptable way forward but concede certain important limitations to take into account.

Same but different: Comparative modes of information processing are implicated in the construction of perceptions of autonomy support.

PubMed

Lee, Rebecca Rachael; Chatzisarantis, Nikos L D

2017-11-01

An implicit assumption behind tenets of self-determination theory is that perceptions of autonomy support are a function of absolute modes of information processing. In this study, we examined whether comparative modes of information processing were implicated in the construction of perceptions of autonomy support. In an experimental study, we demonstrated that participants employed comparative modes of information processing in evaluating receipt of small, but not large, amounts of autonomy support. In addition, we found that social comparison processes influenced a number of outcomes that are empirically related to perceived autonomy support such as sense of autonomy, positive affect, perceived usefulness, and effort. Findings shed new light upon the processes underpinning construction of perceptions related to autonomy support and yield new insights into how to increase the predictive validity of models that use autonomy support as a determinant of motivation and psychological well-being. © 2017 The British Psychological Society.

Ethical and legal issues regarding consent in research with adult stroke patients: case study in the ethics of mental health research.

PubMed

Pope, Anne

2012-03-01

This case study describes research into interventions to enhance stroke patients' ability to communicate. Because patients' cognitive abilities are compromised, it is argued that they may lack the capacity to consent and that surrogate consent should be required. In South Africa, this would make conducting the research difficult because only court-appointed curators are "legally appropriate" substitutes for research enrolment. Here, the research ethics committee must balance legal requirements and ethical concerns. It must also balance protection and respect for autonomy, even for cognitively compromised participants. First, incapacity should not simply be assumed but should be individually assessed. However, stroke patients present a further complication for capacity assessment because they may retain the capacity to reason but have lost the ability to communicate effectively. Second, the research ethics committee must decide whether recruitment should be restricted or whether incapacitated participants may be enrolled. Given the low risk of harm, incapacitated persons could be enrolled by proxies.

Ethical Issues Raised by Private Practice Physiotherapy Are More Diverse than First Meets the Eye: Recommendations from a Literature Review

PubMed Central

Drolet, Marie-Josée; Williams-Jones, Bryn

2015-01-01

ABSTRACT Purpose: Physiotherapy in private practice differs from physiotherapy practised in a public setting in several ways, the most evident of which is the for-profit nature of private physiotherapy clinics; these differences can generate distinct and challenging ethical issues. The objectives of this article are to identify ethical issues encountered by physiotherapists in private practice settings and to identify potential solutions and recommendations to address these issues. Method: After a literature search of eight databases, 39 studies addressing ethical issues in a private practice context were analyzed. Results: A total of 25 ethical issues emerging from the included studies were classified into three main categories: (1) business and economic issues (e.g., conflicts of interests, inequity in a managed care context, lack of time affecting quality of care); (2) professional issues (e.g., professional autonomy, clinical judgment, treatment effectiveness, professional conduct); and (3) patients' rights and welfare issues (e.g., confidentiality, power asymmetries, paternalism vs. patient autonomy, informed consent). Recommendations as to how physiotherapists could better manage these issues were then identified and categorized. Conclusions: The physiotherapy community should reflect on the challenges raised by private practice so that professionals can be supported—through education, research, and good governance—in providing the best possible care for their patients. PMID:25931663

Legal review: informed consent--a shift from paternalism to self-determination?

PubMed

Smith, C K

1990-09-01

This shift from a paternalistic standard for determining how much information should be disclosed to a person to a standard that values the self-determination of a person is consistent with the philosophical change in decision-making in a variety of areas of health care. Haber begins his article with a discussion of the psychiatry profession's proposed change in terminology from "patient" to "client." He argues that such a change would be more than semantic: It would serve the moral purpose of increasing such a person's autonomy. The right of patients to see their own medical records was formally recognized as part of the Patient's Bill of Rights in 1972 and has since been recognized by courts and incorporated into many state statutes. Likewise, the refusal of medical treatment has become a right more commonly recognized by the law throughout the 1970s and 1980s. For example, "living wills" are now a common vehicle for patients to express their views regarding the right to refuse treatment. Courts have recognized this right in cases of Jehovah's Witnesses refusing transfusions, the right to have life-sustaining procedures discontinued, and the restrictive involuntary commitment statutes that arose in the 1970s. Both the risks and benefits of medical treatments have increased with the forward march of technology. Patients have the right to choose to participate with their physicians in their own health care decision making; the trend toward the reasonable patient standard in medical malpractice suits that relied on negligent failure to obtain informed consent reflects a recognition of that right.

Comparison of Informed Consent Preferences for Multiplex Genetic Carrier Screening among a Diverse Population.

PubMed

Reeves, Ashley; Trepanier, Angela

2016-02-01

Multiplex genetic carrier screening is increasingly being integrated into reproductive care. Obtaining informed consent becomes more challenging as the number of screened conditions increases. Implementing a model of generic informed consent may facilitate informed decision-making. Current Wayne State University students and staff were invited to complete a web-based survey by blast email solicitation. Participants were asked to determine which of two generic informed consent scenarios they preferred: a brief versus a detailed consent. They were asked to rank the importance of different informational components in making an informed decision and to provide demographic information. Comparisons between informational preferences, demographic variables and scenario preferences were made. Six hundred ninety three participants completed the survey. When evaluating these generic consents, the majority preferred the more detailed consent (74.5%), and agreed that it provided enough information to make an informed decision (89.5%). Those who thought it would be more important to know the severity of the conditions being screened (p = .002) and range of symptoms (p = .000) were more likely to prefer the more detailed consent. There were no significant associations between scenario preferences and demographic variables. A generic consent was perceived to provide sufficient information for informed decision making regarding multiplex carrier screening with most preferring a more detailed version of the consent. Individual attitudes rather than demographic variables influenced preferences regarding the amount of information that should be included in the generic consent. The findings have implications for how clinicians approach providing tailored informed consent.

Balancing justice and autonomy in clinical research with healthy volunteers.

PubMed

Kass, N E; Myers, R; Fuchs, E J; Carson, K A; Flexner, C

2007-08-01

In clinical research, ethics review generally first examines whether study risks are reasonable in light of benefits provided. Through informed consent, then, prospective subjects consider whether the risk/benefit balance and procedures are reasonable for them. Unique ethics issues emerge in clinical research with healthy volunteers. Certain types of studies only recruit healthy volunteers as participants. Phase 1 studies, for example, including first time in human studies of investigational drugs and vaccines, generally are conducted in healthy volunteers. Although such research carries inherent and often unknown risks, healthy subjects provide the most efficient target population in which to conduct such research, as these volunteers generally are free of concurrent diseases or medications that could confound interpretation of toxicity. Other studies enrolling healthy volunteers often are simply looking for the most scientifically sound population for the study of normal human physiology.

[Dialogues on risks and health resources in general practice].

PubMed

Hollnagel, Hanne; Malterud, Kirsti

2002-11-04

The healing and preventive forces related to individuals' health resources and self-assessed knowledge have hitherto been underestimated in medicine. In this article, we draw attention to ethical and epistemological challenges in relation to values, communication, knowledge, and autonomy that are embedded in the prevailing risk-oriented epidemiology. We have developed a theoretical model for a patient-centered, salutogenetic approach with the aim of a better balance between health resources and risk factors. We briefly present results of dialogues in the general practice consultation based on key questions about self-assessed health resources. We discuss pitfalls related to causality, group-based probabilities, medicalization, and informed consent, focusing on the clinical encounter with the individual patient. By introducing a salutogenetic perspective, we hope to shift attention towards the patient's resources and strengths. Communication can mediate oppression as well as empowerment.

Why Bioethics Should Be Concerned With Medically Unexplained Symptoms.

PubMed

O'Leary, Diane

2018-05-01

Biomedical diagnostic science is a great deal less successful than we've been willing to acknowledge in bioethics, and this fact has far-reaching ethical implications. In this article I consider the surprising prevalence of medically unexplained symptoms, and the term's ambiguous meaning. Then I frame central questions that remain answered in this context with respect to informed consent, autonomy, and truth-telling. Finally, I show that while considerable attention in this area is given to making sure not to provide biological care to patients without a need, comparatively little is given to the competing, ethically central task of making sure never to obstruct access to biological care for those with diagnostically confusing biological conditions. I suggest this problem arises from confusion about the philosophical value of vagueness when it comes to the line between biological and psychosocial needs.

Adolescent autonomy revisited: clinicians need clearer guidance.

PubMed

Brierley, Joe; Larcher, Victor

2016-08-01

In 1996, Brazier and Bridge raised the question 'is adolescent autonomy truly dead and buried' following judicial decisions which had seemed to reverse the Gillick-inspired trend for greater child autonomy in healthcare. Subsequent decisions by the courts have reinforced the view that those below 18 years in England and Wales remain children with limited rights to refuse treatment compared with adults. This is at variance with the daily experience of those working with young people who increasingly seek to actively involve them in making freely informed decisions about their healthcare, in accordance with the principles enunciated in the UN Convention of the Rights of the Child and the UK Children Acts. We review the derivation of the law in England and Wales in this area, in the light of another recent family court judgement enforcing treatment on a 'competent' child without his or her consent and ask: 'How can the Common Law and the ethical practice of those caring for young people have diverged so far?' Either young people can decide whether to have a recommended treatment, or they cannot. Given Ian McEwan's book, the Children Act, has stimulated wider social debate in this area might this be an opportune moment to seek public policy resolution with regards to healthcare decision making by young people? We argue that events since the Gillick case have underlined the need for a comprehensive review of legal policy and practice in this area. While absolute autonomy and freedom of choice are arguably inconsistent with the protection rights that society has agreed are owed to children, healthcare practitioners need clarity over the circumstances in which society expects that autonomous choices of adolescents can be overridden. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting.

PubMed

Addissie, Adamu; Abay, Serebe; Feleke, Yeweyenhareg; Newport, Melanie; Farsides, Bobbie; Davey, Gail

2016-07-12

Maximizing comprehension is a major challenge for informed consent processes in low-literacy and resource-limited settings. Application of rapid qualitative assessments to improve the informed consent process is increasingly considered useful. This study assessed the effects of Rapid Ethical Assessment (REA) on comprehension, retention and quality of the informed consent process. A cluster randomized trial was conducted among participants of HPV sero-prevalence study in two districts of Northern Ethiopia, in 2013. A total of 300 study participants, 150 in the intervention and 150 in the control group, were included in the study. For the intervention group, the informed consent process was designed with further revisions based on REA findings. Informed consent comprehension levels and quality of the consent process were measured using the Modular Informed Consent Comprehension Assessment (MICCA) and Quality of Informed Consent (QuIC) process assessment tools, respectively. Study recruitment rates were 88.7 % and 80.7 % (p = 0.05), while study retention rates were 85.7 % and 70.3 % (p < 0.005) for the intervention and control groups respectively. Overall, the mean informed consent comprehension scores for the intervention and control groups were 73.1 % and 45.2 %, respectively, with a mean difference in comprehension score of 27.9 % (95 % CI 24.0 % - 33.4 %; p < 0.001,). Mean scores for quality of informed consent for the intervention and control groups were 89.1 % and 78.5 %, respectively, with a mean difference of 10.5 % (95 % CI 6.8 -14.2 %; p < 0.001). Levels of informed consent comprehension, quality of the consent process, study recruitment and retention rates were significantly improved in the intervention group. We recommend REA as a potential modality to improve informed consent comprehension and quality of informed consent process in low resource settings.

Improving informed consent: Stakeholder views

PubMed Central

Anderson, Emily E.; Newman, Susan B.; Matthews, Alicia K.

2017-01-01

Purpose Innovation will be required to improve the informed consent process in research. We aimed to obtain input from key stakeholders—research participants and those responsible for obtaining informed consent—to inform potential development of a multimedia informed consent “app.” Methods This descriptive study used a mixed-methods approach. Five 90-minute focus groups were conducted with volunteer samples of former research participants and researchers/research staff responsible for obtaining informed consent. Participants also completed a brief survey that measured background information and knowledge and attitudes regarding research and the use of technology. Established qualitative methods were used to conduct the focus groups and data analysis. Results We conducted five focus groups with 41 total participants: three groups with former research participants (total n = 22), and two groups with researchers and research coordinators (total n = 19). Overall, individuals who had previously participated in research had positive views regarding their experiences. However, further discussion elicited that the informed consent process often did not meet its intended objectives. Findings from both groups are presented according to three primary themes: content of consent forms, experience of the informed consent process, and the potential of technology to improve the informed consent process. A fourth theme, need for lay input on informed consent, emerged from the researcher groups. Conclusions Our findings add to previous research that suggests that the use of interactive technology has the potential to improve the process of informed consent. However, our focus-group findings provide additional insight that technology cannot replace the human connection that is central to the informed consent process. More research that incorporates the views of key stakeholders is needed to ensure that multimedia consent processes do not repeat the mistakes of paper-based consent forms. PMID:28949896

A Patient-Centered Approach to Informed Consent: Results from a Survey and Randomized Trial.

PubMed

Krishnamurti, Tamar; Argo, Nichole

2016-08-01

Traditional informed consent documents tend to be too lengthy and technical to facilitate proper patient engagement. Patient-centered, short informed consent content could be equally informative, while minimizing patient burden and producing greater patient engagement. This study aimed to develop and evaluate patient-centered, patient-designed paper and video informed consent formats. Two studies were conducted. In study 1, 118 self-identifying asthma patients recruited from a national, online pool completed survey tasks from their personal computers. Participants in study 1 were randomly assigned to examine sections of a standard informed consent document for an asthma trial and to select information they deemed critical to their decision making. In study 2, a sample of 83 self-identifying asthma patients completed experimental tasks in a university laboratory. Participants in study 2 were randomly assigned to a full informed consent document; a shortened, patient-designed informed consent document created from study 1; or a video with content matched to the shortened paper form. Study 1 yielded a more readable, concise version of a standard informed consent document (5 v. 17 pages). This shortened, patient-designed form closely met normative criteria for good clinical practice. In study 2, participants who viewed either the shortened paper consent or video reported greater engagement than those viewing the standard paper consent, without lowered performance on any other decision-relevant variables (i.e., comprehension, judged risk/benefit, feelings of trust). The video consent format did not cause increased enrollment. Results suggest that providing concise informed consent content, systematically developed from patients' self-reported information needs, may be more effective at engaging and informing clinical trial participants than the traditional consent approach, without detriment to trial comprehension, risk assessment, or enrollment. © The Author(s) 2016.

Re-Thinking the Role of the Family in Medical Decision-Making.

PubMed

Cherry, Mark J

2015-08-01

This paper challenges the foundational claim that the human family is no more than a social construction. It advances the position that the family is a central category of experience, being, and knowledge. Throughout, the analysis argues for the centrality of the family for human flourishing and, consequently, for the importance of sustaining (or reestablishing) family-oriented practices within social policy, such as more family-oriented approaches to consent to medical treatment. Where individually oriented approaches to medical decision-making accent an ethos of isolated personal autonomy family-oriented approaches acknowledge the central social and moral reality of the family. I argue that the family ought to be appreciated as more than a mere network of personal relations and individual undertakings; the family possesses a being that is social and moral such that it realizes a particular structure of human good and sustains the necessary conditions for core areas of human flourishing. Moreover, since the family exists as a nexus of face-to-face relationships, the consent of persons, including adults, to be members of a particular family, subject to its own respective account of family sovereignty, is significantly more amply demonstrated than the consent of citizens to be under the authority of a particular state. As a result, in the face of a general Western bioethical affirmation of the autonomy of individuals, as if adults and children were morally and socially isolated agents, this paper argues that social space must nevertheless be made for families to choose on behalf of their own members. © The Author 2015. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The role of male partners in women's participation in research during pregnancy: a case study from the partners demonstration project.

PubMed

Ngure, Kenneth; Trinidad, Susan Brown; Beima-Sofie, Kristin; Baeten, Jared M; Mugo, Nelly R; Bukusi, Elizabeth A; Heffron, Renee; John-Stewart, Grace; Kelley, Maureen C

2017-12-14

The exclusion of pregnant women from health research remains a significant challenge globally. In settings where cultural traditions and gender norms support a more restricted decision-making role for women in general, little is known about the attitudes of male partners toward the inclusion of women in research during pregnancy. Understanding the expectations of both men and women in such cultural settings offers an opportunity to engage and address local ethical concerns to improve women's access to research during pregnancy and enhance intervention development. In this paper, we present a qualitative research ethics case study, drawn from the Partners Demonstration Project of pre-exposure prophylaxis (PrEP) in Kenya, regarding the role of male partners in decision-making to continue PrEP during pregnancy. PrEP is an effective HIV prevention tool; however, since pregnant women were excluded from early PrEP clinical trials, safety and efficacy data during pregnancy are limited. Given continued high rates of HIV infection for women, some pregnant women are now being provided with PrEP or are involved in PrEP research. Men and women in our study were equally concerned about the health risks of PrEP to the fetus and depended on healthcare provider guidance to understand these risks. Because the demonstration project enrolled couples, an implicit social expectation for many women's continuation of PrEP during pregnancy was consultation with male partners. Some women reported that consenting to participate was exclusively a woman's decision; however, many reported that they deferred to their male partner's opinion and support during the decision-making process. Most male partners believed women should not participate in research studies without their partner's permission, while a few men believed participation was ultimately a woman's decision. We suggest that relational autonomy can support a middle ground for informed consent that promotes women's autonomy while accommodating partner engagement.

Informed Consent in Dentistry.

PubMed

Reid, Kevin I

2017-03-01

A review of literature regarding informed consent in dentistry reveals a paucity of information and minimal scholarship devoted to this subject. But this begs the question about informed consent somehow being different for dentistry than for medicine or other healthcare delivery. My account draws distinctions where appropriate but is rooted in the premise that informed consent is an ethical construct applicable to vulnerable people as patients independent of what type of treatment or body part being considered. This paper highlights the crucial importance of the process of informed consent and refusal in dentistry, underscoring its important place in oral healthcare. This paper will not address the unique circumstances involving consent in those without capacity or focus on informed consent in the research setting; our focus will be on those patients with full decisionmaking capacity in the clinical setting. I will emphasize the importance of disclosure of treatment options and highlight the benefits of shared-decision-making in the informed consent process.

How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India.

PubMed

Rajaraman, Divya; Jesuraj, Nelson; Geiter, Lawrence; Bennett, Sean; Grewal, Harleen Ms; Vaz, Mario

2011-02-15

A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed. The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation. In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process. In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location. The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease.

When is informed consent required in cluster randomized trials in health research?

PubMed Central

2011-01-01

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice? We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it is not a substitute for valid informed consent. Fifth, while health professionals may have a moral obligation to participate as subjects in research, this does not diminish the necessity of informed consent to study participation. PMID:21906277

Attitudes and Beliefs of African Americans Toward Participation in Medical Research

PubMed Central

Corbie-Smith, Giselle; Thomas, Stephen B; Williams, Mark V; Moody-Ayers, Sandra

1999-01-01

OBJECTIVE To describe barriers to participation of African Americans in research. DESIGN Focus group interviews conducted in 1997. PATIENTS Thirty-three African-American adults presenting to an urban public hospital for outpatient medical care participated in one of five focus groups. MEASUREMENTS AND MAIN RESULTS African-American patients' attitudes toward medical research were measured. Mistrust of doctors, scientists, and the government was reported consistently by the participants. Many participants described concerns about the ethical conduct of clinicians and investigators when poor or minority patients are involved and cited examples of exploitation as supporting evidence for their mistrust of the medical establishment. While participants were clear about the violation of human rights in the Tuskegee Syphilis Study, all were misinformed of the historical facts of the study. Few participants understood the concept of informed consent. Participants saw signing the document as relinquishing their autonomy and as a legal protection for physicians. Despite these concerns, participants gave recommendations to improve minority participation in research. CONCLUSIONS African-American participants in this study described distrust of the medical community as a prominent barrier to participation in clinical research. Participants described real and perceived examples of exploitation to support their distrust of researchers. The goal of the consent process, to inform patients of risks and benefits so as to facilitate self-determination, was misinterpreted by these participants. Understanding the importance of interpersonal trust within the clinical relationship may prove to be a significant factor in enhancing participation in clinical trials. PMID:10491242

Organ procurement organizations Internet enrollment for organ donation: Abandoning informed consent

PubMed Central

Woien, Sandra; Rady, Mohamed Y; Verheijde, Joseph L; McGregor, Joan

2006-01-01

Background Requirements for organ donation after cardiac or imminent death have been introduced to address the transplantable organs shortage in the United States. Organ procurement organizations (OPOs) increasingly use the Internet for organ donation consent. Methods An analysis of OPO Web sites available to the public for enrollment and consent for organ donation. The Web sites and consent forms were examined for the minimal information recommended by the United States Department of Health and Human Services for informed consent. Content scores were calculated as percentages of data elements in four information categories: donor knowledge, donor consent reinforcement, donation promotion, and informed consent. Results There were 60 Web sites for organ donation enrollment serving the 52 states. The median percent (10 percentile-90 percentile) content scores of the Web sites for donor knowledge, donor consent reinforcement, and donation promotion were 33% (20–47), 79% (57–86), and 75% (50–100), respectively. The informed consent score was 0% (0–33). The content scores for donor knowledge and informed consent were significantly lower than donor consent reinforcement and donation promotion for all Web sites (P < .05). The content scores for the four categories were similar among the 11 regions of the United Network for Organ Sharing. Conclusion The Web sites and consent forms for public enrollment in organ donation do not fulfill the necessary requirements for informed consent. The Web sites predominantly provide positive reinforcement and promotional information rather than the transparent disclosure of organ donation process. Independent regulatory oversight is essential to ensure that Internet enrollment for organ donation complies with legal and ethical standards for informed consent. PMID:17187671

A Rural Community's Involvement in the Design and Usability Testing of a Computer-Based Informed Consent Process for the Personalized Medicine Research Project

PubMed Central

Mahnke, Andrea N; Plasek, Joseph M; Hoffman, David G; Partridge, Nathan S; Foth, Wendy S; Waudby, Carol J; Rasmussen, Luke V; McManus, Valerie D; McCarty, Catherine A

2014-01-01

Many informed consent studies demonstrate that research subjects poorly retain and understand information in written consent documents. Previous research in multimedia consent is mixed in terms of success for improving participants’ understanding, satisfaction, and retention. This failure may be due to a lack of a community-centered design approach to building the interventions. The goal of this study was to gather information from the community to determine the best way to undertake the consent process. Community perceptions regarding different computer-based consenting approaches were evaluated, and a computer-based consent was developed and tested. A second goal was to evaluate whether participants make truly informed decisions to participate in research. Simulations of an informed consent process were videotaped to document the process. Focus groups were conducted to determine community attitudes towards a computer-based informed consent process. Hybrid focus groups were conducted to determine the most acceptable hardware device. Usability testing was conducted on a computer-based consent prototype using a touch-screen kiosk. Based on feedback, a computer-based consent was developed. Representative study participants were able to easily complete the consent, and all were able to correctly answer the comprehension check questions. Community involvement in developing a computer-based consent proved valuable for a population-based genetic study. These findings may translate to other types of informed consents, such as genetic clinical trials consents. A computer-based consent may serve to better communicate consistent, clear, accurate, and complete information regarding the risks and benefits of study participation. Additional analysis is necessary to measure the level of comprehension of the check-question answers by larger numbers of participants. The next step will involve contacting participants to measure whether understanding of what they consented to is retained over time. PMID:24273095

Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy

PubMed Central

Borello, Alessandro; Passera, Roberto; Surace, Alessandra; Marola, Silvia; Buccelli, Claudio; Niola, Massimo; Di Lorenzo, Pierpaolo; Amato, Maurizio; Di Domenico, Lorenza; Solej, Mario; Martino, Valter

2016-01-01

Abstract Background Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. Methods This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed. Results Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension. Conclusions Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding. PMID:28352847

Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy.

PubMed

Borello, Alessandro; Ferrarese, Alessia; Passera, Roberto; Surace, Alessandra; Marola, Silvia; Buccelli, Claudio; Niola, Massimo; Di Lorenzo, Pierpaolo; Amato, Maurizio; Di Domenico, Lorenza; Solej, Mario; Martino, Valter

2016-01-01

Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed. Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension. Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding.

Ethical challenges and solutions regarding delirium studies in palliative care.

PubMed

Sweet, Lisa; Adamis, Dimitrios; Meagher, David J; Davis, Daniel; Currow, David C; Bush, Shirley H; Barnes, Christopher; Hartwick, Michael; Agar, Meera; Simon, Jessica; Breitbart, William; MacDonald, Neil; Lawlor, Peter G

2014-08-01

Delirium occurs commonly in settings of palliative care (PC), in which patient vulnerability in the unique context of end-of-life care and delirium-associated impairment of decision-making capacity may together present many ethical challenges. Based on deliberations at the Studies to Understand Delirium in Palliative Care Settings (SUNDIPS) meeting and an associated literature review, this article discusses ethical issues central to the conduct of research on delirious PC patients. Together with an analysis of the ethical deliberations at the SUNDIPS meeting, we conducted a narrative literature review by key words searching of relevant databases and a subsequent hand search of initially identified articles. We also reviewed statements of relevance to delirium research in major national and international ethics guidelines. Key issues identified include the inclusion of PC patients in delirium research, capacity determination, and the mandate to respect patient autonomy and ensure maintenance of patient dignity. Proposed solutions include designing informed consent statements that are clear, concise, and free of complex phraseology; use of concise, yet accurate, capacity assessment instruments with a minimally burdensome schedule; and use of PC friendly consent models, such as facilitated, deferred, experienced, advance, and proxy models. Delirium research in PC patients must meet the common standards for such research in any setting. Certain features unique to PC establish a need for extra diligence in meeting these standards and the employment of assessments, consent procedures, and patient-family interactions that are clearly grounded on the tenets of PC. Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Do the Benefits of Male Circumcision Outweigh the Risks? A Critique of the Proposed CDC Guidelines.

PubMed

Earp, Brian D

2015-01-01

The Centers for Disease Control and Prevention (CDC) have announced a set of provisional guidelines concerning male circumcision, in which they suggest that the benefits of the surgery outweigh the risks. I offer a critique of the CDC position. Among other concerns, I suggest that the CDC relies more heavily than is warranted on studies from Sub-Saharan Africa that neither translate well to North American populations nor to circumcisions performed before an age of sexual debut; that it employs an inadequate conception of risk in its benefit vs. risk analysis; that it fails to consider the anatomy and functions of the penile prepuce (i.e., the part of the penis that is removed by circumcision); that it underestimates the adverse consequences associated with circumcision by focusing on short-term surgical complications rather than long-term harms; that it portrays both the risks and benefits of circumcision in a misleading manner, thereby undermining the possibility of obtaining informed consent; that it evinces a superficial and selective analysis of the literature on sexual outcomes associated with circumcision; and that it gives less attention than is desirable to ethical issues surrounding autonomy and bodily integrity. I conclude that circumcision before an age of consent is not an appropriate health-promotion strategy.

Ethical aspects of medical age assessment in the asylum process: a Swedish perspective.

PubMed

Malmqvist, Erik; Furberg, Elisabeth; Sandman, Lars

2018-05-01

According to European regulations and the legislations of individual member states, children who seek asylum have a different set of rights than adults in a similar position. To protect these rights and ensure rule of law, migration authorities are commonly required to assess the age of asylum seekers who lack reliable documentation, including through various medical methods. However, many healthcare professionals and other commentators consider medical age assessment to be ethically problematic. This paper presents a simplified and amended account of the main findings of a recent ethical analysis of medical age assessment in the asylum process commissioned by the Swedish National Board of Health and Welfare. A number of ethical challenges related to conflicting goals, equality and fairness, autonomy and informed consent, privacy and integrity, and professional values and roles are identified and analysed. It is concluded that most of these challenges can be met, but that this requires a system where the assessment is sufficiently accurate and where adequate safeguards are in place. Two important ethical questions are found to warrant further analysis. The first is whether asylum seekers' consent to the procedure can be considered genuinely voluntary. The second is whether and how medical age assessments could affect negative public attitudes towards asylum seekers or discriminatory societal views more generally.

Ethics and law in the intensive care unit.

PubMed

Danbury, C M; Waldmann, C S

2006-12-01

Intensive Care Medicine epitomises the difficulties inherent in modern medicine. In this chapter we examine some key medicolegal and ethical areas that are evolving. The principles of autonomy and consent are well established, but developments in UK caselaw have shown that the courts may be moving away from their traditional deference of the medical profession. We examine some recent cases and discuss the impact that these cases may have on practice in Intensive Care.

Informed consent under the European Convention on Biomedicine and the UNESCO Declaration on Bioethics.

PubMed

Salako, Solomon E

2011-03-01

The desirability of obtaining freely given consent is universally accepted. The point, however, is that there is no unanimity on the definition of informed consent or its application in bioethics. Whether informed consent is based on principalism or casuistry or the virtue theory, the problem is how to handle the ethically complex situation created in the interface between informed consent and social justice under international biomedical instruments. This article will proceed by offering detailed historical and critical analyses of informed consent under the European Convention on Human Rights and Biomedicine 1997 and The UNESCO Universal Declaration on Bioethics and Human Rights 2005. Three conceptions of justice will be utilised to show that the doctrine of informed consent has driven the ethos of research on human beings and shaped the physician-patient relationship; and that casuistry and virtue theory are consistent with and not rivals of a principle-based account of informed consent.

42 CFR 441.257 - Informed consent.

Code of Federal Regulations, 2011 CFR

2011-10-01

... individual has given informed consent only if— (1) The person who obtained consent for the sterilization..., provided a copy of the consent form and provided orally all of the following information or advice to the individual to be sterilized: (i) Advice that the individual is free to withhold or withdraw consent to the...

42 CFR 441.257 - Informed consent.

Code of Federal Regulations, 2010 CFR

2010-10-01

... individual has given informed consent only if— (1) The person who obtained consent for the sterilization..., provided a copy of the consent form and provided orally all of the following information or advice to the individual to be sterilized: (i) Advice that the individual is free to withhold or withdraw consent to the...

[Psychiatric medication as restraint: between autonomy and protection, is there place for a legal framework?].

PubMed

Bernheim, Emmanuelle

2010-01-01

The use of chemical restraint has been regulated for the past ten years in Quebec. However, clinical, ethical and legal issues, sometimes contradictory, have not really been considered during the legislative process leading to consolidation in its current form. The author supports that, because of the absence of consent and the effects of medication, a specific legal framework to the use of medication is necessary in a context of unplanned intervention to protect both patients and medical staff. This framework would prescribe good practice, take into account the non-medical aspects of consent to care and formalize the practice as an exception to the rule. In addition, the symbolism of law, through which social solidarity can be expressed, must not be underestimated.

BREACHING THE SEXUAL BOUNDARIES IN THE DOCTOR–PATIENT RELATIONSHIP: SHOULD ENGLISH LAW RECOGNISE FIDUCIARY DUTIES?

PubMed Central

Ost, Suzanne

2016-01-01

In this article, I argue that sexual exploitation in the doctor–patient relationship would be dealt with more appropriately by the law in England and Wales on the basis of a breach of fiduciary duty. Three different types of sexual boundary breaches are discussed, and the particular focus is on breaches where the patient's consent is obtained through inducement. I contend that current avenues of redress do not clearly catch this behaviour and, moreover, they fail to capture the essence of the wrong committed by the doctor—the knowing breach of trust for self-gain—and the calculated way in which consent is induced. Finally, I demonstrate that the fiduciary approach is compatible with the contemporary pro-patient autonomy model of the doctor–patient relationship. PMID:26846652

A rural community's involvement in the design and usability testing of a computer-based informed consent process for the Personalized Medicine Research Project.

PubMed

Mahnke, Andrea N; Plasek, Joseph M; Hoffman, David G; Partridge, Nathan S; Foth, Wendy S; Waudby, Carol J; Rasmussen, Luke V; McManus, Valerie D; McCarty, Catherine A

2014-01-01

Many informed consent studies demonstrate that research subjects poorly retain and understand information in written consent documents. Previous research in multimedia consent is mixed in terms of success for improving participants' understanding, satisfaction, and retention. This failure may be due to a lack of a community-centered design approach to building the interventions. The goal of this study was to gather information from the community to determine the best way to undertake the consent process. Community perceptions regarding different computer-based consenting approaches were evaluated, and a computer-based consent was developed and tested. A second goal was to evaluate whether participants make truly informed decisions to participate in research. Simulations of an informed consent process were videotaped to document the process. Focus groups were conducted to determine community attitudes towards a computer-based informed consent process. Hybrid focus groups were conducted to determine the most acceptable hardware device. Usability testing was conducted on a computer-based consent prototype using a touch-screen kiosk. Based on feedback, a computer-based consent was developed. Representative study participants were able to easily complete the consent, and all were able to correctly answer the comprehension check questions. Community involvement in developing a computer-based consent proved valuable for a population-based genetic study. These findings may translate to other types of informed consents, including those for trials involving treatment of genetic disorders. A computer-based consent may serve to better communicate consistent, clear, accurate, and complete information regarding the risks and benefits of study participation. Additional analysis is necessary to measure the level of comprehension of the check-question answers by larger numbers of participants. The next step will involve contacting participants to measure whether understanding of what they consented to is retained over time. © 2013 Wiley Periodicals, Inc.

Recruitment of subjects for clinical trials after informed consent: does gender and educational status make a difference?

PubMed

Gitanjali, B; Raveendran, R; Pandian, D G; Sujindra, S

2003-01-01

Researchers and investigators have argued that getting fully informed written consent may not be possible in the developing countries where illiteracy is widespread. To determine the percentage of patients who agree to participate in a trial after receiving either complete or partial information regarding a trial and to find out whether there were gender or educational status-related differences. To assess reasons for consenting or refusing and their depth of understanding of informed consent. A simulated clinical trial in two tertiary health care facilities on in-patients. An informed consent form for a mock clinical trial of a drug was prepared. The detailed / partial procedure was explained to a purposive sample of selected in-patients and their consent was asked for. Patients were asked to free list the reasons for giving or withholding consent. Their depth of understanding was assessed using a questionnaire. Chi-square test was used for statistical analyses. The percentages of those consenting after full disclosure 29/102 (30%) and after partial disclosure 15/50 (30%) were the same. There was a significant (p=0.043) gender difference with a lesser percentage of females (30%) consenting to participation in a trial. Educational status did not alter this percentage. Most patients withheld consent because they did not want to give blood or take a new drug. Understanding of informed consent was poor in those who consented. The fact that only one-third of subjects are likely to give consent to participate in a trial needs to be considered while planning clinical trials with a large sample size. Gender but not educational status influences the number of subjects consenting for a study. Poor understanding of the elements of informed consent in patients necessitates evolving better methods of implementing consent procedures in India.

Paper trails, trailing behind: improving informed consent to IVF through multimedia applications

PubMed Central

Madeira, Jody Lyneé; Andraka-Christou, Barbara

2016-01-01

Though intended to educate patients on the risks, benefits, side effects and alternatives within medical treatment, informed consent documents may have unanticipated consequences for patients. Patients may regard these forms as little more than a ritual to access treatment. Or patients may perceive that these forms exist to protect doctors rather than to contribute to a meaningful, patient-protective educational interaction. To rehabilitate the informed consent project, this essay considers the baggage that informed consent documents have acquired through practical use, explores patients' and providers' lived experience of informed consent, and considers whether a multimedia consent application would be a viable solution to the various difficulties that currently erode perceptions of and confidence in the informed consent process. PMID:27774231

Understanding and retention of trial-related information among participants in a clinical trial after completing the informed consent process.

PubMed

Mexas, Fernanda; Efron, Anne; Luiz, Ronir Raggio; Cailleaux-Cezar, Michelle; Chaisson, Richard E; Conde, Marcus B

2014-02-01

for assessing the level of understanding of trial-related information during the informed consent (IC) process in developing countries are lacking. To assess the understanding and retention of trial-related information presented in the IC process by administering an informed consent assessment instrument (ICAI) to participants in a clinical trial for a new tuberculosis (TB) regimen being conducted in Rio de Janeiro (Brazil). Methods The format of the ICAI was based on the language and structure of the United States National Cancer Institute's IC comprehension checklist. The ICAI was designed to assess points of the RioMAR study IC process that addressed the principles of research ethics requested by Brazilian Regulatory Authority: autonomy, beneficence, non-maleficence, and justice. Briefly, (1) Is the respondent participating in a clinical trial? (2) Are two different treatments being evaluated? (3) Is the treatment arm chosen by chance? (4) Is an HIV test required? (5) Are liver function tests required? (6) Can participants leave the study at any time? (7) Are the risks and benefits of taking part in the study clear? (8) May pregnant women participate in the study? (9) Can one of the study drugs reduce the effectiveness of contraceptives? (10) Are patients paid to participate in the study? The ICAI was applied at two time points: immediately after enrollment in the clinical trial and 2 months later. A total of 61 patients who enrolled in the RioMAR study participated in this study. The percentage of correct answers to all questions was 82% at the time of the first ICAI; 31 participants (51%) did not recall that an HIV test was required (question 4) and 43 (70%) did not know that they could leave the study (question 6). Other individual questions were answered correctly by at least 76% of participants. There was no association between incorrect answers and age, gender, monthly family income, neighborhood, or level of education (p > 0.07). When the responses to the first and the second ICAI questions were compared, 15% or more of participants had conflicting answers to 5 of the 10 questions. The ICAI uses dichotomous responses, leading to a 50% chance of guessing the correct answers. Two questions were asked only of women. Finally, only 6 of the 10 questions on the current version of the ICAI apply to most trials; others are trial-specific. The ICAI may be adapted to an individual trial and may prove to be a useful tool following a consent discussion to identify issues not fully understood by the research participants, thus prompting study staff to re-explain topics, possibly in a more elementary manner.

Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study.

PubMed

Williams, Barbara F; French, John K; White, Harvey D

2003-03-15

Anxiety, fear, pain, and treatment with morphine might compromise the ability of patients to comprehend information about, and give informed consent for, participation in clinical trials. We aimed to assess whether patients with acute myocardial infarction could understand written and verbal information and whether they were competent to give autonomous informed consent to participate in a clinical trial. We prospectively studied 399 patients with acute myocardial infarction in 16 hospitals in New Zealand and Australia who were eligible for participation in the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial. We assessed readability of patient information sheets, patients' educational status, their views of the consent process, comprehension of verbal and written information, and competence to give consent. The patient information sheet needed a year 13 (age 18) educational level for comprehension, although only 75 of 345 patients (22%) had been educated beyond secondary school. Only 63 of 346 (18%) read the patient information sheet before giving or refusing consent to participate. Patients who gave consent were more likely to report good or partial comprehension of the information provided than were those who refused consent (272 [89%] vs 14 [70%], respectively; p=0.009). In an assessment of competence to make an autonomous decision, 75 of 145 (52%) were ranked at the lowest grade and 26 (18%) were not competent to consent. Although the consent process for HERO-2 met regulatory requirements for clinical trials, it was inappropriate for the needs of most patients. The patients' comprehension of the information provided and their competence to autonomously give consent was less than optimum.

Enhancing informed consent for research and treatment.

PubMed

Dunn, L B; Jeste, D V

2001-06-01

Increased scrutiny of informed consent calls for further research into decision making by patients who may be at risk for impairments. We review interventions designed to improve patient understanding of informed consent. A number of studies, within as well as outside psychiatry, have evaluated the effectiveness of specific interventions, as well as possible "predictors" of understanding of consent, such as subject characteristics, psychiatric symptoms, and cognitive impairment. Deficits in patients' understanding of informed consent may be partially related to poorly conceived, written, or organized informed consent materials; these deficits may be remediable with educational interventions. We find that effective interventions include corrected feedback, multiple learning trials, and more organized or simplified consent forms. Educational levels of patients generally correlate with levels of understanding. Even among individuals with psychiatric illness or cognitive impairment, deficits in understanding can be remedied with certain educational interventions. A variety of interventions can enhance understanding of informed consent.

Telemedicine Provides Non-Inferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

PubMed Central

Bobb, Morgan R.; Van Heukelom, Paul G.; Faine, Brett A.; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.

2016-01-01

Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face-to-face consent for delivering research informed consent, with no detected differences in comprehension and patient-reported understanding. This consent study will inform design of future telemedicine-enabled clinical trials. PMID:26990899

What emergency physicians should know about informed consent: legal scenarios, cases, and caveats.

PubMed

Moore, Gregory P; Moffett, Peter M; Fider, Cyril; Moore, Malia J

2014-08-01

The basic concept of obtaining informed consent is familiar to emergency physicians, and many consider themselves well versed on the topic; however, lack of obtaining proper informed consent is a frequent source of lawsuits. The legal definitions and nuances of informed consent might surprise even the most experienced physician. This article will detail the historical legal evolution of the concept of informed consent. It will also report defining and recent court cases that illustrate the current medical-legal status of informed consent. Special scenarios, caveats, and documentation recommendations are discussed. After reading this article the emergency physician will know how to practice and document the appropriate aspects of informed consent in emergency medicine, as well as understand available legal defenses if a lawsuit should arise. © 2014 by the Society for Academic Emergency Medicine.

Monetary Incentives Improve Recall of Research Consent Information: A Randomized Pilot Study

PubMed Central

Festinger, David S.; Marlowe, Douglas B.; Croft, Jason R.; Dugosh, Karen L.; Arabia, Patricia L.; Benasutti, Kathleen M.

2011-01-01

Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days. Numerous interventions have proven effective at improving consent recall; however, virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors. In this pilot study, we randomly assigned 31 drug court clients participating in a clinical research trial to a standard consent procedure or to the same procedure plus incentives for correctly recalling consent information. The incentive group was told they would receive $5 for each of the 15 consent items they could answer correctly 1-week later. At the follow-up, the incentive group recalled a significantly greater percentage of consent information overall than the standard group (65% vs. 42%; p < .01). Similar findings were observed for specific categories of consent information, including study purpose and design, risks and benefits, and human subject protections. Effect sizes were all large (d = 0.89 to 1.25). Findings suggest that motivation plays a key role in recall of consent information and should be considered in the development of future interventions. PMID:19331486

The adequacy of informed consent forms in genetic research in Oman: a pilot study.

PubMed

Al-Riyami, Asya; Jaju, Deepali; Jaju, Sanjay; Silverman, Henry J

2011-08-01

Genetic research presents ethical challenges to the achievement of valid informed consent, especially in developing countries with areas of low literacy. During the last several years, a number of genetic research proposals involving Omani nationals were submitted to the Department of Research and Studies, Ministry of Health, Oman. The objective of this paper is to report on the results of an internal quality assurance initiative to determine the extent of the information being provided in genetic research informed consent forms. In order to achieve this, we developed checklists to assess the inclusion of basic elements of informed consent as well as elements related to the collection and future storage of biological samples. Three of the authors independently evaluated and reached consensus on seven informed consent forms that were available for review. Of the seven consent forms, four had less than half of the basic elements of informed consent. None contained any information regarding whether genetic information relevant to health would be disclosed, whether participants may share in commercial products, the extent of confidentiality protections, and the inclusion of additional consent forms for future storage and use of tissue samples. Information regarding genetic risks and withdrawal of samples were rarely mentioned (1/7), whereas limits on future use of samples were mentioned in 3 of 7 consent forms. Ultimately, consent forms are not likely to address key issues regarding genetic research that have been recommended by research ethics guidelines. We recommend enhanced educational efforts to increase awareness, on the part of researchers, of information that should be included in consent forms. © 2011 Blackwell Publishing Ltd.

Developing a new model for patient recruitment in mental health services: a cohort study using Electronic Health Records

PubMed Central

Callard, Felicity; Broadbent, Matthew; Denis, Mike; Hotopf, Matthew; Soncul, Murat; Wykes, Til; Lovestone, Simon; Stewart, Robert

2014-01-01

Objectives To develop a new model for patient recruitment that harnessed the full potential of Electronic Health Records (EHRs). Gaining access to potential participants’ health records to assess their eligibility for studies and allow an approach about participation (‘consent for contact’) is ethically, legally and technically challenging, given that medical data are usually restricted to the patient's clinical team. The research objective was to design a model for identification and recruitment to overcome some of these challenges as well as reduce the burdensome (and/or time consuming) gatekeeper role of clinicians in determining who is appropriate or not to participate in clinical research. Setting Large secondary mental health services context, UK. Participants 2106 patients approached for ‘consent for contact’. All patients in different services within the mental health trust are gradually and systematically being approached by a member of the clinical care team using the ‘consent for contact’ model. There are no exclusion criteria. Primary and secondary outcome measures Provision of ‘consent for contact’. Results A new model (the South London and Maudsley NHS Trust Consent for Contact model (SLaM C4C)) for gaining patients’ consent to contact them about research possibilities, which is built around a de-identified EHR database. The model allows researchers to contact potential participants directly. Of 2106 patients approached by 25 October 2013, nearly 3 of every 4 gave consent for contact (1560 patients; 74.1%). Conclusions The SLaM C4C model offers an effective way of expediting recruitment into health research through using EHRs. It reduces the gatekeeper function of clinicians; gives patients greater autonomy in decisions to participate in research; and accelerates the development of a culture of active research participation. More research is needed to assess how many of those giving consent for contact subsequently consent to participate in particular research studies. PMID:25468503

42 CFR 50.204 - Informed consent requirement.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Informed consent requirement. 50.204 Section 50.204 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent requirement. Informed consent...

42 CFR 50.204 - Informed consent requirement.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Informed consent requirement. 50.204 Section 50.204 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent requirement. Informed consent...

42 CFR 50.204 - Informed consent requirement.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Informed consent requirement. 50.204 Section 50.204 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent requirement. Informed consent...

42 CFR 50.204 - Informed consent requirement.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Informed consent requirement. 50.204 Section 50.204 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent requirement. Informed consent...

42 CFR 50.204 - Informed consent requirement.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Informed consent requirement. 50.204 Section 50.204 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent requirement. Informed consent...

National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis.

PubMed

Mendelson, Scott J; Courtney, D Mark; Gordon, Elisa J; Thomas, Leena F; Holl, Jane L; Prabhakaran, Shyam

2018-03-01

No standard approach to obtaining informed consent for stroke thrombolysis with tPA (tissue-type plasminogen activator) currently exists. We aimed to assess current nationwide practice patterns of obtaining informed consent for tPA. An online survey was developed and distributed by e-mail to clinicians involved in acute stroke care. Multivariable logistic regression analyses were performed to determine independent factors contributing to always obtaining informed consent for tPA. Among 268 respondents, 36.7% reported always obtaining informed consent and 51.8% reported the informed consent process caused treatment delays. Being an emergency medicine physician (odds ratio, 5.8; 95% confidence interval, 2.9-11.5) and practicing at a nonacademic medical center (odds ratio, 2.1; 95% confidence interval, 1.0-4.3) were independently associated with always requiring informed consent. The most commonly cited cause of delay was waiting for a patient's family to reach consensus about treatment. Most clinicians always or often require informed consent for stroke thrombolysis. Future research should focus on standardizing content and delivery of tPA information to reduce delays. © 2018 American Heart Association, Inc.

Informed consent comprehension in African research settings.

PubMed

Afolabi, Muhammed O; Okebe, Joseph U; McGrath, Nuala; Larson, Heidi J; Bojang, Kalifa; Chandramohan, Daniel

2014-06-01

Previous reviews on participants' comprehension of informed consent information have focused on developed countries. Experience has shown that ethical standards developed on Western values may not be appropriate for African settings where research concepts are unfamiliar. We undertook this review to describe how informed consent comprehension is defined and measured in African research settings. We conducted a comprehensive search involving five electronic databases: Medline, Embase, Global Health, EthxWeb and Bioethics Literature Database (BELIT). We also examined African Index Medicus and Google Scholar for relevant publications on informed consent comprehension in clinical studies conducted in sub-Saharan Africa. 29 studies satisfied the inclusion criteria; meta-analysis was possible in 21 studies. We further conducted a direct comparison of participants' comprehension on domains of informed consent in all eligible studies. Comprehension of key concepts of informed consent varies considerably from country to country and depends on the nature and complexity of the study. Meta-analysis showed that 47% of a total of 1633 participants across four studies demonstrated comprehension about randomisation (95% CI 13.9-80.9%). Similarly, 48% of 3946 participants in six studies had understanding about placebo (95% CI 19.0-77.5%), while only 30% of 753 participants in five studies understood the concept of therapeutic misconception (95% CI 4.6-66.7%). Measurement tools for informed consent comprehension were developed with little or no validation. Assessment of comprehension was carried out at variable times after disclosure of study information. No uniform definition of informed consent comprehension exists to form the basis for development of an appropriate tool to measure comprehension in African participants. Comprehension of key concepts of informed consent is poor among study participants across Africa. There is a vital need to develop a uniform definition for informed consent comprehension in low literacy research settings in Africa. This will be an essential step towards developing appropriate tools that can adequately measure informed consent comprehension. This may consequently suggest adequate measures to improve the informed consent procedure. © 2014 John Wiley & Sons Ltd.

Lay concepts in informed consent to biomedical research: the capacity to understand and appreciate risk.

PubMed

Iltis, Ana

2006-08-01

Persons generally must give their informed consent to participate in research. To provide informed consent persons must be given information regarding the study in simple, lay language. Consent must be voluntary, and persons giving consent must be legally competent to consent and possess the capacity to understand and appreciate the information. This paper examines the relationship between the obligation to disclose information regarding risks and the requirement that persons have the capacity to understand and appreciate the information. There has been insufficient attention to the extent to which persons must be able to understand and appreciate study information in order to have their consent deemed valid when the information is provided in simple, lay language. This paper argues that (1) the capacity to understand and appreciate information that should be deemed necessary to give valid consent should be defined by the capacity of the typical, cognitively normal adult and (2) the capacity of the typical, cognitively normal adult to understand and appreciate the concept of risk is limited. Therefore, (3) all things being equal, potential subjects must possess a limited capacity to understand and appreciate risk to be deemed competent to consent to research participation. (4) In some cases investigators ought to require that persons possess a greater than typical capacity to understand and appreciate risk.

Ethical issues in neonatal intensive care units.

PubMed

Liu, Jing; Chen, Xin-Xin; Wang, Xin-Ling

2016-01-01

On one hand, advances in neonatal care and rescue technology allow for the healthy survival or prolonged survival time of critically ill newborns who, in the past, would have been non-viable. On the other hand, many of the surviving critically ill infants have serious long-term disabilities. If an infant eventually cannot survive or is likely to suffer severe disability after surviving, ethical issues in the treatment process are inevitable, and this problem arises not only in developed countries but is also becoming increasingly prominent in developing countries. In addition, ethical concerns cannot be avoided in medical research. This review article introduces basic ethical guidelines that should be followed in clinical practice, including respecting the autonomy of the parents, giving priority to the best interests of the infant, the principle of doing no harm, and consent and the right to be informed. Furthermore, the major ethical concerns in neonatal intensive care units (NICUs) in China are briefly introduced.

Ethical issues in cancer screening and prevention.

PubMed

Plutynski, Anya

2012-06-01

November 2009's announcement of the USPSTF's recommendations for screening for breast cancer raised a firestorm of objections. Chief among them were that the panel had insufficiently valued patients' lives or allowed cost considerations to influence recommendations. The publicity about the recommendations, however, often either simplified the actual content of the recommendations or bypassed significant methodological issues, which a philosophical examination of both the science behind screening recommendations and their import reveals. In this article, I discuss two of the leading ethical considerations at issue in screening recommendations: respect for patient autonomy and beneficence and then turn to the most significant methodological issues raised by cancer screening: the potential biases that may infect a trial of screening effectiveness, the problem of base rates in communicating risk, and the trade-offs involved in a judgment of screening effectiveness. These issues reach more broadly, into the use of "evidence-based" medicine generally, and have important implications for informed consent.

A history of ethics and law in the intensive care unit.

PubMed

Luce, John M; White, Douglas B

2009-01-01

Because they provide potential benefit at great personal and public cost, the intensive care unit (ICU) and the interventions rendered therein have become symbols of both the promise and the limitations of medical technology. At the same time, the ICU has served as an arena in which many of the ethical and legal dilemmas created by that technology have been defined and debated. This article outlines major events in the history of ethics and law in the ICU, covering the evolution of ICUs, ethical principles, informed consent and the law, medical decision-making, cardiopulmonary resuscitation, withholding and withdrawing life-sustaining therapy, legal cases involving life support, advance directives, prognostication, and futility and the allocation of medical resources. Advancement of the ethical principle of respect for patient autonomy in ICUs increasingly is in conflict with physicians' concern about their own prerogatives and with the just distribution of medical resources.

[Is it possible to think a Psycho-Ethic?].

PubMed

Rovaletti, María L

2007-01-01

Taking into account Kant's "Critique of Pure Reason" we may ask ourselves the question about why Bioethic does not advance over human and/or social sciences in the way it does advance in the medical field. To be more precise: which is the position of psychiatric/psychological psychopathology, considering that they feed themselves from both types of sciences? It's now the time to think: how should we respond to the way we treat particular vulnerabilities of the mentally ill, taking into account the way in which it may be affected their subjectivity and autonomy? Which is the competence of the patient to consent, without being internally or externally compelled by certain therapeutical practices or before their inclusion in investigation protocols? How is it possible to keep confidentiality, specially in institutions in which exist an interdisciplinary approach of the patient and where the registration of the information is done by means of informatic case reports?

Some legal aspects of genetic screening.

PubMed

Abbing, H R

2003-01-01

Screening activities in health care are not always useful and sometimes harmful. The mere offer of a screening test puts the individual's autonomy under constraint. With genetic (predictive and risk assessment) tests, the right to free, informed consent and to protection of privacy and medical confidentiality is even more warranted. Screening evokes many questions from the perspective of the right to health care as well as (in particular with genetic screening) from the perspective of respect for individual human rights. Fear of liability puts pressure on professional restraint not to offer every screening test available. States have to take legislative measures for guaranteeing that only those screening activities become available that can significantly contribute to individual and public health. They also should consider additional rules for protecting individual rights where those that are generally accepted in the "ordinary" medical setting (the individual patient-doctor relationship), offer insufficient protection.

An ethical framework for the responsible leadership of accountable care organizations.

PubMed

McCullough, Laurence B

2012-01-01

Using the ethical concepts of co-fiduciary responsibility in patient care and of preventive ethics, this article provides an ethical framework to guide physician and lay leaders of accountable care organizations. The concept of co-fiduciary responsibility is based on the ethical concept of medicine as a profession, which was introduced into the history of medical ethics in the 18th century. Co-fiduciary responsibility applies to everyone who influences the processes of patient care: physicians, organizational leaders, patients, and patients' surrogates. A preventive ethics approach to co-fiduciary responsibility requires leaders of accountable care organizations to create organizational cultures of fiduciary professionalism that implement and support the following: improving quality based on candor and accountability, reasserting the physician's professional role in the informed consent process, and constraining patients' and surrogates' autonomy. Sustainable organizational cultures of fiduciary professionalism will require commitment of organizational resources and constant vigilance over the intellectual and moral integrity of organizational culture.

Ethics research in critically ill patients.

PubMed

Estella, A

2018-05-01

Research in critical care patients is an ethical obligation. The ethical conflicts of intensive care research arise from patient vulnerability, since during ICU admission these individuals sometimes lose all or part of their decision making capacity and autonomy. We therefore must dedicate effort to ensure that neither treatment (sedation or mechanical ventilation) nor the disease itself can affect the right to individual freedom of the participants in research, improving the conditions under which informed consent must be obtained. Fragility, understood as a decrease in the capacity to tolerate adverse effects derived from research must be taken into account in selecting the participants. Research should be relevant, not possible to carry out in non-critical patients, and a priori should offer potential benefits that outweigh the risks that must be known and assumable, based on principles of responsibility. Copyright © 2018 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.

Neuropsychiatric Symptoms of Dementia: Consent, Quality of Life, and Dignity

PubMed Central

Passmore, Michael J.

2013-01-01

Degenerative forms of dementia are progressive, incurable, fatal, and likely to cause suffering in conjunction with personal incapacity. Timely diagnostic disclosure and counseling can facilitate important advance care planning. The risk of harm associated with neuropsychiatric symptoms (NPS) of dementia often has to be balanced against the risk of harm associated with medication management of NPS. A palliative care framework can help preserve autonomy, quality of life, comfort, and dignity for patients with NPS. PMID:23853768

Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study

PubMed Central

Nusbaum, Lika; Douglas, Brenda; Damus, Karla; Paasche-Orlow, Michael; Estrella-Luna, Neenah

2017-01-01

Multiple studies have documented major limitations in the informed consent process for the recruitment of clinical research participants. One challenging aspect of this process is successful communication of risks and benefits to potential research participants. This study explored the opinions and attitudes of informed consent experts about conveying risks and benefits to inform the development of a survey about the perspectives of research nurses who are responsible for obtaining informed consent for clinical trials. The major themes identified were strategies for risks and benefits communication, ensuring comprehension, and preparation for the role of the consent administrator. From the experts’ perspective, inadequate education and training of the research staff responsible for informed consent process contribute to deficiencies in the informed consent process and risks and benefits communication. Inconsistencies in experts’ opinions and critique of certain widely used communication practices require further consideration and additional research. PMID:28975139

Autonomy and Acceptance of Long-Term Care

ERIC Educational Resources Information Center

Hsu, Hui-Chuan; Ting, Yu-Shan; Jiang, Ting-Wen; Chien, Ming-Chih; Chien, Chih-Hsin

2009-01-01

This study explored the relationship between four types of autonomy (health autonomy, informational autonomy, living autonomy, and financial autonomy) and the acceptance of five types of long-term care (adult day care, respite care, assisted living, unit care, and group home) for the elderly in Taiwan. Data were collected from 167 middle-aged and…

Beyond informed consent.

PubMed Central

Bhutta, Zulfiqar A.

2004-01-01

Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions. The emphasis in most externally sponsored research projects in developing countries is on laborious documentation of several mechanical aspects of the research process rather than on assuring true comprehension and voluntary participation. The onus for the oversight of this process is often left to overworked and ill-equipped local ethics review committees. Current guidelines and processes for obtaining informed consent should be reviewed with the specific aim of developing culturally appropriate methods of sharing information about the research project and obtaining and documenting consent that is truly informed. Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings. PMID:15643799

Diabetes and end of life: ethical and methodological issues in gathering evidence to guide care.

PubMed

Dunning, Trisha; Duggan, Nicole; Savage, Sally; Martin, Peter

2013-03-01

Providing palliative care for people with diabetes at the end of life is part of the chronic disease care trajectory, but end of life care is complex and the presence of diabetes further complicates management. The aim of the paper is to discuss the ethical and methodological issues encountered when undertaking research to develop guidelines for managing diabetes at the end of life and the strategies used to address the issues. The issues emerged as we developed guidelines for managing diabetes at the end of life, which included conducting individual interviews with 14 people with diabetes requiring palliative care and 10 family members. A reflexive researcher journal was maintained throughout the guideline development process. The interview transcripts and researcher's journal were analysed to determine key methodological, ethical and researcher-related issues. Key themes were vulnerability of the sampling population, methodological issues included recruiting participants and ensuring rigor, ethical issues concerned benefit and risk, justice, autonomy, privacy, professional boundaries and informed consent. Researcher-related issues were identified such as managing participant distress and their own emotional distress. People were willing to discuss end of life diabetes management preferences. Undertaking research with people at the end of life is complex because of their vulnerability and the ethical issues involved. However, the ethical principles of autonomy and justice apply and people should be given the relevant information and opportunity to decide whether to participate or not. © 2012 The Authors. Scandinavian Journal of Caring Sciences © 2012 Nordic College of Caring Science.

Patient Education and Informed Consent for Preimplantation Genetic Diagnosis: Health Literacy for Genetics and Assisted Reproductive Technology

PubMed Central

McGowan, Michelle L.; Burant, Chris; Moran, Rocio; Farrell, Ruth

2013-01-01

Introduction Innovative applications of genetic testing have emerged within the field of assisted reproductive technology through preimplantation genetic diagnosis (PGD). As in all forms of genetic testing, adequate genetic counseling and informed consent are critical. Despite the growing recognition of the role of informed consent in genetic testing, there is little data available about how this process occurs in the setting of PGD. Methods A cross sectional study of IVF clinics offering PGD in the U.S. was conducted to assess patient education and informed consent practices. Descriptive data were collected with a self-administered survey instrument. Results More than half of the clinics offering PGD required genetic counseling prior to PGD (56%). Genetic counseling was typically performed by certified genetic counselors (84 %). Less than half (37%) of the clinics required a separate informed consent process for genetic testing of embryonic cells. At a majority of those clinics requiring a separate informed consent for genetic testing (54%), informed consent for PGD and genetic testing took place as a single event before beginning IVF procedures. Conclusions The results suggest that patient education and informed consent practices for PGD have yet to be standardized. These findings warrant the establishment of professional guidelines for patient education and informed consent specific to embryonic genetic testing. PMID:19652605

Negative ethical behaviors in Saudi hospitals: How prevalent are they perceived to be? – Statement agreement study

PubMed Central

Fayez, R.; Nawwab, A.; Al-Jahdali, H.; Baharoon, S.; Binsalih, S.; Al Sayyari, A.

2013-01-01

BACKGROUND: There is limited information about the prevalence of unethical behavior and how is perceived among health care providers. The aim of this study is to assess such behavior and how is perceived. MATERIALS AND METHODS: This is a cross-sectional study among three groups of professionals. Total participants were 370 and included medical staff, medical residents, and nurses in five medical specialties in four tertiary hospitals in Saudi Arabia (two Ministry of Health Hospitals and two military Hospitals). Participants were asked to rate their agreement with occurrence of 15 “negative” unethical behavior scenarios in their workplace. The scenarios covered areas of “respect for persons”, “interprofessional relationships”, and “empathy with patients”. RESULTS: Majority of respondents agreed that “unethical” behavior occurred in their workplace, including confidentiality being compromised (36.3%), informed consent not taken properly (60.2%), and bad news not well-delivered (62.2%). Other significant area agreement included doctors lacking empathy (47.8%), patient autonomy not fully respected (42.5%), discrimination (41.2%), and being pressurized to write inaccurate reports (31.2%). Respondents in medicine had the lowest rate of agreement and those in psychiatry had the highest (mean of 49.8% and 82.3%, respectively). Respondents with length of employment of less than 6 years had significantly higher agreement that unethical behavior occurs compared to those with length of employment of more than 6 years. Males were more likely than females to agree that unethical behavior occurs. The biggest difference was seen in the behavior of “informed consent not properly taken” with a gender margin of 18.7% (P = 0.001). CONCLUSION: There is high prevalence of behavior that is considered unethical as perceived by various health care workers at Saudi hospitals. PMID:24251232

Informed consent for genetic research.

PubMed

Hamvas, Aaron; Madden, Katherine K; Nogee, Lawrence M; Trusgnich, Michelle A; Wegner, Daniel J; Heins, Hillary B; Cole, F Sessions

2004-06-01

Rapid technological advances in genetic research and public concern about genetic discrimination have led to anticipatory safeguards in the informed consent process in the absence of legal examples of proven discrimination. Despite federal and state regulations to restrict access to personal health information, including genetic information, institutional review boards have required the addition of language to informed consent documents that warns about the risks of discrimination with participation in genetic research. To determine the reasons that families refused consent for their infant's participation in a study evaluating a genetic cause of respiratory distress syndrome. Survey conducted between February 1, 2002, and March 31, 2003. Academic, tertiary free-standing children's hospital. A convenience sample of 465 families were approached for consent. The 135 families who refused consent were surveyed. Reasons for refusal. Of the nonconsenting families, 79% spontaneously and specifically identified institutionally required language in our consent form concerning the risk of denial of access to health insurance and employment as the primary reason for refusal; 97% indicated that their fears resulted directly from language in our consent form. Only 20% of families who refused consent cited inadequate time to consider the study. The institutionally required description of risk of genetic discrimination due solely to participation in genetic research was the primary reason for refusal to consent in this cohort. Information about federally and institutionally mandated protections for confidentiality of participants in genetic research should be included in the informed consent document to balance the description of hypothetical risks and more accurately inform subjects.

Direct and enhanced disclosure of researcher financial conflicts of interest: the role of trust.

PubMed

Spece, Roy G

2013-01-01

In earlier writing, I recommended direct disclosure of major researcher financial conflicts of interest in per capita funding arrangements--the practice of providing researchers with a fixed sum for each subject recruited and enrolled in a study. This Article adds a recommendation for enhanced direct disclosure. The enhancement in the disclosure is a summary of why per capita and excess payments are being discussed and further includes whether the sponsors of the research and the researchers have claimed that there are no excess payments. The reason per capita payments are being discussed is because of the risk--with special caution when sponsors and researchers are not willing to claim that there are no excess payments--of introducing bias into researchers' decisions regarding study design, implementation, and interpretation, as well as concerning whom to enroll or keep in studies. Researchers' claims that there are no excess payments do not vitiate the risk of such payments. Nevertheless, a special admonition when sponsors and researchers do not claim the absence of excess payments would hopefully encourage them to eschew excess payments. My recommendations are required by the rights to bodily integrity and autonomy embedded in informed consent. Several arguments have been made against my recommendations, many of which relate to supposed effects on trust. My rights-based recommendations should not be rejected because of objections based on propositions that (1) are conceptually unclear because of a failure to unbundle different kinds and degrees of trust and (2) have not been empirically proven even where concepts are clarified. In some instances, the required strong empirical confirmation cannot be made because of practical or ethical restraints, including the fact that some of the necessary studies would require invasion of the right to informed consent. Finally, I suggest and partially apply an organizational method to generate empirical questions and guidance for future research in this area. Even the few hypothetical scenarios addressed demonstrate how complex--and sometimes practically or ethically impossible--the empirical studies must be to adduce proofs sufficient to overcome the imperative of informed consent.

Development and Pilot Testing of a Video-Assisted Informed Consent Process

PubMed Central

Sonne, Susan C.; Andrews, Jeannette O.; Gentilin, Stephanie M.; Oppenheimer, Stephanie; Obeid, Jihad; Brady, Kathleen; Wolf, Sharon; Davis, Randal; Magruder, Kathryn

2013-01-01

The informed consent process for research has come under scrutiny, as consent documents are increasingly long and difficult to understand. Innovations are needed to improve comprehension in order to make the consent process truly informed. We report on the development and pilot testing of video clips that could be used during the consent process to better explain research procedures to potential participants. Based on input from researchers and community partners, 15 videos of common research procedures/concepts were produced. The utility of the videos was then tested by embedding them in mock informed consent documents that were presented via an online electronic consent system designed for delivery via iPad. Three mock consents were developed, each containing five videos. All participants (n=61) read both a paper version and the video-assisted iPad version of the same mock consent and were randomized to which format they reviewed first. Participants were given a competency quiz that posed specific questions about the information in the consent after reviewing the first consent document to which they were exposed. Most participants (78.7%) preferred the video-assisted format compared to paper (12.9%). Nearly all (96.7%) reported that the videos improved their understanding of the procedures described in the consent document; however, comprehension of material did not significantly differ by consent format. Results suggest videos may be helpful in providing participants with information about study procedures in a way that is easy to understand. Additional testing of video consents for complex protocols and with subjects of lower literacy is warranted. PMID:23747986

Development and pilot testing of a video-assisted informed consent process.

PubMed

Sonne, Susan C; Andrews, Jeannette O; Gentilin, Stephanie M; Oppenheimer, Stephanie; Obeid, Jihad; Brady, Kathleen; Wolf, Sharon; Davis, Randal; Magruder, Kathryn

2013-09-01

The informed consent process for research has come under scrutiny, as consent documents are increasingly long and difficult to understand. Innovations are needed to improve comprehension in order to make the consent process truly informed. We report on the development and pilot testing of video clips that could be used during the consent process to better explain research procedures to potential participants. Based on input from researchers and community partners, 15 videos of common research procedures/concepts were produced. The utility of the videos was then tested by embedding them in mock-informed consent documents that were presented via an online electronic consent system designed for delivery via iPad. Three mock consents were developed, each containing five videos. All participants (n = 61) read both a paper version and the video-assisted iPad version of the same mock consent and were randomized to which format they reviewed first. Participants were given a competency quiz that posed specific questions about the information in the consent after reviewing the first consent document to which they were exposed. Most participants (78.7%) preferred the video-assisted format compared to paper (12.9%). Nearly all (96.7%) reported that the videos improved their understanding of the procedures described in the consent document; however, the comprehension of material did not significantly differ by consent format. Results suggest videos may be helpful in providing participants with information about study procedures in a way that is easy to understand. Additional testing of video consents for complex protocols and with subjects of lower literacy is warranted. Copyright © 2013 Elsevier Inc. All rights reserved.

Analysis of Informed Consent Document Utilization in a Minimal-Risk Genetic Study

PubMed Central

Desch, Karl; Li, Jun; Kim, Scott; Laventhal, Naomi; Metzger, Kristen; Siemieniak, David; Ginsburg, David

2012-01-01

Background The signed informed consent document certifies that the process of informed consent has taken place and provides research participants with comprehensive information about their role in the study. Despite efforts to optimize the informed consent document, only limited data are available about the actual use of consent documents by participants in biomedical research. Objective To examine the use of online consent documents in a minimal-risk genetic study. Design Prospective sibling cohort enrolled as part of a genetic study of hematologic and common human traits. Setting University of Michigan Campus, Ann Arbor, Michigan. Participants Volunteer sample of healthy persons with 1 or more eligible siblings aged 14 to 35 years. Enrollment was through targeted e-mail to student lists. A total of 1209 persons completed the study. Measurements Time taken by participants to review a 2833-word online consent document before indicating consent and identification of a masked hyperlink near the end of the document. Results The minimum predicted reading time was 566 seconds. The median time to consent was 53 seconds. A total of 23% of participants consented within 10 seconds, and 93% of participants consented in less than the minimum predicted reading time. A total of 2.5% of participants identified the masked hyperlink. Limitation The online consent process was not observed directly by study investigators, and some participants may have viewed the consent document more than once. Conclusion Few research participants thoroughly read the consent document before agreeing to participate in this genetic study. These data suggest that current informed consent documents, particularly for low-risk studies, may no longer serve the intended purpose of protecting human participants, and the role of these documents should be reassessed. Primary Funding Source National Institutes of Health. PMID:21893624

Randomization to Standard and Concise Informed Consent Forms: Development of Evidence-Based Consent Practices

PubMed Central

Enama, Mary E.; Hu, Zonghui; Gordon, Ingelise; Costner, Pamela; Ledgerwood, Julie E.; Grady, Christine

2012-01-01

Background Consent to participate in research is an important component of the conduct of ethical clinical trials. Current consent practices are largely policy-driven. This study was conducted to assess comprehension of study information and satisfaction with the consent form between subjects randomized to concise or to standard informed consent forms as one approach to developing evidence-based consent practices. Methods Participants (N=111) who enrolled into two Phase I investigational influenza vaccine protocols (VRC 306 and VRC 307) at the NIH Clinical Center were randomized to one of two IRB-approved consents; either a standard or concise form. Concise consents had an average of 63% fewer words. All other aspects of the consent process were the same. Questionnaires about the study and the consent process were completed at enrollment and at the last visit in both studies. Results Subjects using concise consent forms scored as well as those using standard length consents in measures of comprehension (7 versus 7, p=0.79 and 20 versus 21, p=0.13), however, the trend was for the concise consent group to report feeling better informed. Both groups thought the length and detail of the consent form was appropriate. Conclusions Randomization of study subjects to different length IRB-approved consents forms as one method for developing evidence-based consent practices, resulted in no differences in study comprehension or satisfaction with the consent form. A concise consent form may be used ethically in the context of a consent process conducted by well-trained staff with opportunities for discussion and education throughout the study. PMID:22542645

Ethics, informed consent, and assisted reproduction.

PubMed

Macklin, R

1995-09-01

Informed consent to treatment is an ethical requirement often misunderstood or not fully appreciated by physicians. The purpose of obtaining informed consent is to ensure that patients know what doctors propose to do and freely grant their permission. Although the purpose of informed consent and the standards by which it is to be employed are the same in all areas of medical practice, special problems arise in assisted reproduction. Voluntary, informed consent is an instance of a reproductive right that should be recognized by the international medical community, and not limited to Western and European countries.

Response to Orr and Siegler--collective intentionality and procreative desires: the permissible view on consent to posthumous conception.

PubMed

Parker, M

2004-08-01

Orr and Siegler have recently defended a restrictive view concerning posthumous sperm retrieval and conception, which would limit insemination to those cases where the deceased man has provided explicit consent for such a procedure. The restrictive view dominates current law and practice. A permissible view, in contrast, would allow insemination and conception in all but those cases where the posthumous procedure has been explicitly refused, or where there is no reasonable evidence that the deceased person desired children. I describe a phenomenology of procreative desires which supports the permissible view, and which is compatible with requirements concerning the interests of the decedent, concepts of medical infertility, and the welfare of the future child. The account illustrates how our current obsession with individual rights and autonomy can be self-defeating and repressive.

Analysis of the status of informed consent in medical research involving human subjects in public hospitals in Shanghai.

PubMed

Jianping, Wang; Li, Lan; Xue, Di; Tang, Zhongjin; Jia, Xieyang; Wu, Rong; Xi, Yiqun; Wang, Tong; Zhou, Ping

2010-07-01

The objectives of the study are to understand the current practice of informed consent in medical research in public hospitals in Shanghai, and to share our views with other countries, especially developing countries. In the study, 145 consent forms (CFs) of the selected research projects in eight public hospitals with ethics committees in Shanghai were audited, and the principle investigators (PIs) of these research projects and 40 student subjects who had participated in clinical drug tests were surveyed by questionnaires. The CFs of medical researches in public hospitals with ethics committees in Shanghai were generally acceptable. However, there were some defects in the CFs. Although most of the surveyed PIs had correct recognition of informed consent, some processes of informed consent were not in accordance with generally accepted requirements. A large number of the PIs considered the greatest difficulty with informal consent was lack of correct recognition of subjects or legally authorised representatives on medical research. Informed consent in medical research should consider the research ethics, the background of potential subjects, the local resources and culture of medical research. In addition, special protection is needed for student subjects in informed consent as well as efforts for building and restoring the public's trust in biomedical research. The informed consent in Shanghai's public hospitals with ethics committees was generally acceptable and the achievement of adequate informed consent is influenced by many factors.

Scientists' perspectives on consent in the context of biobanking research

PubMed Central

Master, Zubin; Campo-Engelstein, Lisa; Caulfield, Timothy

2015-01-01

Most bioethics studies have focused on capturing the views of patients and the general public on research ethics issues related to informed consent for biobanking and only a handful of studies have examined the perceptions of scientists. Capturing the opinions of scientists is important because they are intimately involved with biobanks as collectors and users of samples and health information. In this study, we performed interviews with scientists followed by qualitative analysis to capture the diversity of perspectives on informed consent. We found that the majority of scientists in our study reported their preference for a general consent approach although they do not believe there to be a consensus on consent type. Despite their overall desire for a general consent model, many reported several concerns including donors needing some form of assurance that nothing unethical will be done with their samples and information. Finally, scientists reported mixed opinions about incorporating exclusion clauses in informed consent as a means of limiting some types of contentious research as a mechanism to assure donors that their samples and information are being handled appropriately. This study is one of the first to capture the views of scientists on informed consent in biobanking. Future studies should attempt to generalize findings on the perspectives of different scientists on informed consent for biobanking. PMID:25074466

Implications of the UK NHS consent policy for nuclear medicine practice.

PubMed

Greaves, Claire D; Tindale, Wendy B

2005-02-01

To comply with government policy on consent, the Sheffield Teaching Hospitals (STH) National Health Service (NHS) Trust introduced a new consent policy in February 2002. Verbal or written consent (depending on the level of risk) must be obtained prior to each study. The patient must be fully informed and given time to reach a decision. Consideration needs to be given to the following: to whom, when and how to provide such information and obtain consent. Each study type and patient circumstance needs to be classified according to risk. Consideration of the risks resulted in a local policy in which written consent is required for the following: therapeutic procedures, studies on pregnant women, studies in which pregnancy needs to be avoided, research procedures, cardiac stress for myocardial perfusion scintigraphy and intrathecal administration. Patient information leaflets have been updated with new information about the study and any risks. Information is now available for both patients and hospital staff. Compliance with the consent policy in a service department provides logistic challenges, but it is possible to fully inform patients in advance about their treatment, allowing them to give informed consent.

Varied and principled understandings of autonomy in English law: justifiable inconsistency or blinkered moralism?

PubMed

Coggon, John

2007-09-01

Autonomy is a concept that holds much appeal to social and legal philosophers. Within a medical context, it is often argued that it should be afforded supremacy over other concepts and interests. When respect for autonomy merely requires non-intervention, an adult's right to refuse treatment is held at law to be absolute. This apparently simple statement of principle does not hold true in practice. This is in part because an individual must be found to be competent to make a valid refusal of consent to medical treatment, and capacity to decide is not an absolute concept. But further to this, I argue that there are three relevant understandings of autonomy within our society, and each can demand in differing cases that different courses of action be followed. Judges, perhaps inadvertently, have been able to take advantage of the equivocal nature of the concept to come tacitly to decisions that reflect their own moral judgments of patients or decisions made in particular cases. The result is the inconsistent application of principle. I ask whether this is an unforeseen outcome or if it reflects a wilful disregard for equal treatment in favour of silent moral judgments in legal cases. Whatever the cause, I suggest that once this practice is seen to occur, acceptable justification of it in some cases is difficult to find.

Educating anesthesia residents to obtain and document informed consent for epidural labor analgesia: does simulation play a role?

PubMed

Antoniou, A; Marmai, K; Qasem, F; Cherry, R; Jones, P M; Singh, S

2018-05-01

Informed consent is required before placing an epidural. At our hospital, teaching of residents about this is done informally at the bedside. This study aimed to assess the ability of anesthesia residents to acquire and retain knowledge required when seeking informed consent for epidural labor analgesia. It assessed how well this knowledge was translated to clinical ability, by assessing the verbal consent process during an interaction with a standardized patient. Twenty anesthesia residents were randomized to a 'didactic group' or a 'simulation group'. Each resident was presented with a written scenario and asked to document the informed consent process, as they normally would do (pre-test). The didactic group then had a presentation about informed consent, while the simulation group members interviewed a simulated patient, the scenarios focusing on different aspects of consent. All residents then read a scenario and documented their informed consent process (post-test). Six weeks later all residents interviewed a standardized patient in labor and documented the consent from this interaction (six-week test). There was no significant difference in the baseline performance of the two groups. Both groups showed significant improvement in their written consent documentation at the immediate time point, the improvement in the didactic group being greater. The didactic group performed better at both the immediate time point and the six-week time point. In this small study, a didactic teaching method proved better than simulation-based teaching in helping residents to gain knowledge needed to obtain informed consent for epidural labor analgesia. Copyright © 2017 Elsevier Ltd. All rights reserved.

Best practice guidelines on informed consent for weight loss surgery patients.

PubMed

Sabin, James; Fanelli, Robert; Flaherty, Helen; Istfan, Nawfal; Mariner, Wendy; Barnes, Janet Nally; Pratt, Janey S A; Rossi, Laura; Samour, Patricia

2005-02-01

To provide evidence-based guidelines on informed consent and the education that underlies it for legally competent, severely obese weight loss surgery (WLS) patients. We conducted a systematic review of the scientific literature published on MEDLINE between 1984 and 2004. Three articles focused on informed consent for WLS; none was based on empirical studies. We summarized each paper and assigned evidence categories according to a grading system derived from established evidence-based models. We also relied on informed consent and educational materials from six WLS programs in Massachusetts. All evidence is Category D. Recommendations were based on a review of the available literature, informed consent materials from WLS programs, and expert opinion. This Task Group found that the informed consent process contributes to long-term outcome in multiple ways but is governed by limited legal requirements. We focused our report on the legal and ethical issues related to informed consent, i.e., disclosure vs. comprehension. Recommendations centered on the importance of assessing patient comprehension of informed consent materials, the content of those materials, and the use of active teaching/learning techniques to promote understanding. Although demonstrated comprehension is not a legal requirement for informed consent in Massachusetts or other states, the members of this Task Group found that the best interests of WLS patients, providers, and facilities are served when clinicians engage patients in active learning and collaborative decision making.

Dynamic axes of informed consent in Japan.

PubMed

Specker Sullivan, Laura

2017-02-01

Scholarship in cross-cultural bioethics routinely frames Japanese informed consent in contrast to informed consent in North America. This contrastive analysis foregrounds cancer diagnosis disclosure and physician paternalism as unique aspects of Japanese informed consent that deviate from American practices. Drawing on in-depth interviews with 15 Japanese medical professionals obtained during fieldwork in Japan from 2013 to 15, this article complicates the informed consent discourse beyond East-West comparisons premised on Anglo-American ethical frameworks. It expands professional perspectives to include nurses, medical social workers, clinical psychologists, and ethicists and it addresses informed consent for a broad range of conditions in addition to cancer. The results suggest that division of affective labor is an under-theorized dimension of informed consent that is perceived as at odds with principled demands for universal informed consent. These practical tensions are conceptualized as cultural differences, with Japan identified in terms of omakase as practical and supportive and the United States identified in terms of jiko kettei as principled and self-determining. These results have implications for the methodology of cross-cultural bioethics as well as for theories and practices of informed consent in both Japan and the United States. I conclude that responsible cross-cultural work in bioethics must begin from the ground up, incorporating all relevant stakeholder perspectives, attitudes, and experiences. Copyright © 2016 Elsevier Ltd. All rights reserved.

Measuring the Process and Quality of Informed Consent for Clinical Research: Development and Testing

PubMed Central

Cohn, Elizabeth Gross; Jia, Haomiao; Smith, Winifred Chapman; Erwin, Katherine; Larson, Elaine L.

2013-01-01

Purpose/Objectives To develop and assess the reliability and validity of an observational instrument, the Process and Quality of Informed Consent (P-QIC). Design A pilot study of the psychometrics of a tool designed to measure the quality and process of the informed consent encounter in clinical research. The study used professionally filmed, simulated consent encounters designed to vary in process and quality. Setting A major urban teaching hospital in the northeastern region of the United States. Sample 63 students enrolled in health-related programs participated in psychometric testing, 16 students participated in test-retest reliability, and 5 investigator-participant dyads were observed for the actual consent encounters. Methods For reliability and validity testing, students watched and rated videotaped simulations of four consent encounters intentionally varied in process and content and rated them with the proposed instrument. Test-retest reliability was established by raters watching the videotaped simulations twice. Inter-rater reliability was demonstrated by two simultaneous but independent raters observing an actual consent encounter. Main Research Variables The essential elements of information and communication for informed consent. Findings The initial testing of the P-QIC demonstrated reliable and valid psychometric properties in both the simulated standardized consent encounters and actual consent encounters in the hospital setting. Conclusions The P-QIC is an easy-to-use observational tool that provides a quick assessment of the areas of strength and areas that need improvement in a consent encounter. It can be used in the initial trainings of new investigators or consent administrators and in ongoing programs of improvement for informed consent. Implications for Nursing The development of a validated observational instrument will allow investigators to assess the consent process more accurately and evaluate strategies designed to improve it. PMID:21708532

An evaluation of "informed consent" with volunteer prisoner subjects.

PubMed

Marini, J L; Sheard, M H; Bridges, C I

1976-11-01

"Informed consent" sets a goal for investigators experimenting with human subjects, but little is known about how to achieve or evaluate it in an experiment. In a 3-year, double-blind study with incarcerated men, we attempted to provide a "free and informed consent" and evaluated our efforts with an unannounced questionnaire administered to subjects after they completed the experiment. At that time, approximately two-thirds had sufficient information for an informed consent, but only one-third was well informed about all key aspects of the experiment and one-third was insufficiently informed to give an informed consent. We found that institution- or study-based coercion was minimal in our experiment. From our evaluation of the questionnaire and experience at the study institution, we conclude that an experiment with human subjects should be designed to include an ongoing evaluation of informed consent, and active attempts should be made to avoid or minimize coercive inducements. Experiments with significant risk, which require a long duration and/or large sample size relative to the institution's population, should probably not be performed on prisoner subjects. The experimenter should be independent of the penal institution's power structure. Presenting and explaining a consent form to volunteers on one occasion is probably an in adequate procedure for obtaining and maintaining an informed consent.

Screening the use of informed consent forms prior to procedures involving operative dentistry: ethical aspects

PubMed Central

Graziele Rodrigues, Livia; De Souza, João Batista; De Torres, Erica Miranda; Ferreira Silva, Rhonan

2017-01-01

Background. The present study aimed to screen the knowledge and attitudes of dentists toward the use of informed consent forms prior to procedures involving operative dentistry. Methods. A research tool containing questions (questionnaire) regarding the use of informed consent forms was developed. The questionnaire consisted of seven questions structured to screen the current practice in operative dentistry towards the use of informed consent forms. Results. The questionnaires were distributed among 731 dentists, of which 179 returned them with answers. Sixty-seven dentists reported not using informed consent forms. The main reasons for not using informed consent forms were: having a complete dental record signed by the patient (67.2%) and having a good relation with patients (43.6%). The dentists who reported using informed consent forms revealed that they obtained them from other dentists and made their own modifications (35.9%). Few dentists revealed contacting lawyers (1.7%) and experts in legal dentistry (0.9%) for the development of their informed consent forms. Conclusion. A high number of dentists working in the field of operative dentistry behave according to the ethical standards in the clinical practice, becoming unprotected against ethical and legal actions. PMID:28413600

PATIENT'S RIGHT TO INFORMED CONSENT IN REPUBLIC SRPSKA: LEGAL AND ETHICAL ASPECTS (WITH SPECIAL REFERENCE TO PHYSICAL REHABILITATION).

PubMed

Milinkovic, Igor; Majstorovic, Biljana

2014-12-01

The principle of informed consent, which requires a patient's fully-informed consent prior to the medical treatment, is closely connected with the value of human dignity. The realization and protection of a patient's dignity is not possible without his/her right to choose the character and scope of medical treatment. This goal cannot be adequately achieved within the traditional model of medical paternalism characterized by the physician's authoritative position. The first part of the article deals with the content and ethical significance of the informed consent doctrine. The legal framework of informed consent in Republic Srpska (RS), one of the two Bosnia and Herzegovina (BH)entities, is analyzed. Special reference is made to the relevance of the informed consent principle within the physical rehabilitation process. Although ethical aspects of physical rehabilitation are often overlooked, this medical field possesses a strong ethical dimension (including an appropriate realization of the patient's right to informed consent).

Twenty-first Century ethics of medical research involving human subjects: achievements and challenges.

PubMed

Tzamaloukas, Antonios H; Konstantinov, Konstantin N; Agaba, Emmanuel I; Raj, Dominic S C; Murata, Glen H; Glew, Robert H

2008-01-01

The field of ethics in medical research has seen important developments in the last three decades, but it also faces great challenges in the new century. The purposes of this report are to examine the current status of ethics of medical research involving human subjects and the nature of the ethical challenges facing this research, to identify the weakness of the current system of safeguards for ethical research, and to stress the importance of the ethical character of the researcher, which is the safeguard that has the greatest potential for protecting the research subjects. Researchers appreciate the risks of human medical research that create ethical dilemmas and the need for an ethical compromise in order to proceed with the research. The main elements of the compromise, formulated primarily from experiences in the Second World War, include: (1) the dominant position of the ethical principle of autonomy; (2) the demand for a signed informed consent; (3) the likelihood of improving health with the research protocol, which must be approved by a duly appointed supervising committee; and (4) an acceptable risk/benefit ratio. The main weakness of this set of safeguards is the difficulty with obtaining a truly informed consent. The new challenges to ethical medical research stem from certain types of research, such as genetic and stem cell research, and from the increasing involvement of the industry in planning and funding the research studies. Developing medical researchers with an ethical character and knowledge about ethics in medicine may be the most effective safeguard in protecting participants of medical research experiments.

Ethics in clinical research: the Indian perspective.

PubMed

Sanmukhani, J; Tripathi, C B

2011-03-01

Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.

Informed Consent for Electroconvulsive Therapy--Finding Balance.

PubMed

Mankad, Mehul

2015-09-01

Informed consent underpins all medical decisions, including the decision to undergo electroconvulsive therapy (ECT). Written informed consent remains the standard before the initiation of ECT and requires the inclusion of several components to be considered valid. Prospective patients must be aware of risks and benefits of ECT as well as risks and benefits of alternate, and potentially less effective, interventions. Patients must also possess adequate decision-making capacity to make an informed choice about treatment. Consent for ECT may present unique issues, such as the interplay between potential cognitive adverse effects and informed consent. Options to address this concern include thorough explanation of this topic before the initiation of ECT, continued reassessment of consent during ECT, or some combination of approaches.

Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials.

PubMed

Sengupta, Sohini; Lo, Bernard; Strauss, Ronald P; Eron, Joseph; Gifford, Allen L

2011-11-01

Assessing and improving informed consent understanding is equally important as obtaining consent from participants in clinical trial research, but developing interventions to target gaps in participants' informed consent understanding remains a challenge. We used a randomized controlled study design to pilot test an educational intervention to improve actual informed consent understanding of new enrollees in the Adult AIDS Clinical Trial Group (AACTG). Questionnaires were administered to 24 enrollees to assess their baseline understanding on eight elements of informed consent associated with AIDS clinical trials. Enrollees who scored 18/21(85%) or less were randomly assigned to in-person, targeted education (intervention), or delayed education (control). Two follow-up assessments were administered. Repeated measures ANOVA was performed to determine intervention effectiveness in improving actual informed consent understanding over time. Actual understanding improved at the immediate post-intervention time point with a significant score difference of 2.5 when comparing the intervention and delayed groups. In addition, there was a significant score difference of 3.2 when comparing baseline to three-month follow-up for the two groups, suggesting a statistically significant intervention effect to improve actual understanding of the basic elements of informed consent. The findings demonstrated that one-time targeted education can improve actual informed consent understanding one week after the intervention, but retention of these concepts may require periodic monitoring to ensure comprehension throughout the course of a clinical trial.

Systems autonomy

NASA Technical Reports Server (NTRS)

Lum, Henry, Jr.

1988-01-01

Information on systems autonomy is given in viewgraph form. Information is given on space systems integration, intelligent autonomous systems, automated systems for in-flight mission operations, the Systems Autonomy Demonstration Project on the Space Station Thermal Control System, the architecture of an autonomous intelligent system, artificial intelligence research issues, machine learning, and real-time image processing.

Diagnosis and management of Alzheimer's disease: past, present and future ethical issues.

PubMed

Gauthier, S; Leuzy, A; Racine, E; Rosa-Neto, P

2013-11-01

There is great interest in the ethical issues associated with Alzheimer's disease (AD) and related dementias given the prevalence of AD and the evolving neuroscience landscape in matters of diagnoses and therapeutics. Much of the ethics discussion arises in the tension between the principle of not doing harm (principle of non-maleficence) in this vulnerable population and the development of effective treatments (principle of beneficence). Autonomy and capacity issues are also numerous, wide-ranging, and concern (1) day to day affairs such as driving safely and spending money wisely, (2) life-time events such as designating a legal representative in case of incapacity, making a will, (3) consenting to treatment and diagnostic procedures, (4) participating in research. The latter issue is particularly thorny and illustrates well the complexity of tackling concerns related to capacity. The impetus to protect AD patients has partly led to ethics regulation and policies making research on inapt patients more difficult because of stringent requirements for signed informed consent or for showing the value of the research to this specific patient population. New issues are arising that relate to earlier diagnosis using biomarkers and (possibly soon) the use of drugs that modify disease progression. We here summarize and discuss the different ethical issues associated with AD from a historical perspective, with emphasis on diagnostic and treatments issues. Copyright © 2013 Elsevier Ltd. All rights reserved.

Patient preferences toward an interactive e-consent application for research using electronic health records.

PubMed

Harle, Christopher A; Golembiewski, Elizabeth H; Rahmanian, Kiarash P; Krieger, Janice L; Hagmajer, Dorothy; Mainous, Arch G; Moseley, Ray E

2017-12-19

The purpose of this study was to assess patient perceptions of using an interactive electronic consent (e-consent) application when deciding whether or not to grant broad consent for research use of their identifiable electronic health record (EHR) information. For this qualitative study, we conducted a series of 42 think-aloud interviews with 32 adults. Interview transcripts were coded and analyzed using a modified grounded theory approach. We identified themes related to patient preferences, reservations, and mixed attitudes toward consenting electronically; low- and high-information-seeking behavior; and an emphasis on reassuring information, such as data protections and prohibitions against sharing data with pharmaceutical companies. Participants expressed interest in the types of information contained in their EHRs, safeguards protecting EHR data, and specifics on studies that might use their EHR data. This study supports the potential value of interactive e-consent applications that allow patients to customize their consent experience. This study also highlights that some people have concerns about e-consent platforms and desire more detailed information about administrative processes and safeguards that protect EHR data used in research. This study contributes new insights on how e-consent applications could be designed to ensure that patients' information needs are met when seeking consent for research use of health record information. Also, this study offers a potential electronic approach to meeting the new Common Rule requirement that consent documents contain a "concise and focused" presentation of key information followed by more details. © The Author(s) 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Principles of medical ethics in supportive care: a reflection.

PubMed

O'Hare, Daniel G

2004-02-01

The possibility of medical-moral controversy in contemporary health care delivery is occasioned by the interfacing of expanding technology with both professional and personal value systems, frequent and significant knowledge deficits on the part of health care consumers, and increased circumspection of and economic constraints experienced by health care providers. Particularly in an era of increasing regulatory mandates and the frequent and lamentable decrease in the availability of human, natural, and institutional resources, an understanding of the function of ethical analysis is indigenous to care, which is simultaneously medically appropriate and morally indicated. But while a familiarity with and an appreciation of the potential contribution of ethical reasoning is essential in all health care delivery, it assumes critical importance in supportive care. In that venue, where the rigors and demands of aggressively therapeutic interventions have ceased and the goal and the demeanor of care have shifted to the palliative mode, heightened attention to the principles of medical ethics is necessary for the balancing of rights and responsibilities for health care consumers and providers alike. This issue ultimately can be singularly salient in providing care that is patient centered and directed. Individuals acting as moral agents, suggesting what "ought" to be done in a given situation, either for themselves or as they are involved in rendering or supporting decisions proffered for or by other moral agents, particularly those in extremis, those in the throes of terminal illness following the collapse of the curative mode, need recourse to principles to facilitate their reasoning. Although the employment of each principle of medical ethics offers guidelines for reflection on the most comprehensive and appropriate care, it is attention to autonomy, informed consent, and beneficence that promotes the most effective supportive care. For even as the question of medical viability is settled in favor of palliation over aggression, there remain the entanglements of psychological stability, conflicting value systems, and the impact of the social milieu as well as the issues of economic responsibility and resource accountability. It is in the attention to the medical ethical principles of autonomy and informed consent, especially as amplified by the creation of and respect for advance directives, that the most holistic and productive supportive care can be offered. It is also in this posture that appeal to the principle of beneficence is made. Just as the progress of disease and, therefore, the realistic goals of care change, so too can an individual's considered opinion with regard to end-of-life decisions. Preserving the integrity of patients and caregivers alike and engaging in fruitful and informative dialog prior to seeking volitional authorization or operationalizing a supportive approach demonstrates renewed concern for both patient autonomy and professional accountability in the provision of a comprehensive end-of-life care plan. Discussions will not be avoided until they can no longer effectively take place, salient questions will not go unanswered, and decisions around end-of-life questions, in the mode of supportive care, will not be absent where care was exercised to engage patients in significant dialog earlier rather than later in their disease processes.

Expect the unexpected: screening for secondary findings in clinical genomics research.

PubMed

Mackley, Michael P; Capps, Benjamin

2017-06-01

Due to decreasing cost, and increasing speed and precision, genomic sequencing in research is resulting in the generation of vast amounts of genetic data. The question of how to manage that information has been an area of significant debate. In particular, there has been much discussion around the issue of 'secondary findings' (SF)-findings unrelated to the research that have diagnostic significance. The following includes ethical commentaries, guidelines and policies in respect to large-scale clinical genomics studies. Research participant autonomy and their informed consent are paramount-policies around SF must be made clear and participants must have the choice as to which results they wish to receive, if any. While many agree that clinically 'actionable' findings should be returned, some question whether they should be actively sought within a research protocol. SF present challenges to a growing field; diverse policies around their management have the potential to hinder collaboration and future research. The impact of returning SF and accurate estimates of their clinical utility are needed to inform future protocol design. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Governance Through Privacy, Fairness, and Respect for Individuals.

PubMed

Baker, Dixie B; Kaye, Jane; Terry, Sharon F

2016-01-01

Individuals have a moral claim to be involved in the governance of their personal data. Individuals' rights include privacy, autonomy, and the ability to choose for themselves how they want to manage risk, consistent with their own personal values and life situations. The Fair Information Practices principles (FIPPs) offer a framework for governance. Privacy-enhancing technology that complies with applicable law and FIPPs offers a dynamic governance tool for enabling the fair and open use of individual's personal data. Any governance model must protect against the risks posed by data misuse. Individual perceptions of risks are a subjective function involving individuals' values toward self, family, and society, their perceptions of trust, and their cognitive decision-making skills. Individual privacy protections and individuals' right to choose are codified in the HIPAA Privacy Rule, which attempts to strike a balance between the dual goals of information flow and privacy protection. The choices most commonly given individuals regarding the use of their health information are binary ("yes" or "no") and immutable. Recent federal recommendations and law recognize the need for granular, dynamic choices. Individuals expect that they will govern the use of their own health and genomic data. Failure to build and maintain individuals' trust increases the likelihood that they will refuse to grant permission to access or use their data. The "no surprises principle" asserts that an individual's personal information should never be collected, used, transmitted, or disclosed in a way that would surprise the individual were she to learn about it. The FIPPs provide a powerful framework for enabling data sharing and use, while maintaining trust. We introduce the eight FIPPs adopted by the Department of Health and Human Services, and provide examples of their interpretation and implementation. Privacy risk and health risk can be reduced by giving consumers control, autonomy, and transparency, and by engaging them in managing their own health. Explicit "consent" may not always be necessary - the FIPPs offer multiple ways to engender trust and avoid surprises.

Using informed consent to save trust.

PubMed

Eyal, Nir

2014-07-01

Increasingly, bioethicists defend informed consent as a safeguard for trust in caretakers and medical institutions.This paper discusses an ‘ideal type’ of that move. What I call the trust-promotion argument for informed consent states:1. Social trust, especially trust in caretakers and medical institutions, is necessary so that, for example,people seek medical advice, comply with it, and participate in medical research.2. Therefore, it is usually wrong to jeopardise that trust.3. Coercion, deception, manipulation and other violations of standard informed consent requirements seriously jeopardise that trust.4. Thus, standard informed consent requirements are justified.This article describes the initial promise of this argument, then identifies challenges to it. As I show, the value of trust fails to account for some common sense intuitions about informed consent. We should revise the argument, common sense morality, or both.

Human/autonomy collaboration for the automated generation of intelligence products

NASA Astrophysics Data System (ADS)

DiBona, Phil; Schlachter, Jason; Kuter, Ugur; Goldman, Robert

2017-05-01

Intelligence Analysis remains a manual process despite trends toward autonomy in information processing. Analysts need agile decision-­-support tools that can adapt to the evolving information needs of the mission, allowing the analyst to pose novel analytic questions. Our research enables the analysts to only provide a constrained English specification of what the intelligence product should be. Using HTN planning, the autonomy discovers, decides, and generates a workflow of algorithms to create the intelligence product. Therefore, the analyst can quickly and naturally communicate to the autonomy what information product is needed, rather than how to create it.

Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process.

PubMed

Allmark, P; Mason, S

2006-08-01

To assess whether continuous consent, a process in which information is given to research participants at different stages in a trial, and clinician training in that process were effective when used by clinicians while gaining consent to the Total Body Hypothermia (TOBY) trial. The TOBY trial is a randomised controlled trial (RCT) investigating the use of whole-body cooling for neonates with evidence of perinatal asphyxia. Obtaining valid informed consent for the TOBY trial is difficult, but is a good test of the effectiveness of continuous consent. Semistructured interviews were conducted with 30 sets of parents who consented to the TOBY trial and with 10 clinicians who sought it by the continuous consent process. Analysis was focused on the validity of parental consent based on the consent components of competence, information, understanding and voluntariness. No marked problems with consent validity at the point of signature were observed in 19 of 27 (70%) couples. Problems were found mainly to lie with the competence and understanding of the parents: mothers, particularly, had problems with competence in the early stages of consent. Problems in understanding were primarily to do with side effects. Problems in both competence and understanding were observed to reduce markedly, particularly for mothers, in the post-signature phase, when further discussion took place. Randomisation was generally understood but unpopular. Information was not always given by clinicians in stages during the short period available before parents gave consent. Most clinicians, however, were able to give follow-up information. Consent validity was found to compare favourably with similar trials examined in the Euricon study. Adopting the elements of the continuous consent process and clinician training in RCTs should be considered by researchers, particularly when they have concerns about the quality of consent they are likely to obtain by using a conventional process.

Increased Access to Professional Interpreters in the Hospital Improves Informed Consent for Patients with Limited English Proficiency.

PubMed

Lee, Jonathan S; Pérez-Stable, Eliseo J; Gregorich, Steven E; Crawford, Michael H; Green, Adrienne; Livaudais-Toman, Jennifer; Karliner, Leah S

2017-08-01

Language barriers disrupt communication and impede informed consent for patients with limited English proficiency (LEP) undergoing healthcare procedures. Effective interventions for this disparity remain unclear. Assess the impact of a bedside interpreter phone system intervention on informed consent for patients with LEP and compare outcomes to those of English speakers. Prospective, pre-post intervention implementation study using propensity analysis. Hospitalized patients undergoing invasive procedures on the cardiovascular, general surgery or orthopedic surgery floors. Installation of dual-handset interpreter phones at every bedside enabling 24-h immediate access to professional interpreters. Primary predictor: pre- vs. post-implementation group; secondary predictor: post-implementation patients with LEP vs. English speakers. Primary outcomes: three central informed consent elements, patient-reported understanding of the (1) reasons for and (2) risks of the procedure and (3) having had all questions answered. We considered consent adequately informed when all three elements were met. We enrolled 152 Chinese- and Spanish-speaking patients with LEP (84 pre- and 68 post-implementation) and 86 English speakers. Post-implementation (vs. pre-implementation) patients with LEP were more likely to meet criteria for adequately informed consent (54% vs. 29%, p = 0.001) and, after propensity score adjustment, had significantly higher odds of adequately informed consent (AOR 2.56; 95% CI, 1.15-5.72) as well as of each consent element individually. However, compared to post-implementation English speakers, post-implementation patients with LEP had significantly lower adjusted odds of adequately informed consent (AOR, 0.38; 95% CI, 0.16-0.91). A bedside interpreter phone system intervention to increase rapid access to professional interpreters was associated with improvements in patient-reported informed consent and should be considered by hospitals seeking to improve care for patients with LEP; however, these improvements did not eliminate the language-based disparity. Additional clinician educational interventions and more language-concordant care may be necessary for informed consent to equal that for English speakers.

78 FR 27404 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-10

...; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are... on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are... submitted a proposed collection of information entitled ``Guidance on Informed Consent for In Vitro...

A randomized trial comparing concise and standard consent forms in the START trial

PubMed Central

Touloumi, Giota; Walker, A. Sarah; Smolskis, Mary; Sharma, Shweta; Babiker, Abdel G.; Pantazis, Nikos; Tavel, Jorge; Florence, Eric; Sanchez, Adriana; Hudson, Fleur; Papadopoulos, Antonios; Emanuel, Ezekiel; Clewett, Megan; Munroe, David; Denning, Eileen

2017-01-01

Background Improving the effectiveness and efficiency of research informed consent is a high priority. Some express concern about longer, more complex, written consent forms creating barriers to participant understanding. A recent meta-analysis concluded that randomized comparisons were needed. Methods We conducted a cluster-randomized non-inferiority comparison of a standard versus concise consent form within a multinational trial studying the timing of starting antiretroviral therapy in HIV+ adults (START). Interested sites were randomized to standard or concise consent forms for all individuals signing START consent. Participants completed a survey measuring comprehension of study information and satisfaction with the consent process. Site personnel reported usual site consent practices. The primary outcome was comprehension of the purpose of randomization (pre-specified 7.5% non-inferiority margin). Results 77 sites (2429 participants) were randomly allocated to use standard consent and 77 sites (2000 participants) concise consent, for an evaluable cohort of 4229. Site and participant characteristics were similar for the two groups. The concise consent was non-inferior to the standard consent on comprehension of randomization (80.2% versus 82%, site adjusted difference: 0.75% (95% CI -3.8%, +5.2%)); and the two groups did not differ significantly on total comprehension score, satisfaction, or voluntariness (p>0.1). Certain independent factors, such as education, influenced comprehension and satisfaction but not differences between consent groups. Conclusions An easier to read, more concise consent form neither hindered nor improved comprehension of study information nor satisfaction with the consent process among a large number of participants. This supports continued efforts to make consent forms more efficient. Trial registration Informed consent substudy was registered as part of START study in clinicaltrials.gov #NCT00867048, and EudraCT # 2008-006439-12 PMID:28445471

BREACHING THE SEXUAL BOUNDARIES IN THE DOCTOR-PATIENT RELATIONSHIP: SHOULD ENGLISH LAW RECOGNISE FIDUCIARY DUTIES?

PubMed

Ost, Suzanne

2016-01-01

In this article, I argue that sexual exploitation in the doctor-patient relationship would be dealt with more appropriately by the law in England and Wales on the basis of a breach of fiduciary duty. Three different types of sexual boundary breaches are discussed, and the particular focus is on breaches where the patient's consent is obtained through inducement. I contend that current avenues of redress do not clearly catch this behaviour and, moreover, they fail to capture the essence of the wrong committed by the doctor-the knowing breach of trust for self-gain-and the calculated way in which consent is induced. Finally, I demonstrate that the fiduciary approach is compatible with the contemporary pro-patient autonomy model of the doctor-patient relationship. © The Author 2016. Published by Oxford University Press; all rights reserved. For Permissions, please email: journals.permissions@oup.com.

Improving the Quality of Informed Consent in Clinical Research with Information Technology.

PubMed

Taber, Celia; Warren, Jim; Day, Karen

2016-01-01

The clinical research industry has yet to fully embrace information technology (IT) for informed consent purposes, even though it is used indispensably in our everyday lives and in other areas of clinical research and healthcare. This paper presents findings of a meta-narrative literature review to discuss the potential for IT to improve the quality of clinical research informed consent. The review reveals three main rationales for including IT in research consent. First, in the current context consent documents frequently fail to be effective decision aids for patients, and the lack of patient centricity in the process. Second, social media provides opportunities for patients to consult with a broader community during research consent to seek broader support, and potential to participate in creating a more patient centric process. Third, multimedia tools provide opportunities for improved patient education, engagement and decision making during research consent. IT offers opportunities to achieve more meaningful research consent, but more research is needed to create an evidence base, policies and economic analyses on the return on investment of using IT in the process.

A Randomized Controlled Trial of Short and Standard-Length Consent Forms for a Genetic Cohort Study: Is Longer Better?

PubMed Central

Matsui, Kenji; Lie, Reidar K.; Turin, Tanvir C.; Kita, Yoshikuni

2012-01-01

Background Although the amount of detail in informed consent documents has increased over time and the documents have therefore become very long, there is little research on whether longer informed consent documents actually result in (1) better informed research subjects or (2) higher consent rates. We therefore conducted an add-on randomized controlled trial to the Takashima Study, a prospective Japanese population-based genetic cohort study, to test the hypothesis that a shorter informed consent form would satisfy both of the above goals. Methods Standard (10 459 words, 11 pages) and short (3602 words, 5 pages) consent forms in Japanese were developed and distributed using cluster-randomization to 293 potential cohort subjects living in 9 medico-social units and 288 subjects in 8 medico-social units, respectively. Results Few differences were found between the 2 groups with regard to outcome measures, including participants’ self-perceived understanding, recall of information, concerns, voluntariness, trust, satisfaction, sense of duty, and consent rates. Conclusions A short informed consent form was no less valid than a standard form with regard to fulfilling ethical requirements and securing the scientific validity of research. PMID:22447213

Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia

PubMed Central

Vučemilo, Luka; Borovečki, Ana

2015-01-01

Background High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. Methods 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. Results The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10–19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Conclusions Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation. PMID:26376183

The legal and ethical implications of consent to nursing procedures.

PubMed

Power, K J

Nurses are increasingly expanding their practice to include many more invasive procedures. Consequently, there is a need to re-examine nurses' responsibilities in relation to obtaining consent for nursing as opposed to medical procedures. Fully informed consent is not a legal requirement in England, for either medical or nursing procedures. However, this article argues that to comply with the standard set by the Code of Professional Conduct nurses should obtain informed consent for any proposed procedure they undertake. The concept of informed consent is examined and applied to practice. Ultimately, nurses are charged with four key tasks in relation to securing consent for nursing procedures: educating themselves about the risks and benefits of the procedures they propose to undertake; conveying this information to patients; assessing their understanding of the information given; and endeavouring to support the patient in his/her decision.

Nudging, informed consent and bullshit.

PubMed

Simkulet, William

2017-11-18

Some philosophers have argued that during the process of obtaining informed consent, physicians should try to nudge their patients towards consenting to the option the physician believes best, where a nudge is any influence that is expected to predictably alter a person's behaviour without (substantively) restricting her options. Some proponents of nudging even argue that it is a necessary and unavoidable part of securing informed consent. Here I argue that nudging is incompatible with obtaining informed consent. I assume informed consent requires that a physician tells her patient the truth about her options and argue that nudging is incompatible with truth-telling. Instead, nudging satisfies Harry Frankfurt's account of bullshit. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A computer-based education intervention to enhance surrogates' informed consent for genomics research.

PubMed

Shelton, Ann K; Freeman, Bradley D; Fish, Anne F; Bachman, Jean A; Richardson, Lloyd I

2015-03-01

Many research studies conducted today in critical care have a genomics component. Patients' surrogates asked to authorize participation in genomics research for a loved one in the intensive care unit may not be prepared to make informed decisions about a patient's participation in the research. To examine the effectiveness of a new, computer-based education module on surrogates' understanding of the process of informed consent for genomics research. A pilot study was conducted with visitors in the waiting rooms of 2 intensive care units in a Midwestern tertiary care medical center. Visitors were randomly assigned to the experimental (education module plus a sample genomics consent form; n = 65) or the control (sample genomics consent form only; n = 69) group. Participants later completed a test on informed genomics consent. Understanding the process of informed consent was greater (P = .001) in the experimental group than in the control group. Specifically, compared with the control group, the experimental group had a greater understanding of 8 of 13 elements of informed consent: intended benefits of research (P = .02), definition of surrogate consenter (P= .001), withdrawal from the study (P = .001), explanation of risk (P = .002), purpose of the institutional review board (P = .001), definition of substituted judgment (P = .03), compensation for harm (P = .001), and alternative treatments (P = .004). Computer-based education modules may be an important addition to conventional approaches for obtaining informed consent in the intensive care unit. Preparing patients' family members who may consider serving as surrogate consenters is critical to facilitating genomics research in critical care. ©2015 American Association of Critical-Care Nurses.

Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review.

PubMed

Schenker, Yael; Fernandez, Alicia; Sudore, Rebecca; Schillinger, Dean

2011-01-01

Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. . To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources. A systematic literature search of English-language articles in MEDLINE (1949-2008) and EMBASE (1974-2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection. Randomized controlled trials and controlled trials with nonrandom allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction. Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis. Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations. Many studies failed to include adequate description of the study population, and outcome measures varied widely. . A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations.

Do surgeons and patients discuss what they document on consent forms?

PubMed

Hall, Daniel E; Hanusa, Barbara H; Fine, Michael J; Arnold, Robert M

2015-07-01

Previous studies of surgeon behavior report that surgeons rarely meet basic standards of informed consent, raising concerns that current practice requires urgent remediation. We wondered if the Veterans Affairs Healthcare System's recent implementation of standardized, procedure-specific consent forms might produce a better practice of informed consent than has been reported previously. Our goal was to determine how the discussions shared between surgeons and patients correspond to the VA's standardized consent forms. We enrolled a prospective cohort of patients presenting for possible cholecystectomy or inguinal herniorrhaphy and the surgical providers for those patients. Audio recordings captured the clinical encounter(s) culminating in a decision to have surgery. Each patient's informed consent was documented using a standardized, computer-generated form. We abstracted and compared the information documented with the information discussed. Of 75 consecutively enrolled patients, 37 eventually decided to have surgery and signed the standardized consent form. Patients and providers discussed 37% (95% confidence interval, 0.07-0.67) and 33% (95% confidence interval, 0.21-0.43) of the information found on the cholecystectomy and herniorrhaphy consent forms, respectively. However, the patient-provider discussions frequently included relevant details nowhere documented on the standardized forms, culminating in discussions that included a median 27.5 information items for cholecystectomy and 20 items for herniorrhaphy. Fully, 80% of cholecystectomy discussions and 76% of herniorrhaphy discussions mentioned at least one risk, benefit or alternative, indication for, and description of the procedure. The patients and providers observed here collaborated in a detailed process of informed consent that challenges the initial reports suggesting the need to remediate surgeon's practice of informed consent. However, because the discrepancy between the information documented and discussed exposes legal and ethical liability, there is an opportunity to improve the iMed system so that it better reflects what surgeons discuss and more frequently includes all the information patients need. Published by Elsevier Inc.

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: A Systematic Review

PubMed Central

Schenker, Yael; Fernandez, Alicia; Sudore, Rebecca; Schillinger, Dean

2017-01-01

Background Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. Purpose To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources A systematic literature search of English-language articles in MEDLINE (1949–2008) and EMBASE (1974–2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection Randomized controlled trials and controlled trials with non-random allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations Many studies failed to include adequate description of the study population, and outcome measures varied widely. Conclusions A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations. PMID:20357225

Doctors' perspectives of informed consent for non-emergency surgical procedures: a qualitative interview study.

PubMed

Wood, Fiona; Martin, Sean Michael; Carson-Stevens, Andrew; Elwyn, Glyn; Precious, Elizabeth; Kinnersley, Paul

2016-06-01

The need to involve patients more in decisions about their care, the ethical imperative and concerns about ligation and complaints has highlighted the issue of informed consent and how it is obtained. In order for a patient to make an informed decision about their treatment, they need appropriate discussion of the risks and benefits of the treatment. To explore doctors' perspectives of gaining informed consent for routine surgical procedures. Qualitative study using semi-structured interviews selected by purposive sampling. Data were analysed thematically. Twenty doctors in two teaching hospitals in the UK. Doctors described that while consent could be taken over a series of consultations, it was common for consent to be taken immediately prior to surgery. Juniors were often taking consent when they were unfamiliar with the procedure. Doctors used a range of communication techniques to inform patients about the procedure and its risks including quantifying risks, personalizing risk, simplification of language and use of drawings. Barriers to effective consent taking were reported to be shortage of time, clinician inexperience and patients' reluctance to be involved. Current consent processes do not appear to be ideal for many doctors. In particular, junior doctors are often not confident taking consent for surgical procedures and require more support to undertake this task. This might include written information for junior staff, observation by senior colleagues when undertaking the task and ward-based communication skills teaching on consent taking. © 2014 John Wiley & Sons Ltd.

Current practices and medico-legal aspects of pre-operative consent.

PubMed

Osime, O C; Okojie, O; Osadolor, F; Mohammed, S

2004-07-01

Written informed consent is a pre requisite for surgical intervention as it provides the forum for the patient to appreciate implications of the procedure and the doctor to explain details and effects of the surgery. To evaluate the practice of obtaining informed consent pre-operatively by surgeons in Benin City and proffer solutions that would enhance its practice. Cross-sectional study involving surgical patients or their relations or gurdian (in cases involving minors and unconscious patients) who were interviewed with structured ended questionnaires. Study was carried out at the University of Benin Teaching Hospital, Benin City, between 5th July and 6th September 2002. One hundred and thirty-three respondents; 53(39.2%) males and 80(60.2%) females were interviewed. Documentations regarding consent were noted in 118(88.7%) cases. Of these, 74.6% felt they had enough time to reflect on the consent obtained while 48(36.1%) respondents were meeting the individual who obtained their consent for the first time. The content of information offered patients prior to obtaining consent was found to be significantly related to the levels of education (X2= 31.44; P<0.001). Over a hundred respondents were not informed of risk of procedure. Nonetheless over 50% of respondents felt satisfied with information supplied. The quality of consent obtained from the average patient fell below expected standard. There is need for greater awareness amongst administrators of consent on the essence of improving quality of information given and mode of obtaining consent from patients.

Securing recruitment and obtaining informed consent in minority ethnic groups in the UK.

PubMed

Lloyd, Cathy E; Johnson, Mark R D; Mughal, Shanaz; Sturt, Jackie A; Collins, Gary S; Roy, Tapash; Bibi, Rukhsana; Barnett, Anthony H

2008-03-30

Previous health research has often explicitly excluded individuals from minority ethnic backgrounds due to perceived cultural and communication difficulties, including studies where there might be language/literacy problems in obtaining informed consent. This study addressed these difficulties by developing audio-recorded methods of obtaining informed consent and recording data. This report outlines 1) our experiences with securing recruitment to a qualitative study investigating alternative methods of data collection, and 2) the development of a standardised process for obtaining informed consent from individuals from minority ethnic backgrounds whose main language does not have an agreed written form. Two researchers from South Asian backgrounds recruited adults with Type 2 diabetes whose main language was spoken and not written, to attend a series of focus groups. A screening tool was used at recruitment in order to assess literacy skills in potential participants. Informed consent was obtained using audio-recordings of the patient information and recording patients' verbal consent. Participants' perceptions of this method of obtaining consent were recorded. Recruitment rates were improved by using telephone compared to face-to-face methods. The screening tool was found to be acceptable by all potential participants. Audio-recorded methods of obtaining informed consent were easy to implement and accepted by all participants. Attrition rates differed according to ethnic group. Snowballing techniques only partly improved participation rates. Audio-recorded methods of obtaining informed consent are an acceptable alternative to written consent in study populations where literacy skills are variable. Further exploration of issues relating to attrition is required, and a range of methods may be necessary in order to maximise response and participation rates.

Consenting options for posthumous organ donation: presumed consent and incentives are not favored

PubMed Central

2012-01-01

Background Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries. Methods We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable) the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive. Results Mean(SD) age was 32(9) year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p < 0.001), donor-only informed consent (5[3,7], p < 0.001), and presumed consent (7[3,10], p < 0.001). The addition of a financial or medical incentive, respectively, reduced ranking of mandated choice to 7[4,9], p < 0.001, and 5[3,8], p < 0.001; for donor-or-surrogate informed consent to 7[5,9], p < 0.001, and 5[3,7], p = 0.004; and for donor-only informed consent to 8[6,10], p < 0.001, and 5[3,7], p = 0.56. Distribution of ranking score of perception of norm and preference were similar except for no-organ donation (11[7,11] vs. 11[6,11], respectively, p = 0.002). Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p < 0.001), more preferred mandated choice with financial incentive option (6[3,8] vs. 8[4,9], p < 0.001), and less preferred mandated choice with medical incentive option (7[4,9] vs. 5[2,7], p < 0.001). There was no association between consenting options ranking scores and age, health status, education level, or knowing an organ donor or recipient. Conclusions We conclude that: 1) most respondents were in favor of posthumous organ donation, 2) mandated choice system was the most preferred and presumed consent system was the least preferred, 3) there was no difference between preference and perception of norm in consenting systems ranking, and 4) financial (especially in females) and medical (especially in males) incentives reduced preference. PMID:23173834

Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

PubMed

Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

2018-02-01

Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

42 CFR 441.257 - Informed consent.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Informed consent. 441.257 Section 441.257 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations § 441.257 Informed consent. (a) Informing...

42 CFR 441.257 - Informed consent.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Informed consent. 441.257 Section 441.257 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations § 441.257 Informed consent. (a) Informing...

42 CFR 441.257 - Informed consent.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Informed consent. 441.257 Section 441.257 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations § 441.257 Informed consent. (a) Informing...

Patients' consent preferences for research uses of information in electronic medical records: interview and survey data

PubMed Central

Willison, Donald J; Keshavjee, Karim; Nair, Kalpana; Goldsmith, Charlie; Holbrook, Anne M

2003-01-01

Objectives To assess patients' preferred method of consent for the use of information from electronic medical records for research. Design Interviews and a structured survey of patients in practices with electronic medical records. Setting Family practices in southern Ontario, Canada. Participants 123 patients: 17 were interviewed and 106 completed a survey. Main outcome measures Patients' opinions and concerns on use of information from their medical records for research and their preferences for method of consent. Results Most interviewees were willing to allow the use of their information for research purposes, although the majority preferred that consent was sought first. The seeking of consent was considered an important element of respect for the individual. Most interviewees made little distinction between identifiable and anonymised data. Research sponsored by private insurance firms generated the greatest concern, and research sponsored by foundation the least. Sponsorship by drug companies evoked negative responses during interview and positive responses in the survey. Conclusions Patients are willing to allow information from their medical records to be used for research, but most prefer to be asked for consent either verbally or in writing. What is already known on this topicLegislation is being introduced worldwide to restrict the circumstances under which personal information may be used for secondary purposes without consentLittle empirical information exists about patients' concerns over privacy and preferences for consent for use of such information for researchWhat this study addsPatients are willing to allow personal information to be used for research purposes but want to be actively consulted firstPatients make little distinction between identifiable and non-identifiable informationMost patients prefer a time limit for their consent PMID:12586673

Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond

PubMed Central

Yoshizawa, Go; Sasongko, Teguh H.; Ho, Chih-Hsing; Kato, Kazuto

2017-01-01

The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia – the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More than simply tools to gain consent from research participants, ICFs function rather as a device of social communication between research communities and civic communities in liaison with intermediary agents like ethics committees, genetic counselors, and public biobanks and databases. PMID:28775738

Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond.

PubMed

Yoshizawa, Go; Sasongko, Teguh H; Ho, Chih-Hsing; Kato, Kazuto

2017-01-01

The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia - the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More than simply tools to gain consent from research participants, ICFs function rather as a device of social communication between research communities and civic communities in liaison with intermediary agents like ethics committees, genetic counselors, and public biobanks and databases.

Enhancing the informed consent process for critical care research: strategies from a thromboprophylaxis trial.

PubMed

Smith, Orla M; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Fleury, Suzie; Krause, Katie; McArdle, Tracey; Skrobik, Yoanna; Cook, Deborah J

2013-12-01

Critically ill patients lack capacity for decisions about research participation. Consent to enrol these patients in studies is typically obtained from substitute decision-makers. To present strategies that may optimise the process of obtaining informed consent from substitute decision-makers for participation of critically ill patients in trials. We use examples from a randomised trial of heparin thromboprophylaxis in the intensive care unit (PROTECT, clinicaltrials.gov NCT00182143). 3764 patients were randomised, with an informed consent rate of 82%; 90% of consents were obtained from substitute decision-makers. North American PROTECT research coordinators attended three meetings to discuss enrolment: (1) Trial start-up (January 2006); (2) Near trial closure (January 2010); and (3) Post-publication (April 2011). Data were derived from slide presentations, field notes from break-out groups and plenary discussions, then analysed inductively. We derived three phases for the informed consent process: (1) Preparation for the Consent Encounter; (2) The Consent Encounter; and (3) Follow-up to the Consent Encounter. Specific strategies emerged for each phase: Phase 1 (four strategies); Phase 2 (six strategies); and Phase 3 (three strategies). We identified 13 strategies that may improve the process of obtaining informed consent from substitute decision-makers and be generalisable to other settings and studies. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

Health information technology and the idea of informed consent.

PubMed

Goldstein, Melissa M

2010-01-01

During this early stage of HIT adoption, it is critical that we engage in discussions regarding informed consent's proper role in a health care environment in which electronic information sharing holds primary importance. This article discusses current implementation of the doctrine within health information exchange networks; the relationship between informed consent and privacy; the variety of ways that the concept is referenced in discussions of information sharing; and challenges that surround incorporation of the doctrine into the evolving HIT environment. The article concludes by reviewing the purpose behind the traditional obligation to obtain informed consent and the possibility of maintaining its relevance in the new environment.

The ethics of research using biobanks: reason to question the importance attributed to informed consent.

PubMed

Hoeyer, Klaus; Olofsson, Bert-Ove; Mjörndal, Tom; Lynöe, Niels

2005-01-10

During the past decade, the use of stored tissue has become an object of increased ethical query. A Swedish biobank and a biotech company have been praised for solving the ethical problems with explicit informed consent procedures, and we decided to investigate donors' perceptions of the system. A questionnaire was sent to a randomized sample of 1200 donors who had donated blood and signed informed consent forms. The response rate was 80.9%. Of the respondents, 64.5% were aware that they had consented to donate a blood sample, 55.4% thought that they had consented to donate phenotypic information, and 31.6% believed that they could withdraw their consent. Among respondents, 3.9% considered informing donors about the research objective as the most important ethical issue in relation to biobanks, and 5.6% were unsatisfied with the information they had been given. There was 85.9% acceptance of surrogate decision making by regional research ethics committees. Considering that the donors in this study were not always aware of their donation but generally were not unsatisfied with the information they had received, and that they did not rate being informed about the research objective as an important issue, informed consent seems to be an inadequate measure of public acceptance of biobank-based research.

Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study.

PubMed

Abay, Serebe; Addissie, Adamu; Davey, Gail; Farsides, Bobbie; Addissie, Thomas

2016-01-01

Informed consent is a key component of bio-medical research involving human participants. However, obtaining informed consent is challenging in low literacy and resource limited settings. Rapid Ethical Assessment (REA) can be used to contextualize and simplify consent information within a given study community. The current study aimed to explore the effects of social, cultural, and religious factors during informed consent process on a proposed HPV-serotype prevalence study. A qualitative community-based REA was conducted in Adigudom and Mynebri Kebeles, Northern Ethiopia, from July to August 2013. Data were collected by a multi-disciplinary team using open ended questions concerning informed consent components in relation to the parent study. The team conducted one-to-one In-Depth Interviews (IDI) and Focus Group Discussions (FGDs) with key informants and community members to collect data based on the themes of the study. Tape recorded data were transcribed in Tigrigna and then translated into English. Data were categorized and thematically analyzed using open coding and content analysis based on pre-defined themes. The REA study revealed a number of socio-cultural issues relevant to the proposed study. Low community awareness about health research, participant rights and cervical cancer were documented. Giving a vaginal sample for testing was considered to be highly embarrassing, whereas giving a blood sample made participants worry that they might be given a result without the possibility of treatment. Verbal consent was preferred to written consent for the proposed study. This rapid ethical assessment disclosed important socio-cultural issues which might act as barriers to informed decision making. The findings were important for contextual modification of the Information Sheet, and to guide the best consent process for the proposed study. Both are likely to have enabled participants to understand the informed consent better and consequently to comply with the study.

How to achieve informed consent for research from Spanish-speaking individuals with low literacy: a qualitative report.

PubMed

Cortés, Dharma E; Drainoni, Mari-Lynn; Henault, Lori E; Paasche-Orlow, Michael K

2010-01-01

Investigators have the responsibility to ensure that prospective participants are fully informed about a research protocol prior to consenting to participate, yet many researchers face challenges when obtaining consent, since the majority of the general population has limited or no familiarity with research studies. These challenges are further magnified when obtaining consent from individuals with low literacy levels and who speak languages other than English. In this article we present findings from a qualitative study conducted with Spanish-speaking individuals with low-literacy designed to refine the Agency for Healthcare Research and Quality's Informed Consent and Authorization Toolkit for Minimal Risk Research. Findings from this study indicate that familiarity with providing informed consent and authorization for research or the experience of being a research participant appear to play key roles in an individual's ability to understand the consent and authorization process. While the text of the consent and authorization documents can be simplified using plain language principles, comprehension of several fundamental ideas such as risk and privacy need to be safeguarded with a consent process that confirms comprehension. Recommendations are provided to address the informational needs of individuals with low literacy levels and limited or no experience with research participation.

Multimedia patient education to assist the informed consent process for knee arthroscopy.

PubMed

Cornoiu, Andrei; Beischer, Andrew D; Donnan, Leo; Graves, Stephen; de Steiger, Richard

2011-03-01

In contemporary clinical practice, the ability for orthopaedic surgeons to obtain true 'informed consent' is becoming increasingly difficult. This problem has been driven by factors including increased expectations of surgical outcome by patients and increasing complexity of surgical procedures. Surgical pamphlets and computer presentations have been advocated as ways of improving patient education, but evidence of their efficacy is limited. The aim of this study was to compare the efficacy of a computer-based multimedia (MM) presentation against standardized verbal consent and information pamphlets for patients considering knee arthroscopy surgery. A randomized, controlled prospective trial was conducted, comparing the efficacy of three methods of providing preoperative informed consent information to patients. Sixty-one patients were randomly allocated into MM, verbal consent or pamphlet groups 3-6 weeks prior to knee arthroscopy surgery. Information recall after the initial consent process was assessed by questionnaire. Retention of this information was again assessed by questionnaire at the time of surgery and 6 weeks after surgery. The MM group demonstrated a significantly greater proportion of correct responses, 98%, in the questionnaire at the time of consent, in comparison with 88% for verbal and 76% for pamphlet groups, with no difference in anxiety levels. Information was also better retained by the MM group up to 6 weeks after surgery. Patient satisfaction with information delivery was higher in the MM group. MM is an effective tool for aiding in the provision and retention of information during the informed consent process. © 2010 The Authors. ANZ Journal of Surgery © 2010 Royal Australasian College of Surgeons.

[Information needs of the health and diseases in users of healthcare services in Primary Care at Salamanca, Spain].

PubMed

Bernad Vallés, Mercedes; Maderuelo Fernández, José Ángel; Moreno González, Pilar

2016-01-01

To learn, interpret and understand the information needs of health and disease in users of the healthcare services of the urban Primary Care of Salamanca. Qualitative research corresponding an exploratory qualitative/structural perspective. Primary Care. Urban area, Salamanca in 2007. Ten discussion groups, 2 composed of members of health-related associations and 8 primary care users, involved a total of 83 people. The structural variables considered are: gender, age, educational level and membership or not associations. Generate information to achieve information saturation in the discussion groups. Upon obtaining their informed consent, all subjects in the study participated in videotaped conversations, which were transcribed verbatim. Four researchers categorized the content, intentionality of discourse and developed the concept map. After categorization, triangulation and coding, content obtained was analysed with the NudistQ6 program. Informative content suggest four information needs: health and prevention, early diagnosis, first aid and disease. Different intentions (information needs, watching, claim and improvement) and needs profiles are detected as structural variables. Major information needs are relate to diagnosis, prognosis and therapeutic options. There is agreement between the groups that the information transmitted to the patient must be intelligible, updated and coordinated among the different professionals and care levels. Participants require information of a clinical nature to exercise their right to autonomy translating tendency to empower users as part of the social change. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia

PubMed Central

Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M

2009-01-01

Abstract Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of – and responsibility for – group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test. PMID:19876544

28 CFR 549.52 - Informed consent.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

28 CFR 549.52 - Informed consent.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

28 CFR 549.52 - Informed consent.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

28 CFR 549.52 - Informed consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

28 CFR 549.52 - Informed consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

Allegations of Failure to Obtain Informed Consent in Spinal Surgery Medical Malpractice Claims.

PubMed

Grauberger, Jennifer; Kerezoudis, Panagiotis; Choudhry, Asad J; Alvi, Mohammed Ali; Nassr, Ahmad; Currier, Bradford; Bydon, Mohamad

2017-06-21

Predictive factors associated with increased risk of medical malpractice litigation have been identified, including severity of injury, physician sex, and error in diagnosis. However, there is a paucity of literature investigating informed consent in spinal surgery malpractice. To investigate the failure to obtain informed consent as an allegation in medical malpractice claims for patients undergoing a spinal procedure. In this retrospective cohort study, a national medicolegal database was searched for malpractice claim cases related to spinal surgery for all years available (ie, January 1, 1980, through December 31, 2015). Failure to obtain informed consent and associated medical malpractice case verdict. A total of 233 patients (117 [50.4%] male and 116 [49.8%] female; 80 with no informed consent allegation and 153 who cited lack of informed consent) who underwent spinal surgery and filed a malpractice claim were studied (mean [SD] age, 47.1 [13.1] years in the total group, 45.8 [12.9] years in the control group, and 47.9 [13.3] years in the informed consent group). Median interval between year of surgery and year of verdict was 5.4 years (interquartile range, 4-7 years). The most common informed consent allegations were failure to explain risks and adverse effects of surgery (52 [30.4%]) and failure to explain alternative treatment options (17 [9.9%]). In bivariate analysis, patients in the control group were more likely to require additional surgery (45 [56.3%] vs 53 [34.6%], P = .002) and have more permanent injuries compared with the informed consent group (46 [57.5%] vs 63 [42.0%], P = .03). On multivariable regression analysis, permanent injuries were more often associated with indemnity payment after a plaintiff verdict (odds ratio [OR], 3.12; 95% CI, 1.46-6.65; P = .003) or a settlement (OR, 6.26; 95% CI, 1.06-36.70; P = .04). Informed consent allegations were significantly associated with less severe (temporary or emotional) injury (OR, 0.52; 95% CI, 0.28-0.97; P = .04). In addition, allegations of informed consent were found to be predictive of a defense verdict vs a plaintiff ruling (OR, 0.41; 95% CI, 0.17-0.98; P = .046) or settlement (OR, 0.01; 95% CI, 0.001-0.15; P < .001). Lack of informed consent is an important cause of medical malpractice litigation. Although associated with a lower rate of indemnity payments, malpractice lawsuits, including informed consent allegations, still present a time, money, and reputation toll for physicians. The findings of this study can therefore help to improve preoperative discussions to protect spinal surgeons from malpractice claims and ensure that patients are better informed.

The therapeutic misconception and our models of competency and informed consent.

PubMed

Lidz, Charles W

2006-01-01

The doctrine of informed consent rests on empirical claims. This is true particularly of what commentators have characterized as the "strong" model of informed consent. This model assumes that if adequate information is given to a competent individual, understanding will result and, permitted to make a voluntary decision, the individual will make a rational decision. However, the "therapeutic misconception" posits that individuals may confuse the goals of research with those of treatment and may make decisions that do not rest on adequate understanding. This article reviews research suggesting that this may in fact be true, and concludes that, as a result, traditional notions of informed consent may not yield results consistent with the assumptions on which the doctrine of informed consent rests. Copyright (c) 2006 John Wiley & Sons, Ltd.

[Ethics committees bear a responsibility for patient information. Informed consent implies that the patient understands what he has consented to].

PubMed

Werkö, Lars

2002-03-19

A cornerstone in health care is the duty to inform patients not only of their right to partake in decisions about their care but also of the various options for treatment. This applies particularly in clinical research, for which the Helsinki Declaration has defined patients' rights. Informed consent is of great importance both in routine care and in clinical research. Directives defining informed consent in relation to clinical trials have been issued by The EU Commission. The Department of Health and Social Security in England has also published several documents governing patient consent. Even if information is given to the patient it is not always comprehended. In one study of cancer treatment about one third of the patients had misunderstood the information in certain respects.

Balancing the quality of consent.

PubMed Central

Hansson, M O

1998-01-01

The rule that one must obtain informed consent is well established in medical ethics and an intrinsic part of clinical practice and of research in biomedicine. However, there is a tendency that the rule today is being applied too rigidly and with too little sensitivity to the values that are at stake in connection with different kinds of research protocols. It is here argued that the quality of consent needs to be balanced against variables such as degree of confidentiality and importance of values at stake, in order to be ethically acceptable. Appropriate information and consent procedures should be adjusted accordingly. Three levels are suggested, ranging from extensively informed consent with both written and oral information, through informed refusal with only a limited amount of information given to, at the other end of the scale, just making relevant information available. PMID:9650113

Survey of risks and benefits communication strategies by research nurses.

PubMed

Nusbaum, Lika; Douglas, Brenda; Estrella-Luna, Neenah; Paasche-Orlow, Michael; Damus, Karla

2017-01-01

An ethical, informed consent process requires that potential participants understand the study, their rights, and the risks and benefits. Yet, despite strategies to improve communication, many participants still lack understanding of potential risks and benefits. Investigating attitudes and practices of research nurses can identify ways to improve the informed consent process. What are the attitudes, practices, and preparedness of nurses involved in the informed consent process regarding communication of risks and benefits? A survey was developed and administered online to a national purposive sample of 107 research nurses with experience obtaining informed consent for clinical trials. Survey responses stratified by selected work-related characteristics were analyzed. Ethical considerations: Participants were instructed they need not answer each question and could stop at any time. They consented by clicking "accept" on the email which linked to the survey. The study was approved by the Northeastern University Institutional Review Board, Boston, Massachusetts (NU-IRB Protocol #: 13-06-17). Most research nurses (87%) used a teach-back method to assess participant comprehension, while 72% relied on their intuition. About one-third did not feel prepared to communicate related statistics. About 20% did not feel prepared to tailor information, and half did not feel competent using supplemental materials to enhance risks and benefits comprehension. Only 70% had received training in the informed consent process which included in-person training (84%), case studies (69%), online courses (57%), feedback during practice sessions (54%), and simulation, such as role playing (49%) and viewing videos (45%). Perceived preparedness was significantly associated with greater informed consent experience and training. Research nurses may have inadequate training to encourage, support, and reinforce communication of risks and benefits during the informed consent process. Relevant purposeful education and training should help to improve and standardize the ethical informed consent process.

75 FR 7278 - Agency Information Collection Activities; Proposed Collection; Comment Request; Exception From...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-18

... the general requirements for informed consent to permit the use of investigational in vitro diagnostic... general requirements for informed consent, to permit the use of investigational in vitro diagnostic... exception to the general rule that informed consent is required for the use of an investigational in vitro...

Sociotechnical Analysis of Health Information Exchange Consent Processes in an HIV Clinic.

PubMed

Ramos, S Raquel; Gordon, Peter; Bakken, Suzanne; Schnall, Rebecca

Federal regulations have encouraged the electronic sharing of protected health information (PHI). As an opt-in state, New York abides by an affirmative consent model where PHI is electronically shared only after written consent is obtained. The purpose of our study was to describe sociotechnical factors that influence health information exchange (HIE) consent for persons living with HIV (PLWH) at one clinic in New York City. We employed mixed methods to gather perceptions of facilitators and barriers to HIE consent. Study participants included PLWH, staff, and clinicians. The mixed-methods approach revealed multiple interruptions in clinical workflow, staff and providers' time constraints, and lack of dedicated personnel focused on HIE consent as the major barriers to HIE consent. Although there is no one strategy to resolve barriers to HIE consent, having a dedicated person was identified as the most salient factor for facilitating HIE consent. Copyright © 2016 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.

Improving Informed Consent with Minority Participants: Results from Researcher and Community Surveys

PubMed Central

Quinn, Sandra Crouse; Garza, Mary A.; Butler, James; Fryer, Craig S.; Casper, Erica T.; Thomas, Stephen B.; Barnard, David; Kim, Kevin H.

2013-01-01

Strengthening the informed consent process is one avenue for improving recruitment of minorities into research. This study examines that process from two different perspectives, that of researchers and that of African American and Latino community members. Through the use of two separate surveys, we compared strategies used by researchers with the preferences and attitudes of community members during the informed consent process. Our data suggest that researchers can improve the informed consent process by incorporating methods preferred by the community members along with methods shown in the literature for increasing comprehension. With this approach, the informed consent process may increase both participants’ comprehension of the material and overall satisfaction, fostering greater trust in research and openness to future research opportunities. PMID:23324203

Alternatives to project-specific consent for access to personal information for health research: Insights from a public dialogue

PubMed Central

Willison, Donald J; Swinton, Marilyn; Schwartz, Lisa; Abelson, Julia; Charles, Cathy; Northrup, David; Cheng, Ji; Thabane, Lehana

2008-01-01

Background The role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues. Methods We conducted seven day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly. Results Broad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research. Conclusion Because no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than clinical care. This could be done, for example, through a web-based patient portal to their electronic health record. Researchers and policy makers should continue to engage the public to promote greater public understanding of the research process and to look for feasible alternatives to existing approaches to project-specific consent for observational research. PMID:19019239

Development of a tiered and binned genetic counseling model for informed consent in the era of multiplex testing for cancer susceptibility.

PubMed

Bradbury, Angela R; Patrick-Miller, Linda; Long, Jessica; Powers, Jacquelyn; Stopfer, Jill; Forman, Andrea; Rybak, Christina; Mattie, Kristin; Brandt, Amanda; Chambers, Rachelle; Chung, Wendy K; Churpek, Jane; Daly, Mary B; Digiovanni, Laura; Farengo-Clark, Dana; Fetzer, Dominique; Ganschow, Pamela; Grana, Generosa; Gulden, Cassandra; Hall, Michael; Kohler, Lynne; Maxwell, Kara; Merrill, Shana; Montgomery, Susan; Mueller, Rebecca; Nielsen, Sarah; Olopade, Olufunmilayo; Rainey, Kimberly; Seelaus, Christina; Nathanson, Katherine L; Domchek, Susan M

2015-06-01

Multiplex genetic testing, including both moderate- and high-penetrance genes for cancer susceptibility, is associated with greater uncertainty than traditional testing, presenting challenges to informed consent and genetic counseling. We sought to develop a new model for informed consent and genetic counseling for four ongoing studies. Drawing from professional guidelines, literature, conceptual frameworks, and clinical experience, a multidisciplinary group developed a tiered-binned genetic counseling approach proposed to facilitate informed consent and improve outcomes of cancer susceptibility multiplex testing. In this model, tier 1 "indispensable" information is presented to all patients. More specific tier 2 information is provided to support variable informational needs among diverse patient populations. Clinically relevant information is "binned" into groups to minimize information overload, support informed decision making, and facilitate adaptive responses to testing. Seven essential elements of informed consent are provided to address the unique limitations, risks, and uncertainties of multiplex testing. A tiered-binned model for informed consent and genetic counseling has the potential to address the challenges of multiplex testing for cancer susceptibility and to support informed decision making and adaptive responses to testing. Future prospective studies including patient-reported outcomes are needed to inform how to best incorporate multiplex testing for cancer susceptibility into clinical practice.Genet Med 17 6, 485-492.

A Randomized Controlled Trial of an Electronic Informed Consent Process

PubMed Central

Rothwell, Erin; Wong, Bob; Rose, Nancy C.; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A.; Botkin, Jeffrey R.

2018-01-01

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. PMID:25747685

Informed Consent to Research in Long-Term Care Settings

PubMed Central

Jablonski, Rita A.; Bourbonniere, Meg; Kolanowski, Ann

2010-01-01

Informed consent to nursing home research is a two-tiered process that begins with obtaining the consent of a long-term care community at the institutional level and progresses to the engagement of individuals in the consent process. Drawing on a review of the literature and the authors’ research experiences and institutional review board service, this paper describes the practical implications of nurse investigators’ obligation to ensure informed consent among participants in long-term care research. Recommendations focus on applying a community consent model to long-term care research, promoting an evidence-based approach to the protection of residents with decisional impairment, and increasing investigators’ attention to ethical issues involving long-term care staff. PMID:20078005

User-Centered Design, Experience, and Usability of an Electronic Consent User Interface to Facilitate Informed Decision-Making in an HIV Clinic.

PubMed

Ramos, S Raquel

2017-11-01

Health information exchange is the electronic accessibility and transferability of patient medical records across various healthcare settings and providers. In some states, patients have to formally give consent to allow their medical records to be electronically shared. The purpose of this study was to apply a novel user-centered, multistep, multiframework approach to design and test an electronic consent user interface, so patients with HIV can make more informed decisions about electronically sharing their health information. This study consisted of two steps. Step 1 was a cross-sectional, descriptive, qualitative study that used user-centric design interviews to create the user interface. This informed Step 2. Step 2 consisted of a one group posttest to examine perceptions of usefulness, ease of use, preference, and comprehension of a health information exchange electronic consent user interface. More than half of the study population had college experience, but challenges remained with overall comprehension regarding consent. The user interface was not independently successful, suggesting that in addition to an electronic consent user interface, human interaction may also be necessary to address the complexities associated with consenting to electronically share health information. Comprehension is key factor in the ability to make informed decisions.

Achieving new levels of recall in consent to research by combining remedial and motivational techniques.

PubMed

Festinger, David S; Dugosh, Karen L; Marlowe, Douglas B; Clements, Nicolle T

2014-04-01

Research supports the efficacy of both a remedial consent procedure (corrected feedback (CF)) and a motivational consent procedure (incentives) for improving recall of informed consent to research. Although these strategies were statistically superior to standard consent, effects were modest and not clinically significant. This study examines a combined incentivised consent and CF procedure that simplifies the cognitive task and increases motivation to learn consent information. We randomly assigned 104 individuals consenting to an unrelated host study to a consent as usual (CAU) condition (n=52) or an incentivised CF (ICF) condition (n=52). All participants were told they would be quizzed on their consent recall following their baseline assessment and at 4 monthly follow-ups. ICF participants were also informed that they would earn $5 for each correct answer and receive CF as needed. Quiz scores in the two conditions did not differ at the first administration (p=0.39, d=0.2); however, ICF scores were significantly higher at each subsequent administration (second: p=0.003, Cohen's d=0.6; third: p<0.0001, d=1.4; fourth: p<0.0001, d=1.6; fifth: p<0.0001, d=1.8). The ICF procedure increased consent recall from 72% to 83%, compared with the CAU condition in which recall decreased from 69% to 59%. This supports the statistical and clinical utility of a combined remedial and motivational consent procedure for enhancing recall of study information and human research protections.

Enhancing clinician provision of informed consent and counseling: some pedagogical strategies.

PubMed

Wear, S

1999-02-01

Although long touted as an ethical and legal requirement, some clinicians still seem to offer less than fully adequate informed consent processes; similarly the counseling of patients and families, particularly about post-intervention scenarios, is often perfunctory at best. Keyed to a narrative of a patient's experience with surgery for a deviated septum, this article reflects on why such less than adequate clinician behaviors tend to occur and what might be done about them. Certain legal misconceptions about informed consent are highlighted in this reflection, as well as why certain clinicians seem to take such a narrow view of their responsibilities to patients. Further reference in this regard is also made to a recently constructed module on informed consent for medical residents. In it, though legal requirements for informed consent are reviewed, the basic perspective taken regards informed consent as a clinical intervention that pursues certain basic goods and values, only one of which lies in determining when legal closure for such processes has occurred.

Considerations for use of dental photography and electronic media in dental education and clinical practice.

PubMed

Stieber, Jane C; Nelson, Travis; Huebner, Colleen E

2015-04-01

Photography and electronic media are indispensable tools for dental education and clinical practice. Although previous research has focused on privacy issues and general strategies to protect patient privacy when sharing clinical photographs for educational purposes, there are no published recommendations for developing a functional, privacy-compliant institutional framework for the capture, storage, transfer, and use of clinical photographs and other electronic media. The aims of this study were to research patient rights relating to electronic media and propose a framework for the use of patient media in education and clinical care. After a review of the relevant literature and consultation with the University of Washington's director of privacy and compliance and assistant attorney general, the researchers developed a privacy-compliant framework to ensure appropriate capture, storage, transfer, and use of clinical photography and electronic media. A four-part framework was created to guide the use of patient media that reflects considerations of patient autonomy and privacy, informed consent, capture and storage of media, and its transfer, use, and display. The best practices proposed for capture, storage, transfer, and use of clinical photographs and electronic media adhere to the health care code of ethics (based on patient autonomy, nonmaleficence, beneficence, justice, and veracity), which is most effectively upheld by a practical framework designed to protect patients and limit institutional liability. Educators have the opportunity and duty to convey these principles to students who will become the next generation of dentists, researchers, and educators.

Circumcision Is Unethical and Unlawful.

PubMed

Svoboda, J Steven; Adler, Peter W; Van Howe, Robert S

2016-06-01

The foreskin is a complex structure that protects and moisturizes the head of the penis, and, being the most densely innervated and sensitive portion of the penis, is essential to providing the complete sexual response. Circumcision-the removal of this structure-is non-therapeutic, painful, irreversible surgery that also risks serious physical injury, psychological sequelae, and death. Men rarely volunteer for it, and increasingly circumcised men are expressing their resentment about it.Circumcision is usually performed for religious, cultural and personal reasons. Early claims about its medical benefits have been proven false. The American Academy of Pediatrics and the Centers for Disease Prevention and Control have made many scientifically untenable claims promoting circumcision that run counter to the consensus of Western medical organizations.Circumcision violates the cardinal principles of medical ethics, to respect autonomy (self-determination), to do good, to do no harm, and to be just. Without a clear medical indication, circumcision must be deferred until the child can provide his own fully informed consent.In 2012, a German court held that circumcision constitutes criminal assault. Under existing United States law and international human rights declarations as well, circumcision already violates boys› absolute rights to equal protection, bodily integrity, autonomy, and freedom to choose their own religion. A physician has a legal duty to protect children from unnecessary interventions. Physicians who obtain parental permission through spurious claims or omissions, or rely on the American Academy of Pediatrics' position, also risk liability for misleading parents about circumcision. © 2016 American Society of Law, Medicine & Ethics.

Choice is not the issue. The misrepresentation of healthcare in bioethical discourse

PubMed Central

Førde, Reidun; Wifstad, Åge

2010-01-01

The principle of respect for autonomy has shaped much of the bioethics' discourse over the last 50 years, and is now most commonly used in the meaning of respecting autonomous choice. This is probably related to the influential concept of informed consent, which originated in research ethics and was soon also applied to the field of clinical medicine. But while available choices in medical research are well defined, this is rarely the case in healthcare. Consideration of ordinary medical practice reveals that the focus on patient choice does not properly grasp the moral aspects involved in healthcare. Medical decisions are often portrayed as if doctors and patients in confidence confront specific decisions about examinations or treatment, yet the reality often involves many different participants, with decisions being made over time and space. Indeed, most of the decisions are never even presented to patients, as it would be unethical to suggest something that is not medically justifiable. The options patients do confront are somewhat arbitrarily constructed within the narrow framework of both what is deemed to be medically appropriate and how the healthcare system is organised practically. While the autonomy discourse has proven valuable, a failure to distinguish between the fields of medical research and clinical medicine has generated a focus on patient choice that does not reflect what is really at stake in healthcare settings. This is alarming, because the current discourse misrepresents medical practice in a way that actually contributes to bioethical self-delusion. PMID:21131609

Sexuality in institutionalized elderly persons: a systematic review of argument-based ethics literature.

PubMed

Mahieu, Lieslot; Gastmans, Chris

2012-03-01

Admission to a nursing home might challenge the way in which individuals experience their own sexuality, but it does not automatically diminish their need and desire for sexual fulfillment. Despite the fact that sexuality proves to be an intrinsic part of human existence, the sexual expression of geriatric residents remains a sensitive subject for many caregivers and family members. It evokes a variety of ethical issues and concerns, especially when dementia patients are involved. The overall objective of this review was to examine the ethical arguments and concepts about the debate on sexuality within a nursing home environment. We conducted a systematic search for argument-based ethics literature focusing on sexuality in institutionalized elderly people. Twenty-five appropriate studies were identified. A thematic analysis of the included literature led us to distinguish two major groups of ethical arguments: (i) principles and (ii) care. Ethics arguments on sexuality in institutionalized elderly are particularly guided by the principle of respect for autonomy and the concomitant notion of informed consent. Arguments related to care were also apparent within the research literature although they received considerably less attention than the arguments related to the principles of respect for autonomy, beneficence, nonmaleficence and justice. The lack of clarity in the conceptualization of the arguments referred to in the research literature indicates that there is a pressing need for a better defined, more fundamental philosophical-ethical analysis of the values at stake.

10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

Code of Federal Regulations, 2013 CFR

2013-01-01

... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a DOE...

10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

Code of Federal Regulations, 2012 CFR

2012-01-01

... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a DOE...

10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

Code of Federal Regulations, 2014 CFR

2014-01-01

... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a DOE...

10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

Code of Federal Regulations, 2011 CFR

2011-01-01

... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a DOE...

10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

Code of Federal Regulations, 2010 CFR

2010-01-01

... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a DOE...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2012 CFR

2012-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

34 CFR 303.401 - Definitions of consent, native language, and personally identifiable information.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 34 Education 2 2011-07-01 2010-07-01 true Definitions of consent, native language, and personally... Definitions of consent, native language, and personally identifiable information. As used in this subpart— (a... which consent is sought, in the parent's native language or other mode of communication; (2) The parent...

[The origin of informed consent].

PubMed

Mallardi, V

2005-10-01

The principle of informed consent, aimed at the lawfulness of health assistance, tends to reflect the concept of autonomy and of decisional autodetermination of the person requiring and requesting medical and/or surgical interventions. This legal formula, over the last few years, has gained not only considerable space but also importance in the doctrinal elaboration and approaches, as well as juridical interpretations, thereby influencing the everyday activities of the medical profession. Informed consent is still the object of continuous explorations, not only asfar as concerns the already confirmed theoretical profile but, instead, the ambiguous practical and consequential aspect. Analysing how the concept and role of consensus was born and developed with the more adequate and reasonable excursions to make it valid and obtain it, it is impossible not to take into consideration, on the one hand, the very ancient philosophical origins and, on the other, the fact that it was conditioned by religion with the moral aspects and the accelerated deontological evolution with pathways parallel to the needs and the progress offered by new forms of treatment and novel biotechnological applications. The principle of consent is a relatively new condition. In fact, already in the times of not only the Egyptian civilisation, but also the Greek and Roman, documents have been found which show how the doctor's intervention had, in some way, first to be approved by the patient. Plato (law IV) had already foreseen the problems, the procedures and the modes of information which are, in synthesis, at the root of the principles of the present formula of informed consent and correlated the practice of the information and consensus with the quality and social position of the patient. The only guarantee that the patient might have, derived from a fundamental principle of medicine of all times: "in disease, focus on two aims, to improve and not to cause damage". A figure can be recognised, in the Hippocratic physician, that cared about the patient's suffering, but never neglected looking after his own outcome, endeavouring to avoid becoming involved in lack of success and death of a patient. The concept of consensus is inexistent, albeit, there is an awareness of the presence of precautious and preventive information. In the behaviour of doctors, in ancient times, it is not difficult to recognize the true motives and the real reasons that, already in those days, give rise to the necessary "defensive medicine" particularly as far as concerns the social status of the patient. Already from the early origins, continuing the Hippocratic tradition, the relationship between doctor and patient was consolidated, based upon two very definite criteria, represented, on the one hand, by the professional duty of the physician to do what is bestfor the patient and, on the other, the duty of the patient to completely accept the physician's decisions and intervention. The Hippocratic physician respected a principle of professional responsibility which was more religious and of a moral type, but, from a legal point of view, very weak inasmuch as it depended upon regulations elaborated by human beings. The conviction and certainty that the physician acted, in the interest of his patient's well-being, has been passed down over the centuries endowing the physician with moral authority and a kind of legal impunity, conditions which corresponded, in an almost reflection-likefashion, with the duty of obedience and subjection, on the part of the patient. Christianity was grafted into this consolidated vision of the sacral character of medicine and medical practice, which did not substantially change the Hippocratic type of ethical behaviour. Non only the population but also the Christian physician was aware of the religious importance of his intense activity as a mission and compared to a special kind of priesthood in safe-guarding health, considered as a gift of God. Therefore, invested with this authority which derived from his professional role and from his very work, he felt it his duty to guide the patient, deciding and for him. The patient is an ignorant person who does not have the knowledge, the intellectual capacity or moral authority to oppose or disagree with the wishes and decisions of the physician who, instead, on account of his doctrine, knows exactly what is goodfor him. In this regard, if we were to speak of consensus concerning the physician's intervention, he would be considered useless in as much as obvious and understood when seeking help. The attitude of the patient towards the physician has always tended to one of strong faith and characterized by psychological subjection borne out by traditions thousands of years old. A patient who was sick, again, as an attitude of respect and gratitude, followed the treatment but never asked for any explanations regarding the therapeutic effects and the physician refrained from taking any initiative to inform the patient or his/her family. Each phenomenon, therefore, has a precise origin, a well-defined history and when its importance tends to significantly condition the activities concerning Man, a desire emerges to learn the origin and the history. As is well known, a trial commenced in Nuremberg, on December 19, 1946, of Nazi doctors and a code was defined in which the judges, all Americans, clearly emphasized a view of medical research and technology: science should never transform or consider human beings as an instrument to be employed for scientific purposes. In actual fact, documents exist providing evidence that a few decades before the drawing up of the Nuremberg Code, the need had been expressed, in Germany itself to somehow make medical interventions and actions legal by means of the use and practice of consensus. The moral and ethical principles in those documents, even if not available as bibliographic references in the English literature, certainly merit, from a historical viewpoint to be considered as conceptual elements and doctrinal and socio-cultural products, even if at that time, of little practical importance, which belong to the European culture and, in particular, and almost paradoxically, in the light of what happened, to the German culture. The United States of America is held to be the country of origin of informed consent, the initial aim of which was make sure that the correct dignity of the patient's independence be reserved at the time of decision making and choice of medical options. Reports on this topic, in fact, first appeared in the USA, at the beginning of the 18th Century, with problems focusing on and limited to only the simple rights of the patient in giving his/her approval of the health intervention later to be conceptually developed, along the lines of an itinerary with, at intervals, famous legal actions, until in the 20th Century, informed consent was reached, a criterion that, as is well known, foresees and includes not only the important and fundamental autonomy of the patient to decide, which stems ones personal rights, but also the essential objective element, which is, information. The expression informed consent has simply been transposed in Italian and roughly translated in an ambiguous fashion into "consenso informato" when, on the contrary, it should be referred to as "informazione per il consenso" "information for consensus" not only to respect the concept but, surely, for a more correct deciphering and a more precise interpretation related to the numerous concepts it presupposes and implies. Information and consent may be compared to the two sides of the same coin. These are the two important pillars that coincide and are joined giving weight to the medical responsibility, as far as concerns consent to the health intervention: on the one hand, having obtained consent,following correct and sincere information interpreted and deciphered as an important phase and an essential indicator of correct, scrupulous medico-professional procedure and, on the other, the consensus itself conceived as a duty aiming at the maximum respect of the rights to autodetermination, independence and autonomy of the patient, as a person. At the beginning of the Nineties, as we have seen, we were made aware of a series of legal actions regarding medical responsibility which was greatly conditioned by the Anglosaxon influence which initially induced many Italian magistrates and forensic physicians to adopt an extremely rigid attitude with no attempt to comply, in any way, with the culture and traditions of our country and our tradition which has always been inspired by good common sense, both medical and human. The American experience has been very rapidly adopted, by some, without a profound, complete and necessary historical and evolutional analysis aimed at those intertwined principles that have been motifs that have gradually led to the legal references in those emblematic cases referred to, the conclusions of which continue to attract a great deal of attention. In Italy, the legal and doctrinal evolution of informed consent, even if following a little more rapidly the traces, steps, problems and interpretations of the various aspects drawn up, characterized and applied in the United States, has not only occurred at a later time, but, despite reaching the same meaningful objectives, the same considerations, the same importance, and, unfortunately, the same inconveniences, has had quite different aims, approaches and articulations. In this respect, it is enough to focus attention on the different cultural traditions and religious routes, on the different doctrinal background, the particular historical origins and the individual legal aspects, all extremely different one from the other. (ABSTRACT TRUNCATED)

What does respect for the patient's autonomy require?

PubMed

Cheng, Kam-Yuen

2013-11-01

Personal autonomy presupposes the notion of rationality. What is not so clear is whether, and how, a compromise of rationality to various degrees will diminish a person's autonomy. In bioethical literature, three major types of threat to the rationality of a patient's medical decision are identified: insufficient information, irrational beliefs/desires, and influence of different framing effects. To overcome the first problem, it is suggested that patients be provided with information about their diseases and treatment choices according to the objective standard. I shall explain how this should be finessed. Regarding the negative impact of irrational beliefs/desires, some philosophers have argued that holding irrational beliefs can still be an expression of autonomy. I reject this argument because the degree of autonomy of a decision depends on the degree of rationality of the beliefs or desires on which the decision is based. Hence, to promote patient autonomy, we need to eliminate irrational beliefs by the provision of evidence and good arguments. Finally, I argue that the way to smooth out the framing effects is to present the same information in different perspectives: it is too often assumed that medical information can always be given in a complete and unadorned manner. This article concludes with a cautionary note that the protection of patient autonomy requires much more time and effort than the current practice usually allows. © 2012 John Wiley & Sons Ltd.

Right to refuse treatment in Turkey: a diagnosis and a slightly less than modest proposal for reform.

PubMed

Irmak, Nurbay

2016-07-01

This paper examines the current state of right to refuse medical treatment in Turkey. Even though there are only a few studies carried out with Turkish physicians on their attitude towards the right to refuse treatment, I argue that recent studies on physicians' views on informed consent and honest disclosure show that Turkish physicians do not tend to recognise their patients' right to decline treatment. This is because the refusal of treatment crucially requires that patients be properly informed and asked for their consent before the treatment. Turkish physicians and healthcare providers' tendency to ignore the right to decline medical treatment cannot be separated from their paternalistic approach to patients and their rights. I argue that part of the problem is the legal framework, which, in essence, is still paternalistic. More specifically, the frequent appearance of the phrase 'medical necessity' in the relevant legislation is conveniently used to justify medical intervention against a patient's will. I conclude the paper by proposing reforms in the legal documents defining and regulating patient rights, including the Constitution of the Turkish Republic, and I will argue that these reforms will help enhance patient rights in Turkey. Turkey has been discussing a new Constitution for the past several years, so my proposal should best be understood as contributing to public discussion of the new Constitution by initiating debate about medical paternalism and patient autonomy in Turkish medicine. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Use of a modified informed consent process among vulnerable patients: a descriptive study.

PubMed

Sudore, Rebecca L; Landefeld, C Seth; Williams, Brie A; Barnes, Deborah E; Lindquist, Karla; Schillinger, Dean

2006-08-01

Little is known about patient characteristics associated with comprehension of consent information, and whether modifications to the consent process can promote understanding. To describe a modified research consent process, and determine whether literacy and demographic characteristics are associated with understanding consent information. Descriptive study of a modified consent process: consent form (written at a sixth-grade level) read to participants, combined with 7 comprehension questions and targeted education, repeated until comprehension achieved (teach-to-goal). Two hundred and four ethnically diverse subjects, aged > or = 50, consenting for a trial to improve the forms used for advance directives. Number of passes through the consent process required to achieve complete comprehension. Literacy assessed in English and Spanish with the Short Form Test of Functional Health Literacy in Adults (scores 0 to 36). Participants had a mean age of 61 years and 40% had limited literacy (s-TOHFLA<23). Only 28% of subjects answered all comprehension questions correctly on the first pass. After adjustment, lower literacy (P=.04) and being black (P=.03) were associated with requiring more passes through the consent process. Not speaking English as a primary language was associated with requiring more passes through the consent process in bivariate analyses (P<.01), but not in multivariable analyses (P>.05). After the second pass, most subjects (80%) answered all questions correctly. With a teach-to-goal strategy, 98% of participants who engaged in the consent process achieved complete comprehension. Lower literacy and minority status are important determinants of understanding consent information. Using a modified consent process, little additional education was required to achieve complete comprehension, regardless of literacy or language barriers.

Efficacy of a separate informed consent for anesthesia services: A prospective study from the Caribbean.

PubMed

Rampersad, Kavi; Chen, Deryk; Hariharan, Seetharaman

2016-01-01

This study aimed to determine whether a separate written consent form improved the efficacy of the informed consent process for anesthesia in adult patients undergoing elective surgery at a tertiary care teaching hospital. We randomized patients into two groups prospectively. The first group (Group A) signed the hospital's standard Consent for Operation form only while the second group (Group B) signed a separate Consent for Anesthesia form additionally. Patients were interviewed postoperatively with an eight-item questionnaire with responses in a 5-point Likert scale. A composite adequacy of consent index was generated from the responses and analyzed. Two hundred patients (100 in each group) were studied. All patients indicated that the anesthesiologist(s) had their permission to proceed with their anesthesia care. The mean adequacy of consent index score in Group B was higher than that of Group A (30.6 ± 4.6 [standard deviation (SD)] vs. 27.9 ± 5.2 [SD]) (P < 0.001). The separate written consent had a positive impact on the patients' understanding of the nature and purpose of the intended anesthesia procedures (P = 0.04), satisfaction with the adequacy of information provided about common side effects (P < 0.001) and rare but serious complications (P = 0.008). A separate written consent for anesthesia improved the efficacy of the informed consent process with respect to better information about the nature and purpose of anesthesia, common side effects, and rare but serious complications.

[Schizophrenia and informed consent to research].

PubMed

Fovet, T; Amad, A; Thomas, P; Jardri, R

2015-10-01

Informed consent to research remains a complex issue, while sometimes staying difficult to obtain, even in the general population. This problem may be maximized with patients suffering from schizophrenia. This paper summarizes available data in the literature about informed consent for research involving patients suffering from schizophrenia. Medline and Google Scholar searches were conducted using the following MESH terms: schizophrenia, informed consent and research. Studies using dedicated standardized scales (e.g. MacCAT-CR) revealed a decrease in the capacity to consent of patients with schizophrenia when compared with healthy individuals. Keeping in mind that schizophrenia is an heterogeneous disorder, patients with the lowest insight as well as those with the most severe cognitive symptoms appeared more impaired in their capacity to consent. Such a poor capacity to understand and consent to trials was shown linked with alterations in decision-making. For these specific patients, interventions may be set up to increase their capacity to consent. Various strategies were proposed: enhanced consent forms, extended discussion, test/feedback method or multimedia interventions. Among them, interventions relying on communication and the growing field of information technologies (e.g. web-based tools) seem promising. Finally, associations grouping families and patients (like the French Association UNAFAM) may facilitate the involvement of patients in research programs with safer conditions. Patients suffering from schizophrenia appear able to consent to research programs when suitable interventions are proposed. Further studies are now needed to optimize and individualize such interventions. Copyright © 2014 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

32 CFR 219.117 - Documentation of informed consent.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 2 2014-07-01 2014-07-01 false Documentation of informed consent. 219.117 Section 219.117 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.117 Documentation of informed consent. (a...

[End of life non-therapeutic intensive care for organ preservation and donation: legal and ethical issues].

PubMed

Baumann, Antoine; Ducrocq, Xavier; Audibert, Gérard; Coudane, Henry; Mertes, Paul-Michel; Claudot, Frédérique

2012-10-01

Stroke is presently the first cause of brain death in France. In this context, the question of elective non-therapeutic ventilation and resuscitation arises, aiming at enabling the patients for whom a decision to stop all the therapeutics has been made to evolve towards brain death and organ donation. In 2010, the French society of intensive care has released guidelines regarding stroke management including strategy on this topic. The question has also been referred to the Ethics Committee of Nancy university hospital by a chief-nurse of our hospital and we report here its conclusions and propositions. A workgroup was appointed and has tackled the major issues: the justification, the risks for the patient and the society, the expression of the patient's consent, the legality of this care benefiting only a third party, and the practical details. Elective intensive care following decision to stop any treatment after severe stroke seems to be justified with regard to public health as well as individual or collective ethics, providing the patient has expressed his/her consent or his/her non-opposition before stroke occurrence. In France there is no legal frame regulating this practice, no information of the general public, and a public debate has yet to be initiated. Regarding the practical details, a priori agreement of the organ procurement organisation, patient's consent, and approval of the consultant required by the law of April 22, 2005 relating to Patients' rights and to the end of life to rule out any conflict of interest, have to be checked before referring the patient to ICU. Advance directives drafting must be developed and their scope extended to organ donation and elective resuscitation. Therefore, fair information of the general public and clarity and transparency of the procedures are needed. The prolongation of the French moratorium on Maastricht III type non-heart beating organ donation - grounded on fears of possible conflicts on interest - seems obsolete with regard to the increasing respect of the patient's autonomy and to the risk of harmfulness entailed by elective resuscitation before death. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

A History of Ethics and Law in the Intensive Care Unit

PubMed Central

Luce, John M.; White, Douglas B.

2009-01-01

Synopsis Because they provide potential benefit at great personal and public cost, the intensive care unit (ICU) and the interventions rendered therein have become symbols of both the promise and the limitations of medical technology. At the same time, the ICU has served as an arena in which many of the ethical and legal dilemmas created by that technology have been defined and debated. In this essay, we outline major events in the history of ethics and law in the ICU. We cover 10 areas: 1) the evolution of ICUs, 2) ethical principles, 3) informed consent and the law, 4) medical decision-making, 5) cardiopulmonary resuscitation, 6) withholding and withdrawing life-sustaining therapy, 7) legal cases involving life support, 8) advance directives, 9) prognostication, and 10) futility and the allocation of medical resources. We emphasize that advancement of the ethical principle of respect for patient autonomy in ICUs increasingly is conflicting with physicians’ concern about their own prerogatives and with the just distribution of medical resources. PMID:19268804

EFFECTIVE COMMUNICATION AS AN IMPORTANT SKILL FOR QUALITY CARE IN ELDERLY PATIENTS.

PubMed

Rubinstein, Dorit

2014-10-01

The increase in the number of older people in the world emphasizes the need to reevaluate and change health care policy and care services priorities. The provision of health care for this growing population has consequently become an important worldwide concern. The purpose of this article is to highlight the challenges stemming from the growing number of elderly people and their need for care. Collaborative and coordinated health care services for elderly people should be focused on the ethical issues deriving from the interpersonal relationships between the professional caregiver and the older person. Any discussion on ethics and aging should be focused on the roles of autonomy, informed consent, respect, advance directive, end of life decisions and privacy. In addition, such a discussion should stress the important role of effective communication and its effect on the older person's adherence with the recommended treatment. The desired consequence should be the empowerment of positive and successful experiences attained by the recipients of the health care services.

Modified mandated choice for organ procurement

PubMed Central

Chouhan, P; Draper, H

2003-01-01

Presumed consent to organ donation looks increasingly unlikely to be a palatable option for increasing organ procurement in the UK following the publication of the report into events at Alder Hey and elsewhere. Yet, given that the alternative to increasing the number of cadaveric organs available is either to accept a greater number of live donations, or accept that people will continue to die for the want of an organ, public policy makers remain obliged to consider other means of increasing the procurement rate. In this paper, we meet the main objections to mandated choice (namely that it undermines autonomy and that mandated donation is preferable). We have modified the traditional approach to mandated choice to take into account the force of the objection that mandated donation is preferable, by accepting that people can and do make bad decisions about organ donation and proposing that all accompanying public education and information about cadaveric donation should be directed in favour of donation. PMID:12796435

Social media and organ donation: Ethically navigating the next frontier.

PubMed

Henderson, M L; Clayville, K A; Fisher, J S; Kuntz, K K; Mysel, H; Purnell, T S; Schaffer, R L; Sherman, L A; Willock, E P; Gordon, E J

2017-11-01

As the organ shortage continues to grow, the creation of social media communities by transplant hospitals and the public is rapidly expanding to increase the number of living donors. Social media communities are arranged in myriad ways and without standardization, raising concerns about transplant candidates' and potential donors' autonomy and quality of care. Social media communities magnify and modify extant ethical issues in deceased and living donation related to privacy, confidentiality, professionalism, and informed consent, and increase the potential for undue influence and coercion for potential donors and transplant candidates. Currently, no national ethical guidelines have been developed in the United States regarding the use of social media to foster organ transplantation. We provide an ethical framework to guide transplant stakeholders in using social media for public and patient communication about transplantation and living donation, and offer recommendations for transplant clinical practice and future research. © 2017 The American Society of Transplantation and the American Society of Transplant Surgeons.

Autonomy Support as an Interpersonal Motivating Style: Is It Teachable?

PubMed

Reeve

1998-07-01

Students benefit when teachers support their autonomy. Recognizing this, the present study examined the motivating styles of beginning preservice teachers by asking two questions: (1) Do personality characteristics orient preservice teachers toward either an autonomy-supportive or controlling motivating style? and (2) Is the autonomy-supportive style teachable to preservice teachers? Study 1, which addressed the first question, relied on self-determination theory to identify and confirm causality orientation as one personality characteristic related to motivating style. Study 2, which addressed the second question, randomly assigned preservice teachers to receive training in either autonomy-supportive, controlling, or neutral instructional strategies. Results showed that the autonomy-supportive style was teachable. Autonomy-oriented preservice teachers (as measured by causality orientation) assimilated the information rather easily, while control-oriented preservice teachers accommodated the information only in proportion to the extent that they perceived it to be highly plausible and classroom applicable. The discussion relies on self-determination theory and the conceptual change literature to recommend how teacher certification programs can assist teachers-in-training develop an autonomy-supportive motivating style. Copyright 1998 Academic Press.

Obtaining consent to oral and maxillofacial surgery.

PubMed

Poswillo, D

1989-09-01

The question of whether or not a patient has consented to treatment has recently become significant to all who practise oral and maxillofacial surgery. It is often linked to professional negligence when the outcome differs from the patient's perception or expectation of the operation. Consent may be oral or written, applies to referred patients and all those with physical and mental handicap and religious restrictions. Examples of procedure in discussing consent assist the surgeon to inform without creating fear. Knowledge of the benefits of informed consent and current legal opinion assist the oral and maxillofacial surgeon to avoid the pitfalls of failure to inform.

Customising informed consent procedures for people with schizophrenia in India.

PubMed

Chatterjee, Sudipto; Kieselbach, Berit; Naik, Smita; Kumar, Shuba; John, Sujit; Balaji, Madhumitha; Koschorke, Mirja; Dabholkar, Hamid; Varghese, Mathew; Patel, Vikram; Thornicroft, Graham; Thara, Rangaswamy

2015-10-01

There is little information on how the ethical and procedural challenges involved in the informed participation of people with schizophrenia in clinical trials are addressed in low- and middle-income countries (LMICs). The informed consent procedure used in the collaborative community care for people with schizophrenia in India (COPSI) RCT was developed keeping these challenges in mind. We describe the feasibility of conducting the procedure from the trial, researcher and participants perspectives and describe the reasons for people consenting to participate in the trial or refusing to do so. Three sources of information were used to describe the feasibility of the COPSI consent procedure: key process indicators for the trial perspective, data from a specially designed post-interview form for participant's observations and focus group discussion (FGD) with the research interviewers. Categorical data were analysed by calculating frequencies and proportions, while the qualitative data from the FGD, and the reasons for participation or refusal were analysed using a thematic content analysis approach. 434 people with schizophrenia and their primary caregiver(s) were approached for participation in the trial. Consent interviews were conducted with 332, of whom 303 (91%) agreed to participate in the trial. Expectation of improvement was the most common reason for agreeing to participate in the trial, while concerns related to the potential disclosure of the illness, especially for women, were an important reason for refusing consent. The COPSI consent procedure demonstrates preliminary, observational information about the feasibility of customising informed consent procedures for people with schizophrenia LMIC contexts. This and other similar innovations need to be refined and rigorously tested to develop evidence-based guidelines for informed consent procedures in such settings.

Assessing informed consent in an opioid relapse prevention study with adults under current or recent criminal justice supervision.

PubMed

Allen, Ashleigh A; Chen, Donna T; Bonnie, Richard J; Ko, Tomohiro M; Suratt, Colleen E; Lee, Joshua D; Friedmann, Peter D; Gordon, Michael; McDonald, Ryan; Murphy, Sean M; Boney, Tamara Y; Nunes, Edward V; O'Brien, Charles P

2017-10-01

Concerns persist that individuals with substance use disorders who are under community criminal justice supervision experience circumstances that might compromise their provision of valid, informed consent for research participation. These concerns include the possibilities that desire to obtain access to treatment might lead individuals to ignore important information about research participation, including information about risks, or that cognitive impairment associated with substance use might interfere with attending to important information. We report results from a consent quiz (CQ) administered in a multisite randomized clinical trial of long-acting naltrexone to prevent relapse to opioid use disorder among adults under community criminal justice supervision-a treatment option difficult to access by this population of individuals. Participants were required to answer all 11 items correctly before randomization. On average, participants answered 9.8 items correctly (89%) at baseline first attempt (n=306). At week 21 (n=212), participants scored 87% (9.5 items correct) without review. Performance was equivalent to, or better than, published results from other populations on a basic consent quiz instrument across multiple content domains. The consent quiz is an efficient method to screen for adequate knowledge of consent information as part of the informed consent process. Clinical researchers who are concerned about these issues should consider using a consent quiz with corrected feedback to enhance the informed consent process. Overall, while primarily useful as an educational tool, employing a CQ as part of the gateway to participation in research may be particularly important as the field continues to advance and tests novel experimental treatments with significant risks and uncertain potential for benefit. Copyright © 2017. Published by Elsevier Inc.

Towards a standardized informed consent procedure for live donor nephrectomy: What do surgeons tell their donors?

PubMed

Kortram, Kirsten; Ijzermans, Jan N M; Dor, Frank J M F

2016-08-01

Living kidney donors comprise a unique group of "patients", undergoing an operation for the benefit of others. The informed consent process is therefore valued differently. Although this is a team effort, the surgeon is responsible for performing the donor nephrectomy, and often the one held accountable, should adverse events occur. Although there is some consensus on how the informed consent procedure should be arranged, practices vary. The aim of this study was to evaluate the surgical informed consent procedure for live donor nephrectomy, with special regards to disclosure of complications. A web-based survey was sent to all kidney transplant surgeons (n = 50) in eight transplant centers with questions regarding the local procedure and disclosure of specific details. Response rate was 98% (n = 49), of which 32 (65%) were involved in living donor education; overall, transplant- (50%), vascular- (31%), and abdominal surgeons (13%), and urologists (6%) performed donor nephrectomies in the eight centers. Informed consent procedures varied, ranging from assumed to signed consent. Bleeding was the only complication every surgeon mentioned. Risk of death was always mentioned by 16 surgeons (50%), sometimes by 13 (41%), three surgeons (9%) never disclosed this disastrous complication. Reported mortality rates ranged from 0.003% to 0.1%. Mentioning frequencies for all other complications varied. Important complications are not always disclosed during the surgical informed consent process for live donor nephrectomy. Informed consent procedures vary. To optimally prepare living kidney donors for the procedure, a standardized informed consent procedure for live donor nephrectomy is highly recommended. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.