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Sample records for adequate informed consent

  1. Elements for adequate informed consent in the surgical context.

    PubMed

    Abaunza, Hernando; Romero, Klaus

    2014-07-01

    Given a history of atrocities and violations of ethical principles, several documents and regulations have been issued by a wide variety of organizations. They aim at ensuring that health care and clinical research adhere to defined ethical principles. A fundamental component was devised to ensure that the individual has been provided the necessary information to make an informed decision regarding health care or participation in clinical research. This article summarizes the history and regulations for informed consent and discusses suggested components for adequate consent forms for daily clinical practice in surgery as well as clinical research.

  2. The informed consent in Southern Italy does not adequately inform parents about infant vaccination

    PubMed Central

    2014-01-01

    Background Vaccination centres in the Campania Region, southern Italy, vaccinate children with a hexavalent vaccine that contains the mandatory vaccines diphtheria, tetanus, poliomyelitis, and viral Hepatitis B. This vaccine also includes two non-mandatory vaccines, pertussis and Haemophilus influenzae type B. Information about these optional vaccines should be communicated to the parents, and informed consent should be obtained from parents before vaccination. We explored whether informed consent was delivered to the parents, whether they signed the consent form, and whether they read and acquired the information about the vaccination that their child would receive. Methods Childhood immunisations are provided at specific public health vaccination centres, "Unità Operative Materno-infantili’s" (UOMIs). We selected four UOMI from the Campania Region where we interviewed 1039 parents bringing their children for the 1st, 2nd, or 3rd doses of hexavalent vaccine. The consent forms were collected from the four vaccination centres and were analysed with respect to clarity and completeness. Results Most of the respondents (89.5%) were mothers between 20 and 39 years of age (80.4% vs 59.6% of the fathers), they were married (87.2% vs 93.5% of the fathers), and only one-half of them were employed (50.2% vs 92.6% of the fathers). The informed consent form was received from 58.1% of the parents and signed by 52.8%, but read by 35.0% of them. Only 1.5% of parents knew which vaccines were mandatory, and 25.0% of them believed that the entire hexavalent vaccine was mandatory. When we asked the parents which non-mandatory vaccinations were administered to their children, only 0.5% indicated the Haemophilus influenzae type B and none indicated the pertussis vaccine. Thirty-six per cent of the parents replied that their child had not received any non-mandatory vaccines. No parents were informed by the operators that their children would receive non-mandatory vaccines

  3. [Informed consent].

    PubMed

    Medina Castellano, Carmen Delia

    2009-10-01

    At present times, numerous complaints claiming defects produced at some point in the process of obtaining informed consent are filed in courts of justice; in these complaints there is an underlying comment element which is the roles that health professionals have in these processes. In obtaining this consent, one can see this more as a means to obtain judicial protection for professional practices rather than this process being a respectful exercise for the dignity and freedom which health service patients have. This article reflects on two basic rights related to informed consent: adequately obtaining this consent and the need to protect those people who lack, either partially or totally, the capacity to make this decision by themselves. Afterwards, the author makes some considerations about the necessity to obtain informed consent for nursing practices and treatment.

  4. Informed Consent

    MedlinePlus

    ... ask during informed consent? Can I change my mind after I’ve signed the consent? What if I don’t want the treatment that’s being offered? How is informed consent for a clinical trial or research study different from consent for standard treatment? How is ...

  5. Informed consent.

    PubMed

    Sacchini, D; Pennacchini, M

    2010-01-01

    Informed consent (IC) in clinical experimentation is a process by which a subject voluntarily and freely confirms his/her willingness to participate in a trial, after having been informed of all involved aspects. IC is a concept enough recent within medical tradition. Unquestionably, Nuremberg trials (1945-1947) influenced thought about consent in Medicine. When the idea of IC evolved, discussion for appropriate guidelines moved increasingly from a narrow focus on the physician's/researcher's obligation. IC shall be obtained in writing and documented before a subject is enrolled into clinical investigation. , Particularly in the case of medical devices, it is necessary an adequate information to the patient on possible incidents occurring following placing of devices.

  6. Informed consent.

    PubMed

    Steevenson, Grania

    2006-08-01

    Disclosure of information prior to consent is a very complex area of medical ethics. On the surface it would seem to be quite clear cut, but on closer inspection the scope for 'grey areas' is vast. In practice, however, it could be argued that the number of cases that result in complaint or litigation is comparatively small. However, this does not mean that wrong decisions or unethical scenarios do not occur. It would seem that in clinical practice these ethical grey areas concerning patients' full knowledge of their condition or treatment are quite common. One of the barometers for how much disclosure should be given prior to consent could be the feedback obtained from the patients. Are they asking relevant questions pertinent to their condition and do they show a good understanding of the options available? This should be seen as a positive trait and should be welcomed by the healthcare professionals. Ultimately it gives patients greater autonomy and the healthcare professional can expand and build on the patient's knowledge as well as allay fears perhaps based on wrongly held information. Greater communication with the patient would help the healthcare professional pitch their explanations at the right level. Every case and scenario is different and unique and deserves to be treated as such. Studies have shown that most patients can understand their medical condition and treatment provided communication has been thorough (Gillon 1996). It is in the patients' best interests to feel comfortable with the level of disclosure offered to them. It can only foster greater trust and respect between them and the healthcare profession which has to be mutually beneficial to both parties.

  7. Informed consent - adults

    MedlinePlus

    ... state) What Should Occur During the Informed Consent Process? When asking for your informed consent, your doctor ... What is Your Role in the Informed Consent Process? You are an important member of your health ...

  8. Informed consent in gerontology.

    PubMed

    Glock, Rosana Soibelmann; Goldim, Jose Roberto

    2003-01-01

    The aim of this study was to assess the use and adequacy of informed consent in research involving the elderly in Brazil. Using a reading index, we observed that in 83% of informed consent forms, the text was considered difficult, and demanded a higher schooling level than that presented by the subjects. Whereas 100% of the investigators considered the text in informed consent forms accessible, 75% of the subjects considered it hard to understand. This difference was statistically significant. 94% percent of the elderly participating in research protocols made the decision to participate in the study before reading the term of consent. More attention should be given both to the writing of informed consent forms and to the entire informed consent process, which in gerontology research, should be reviewed at each encounter with study participants.

  9. 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

  10. Informed consent and research

    PubMed Central

    Mandal, Jharna; Parija, Subhash Chandra

    2014-01-01

    Informed consent is the central doctrine to any research based on the principles of autonomy and self-determination. For it to be genuine and effective, it should be in simple regional language catering to the cultural and psychological and social requisites of the participant. The information entailed in the consent form must be true, should cover all the relevant aspects, and no fact should be hidden however seemingly important or unimportant. Every research volunteer puts his or her health and life at risk for the sake of science, and this must be respected at all times during the research. PMID:25250226

  11. Informed consent in clinical research.

    PubMed

    Pick, Andrew; Berry, Shelley; Gilbert, Kayleigh; McCaul, James

    Since increasing numbers of patients are asked to take part in clinical trials, nurses need to be aware of the principles of valid, informed consent. This article explores consent, which aims to protect the rights, safety and wellbeing of patients. In particular, the history of consent in research and the elements involved in obtaining informed consent from potential participants in research studies are discussed.

  12. Informed Consent for Braces

    PubMed Central

    Trehan, Mridula; Rathore, Nidhi; Rathee, Pooja; Agarwal, Deepesh; Mathur, Nikunj

    2014-01-01

    ABSTRACT The influence of law on the orthodontic profession has greatly increased in the last few decades. Dental law has emerged today as a full-fedged specialty dealing with a variety of areas, like professional negligence, doctor-patient contracts, consumer protection laws, ethics, general and special health legislations and practice regulatory mechanisms. This article highlights the concept of informed consent which is based on the premise that each individual has a right to make decisions concerning his health, disease and treatment. How to cite this article: Jharwal V, Trehan M, Rathore N, Rathee P, Agarwal D, Mathur N. Informed Consent for Braces. Int J Clin Pediatr Dent 2014;7(2):105-108. PMID:25356009

  13. Informed Consent for Reconstructive Pelvic Surgery.

    PubMed

    Alam, Pakeeza; Iglesia, Cheryl B

    2016-03-01

    Informed consent is the process in which a patient makes a decision about a surgical procedure or medical intervention after adequate information is relayed by the physician and understood by the patient. This process is critical for reconstructive pelvic surgeries, particularly with the advent of vaginal mesh procedures. In this article, we review the principles of informed consent, the pros and cons of different approaches in reconstructive pelvic surgery, the current legal issues surrounding mesh use for vaginal surgery, and tips on how to incorporate this information when consenting patients for pelvic floor surgery.

  14. Some limits of informed consent.

    PubMed

    O'Neill, O

    2003-02-01

    Many accounts of informed consent in medical ethics claim that it is valuable because it supports individual autonomy. Unfortunately there are many distinct conceptions of individual autonomy, and their ethical importance varies. A better reason for taking informed consent seriously is that it provides assurance that patients and others are neither deceived nor coerced. Present debates about the relative importance of generic and specific consent (particularly in the use of human tissues for research and in secondary studies) do not address this issue squarely. Consent is a propositional attitude, so intransitive: complete, wholly specific consent is an illusion. Since the point of consent procedures is to limit deception and coercion, they should be designed to give patients and others control over the amount of information they receive and opportunity to rescind consent already given.

  15. [Informed consent in emergency medicine].

    PubMed

    Ersoy, Nermin; Ozcan Senses, Müesser; Aydin Er, Rahime

    2010-01-01

    Informed consent is a prerequisite for the ethical and legal validity of the emergency intervention in emergency medicine, since it protects the fiduciary relationship between the physician and patient; the principle of honesty that grounds this relationship; the principle of autonomy that necessitates right of self-determination; and the principle of respect for persons. Informed consent in emergency medicine, which is supposed to include the nature, benefits and risks of emergency medical intervention, differentiates with respect to definite groups of patients: (1) conscious patients, (2) unconscious patients, and (3) children and mature minors. In addition, informed consent differentiates between medical, psychological and even social circumstances of the patients, referred to as valid consent, expressed-explicit consent, blanket consent, presumed consent, tacit consent, proxy consent, and parental consent. There are a few exceptions in which emergency medical intervention is administered without informed consent. In addition to the exceptions of life-saving interventions, when a patient can not decide for herself/himself, intervention of the physician in the best interest of the patient or children is based on the "therapeutic privilege" of the physician. As an ethically defensible right, since therapeutic privilege may open a door to hard paternalistic approaches, in those situations, emergency physicians should be cautious not to violate a patient's autonomy.

  16. Informed consent in rheumatology care practice.

    PubMed

    Marques Filho, José

    2011-01-01

    Informed consent is a mandatory document in human subject research protocols. Its principles have been recently established in the history of Medicine, and the first official document to establish the need for an informed consent from the research subject was the Nuremberg Code (1947). All following documents confirmed that the informed consent is mandatory in human subject research. However, the informed consent, which represents patients' autonomy or self-determination regarding their relationship with their physicians, took a while to be included in medical care practice and medical deontology codes. The convenience of using the informed consent in medical practice is widely discussed today, especially in rheumatology. Our opinion is that the obligation of a signed informed consent provided by the patient for every medical procedure is neither reasonable nor practical. It should be used for more invasive or risky therapeutic procedures. We understand that the informed consent does not guarantee that the patient has been fully informed, which is an essential condition for the current rheumatological practice. Its adoption in routine medical care practice would make medical intervention bureaucratic, and, thus, quite different from the Hippocratic view, which considered the trustful physician-patient relationship fundamental for an adequate medical care practice.

  17. Informed consent in medical research.

    PubMed

    Evans, John Grimley; Beck, Peter

    2002-01-01

    That people should only be enrolled in medical research if they have given free and informed consent is now an unquestioned principle of research ethics. It is however a recent innovation. Prior to the prominence given to consent to participation in research in the condemnation of German doctors arraigned at Nuremberg in 1945, informed consent had appeared in American litigation, but only as an issue in clinical malpractice suits. Informed consent as an ethical requirement in medical research had arisen in some earlier European contexts. Despite the Nuremberg judgement, informed consent by participants in research was not widely recognised as ethically mandatory until the early 1970s. This delay seems to have been due in part to scepticism about the practicability of truly informed consent, but medical paternalism and the circumstances surrounding military research during the Cold War period may have contributed.

  18. Do informed consent documents matter?

    PubMed

    Resnik, David B

    2009-03-01

    This commentary argues that, despite extensive critiques of informed consent documents, there are several ethical and legal reasons for investigators and IRB members to take these documents seriously.

  19. Human Subjects and Informed Consent.

    ERIC Educational Resources Information Center

    Smith, Arthur A.

    1988-01-01

    The doctrine of informed consent has been enumerated to protect the rights of human subjects involved in biomedical research. The elements of informed consent are summarized along with the changes of emphasis that have evolved. The issue of liability and means for minimizing its impact are discussed. (Author/MLW)

  20. Informed consent for clinical photography.

    PubMed

    Johns, Martin K

    2002-06-01

    The question of (informed) consent to medical photography has long been a vexed one. This paper briefly considers key landmarks in the debate, and examines in detail the evolution of the Addenbrooke's NHS Trust policy Photography and Video Recordings of Patients: Confidentiality and Consent, Copyright and Storage. The impact of the 1998 Data Protection Act, the Department of Health's Model Policy on Consent, and the implications of wider access to digital photography are discussed together with their integration into the Addenbrooke's policy.

  1. Proposing modesty for informed consent.

    PubMed

    Burgess, Michael M

    2007-12-01

    The extension of informed consent into social science research has met with considerable opposition. The history and concept of informed consent, however, is based on a substantive ethical notion of the research relationship as informed and voluntary that is appropriate for social science research relationships. Yet social science research might sometimes be different from health research in ways that justify a different approach to informed consent and research relationships. Social science research tends to have a lower magnitude of risk, usually does not need to disrupt the therapeutic assumption common in health research contexts or when researchers are health professionals, and recruitment is sometimes incremental and reflects a building of trust and development of the research participant's role. These differences may sometimes justify novel approaches to the research relationship and require case-by-case evaluation to determine their relevance to establishing the informed and voluntary nature of the relationship through the use of informed consent procedures. Ultimately, respect for research participants requires social research into practices that can support or replace informed consent. The institutional role of informed consent and the goal of informed and voluntary research participation serve modest but important roles in health and social research. Their proper role in health and social research requires flexibility and experimentation, but does not justify abdication of informed consent or the notion of informed and voluntary participation.

  2. Informed Consent: Reality or Illusion?

    ERIC Educational Resources Information Center

    Janik, Carol J.; And Others

    The goal of this study was to produce an improved medical consent form. This form was designed to record the informed consent discussion between doctor and patient which should include an explanation of what procedure will be performed, by whom, why, the risks, and the alternatives. Patients, doctors, and hospitals may all benefit from the use of…

  3. [Informed consent in valvular diseases].

    PubMed

    Ito, Toshiaki

    2014-09-01

    Informed consent has two aspects. First, we must give patients sufficient, precise information on the nature of their disease, natural history, possible choices of treatment, and risks of the treatment to help them make their own decisions. The estimated risks should be based on a database, not on personal impressions or limited experience. In choosing the type of prosthetic valve in young or middle-aged patients, unbiased information based on guidelines should be presented. The second aspect of informed consent is its role as a contract for providing medical service. Estimated in-hospital mortality and major morbidities should be clarified in percentages on the consent form as confirmation of understanding.

  4. Informed consent: information or knowledge?

    PubMed

    Berger, Ken

    2003-01-01

    A fiduciary relationship should be nurtured between patient and physician. This requires effective communication throughout all aspects of care - especially pertaining to treatment decisions. In the context of illness as experienced by the patient a unique set of circumstances is presented. However, communication in an illness context is fraught with problems. The patient is vulnerable and the situation may be overwhelming. Voluminous amounts of information are available to patients from a host of health care providers, family members, support groups, advocacy centers, books, journals, and the internet. Often conflicting and confusion, frequently complex, this information may be of greater burden than benefit. Some information is of high validity and reliability while other information is of dubious reliability. The emotional freight of bad news may further inhibit understanding. An overload of information may pose an obstacle in decision-making. To facilitate the transformation of information into knowledge, the health care provider must act on some occasions as a filter, on other occasions as a conduit, and on still other occasions simply as a reservoir. The evolution of patient rights to receive or refuse treatment, the right to know or not to know calls for a change in processing of overwhelming information in our modem era. In this paper we will discuss the difference between information and knowledge. How can health care providers ensure they have given their patients all necessary and sufficient information to make an autonomous decision? How can they facilitate the transformation of information into knowledge? The effect of knowledge to consent allows a more focused, relevant and modern approach to choice in health care.

  5. Clinical research before informed consent.

    PubMed

    Miller, Franklin G

    2014-06-01

    Clinical research with patient-subjects was routinely conducted without informed consent for research participation prior to 1966. The aim of this article is to illuminate the moral climate of clinical research at this time, with particular attention to placebo-controlled trials in which patient-subjects often were not informed that they were participating in research or that they might receive a placebo intervention rather than standard medical treatment or an experimental treatment for their condition. An especially valuable window into the thinking of clinical investigators about their relationship with patient-subjects in the era before informed consent is afforded by reflection on two articles published by psychiatric researchers in 1966 and 1967, at the point of transition between clinical research conducted under the guise of medical care and clinical research based on consent following an invitation to participate and disclosure of material information about the study. Historical inquiry relating to the practice of clinical research without informed consent helps to put into perspective the moral progress associated with soliciting consent following disclosure of pertinent information; it also helps to shed light on an important issue in contemporary research ethics: the conditions under which it is ethical to conduct clinical research without informed consent.

  6. [Parental Information and Consent in Neonatology].

    PubMed

    Ehlen, M; Budde, A

    2015-06-01

    Careful analysis of current adjudication reveals increasing demand of adequate record-keeping as well as meticulously documented informed consent forms regarding all aspects of medicine. Although standardized informed consent forms or explicit guidelines for obtaining procedural consent already exist in surgical disciplines there is strong evidence that, however, in neonatology (and paediatric intensive care) these processes are still incomplete and qualitatively insufficiently implemented. Therefore the author discussed all existing information prescriptions with the legal department and quality management of a large German clinic group especially in terms of relevant legislation, recent case law and specialist literature in order to obtain potential for improvement. Based on the results of this audit of expert opinions improved recommendations could be implemented in the daily practise of a department of neonatology and paediatric intensive care on a tertiary level.

  7. [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

  8. Informed consent and moral integrity.

    PubMed Central

    Gillett, G R

    1989-01-01

    Informed consent is required for any medical procedure although the situations in which it is given are beset by uncertainties and indeterminacies. These make medicolegal scrutiny of such situations very difficult. Although some people find the decision in the Sidaway case incomprehensible because of its continuing regard for a 'professional practice standard' in informed consent, I will argue that an important fact in many cases is the moral integrity of the doctor concerned and the pattern of his practice. This may provide the only morally principled and legally accessible evidence enabling a correct decision to be made in a difficult case. Although the epistemological significance of a professional practice standard is thereby defended the 'prudent patient standard' for what counts as consent is left intact. PMID:2795625

  9. Informed consent in the nuclear medicine setting.

    PubMed

    Rosenthal, M Sara

    2011-03-01

    In the nuclear medicine setting, the task of obtaining informed consent for procedures that require it is frequently left to the nuclear medicine technologist. Unfortunately, a patient's signature on a consent form does not mean the patient has given informed consent, or what legal scholars call valid consent. On completion of this scholarly bioethics article, the reader will understand the troubled history that led to informed consent as social and regulatory policy. Additionally, the reader will discover the meaning of "informed consent," which includes 3 critical components: disclosure, decision-making capacity, and voluntariness. Finally, this article will discuss which nuclear medicine procedures require informed consent, how to assess whether patients have given informed consent, what to do when the patient refuses a procedure, and what to do when informed consent is unachievable.

  10. Ensuring Subjects' Understanding of Informed Consent.

    ERIC Educational Resources Information Center

    Smith, Deborah L.; And Others

    1995-01-01

    A discussion of informed consent by human subjects in experimentation presents background on the consent issue, including federal requirements; lists factors that may affect a subject's ability to understand the consent document; and offers suggestions for preparing consent forms to ensure the subject's better comprehension. (Author/MSE)

  11. On Taylor's justification of medical informed consent.

    PubMed

    Varelius, Jukka

    2012-05-01

    In contemporary Western biomedical ethics, informed consent practices are commonly justified in terms of the intrinsic value of patient autonomy. James Stacey Taylor maintains that this conception of the moral grounding of medical informed consent is mistaken. On the basis of his reasoning to that effect, Taylor argues that medical informed consent is justified by the instrumental value of personal autonomy. In this article, I examine whether Taylor's justification of medical informed consent is plausible.

  12. Identity change and informed consent.

    PubMed

    Witt, Karsten

    2017-03-20

    In this paper, I focus on a kind of medical intervention that is at the same time fascinating and disturbing: identity-changing interventions. My guiding question is how such interventions can be ethically justified within the bounds of contemporary bioethical mainstream that places great weight on the patient's informed consent. The answer that is standardly given today is that patients should be informed about the identity effects, thus suggesting that changes in identity can be treated like 'normal' side effects. In the paper, I argue that this approach is seriously lacking because it misses important complexities going along with decisions involving identity changes and consequently runs into mistakes. As a remedy I propose a new approach, the 'perspective-sensitive account', which avoids these mistakes and thus provides the conceptual resources to systematically reflect on and give a valid consent to identity-changing interventions.

  13. Informed Consent for AAA Repair: The Patient’s Perspective

    PubMed Central

    Berman, Loren; Curry, Leslie; Gusberg, Richard; Dardik, Alan; Fraenkel, Liana

    2009-01-01

    BACKGROUND Although information about risks, benefits and alternatives to intervention is central to ensuring adequate informed consent, patients are often not well-informed about potential adverse outcomes when they are considering whether to have surgery. Whether or not to undergo surgery for abdominal aortic aneurysm (AAA), and whether to have open or endovascular repair (EVAR), is a complex decision that relies heavily on patient preferences, and yet little is known about the patient perspective on informed consent in this context. Understanding patients’ views on their decision-making processes and the quality of surgeon-patient communication could inform improvements in informed consent for AAA repair. METHODS We conducted in-depth interviews with AAA patients (n=20) who underwent open AAA repair, endovascular repair, or declined surgery. Data were independently transcribed and analyzed by a team of individuals with diverse backgrounds, using the constant comparative method of analysis and systematic coding procedures. RESULTS We identified four central themes characterizing patients’ experiences with informed consent for AAA repair: 1) some patients perceived that there was no choice regarding whether or not to have surgery; 2) some patients did not feel adequately informed prior to making a decision; 3) patients differed in the scope and content of information they desired during informed consent; and 4) trust in the surgeon had an impact on the informed consent process. CONCLUSION Our research highlights the limitations of the informed consent encounter in the current clinical context, and points to several ways in which informed consent could be improved. Adapting the informed consent encounter to incorporate the patient’s perspective is critical in order to ensure that the decision regarding AAA repair is consistent with the patient’s informed preference. PMID:18572357

  14. Interactive Informed Consent: Randomized Comparison with Paper Consents

    PubMed Central

    Rowbotham, Michael C.; Astin, John; Greene, Kaitlin; Cummings, Steven R.

    2013-01-01

    Informed consent is the cornerstone of human research subject protection. Many subjects sign consent documents without understanding the study purpose, procedures, risks, benefits, and their rights. Proof of comprehension is not required and rarely obtained. Understanding might improve by using an interactive system with multiple options for hearing, viewing and reading about the study and the consent form at the subject’s own pace with testing and immediate feedback. This prospective randomized study compared the IRB-approved paper ICF for an actual clinical research study with an interactive presentation of the same study and its associated consent form using an iPad device in two populations: clinical research professionals, and patients drawn from a variety of outpatient practice settings. Of the 90 participants, 69 completed the online test and survey questions the day after the session (maximum 36 hours post-session). Among research professionals (n = 14), there was a trend (p  = .07) in the direction of iPad subjects testing better on the online test (mean correct  =  77%) compared with paper subjects (mean correct  =  57%). Among patients (n = 55), iPad subjects had significantly higher test scores than standard paper consent subjects (mean correct  =  75% vs 58%, p < .001). For all subjects, the total time spent reviewing the paper consent was 13.2 minutes, significantly less than the average of 22.7 minutes total on the three components to be reviewed using the iPad (introductory video, consent form, interactive quiz). Overall satisfaction and overall enjoyment slightly favored the interactive iPad presentation. This study demonstrates that combining an introductory video, standard consent language, and an interactive quiz on a tablet-based system improves comprehension of research study procedures and risks. PMID:23484041

  15. Are Good Intentions Good Enough?: Informed Consent Without Trained Interpreters

    PubMed Central

    de Voogd, Katherine B.

    2007-01-01

    Objective To examine the informed consent process when trained language interpreters are unavailable. Background Ensuring sufficient patient understanding for informed consent is especially challenging for patients with Limited English Proficiency (LEP). While US law requires provision of competent translation for LEP patients, such services are commonly unavailable. Design and Participants Qualitative data was collected in 8 prenatal genetics clinics in Texas, including interviews and observations with 16 clinicians, and 30 Latina patients. Using content analysis techniques, we examined whether the basic criteria for informed consent (voluntariness, discussion of alternatives, adequate information, and competence) were evident for each of these patients, contrasting LEP patients with patients not needing an interpreter. We present case examples of difficulties related to each of these criteria, and compare informed consent scores for consultations requiring interpretation and those which did not. Results We describe multiple communication problems related to the use of untrained interpreters, or reliance on clinicians’ own limited Spanish. These LEP patients appear to be consistently disadvantaged in each of the criteria we examined, and informed consent scores were notably lower for consultations which occurred across a language barrier. Conclusions In the absence of adequate Spanish interpretation, it was uncertain whether these LEP patients were provided the quality and content of information needed to assure that they are genuinely informed. We offer some low-cost practice suggestions that might mitigate these problems, and improve the quality of language interpretation, which is essential to assuring informed choice in health care for LEP patients. PMID:17443367

  16. Solicitation for patient's consent creates duty to inform fully.

    PubMed

    1999-10-15

    A U.S. district judge in Philadelphia rejected part of a defense motion to dismiss an informed consent complaint. A heart surgery patient, [name removed], gave informed consent to have a blood transfusion in January 1992. His physician neglected to tell him about the risk of HIV transmission from a transfusion, and did not mention a directed donor option where the patient receives a transfusion from a family member or friend. The judge said that when a provider seeks consent voluntarily, the provider assumes a duty to use reasonable care in performing the task. The hospital prevailed in another aspect of the suit. The judge said the hospital cannot be held liable for allegations of negligence in failing to establish adequate policies governing informed consent.

  17. 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.

  18. 21 CFR 640.61 - Informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The...

  19. 21 CFR 640.61 - Informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The...

  20. 21 CFR 640.61 - Informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The...

  1. 21 CFR 640.61 - Informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The...

  2. 21 CFR 640.61 - Informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The...

  3. 28 CFR 512.16 - Informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Informed consent. 512.16 Section 512.16 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE GENERAL MANAGEMENT AND ADMINISTRATION RESEARCH Research § 512.16 Informed consent. (a) Before commencing a research project...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. Informed consent for medical photographs

    PubMed Central

    Cunniff, Christopher; Byrne, Janice L.B.; Hudgins, Louanne M.; Moeschler, John B.; Olney, Ann Haskins; Pauli, Richard M.; Seaver, Lauri H.; Stevens, Cathy A.; Figone, Christopher

    2000-01-01

    Patient images are used for many purposes in medical practice. They are placed in the medical record as an adjunct to clinical care, displayed to colleagues, students and other audiences in educational settings, and published in medical journals or other media as part of medical research. In each case it is not only prudent, but necessary for the patients’ protection and interest that appropriate consent be obtained. While medical journals invariably require written consent for photographs that may identify the patient, the format of the photograph consent form is usually not specified, nor is it always clear which images require consent. With the proliferation of published images on the Internet it has become particularly important to obtain permission for all uses that will be made of medical images, including worldwide distribution through various electronic media. PMID:11339658

  10. Medical ghostwriting and informed consent.

    PubMed

    Almassi, Ben

    2014-11-01

    Ghostwriting in its various forms has received critical scrutiny from medical ethicists, journal editors, and science studies scholars trying to explain where ghostwriting goes wrong and ascertain how to counter it. Recent analyses have characterized ghostwriting as plagiarism or fraud, and have urged that it be deterred through stricter compliance with journal submission requirements, conflict of interest disclosures, author-institutional censure, legal remedies, and journals' refusal to publish commercially sponsored articles. As a supplement to such efforts, this paper offers a critical assessment of medical ghostwriting as contrary to good patient care, on the grounds that it contradicts established general principles guiding clinical ethics. Specifically, I argue that ghostwriting undermines trust relationships between authors and their readers, and between these readers and their trusting patients, and in so doing contradicts the duty of respect for patient autonomy by obstructing informed consent. For this reason, complicity in ghostwriting practices should be understood as a violation of the professional ethical duties of physicians and other healthcare workers.

  11. 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.

  12. Use of informed consent with therapeutic paradox.

    PubMed

    Farkas, M M

    1992-01-01

    Debate persists in the literature and among clinicians about the ethical appropriateness of paradoxical interventions. It has been suggested that informed consent with therapeutic paradox would alleviate ethical concerns of deception, manipulation, harm to the client, and withholding of information from the client in therapy. The purpose of this study was to explore health care consumer reactions to the benefits and risks of therapeutic paradox as stated in a consent for treatment form. The study explored the responses of 32 medical patients to a hypothetical consent for treatment form for therapeutic paradox. Data were collected in a brief semistructured interview after subjects read the hypothetical consent form. Utilizing a case study, the investigator then offered an example of a successful paradoxical intervention and additional subject comments were solicited. Content analysis of the responses was made. Health care consumers had mixed responses to the consent form. While the consent form served as an obstacle for some consumers, many were willing to sign the consent form and accept treatment even though they had internal reservations and questions. Appropriateness of the consent form format is discussed.

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

    PubMed

    Kongsholm, Nana Cecilie Halmsted; Kappel, Klemens

    2017-02-27

    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.

  14. Informed consent in trauma: does written information improve patient recall of risks? A prospective randomised study.

    PubMed

    Smith, Hannah K; Manjaly, Joseph G; Yousri, Taher; Upadhyay, Neil; Taylor, Hazel; Nicol, Stephen G; Livingstone, James A

    2012-09-01

    Informed consent is vital to good surgical practice. Pain, sedative medication and psychological distress resulting from trauma are likely to adversely affect a patient's ability to understand and retain information thus impairing the quality of the consent process. This study aims to assess whether provision of written information improves trauma patient's recall of the risks associated with their surgery. 121 consecutive trauma patients were randomised to receive structured verbal information or structured verbal information with the addition of supplementary written information at the time of obtaining consent for their surgery. Patients were followed up post-operatively (mean 3.2 days) with a questionnaire to assess recall of risks discussed during the consent interview and satisfaction with the consent process. Recall of risks discussed in the consent interview was found to be significantly improved in the group receiving written and verbal information compared to verbal information alone (mean questionnaire score 41% vs. 64%), p=0.0014 using the Mann-Whitney U test. Patient satisfaction with the consent process was improved in the group receiving written and verbal information and 90% of patients in both groups expressed a preference for both written and verbal information compared to verbal information alone. Patients awaiting surgery following trauma can pose a challenge to adequately inform about benefits conferred, the likely post operative course and potential risks. Written information is a simple and cost-effective means to improve the consent process and was popular with patients.

  15. A linguistic model of informed consent.

    PubMed

    Marta, J

    1996-02-01

    The current disclosure model of informed consent ignores the linguistic complexity of any act of communication, and the increased risk of difficulties in the special circumstances of informed consent. This article explores, through linguistic analysis, the specificity of informed consent as a speech act, a communication act, and a form of dialogue, following on the theories of J.L. Austin, Roman Jakobson, and Mikhail Bakhtin, respectively. In the proposed model, informed consent is a performative speech act resulting from a series of communication acts which together constitute a dialogic, polyphonic, heteroglossial discourse. It is an act of speech that results in action being taken after a conversation has happened where distinct individuals, multiple voices, and multiple perspectives have been respected, and convention observed and recognized. It is more meaningful and more ethical for both patient and physician, in all their human facets including their interconnectedness.

  16. Open consent, biobanking and data protection law: can open consent be 'informed' under the forthcoming data protection regulation?

    PubMed

    Hallinan, Dara; Friedewald, Michael

    2015-01-01

    This article focuses on whether a certain form of consent used by biobanks--open consent--is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent--in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context--exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of 'data'. The authors argue that these assumptions are difficult to apply to genetic data

  17. Do the Patients Read the Informed Consent?

    PubMed Central

    Özhan, Mehmet Özgür; Süzer, Mehmet Anıl; Çomak, İlker; Çaparlar, Ceyda Özhan; Aydın, Gözde Bumin; Eşkin, Mehmet Burak; Atik, Bülent; Ergin, Atilla; Çekmen, Nedim; Kurt, Ercan

    2014-01-01

    Background: Informed consent is a process which consists of informing the patient about the medical interventions planned to be applied to the patient’s body and making the patient active in the decision making process. Aims: The aim of this study was to evaluate whether the patients read the informed consent document or not and if not, to determine why they did not read it. This was achieved via a questionnaire administered at the pre-anaesthetic visit to assess the perception of patients to the informed consent process. Study Design: Survey study. Methods: The patients were given a questionnaire after signing the informed consent document at the pre-anaesthetic visit. We studied whether the patients read the informed consent document or not and asked for their reasons if they did not. Results: A total of 522 patients were included during the two month study (mean age: 38.1 years; 63.8% male, 36.2% female). Overall, 54.8% of patients reported that they did not read the informed consent. Among them, 50.3% did not care about it because they thought they would have the operation anyway, 13.4% did not have enough time to read it, 11.9% found it difficult to understand, 5.9% could not read because they had no glasses with them, and 5.2% found it frightening and gave up reading. Inpatients, older patients and patients with co-morbidities were less likely to read the informed consent document than outpatients, and younger and healthy patients (p<0.05). Also, 57.9% of parents whose children would be operated on had read the document. Conclusion: This study shows that the majority of our patients did not understand the importance of the informed consent. It is therefore concluded that informed consent documents should be rearranged to be easily read and should be supported with visual elements such as illustrations or video presentations, as informed consent is a process rather than just simply signing a form. PMID:25207184

  18. [Informed consent in clinical practice: persistent doubts].

    PubMed

    Kottow, Miguel

    2016-11-01

    Informed consent is the core aspect of the patient-physician relationship. Since its beginnings, clinical bioethics was opposed to the authoritarian paternalism characteristic of medicine since the 19th century. The informed consent was developed to provide patients with sufficient information to allow autonomous decisions when faced with medical diagnostic and therapeutic alternatives. In spite of bioethics’ effort to perfect informed consent, the discipline has been unable to avoid informed consent from becoming an impersonal and administrative procedure. Even though the major goal of this procedure is to provide sufficient information to allow patients an objective weighting of benefits and risks of medical practice, the uncertainties of medicine make full disclosure unattainable. Collecting more information finally leads to indecision and ultimate trust in medical advice. The clinical encounter is fundamentally a fiduciary relationship, and bioethics ought to accept that its main objective is to strengthen the trust bond that is essential to the clinical encounter. This goal may become incompatible with the quest for unlimited autonomy. Patients often will only require information as long as they distrust that medical institutions and their professionals are considering their interests and needs. The main proposal of this article is to temper bioethics’ insistence on autonomy, and accept that patients essentially seek to be protected and cared for. Informed consent ought to relent its efforts at full autonomy to the benefit of trustworthiness in medicine, and trust in clinical practice.

  19. The battering of informed consent

    PubMed Central

    Kottow, M

    2004-01-01

    Autonomy has been hailed as the foremost principle of bioethics, and yet patients' decisions and research subjects' voluntary participation are being subjected to frequent restrictions. It has been argued that patient care is best served by a limited form of paternalism because the doctor is better qualified to take critical decisions than the patient, who is distracted by illness. The revival of paternalism is unwarranted on two grounds: firstly, because prejudging that the sick are not fully autonomous is a biased and unsubstantial view; secondly, because the technical knowledge of healthcare professionals does not include the ethical qualifications and prerogative to decide for others. Clinical research settings are even more prone to erode subjects' autonomy than clinical settings because of the tendency and temptation to resort to such practices as shading the truth when consent to participation is sought, or waiving consent altogether when research is done in emergency settings. Instead of supporting such dubious practices with unconvincing arguments, it would seem to be the task of bioethics to insist on reinforcing autonomy. PMID:15574446

  20. Written Informed Consent: Closing the Door to Clinical Research. and Another Look at Informed Consent.

    ERIC Educational Resources Information Center

    Noble, Mary Anne; Oberst, Marilyn T.

    1985-01-01

    Two viewpoints on written informed consent are presented: Written informed consent should not be required unless research goes beyond the bounds of normal practice and poses danger or discomfort to the patient; and the principles of autonomy and individual rights must be applied at least as stringently to research as to practice. (CT)

  1. The limits of informed consent.

    PubMed

    1975-09-01

    The patient, a 59-year-old man, was referred to a psychiatric hospital with what appeared initially to be the signs and symptoms of mental disorder. In hospital a lesion of the brain was diagnosed and surgery was proposed to relieve the condition. The patient, however, during this and subsequent admissions to hospital, refused operation. His refusal to consent was regarded as valid as he seemed to have good insight into his condition. Finally, under section 26 of the Mental Health Act, he was treated surgically. Unfortunately the patient died six weeks later of intracranial haemorrhage. Three comments are made on this case - two by psychiatrists, Dr K Davison and Dr Ashley Robin, the other by a professor of Christian ethics, Professor F C Blackie. Both psychiatrists argue that when a patient's mind is affected by mental or organic illness to the degree that 'he cannot bring a rational and conscious mind' to the question of his treatment then the doctor, in consultation with the relatives, making clear to them the likely course of events if an operation is not performed, must take whatever is the proper course of action, in this case surgery. In this view, such an operation performed immediately the diagnosis was confirmed might not have been so complicated. Professor Blackie, commending 'the attempt to regard the patient as a responsible human being' with a 'moral right to be consulted on all aspects of treatment', questions in this patient the limits to which the appeal to reason was carried. He concludes that 'in this situation the advice and consent of the family must weigh more heavily than the statements of the patient'.

  2. 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

  3. Learning Ethics through Everyday Problems: Informed Consent

    ERIC Educational Resources Information Center

    Verdu, Fernando; Frances, Francesc; Castello, Ana

    2012-01-01

    The teaching of bioethics and its importance in clinical relationships is to a certain extent complicated when we address students of medicine, young people who are more used to dealing with and solving strictly clinical problems. Informed Consent is one of the aspects of professional practice that is generally and widely accepted in Western…

  4. 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

  5. Informed Consent and the "Medical Student Psychiatrist."

    ERIC Educational Resources Information Center

    Cohen, Daniel L.; And Others

    1990-01-01

    Responses to a 1986 questionnaire by 91 departments of clinical psychiatry in U.S. medical schools revealed that a substantial proportion (29.3 percent) were not fully compliant with established guidelines requiring informed consent from patients before allowing students to participate in their psychiatric assessment and care. (Author/DB)

  6. Limning the Semantic Frontier of Informed Consent.

    PubMed

    Washington, Harriet A

    2016-09-01

    It is the researcher's responsibility to provide accurate, complete, and unbiased verbal and written information yet, as this essay discusses, challenges to meaningful research consent abound in the communication between researcher and subject. This discussion of these challenges is far from exhaustive, but it will flag some of the potholes that researchers must anticipate on the sometimes rocky road to eliciting meaningful consent. These include, but are not limited to, inadequate scientific literacy, poorly written consent forms, and even the deployment of scientific terms and seductive acronyms like CURE and MIRACL. Studies with acronyms, for example, enroll five times as many patients as those without, are more likely to be published by prestigious journals, and have higher Jadad methodologic quality scores although they are no more likely to conclude with positive findings. Other barriers to researcher-subject communication include: widely differing beliefs and customs, semiotics, socioeconomic status, iatrophobia, and dramatically different histories of treatment in the medical-research arena.

  7. The nocebo effect of informed consent.

    PubMed

    Cohen, Shlomo

    2014-03-01

    The nocebo effect, the mirror-phenomenon to the placebo effect, is when the expectation of a negative outcome precipitates the corresponding symptom or leads to its exacerbation. One of the basic ethical duties in health care is to obtain informed consent from patients before treatment; however, the disclosure of information regarding potential complications or side effects that this involves may precipitate a nocebo effect. While dilemmas between the principles of respect for patient autonomy and of nonmaleficence are recognized in medical ethics, there has not yet been an ethical discussion focused on the potential dilemma raised by the nocebo effect of informed consent (NEIC). This dilemma is especially pernicious, since it involves a direct causality of harm by the caregiver that is unparalleled by other potential harmful effects of information disclosure. This paper articulates the dilemma of the NEIC and offers a seminal ethical analysis.

  8. Informed consent to HIV cure research.

    PubMed

    Bromwich, Danielle; Millum, Joseph R

    2017-02-01

    Trials with highly unfavourable risk-benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants' motivations for enrolling in potentially high risk research with no prospect of direct benefit; and third, participants' understanding of the details of the trials in which they enrol. We argue that the communication concern is relevant to the validity of informed consent and the quality of decision making, that the motivation concern does not identify a genuine problem with either the validity of consent or the quality of decision making and that the understanding concern may not be relevant to the validity of consent but is relevant to the quality of decision making. In doing so, we derive guidance points for researchers recruiting and enrolling participants into their HIV cure trials, as well as the research ethics committees reviewing proposed studies.

  9. Changes in the Concept of Informed Consent in Medical Encounters.

    ERIC Educational Resources Information Center

    Hollander, Rachelle D.

    1984-01-01

    Recent changes in the conceptualization of informed consent in medical encounters are reviewed to help provide a better understanding of the concept itself and of some difficulties in philosophical justifications for the requirement of informed consent. (Author/MLW)

  10. [The Use of Informed Consent in Clinical Nursing Practice].

    PubMed

    Cheng, Chun-Ting; Lin, Chiu-Chu

    2017-02-01

    Obtaining informed consent and ensuring patient autonomy are critical to implementing a patient-centered model of healthcare. Informed consent is a complex process of communication that includes three elements: disclosure, competence in making decisions, and voluntariness. However, individual patient factors, doctor-patient interaction, and cultural issues are known to influence the process of obtaining informed consent. Individual patient factors include the ability of patients to understand and determine their intent; doctor-patient interaction includes communication skills; and cultural issues include the expectations of patients with regard to family involvement in medical decision-making and in decision-making motives. After assessing the relevant influencing factors, healthcare providers typically provide patients with comprehensive information on the benefits and risks of treatment as well as related alternatives. Moreover, healthcare providers typically provide patients with audio/video, Internet, and written information with illustrations based on individual patient needs. In addition to the above, we suggest that healthcare providers proactively adopt the perspective of patients in order to better encourage patients to address questions, to engage with patients in more productive discussions, and to take the initiative to explain and clarify patients' questions in order to minimize anxiety. This approach will help ensure that patients are adequately informed and free from coercion so that they make appropriate healthcare-related decisions. However, even under this optimal situation, healthcare providers must emphasize the needs of their patients and respect their decisions.

  11. Informed Consent, Deaf Culture, and Cochlear Implants.

    PubMed

    Pass, Lauren; Graber, Abraham D

    2015-01-01

    While cochlear implantation is now considered routine in many parts of the world, the debate over how to ethically implement this technology continues. One's stance on implantation often hinges on one's understanding of deafness. On one end of the spectrum are those who see cochlear implants as a much needed cure for an otherwise intractable disability. On the other end of the spectrum are those who view the Deaf as members of a thriving culture and see the cochlear implant as an attempt to eliminate this culture. Rather than take a stance in this debate, we will argue that the informed consent process for cochlear implantation must include access to Deaf perspectives. Deaf individuals know best what it is like to be a member of the Deaf community; the reasonable person would put significant weight on the testimony of Deaf individuals when considering whether to undergo cochlear implantation. The reasonable person standard determines what information careproviders must present as part of the informed consent process; thus, informed consent for cochlear implantation requires access to the testimony of Deaf individuals.

  12. Status of informed consent in the original articles published in a medical journal of Bangladesh.

    PubMed

    Mollah, As

    2008-01-01

    Informed consent and other ethical issues are included in every guideline of research ethics. Taking informed consent from the participants is essential in human health research. The health researchers are not addressing adequately the issues of informed consent and other relevant issues. In many of the published articles in our country, there is no mention of informed consent and other relevant ethical issues. In this study, a 5-years retrospective review was performed on the original articles that described research involving human subjects, and published in the "Journal of Bangladesh College of Physicians and Surgeons" in the period of 1999 to 2003. The objectives of this review were: i) to document whether the author has mentioned about informed consent in the published original article; and ii) to document whether the author has addressed the informed consent procedure in appropriate details. Fifty three original articles were reviewed, only in 7(13.2%) articles the author has mentioned that informed consent was taken from the participants. In 19 (63%) articles, where the subjects were minors or incompetent, there was no mention from whom informed consent was taken. Only in 2(3.7%) articles, the authors have mentioned about the approval of Ethical Review Committee, and in 4(7.5%) articles about the funding agency. Other ethical issues were also ignored. The study documents deficiencies in informed consent and relevant ethical issues in the published articles. This finding demands greater attention to ethical standards on the part of investigators and the editors.

  13. 10 CFR 745.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Documentation of informed consent. 745.117 Section 745.117 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.117 Documentation of informed consent. (a... embodies the elements of informed consent required by § 745.116. This form may be read to the subject...

  14. A Case for Obtaining Informed Consent from Young Children.

    ERIC Educational Resources Information Center

    Hughes, Teresa; Helling, Mary Kay

    A discussion of informed consent in research on children focuses on the history of informed consent and problems of obtaining informed consent from young children. It is argued that, in the past, researchers and research monitors have assumed that parents will act in the best interests of children participating in research and protect them from…

  15. 10 CFR 745.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Documentation of informed consent. 745.117 Section 745.117 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of...

  16. Informed consent in Texas: theory and practice.

    PubMed

    Cherry, Mark J; Engelhardt, H Tristram

    2004-04-01

    The legal basis of informed consent in Texas may on first examination suggest an unqualified affirmation of persons as the source of authority over themselves. This view of individuals in the practice of informed consent tends to present persons outside of any social context in general and outside of their families in particular. The actual functioning of law and medical practice in Texas, however, is far more complex. This study begins with a brief overview of the roots of Texas law and public policy regarding informed consent. This surface account is then contrasted with examples drawn from the actual functioning of Texas law: Texas legislation regarding out-of-hospital do-not-resuscitate (DNR) orders. As a default approach to medical decision-making when patients lose decisional capacity and have failed to appoint a formal proxy or establish their wishes, this law establishes a defeasible presumption in favor of what the law characterizes as "qualified relatives" who can function as decision-makers for those terminal family members who lose decisional capacity. The study shows how, in the face of a general affirmation of the autonomy of individuals as if they were morally and socially isolated agents, space is nevertheless made for families to choose on behalf of their own members. The result is a multi-tier public morality, one affirming individuals as morally authoritative and the other recognizing the decisional standing of families.

  17. Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents

    PubMed Central

    Munung, Nchangwi Syntia; Marshall, Patricia; Campbell, Megan; Littler, Katherine; Masiye, Francis; Ouwe-Missi-Oukem-Boyer, Odile; Seeley, Janet; Stein, D J; Tindana, Paulina; de Vries, Jantina

    2016-01-01

    Background The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium. Methods A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of test results. Results Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results. Conclusion H3Africa research makes use of three consent models—specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa. PMID:26644426

  18. Vulnerable Subjects: Why Does Informed Consent Matter?

    PubMed

    Goodwin, Michele

    2016-09-01

    This special issue of the Journal Law, Medicine & Ethics takes up the concern of informed consent, particularly in times of controversy. The dominant moral dilemmas that frame traditional bioethical concerns address medical experimentation on vulnerable subjects; physicians assisting their patients in suicide or euthanasia; scarce resource allocation and medical futility; human trials to develop drugs; organ and tissue donation; cloning; xenotransplantation; abortion; human enhancement; mandatory vaccination; and much more. The term "bioethics" provides a lens, language, and guideposts to the study of medical ethics. It is worth noting, however, that medical experimentation is neither new nor exclusive to one country. Authors in this issue address thorny subjects that span borders and patients: from matters dealing with children and vaccination to the language and perception of consent.

  19. [Scientific drug safety information for patients' consent].

    PubMed

    Suzuki-Nishimura, Tamiko

    2011-01-01

    One of the important roles of pharmacists is to continue their contributions to new drug discovery and development. However, it seems to be very difficult to obtain patient satisfaction with new drugs. Because new medicines have both benefit and risk, there should be many systems to maximize the safety and efficacy of the drugs. In clinical trials, the rights, safety and welfare of human subjects under the investigator's care must be protected. Good Clinical Practice is a harmonized ICH-guideline, and the safety information of an investigational product is explained to patients who voluntarily enter the clinical trials. Since safety information about investigational products is still limited, subjects are informed about the results of animal experiments and those of finished clinical trials. The sponsor of clinical trials should be responsible for the on-going safety evaluation of the investigational products. When additional safety information is collected in the clinical trials, the written informed consent form should be appropriately revised. During the review process, quality, safety and efficacy of new drugs are evaluated and judged based on the scientific risk-benefit balance. The safety information collected in clinical trials is reflected in the decision-making process written in the review reports. All-case investigation should be also performed until data from a certain number of patients has been accumulated in order to collect early safety and efficacy data. Important messages written in review reports for drug safety and patient consent are explained. Risk communication will improve the application of patients' consent for new drugs.

  20. 49 CFR 11.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Documentation of informed consent. 11.117 Section 11.117 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.117... following: (1) A written consent document that embodies the elements of informed consent required by §...

  1. 38 CFR 16.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... consent. 16.117 Section 16.117 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.117 Documentation of informed consent. (a) Except as provided in paragraph... elements of informed consent required by § 16.116. This form may be read to the subject or the...

  2. Informed consent: protection or obstacle? Some emerging issues.

    PubMed

    Ellenberg, S S

    1997-12-01

    There is widespread consensus on the need for informed consent procedures in medical research. Nevertheless, aspects of the informed consent process remain controversial, and innovative approaches to research may raise new issues and concerns. The randomized consent design for clinical trials, proposed by Zelen (N Engl J Med 1979; 300:1242-1245), permitted physicians to randomize patients without consent, then obtain informed consent from only those patients randomized to the experimental (as opposed to the standard treatment) arm. More recently, the proposal has been made to allow waiver of informed consent for study of patients in emergency circumstances who may be temporarily incapable of providing such consent, and for whom no family member is immediately available to give a "proxy" consent (Biros M.H. et al. JAMA 1995; 273:1283-1287). The medical community and federal regulatory policy have responded differently to these proposals.

  3. Informed Consent, Body Property, and Self-Sovereignty.

    PubMed

    Rao, Radhika

    2016-09-01

    Recent cases involving biosamples taken from indigenous tribes and newborn babies reveal the emptiness of informed consent. This venerable doctrine often functions as a charade, a collective fiction which thinly masks the uncomfortable fact that the subjects of human research are not actually afforded full information regarding the types of research that may be contemplated, nor do they provide meaningful consent. But if informed consent fails to provide adequate protection to the donors of biological materials, why not turn to principles of property law? Property is power, yet current law permits everyone except for those who donate biological materials to possess property rights. The reluctance to invoke property probably stems from fears of resurrecting slavery and the commodification of human beings. But ironically, avoidance of property transforms the subjects of human research into objects that can be owned only by others, resulting in new forms of oppression and exploitation. Human research subjects are autonomous individuals who should not only possess the power to contribute their biological materials, but also the right to help control the course of research, and to share in the resulting benefits or profits. Conferring body property might enable research subjects to regain power and a measure of self-sovereignty.

  4. Legal issues in blood banking. Elements of informed consent.

    PubMed

    Sherman, L A

    1996-12-01

    In the past, informed consent in pathology was confined chiefly to autopsies. Changes in both consent law and pathology practice led to consent being important in a broader sense in the laboratory. Areas discussed in this article include blood transfusion, tissue specimens, fine needle aspiration, and phlebotomy.

  5. Medical Treatment and Human Experimentation: Introducing Illegality, Fraud, Duress and Incapacity to the Doctrine of Informed Consent

    ERIC Educational Resources Information Center

    Foster, Constance B.

    1975-01-01

    The court held in Kaimowitz v. Department of Mental Health that "involuntarily detained mental patients cannot give informed and adequate consent to experimental psychosurgical procedures on the brain." This note argues that the present theory of informed consent is inadequate for such cases and proposes a new theory. (JT)

  6. [About medical accidents and their medicolegal implications. Information and consent].

    PubMed

    El Banna, S; Beauthier, F; Beauthier, J P

    2013-01-01

    Medical practice today is not simple because of various factors impinging on the doctor-patient relationship. The concept of consent arises from the ethical principle of patient autonomy and basic human rights. It is also the rule of law (Civil Code article 16-3) that guarantees the patient's right and freedom to decide what should or should not happen to his/her body and to gather information before undergoing a test/procedure/surgery. No one else has the right to coerce the patient to act in a particular way. The authors after a reflexion about medical accidents and their medicolegal implications, discuss the means to display in order to provide to the patients the adequate information about their disease and proposed treatment, therefore protecting the medical practitioner from the consequences of insufficient or ill information.

  7. Research without informed patient consent in incompetent patients.

    PubMed

    Dobb, G J

    2015-05-01

    Most patients needing intensive care cannot give informed consent to participation in research. This includes the most acutely and severely ill, with the highest mortality and morbidity where research has the greatest potential to improve patient outcomes. In these circumstances consent is usually sought from a substitute decision maker, but while survivors of intensive care believe substitute decision makers will look after their interests, evidence suggests substitute decision makers are poorly equipped for this task. Various models have been suggested for research without patient informed consent when intervention is urgent and cannot wait until first person consent is possible, including a waiver of consent if conditions are met. A nationally consistent model is proposed for Australia with a robust process for initial waiver of consent followed by first person consent to further research-related procedures or ongoing follow-up when this can be competently provided.

  8. Informed Consent for Interventional Radiology Procedures: A Survey Detailing Current European Practice

    SciTech Connect

    O'Dwyer, H.M.; Lyon, S.M.; Fotheringham, T.; Lee, M.J.

    2003-09-15

    Purpose: Official recommendations for obtaining informed consent for interventional radiology procedures are that the patient gives their consent to the operator more than 24 hr prior to the procedure. This has significant implications for interventional radiology practice. The purpose of this study was to identify the proportion of European interventional radiologists who conform to these guidelines. Methods: A questionnaire was designed consisting of 12 questions on current working practice and opinions regarding informed consent. These questions related to where, when and by whom consent was obtained from the patient. Questions also related to the use of formal consent forms and written patient information leaflets. Respondents were asked whether they felt patients received adequate explanation regarding indications for intervention,the procedure, alternative treatment options and complications. The questionnaire was distributed to 786 European interventional radiologists who were members of interventional societies. The anonymous replies were then entered into a database and analyzed. Results: Two hundred and fifty-four (32.3%) questionnaires were returned. Institutions were classified as academic (56.7%),non-academic (40.5%) or private (2.8%). Depending on the procedure,in a significant proportion of patients consent was obtained in the outpatient department (22%), on the ward (65%) and in the radiology day case ward (25%), but in over half (56%) of patients consent or re-consent was obtained in the interventional suite. Fifty percent of respondents indicated that they obtain consent more than 24 hr before some procedures, in 42.9% consent is obtained on the morning of the procedure and 48.8% indicated that in some patients consent is obtained immediately before the procedure. We found that junior medical staff obtained consent in 58% of cases. Eighty-two percent of respondents do not use specific consent forms and 61% have patient information leaflets. The

  9. 49 CFR 11.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 1 2011-10-01 2011-10-01 false Documentation of informed consent. 11.117 Section 11.117 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed...

  10. 49 CFR 11.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 1 2012-10-01 2012-10-01 false Documentation of informed consent. 11.117 Section 11.117 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed...

  11. Autonomy, consent and responsibility. Part II. Informed consent in medical care and in the law.

    PubMed

    Mellado, J M

    Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility.

  12. 77 FR 56644 - Federal Acquisition Regulation; Information Collection; Subcontract Consent

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-13

    ... forms of information technology. DATES: Submit comments on or before October 15, 2012. ADDRESSES: Submit... information. For example, consideration is given to an entity reviewing instructions; using technology to... Acquisition Regulation; Information Collection; Subcontract Consent AGENCY: Department of Defense...

  13. 14 CFR 1230.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Documentation of informed consent. 1230.117 Section 1230.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of...

  14. 14 CFR 1230.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Documentation of informed consent. 1230.117 Section 1230.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of...

  15. 14 CFR 1230.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true General requirements for informed consent. 1230.116 Section 1230.116 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.116 General requirements for informed consent. Except as...

  16. 14 CFR 1230.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Documentation of informed consent. 1230.117 Section 1230.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of...

  17. 14 CFR 1230.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false General requirements for informed consent. 1230.116 Section 1230.116 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.116 General requirements for informed consent. Except as...

  18. 14 CFR 1230.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Documentation of informed consent. 1230.117 Section 1230.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of...

  19. 21 CFR 50.20 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Section 50.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.20 General requirements for informed consent. Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a...

  20. 21 CFR 50.20 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Section 50.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.20 General requirements for informed consent. Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a...

  1. 21 CFR 50.20 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Section 50.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.20 General requirements for informed consent. Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a...

  2. 21 CFR 50.20 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Section 50.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.20 General requirements for informed consent. Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a...

  3. 21 CFR 50.20 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Section 50.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.20 General requirements for informed consent. Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a...

  4. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Documentation of informed consent. 97.117 Section 97.117 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal...) § 97.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this...

  5. 15 CFR 27.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ....117 Section 27.117 Commerce and Foreign Trade Office of the Secretary of Commerce PROTECTION OF HUMAN SUBJECTS § 27.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this... either of the following: (1) A written consent document that embodies the elements of informed...

  6. 32 CFR 219.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 2 2010-07-01 2010-07-01 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....

  7. 16 CFR 1028.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Documentation of informed consent. 1028.117 Section 1028.117 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of...

  8. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ....117 Section 26.117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF... EPA § 26.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this... either of the following: (1) A written consent document that embodies the elements of informed...

  9. 28 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Documentation of informed consent. 46.117 Section 46.117 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this...

  10. 45 CFR 690.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 3 2010-10-01 2010-10-01 false Documentation of informed consent. 690.117 Section 690.117 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.117 Documentation of informed consent. (a) Except as provided in...

  11. Consent, Informal Organization and Job Rewards: A Mixed Methods Analysis

    ERIC Educational Resources Information Center

    Laubach, Marty

    2005-01-01

    This study uses a mixed methods approach to workplace dynamics. Ethnographic observations show that the consent deal underlies an informal stratification that divides the workplace into an "informal periphery," a "conventional core" and an "administrative clan." The "consent deal" is defined as an exchange of autonomy, voice and schedule…

  12. 38 CFR 16.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2013-07-01 2013-07-01 false Documentation of informed consent. 16.117 Section 16.117 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.117 Documentation of informed consent. (a) Except as provided in...

  13. 28 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Documentation of informed consent. 46.117 Section 46.117 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this...

  14. 45 CFR 690.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 3 2012-10-01 2012-10-01 false Documentation of informed consent. 690.117 Section 690.117 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.117 Documentation of informed consent. (a) Except as provided in...

  15. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Documentation of informed consent. 26.117 Section 26.117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF... EPA § 26.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of...

  16. 28 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Documentation of informed consent. 46.117 Section 46.117 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this...

  17. 28 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Documentation of informed consent. 46.117 Section 46.117 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this...

  18. 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....

  19. Contemporary interpretation of informed consent: autonomy and paternalism.

    PubMed

    Robertson, Louise

    2016-06-01

    The Supreme Court's decision in the Montgomery case has questioned what is meant by 'informed consent'. Clinicians must establish who is a reasonable patient and exactly what they want to know. Obtaining informed consent requires a relationship to be built between patient and clinician and must respect patient autonomy.

  20. Informed consent for paediatric clinical trials in Europe

    PubMed Central

    Lepola, Pirkko; Needham, Allison; Mendum, Jo; Sallabank, Peter; Neubauer, David; de Wildt, Saskia

    2016-01-01

    Objective Paediatric clinical trials are often conducted as multinational trials. Informed consent or assent is part of the ethics committee approval for clinical trials. The consent requirements vary between countries due to national laws and regulations, which are not harmonised in Europe. These discrepancies can present challenges for paediatric clinical trials. The aim of this study was to assemble these consent and assent requirements across the European Economic Area. The collated national requirements have not been publicly available before, despite a real need for this data. Methods National consent and assent requirements for paediatric clinical trials were analysed and collated for 25 European Union Member States and 2 European Free Trade Association countries until the end of 2014. The data were retrieved from existing databases and through communication with the competent authorities and selected ethics committees. Results from a literature search for international or national guidelines, declarations and conventions and academic societies' publications served as comparison material. Results Consent and assent requirements are heterogeneous across these countries. We compiled our findings in ‘The Informed Consent and Assent Tool Kit’, a table including 27 national consent and assent requirements listed by individual country. Conclusions Wide variation in paediatric consents and assents presents challenges for multinational paediatric trials in Europe. The toolkit is available for all those involved in paediatric clinical trials and ethics committees, providing a new platform for proactive feedback on informed consent requirements, and may finally lead to a needed harmonisation process, including uniform standards accepted across Europe. PMID:27226526

  1. Experiences with Obtaining Informed Consent for Genomic Sequencing

    PubMed Central

    Bernhardt, Barbara A.; Roche, Myra I.; Perry, Denise L.; Scollon, Sarah R.; Tomlinson, Ashley N.; Skinner, Debra

    2016-01-01

    Despite the increased utilization of genome and exome sequencing, little is known about the actual content and process of informed consent for sequencing. We addressed this by interviewing 29 genetic counselors and research coordinators experienced in obtaining informed consent for sequencing in research and clinical settings. Interviews focused on the process and content of informed consent; patients/participants’ common questions, concerns and misperceptions; and challenges to obtaining informed consent. Content analysis of transcribed interviews revealed that the main challenges to obtaining consent related to the broad scope and uncertainty of results, and patient/ participants’ unrealistic expectations about the likely number and utility of results. Interviewees modified their approach to sessions according to contextual issues surrounding the indication for testing, type of patient, and timing of testing. With experience, most interviewees structured sessions to place less emphasis on standard elements in the consent form and technological aspects of sequencing. They instead focused on addressing misperceptions and helping patients/participants develop realistic expectations about the types and implications of possible results, including secondary findings. These findings suggest that informed consent sessions should focus on key issues that may be misunderstood by patients/participants. Future research should address the extent to which various stakeholders agree on key elements of informed consent. PMID:26198374

  2. Epidural analgesia for labour: maternal knowledge, preferences and informed consent.

    PubMed

    Fröhlich, S; Tan, T; Walsh, A; Carey, M

    2011-01-01

    Epidural analgesia has become increasingly popular as a form of labour analgesia in Ireland. However obtaining true inform consent has always been difficult. Our study recruited 100 parturients who had undergone epidural analgesia for labour, aimed to determine the information they received prior to regional analgesia, and to ascertain their preferences regarding informed consent. Only 65 (65%) of patients planned to have an epidural. Knowledge of potential complications was variable and inaccurate, with less than 30 (30%) of women aware of the most common complications. Most women 79 (79%) believed that discomfort during labour affected their ability to provide informed consent, and believe consent should be taken prior to onset of labour (96, 96%). The results of this study helps define the standards of consent Irish patients expect for epidural analgesia during labour.

  3. The process of informed consent for urgent abdominal surgery

    PubMed Central

    Kay, R; Siriwardena, A

    2001-01-01

    Objectives—To assess perceptions of the informed consent process in patients undergoing urgent abdominal surgery. Design—A prospective observational study was carried out using structured questionnaire-based interviews. Patients who had undergone urgent abdominal surgery were interviewed in the postoperative period to ascertain their perceptions of the informed consent process. Replies were compared to responses obtained from a control group undergoing elective surgery, to identify factors common to the surgical process and those specific to urgent surgery. Patients' perceptions of received information were also compared to the information perceived to have been provided by the consent obtainers. Setting—Gastrointestinal surgical service of a university teaching hospital. Patients—Seventy-four consecutive patients undergoing urgent abdominal surgery and 80 control patients undergoing elective surgery. Main measurements—Principal outcome measures were patients' perceptions of factors interfering with the ability to give informed consent, assessment of the quality of informed consent and the degree of discussion of the expected outcomes. Results—Forty-nine of the seventy-four (66%) patients undergoing urgent surgery perceived that pain did not affect their ability to give informed consent. Twenty-seven reported an adverse effect of analgesia on the ability to give informed consent. Only 22% of patients undergoing urgent surgery perceived that there had been any discussion of potential side effects and complications of surgery. Conclusion–The majority of patients in this series with acute intra-abdominal surgical conditions perceive that they retain the ability to give informed consent for surgery. There is a need for improved discussion of therapeutic options and likely outcomes. Key Words: Informed consent • urgent abdominal surgery PMID:11417021

  4. Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico

    PubMed Central

    Verástegui, Emma L

    2006-01-01

    Background A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important. Methods To gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale. Results Thirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8TH Grade. Conclusion The results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the

  5. 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

  6. Ethical Issues Regarding Informed Consent for Minors for Space Tourism

    NASA Astrophysics Data System (ADS)

    Marsh, Melvin S.

    2010-01-01

    This paper describes the difficulty with informed consent and debates whether or not whether adults should be able to ethically, morally, and legally consent for their children during the high-risk activity of space tourism. The experimental nature of space vehicles combined with the high likelihood of medical complications and the destination places space tourism legally in the category of "adventure activities," which include adventure travel to exotic locations as well as adventure sports, such as mountain climbing, rafting, etc. which carry a high risk of danger (http://rescommunis.wordpress.com/2008/02/14/interview-tracey-l-knutson-adventure-sports-defense-attorney-on-space-tourism-risk-and-informed-consente/). However, unlike other adventure sports, adults currently cannot consent for their minor children. Other topics also receive attention, such as a "mature minors" clause, radiation exposure of potential future children, and other difficulties preventing adults from legally consenting to space travel.

  7. "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.

  8. "Sign Here": Nursing Value and the Process of Informed Consent.

    PubMed

    Cook, Wesley E

    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.

  9. Surgeons' silence: a history of informed consent in orthopaedics.

    PubMed

    Jones, Kevin B

    2007-01-01

    The moment of decision to proceed with surgical intervention is charged with some of the deepest uncertainties in medicine, but has long been cloaked under the confidence asserted by the traditionally custodial surgeon. This paper reviews the history and ethical basis for informed surgical consent. Beginning with theoretical foundations and the changing ethics of medical decision making since the ancient Greeks, it then reviews how the stage was set for informed consent by technological breakthroughs that made surgical interventions tolerable and acceptably safe. Finally, the legal generation of the doctrine of informed consent is reviewed and the current state of disclosure, shared decision-making, and uncertainty explored.

  10. Sub-orbital commercial human spaceflight and informed consent.

    PubMed

    Carminati, Maria-Vittoria; Griffith, Doug; Campbell, Mark R

    2011-02-01

    Commercial spaceflight is expected to rapidly develop in the near future. This will begin with sub-orbital missions and then progress to orbital flights. Technical informed consent of spaceflight participants is required by the commercial spaceflight operator for regulatory purposes. Additionally, though not required by regulation, the aerospace medicine professional involved in the medical screening of both spaceflight participants and crewmembers will be asked to assist operators in obtaining medical informed consent for liability purposes. The various federal and state regulations regarding informed consent for sub-orbital commercial spaceflight are evolving and are unfamiliar to most aerospace medical professionals and are reviewed and discussed.

  11. Screening for prostate cancer. How can patients give informed consent?

    PubMed Central

    Marshall, K. G.

    1993-01-01

    Many urologists in North America are increasingly enthusiastic about prostatic cancer screening. Annual digital rectal examination is almost universally endorsed, and prostate-specific antigen testing is favored by most. But doctors really should not screen by either method without patients' informed consent. However, the information required for informed consent is complex and contradictory, difficult for physicians to give and for patients to absorb. PMID:7505673

  12. Informed consent for surgery: risk discussion and documentation

    PubMed Central

    Hanson, Melissa; Pitt, Dennis

    2017-01-01

    Summary Informed consent for surgery has become a critical component of surgical practice. There are specific legal requirements for what has to be disclosed to patients and for the accompanying documentation. The hospital consent for surgery form with the patient’s signature is a small part of the process. A quality assurance review of the documentation of informed consent by our surgical group indicated major deficiencies and prompted this article (and its Appendix containing further information). Our intent was to inform surgeons about modern standards and to discuss particular challenges. Informed consent for surgery entails what surgeons communicate to their patients about the proposed surgery and is a key element in the trust patients have in surgeons. It is of increasing importance, and we must keep up to date with patient and legal expectations. PMID:28234594

  13. Assessing the content, presentation, and readability of dental informed consents.

    PubMed

    Glick, Aaron; Taylor, David; Valenza, John A; Walji, Muhammad F

    2010-08-01

    Informed consents are important aids in helping patients make optimal decisions. Little knowledge exists about the quality of dental informed consents. Fifty-two informed consents used throughout the University of Texas Health Science Center at Houston Dental Branch were evaluated based on the quality of their content, readability, and presentation. Content quality was judged on four basic elements: description of procedure, risk, benefits, and alternatives. Of the clinical consents, 26 percent of forms contained all four of the basic content elements, 48 percent contained three of four elements, 16 percent contained two of four elements, and 10 percent contained one of four elements. Presentation quality was judged on twelve criteria items. The average clinical consent included seven out of twelve presentation items, and the average nonclinical consent included eight out of twelve items. Readability was judged using three standard instruments for rating readability: Flesch Reading Ease, Flesch-Kincaid Grade-Level, and Simple Measure of Gobbledygook (SMOG) grading. Average Flesch-Kincaid Grade-Level was 12.7 (range, 7.4 to 19.1), significantly higher than the recommended ninth grade level (p<.001). The results suggest that many existing dental informed consents may be improved by 1) increasing the comprehensiveness of the content, 2) improving the design and layout, and 3) reducing the readability levels for patient comprehension.

  14. On the Ottoman consent documents for medical interventions and the modern concept of informed consent.

    PubMed

    Kara, Mahmut A; Aksoy, Sahin

    2006-09-01

    Information for patients prior to medical intervention is one of the principles of modern medical practice. In this study, we looked at an earlier practice of this principle. Ottoman judges had record books called sicil. One of the categories in sicils was the consent documents called riza senedi, which was a patient-physician contract approved by the courts. These contracts were especially for the protection of physicians from punishment if the patient dies. It is not clear whether patients were informed properly or not. Consent for minors was obtained from parents. However, a situation where an adult does not have the capacity to consent, was not clear in these documents. Any sign of free withdrawal of consent was not found in these records. Due to the legal system of Ottoman State, these contracts were related to Islamic law rather than modern civil law. We aim, in this paper, to present a legal practice, which is possible to consider as an early example of the informed consent practice.

  15. Informed consent for research participation in frail older persons.

    PubMed

    Barron, Jeremy S; Duffey, Patricia L; Byrd, Linda Jo; Campbell, Robin; Ferrucci, Luigi

    2004-02-01

    Informed consent has been the most scrutinized and controversial aspect of clinical research ethics. Institutional review boards (IRBs), government regulatory agencies, and the threat of litigation have all contributed to increasingly detailed consent documents that hope to ensure that subjects are not misled or coerced. Unfortunately, the growing regulatory burden on researchers has not succeeded in protecting subjects, but has rather made the consent process less effective and has discouraged research on vulnerable populations. As a matter of fact, investigators and ethicists continue to identify failures of the consenting process, particularly concerning participation in research of older individuals. The challenges involved in ensuring appropriate consent from the elderly include physical frailty, reduced autonomy and privacy, and impaired decision-making capacity due to dementia, delirium, or other neuropsychiatric illnesses. Ageism among investigators also contributes to failure of informed consent. The evaluation and continuing re-evaluation of an individual's decision-making capacity is critical but difficult. In the most extreme cases, the older adult's ability to participate in the consent process is clearly impaired. However, in many instances, the decision-making capacity is only partially impaired but declines during the course of a research project. Implementing methods of effective communication may enable many frail elderly individuals to make informed decisions. Special challenges are posed by research on end-of-life care, which typically involves frail, older subjects who are uniquely vulnerable, and research is conducted in institutional settings where subtle violations of autonomy are routine. Clearly, the frail elderly represent a vulnerable population that deserves special attention when developing and evaluating an informed consent process. Two important ethical conflicts should be kept in mind. First, although vulnerable older patients must

  16. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1117 Documentation of informed consent....

  17. 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.

  18. Informed consent and ethical issues in military medical research.

    PubMed

    McManus, John; Mehta, Sumeru G; McClinton, Annette R; De Lorenzo, Robert A; Baskin, Toney W

    2005-11-01

    Informed consent in military research shares many of the same fundamental principles and regulations that govern civilian biomedical research. In fact, much of modern research ethics is grounded in events that occurred in the context of war or government-sponsored research. Despite these similarities and common origins, research in the military has additional requirements designed to preserve service members' informed consent rights. The special nature of the superior-subordinate relationship in the military necessitates careful protections to avoid perceptions of coercion or undue influence on a military subject. Additionally, current legal and regulatory requirements for advanced informed consent significantly restrict the flexibility of the military to conduct research using waiver of consent. This has implications on the ability of the nation to develop effective medical treatments for the global war on terrorism. Nevertheless, work is under way to realign defense research policy with the norms of civilian biomedical practice. Future directions include the adoption of waivers for military emergency research, and the cautious introduction of human subject studies on the battlefield. This paper discusses historical background, regulatory differences, and concerns and challenges of some of these regulatory differences for research personnel that apply to informed consent and waiver of said informed consent for emergency research conducted by the U.S. military.

  19. Different Aspects of Informed Consent in Aesthetic Surgeries

    PubMed Central

    Nejadsarvari, Nasrin; Ebrahimi, Ali

    2014-01-01

    Providing an informed consent has an important role in promotion of medical treatments and reduction of judiciary litigations in this process. Today with cultural changes and wide propagation that is usually charming, the request for aesthetic surgery has an increasing trend. These problems with complexity of cosmetic surgeries lead to deeper differences of information between plastic surgeons and patients, so the discussion on giving information to a patient is of great importance. Regarding the elective choice of aesthetic surgeries, there is a need on providing a standard informed consent form. There are some problems on advertisements of aesthetic surgeries by non-plastic surgeons, taking insufficient or incorrect information to the patients affecting the patients’ autonomy. In fact, correct operative information should be share with the patients. Probable complications and alternative procedures should be presented to the patient to choose an operative option freely and without any charming. Obtaining a written informed consent can protect researchers and their sponsor institutions from any litigation. Patients with psychiatric problems can not benefit from aesthetic surgery and also they have no competency for giving any informed consent. So psychiatric problems can even worsen the surgical interventions. In this article, fundamentals of plastic surgery to provide an informed consent were reviewed and the legal and ethical considerations were evaluated. PMID:25489529

  20. 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.

  1. [Informed consent in clinical practice and medical research].

    PubMed

    Santillan-Doherty, Patricio; Cabral-Castañeda, Antonio; Soto-Ramírez, Luis

    2003-01-01

    The present paper deals with the basic aspects, influences and elements that constitute Informed Consent seeing it as a process and not only as an administrative format. Both the patient-physician relationship, as well as the research subject-investigator relationship, should be seen in the same manner, in spite of recognizing specific objectives for each one. For this reason, Informed Consent should not be different regarding both clinical as well as research activities. The patient-physician relationship presents a disbalance of power within the relationship in favor of the physician; this adds to the moral considerations that take place within both participants. Informed Consent should be defined in a broad sense as all those actions that promote a process of communication and dialogue which facilitates a person in order to make decisions with respect of an action, practice or product that have an impact on his/her body, intimacy or other vital spaces. Informed Consent has influences that originate in basic bioethical principles (autonomy, beneficience, non-maleficence, justice), professional and international declarations (Hippocratic Oath, Declaration of Helsinki), as well as legal considerations pertinent to each country. In our country legality emmanates from the General Health Law which, unfortunately, only contemplates Informed Consent as part of the relation established in clinical research. However, the Official Medican Norm on the Clinical Record establishes the conditions where Informed Consent must be obtained during clinical as well as research activities. Primary components of Informed Consent (revelation, capacity to understand and voluntariness), can be better understood when divided into several elements: information, voluntariness, risks and benefits, confidentiality, return of information, utility of the process and management of fragility. Informed Consent should be legally instrumented in an explicit written manner (administrative formats

  2. Improving the informed consent process in international collaborative rare disease research: effective consent for effective research

    PubMed Central

    Gainotti, Sabina; Turner, Cathy; Woods, Simon; Kole, Anna; McCormack, Pauline; Lochmüller, Hanns; Riess, Olaf; Straub, Volker; Posada, Manuel; Taruscio, Domenica; Mascalzoni, Deborah

    2016-01-01

    The increased international sharing of data in research consortia and the introduction of new technologies for sequencing challenge the informed consent (IC) process, adding complexities that require coordination between research centres worldwide. Rare disease consortia present special challenges since available data and samples may be very limited. Thus, it is especially relevant to ensure the best use of available resources but at the same time protect patients' right to integrity. To achieve this aim, there is an ethical duty to plan in advance the best possible consent procedure in order to address possible ethical and legal hurdles that could hamper research in the future. Therefore, it is especially important to identify key core elements (CEs) to be addressed in the IC documents for international collaborative research in two different situations: (1) new research collections (biobanks and registries) for which information documents can be created according to current guidelines and (2) established collections obtained without IC or with a previous consent that does not cover all CEs. We propose here a strategy to deal with consent in these situations. The principles have been applied and are in current practice within the RD-Connect consortia – a global research infrastructure funded by the European Commission Seventh Framework program but forward looking in terms of issues addressed. However, the principles established, the lessons learned and the implications for future research are of direct relevance to all internationally collaborative rare-disease projects. PMID:26860059

  3. Rethinking Informed Consent in Research on Heroin-Assisted Treatment.

    PubMed

    Uusitalo, Susanne; Broers, Barbara

    2015-09-01

    Can heroin addicts give consent to research on trials in which heroin is prescribed to them? Analyses of addicts and informed consent have been objects of debate in several articles. Informed consent requires the agent not only to be competent but also to give consent voluntarily. This has been questioned because of alleged features of heroin addiction. Until recently the discussion has focused on heroin addicts' desires for heroin, whether these are irresistible and thus pose a problem for giving consent. Still, in light of empirical evidence, there seems to be a consensus more or less that the problem is not whether the addicts can resist their desire for heroin. A recent article concentrates specifically on heroin addicts' false assumptions of options and voluntariness. We argue that the prevailing framing of the options in this discussion in terms of heroin and access to it is problematic. The way in which the options are typically laid out suggests an assumption that participation in the research is allegedly based on the addicts' views on using the drug. We argue that this way of presenting the options is, first, a mismatch to the studies carried out and, second, symptomatic of potential misconceptions about heroin addiction and addicts. Furthermore, we also suggest that the account of voluntariness needs to be realistic in order for subjects to be able to give consent voluntarily in actual situations, and for medical research to carry out studies on improving outcomes in addiction treatment in an ethical way.

  4. Informed Consent Conversations and Documents: A Quantitative Comparison

    PubMed Central

    Koyfman, Shlomo A.; Reddy, Chandana A.; Hizlan, Sabahat; Leek, Angela C.; Kodish, Eric

    2015-01-01

    Background Informed consent for clinical research includes two components: informed consent documents (ICD) and informed consent conversations (ICC). Readability software has been used to help simplify the language of the ICD, but rarely employed to assess the language during the ICC, which may influence the quality of informed consent. This analysis was completed to determine if length and reading levels of transcribed ICCs are lower than their corresponding ICDs for selected clinical trials, and to assess whether investigator experience affected use of simpler language and comprehensiveness. Methods Prospective study where ICCs were audio-recorded at 6 institutions when families were offered participation in pediatric phase I oncology trials. Word count, Flesch-Kincaid Grade Level (FKGL) and Flesch Reading Ease Score (FRES) of ICCs were compared to corresponding ICDs, including the frequency that investigators addressed 8 pre-specified critical consent elements during the ICC. Results Sixty-nine unique physician/protocol pairs were identified. Overall, ICCs contained fewer words (4,677 vs. 6,364; p=0.0016), had lower FKGL (6 vs. 9.7; p=<0.0001) and higher FRES (77.8 vs. 56.7; p<0.0001) than their respective ICDs, but were more likely to omit critical consent elements, such as voluntariness (55%) and dose limiting toxicities (26%). Years of investigator experience was not correlated with reliably covering critical elements or decreased linguistic complexity. Conclusions Clinicians use more understandable language during ICCs than the corresponding ICD, but less reliably cover elements critical to fully informed consent. Focused efforts at providing communication training for clinician-investigators should be done to optimize the synergy between the ICD and conversation. PMID:26505269

  5. Informed or Misinformed Consent? Abortion Policy in the United States.

    PubMed

    Daniels, Cynthia R; Ferguson, Janna; Howard, Grace; Roberti, Amanda

    2016-04-01

    Since 2010, the United States has witnessed a dramatic expansion of state-based restrictions on abortion. The most common of these are informed consent statutes, which require that a woman seeking an abortion receive a state-authored informational packet before the abortion procedure can be performed. These laws, in addition to requiring the provision of information about alternatives to and risks of abortion, all also require details of embryological and fetal development. This article presents the findings of a comprehensive study of state-authored informed consent materials regarding embryological and fetal development. To conduct this study, we recruited a panel of experts in human anatomy to assess the accuracy of these materials in the context of the constitutional standard established inPlanned Parenthood of Southeastern Pennsylvania et al. v. Robert P. Casey et al.(505 U.S. 833 (1992)): that such information must be "truthful" and "nonmisleading." We find that nearly one-third of the informed consent information is medically inaccurate, that inaccurate information is concentrated primarily in the earlier weeks of pregnancy and is clustered around particular body systems. We discuss the implications of our findings for the question of the constitutionality of informed consent laws as they have been implemented in practice.

  6. INFORMED CONSENT: THE MEDICAL AND LEGAL CHALLENGE OF OUR TIME

    PubMed Central

    Séllos Simões, Luiz Carlos

    2015-01-01

    Objective: To assess the real importance of obtaining informed consent, through an appropriate form, and its role in the outcome from civil liability claims. Methods: The wordings of the current Brazilian law and jurisprudence were compared with rulings from the State Court of the State of Rio de Janeiro, in 269 civil liability claims against healthcare professionals and hospitals. Results: Favorable and unfavorable outcomes (i.e. acquittals and convictions) were compared, and possible variations in the verdicts were discussed in relation to whether informed consent forms had been filled out or not. Conclusions: Obtaining informed consent, by means of appropriate forms, is still not a widespread practice in the Brazilian healthcare or judicial systems. It is recommended that this practice be adopted in the manner described in this paper, since this is prescribed in Brazilian law. PMID:27022541

  7. An ethical analysis of exception from informed consent regulations.

    PubMed

    Morris, Marilyn C

    2005-11-01

    Federal regulations enacted in 1996 allow clinical research with an exception from informed consent in select emergency circumstances. Such research is only permitted when the therapy may directly benefit the research participant and it is not possible to conduct the research with informed consent. Among others, protective mechanisms include a process of community consultation and public disclosure and the establishment of a mandatory data safety monitoring board. Although the regulations do not preserve the right of self-determination of the research participant, the author argues that they do provide an ethical means to advance the science of resuscitation.

  8. 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

  9. Genetic counseling practice in next generation sequencing research: implications for the ethical oversight of the informed consent process.

    PubMed

    Egalite, Nathalie; Groisman, Iris Jaitovich; Godard, Beatrice

    2014-08-01

    The potential for next generation sequencing research (NGS) to generate individual genetic results could have implications for the informed consent process and the provision of genetic counseling. We undertook a content analysis of informed consent templates and guidelines produced by Canadian institutional review boards, purposively sampling documents used by researchers to obtain consent from participants in genetics studies. Our goal was to examine the extent to which the informed consent documents addressed genetic counseling and the return of individual genetic results. Our analysis reveals that the majority of informed consent documents did not mention genetic counseling while several did not mention the return of results. We found differences in the ways in which documents addressed availability of counseling, eligibility criteria for referral to a genetic counselor, genetic counselor involvement, provision of services to family members of participants and incidental findings. From an ethical standpoint, consent documents should provide appropriate information so that participants may make an informed decision about their participation in research. The need to ensure adequate counseling for study populations in an NGS research context will necessarily involve adapting values that underlie care in genetic counseling practice. If the interests of research participants are to be truly promoted, the drafting and review of informed consent documents should give proper due to genetic counseling.

  10. Beyond informed consent: the therapeutic misconception and trust.

    PubMed

    de Melo-Martín, I; Ho, A

    2008-03-01

    The therapeutic misconception has been seen as presenting an ethical problem because failure to distinguish the aims of research participation from those receiving ordinary treatment may seriously undermine the informed consent of research subjects. Hence, most theoretical and empirical work on the problems of the therapeutic misconception has been directed to evaluate whether, and to what degree, this confusion invalidates the consent of subjects. We argue here that this focus on the understanding component of informed consent, while important, might be too narrow to capture the ethical complexity of the therapeutic misconception. We show that concerns about misplaced trust and exploitation of such trust are also relevant, and ought to be taken into account, when considering why the therapeutic misconception matters ethically.

  11. Hypothetical contractarianism and the disclosure requirement problem in informed consent.

    PubMed

    Cust, Kenneth F T

    1991-01-01

    Two of the more deeply problematic issues surrounding the doctrine of informed consent are providing a justification for the practice of informed consent and providing an account of the nature and amount of information that must be disclosed in order for informed consent to take place. This paper is concerned with the latter problem, the problem of disclosure requirements, but it deals with this problem in a novel way; it approaches the problem by asking what fully informed and fully rational agents would agree to under certain hypothetical conditions. In general terms I juxtapose the hypothetical contractarianism found in Rawls' A Theory of Justice with that found in Gauthier's Morals By Agreement and ask what their respective hypothetical contractors would agree to with respect to choosing a particular standard of disclosure to govern the practice of informed consent. In more specific terms a contrast is made between what a Rawlsian agent behind a veil of ignorance would choose as compared to what, in Gauthier's terms, an ideal actor making an Archimedean choice would choose. The idea of an Archimedean point, and the subsequent choice made from that point, although technically identified by Rawls, originated with Archimedes of Syracuse.

  12. Waiving informed consent in newborn screening research: balancing social value and respect.

    PubMed

    Tarini, Beth A; Burke, Wylie; Scott, C Ronald; Wilfond, Benjamin S

    2008-02-15

    While newborn screening (NBS) programs have historically relied on presumptive benefit in deciding when to implement new tests, experience has demonstrated that this approach can lead to screening tests that lack efficacy or, worse yet, cause harm. Population-based NBS research provides an opportunity to evaluate safety and effectiveness of potential tests prior to widespread implementation. Using the example of Pompe disease, we argue that waiving the requirement for informed consent is appropriate for research evaluating the screening phase of potential NBS tests when data support the potential health benefits of testing and when other research safeguards are present. The regulatory requirement for informed consent can be waived if a research study meets criteria of minimal risk, protecting rights and welfare, and practicability. In population-based NBS research, the main risks are related to false positive results and results with ambiguous implications for treatment-risks that are comparable to those posed by many tests newly added to NBS programs without prior population-based NBS research. Waiving the informed consent requirement facilitates the development of flexible strategies for informing and educating parents about NBS research that reflect the logistics of population-based NBS screening. A strict interpretation of the regulatory requirement of informed consent may create significant logistical and financial barriers to adequate evaluation of NBS tests. Without a broader interpretation of this regulatory requirement in NBS research for which there is evidence of a clinically meaningful benefit from treatment, we may create incentives for the implementation of inadequately evaluated NBS tests.

  13. Usual Care and Informed Consent in Clinical Trials of Oxygen Management in Extremely Premature Infants

    PubMed Central

    Cortés-Puch, Irene; Wesley, Robert A.; Carome, Michael A.; Danner, Robert L.; Wolfe, Sidney M.; Natanson, Charles

    2016-01-01

    Objective The adequacy of informed consent in the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) has been questioned. SUPPORT investigators and publishing editors, heads of government study funding agencies, and many ethicists have argued that informed consent was adequate because the two oxygen saturation target ranges studied fell within a range commonly recommended in guidelines. We sought to determine whether each oxygen target as studied in SUPPORT and four similar randomized controlled trials (RCTs) was consistent with usual care. Design/Participants/Setting PubMed, EMBASE, Web of Science, and Scopus were searched for English articles back to 1990 providing information on usual care oxygen management in extremely premature infants. Data were extracted on intended and achieved oxygen saturation levels as determined by pulse oximetry. Twenty-two SUPPORT consent forms were examined for statements about oxygen interventions. Results While the high oxygen saturation target range (91 to 95%) was consistent with usual care, the low range (85 to 89%) was not used outside of the SUPPORT trial according to surveys and clinical studies of usual care. During usual care, similar lower limits (< 88%) were universally paired with higher upper limits (≥ 92%) and providers skewed achieved oxygen saturations toward the upper-end of these intended ranges. Blinded targeting of a low narrow range resulted in significantly lower achieved oxygen saturations and a doubling of time spent below the lower limit of the intended range compared to usual care practices. The SUPPORT consent forms suggested that the low oxygen saturation arm was a widely practiced subset of usual care. Conclusions SUPPORT does not exemplify comparative effectiveness research studying practices or therapies in common use. Descriptions of major differences between the interventions studied and commonly practiced usual care, as well as potential risks associated with these

  14. Heroin addiction and voluntary choice: the case of informed consent.

    PubMed

    Henden, Edmund

    2013-09-01

    Does addiction to heroin undermine the voluntariness of heroin addicts' consent to take part in research which involves giving them free and legal heroin? This question has been raised in connection with research into the effectiveness of heroin prescription as a way of treating dependent heroin users. Participants in such research are required to give their informed consent to take part. Louis C. Charland has argued that we should not presume that heroin addicts are competent to do this since heroin addiction by nature involves a loss of ability to resist the desire for heroin. In this article, I argue that Charland is right that we should not presume that heroin addicts are competent to consent, but not for the reason he thinks. In fact, as Charland's critics correctly point out, there is plenty of evidence showing that heroin addicts can resist their desire for heroin. These critics are wrong, however, to conclude from this that we should presume that heroin addicts are competent to give their voluntary consent. There are, I shall argue, other conditions associated with heroin addiction that might constrain heroin addicts' choice in ways likely to undermine the voluntariness of their consent. In order to see this, we need to move beyond the focus on the addicts' desires for heroin and instead consider the wider social and psychological circumstances of heroin addiction, as well as the effects these circumstances may have on the addicts' beliefs about the nature of their options.

  15. [Informed consent of the surgical patient].

    PubMed

    Kovács, József

    2014-02-01

    The article analyses the consequences of the paradigm shift in the surgical practice in the last fifty years. The earlier, paternalistic physician-patient relationship has been replaced by an equal one, which is based on informing the patient and involving him or her in the treatment decisions. This shift did not happen uniformly in various medical subspecialties. In this respect, surgery is more conservative than general medicine. The article analyses the most frequent problems of informing patients, and examines the major elements of information, together with their technical conditions in surgery. It reflects on specifics of surgical information disclosure and conditions of refusing medical interventions.

  16. 7 CFR 1c.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... may involve a human being as a subject in research covered by this policy unless the investigator has... the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the...

  17. 28 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., no investigator may involve a human being as a subject in research covered by this policy unless the... subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the...

  18. 10 CFR 745.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... a subject in research covered by this policy unless the investigator has obtained the legally... shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the...

  19. 32 CFR 219.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... subject in research covered by this policy unless the investigator has obtained the legally effective... language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to...

  20. 49 CFR 11.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... investigator may involve a human being as a subject in research covered by this policy unless the investigator... the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the...

  1. Informed Consent, Disclosure, and Performance of Human Research Subjects.

    ERIC Educational Resources Information Center

    Mason, Emanuel J.; Remer, Rory

    The effects of conditions of informed consent and disclosure on the performance of 84 students doing a statistics laboratory assignment for an introductory graduate course in statistics at a state university in the southeast were studied. Four separate classes taught by three instructors were included. Subjects ranged in age from 22 to 47 years,…

  2. Confidentiality and Informed Consent: School Counsellors' Perceptions of Ethical Practices

    ERIC Educational Resources Information Center

    Lehr, Ron; Lehr, Andria; Sumarah, John

    2007-01-01

    This article presents the findings of in-depth interviews with school counsellors in Nova Scotia on issues related to confidentiality and informed consent. Of the 224 school counsellors in the province, 43 counsellors, representing all school boards, agreed to a 45-minute semi-structured telephone interview focusing on their current practices…

  3. Teaching the Process of Obtaining Informed Consent to Medical Students.

    ERIC Educational Resources Information Center

    Johnson, Shirley M.; And Others

    1992-01-01

    A unit on informed consent for first-year osteopathy students consists of pre- and posttests, a lecture, readings, small-group discussion, a model videotaped interview, and students' videotaped interviews with a simulated patient. Students were most successful in establishing patient rapport and discussion, least successful in conflict resolution…

  4. Informed consent in opioid therapy: a potential obligation and opportunity.

    PubMed

    Cheatle, Martin D; Savage, Seddon R

    2012-07-01

    Most patients receiving opioids for the spectrum of pain disorders tolerate opioids well without major complications. However, a subset of this population encounters significant difficulties with opioid therapy (OT). These problems include protracted adverse effects, as well as misuse, abuse, and addiction, which can result in significant morbidity and mortality and make informed consent an important consideration. Opioid treatment agreements (OTAs), which may include documentation of informed consent, have been used to promote the safe use of opioids for pain. There is a debate regarding the effectiveness of OTAs in reducing the risk of opioid misuse; however, most practitioners recognize that OTAs provide an opportunity to discuss the potential risks and benefits of OT and establish mutually agreed-on treatment goals, a clear plan of treatment, and circumstances for continuation and discontinuation of opioids. Informed consent is an important component of an OTA but not often the focus of consideration in discussions of OTAs. This article examines the principles, process, and content of informed consent for OT of pain in the context of OTAs.

  5. 45 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false Documentation of informed consent. 46.117 Section 46.117 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.117 Documentation...

  6. Informed Consent in Opioid Therapy: A Potential Obligation and Opportunity

    PubMed Central

    Cheatle, Martin D.; Savage, Seddon R.

    2012-01-01

    The majority of patients receiving opioids for the spectrum of pain disorders experiences negligible or short-term adverse effects (AEs), and rarely develops addiction. However, a subset of this population encounters significant difficulties with opioid therapy. These problems include protracted AEs, as well as misuse, abuse and addiction, which can result in significant morbidity and mortality and makes informed consent an important consideration. Opioid treatment agreements (OTAs), which may include documentation of informed consent, have been employed to promote the safe use of opioids for pain. There is debate regarding the effectiveness of OTAs in reducing the risk of opioid misuse; however, most practitioners recognize that OTAs provide an opportunity to discuss the potential risks and benefits of opioid therapy and to establish mutually agreed upon treatment goals, a clear plan of treatment, and circumstances for continuation and discontinuation of opioids. Informed consent is an important component of an OTA but is not often the focus of consideration in discussions of OTAs. This article examines the principles, process, and content of informed consent for opioid therapy of pain in the context of OTAs. PMID:22445273

  7. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 1 2013-07-01 2013-07-01 false Documentation of informed consent. 97.117 Section 97.117 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research...

  8. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 1 2014-07-01 2014-07-01 false Documentation of informed consent. 97.117 Section 97.117 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research...

  9. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 false Documentation of informed consent. 97.117 Section 97.117 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research...

  10. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 1 2012-07-01 2012-07-01 false Documentation of informed consent. 97.117 Section 97.117 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research...

  11. 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 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION... and that notes the possibility that the Food and Drug Administration may inspect the records. (6)...

  12. 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 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION... and that notes the possibility that the Food and Drug Administration may inspect the records. (6)...

  13. 21 CFR 50.25 - Elements of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Elements of informed consent. 50.25 Section 50.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION... and that notes the possibility that the Food and Drug Administration may inspect the records. (6)...

  14. Informed consent in Croatia. A work in progress.

    PubMed

    Vučemilo, Luka; Borovečki, Ana

    2014-07-01

    As Croatia makes the transition from one political system and type of economy to another, there are inevitable social and political changes that have a profound affect on the healthcare system. This article charts some of the progress of change with respect to patients' rights and informed consent.

  15. Informed Consent for Return of Incidental Findings in Genomic Research

    PubMed Central

    Appelbaum, Paul S.; Waldman, Cameron R.; Fyer, Abby; Klitzman, Robert; Parens, Erik; Martinez, Josue; Price, W. Nicholson; Chung, Wendy K.

    2013-01-01

    Purpose Researchers face the dilemma of how to obtain consent for return of incidental findings (IFs) from genomic research. We surveyed and interviewed investigators and study participants, with the goal of providing suggestions for how to shape the consent process. Methods We performed an online survey of 254 US genetic researchers identified through the NIH RePORTER database and abstracts from the 2011 American Society of Human Genetics meeting; and qualitative semi-structured interviews with 28 genomic researchers and 20 research participants. Results Most researchers and participants endorsed disclosure of a wide range of information about return of IFs, including: risks, benefits, impact on family members, data security, and procedures for return of results in the event of death or incapacity and for recontact. However, most researchers were willing to devote 30 minutes or less to this process, and expressed concerns that disclosed information would overwhelm participants, a concern shared by many participants themselves. Conclusion There is a disjunction between the views of investigators and participants about the amount of information that should be disclosed and the practical realities of the research setting, including time available for consent discussions. This strongly suggests the need for innovative approaches to the informed consent process. PMID:24158054

  16. Assessing elements of informed consent among living donors

    PubMed Central

    Valapour, M; Kahn, JP; Bailey, R; Matas, AJ

    2011-01-01

    Living organ donors – 50% of solid organ donors in the United States – represent a unique population who accept medical risk for the benefit of another. One of the main justifications for this practice has been respect for donor autonomy, as realized through informed consent. In this retrospective study of living donors, we investigate 2 key criteria of informed consent: (1) depth of understanding and (2) degree of voluntariness. In our survey of 262 living kidney donors 2 to 40 months post donation, we found that more than 90% understood the effects of living donation on recipient outcomes, the screening process, and the short-term medical risks of donation. In contrast, only 69% understood the psychological risks of donation; 52% the long-term medical risks of donation; and 32%, the financial risks of donation. Understanding the effects of living donation on recipient outcomes was the only factor that would affect donors' decision to donate again. 40% of donors reported feeling some pressure to donate. Donors who are related to the recipient were more likely to report feeling pressure to donate. We conclude that more studies of informed consent are needed to identify factors that may compromise the validity of informed consent. PMID:21158924

  17. Demoralisation: its impact on informed consent and medical care.

    PubMed

    Kissane, D W

    2001-11-19

    Demoralisation, a mental state characterised by hopelessness and meaninglessness, can be differentiated from depression in that demoralised patients can enjoy the present, their lack of hope being confined to the future. However, like severe depression, demoralisation can interfere with a person's capacity to give informed consent. Doctors and other health professionals are also subject to demoralisation, which influences medical care.

  18. 7 CFR 1c.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject...: (1) A statement that the study involves research, an explanation of the purposes of the research...

  19. 10 CFR 745.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative... the study involves research, an explanation of the purposes of the research and the expected...

  20. Informed Consent in Educational Settings and the Novice Researcher

    ERIC Educational Resources Information Center

    Sanderson, Lara

    2010-01-01

    Research ethics are of fundamental importance to any research. They define and shape the research process from the very beginning as they are the code on which academics rely on as guiding practice in the field (Hopf, 2004). Informed consent is an interesting concept as it is interwoven with other ethical issues that include power, privacy and…

  1. Informed Consent Policies Governing Medical Students' Interactions with Patients.

    ERIC Educational Resources Information Center

    Cohen, Daniel L.; And Others

    1987-01-01

    To determine compliance with the guidelines of the U.S. government and the Joint Committee on Accreditation of Hospitals pertaining to informed consent, hospital administrators, medical school department chairpersons, and medical school deans were surveyed about policies on student involvement in patient care. (Author/MLW)

  2. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides...

  3. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides...

  4. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides...

  5. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides...

  6. 40 CFR 26.1116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... informed consent. No investigator may involve a human being as a subject in research covered by this... study involves research, an explanation of the purposes of the research and the expected duration of...

  7. 40 CFR 26.1116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... informed consent. No investigator may involve a human being as a subject in research covered by this... provided to each subject: (1) A statement that the study involves research, an explanation of the...

  8. Use of altered informed consent in pragmatic clinical research

    PubMed Central

    McKinney, Ross E.; Beskow, Laura M.; Ford, Daniel E.; Lantos, John D.; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J.; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin

    2015-01-01

    There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to IRBs as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients’ rights and interests. PMID:26374677

  9. Use of altered informed consent in pragmatic clinical research.

    PubMed

    McKinney, Ross E; Beskow, Laura M; Ford, Daniel E; Lantos, John D; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin

    2015-10-01

    There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to institutional review boards as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients' rights and interests.

  10. 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. 
.

  11. Guiding patients through the choices for treating vestibular schwannomas: balancing options and ensuring informed consent. 2007.

    PubMed

    Backous, Douglas D; Pham, Huong T

    2008-04-01

    Counseling patients who are diagnosed with vestibular schwannomas, formerly known as acoustic neuromas, can be challenging. The health care provider has the responsibility to explain, in understandable language, to the patient or legal representative the proposed treatment options, risks and complications associated with each form of treatment, and alternatives to treatment, including no therapy. Patients should be encouraged to gather information before making a treatment decision. For the physicians managing these patients, information should be delivered in a balanced way to ensure patient understanding of their options leading to adequate informed consent.

  12. Historical trends in the timing of informed consent for research into intrapartum complications.

    PubMed

    Patel, D; Nasir, S; Elati, A; Vernon, G; Weeks, A D

    2012-02-01

    Obtaining informed consent for clinical trials involving the management of intrapartum complications is complex. This article describes the strategies used to obtain consent over the last 60 years using data from the Cochrane Library. Of 138 intrapartum randomised studies, 37% had no record of the consent procedures. Of the remainder, 74% sought consent only when the complication developed, 11% sought consent from all women in early labour, and 13% gave all women antenatal information and then sought written consent when the complication arose. Despite the existence of ethics guidelines for intrapartum consent, many studies fail to follow their advice.

  13. Aspects of vulnerable patients and informed consent in clinical trials

    PubMed Central

    Kuthning, Maria; Hundt, Ferdinand

    2013-01-01

    Scope: To discuss the rationale behind informed consent in clinical trials focusing on vulnerable patients from a European and German viewpoint. Methods: Scientific literature search via PubMed, Medline, Google. Results: Voluntary informed consent is the cornerstone of policies regulating clinical trials. To enroll a patient into a clinical trial without having obtained written and signed consent is to be considered as a serious issue in the conduct of a clinical trial. Development of ethical guidance for physicians started before Christ Era with the Hippocratic Oath. Main function of consent, as articulated in all guidelines developed for clinical research, is to facilitate an individual’s freedom of choice, respect autonomy, and thus to ensure welfare of the participants in clinical trials. Minors are unable to provide legally binding informed consent, this issue is addressed through a combination of parental permission and minor’s assent. Illiteracy is a critical problem that affects all corners of our earth; it has no boundaries and exists among every race and ethnicity, age group, and economic class. New strategies to improve communication with patients including the use of videotapes or animated cartoon illustrations could be taught. Finally the time with the potential participant seems to be the best way to improve understanding. Conclusion: Discovery of life saving and life enhancing new treatments requires partnership that is based on good communication and trust between patients and researchers, sponsors, ethics committees, authorities, lawyers and politicians so that vulnerable patients can benefit from the results of well controlled clinical trials. PMID:23346043

  14. Clinical writing about clients: is informed consent sufficient?

    PubMed

    Barnett, Jeffrey E

    2012-03-01

    The use of client information in clinical writings or presentations may be very helpful in advancing the knowledge base of the profession. Yet, the very act of asking a client for permission to use their treatment information in this way may be detrimental to the therapeutic alliance and treatment process. As such, great care must be taken in how such issues are considered and acted upon. Sieck's article (2011, Obtaining clinical writing informed consent versus using client disguise and recommendations for practice. Psychotherapy, 49, pp. 3-11.) on the use of informed consent for obtaining permission to use a client's treatment information for professional writing and presentations is examined and discussed. The nature and role of the informed consent process is accentuated; psychotherapist needs and goals and client vulnerabilities are each addressed in the context of the relevant sections of the APA Ethics Code and each psychotherapist's obligation to act only in ways consistent with each client's best interests. Recommendations for a thoughtful consideration of these issues are presented, consistent with Sieck's proposed decision-making process for use in these situations.

  15. [Medical intervention and assault: On the legal foundations of informed consent in German surgery, 1892-1940].

    PubMed

    Maehle, Andreas-Holger

    2003-01-01

    The recent historiography of informed consent in German medicine has chiefly focused on the issue of consent to human experimentation. This paper widens the historical perspective by demonstrating that the foundations of the concept of informed consent to surgery were laid in German law around 1900. From the 1890s onwards a debate about the legal basis of surgical operations developed in response to cases of medical intervention without full consent. While surgeons were unwilling to accept a legal interpretation of non-consensual treatment as assault, jurists were divided over the issue. Whereas Carl Stooss (1849-1934) and Joseph Heimberger (1865-1927) and Ludwig von Bar (1836-1913), endorsed the view that consent was a crucial requirement for the legality of surgical operations. Moreover, the German Supreme Court (Reichsgericht) in Leipzig consistently emphasized in its decisions the necessity of patients' consent. From 1912 it dealt also with the question of adequate pre-operative information of patients. Despite pressures during the Third Reich to reduce patients' "rule" over their own body in favour of notions of the health of the Volk, the Supreme Court upheld the requirement of individual patient consent in two further decisions, in 1936 and 1940.

  16. Epidural analgesia during labour - maternal understanding and experience - informed consent.

    PubMed

    Mahomed, K; Chin, D; Drew, A

    2015-01-01

    Women obtain information on epidural analgesia from various sources. For epidural for pain relief in labour this is provided by the anaesthetist as part of the consenting process. There is much discussion about the inadequacy of this consenting process; we report on women's knowledge, experience and recall of this process at a regional hospital with a 24-h epidural service. Fifty-four women were interviewed within 72 h of a vaginal birth. 91% of the women had acquired information from friends, relatives and antenatal classes. Lack of recall of benefits of epidural analgesia accounted for 26 (38%) and 25 (26%) of the responses, respectively. Similarly in terms of amount of pain relief they could expect, 13 (21%) could not remember and 13 (21%) thought that it may not work. We suggest use of varying methods of disseminating information and wider utilisation of anaesthetists in the antenatal educational programmes.

  17. Legal issues affecting confidentiality and informed consent in reproductive health.

    PubMed

    Rockett, L R

    2000-01-01

    The law governing confidentiality and informed consent has acquired unique characteristics in the area of reproductive health, as a consequence of both the establishment of a constitutional right to privacy in reproductive health matters and the reaction of those politically and morally opposed to the exercise of that right. The primary issues have involved: 1) the right of minors to receive reproductive health services without parental consent, which remains a political battleground; 2) laws requiring physicians to provide information to pregnant patients that is intended, not to inform them of the risks and benefits of the procedure, but to discourage them from obtaining abortions; 3) coerced and prohibited sterilizations; 4) court-ordered contraception and procedures to protect the fetus; and 5) restrictions on counseling about abortion, contraception, sterilization, and other reproductive health services authorized by state conscience or noncompliance clauses that shield such restrictions from the usual ethical, medical, and legal rules governing informed consent. The last area is of profound significance to the ability of women to make informed decisions about their reproductive health options. In the current economic environment, which fuels mergers and acquisitions involving sectarian and nonsectarian institutions, women are increasingly being put at risk as a result of such restrictions.

  18. Fiberoptic endoscopic evaluation of swallowing (FEES): proposal for informed consent

    PubMed Central

    Nacci, A; Ursino, F; La Vela, R; Matteucci, F; Mallardi, V; Fattori, B

    2008-01-01

    Summary Fiberoptic endoscopic evaluation of swallowing (FEES) is now a first choice method for studying swallowing disorders on account of the various advantages it offers: easy to use, very well tolerated, allows bedside examination and is economic. Nevertheless, this diagnostic procedure is not without risks, the most probable consequences of which include discomfort, gagging and/or vomiting, vasovagal syncope, epistaxis, mucosal perforation, adverse reactions to topical anaesthetics and laryngospasm. The risks involved with FEES stress the importance of informing the patient of these; this is an important aspect in medicine that necessarily and immediately implies receiving the patient’s so-called “informed consent”. Informed consent should be obtained not only by means of specific printed forms but also after the patient has had an interview with the physician who will be performing the procedure and who will offer information according to the personal clinical, psychological, cultural and linguistic situation of the patient and in keeping with the type of procedure proposed. In the case of FEES, as with other invasive or non-invasive diagnostic procedures, therefore, routine written and signed consent, together with a patient/physician interview should fulfil what is known as “complete information”. In this report, a specific form for informed consent to FEES procedures, is proposed. PMID:18939710

  19. 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.

  20. 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.

  1. Informed consent in experimentation involving mentally impaired persons: ethical issues.

    PubMed

    Petrini, Carlo

    2010-01-01

    The problem of experimentation involving subjects whose mental condition prevents them from understanding information and providing proper informed consent has been addressed in various codes, declarations, conventions, treaties and regulations adopted by national, international and supranational institutions and authorities. This article summarizes the basic ethical criteria these documents provide and stresses the historical development from the nearly total exclusion of incapacitated subjects, established in the mid-twentieth century, to their contemporary inclusion in clinical trials on certain ethical conditions. The problem of proxy consent by legal representatives for participation in clinical trials is addressed particularly in reference to current Italian regulations. Exceptions to human experimentation requirements in emergency situations are also briefly discussed.

  2. Autonomy, consent and responsability. Part 1: limitations of the principle of autonomy as a foundation of informed consent.

    PubMed

    Mellado, J M

    2016-01-01

    Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility.

  3. The effects of informed consent format on preoperative anxiety in patients undergoing inferior third molar surgery

    PubMed Central

    Heras-Meseguer, Marisa; Azcárate-Velázquez, Francisco; Hita-Iglesias, Pilar; Ruiz-de-León-Hernández, Gonzalo; Hernández-Pacheco, Esther; Gutiérrez-Pérez, José L.

    2014-01-01

    Objectives: To evaluate the effect of informed consent format on preoperative anxiety of patients. Material and Methods: We performed a prospective study (91 patients) undergoing lower third molar extraction. Patients were distributed into three groups. Informed consent for surgery was obtained through a written document, an oral interview or a video recording. Afterwards, patients were asked about their anxiety level and the effect the informed consent had had on it. Results: Whereas the information conveyed both in oral and written formats relieved the patient to some extent (in a scale of -3 to +3) 0.97±1.21 and 0.29±0.97, respectively), the video recording increased patient’s anxiety in a statistically significant way (in a scale of -3 to +3, -0.57±1.43). The difference obtained between the values obtained in oral and written information was not statistically significant. Discussion: The most adequate format, according to our study, would be the oral format. Key words:Anxiety, satisfaction, third molar surgery, Spielberger State-Trait Anxiety Inventory. PMID:24316709

  4. 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.

  5. Informed consent in human experimentation before the Nuremberg code.

    PubMed Central

    Vollmann, J.; Winau, R.

    1996-01-01

    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. Images p1445-a p1446-a PMID:8973233

  6. Patient Privacy, Consent, and Identity Management in Health Information Exchange

    PubMed Central

    Hosek, Susan D.; Straus, Susan G.

    2013-01-01

    Abstract The Military Health System (MHS) and the Veterans Health Administration (VHA) have been among the nation's leaders in health information technology (IT), including the development of health IT systems and electronic health records that summarize patients' care from multiple providers. Health IT interoperability within MHS and across MHS partners, including VHA, is one of ten goals in the current MHS Strategic Plan. As a step toward achieving improved interoperability, the MHS is seeking to develop a research roadmap to better coordinate health IT research efforts, address IT capability gaps, and reduce programmatic risk for its enterprise projects. This article contributes to that effort by identifying gaps in research, policy, and practice involving patient privacy, consent, and identity management that need to be addressed to bring about improved quality and efficiency of care through health information exchange. Major challenges include (1) designing a meaningful patient consent procedure, (2) recording patients' consent preferences and designing procedures to implement restrictions on disclosures of protected health information, and (3) advancing knowledge regarding the best technical approaches to performing patient identity matches and how best to monitor results over time. Using a sociotechnical framework, this article suggests steps for overcoming these challenges and topics for future research. PMID:28083296

  7. Towards better-informed consent: Research with livestock-keepers and informal traders in East Africa.

    PubMed

    Cooper, Tarni Louisa; Kirino, Yumi; Alonso, Silvia; Lindahl, Johanna; Grace, Delia

    2016-06-01

    With the rise of the One Health paradigm, ethicists have called for new research approaches, considering the interdependent relationships of humans, animals, and their environment. These relationships can be particularly complex within resource-poor, smallholder livestock systems, necessitating a rigorous informed-consent process. Little has been published on informed consent beyond human-subject research. This paper outlines two studies on informed consent, for research identifying diseases of animal and human importance, within smallholder livestock value chains. Firstly, a randomized independent-group study compared three communication tools (written, cartoons, and photographs) for informing 22 Tanzanian livestock-keepers before seeking their consent. A significant difference in comprehension and engagement in the informed-consent process was found between tools, and cartoons had the highest (i.e. best combined comprehension and engagement) scores. Most (21 out of 22) farmers answered half or more the questions correctly, but none were able to answer all questions. Comprehension testing allowed identification of common misunderstandings, such as immediate benefits the farmers would receive and the process to be used for relaying research results. Dialogue stimulated by cartoons and photographs allowed researchers to determine and respond to participants' varied relationships with their livestock. The second study assessed preferred methods for indicating consent among informal-sector milk vendors in Nairobi, Kenya. Of consenting participants, 61% (140/230) indicated consent verbally, 39% (90/230) signed consent and none chose thumbprint. There was a significant enumerator-effect on both overall consent and the methods chosen. Several of these findings echo those published in human-medical research. Additionally, highlighted here is the importance of facilitating dialogue during the informed-consent process in One Health research, for a more nuanced understanding

  8. Informed consent in direct-to-consumer personal genome testing: the outline of a model between specific and generic consent.

    PubMed

    Bunnik, Eline M; Janssens, A Cecile J W; Schermer, Maartje H N

    2014-09-01

    Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue that current practices of information provision are insufficient and that there is a place--and a need--for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings.

  9. Informed consent: what health care professionals need to know, Part 2.

    PubMed

    Fiesta, J

    1999-07-01

    In Part 1, the author explained that although the responsibility to obtain informed consent typically rests with physicians, nurse managers need to understand their role as caregivers and members of the health care team. This month, read about informed consent issues such as the verbal contract, emergency procedures, and the patient's competence to consent.

  10. Informed consent in robotic surgery: quality of information and patient perception

    PubMed Central

    Pozzi, Giada; Borghi, Felice; Pellegrino, Luca; Di Lorenzo, Pierpaolo; Amato, Bruno; Santangelo, Michele; Niola, Massimo; Martino, Valter; Capasso, Emanuele

    2016-01-01

    Abstract Introduction Obtaining a valid informed consent in the medical and surgical field is a long debated issue in the literature. In robotic surgery we believe in the necessity to follow three arrangements to make the informed consent more complete. Material and methods This study presents correlations and descriptions based on forensic medicine concepts research, literature review, and the proposal of an integration in the classic concept of informed consent. Conclusion In robotic surgery we believe in the necessity to follow three arrangements to make the IC more complete. Integrate the information already present in the informed consent with data on the surgeon’s experience in RS, the number of procedures of the department and the regional map of expertises by procedure. PMID:28352808

  11. 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.

  12. 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.

  13. Informed consent procedures: responsibilities of researchers in developing countries.

    PubMed

    Sanchez, S; Salazar, G; Tijero, M; Diaz, S

    2001-10-01

    We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision-making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and to discuss it with partners or relatives; and perceived benefits such as quality of care, non-cost provision of methods and medical care. For some women, participation was an opportunity to express altruism. The main obstacles for participation were perceived side effects or risks. The final risk-benefit balance was strongly influenced by women's needs. Women perceived that the consent form benefited the clinic, proving that participants had made a free decision, and benefited the volunteers by warranting their right to free medical care. The most important problem detected was occasional misunderstanding of the information given on the form. We concluded that a full decision-making process enhances women's ability to exercise their right to choose, and assures research institutions that trials are conducted without coercion and that the participants are committed to the study. Researchers have the responsibility of conducting this process.

  14. Why does informed consent fail? A discourse analytic approach.

    PubMed

    Ness, David E; Kiesling, Scott F; Lidz, Charles W

    2009-01-01

    Informed consent often fails to meet the intended goals that a prospective subject should understand fully and choose autonomously to participate in research. The current study is an attempt to understand such failures by applying linguistic methods of discourse analysis to the transcripts of informed consent interviews. Elements of conversation and of the frame of discourse were analyzed to understand how the participants shaped their spoken interaction during the interview. We looked at the degree to which the subject appeared to be fully informed, at the problem of therapeutic misconception, and at the degree to which the subject was helped to explore concerns relevant to the choice at hand. We found that lapses or miscommunications could be understood specifically in terms of conversational elements and framing. This kind of detailed, language-based analysis is an alternative to approaches that are more abstract and inferential, such as those that are based upon the attitudes or the cognitive performance of speakers. We discuss possible educational and research implications of this approach.

  15. Cross-cultural perspectives on research participation and informed consent.

    PubMed

    Barata, Paula C; Gucciardi, Enza; Ahmad, Farah; Stewart, Donna E

    2006-01-01

    This study examined Portuguese Canadian and Caribbean Canadian immigrants' perceptions of health research and informed consent procedures. Six focus groups (three in each cultural group) involving 42 participants and two individual interviews were conducted. The focus groups began with a general question about health research. This was followed by three short role-plays between the moderator and the assistant. The role-plays involved a fictional health research study in which a patient is approached for recruitment, is read a consent form, and is asked to sign. The role-plays stopped at key moments at which time focus group participants were asked questions about their understanding and their perceptions. Focus group transcripts were coded in QSR NUDIST software using open coding and then compared across cultural groups. Six overriding themes emerged: two were common in both the Portuguese and Caribbean transcripts, one emphasized the importance of trust and mistrust, and the other highlighted the need and desire for more information about health research. However, these themes were expressed somewhat differently in the two groups. In addition, there were four overriding themes that were specific to only one cultural group. In the Portuguese groups, there was an overwhelming positive regard for the research process and an emphasis on verbal as opposed to written information. The Caribbean participants qualified their participation in research studies and repeatedly raised images of invasive research.

  16. 34 CFR 303.401 - Definitions of consent, native language, and personally identifiable information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 2 2010-07-01 2010-07-01 false 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...

  17. 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...

  18. Intentional Learning: The Need for Explicit Informed Consent in Higher Education.

    ERIC Educational Resources Information Center

    Connelly, R. J.

    2000-01-01

    Argues that student consent should be practiced in higher education, and that general education, which emphasizes critical thinking, should bear the greatest responsibility for promoting this movement. Discusses the history of informed consent in medicine and paternalism in health care and higher education, stressing that consent in postsecondary…

  19. Managing the "known unknowns": theranostic cancer nanomedicine and informed consent.

    PubMed

    Jotterand, Fabrice; Alexander, Archie A

    2011-01-01

    The potential clinical applications and the economic benefits of theranostics represent a tremendous incentive to push research and development forward. However, we should also carefully examine the possible downsides. In this chapter, we address the issue of how theranostics might challenge our current concept of informed consent, especially the disclosure of information concerning diagnosis and treatment options to human subjects. We argue that our lack of data concerning long-term effects and risks of nanoparticles on human health and the environment could undermine the process when it comes to weighing the risks against the benefits. Our lack of an agreed upon framework for risk management in nanomedicine may require us to adopt an "upstream" approach that emphasizes communication and transparency among all relevant stakeholders to help them make informed choices that enable safety or progress.

  20. [Patient autonomy and informed consent - ethical and legal issues].

    PubMed

    Wolf-Braun, Barbara; Wilke, Hans-Joachim

    2015-03-01

    Informing patients about the benefits and risks of and alternatives to proposed medical or surgical procedures is crucial to the patient-physician relationship. It is a legal and ethical precondition to a patient's informed consent to a course of action. Particularly in cases of serious illness and when there are far reaching implications for a patient's lifestyle, this process entails much more than just imparting information. Indeed, it is a dialogue through which the physician empowers the patient to reach a decision which reflects the patient's life situation and system of values. This process promotes patient autonomy. Studies have shown that this approach builds trust, increases patient satisfaction with health care and results in a higher degree of professional fulfilment for the physician.

  1. Hope and Persuasion by Physicians During Informed Consent

    PubMed Central

    Miller, Victoria A.; Cousino, Melissa; Leek, Angela C.; Kodish, Eric D.

    2014-01-01

    Purpose To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure. Patients and Methods Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire. Results The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower. Conclusion Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain. PMID:25199753

  2. Informed Consent in cross-cultural perspective: clinical research in the Tibetan Autonomous Region, PRC.

    PubMed

    Adams, Vincanne; Miller, Suellen; Craig, Sienna; Sonam; Nyima; Droyoung; Le, Phuoc V; Varner, Micheal

    2007-12-01

    Procedures of Informed Consent are considered a high priority for international biomedical research. However, informed consent protocols are not necessarily transferable across cultural, national or ethnic groups. Recent debates identify the need for balancing ethical universals with practical and local conditions and paying attention to questions of cultural competence when it comes to the Informed Consent process for clinical biomedical research. This article reports on the results of a two-year effort to establish a culturally appropriate Informed Consent process for biomedical research in the Tibet Autonomous Region in the People's Republic of China. A team of Tibetan and American researchers, physicians, health professionals and medical anthropologists conducted the research. The Informed Consent was specifically for undertaking a triple-blind, double placebo-controlled randomized clinical trial of a Tibetan medicine compared with Misoprostol for reducing postpartum blood loss. The findings suggest greater need for flexibility and cooperation in establishing Informed Consent protocols across cultures and nations.

  3. 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.

  4. Informed consent and the history of inclusion of women in clinical research.

    PubMed

    Stevens, Patricia E; Pletsch, Pamela K

    2002-12-01

    The purposes of this paper are to (a) discuss the troubled history of informed consent for research on women and its ramifications for women's participation in clinical trials; (b) interrogate current informed consent practices as to their accountability and justice in the treatment of women; and (c) recommend to nurse researchers and clinical nurses ways of improving the practice of informed consent in research with women.

  5. 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

  6. The politics of information: informed consent in abortion and end-of-life decision making.

    PubMed

    Suter, Sonia M

    2013-01-01

    The politics of reproduction dominate the political landscape now more than ever. One area of controversy has been informed consent statutes for abortion, which have been praised by the pro-life movement but derided by the pro-choice movement. More recently, legislatures have begun to enact informed consent statutes with respect to end-of-life decision making, an area almost as politically controversial as abortion. Like many abortion disclosure laws, some of these have been entitled "Right to Know" statutes. Yet, the supporters and opponents of each set of statutes tend not to be the same, aligning to a large extent based on their place in the culture wars over life and death. In this Article, I strive not only to show the remarkably similar critiques each side marshals but also to use these concerns to think in more nuanced ways about the goals of informed consent and whether the disclosure mandates achieve those goals. I first argue in favor of the aspirational goals of informed consent as a process that allows patients to participate in their medical decision making. While conceding the inherently political nature of abortion and end-of-life care, I also contend that the significance of decisions regarding those matters warrants, at least in theory, legislative efforts to ensure that patients have the opportunity to engage in deliberative and informed decision making. In describing and responding to the similar critiques of both sets of laws--the political bias of the statutes; the efforts to persuade, especially with non-medical information; the potential vulnerability of the targeted audience; and the interference with physician discretion--I uncover and challenge some of the presumptions about informed consent inherent in those critiques. Although information that persuades or influences is not per se problematic, I argue that disclosure of information that is inaccurate, untrue, or emotionally inflammatory harms informed consent. Even well-crafted informed

  7. 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.

  8. 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

  9. Comparison of participant information and informed consent forms of five European studies in genetic isolated populations

    PubMed Central

    Mascalzoni, Deborah; Janssens, A Cecile JW; Stewart, Alison; Pramstaller, Peter; Gyllensten, Ulf; Rudan, Igor; van Duijn, Cornelia M; Wilson, James F; Campbell, Harry; Quillan, Ruth Mc

    2010-01-01

    Family-based research in genetically isolated populations is an effective approach for identifying loci influencing variation in disease traits. In common with all studies in humans, those in genetically isolated populations need ethical approval; however, existing ethical frameworks may be inadequate to protect participant privacy and confidentiality and to address participants' information needs in such populations. Using the ethical–legal guidelines of the Council for International Organizations of Medical Sciences (CIOMS) as a template, we compared the participant information leaflets and consent forms of studies in five European genetically isolated populations to identify additional information that should be incorporated into information leaflets and consent forms to guarantee satisfactorily informed consent. We highlight the additional information that participants require on the research purpose and the reasons why their population was chosen; on the potential risks and benefits of participation; on the opportunities for benefit sharing; on privacy; on the withdrawal of consent and on the disclosure of genetic data. This research raises some important issues that should be addressed properly and identifies relevant types of information that should be incorporated into information leaflets for this type of study. PMID:19826451

  10. Monetary incentives improve recall of research consent information: it pays to remember.

    PubMed

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

    2009-04-01

    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, the authors randomly assigned 31 drug court clients participating in a clinical research trial to a control group that received a standard informed consent procedure or to a group that received 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 control group (65% vs. 42%, p<.01). Findings from this study have important implications for the ethical conduct of human subject research. The incentivized consent procedure may be useful for improving consent recall in research studies, particularly those involving potentially serious side effects. The results also provide an important "proof of concept" regarding the utility of motivational procedures for improving recall of consent information.

  11. [Is my patient able to provide informed consent? A practical guideline].

    PubMed

    Vinkers, Christiaan H; van de Kraats, Gerrit B; Biesaart, Monique C; Tijdink, Joeri K

    2014-01-01

    Patient autonomy is a fundamental issue. Sometimes it is unclear whether a patient is capable to consent to a treatment decision. The treating physician judges whether a patient is able to provide informed consent. This judgement is a medical and not a legal decision. Considerations as to whether a patient can provide informed consent should always be systematically and in detail included in the medical records and should be periodically re-evaluated. Even if a patient incapable to consent to a particular medical decision, efforts should be put into finding the optimal treatment (proportional, effective and least substantial). It can be useful to involve a psychiatrist as a second and independent judge of a patient's ability to provide informed consent. A psychiatrist can also judge whether a psychiatric or cognitive disorder influences the ability to consent.

  12. 45 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... the research would be the consent document and the principal risk would be potential harm resulting... presents no more than minimal risk of harm to subjects and involves no procedures for which written consent... regarding the research. (Approved by the Office of Management and Budget under Control Number 0990-0260)...

  13. 34 CFR 99.31 - Under what conditions is prior consent not required to disclose information?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 false Under what conditions is prior consent not required to disclose information? 99.31 Section 99.31 Education Office of the Secretary, Department of Education FAMILY... Information From Education Records? § 99.31 Under what conditions is prior consent not required to...

  14. 21 CFR 50.24 - Exception from informed consent requirements for emergency research.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... emergency research. 50.24 Section 50.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Exception from informed consent requirements for emergency research. (a) The IRB responsible for the review... investigation without requiring that informed consent of all research subjects be obtained if the IRB (with...

  15. 21 CFR 50.24 - Exception from informed consent requirements for emergency research.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... emergency research. 50.24 Section 50.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Exception from informed consent requirements for emergency research. (a) The IRB responsible for the review... investigation without requiring that informed consent of all research subjects be obtained if the IRB (with...

  16. 21 CFR 50.24 - Exception from informed consent requirements for emergency research.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... emergency research. 50.24 Section 50.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Exception from informed consent requirements for emergency research. (a) The IRB responsible for the review... investigation without requiring that informed consent of all research subjects be obtained if the IRB (with...

  17. 21 CFR 50.24 - Exception from informed consent requirements for emergency research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... emergency research. 50.24 Section 50.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Exception from informed consent requirements for emergency research. (a) The IRB responsible for the review... investigation without requiring that informed consent of all research subjects be obtained if the IRB (with...

  18. Random Assignment and Informed Consent: A Case Study of Multiple Perspectives

    ERIC Educational Resources Information Center

    Walker, Robert; Hoggart, Lesley; Hamilton, Gayle

    2008-01-01

    Although random assignment is generally the preferred methodology in impact evaluations, it raises numerous ethical concerns, some of which are addressed by securing participants' informed consent. However, there has been little investigation of how consent is obtained in social experiments and the amount of information that can be conveyed--and…

  19. Meaningful Informed Consent with Young Children: Looking Forward through an Interactive Narrative Approach

    ERIC Educational Resources Information Center

    Mayne, Fiona; Howitt, Christine; Rennie, Léonie

    2016-01-01

    Ideas about ethical research with young children are evolving at a rapid rate. Not only can young children participate in the informed consent process, but researchers now also recognize that the process must be meaningful for them. As part of a larger study, this article reviews children's rights and informed consent literature as the foundation…

  20. 46 CFR Exhibit No. 2 to Subpart S... - Respondent's Consent Form for Informal Adjudication

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 9 2010-10-01 2010-10-01 false Respondent's Consent Form for Informal Adjudication No. Exhibit No. 2 to Subpart S of Part 502 Shipping FEDERAL MARITIME COMMISSION GENERAL AND ADMINISTRATIVE.... S, Exh. 2 Exhibit No. 2 to Subpart S of Part 502—Respondent's Consent Form for Informal...

  1. A National Survey Concerning the Ethical Aspects of Informed Consent and Role of Medical Students.

    ERIC Educational Resources Information Center

    Cohen, Daniel L.; And Others

    1988-01-01

    A national sample of medical students was surveyed to identify the ways the students obtained informed consent from their patients and to learn the students' views of certain issues concerning informed consent. All the students were less forthright about their status when given the opportunity to perform invasive procedures. (Author/MLW)

  2. 34 CFR 99.30 - Under what conditions is prior consent required to disclose information?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Under what conditions is prior consent required to disclose information? 99.30 Section 99.30 Education Office of the Secretary, Department of Education FAMILY... Information From Education Records? § 99.30 Under what conditions is prior consent required to...

  3. 38 CFR 17.32 - Informed consent and advance care planning.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... a proposed course of treatment or procedure involves approved medical research in whole or in part... AFFAIRS MEDICAL Protection of Patient Rights § 17.32 Informed consent and advance care planning. (a... the treatment or procedure. For the purpose of obtaining informed consent for medical treatment,...

  4. 38 CFR 17.32 - Informed consent and advance care planning.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... a proposed course of treatment or procedure involves approved medical research in whole or in part... AFFAIRS MEDICAL Protection of Patient Rights § 17.32 Informed consent and advance care planning. (a... the treatment or procedure. For the purpose of obtaining informed consent for medical treatment,...

  5. 38 CFR 17.32 - Informed consent and advance care planning.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... a proposed course of treatment or procedure involves approved medical research in whole or in part... AFFAIRS MEDICAL Protection of Patient Rights § 17.32 Informed consent and advance care planning. (a... the treatment or procedure. For the purpose of obtaining informed consent for medical treatment,...

  6. 38 CFR 17.32 - Informed consent and advance care planning.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... a proposed course of treatment or procedure involves approved medical research in whole or in part... AFFAIRS MEDICAL Protection of Patient Rights § 17.32 Informed consent and advance care planning. (a... the treatment or procedure. For the purpose of obtaining informed consent for medical treatment,...

  7. Informed consent: a survey of general dental practitioners in Belgaum city.

    PubMed

    Kotrashetti, Vijayalakshmi S; Kale, Alka D; Hebbal, Mamata; Hallikeremath, Seema R

    2010-01-01

    The informed consent process allows the patient or legal guardian to participate in and retain autonomy over the medical service received. Obtaining informed consent may also decrease the practitioner's liability from claims associated with miscommunication. The aim of this study was to assess knowledge and practices of general dental practitioners (GDPs) regarding informed consent. 118 GDPs in Belgaum city, Karnataka, India, were given questionnaires asking for information on their knowledge and practices related to informed consent. The questions covered general information, treatment-specific issues and the consent process. 80 responses were received out of which 44 were complete. 63.6% of GDPs reported that they obtained written consent. All of them reported that they obtained only general consent. 4 of them obtained written consent in the local language. 37 said they gave a detailed explanation of the procedure. 3 said they did not inform their patients on radiation exposure. Dentists should upgrade their knowledge regarding legal jurisprudence and legal medicine to avoid any litigation.

  8. Health literacy predicts participant understanding of orally-presented informed consent information.

    PubMed

    Ownby, Raymond L; Acevedo, Amarilis; Goodman, Kenneth; Caballero, Joshua; Waldrop-Valverde, Drenna

    Informed consent for participation in studies with human subjects is a critically important aspect of clinical research, but research has shown that many potential subjects do not understand information relevant to their participation. A better understanding of factors related to participant understanding of study-related information is thus important. As part of a study to develop a new measure of health literacy, participants viewed a 50 second video in their preferred language (Spanish or English) of a clinician presenting informed consent information. They then responded to six questions about it. In progressively more complicated regression models, we evaluated the relation of demographic variables, general cognitive ability, and health literacy to participants' recall of the information. In a model that only included demographic variables, Spanish language, black race and older age were associated with poorer performance. In a model that included the effects of general cognitive ability and health literacy as well as demographics, education and health literacy were related to performance. Informed consent interventions that take potential research subjects' levels of health literacy into account may result in better understanding of research-related information that can inform their decision to participate.

  9. Improving the Process of Informed Consent for PCI: Patient Outcomes from the ePRISM Study

    PubMed Central

    Spertus, John A.; Bach, Richard; Bethea, Charles; Chhatriwalla, Adnan; Curtis, Jeptha P.; Gialde, Elizabeth; Guerrero, Mayra; Gosch, Kensey; Jones, Philip; Kugelmass, Aaron; Leonard, Bradley M.; McNulty, Edward J.; Shelton, Marc; Ting, Henry H.; Decker, Carole

    2014-01-01

    Background While the process of informed consent is designed to transfer knowledge of the risks and benefits of treatment and to engage patients in shared medical decision-making, this is poorly done in routine clinical care. We assessed the impact of a novel informed consent form for percutaneous coronary intervention (PCI) that is more simply written, includes images of the procedure and embeds individualized estimates of outcomes on multiple domains of successful informed consent and shared decision-making. Methods We interviewed 590 PCI patients receiving traditional consent documents and 527 patients receiving novel ePRISM consents at 9 US centers and compared patients' perceptions, knowledge transfer and engagement in medical decision-making. Heterogeneity across sites was assessed and adjusted for using hierarchical models. Results Site-adjusted analyses revealed more frequent review (72% for ePRISM vs. 45% for original consents) and better understanding of the ePRISM consents (odds ratios (ORs)=1.8–3.0, depending upon the outcome) with marked heterogeneity across sites (median relative difference (MRD) in the ORs of ePRISM's effect = 2–3.2). Patients receiving ePRISM consents better understood the purposes and risks of the procedure (ORs=1.9–3.9, MRDs=1.1–6.2), engaged more in shared decision-making (proportional OR=2.1 [95%CI=1.02–4.4], MRD=2.2) and discussed stent options with their physicians (58% vs. 31%; site-adjusted odds ratio=2.7 [95% CI=1.2, 6.3], MRD=2.6) more often. Conclusions A personalized consent document improved the process of informed consent and shared decision-making. Marked heterogeneity across hospitals highlights that consent documents are but one aspect of engaging patients in understanding and participating in treatment. PMID:25641532

  10. Changing constructions of informed consent: qualitative research and complex social worlds.

    PubMed

    Miller, Tina; Boulton, Mary

    2007-12-01

    Informed consent is a concept which attempts to capture and convey what is regarded as the appropriate relationship between researcher and research participant. Definitions have traditionally emphasised respect for autonomy and the right to self-determination of the individual. However, the meaning of informed consent and the values on which it is based are grounded in society and the practicalities of social relationships. As society changes, so too do the meaning and practice of informed consent. In this paper, we trace the ways in which the meaning and practice of informed consent has changed over the last 35 years with reference to four qualitative studies of parenting and children in the UK which we have undertaken at different points in our research careers. We focus in particular on the shifting boundaries between the professional and personal, and changing expressions of agency and power in a context of heightened perceptions of risk in everyday life. We also discuss developments in information and communication technologies as a factor in changing both the formal requirements for and the situated practicalities of obtaining informed consent. We conclude by considering the implications for informed consent of both increasing bureaucratic regulation and increasingly sophisticated information and communication technologies and suggest strategies for rethinking and managing 'consent' in qualitative research practice.

  11. CTEPP STANDARD OPERATING PROCEDURE FOR OBTAINING INFORMED CONSENT (SOP-1.13)

    EPA Science Inventory

    The CTEPP informed consent procedures are described in the SOP. After an eligible subject provides verbal consent, staff schedule a visit to meet with the subject in person to explain study activities and answer questions about the study. During the visit, staff demonstrate how...

  12. Video-Assisted Informed Consent for Cataract Surgery: A Randomized Controlled Trial

    PubMed Central

    Ruan, Xiangcai; Tang, Haoying; Yang, Weizhong; Xian, Zhuanhua; Lu, Min

    2017-01-01

    Purpose. To investigate whether adding video assistance to traditional verbal informed consent advisement improved satisfaction among cataract surgery patients. Methods. This trial enrolled 80 Chinese patients with age-related cataracts scheduled to undergo unilateral phacoemulsification surgery. Patients were randomized into two groups: the video group watched video explaining cataract-related consent information and rewatched specific segments of the video at their own discretion, before receiving traditional verbal consent advisement; the control group did not watch the video. Outcomes included patient satisfaction, refusal to consent, time to complete the consent process, and comprehension measured by a ten-item questionnaire. Results. All 80 enrolled patients signed informed consent forms. Compared with the control group, members of the video group exhibited greater satisfaction (65% versus 86%, p = 0.035) and required less time to complete the consent process (12.3 ± 6.7 min versus 5.6 ± 5.4 min, p < 0.001), while also evincing levels of comprehension commensurate with those reported for patients who did not watch the video (accuracy rate, 77.5% versus 80.2%, p = 0.386). Conclusion. The video-assisted informed consent process had a positive impact on patients' cataract surgery experiences. Additional research is needed to optimize patients' comprehension of the video. PMID:28191349

  13. The role of effective communication in achieving informed consent for clinical trials.

    PubMed

    Pick, Andrew; Gilbert, Kayleigh; McCaul, James

    2014-11-11

    Informed consent is fundamental to the protection of the rights, safety and wellbeing of patients in clinical research. For consent to be valid, patients must first be given all the information they need about the proposed research to be able to decide whether they would like to take part. This material should be presented in a way that is easy for them to understand. This article explores the importance of communication in clinical research, and how more effective communication with patients during the informed consent process can ensure they are fully informed.

  14. Social Annotation Valence: The Impact on Online Informed Consent Beliefs and Behavior

    PubMed Central

    Shaer, Orit; Okerlund, Johanna; Westendorf, Lauren; Ball, Madeleine; Nov, Oded

    2016-01-01

    Background Social media, mobile and wearable technology, and connected devices have significantly expanded the opportunities for conducting biomedical research online. Electronic consent to collecting such data, however, poses new challenges when contrasted to traditional consent processes. It reduces the participant-researcher dialogue but provides an opportunity for the consent deliberation process to move from solitary to social settings. In this research, we propose that social annotations, embedded in the consent form, can help prospective participants deliberate on the research and the organization behind it in ways that traditional consent forms cannot. Furthermore, we examine the role of the comments’ valence on prospective participants’ beliefs and behavior. Objective This study focuses specifically on the influence of annotations’ valence on participants’ perceptions and behaviors surrounding online consent for biomedical research. We hope to shed light on how social annotation can be incorporated into digitally mediated consent forms responsibly and effectively. Methods In this controlled between-subjects experiment, participants were presented with an online consent form for a personal genomics study that contained social annotations embedded in its margins. Individuals were randomly assigned to view the consent form with positive-, negative-, or mixed-valence comments beside the text of the consent form. We compared participants’ perceptions of being informed and having understood the material, their trust in the organization seeking the consent, and their actual consent across conditions. Results We find that comment valence has a marginally significant main effect on participants’ perception of being informed (F2=2.40, P=.07); specifically, participants in the positive condition (mean 4.17, SD 0.94) felt less informed than those in the mixed condition (mean 4.50, SD 0.69, P=.09). Comment valence also had a marginal main effect on the

  15. Informed consent in human oocyte, embryo, and embryonic stem cell research.

    PubMed

    Lo, Bernard; Chou, Vicki; Cedars, Marcelle I; Gates, Elena; Taylor, Robert N; Wagner, Richard M; Wolf, Leslie; Yamamoto, Keith R

    2004-09-01

    Research with human oocytes, embryos, and additional embryonic stem cell lines is needed to address important scientific questions and to fulfill the promise of stem cell transplantation for degenerative diseases. Proponents need to develop guidelines for the appropriate conduct of embryonic stem cell research. Such guidelines will help build public trust and acceptance for this research. In this article, we offer recommendations for informed consent, discussing who should give consent, what the consent process should cover, when consent should be obtained, and who should obtain consent. Consent to use embryos for research should be obtained from oocyte and sperm donors as well as from the woman or couple undergoing infertility treatment. The consent discussion must cover information that donors need to know to make an informed decision about various types of research. Donations for research should be discussed at the initiation of advanced infertility treatment and reconfirmed if possible at the time of actual donation for research. Treating assisted reproduction technology physicians can help with the consent process, provided that they are not involved in the research.

  16. 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.

  17. Information and consent in internet paternity testing: focus on minors' protection in Italy.

    PubMed

    Caenazzo, Luciana; Tozzo, Pamela; Benciolini, Paolo; Rodriguez, Daniele

    2008-12-01

    Paternity testing in Italy is usually performed by private laboratories and universities having direct contacts with the applicants. Recently, the number of paternity tests offered through laboratory websites has increased in Italy and Europe. The execution of genetic tests, including paternity testing based on DNA analysis, represents a complex act, which contains three main steps. Paternity analyses carried out by laboratories via Internet are performed on samples collected by the applicants and then mailed back to the laboratories without any patient-physician relationship. Information is given to the subjects through the laboratory's website or mailed with the test order form. The execution of "household" DNA analysis without technical precautions may provide an incorrect response with severe consequences on the individual who has undergone testing, on the family involved, and on society in general. The problems connected with this kind of analysis are not technical, but ethical and deontological. In this work, we will discuss the problems related to information and consent by way of outlining the relevant Italian laws and codes of medical ethics. The Italian Privacy's Guarantor is assessing the ethical and legal implications, but regulations are not yet in place. We believe that adequate information related to this practice cannot be given via Internet, and, consequently, the validity of the consent expressed during this kind of procedure can be uncertain. Further, we will analyze issues regarding the importance of minors' protection when a paternity test is performed via Internet. In our opinion, the complexity of the situations and expectations linked to paternity investigations require a special sensitivity in dealing with each case, based on a patient-physician relationship in the decision-making process especially referring to the defense of the minors' well-being.

  18. A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting

    PubMed Central

    2014-01-01

    Background Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia. Methods Mixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among health researchers and regulators including ethics committee members in Ethiopian health research institutions and universities. Results In their evaluation of the consent process, only 40.2% thought that the consent process and information given were adequately understood by study participants; 84.6% claimed they were not satisfied with the current consent process and 85.5% thought the best interests of study participants were not adequately considered. Commonly mentioned consent-related problems included lack of clarity (48.1%), inadequate information (34%), language barriers (28.2%), cultural differences (27.4%), undue expectations (26.6%) and power imbalances (20.7%). About 95.4% believed that consent should be contextualized to the study setting and 39.4% thought REA would be an appropriate approach to improve the perceived problems. Qualitative findings helped to further explore the gaps identified in the quantitative findings and to map-out concerns related to the current research consent process in Ethiopia. Suggestions included, conducting REA during the pre-test (pilot) phase of studies when applicable. The need for clear guidance for researchers on issues such as when and how to apply the REA tools was stressed. Conclusion The study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia. REA is considered

  19. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by... record linking the subject and the research would be the consent document and the principal risk would be... wants documentation linking the subject with the research, and the subject's wishes will govern; or...

  20. 45 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46.117 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.117 Documentation of... the research would be the consent document and the principal risk would be potential harm...

  1. 45 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46.117 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.117 Documentation of... the research would be the consent document and the principal risk would be potential harm...

  2. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by... record linking the subject and the research would be the consent document and the principal risk would be... wants documentation linking the subject with the research, and the subject's wishes will govern; or...

  3. 45 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46.117 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.117 Documentation of... the research would be the consent document and the principal risk would be potential harm...

  4. 22 CFR 225.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... record linking the subject and the research would be the consent document and the principal risk would be...) That the research presents no more than minimal risk of harm to subjects and involves no procedures for... statement regarding the research. (Approved by the Office of Management and Budget under control number...

  5. 22 CFR 225.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... record linking the subject and the research would be the consent document and the principal risk would be...) That the research presents no more than minimal risk of harm to subjects and involves no procedures for... statement regarding the research. (Approved by the Office of Management and Budget under control number...

  6. 7 CFR 1c.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... record linking the subject and the research would be the consent document and the principal risk would be...) That the research presents no more than minimal risk of harm to subjects and involves no procedures for... statement regarding the research. (Approved by the Office of Management and Budget under Control Number...

  7. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... statement regarding the research. (Approved by the Office of Management and Budget under Control Number 0990... HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by... record linking the subject and the research would be the consent document and the principal risk would...

  8. Cognitive Investigation Study of Patients Admitted for Cosmetic Surgery: Information, Expectations, and Consent for Treatment

    PubMed Central

    Cogliandro, Annalisa; La Monaca, Giuseppe; Tambone, Vittoradolfo; Persichetti, Paolo

    2015-01-01

    Background In all branches of medicine, it is the surgeon's responsibility to provide the patient with accurate information before surgery. This is especially important in cosmetic surgery because the surgeon must focus on the aesthetic results desired by the patient. Methods An experimental protocol was developed based on an original questionnaire given to 72 patients. The nature of the responses, the patients' motivation and expectations, the degree of patient awareness regarding the planned operation, and the patients' perceptions of the purpose of the required consent for cosmetic surgery were all analyzed using Fisher's exact test. Results Candidates for abdominal wall surgery had significantly more preoperative psychological problems than their counterparts did (P=0.035). A significantly different percentage of patients under 40 years of age compared to those over 40 years of age searched for additional sources of information prior to the operation (P=0.046). Only 30% of patients with a lower educational background stated that the preoperative information had been adequate, whereas 92% of subjects with secondary schooling or a postsecondary degree felt that the information was sufficient (P=0.001). A statistically significant difference was also present between patients according to their educational background regarding expected improvements in their quality of life postoperatively (P=0.008). Conclusions This study suggests that patients require more attention in presurgical consultations and that clear communication should be prioritized to ensure that the surgeon understands the patient's expectations. PMID:25606489

  9. 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

  10. Evaluation of the Informed Consent Process of a Multicenter Tuberculosis Treatment Trial

    PubMed Central

    Chapman, Kimberley N.; Pevzner, Eric; Mangan, Joan M.; Breese, Peter; Lamunu, Dorcas; Shrestha-Kuwahara, Robin; Nakibali, Joseph G.; Goldberg, Stefan V.

    2016-01-01

    Background Ethical principles obligate researchers to maximize study participants’ comprehension during the informed consent process for clinical trials. A pilot evaluation of the consent process was conducted during an international clinical trial of treatment for pulmonary tuberculosis to assess the feasibility of conducting an evaluation in a larger population and to guide these future efforts. Methods Study staff administered an informed consent assessment tool (ICAT) to a convenience sample of trial participants, measuring comprehension of consent components as derived from the Common Rule and FDA Title 21 Part 50, and satisfaction with the process. Participating site staff completed a consent process questionnaire about consent practices at their respective sites and provided improvement recommendations. ICAT scores and corresponding practices were compared where both were completed. Results ICATs (n = 54) were submitted from one site in Spain (n = 10), one in Uganda (n = 30), and five in the United States (n = 14). Participants were primarily male (76%), born in Africa (n = 31, 57%), and had a median age of 27 years (interquartile range [IQR]: 24–42). Median ICAT scores were 80% (IQR: 67–93) for comprehension and 89% (IQR: 78–100) for satisfaction. Ugandan participants scored higher than participants from other sites on comprehension (87% vs. 64%) and satisfaction (100% vs. 78%). Staff from 14 sites completed consent process questionnaires. Median ICAT scores for comprehension and satisfaction were higher at sites that utilized visual aids. Practice recommendations included shorter forms, simpler documents, and supplementary materials. Conclusions Participants achieved high levels (≥80%) of comprehension and satisfaction with their current consent processes. Higher ICAT scores at one site suggest an additional evaluation may identify approaches to improve comprehension and satisfaction in future trials. Through this pilot evaluation, complexities

  11. A Development of Automatic Audit System for Written Informed Consent using Machine Learning.

    PubMed

    Yamada, Hitomi; Takemura, Tadamasa; Asai, Takahiro; Okamoto, Kazuya; Kuroda, Tomohiro; Kuwata, Shigeki

    2015-01-01

    In Japan, most of all the university and advanced hospitals have implemented both electronic order entry systems and electronic charting. In addition, all medical records are subjected to inspector audit for quality assurance. The record of informed consent (IC) is very important as this provides evidence of consent from the patient or patient's family and health care provider. Therefore, we developed an automatic audit system for a hospital information system (HIS) that is able to evaluate IC automatically using machine learning.

  12. Obtaining clinical writing informed consent versus using client disguise and recommendations for practice.

    PubMed

    Sieck, Barbara C

    2012-03-01

    Clinical writing about psychotherapy clients has long been a part of didactic texts and research articles because it allows new treatments and interventions to be presented in an effective and memorable way. The main ways that clinicians write about their clients include obtaining informed consent, using client disguise, or creating case composites. Although many clinicians use a combination of all three approaches, this article specifically addresses the implications of using clinical writing informed consent. The present article begins with a brief history of clinical writing and an examination of the relevant standards in the current APA Ethics Code and the Health Insurance Portability and Accountability Act; this is followed by a discussion of the benefits of engaging in the clinical writing informed consent process. Subsequently, the limitations of using clinical writing informed consent are explored, including the potentially negative impact on the therapeutic alliance and the client's progress. The article concludes that clinicians should be cautious when deciding to engage in clinical writing informed consent. Recommendations in the form of a checklist are provided to help clinicians identify when it is most appropriate to use client disguise or case composites, and how to do so, as well as when it is appropriate to engage in clinical writing informed consent. Future directions are considered.

  13. ["STeP" ("Students Teaching Patients"): Medical Students Following up on Informed Consent Discussions. Results of a Methodological Change and Further Considerations].

    PubMed

    Chiapponi, C; Meyer, F; Kersten, F; Bruns, C

    2016-12-01

    Background: Literature shows an increasing number of reports on the incompleteness of informed consent discussions held by residents. Residents feel insecure and not adequately prepared for this task. This project aimed to integrate supervised informed consent discussions into the medical curriculum, working with "real" patients instead of other students or actors. Method: "STeP" ("Students Teaching Patients") is a teaching format which has been recently introduced at the University of Magdeburg. Initially, a certified physician prepares medical students for taking informed consent. Using standard questionnaires, students interview patients who have given consent, following up on what patients recall from the informed consent discussion. Afterwards the results are reported to the physician, who then checks back with the patient that there are no new or unanswered questions. In this part of the project, the original process was changed in that a group of patients was interviewed twice to evaluate whether students were able to increase patients' knowledge. Results: Although all students taking part in this study had already completed the surgery course, they were not sufficiently aware of the most relevant complications of laparoscopic cholecystectomy. Also it was difficult for informed patients to render the consequences and complications resulting from such a procedure. Randomly chosen patients recalled only one possible complication on average, although they had signed the informed consent form. Most of them could not explain the effects of a lesion of the bile duct. Although those patients who had been interviewed twice recalled more complications than those who had been interviewed only once, patients generally did not like to be interviewed twice, which caused us to discontinue this part of the project. Conclusions: Based on the analysis of the limitations of this method of repeated interviews, we now plan to perform STeP as a "student consultation" before the

  14. Ensuring smokers are adequately informed: reflections on consumer rights, manufacturer responsibilities, and policy implications

    PubMed Central

    Chapman, S; Liberman, J

    2005-01-01

    The right to information is a fundamental consumer value. Following the advent of health warnings, the tobacco industry has repeatedly asserted that smokers are fully informed of the risks they take, while evidence demonstrates widespread superficial levels of awareness and understanding. There remains much that tobacco companies could do to fulfil their responsibilities to inform smokers. We explore issues involved in the meaning of "adequately informed" smoking and discuss some of the key policy and regulatory implications. We use the idea of a smoker licensing scheme—under which it would be illegal to sell to smokers who had not demonstrated an adequate level of awareness—as a device to explore some of these issues. We also explore some of the difficulties that addiction poses for the notion that smokers might ever voluntarily assume the risks of smoking. PMID:16046703

  15. Placebo treatments, informed consent and 'the grip of a false picture'.

    PubMed

    Glackin, Shane Nicholas

    2015-08-01

    It is widely supposed that the prescription of placebo treatments to patients for therapeutic purposes is ethically problematic on the grounds that the patient cannot give informed consent to the treatment, and is therefore deceived by the physician. This claim, I argue, rests on two confusions: one concerning the meaning of 'informed consent' and its relation to the information available to the patient, and another concerning the relation of body and mind. Taken together, these errors lead naturally to the conclusion that the prescription of placebos to unwitting patients is unethical. Once they are dispelled, I argue, we can see that providing 'full' information against a background of metaphysical confusion may make a patient less informed and that the 'therapeutic' goal of relieving the patient of such confusions is properly the duty of the philosopher rather than the physician. Therapeutic placebos therefore do not violate the patient's informed consent or the ethical duties of the doctor.

  16. Electronic processing of informed consents in a global pharmaceutical company environment.

    PubMed

    Vishnyakova, Dina; Gobeill, Julien; Oezdemir-Zaech, Fatma; Kreim, Olivier; Vachon, Therese; Clade, Thierry; Haenning, Xavier; Mikhailov, Dmitri; Ruch, Patrick

    2014-01-01

    We present an electronic capture tool to process informed consents, which are mandatory recorded when running a clinical trial. This tool aims at the extraction of information expressing the duration of the consent given by the patient to authorize the exploitation of biomarker-related information collected during clinical trials. The system integrates a language detection module (LDM) to route a document into the appropriate information extraction module (IEM). The IEM is based on language-specific sets of linguistic rules for the identification of relevant textual facts. The achieved accuracy of both the LDM and IEM is 99%. The architecture of the system is described in detail.

  17. Applying a sociolinguistic model to the analysis of informed consent documents.

    PubMed

    Granero-Molina, José; Fernández-Sola, Cayetano; Aguilera-Manrique, Gabriel

    2009-11-01

    Information on the risks and benefits related to surgical procedures is essential for patients in order to obtain their informed consent. Some disciplines, such as sociolinguistics, offer insights that are helpful for patient-professional communication in both written and oral consent. Communication difficulties become more acute when patients make decisions through an informed consent document because they may sign this with a lack of understanding and information, and consequently feel deprived of their freedom to make their choice about different treatments or surgery. This article discusses findings from documentary analysis using the sociolinguistic SPEAKING model, which was applied to the general and specific informed consent documents required for laparoscopic surgery of the bile duct at Torrecárdenas Hospital, Almería, Spain. The objective of this procedure was to identify flaws when information was provided, together with its readability, its voluntary basis, and patients' consent. The results suggest potential linguistic communication difficulties, different languages being used, cultural clashes, asymmetry of communication between professionals and patients, assignment of rights on the part of patients, and overprotection of professionals and institutions.

  18. Theoretical Model of Critical issues in Informed Consent in HIV Vaccine Trials

    PubMed Central

    Lewis, Cindi A.; Dewhurst, Stephen; McMahon, James M.; Bunce, Catherine A.; Keefer, Michael C.; Alio, Amina P.

    2014-01-01

    The informed consent (IC) process for HIV vaccine trials poses unique challenges and would benefit from improvements to its historically-based structure and format. Here, we propose a theoretical framework that provides a basis for systematically evaluating and addressing these challenges. The proposed framework follows a linear pathway, starting with the precondition of voluntariness, three main variables of valid decision-making (competency, provision of information and understanding) and then the consequential outcome of either refusal or consent to participate. The existing literature reveals that culturally appropriate provision of information and resultant understanding by the vaccine trial participant are among the most significant factors influencing the authenticity of valid decision-making, though they may be overridden by other considerations, such as individual altruism, mistrust and HIV-related stigma. Community collaborations to foster bidirectional transmission of information and more culturally tailored consenting materials therefore represent a key opportunity to enhance the informed consent process. By providing a visual synopsis of the issues most critical to IC effectiveness in a categorical and relational manner, the framework provided here presents HIV vaccine researchers a tool by which the informed consent process can be more systematically evaluated and consequently improved. PMID:24865892

  19. Informed consent for biobanking research: cancer patient recruitment from rural communities in Maine.

    PubMed

    Morrison, Deborah G; Farah, Christopher; Hock, Janet M

    2013-04-01

    Biobanking research seeks to improve the diversity, availability, and quality of human specimens critical for translational research, including biospecimen collections from disadvantaged minorities. American rural whites are seldom represented in such initiatives as geographic isolation makes obtaining informed consent challenging. We report a case series of 83 newly diagnosed cancer patients, attending a rural community medical center, who consented to participate in cancer research. To enable pooling with population studies, we created a BioGeoBank using 2007 NCI and ISBER Best Practices, after a protocol approval by Eastern Maine Medical Center (EMMC) IRB and OHP HRPO. Informed consent forms were at Flesch-Kincaid 8th Grade reading level, supplemented by NCI educational brochures. Of 108 patients identified, 85 were eligible. Of these, 83 patients (49 lung cancer, 21 breast cancer, and 13 other cancers) consented to donate data, blood, and tissue specimens for future research, and maintained eligibility. Two years later, we executed a legacy protocol to transfer specimens to NCI's biorepository. Of the 69 surviving patients, 9 patients could not be contacted. All those contacted (60) agreed to provide additional data on environmental risks, and consented to specimen transfer. Self-organizing map analyses showed no evidence that age, education, income, familial susceptibility, or lifestyle factors were associated with consent to donate data or biospecimens. Cancer cases reported 1-3 co-morbid chronic diseases (mostly cardiovascular), near lifetime smoking and/or alcohol consumption; familial cancer risks, and many had a prior cancer history. Anecdotally, willingness to consent was based on altruistic hopes that research would generate knowledge to reduce cancer incidence. Our study shows that cancer patients from disadvantaged white rural communities with health disparities associated with geographic isolation are motivated to consent to participate and support

  20. Relevant Information and Informed Consent in Research: In Defense of the Subjective Standard of Disclosure.

    PubMed

    Dranseika, Vilius; Piasecki, Jan; Waligora, Marcin

    2017-02-01

    In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to understand the cultural context, talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups.

  1. Spontaneous decision of organ donation in patients signing informed consent for liver transplantation.

    PubMed

    Heits, N; Guenther, R; Kuechler, T; Becker, T; Braun, F

    2013-05-01

    The shortage of postmortem donor organs is a well-known problem in Germany. Willingness in the general population is 80%, but less than 14% have an organ donor card. We evaluated the free decision of liver transplant candidates who filled out a donor card before signing the informed consent for the transplant procedure. We analyzed 122 patients of mean age 55.9 years (range, 15.4-74.1) who signed an informed consent for liver transplantation between January 10, 2007, and January 24, 2012. The patients received the original text of the German organ donor card with tick boxes on the informed consent form for liver transplantation. All patients were informed that their decision had no impact on further management. Patients were able to choose between (1) becoming a donor, (2) refusal, (3) transfer of the decision to another person, or (4) no decision. All patients signed the informed consent to be listed for liver transplantation: 73.8% (n = 90) chose to become a donor; 5.7% (n = 7) refused; 5.7% (n = 7) transferred the decision to another person; and 14.8% (n = 18) did not come to a decision. Interestingly, not all candidates for liver transplantation were willing to become an organ donor in the time of expressed consent. However, willingness to sign the donor card was much higher among liver transplant candidates compared with the general population.

  2. Informed consent for epidural analgesia in labour: a survey of UK practice.

    PubMed

    Middle, J V; Wee, M Y K

    2009-02-01

    Anaesthetists are legally obliged to obtain informed consent before performing regional analgesia in labour. A postal survey of consultant-led UK anaesthetic units was performed in September 2007 to assess practice regarding obtaining informed consent before inserting an epidural, and documentation of the risks discussed. The response rate was 72% (161/223). There was great variation between units regarding which risks women were informed about and the likely incidence of that risk. One hundred and twenty-three respondents out of 157 providing an epidural service (78%) supported a national standardised information card endorsed by the Obstetric Anaesthetists' Association, with all the benefits and risks stated, to be shown to all women before consenting to an epidural in labour.

  3. Nurses' roles in informed consent in a hierarchical and communal context.

    PubMed

    Susilo, Astrid P; Van Dalen, Jan; Scherpbier, Albert; Tanto, Sugiharto; Yuhanti, Patricia; Ekawati, Nora

    2013-06-01

    Although the main responsibility for informed consent of medical procedures rests with doctors, nurses' roles are also important, especially as patient advocates. Nurses' preparation for this role in settings with a hierarchical and communal culture has received little attention. We explored the views of hospital managers and nurses regarding the roles of nurses in informed consent and factors influencing these roles. We conducted a qualitative study in a private, multispecialty hospital in Indonesia. Semi-structured interviews were conducted with seven managers. Two rounds of focus group discussions with nurses (n = 27) were conducted. Constant comparative approach was used in the analysis. Nurses can act as manager, witness, information giver, and advocate in the informed consent process. These roles are influenced by nurses' preparedness, hospital culture and policy, patients' understanding, family involvement, and cost-related issues. In preparation for these tasks, nurses should acquire communication skills, clinical knowledge, and legal and ethical knowledge.

  4. Informed consent and the security of the electronic health record (EHR): some policy considerations.

    PubMed

    Kluge, Eike-Henner W

    2004-03-31

    Various codes of ethics, and in particular the IMIA Code of Ethics for Health Information Professionals (HIPs), stipulate that the subject of an electronic health record (EHR) has a series of security rights with respect to her/his EHR, and that to some degree these rights center in the notion of informed consent. This paper examines the ethical basis of this position, outlines its implications for professionals, institutions and society in general, and identifies its limits. Further issues that will be discussed include who carries the responsibility for informed consent, what nature it should take, whether web-based EHRs present ethically unique problems, and related security implications.

  5. [Informed consent in cardiology. The Committee on Informed Consent of the Commission on Professional Matters of the Sociedad Española de Cardiología].

    PubMed

    de los Reyes López, M; Iñíguez Romo, A; Goicolea de Oro, A; Funes López, B; Castro Beiras, A

    1998-10-01

    In the last thirty years, the clinical relationship between physicians and patients has been rather modified. There are several factors that have contributed to this change: a) New ways to execute medical practises, specially referred to the development of new techniques; b) Cultural changes in our western society, mainly in the mediterranean area, where there has been progress in the recognition of patients' autonomy to decide about their own lives, health and their own bodies; c) The increasing number of lawsuits, complaints and judgements about the problems that clinical information involves, particularly the informed consent in clinical practise. We consider it necessary to make an extensive and deep discussion from all of the areas in Medicine and Law, to analyze the different ethical and legal parts of the informed consent. For that reason the Spanish Society of Cardiology offers their members a basic document in order to reflect about these facts, developing arguments, justifications and supports. This document has also considered models, conditions to their applicability according to Spanish law, and the experience we have had. Finally, there is a list of diagnostic procedures and interventional practises in cardiology that might be preceded by a written informed consent document. We considered them by the name of Spanish Society of Cardiology recommendations.

  6. Informed consent: the rate-limiting step in acute stroke trials.

    PubMed

    Rose, David Z; Kasner, Scott E

    2011-01-01

    Successful implementation of a randomized clinical trial (RCT) for neuro-vascular emergencies such as cerebral infarction, intracerebral hemorrhage, or subarachnoid hemorrhage is extraordinarily challenging. Besides establishing an accurate, hyper-expedited diagnosis among many mimics in a person with acute neurological deficits, informed consent must be obtained from this vulnerable group of patients who may be unable to convey their own wishes, grasp the gravity of their situation, or give a complete history or examination. We review the influences, barriers, and factors investigators encounter when providing established and putative stroke therapies, and focus on informed consent, the most important research protector of human subjects, as the rate-limiting step for enrollment into acute stroke RCTs. The informed consent process has received relatively little attention in the stroke literature, but is especially important for stroke victims with acute cognitive, aural, lingual, motor, or visual impairments. Consent by a surrogate may not accurately reflect the patient's wishes. Further, confusion about trial methodology, negative opinions of placebo-controlled studies, and therapeutic misconception by patients or surrogates may impede trial enrollment and requires further study. Exception from informed consent offers an opportunity that is rarely if ever utilized for stroke RCTs. Ultimately, advancing the knowledge base and treatment paradigms for acute stroke is essential but autonomy, beneficence (non-malfeasance), and justice must also be carefully interwoven into any well-designed RCT.

  7. Patient Involvement in Informed Consent for Pediatric Phase I Cancer Research

    PubMed Central

    Miller, Victoria A.; Baker, Justin N.; Leek, Angela C.; Drotar, Dennis; Kodish, Eric

    2014-01-01

    Objective To examine children’s and adolescents’ involvement in the informed consent conference for phase I cancer trials and test associations with patient age, ease of understanding, and pressure to participate. Procedure Participants included 61 patients ages 7 through 21 years who were offered participation in a phase I trial. Consent conferences were audiotaped, transcribed, and coded for communication between patients and physicians and between patients and parents. Results Based on word counts, the mean proportion of the consent conference in which the physician was talking to the patient was 36%; the vast majority (73%) of this communication consisted of giving information. Physician-patient communication increased with age, but overall levels of patient-to-physician communication were low (3%). After controlling for patient age, greater physician-to-patient communication was associated with greater ease of understanding. Conclusions The focus on providing information in the context of informed consent may come at the expense of other communication exchanges that are important to patients, especially in the context of end of life decisions. Children and adolescents may benefit from the assent process when physicians direct more of their communication to them. Future research should identify the reasons for low patient communication during the consent conference and strategies to enhance their participation in decision making about phase I trial enrollment. PMID:24487916

  8. Assault in medical law: revisiting the boundaries of informed consent to medical treatment in South Africa.

    PubMed

    Wilson, Maria C I

    2009-05-01

    This article focuses on assault as a cause of action in medical law, with particular emphasis on the requirements for informed consent, both under common law and under the National Health Act 2003 (Sth Africa). In particular, the test for consent, adopted in Castell v De Greef 1994 (4) SA 408 (C), is analysed in detail. It is noted that the wording of this test for informed consent mirrors the wording of the test for negligence laid down in the Australian case of Rogers v Whitaker (1992) 175 CLR 479. Further, the relationship between the delictual elements of wrongfulness and fault in assault is discussed. It is argued that in South African law a valid consent to medical treatment requires knowledge not only of the general nature of medical treatment but also of the consequences of the treatment and, in determining which consequences should be disclosed to a patient, the constitutional rights to equality and self-determination support the application of a subjective patient-centred test for informed consent. However, it is also proposed that the broad right of a patient to information is reined in at the fault element of assault, so that a limited requirement of consciousness of wrongfulness on the part of the defendant negates liability for delictual assault.

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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

  15. Informed Consent in the Medical Care of Transgender and Gender-Nonconforming Patients.

    PubMed

    Cavanaugh, Timothy; Hopwood, Ruben; Lambert, Cei

    2016-11-01

    Informed consent as a model of care has evolved as an alternative to the standard model of care recommended by the World Professional Association for Transgender Health's Standards of Care, version 7, which emphasizes the importance of mental health professionals' role in diagnosing gender dysphoria and in assessing the appropriateness and readiness for gender-affirming medical treatments. By contrast, the informed consent model for gender-affirming treatment seeks to acknowledge and better support the patient's right to, and capability for, personal autonomy in choosing care options without the required involvement of a mental health professional. Clinicians' use of the informed consent model would enable them both to attain a richer understanding of transgender and gender-nonconforming patients and to deliver better patient care in general.

  16. Motivating donors to genetic research? Anthropological reasons to rethink the role of informed consent.

    PubMed

    Hoeyer, Klaus; Lynöe, Niels

    2006-01-01

    In this article we explore the contribution from social anthropology to the medical ethical debates about the use of informed consent in research, based on blood samples and other forms of tissue. The article springs from a project exploring donors' motivation for providing blood and healthcare data for genetic research to be executed by a Swedish start-up genomics company. This article is not confined to empirical findings, however, as we suggest that anthropology provides reason to reassess the theoretical understanding of autonomy as generally defined by Beauchamp and Childress. Careful consideration of the trust expressed by donors through the act of donation, furthermore, suggests that there is reason to redirect the ethical scrutiny from informed consent to issues concerning institutional arrangements and social responsibility. In particular, we suggest that an anthropological approach could facilitate a reconsideration of the political implications of using informed consent as a regulatory practice in tissue-based research.

  17. Informed consent: knowledge, attitude and practice of the researchers in a postgraduate institute of Bangladesh.

    PubMed

    Shakoor, M A; Jaigirdar, Q H; Ullah, M A; Yunus, A B; Rashid, H A

    2009-07-01

    A prospective experimental study was conducted in a postgraduate institute in Dhaka, Bangladesh, from April '05 to September '05. A total of 214 doctors of a postgraduate medical institute were included in the study who was involved in research works. A written questionnaire was given to the respondents to assess their knowledge, attitude and practice about informed consent (IC). The data was analyzed statistically. Chi-Square test was done to see the level of significance. Regarding knowledge of IC, we found maximum participants were more or less knowledgeable about it. The attitude of the respondents was also in favour of taking IC. In practice, most of them had taken informed consent that was verbal (39.3%) and written (47.6%). But some of the researcher (13.1%) had not taken any informed consent. By the present study, it may be concluded that the researchers of the concerned institute were aware of IC.

  18. Understanding of Essential Elements Required in Informed Consent Form among Researchers and Institutional Review Board Members.

    PubMed

    Koonrungsesomboon, Nut; Laothavorn, Junjira; Karbwang, Juntra

    2015-06-01

    The process of informed consent remains a constant challenge in clinical research. The aim of the present study was to evaluate the understanding of researchers and members of Institutional Review Boards (IRBs) regarding the essential elements of an Informed Consent Form (ICF) as required by internationally recognized regulations. Using eight case studies to illustrate basic ethical elements, the study involved 107 participants, mainly from the Asia Pacific and African regions. The results showed that most of the participants had general knowledge regarding the essential elements required in an ICF. However, the issues of confidentiality of data and payment for study participation proved to be problematic for some participants, accounting for 35% and 28% of all incorrect answers respectively. This suggests that participants' understanding of the underlying concepts of the required ICF elements is limited. Ethical training of researchers and IRB members, particularly in the Asia Pacific and African regions, concerning valid informed consent is still needed.

  19. Medical devices; exception from general requirements for informed consent. Final rule.

    PubMed

    2011-06-24

    The Food and Drug Administration (FDA) is issuing a final regulation to confirm, with one change, the interim final rule (IFR) entitled "Medical Devices; Exception From General Requirements for Informed Consent." This final rule confirms the IFR's establishment of a new exception from the general requirements for informed consent to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. FDA has created this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. This final rule adds a requirement that the investigator submit the required documentation to FDA, in addition to submitting it to the reviewing Institutional Review Board (IRB).

  20. Implementing emergency research requiring exception from informed consent, community consultation, and public disclosure.

    PubMed

    Salzman, Joshua G; Frascone, Ralph J; Godding, Bobette K; Provo, Terry A; Gertner, Elie

    2007-10-01

    Conducting emergency research in the out-of-hospital and emergency department setting is a challenge because of the inability of patients to provide informed consent in many situations. Federal guidelines allowing research under an exception from informed consent for emergency research have been established (21 CRF 50.24). Community consultation and public disclosure, 2 required components of obtaining this exception, are seen by many as a barrier to resuscitation research. This article will provide a brief overview of the history of the exception from informed consent for emergency research and summarize our methods recently used to successfully complete community consultation and public disclosure for a trial evaluating 2 devices used during cardiopulmonary resuscitation in a large metropolitan area.

  1. USING FORMATIVE RESEARCH TO DEVELOP A CONTEXT-SPECIFIC APPROACH TO INFORMED CONSENT FOR CLINICAL TRIALS

    PubMed Central

    Corneli, Amy L.; Bentley, Margaret E.; Sorenson, James R.; Henderson, Gail E.; van der Horst, Charles; Moses, Agnes; Nkhoma, Jacqueline; Tenthani, Lyson; Ahmed, Yusuf; Heilig, Charles M.; Jamieson, Denise J.

    2009-01-01

    Participant understanding is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturally appropriate and innovative approaches. To increase the effectiveness of the consent process for a clinical trial in Malawi on interventions to prevent mother-to-child transmission of HIV during breastfeeding, formative research was conducted to explore the community’s understanding of medical research as well as how to explain research through local terms and meanings. Contextual analogies and other approaches were identified to explain consent information. Guided by theory, strategies for developing culturally appropriate interventions, and recommendations from the literature, we demonstrate how the formative data were used to develop culturally appropriate counseling cards specifically for the trial in Malawi. With appropriate contextual modifications, the steps outlined here could be applied in other clinical trials conducted elsewhere, as well as in other types of research. PMID:19385837

  2. Challenges Associated with Informed Consent in Low- and Low-Middle-Income Countries

    PubMed Central

    Upjohn, Melissa; Wells, Kimberly

    2016-01-01

    Obtaining informed consent from research participants is a generally recognized step of undertaking research. While the concept of informed consent is well understood in western research environments, it requires further consideration when reviewing studies involving humans and owned animals in low- and low-middle-income countries (LMICs), in order to take account of different social, educational, and research norms. Here, we identify some of the challenges that need to be considered, and how they might affect the process of obtaining informed consent. We explain the approach taken by an animal welfare non-governmental organization working in LMICs to addressing these challenges. There are also questions that reviewers might consider when commenting on work originating in this context. PMID:27812525

  3. 34 CFR 99.31 - Under what conditions is prior consent not required to disclose information?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... of postsecondary education from disclosing information. (16) The disclosure concerns sex offenders... 34 Education 1 2014-07-01 2014-07-01 false Under what conditions is prior consent not required to disclose information? 99.31 Section 99.31 Education Office of the Secretary, Department of Education...

  4. 14 CFR § 1230.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false General requirements for informed consent. § 1230.116 Section § 1230.116 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION... information shall be provided to each subject: (1) A statement that the study involves research,...

  5. Discretion, Judgment, and Informed Consent: Ethical and Practice Issues in Social Action.

    ERIC Educational Resources Information Center

    Torczyner, Jim

    1991-01-01

    Examines ethical considerations regarding advocacy and social action in atmosphere of uncertainty. Considers use of discretion and protection and defense of fundamental human rights in absence of organized, informed constituency. Examines informed consent and client's best interest when neither individual not collective group has autonomy through…

  6. Elective inguinal hernia repair: a unified informed consent, or who wants to know what?

    PubMed

    Losanoff, Julian E; Litwinczuk, Kathleen M; Ranella, Michael J; Basson, Marc D

    2009-04-01

    Informed consent is increasingly being standardized. We sought to evaluate variability in the amount and quality of information desired by patients in choosing whether to undergo elective surgical hernia repair, a prototypical low- to moderate-risk common procedure. Consecutive stable outpatients were asked to assume that they were considering hernia repair and interviewed with a standard questionnaire that asked them to rate their interest in learning about the natural history, pathology, and management of inguinal hernia as well as herniorrhaphy complications and postoperative recovery. Ninety-eight consecutive patients exhibited substantial interpersonal variability in their level of interest in receiving information. Although interest in some types of information tended to correlate with interest in other types of information, patients' degree of interest in receiving information about anesthesia during the procedure was independent of other variables. Education and previous exposure to individuals with hernias also affected interest in receiving potentially important information before deciding whether to consent to hernia surgery. Patients may vary with regard to the information they want to receive when deciding whether to consent to an invasive procedure. It may be preferable to individualize the consent process to patients' preferences rather than adhering to standardized content.

  7. The Necessity of Professional Disclosure and Informed Consent for Rehabilitation Counselors

    ERIC Educational Resources Information Center

    Carlisle, Jeffrey; Neulicht, Ann T.

    2010-01-01

    Within the rehabilitation counseling arena, professional disclosure and informed consent are critical concepts for the rehabilitation counselor to understand. Once understood, they become key components of a rehabilitation counselor's daily practice. Counselors need to provide sufficient prior information about their evaluation and services to…

  8. Improving the Informed Consent Conversation: A Standardized Checklist that Is Patient Centered, Quality Driven, and Legally Sound.

    PubMed

    Ripley, Beth A; Tiffany, David; Lehmann, Lisa S; Silverman, Stuart G

    2015-11-01

    The informed consent conversation is a key component of patient-centered medicine, a concept that emphasizes the importance of patients actively participating in their care. Studies reveal that many informed consent conversations throughout medical practice lack essential elements and leave patients' needs unmet. This review addresses these deficiencies, discusses solutions, and introduces a standardized checklist that values the patient's role in shared decision making during the informed consent conversation. The checklist could be particularly helpful to interventional radiologists and other consulting physicians who usually obtain informed consent early in their encounters with patients.

  9. Informed Consent: An Ethical Issue in Conducting Research with Male Partner Violent Offenders

    PubMed Central

    Crane, Cory A.; Hawes, Samuel W.; Mandel, Dolores; Easton, Caroline J.

    2014-01-01

    Ethical codes help guide the methods of research that involve samples gathered from “at-risk” populations. The current paper reviews general as well as specific ethical principles related to gathering informed consent from partner violent offenders mandated to outpatient treatment, a group that may be at increased risk of unintentional coercion in behavioral sciences research due to court-mandates that require outpatient treatment without the ethical protections imbued upon prison populations. Recommendations are advanced to improve the process of informed consent within this special population and data supporting the utility of the recommendations in a sample 70 partner violent offenders are provided. Data demonstrate that participants were capable of comprehending all essential elements of consent. PMID:25892900

  10. Informed consent for clinical research involving patients with chest disease in the United States.

    PubMed

    Luce, John M

    2009-04-01

    The concept of informed consent was applied to clinical research in the United States after research abuses were documented in Nazi Germany and this country. The concept is imbedded in the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. Federal regulations governing clinical research require both the consent of subjects and peer review of research proposals by institutional review boards (IRBs). Subpart A of the Code of Federal Regulations contains basic provisions for the protection of research subjects and requirements for informed consent by subjects or their surrogates; surrogate consent may or may not be allowed under state law. Other subparts contain further protections for subjects with diminished capacity, such as children, that limit the kind of research in which they can participate. Whether these protections should be extended to decisionally impaired adults, including those who are critically ill, remains to be determined. Consent can be deferred or waived for emergency research only rarely in the United States, in contrast to other countries.

  11. Approaches to informed consent for hypothesis-testing and hypothesis-generating clinical genomics research

    PubMed Central

    2012-01-01

    Background Massively-parallel sequencing (MPS) technologies create challenges for informed consent of research participants given the enormous scale of the data and the wide range of potential results. Discussion We propose that the consent process in these studies be based on whether they use MPS to test a hypothesis or to generate hypotheses. To demonstrate the differences in these approaches to informed consent, we describe the consent processes for two MPS studies. The purpose of our hypothesis-testing study is to elucidate the etiology of rare phenotypes using MPS. The purpose of our hypothesis-generating study is to test the feasibility of using MPS to generate clinical hypotheses, and to approach the return of results as an experimental manipulation. Issues to consider in both designs include: volume and nature of the potential results, primary versus secondary results, return of individual results, duty to warn, length of interaction, target population, and privacy and confidentiality. Summary The categorization of MPS studies as hypothesis-testing versus hypothesis-generating can help to clarify the issue of so-called incidental or secondary results for the consent process, and aid the communication of the research goals to study participants. PMID:23046515

  12. To see for myself: informed consent and the culture of openness.

    PubMed

    Walter, T

    2008-09-01

    Informed consent needs to be practised within a culture of openness if it is to enhance public trust in medical procedures around death. Openness should entail patients not just receiving information from doctors, but also having the right to see certain medical procedures. This article proposes in particular that it would be desirable for the public to be allowed to attend an autopsy of a person they do not know. Evidence from the UK, where members of the public may go backstage to witness the process of cremation, the other technical process in which dead bodies are violently but legitimately assaulted, suggests benefits from a policy of openness. When a family consents to cremation in Britain, their consent is only minimally informed, but the system has nothing to hide, and trust is high. This suggests that the opportunity for lay people also to witness certain medical procedures might do more to restore public trust in medical procedures around death than a narrow interpretation of informed consent in which information is controlled by the profession.

  13. Knowledge and practices of obtaining informed consent for medical procedures among specialist physicians: questionnaire study in 6 Croatian hospitals.

    PubMed

    Jukic, Marko; Kvolik, Slavica; Kardum, Goran; Kozina, Slavica; Tomic Juraga, Ana

    2009-12-01

    AIM. To assess physicians' knowledge and practices for obtaining patients' informed consent to medical procedures. METHODS. An anonymous and voluntary survey of knowledge and practices for obtaining informed consent was conducted among 470 physicians (63% response rate) working in 6 hospitals: 93 specialists in anesthesiology, 166 in internal medicine, and 211 in surgery. RESULTS. Only 54% physicians were acquainted with the fact that the procedure for obtaining consent was regulated by the law. Internists and surgeons were better informed than anesthesiologists (P=0.024). More than a half of respondents (66%) were familiar with the fact that a law on patient rights was passed in Croatia; there were no differences among different specialties (P=0.638). Only 38% of the physicians were fully informed about the procedure of obtaining consent. Internists and surgeons provided detailed information to the patient in 33% of the cases and anesthesiologists in 16% of the cases (P<0.050). Internists reported spending more time on informing the patient than anesthesiologists and surgeons (P<0.001). There were no differences in knowledge and practices for obtaining informed consent between physicians working in university and those working in community hospitals (P> or =0.05 for all questions). CONCLUSION. Physicians in Croatia have no formal education on informed consent and implement the informed consent process in a rather formal manner, regardless of the type of hospital or medical specialty. Systemic approach at education and training at the national level is needed to improve the informed consent process.

  14. Increased electronic information sharing by sexual health services: confidentiality and consent.

    PubMed

    Hunter, Inga; Haining Ede, Gael; Whiddett, Richard

    2014-03-01

    New Zealand is moving towards an integrated health-care model with information accessible electronically regardless of location, linking existing health provider systems, regional clinical results repositories and a shared care record. However, such information sharing has been a major concern for patients attending sexual health services. In this study, we investigated patient attitudes towards a change in practice to support an integrated care model. Outcomes showed that confidentiality remains a significant concern, and routine sharing of patient information may create barriers to attendance for some, leading to a potential increase in untreated infections. We conclude that sexual health services may be able to change their information management practices to an opt-out consent system and routinely share health information with other health providers, but further public discussion to ensure informed consent is needed before this can happen. Regardless of national policy, it is still necessary to keep clinic visit details confidential for some patients attending sexual health services.

  15. 78 FR 27243 - Proposed Collection; 60-Day Comment Request: Interactive Informed Consent for Pediatric Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ... collection projects, the National Institute Heart, Lung, and Blood Institute (NHBLI), the National Institutes... Heart, Lung, and Blood Institute, NIH, 6701 Rockledge Drive, Room 8102, MSC 7940, Bethesda, MD, or call... Informed Consent for Pediatric Clinical Trials, 0925-New, National Heart, Lung, and Blood Institute...

  16. 34 CFR 99.30 - Under what conditions is prior consent required to disclose information?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 false Under what conditions is prior consent required to disclose information? 99.30 Section 99.30 Education Office of the Secretary, Department of Education FAMILY EDUCATIONAL RIGHTS AND PRIVACY May an Educational Agency or Institution Disclose Personally...

  17. 32 CFR 806b.47 - Rules for releasing Privacy Act information without consent of the subject.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 6 2013-07-01 2013-07-01 false Rules for releasing Privacy Act information without consent of the subject. 806b.47 Section 806b.47 National Defense Department of Defense (Continued... Records Centers remain under Air Force control. (g) Exception 7. A Federal, State, or local agency...

  18. Confidentiality, Informed Consent, and Ethical Considerations in Reviewing the Client's Psychotherapy Records

    ERIC Educational Resources Information Center

    Blunt, David R.

    2006-01-01

    Ethical dilemmas that break the confidentiality of the client eventually test the psychologist's boundaries such that not taking action may place the patient in a position where they suffer, hurt themselves, or others. The effectiveness in obtaining a valid informed consent might depend upon the therapists training, experience, and sound judgment…

  19. 10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Chronic Beryllium Disease Prevention Program Informed Consent Form A Appendix A to Part 850 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Pt. 850, App. A Appendix A to Part 850—Chronic Beryllium Disease Prevention Program...

  20. 10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Chronic Beryllium Disease Prevention Program Informed Consent Form A Appendix A to Part 850 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Pt. 850, App. A Appendix A to Part 850—Chronic Beryllium Disease Prevention Program...

  1. 10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Chronic Beryllium Disease Prevention Program Informed Consent Form A Appendix A to Part 850 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Pt. 850, App. A Appendix A to Part 850—Chronic Beryllium Disease Prevention Program...

  2. 10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Chronic Beryllium Disease Prevention Program Informed Consent Form A Appendix A to Part 850 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Pt. 850, App. A Appendix A to Part 850—Chronic Beryllium Disease Prevention Program...

  3. 10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Chronic Beryllium Disease Prevention Program Informed Consent Form A Appendix A to Part 850 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Pt. 850, App. A Appendix A to Part 850—Chronic Beryllium Disease Prevention Program...

  4. Breast Implant Informed Consent Should Include the Risk of Anaplastic Large Cell Lymphoma.

    PubMed

    Clemens, Mark W; Miranda, Roberto N; Butler, Charles E

    2016-04-01

    Breast implant-associated anaplastic large cell lymphoma (ALCL) is a rare T-cell lymphoma arising around breast implants. Public awareness has increased following a safety communication warning of the association of breast implant-associated ALCL by the U.S. Food and Drug Administration in 2011. Difficulty with determining an accurate assessment of risk, including diagnosis, or standardized treatment regimen has led surgeons to commonly omit preoperative discussion of this rare and frequently misunderstood cancer. Risk disclosure is a form of respect for patient autonomy, and informed consent has positive practical and moral consequences for the practice of plastic surgery. A model of breast implant-associated ALCL informed consent implementation and health care provider education are reviewed with 1-year process follow-up at a tertiary cancer center. Breast implant-associated ALCL should be included during preoperative counseling on the risks of breast implantation when obtaining informed consent. Pertinent aspects of decision-making include disease awareness, presenting symptoms, and resources for concerned patients. Education of health care professionals and provision of patient-focused materials ensures effectiveness of the informed consent process.

  5. REALIZATION OF INFORMED CONSENT AS ONE OF PATIENT'S RIGHTS: CURRENT SITUATION IN AZERBAIJAN.

    PubMed

    Rustamova, F A; Mammadov, V G; Munir, K M

    Azerbaijan is a country in which the law is based on democratic principles. The mentioned principles underlie the national health care law. Democratic values, such as respect for human rights and freedoms, human dignity, as well as universal bioethical principles that are widely implemented in the national law, create conditions for the implementation of the patient's rights. The basic law governing the doctor-patient relationship, Law on Protection of Health of Population in Azerbaijan, reflects the basic patients' rights and obligations of doctors and medical institutions. Informed consent, which is a key component of patient rights, is also reflected, however, to date, a significant drawback of the Azerbaijan medical legislation is described in the article in this field. For example, at the moment there is no single standardized informed consent form in the country's different medical institutions. Due to the absence of any legally approved standards for informed consent forms, public and private health care institutions individually develop such forms, which sometimes can differ significantly. At the moment, one of the important directions in the field of healthcare is its improvement in accordance with international standards. The research made it possible to make conclusions about the necessary measures to improve and unify the informed consent form. The authors also analyzed the main provisions of the medical law of Azerbaijan and identified the main trends of its further development.

  6. 76 FR 36989 - Medical Devices; Exception From General Requirements for Informed Consent

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 50 Medical Devices; Exception From General Requirements for Informed Consent AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is issuing a final regulation to confirm, with one change,...

  7. 38 CFR 17.32 - Informed consent and advance care planning.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... advance care planning. 17.32 Section 17.32 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Protection of Patient Rights § 17.32 Informed consent and advance care planning. (a) Definitions: Advance Directive. Specific written statements made by a patient who has decision-making...

  8. Informed Consent: The Use of Inpatients as Teaching-Patients for Sophomore Medical Students.

    ERIC Educational Resources Information Center

    And Others; Barnes, H. Verdain

    1980-01-01

    In an attempt to assure informed consent and basic patients' rights, and to instruct patient volunteers about the teaching-patient role and its importance to effective medical education, a nonphysician patient-advocate-interviewer (PAI) model was developed. The usefulness of the model is evaluated. (Author/MLW)

  9. 34 CFR 99.31 - Under what conditions is prior consent not required to disclose information?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... student level data from education records for the purpose of education research by attaching a code to... education research and cannot be used to ascertain personally identifiable information about a student; and... 34 Education 1 2012-07-01 2012-07-01 false Under what conditions is prior consent not required...

  10. 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.

  11. Quantitative aspects of informed consent: considering the dose response curve when estimating quantity of information.

    PubMed

    Lynöe, N; Hoeyer, K

    2005-12-01

    Information is usually supposed to be a prerequisite for people making decisions on whether or not to participate in a clinical trial. Previously conducted studies and research ethics scandals indicate that participants have sometimes lacked important pieces of information. Over the past few decades the quantity of information believed to be adequate has increased significantly, and in some instances a new maxim seems to be in place: the more information, the better the ethics in terms of respecting a participant's autonomy. The authors hypothesise that the dose-response curve from pharmacology or toxicology serves as a model to illustrate that a large amount of written information does not equal optimality. Using the curve as a pedagogical analogy when teaching ethics to students in clinical sciences, and also in engaging in dialogue with research institutions, may promote reflection on how to adjust information in relation to the preferences of individual participants, thereby transgressing the maxim that more information means better ethics.

  12. [Ethical dilemma in research: informed consent in clinical studies on persons with dementia].

    PubMed

    Sinoff, Gary

    2012-09-01

    With the world's population aging, there is an increase in the number of demented elderly. It is vital to study this phenomenon in epidemiological and clinical studies, particularly the effects on the increasing numbers of demented elderly. Researchers need to understand the factors predicting the general decline in the demented elderly. However, before any research is undertaken, it is necessary to obtain approval from the Local Internal Review Board. This committee is responsible to maintain accepted national and international ethical standards. The basis for recruitment to a study is the signature on the informed consent form, where the patient is required to understand the study, internalize the study's aim, to consider all options and finally, to express an opinion. Potential elderly participants need to have their judgment evaluated before signing the form. In cases where the subject is incapable, some countries, including Israel, require that there be a legal guardianship. This is a long and complicated process that causes researchers not to recruit demented patients into a study which may actually be beneficial to all. Some countries allow a proxy to sign informed consent forms to permit the demented subject to participate in the study. Often the threshold may depend on the invasiveness of the intervention. The problem of proxies to sign informed consent form troubles researchers worldwide. This article addresses the history and development of ethics in research, and raises the issue to promote an official policy for proxy consent signing.

  13. Between personal and relational privacy: understanding the work of informed consent in cancer genetics in Brazil.

    PubMed

    Goldim, José Roberto; Gibbon, Sahra

    2015-07-01

    Drawing from perspectives of both bioethics and anthropology, this article explores how the boundaries between personal and relational privacy are negotiated by patients and practitioners in the context of an emerging domain of cancer genetics in Brazil. It reflects on the place of informed consent in the history of bioethics in North America in contrast to the development of bioethics in Brazil and the particular social cultural context in which consent is sought in Brazilian public health care. Making use of empirical research with families and individuals receiving genetic counselling related to increased genetic risk for cancer, in genetic clinics in southern Brazil, it examines how informed consent is linked to the necessary movement between personal and relational privacy. The paper illustrates the value of a particular tool known as a 'sociogram' to examine the complex interpersonal dynamics that arise in negotiating informed consent at the interface between the family and the individual in Brazil. The paper, therefore, points to the scope of further interdisciplinary exchanges between anthropology and bioethics, confronting the new challenges that arise in the context of medical genetics in developing country.

  14. Informed Consent in Genome-Scale Research: What Do Prospective Participants Think?

    PubMed Central

    Trinidad, Susan Brown; Fullerton, Stephanie M.; Bares, Julie M.; Jarvik, Gail P.; Larson, Eric B.; Burke, Wylie

    2012-01-01

    Background To promote effective genome-scale research, genomic and clinical data for large population samples must be collected, stored, and shared. Methods We conducted focus groups with 45 members of a Seattle-based integrated healthcare delivery system to learn about their views and expectations for informed consent in genome-scale studies. Results Participants viewed information about study purpose, aims, and how and by whom study data could be used to be at least as important as information about risks and possible harms. They generally supported a tiered consent approach for specific issues, including research purpose, data sharing, and access to individual research results. Participants expressed a continuum of opinions with respect to the acceptability of broad consent, ranging from completely acceptable to completely unacceptable. Older participants were more likely to view the consent process in relational – rather than contractual – terms, compared with younger participants. The majority of participants endorsed seeking study subjects’ permission regarding material changes in study purpose and data sharing. Conclusions Although this study sample was limited in terms of racial and socioeconomic diversity, our results suggest a strong positive interest in genomic research on the part of at least some prospective participants and indicate a need for increased public engagement, as well as strategies for ongoing communication with study participants. PMID:23493836

  15. Informed consent for epidural analgesia in labour: a survey of Irish practice.

    PubMed

    Hegarty, A; Omer, W; Harmon, D

    2014-06-01

    Currently, we do not have a national standard regarding epidural consent in Ireland. The aim of this survey was to assess practice in obstetric units in Ireland with regard to obtaining informed consent prior to epidural insertion, and whether the risks discussed with women are being documented. A postal survey of anaesthetists in Irish obstetric units was performed in January 2012 to assess practice regarding obtaining informed consent prior to epidural insertion, and documentation of the risks discussed. The response rate was 16/18 (88%). There was major variation both in which risks are discussed with women in labour and what risks are quoted. The most frequently quoted risks were headache--15/16 (93.8% of the respondents), partially/not working epidural--15/16 (93.8%), drop in blood pressure--14/16 (87.5%) and temporary backache/local tenderness--12/16 (75%). The more serious risks were not discussed as frequently: permanent nerve damage--8/16 (50%), paralysis--8/16 (50%), epidural abscess/haematoma--6/16 (37.5%), meningitis--3/16 (18.7%). The vast majority of respondents supported introduction of a national standardised information leaflet, detailing all the benefits and risks of epidural analgesia, to be shown to all women before consenting to epidural insertion.

  16. Comprehensive Format of Informed Consent in Research and Practice: A Tool to uphold the Ethical and Moral Standards

    PubMed Central

    Bhupathi, P Arun

    2017-01-01

    Informed consent in research, clinical trial, and practice is a process in which a patient/participant consents to participate or undergo the proposed procedures after being informed of its procedures, risks, and benefits. Ideally, the patient/participant is expected to give his consent only after fully comprehending the information about the procedures, benefits, and risks involved in research/clinical trial/practice. Thus, many ethical issues are entwined in the process of obtaining a proper informed consent. Certain untoward events in the past led to propose guidelines to prevent exploitations and unhealthy practices in the field of life science. Eventually, the practice of obtaining informed consent was emphasized to make sure that a participant’s rights were not in jeopardy. Yet, there are flaws in the practical application of obtaining consent due to lack of understanding, barriers in communication, culture, custom, and various other factors. The present article highlights the need for a complete and comprehensive format of recording informed consent without compromising the rights of an individual and the standards of research or practice on ethical and moral grounds. How to cite this article Bhupathi PA, Ravi GR. Comprehensive Format of Informed Consent in Research and Practice: A Tool to uphold the Ethical and Moral Standards. Int J Clin Pediatr Dent 2017;10(1):73-81. PMID:28377660

  17. 45 CFR 690.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    .... The information that is given to the subject or the representative shall be in language understandable... exculpatory language through which the subject or the representative is made to waive or appear to waive any... levels of payment for benefits or services under those programs; and (2) The research could...

  18. 40 CFR 26.1116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject... exposure of subjects to a pesticide, the subjects of the research must be informed of the identity of...

  19. 16 CFR 1028.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... this policy, no investigator may involve a human being as a subject in research covered by this policy... information that is given to the subject or the representative shall be in language understandable to the... language through which the subject or the representative is made to waive or appear to waive any of...

  20. 15 CFR 27.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... this policy, no investigator may involve a human being as a subject in research covered by this policy... information that is given to the subject or the representative shall be in language understandable to the... language through which the subject or the representative is made to waive or appear to waive any of...

  1. 45 CFR 690.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... provided elsewhere in this policy, no investigator may involve a human being as a subject in research.... The information that is given to the subject or the representative shall be in language understandable... exculpatory language through which the subject or the representative is made to waive or appear to waive...

  2. 38 CFR 16.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... provided elsewhere in this policy, no investigator may involve a human being as a subject in research.... The information that is given to the subject or the representative shall be in language understandable... exculpatory language through which the subject or the representative is made to waive or appear to waive...

  3. 14 CFR 1230.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this... information that is given to the subject or the representative shall be in language understandable to the... language through which the subject or the representative is made to waive or appear to waive any of...

  4. Tailoring Information Provision and Consent Processes to Research Contexts: The Value of Rapid Assessments

    PubMed Central

    Bull, Susan; Farsides, Bobbie; Ayele, Fasil Tekola

    2012-01-01

    Guidance requires that consent processes for research be appropriately tailored to their cultural context. This paper discusses the use of rapid assessments to identify cultural and ethical issues arising when explaining research in studies in The Gambia and Ethiopia. The assessments provided insights into appropriate ways of providing information to minimize the risk of stigmatizing vulnerable research populations; research participants’ views about the most important information to provide about research and their understandings of research; and perceived constraints upon reaching voluntary decisions about participation. These insights demonstrate that rapid assessments are a relatively quick and inexpensive intervention that can provide valuable information to assist in the tailoring of information provision and consent processes to research context while maintaining and enhancing participants’ fundamental protections. PMID:22378133

  5. Informed consent for cord blood donation. A theoretical and empirical study

    PubMed Central

    Petrini, Carlo; Farisco, Michele

    2011-01-01

    Background and objectives Umbilical cord blood (CB) banking and therapeutic use raise several ethical issues: medical indications, legal framework, public versus private biobanks, autologous versus allogeneic use, ownership, commercialisation, quality assurance and many others. Surrogate informed consent is one of the most notable controversial ethical issues. The aim of this study was to analyse and compare informed consent forms for CB collection, storage and use in the 18 accredited biobanks of the Italian Network. Material and methods The first part of the article gives a brief overview of the scientific framework, the comparison of allogeneic and autologous use and Italian regulations. In the second part the contents of the consent forms from the 18 Italian biobanks are compared with the “NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration”. Results Most of the Italian consent forms differ significantly from the NetCord-FACT Standards, with regards both to formal and substantial aspects. Conclusion Italian forms for CB collection, storage and use need standardisation to meet international criteria. PMID:21251456

  6. Informed consent, biobank research, and locality: perceptions of breast cancer patients in three European countries.

    PubMed

    Petersen, Imme; Desmedt, Christine; Harris, Adrian; Buffa, Francesca; Kollek, Regine

    2014-07-01

    Comparative studies are missing that explore how socio-cultural and institutional circumstances influence patient comprehension and expectations regarding informed consent for current and future research on their tissue and data. This study compares how breast cancer patients in three European countries (the United Kingdom, Belgium, and Germany) who have consented to participate in tumor banking assess the given consent and the accompanying local contextual factors influencing it. Our survey demonstrates that only 59% of the patients in the British survey, but about 90% in the German and Belgian surveys, correctly recalled tissue and data donation for study purposes. Of those who remembered the study participation status correctly, about 90% had altruistic motives. At the same time, approximately half of the survey participants, or even 70% of the Belgians, expected personal benefit from research participation and information on cancer risk within the family. About half of the interviewees, but only 27% of the British participants, definitively wanted to be asked for re-consent for future research. Of the local contextual factors under study, participants' appraisals of medical science and data protection were particularly pertinent. More culturally and contextually sensitive comparative research is needed to better understand patient attitudes toward research participation and tissue donation in the context of biobank research.

  7. Specimen collection for induced pluripotent stem cell research: harmonizing the approach to informed consent.

    PubMed

    Lowenthal, Justin; Lipnick, Scott; Rao, Mahendra; Hull, Sara Chandros

    2012-05-01

    Induced pluripotent stem cells (iPSCs) have elicited excitement in both the scientific and ethics communities for their potential to advance basic and translational research. They have been hailed as an alternative to derivation from embryos that provides a virtually unlimited source of pluripotent stem cells for research and therapeutic applications. However, research with iPSCs is ethically complex, uniquely encompassing the concerns associated with genomics, immortalized cell lines, transplantation, human reproduction, and biobanking. Prospective donation of tissue specimens for iPSC research thus requires an approach to informed consent that is constructed for this context. Even in the nascent stages of this field, approaches to informed consent have been variable in ways that threaten the simultaneous goals of protecting donors and safeguarding future research and translation, and investigators are seeking guidance. We address this need by providing concrete recommendations for informed consent that balance the perspectives of a variety of stakeholders. Our work combines analysis of consent form language collected from investigators worldwide with a conceptual balancing of normative ethical concerns, policy precedents, and scientific realities. Our framework asks people to consent prospectively to a broad umbrella of foreseeable research, including future therapeutic applications, with recontact possible in limited circumstances. We argue that the long-term goals of regenerative medicine, interest in sharing iPSC lines, and uncertain landscape of future research all would be served by a framework of ongoing communication with donors. Our approach balances the goals of iPSC and regenerative medicine researchers with the interests of individual research participants.

  8. Information sheets and informed consent forms for clinical study participants: towards standardised recommendations?

    PubMed

    Chassany, Olivier; Bernard-Harlaut, Micheline; Guy, Gilles; Billon, Nathalie

    2009-01-01

    Subjects taking part in biomedical research must be provided with legible and intelligible information enabling them to freely give their informed consent. At present, sponsors tend to provide many different types of information, not all of which is directly connected with or indeed really informative about studies for those taking part.As a result of this observation, a round table was convened during the Clinical Pharmacology meetings to deliberate on the creation of a charter concerning the drafting of information documents for biomedical research participants as well as a code of good practice for the preparation of such documents.Recommendations were made based on the efforts of the various working groups concerned, such as the French National Conference of Ethics Committees (CNCP), users' representatives, patients associations and the French industrial and institutional sponsors association (CPI), together with proposals contained in the literature.The deliberations of the round table may be subsumed under the following 3 categories and 14 points: 1) Format: design, drafting rules, layout, table of contents, glossary. 2) CONTENT: introductory page, description of the study, risks, benefits. 3) Regulatory aspects: legal aspects, CNIL message (data protection), financial aspects, conflict of interests, model and varied signatures. This document should help make research in France more attractive and it was decided after the Clinical Pharmacology meeting to submit the charter and related documents for approval by the various actors involved: DGS (Direction Générale de la Santé), Afssaps (Agence Française de Sécurité Sanitaire des Produits de Santé), CNCP, CPI and LEEM (Les entreprises du médicament). Once the charter has been validated, it will be made available to Sponsors and Ethics Committees in order to ensure greater uniformity and legibility regarding information given to study subjects.

  9. The Impact of Language Barriers on Documentation of Informed Consent at a Hospital with On-Site Interpreter Services

    PubMed Central

    Schenker, Yael; Wang, Frances; Selig, Sarah Jane; Ng, Rita

    2007-01-01

    BACKGROUND Informed consent is legally and ethically required before invasive non-emergent procedures. Language barriers make obtaining informed consent more complex. OBJECTIVE Determine the impact of language barriers on documentation of informed consent among patients in a teaching hospital with on-site interpreter services. DESIGN Matched retrospective chart review study. SUBJECTS Eligible Chinese- and Spanish-speaking patients with limited English proficiency (LEP) who received a thoracentesis, paracentesis, or lumbar puncture were matched with eligible English-speaking patients by procedure, hospital service, and date of procedure. MEASUREMENTS Charts were reviewed for documentation of informed consent (IC), including a procedure note documenting an IC discussion and a signed consent form. For LEP patients, full documentation of informed consent also included evidence of interpretation, or a consent form in the patient’s primary language. RESULTS Seventy-four procedures in LEP patients were matched with 74 procedures in English speakers. Charts of English-speaking patients were more likely than those of LEP patients to contain full documentation of informed consent (53% vs 28%; odds ratio (OR): 2.81; 95% CI, 1.42–5.56; p = 0.003). Upon multivariate analysis adjusting for patient and service factors, English speakers remained more likely than LEP patients to have full documentation of informed consent (Adj OR: 3.10; 95% CI, 1.49–6.47; p = 0.003). When examining the components of informed consent, charts of English-speaking and LEP patients were similar in the proportion documenting a consent discussion; however, charts of English speakers were more likely to contain a signed consent form in any language (85% vs 70%, p = 0.03). CONCLUSIONS Despite the availability of on-site professional interpreter services, hospitalized patients who do not speak English are less likely to have documentation of informed consent for common invasive procedures

  10. [Evaluation of the clinical practice of Informed Consent in clinical trials].

    PubMed

    Gost, J; Silvestre, C; Ezpeleta, P; Astier, P; Díaz de Rada, O; Artázcoz, M T

    2003-01-01

    On the basis of existing publications it would seem legitimate to assume that in a clinical test (CT) the difficulties inherent in the process of researcher-participant communication are in practice greater than desired. Similarly, the hypothesis is adopted that difficulties exist in the formal legibility of the documents of Informed Consent. We present the results of a transversal study made of a random sample (n=160) of the CTs approved by the Ethical Committee of Clinical Research (CEIC) of Navarra during the years 1995-1999. The results found were: in 69.7% of the cases the researcher filed the documents corresponding to the CT, the Informed Consent appears signed by the researcher in 56.6% of the CTs, and in more than 83% of the cases the written information shows shortcomings in legibility, which confirms the correctness of the hypothesis and permits the detection of areas where improvements need to be developed.

  11. Ethics and the law: is there common ground on informed consent for disparities in hospital outcomes?

    PubMed

    Housri, Nadine; Coombs, Mary; Orandi, Babak J; Pawlik, Timothy M; Koniaris, Leonidas G

    2011-08-16

    The association between procedure volume at institutions and outcomes of cancer surgeries has been widely published in the medical literature; discussed in the lay press; and, during the past 15 years, incorporated into quality improvement endeavors. In certain cases, institutional volume has become a proxy for quality. Despite the vast amount of retrospective data on this topic, physicians generally have been unsure how to approach the information and interpret it for their patients. Even more challenging to some physicians has been deciding whether the data oblige them to either direct patients with cancer to high-volume centers for care or discuss the data with these patients as part of informed consent. An additional challenge is that physicians must understand laws related to these issues and that these laws are unclear. This article reviews the ethical arguments for including disparities in hospital outcomes as part of informed consent and examines whether legal precedent can shed light on this debate.

  12. One step forward, two steps back? The GMC, the common law and 'informed' consent.

    PubMed

    Fovargue, Sara; Miola, José

    2010-08-01

    Until 2008, if doctors followed the General Medical Council's (GMC's) guidance on providing information prior to obtaining a patient's consent to treatment, they would be going beyond what was technically required by the law. It was hoped that the common law would catch up with this guidance and encourage respect for patients' autonomy by facilitating informed decision-making. Regrettably, this has not occurred. For once, the law's inability to keep up with changing medical practice and standards is not the problem. The authors argue that while the common law has moved forward and started to recognise the importance of patient autonomy and informed decision-making, the GMC has taken a step back in their 2008 guidance on consent. Indeed, doctors are now required to tell their patients less than they were in 1998 when the last guidance was produced. This is an unfortunate development and the authors urge the GMC to revisit their guidance.

  13. Informed consent or institutionalized eugenics? How the medical profession encourages abortion of fetuses with Down syndrome.

    PubMed

    Dixon, Darrin P

    2008-01-01

    Many women are unprepared to make prenatal decisions about fetuses diagnosed with Down Syndrome because of societal pressures to have "normal" children, a negative view of persons with disabilities by many in society, a fear of legal liability by those in the medical community, the lack of genuine informed consent before undergoing genetic testing and abortion, and the failure of non-directive pre-abortion counseling in the medical community. Moreover, medical professionals fail to communicate correct and unbiased information before and during the genetic screening, diagnostic testing, and abortion decision-making process. This article addresses the contributing factors and causes that ultimately lead to a lack of informed consent and a very high abortion rate for fetuses diagnosed with Down Syndrome.

  14. 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.

  15. Use of Multimedia Technology in the Doctor-Patient Relationship for Obtaining Patient Informed Consent

    PubMed Central

    Michalski, Andrzej; Stopa, Marcin; Miśkowiak, Bogdan

    2016-01-01

    Patient informed consent for surgery or for high-risk methods of treatment or diagnosis means that unlawful breach of the patient’s personal interests is avoided and the patient accepts the risk of surgery and takes the brunt of it. Patient awareness – their knowledge of the condition and circumstances of continued therapeutic procedure, including offered and available methods of treatment and their possible complications – constitutes a particular aspect of the informed-consent process. The rapid development of technologies and methods of treatment may cause communication problems between the doctor and the patient regarding the scope and method of patient education prior to surgery. The use of multimedia technology (e.g., videos of surgical procedures, computer animation, and graphics), in addition to media used in preoperative patient education, may be a factor in improving the quality of the informed consent process. Studies conducted in clinical centers show that with use of multimedia technology, patients remember more of the information presented. The use of new technology also makes it possible to reduce the difference in the amount of information assimilated by patients with different levels of education. The use of media is a way to improve the quality of preoperative patient education and, at the same time, a step towards their further empowerment in the healing process. PMID:27780964

  16. The federal government and academic texts as barriers to informed consent.

    PubMed

    Lanfranchi, Angela

    2008-01-01

    Informed patient consent for medical treatment is required by both law and medical ethics. Yet, both federal agencies and academicians are participating in the suppression of information about the heightened risk of breast cancer posed by oral contraceptives and induced abortion. There is historical precedent in the long-delayed acknowledgement of the smoking/lung cancer link. By law, a patient has the right to be fully informed of the nature of her medical condition and any proposed course of therapy. It is assumed that a patient will be given the complete and true scientific basis of her diagnosis and treatment, to ensure that her well-being and her autonomy in decision-making are protected. Informed consent is the process by which a patient can participate in choices about medical treatment. It originates from the legal and ethical right of the patient to direct what is done to her body, and from the ethical duty of the physician to involve the patient in her medical care. Our federal government has become a barrier to informed consent concerning oral contraceptive drugs and induced abortion.

  17. Use of Multimedia Technology in the Doctor-Patient Relationship for Obtaining Patient Informed Consent.

    PubMed

    Michalski, Andrzej; Stopa, Marcin; Miśkowiak, Bogdan

    2016-10-26

    Patient informed consent for surgery or for high-risk methods of treatment or diagnosis means that unlawful breach of the patient's personal interests is avoided and the patient accepts the risk of surgery and takes the brunt of it. Patient awareness - their knowledge of the condition and circumstances of continued therapeutic procedure, including offered and available methods of treatment and their possible complications - constitutes a particular aspect of the informed-consent process. The rapid development of technologies and methods of treatment may cause communication problems between the doctor and the patient regarding the scope and method of patient education prior to surgery. The use of multimedia technology (e.g., videos of surgical procedures, computer animation, and graphics), in addition to media used in preoperative patient education, may be a factor in improving the quality of the informed consent process. Studies conducted in clinical centers show that with use of multimedia technology, patients remember more of the information presented. The use of new technology also makes it possible to reduce the difference in the amount of information assimilated by patients with different levels of education. The use of media is a way to improve the quality of preoperative patient education and, at the same time, a step towards their further empowerment in the healing process.

  18. Ensuring Adequate Health and Safety Information for Decision Makers during Large-Scale Chemical Releases

    NASA Astrophysics Data System (ADS)

    Petropoulos, Z.; Clavin, C.; Zuckerman, B.

    2015-12-01

    The 2014 4-Methylcyclohexanemethanol (MCHM) spill in the Elk River of West Virginia highlighted existing gaps in emergency planning for, and response to, large-scale chemical releases in the United States. The Emergency Planning and Community Right-to-Know Act requires that facilities with hazardous substances provide Material Safety Data Sheets (MSDSs), which contain health and safety information on the hazardous substances. The MSDS produced by Eastman Chemical Company, the manufacturer of MCHM, listed "no data available" for various human toxicity subcategories, such as reproductive toxicity and carcinogenicity. As a result of incomplete toxicity data, the public and media received conflicting messages on the safety of the contaminated water from government officials, industry, and the public health community. Two days after the governor lifted the ban on water use, the health department partially retracted the ban by warning pregnant women to continue avoiding the contaminated water, which the Centers for Disease Control and Prevention deemed safe three weeks later. The response in West Virginia represents a failure in risk communication and calls to question if government officials have sufficient information to support evidence-based decisions during future incidents. Research capabilities, like the National Science Foundation RAPID funding, can provide a solution to some of the data gaps, such as information on environmental fate in the case of the MCHM spill. In order to inform policy discussions on this issue, a methodology for assessing the outcomes of RAPID and similar National Institutes of Health grants in the context of emergency response is employed to examine the efficacy of research-based capabilities in enhancing public health decision making capacity. The results of this assessment highlight potential roles rapid scientific research can fill in ensuring adequate health and safety data is readily available for decision makers during large

  19. Readability of informed consent forms in clinical trials conducted in a skin research center.

    PubMed

    Samadi, Aniseh; Asghari, Fariba

    2016-01-01

    Obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. In order for the consent to be informed, the patient must receive and comprehend the information appropriately. Complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. The objective of this study was to assess the readability of different templates of informed consent forms (ICFs) used in clinical trials in the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran, Iran. This study was conducted on ICFs of 45 clinical trials of the CRTSDL affiliated with Tehran University of Medical Sciences. ICFs were tested for reading difficulty, using the readability assessments formula adjusted for the Persian language including the Flesch-Kincaid reading ease score, Flesch-Kincaid grade level, and Gunning fog index. Mean readability score of the whole text of ICFs as well as their 7 main information parts were calculated. The mean ± SD Flesch Reading Ease score for all ICFs was 31.96 ± 5.62 that is in the difficult range. The mean ± SD grade level was calculated as 10.71 ± 1.8 (8.23-14.09) using the Flesch-Kincaid formula and 14.64 ± 1.22 (12.67-18.27) using the Gunning fog index. These results indicate that the text is expected to be understandable for an average student in the 11(th) grade, while the ethics committee recommend grade level 8 as the standard readability level for ICFs. The results showed that the readability scores of ICFs assessed in our study were not in the acceptable range. This means they were too complex to be understood by the general population. Ethics committees must examine the simplicity and readability of ICFs used in clinical trials.

  20. Readability of informed consent forms in clinical trials conducted in a skin research center

    PubMed Central

    Samadi, Aniseh; Asghari, Fariba

    2016-01-01

    Obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. In order for the consent to be informed, the patient must receive and comprehend the information appropriately. Complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. The objective of this study was to assess the readability of different templates of informed consent forms (ICFs) used in clinical trials in the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran, Iran. This study was conducted on ICFs of 45 clinical trials of the CRTSDL affiliated with Tehran University of Medical Sciences. ICFs were tested for reading difficulty, using the readability assessments formula adjusted for the Persian language including the Flesch–Kincaid reading ease score, Flesch–Kincaid grade level, and Gunning fog index. Mean readability score of the whole text of ICFs as well as their 7 main information parts were calculated. The mean ± SD Flesch Reading Ease score for all ICFs was 31.96 ± 5.62 that is in the difficult range. The mean ± SD grade level was calculated as 10.71 ± 1.8 (8.23–14.09) using the Flesch–Kincaid formula and 14.64 ± 1.22 (12.67–18.27) using the Gunning fog index. These results indicate that the text is expected to be understandable for an average student in the 11th grade, while the ethics committee recommend grade level 8 as the standard readability level for ICFs. The results showed that the readability scores of ICFs assessed in our study were not in the acceptable range. This means they were too complex to be understood by the general population. Ethics committees must examine the simplicity and readability of ICFs used in clinical trials. PMID:27471590

  1. Informed consent for exome sequencing in diagnostics: exploring first experiences and views of professionals and patients

    PubMed Central

    Rigter, T; van Aart, CJA; Elting, MW; Waisfisz, Q; Cornel, MC; Henneman, L

    2014-01-01

    Next-generation sequencing is increasingly being chosen as a diagnostic tool for cases of expected genetic, but unresolved origin. The consequential increased need for decisions on disclosure of unsolicited findings poses a challenge for the informed consent procedure. This study explored the first experiences with, and needs for, the informed consent procedure in diagnostic exome sequencing, with the stakeholders involved. Semi-structured interviews were conducted with 11 professional experts and one professional gave a written response. Furthermore, the counseling process was observed in three cases where exome sequencing was offered, followed by interviews with the patient (representative) and the genetic counselor. The respondents not only preferred an opt-out for unsolicited findings but also identified many challenges and therefore more experiences with exome sequencing was considered needed. Context-dependent decision-making was observed and an Advisory Board for unsolicited findings was considered helpful while doubts were raised about the feasibility and the possibility of undermining patients' autonomy. Finally, respondents brought up the complexity of information provision, and division of responsibilities between clinicians and the lab. These challenges and needs, raised by stakeholders involved, provide more insight in the next steps needed for an optimal informed consent procedure for exome sequencing in diagnostics. PMID:24117109

  2. Informed consent for exome sequencing in diagnostics: exploring first experiences and views of professionals and patients.

    PubMed

    Rigter, T; van Aart, C J A; Elting, M W; Waisfisz, Q; Cornel, M C; Henneman, L

    2014-05-01

    Next-generation sequencing is increasingly being chosen as a diagnostic tool for cases of expected genetic, but unresolved origin. The consequential increased need for decisions on disclosure of unsolicited findings poses a challenge for the informed consent procedure. This study explored the first experiences with, and needs for, the informed consent procedure in diagnostic exome sequencing, with the stakeholders involved. Semi-structured interviews were conducted with 11 professional experts and one professional gave a written response. Furthermore, the counseling process was observed in three cases where exome sequencing was offered, followed by interviews with the patient (representative) and the genetic counselor. The respondents not only preferred an opt-out for unsolicited findings but also identified many challenges and therefore more experiences with exome sequencing was considered needed. Context-dependent decision-making was observed and an Advisory Board for unsolicited findings was considered helpful while doubts were raised about the feasibility and the possibility of undermining patients' autonomy. Finally, respondents brought up the complexity of information provision, and division of responsibilities between clinicians and the lab. These challenges and needs, raised by stakeholders involved, provide more insight in the next steps needed for an optimal informed consent procedure for exome sequencing in diagnostics.

  3. Evaluating Biomedical Enhancement Research: Assessing Risk & Benefit and Obtaining Informed Consent

    PubMed Central

    Mehlman, Maxwell J.; Berg, Jessica W.

    2013-01-01

    There are two primary human subject protections: assessing and comparing the risks and potential benefits of proposed research, and obtaining potential subjects’ informed consent. While there has been extensive discussion in the literature on these two aspects, no attention has been paid to whether the processes should be different when the objective of an experimental biomedical intervention is to improve individual performance or capacity (“enhancement research”) rather than to prevent, cure, or mitigate disease (“health-oriented research”). This essay examines how both assessment of risks and benefits, and obtaining informed consent in an enhancement experiment might differ from the approaches used in health-oriented investigations, and considers appropriate protections for subjects in enhancement research. PMID:18840248

  4. Musculoskeletal health disparities: health literacy, cultural competency, informed consent, and shared decision making.

    PubMed

    McClellan, Frank M; Wood, James E; Fahmy, Sherin M; Jones, Lynne C

    2014-01-01

    The factors that contribute to musculoskeletal healthcare disparities may influence the results of studies regarding the long-term outcome of orthopaedic implants. Patient decisions regarding their healthcare and their subsequent outcomes are influenced by health literacy. Providing patients with the information that they need to consent to treatment must be provided in a culturally competent manner. The influence of the physician or healthcare provider on the treatment choice varies depending on the type of decision-making process: patient-based, physician-based, or shared decision making. Respecting the patient's autonomy while acknowledging the knowledge and experience of the physician, we advocate for shared decision making. This may require modification of existing regulations regarding informed consent. Furthermore, federal and state directives have been put into place to address healthcare disparities, especially with respect to culturally competent care and access to proper healthcare.

  5. Stakeholders’ opinions on the implementation of pediatric whole exome sequencing: Implications for informed consent

    PubMed Central

    Levenseller, Brooke L.; Soucier, Danielle J.; Miller, Victoria A.; Harris, Diana; Conway, Laura; Bernhardt, Barbara A.

    2013-01-01

    Advances in whole genome and whole exome sequencing (WGS/WES) technologies have led to increased availability in clinical settings. Currently, there are few guidelines relating to the process and content of informed consent for WGS/WES, nor to which results should be returned to families. To address this gap, we conducted focus groups to assess the views of professionals, parents, and adolescents for the future implementation of WES. The discussions assessed understanding of the risks and benefits of WES, preferences for the informed consent discussion, process for return of results, and the decision-making role of the pediatric patient. Professional focus group participants included bioethicists, physicians, laboratory directors, and genetic counselors. Parent focus groups included individuals with children who could be offered sequencing due to a potential genetic cause of the child’s condition. On-line discussion groups were conducted with adolescents aged 13-17 who had a possible genetic disorder. We identified discrepancies between professionals and patient groups regarding the process and content of informed consent, preference for return of results, and the role of the child in decision-making. Professional groups were concerned with the uncertainty regarding professional obligations, changing interpretation in genomic medicine, and practical concerns of returning results over time. Parent and adolescent groups focused on patient choice and personal utility of sequencing results. Each group expressed different views on the role of the child in decision-making and return of results. These discrepancies represent potential barriers to informed consent and a challenge for genetic counselors regarding the involvement of pediatric patients in decision-making and return of results discussions. PMID:23846343

  6. Free will and psychiatric assessments of criminal responsibility: a parallel with informed consent.

    PubMed

    Meynen, Gerben

    2010-11-01

    In some criminal cases a forensic psychiatrist is asked to make an assessment of the state of mind of the defendant at the time of the legally relevant act. A considerable number of people seem to hold that the basis for this assessment is that free will is required for legal responsibility, and that mental disorders can compromise free will. In fact, because of the alleged relationship between the forensic assessment and free will, researchers in forensic psychiatry also consider the complicated metaphysical discussions on free will relevant to the assessment. At the same time, there is concern about the lack of advancement with respect to clarifying the nature of the forensic assessment. In this paper I argue that, even if free will is considered relevant, there may be no need for forensic researchers to engage into metaphysical discussions on free will in order to make significant progress. I will do so, drawing a parallel between the assessment of criminal responsibility on the one hand, and the medical practice of obtaining informed consent on the other. I argue that also with respect to informed consent, free will is considered relevant, or even crucial. This is the parallel. Yet, researchers on informed consent have not entered into metaphysical debates on free will. Meanwhile, research on informed consent has made significant progress. Based on the parallel with respect to free will, and the differences with respect to research, I conclude that researchers on forensic assessment may not have to engage into metaphysical discussions on free will in order to advance our understanding of this psychiatric practice.

  7. Characteristics associated with informed consent for genetic studies in the ACCORD trial

    PubMed Central

    Simons-Morton, Denise G.; Chan, Jeffrey C.; Kimel, Angela R.; Linz, Peter E.; Stowe, Cynthia L.; Summerson, John; Ambrosius, Walter T.

    2014-01-01

    Background Prior studies found some groups have lower genetic consent rates than others. Participant consent for genetic studies enables randomized trials to examine effects of interventions compared to control in participants with different genotypes. Methods Unadjusted and multivariate associations between genetic consent rates and participant, study, and consent characteristics in 9,573 participants approached for genetics consent in the multicenter Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, which used a layered genetics consent. Results Eighty-nine percent of eligible participants consented to genetic studies (“Any Consent”) and 64.7% consented to studies of any genes by any investigator (“Full Consent”), with similar rates in randomized groups. Controlling for multiple characteristics, African-Americans had lower consent rates than others (Any Consent Odds Ratio, OR = 0.62, p=0.0004; Full Consent OR = 0.67, p<0.0001). Those with high school or higher education had higher rates than less than high school graduation (Full Consent ORs 1.41-1.69, p-values <0.0001). Consent rates were lower when genetics consent was separate from the main trial consent on the same day (Any Consent OR 0.30; Full Consent OR 0.52, p values <0.0001) or on a subsequent day (Any Consent OR 0.70, p=0.0022; Full Consent OR 0.76, p=0.0002). Conclusion High rates of consent for genetic studies can be obtained in complex randomized trials, with lower consent rates in African-Americans, in participants with less than high-school education, and for sharing samples with other investigators. A genetics consent separated from the main trial consent was associated with lower consent rates. PMID:24355197

  8. Development of an electronic research permissions management system to enhance informed consents and capture research authorizations data.

    PubMed

    Obeid, Jihad S; Gerken, Katherine; Madathil, Kapil Chalil; Rugg, Daniel; Alstad, Colin E; Fryar, Katrina; Alexander, Randall; Gramopadhye, Anand K; Moskowitz, Jay; Sanderson, Iain C

    2013-01-01

    Informed consents are a critical and essential component of the clinical research process. Currently, most consents and research privacy authorizations are being captured on paper. In this paper we describe a novel method of capturing this information electronically. The objective is to allow easier tracking of research participants' intent for current and future research involvement, enhance consent comprehension and facilitate the research workflow. After multidisciplinary analysis in key hospital registration areas and research participant enrollment, an open source software product was designed to capture this data through a user-friendly touch screen interface. The data may then be fed into a clinical data warehouse for use in cohort discovery or consent tracking. Despite ethical, legal and informatics challenges in clinical and research environments, we propose that this technology opens new avenues for significantly enhancing the consent process and positively impacting recruitment.

  9. Development of an Electronic Research Permissions Management System to Enhance Informed Consents and Capture Research Authorizations Data

    PubMed Central

    Obeid, Jihad S.; Gerken, Katherine; Madathil, Kapil Chalil; Rugg, Daniel; Alstad, Colin E.; Fryar, Katrina; Alexander, Randall; Gramopadhye, Anand K.; Moskowitz, Jay; Sanderson, Iain C.

    Informed consents are a critical and essential component of the clinical research process. Currently, most consents and research privacy authorizations are being captured on paper. In this paper we describe a novel method of capturing this information electronically. The objective is to allow easier tracking of research participants’ intent for current and future research involvement, enhance consent comprehension and facilitate the research workflow. After multidisciplinary analysis in key hospital registration areas and research participant enrollment, an open source software product was designed to capture this data through a user-friendly touch screen interface. The data may then be fed into a clinical data warehouse for use in cohort discovery or consent tracking. Despite ethical, legal and informatics challenges in clinical and research environments, we propose that this technology opens new avenues for significantly enhancing the consent process and positively impacting recruitment. PMID:24303263

  10. Patient Privacy, Consent, and Identity Management in Health Information Exchange: Issues for the Military Health System.

    PubMed

    Hosek, Susan D; Straus, Susan G

    2013-01-01

    The Military Health System (MHS) and the Veterans Health Administration (VHA) have been among the nation's leaders in health information technology (IT), including the development of health IT systems and electronic health records that summarize patients' care from multiple providers. Health IT interoperability within MHS and across MHS partners, including VHA, is one of ten goals in the current MHS Strategic Plan. As a step toward achieving improved interoperability, the MHS is seeking to develop a research roadmap to better coordinate health IT research efforts, address IT capability gaps, and reduce programmatic risk for its enterprise projects. This article contributes to that effort by identifying gaps in research, policy, and practice involving patient privacy, consent, and identity management that need to be addressed to bring about improved quality and efficiency of care through health information exchange. Major challenges include (1) designing a meaningful patient consent procedure, (2) recording patients' consent preferences and designing procedures to implement restrictions on disclosures of protected health information, and (3) advancing knowledge regarding the best technical approaches to performing patient identity matches and how best to monitor results over time. Using a sociotechnical framework, this article suggests steps for overcoming these challenges and topics for future research.

  11. Context and process of informed consent for pharmacologic strategies in labor pain care.

    PubMed

    Lowe, Nancy K

    2004-01-01

    The care of women experiencing labor pain often challenges midwives to provide ethical informed consent for the pharmacologic strategies common in most of America's childbearing environments. A systematic approach to this clinical dilemma begins with a conceptual understanding of the origins of labor pain stimuli, factors affecting their central nervous system processing, and the differentiation of the concepts of pain, suffering, and comfort. These concepts can be integrated into a labor pain care, rather than pain management, model for clinical practice. Because most midwives provide care for laboring women in acute care hospitals, the midwife must also understand how the standards of the Joint Commission on Accreditation of Healthcare Organizations influence the behavior of other professionals in the health care environment for laboring women and the process of informed consent. A systematic approach to informed consent for pharmacologic strategies for labor pain care strategies should begin during pregnancy and includes full, unbiased disclosure of the nature, benefits, risks, side effects, and efficacy of all methods that are available in the chosen birth setting.

  12. Informed Consent

    MedlinePlus

    ... You Want to Be a Surgeon Resident Resources Teaching Resources Online Guide to Choosing a Surgical Residency Practice Management Workshops Patients and Family Patient Education Patient Education ...

  13. Using video-taped examples of standardized patient to teach medical students taking informed consent

    PubMed Central

    HABIBI KHORASANI, SHIRIN; EBRAHIMI, SEDIGHEH

    2015-01-01

    Introduction Medical student should be trained in medical ethics and one of the most essential issues in this field is taking informed consents. In this research, we compared the effect of effectiveness of teaching methods on students’ ability intaking informed consent from patients. Methods This semi-experimental study was carried out on fifty eight subjects from the 4th-year students  of Shiraz University of Medical Sciences who attended in medical ethics coursebefore their 'clinical clerkship'training.Method of sampling was census and students were randomly allocated into two groups of control group(n=28) was trained in traditional lecture-based class and the case groupnamed as A1(n=22) were taught by video-taped examples of standardized patient.Then A1 group attended in traditional lecture-based classes named as A2. The groups were evaluated in terms the ability of recognition of ethical issuesthrough the scenario based ethical examination before and after each training. Scenarios were related to the topics ofinformed consent. Data were analyzed by SPSS 14 software using descriptive statistics and anovatest.P-Value less than 0.05 was considered as significant. Results The mean scores results of A2, A1and B groupwere found to be7.21 , 5.91 and 5.73 out of 8,respectively. Comparison between the groups demonstrated that the ability of taking informed consent was significantly higher in A2 group (p<0.001), followed by A1group (p<0.05),while was the leastin the B group (p=0.875) Conclusion According to this research, lecture-based teaching is still of great value in teaching medical ethics, but when combined with standardized patient, the outcome will be much better.it should be considered that mixed methodsof teaching should be used together for better result. PMID:25927071

  14. [Informed consent in anaesthesiology: period of notice as a requisite of validity].

    PubMed

    Galán Gutiérrez, J C; Galán Cortés, J C

    2014-02-01

    The analysis of one of the requisites of the validity of the informed consent, the notice period, during which the patient should be provided with information, so that he/she can reflect and fully exercise his/her Kantian right of self-determination. National legislation appears to be insufficient when dealing with this issue, which is compensated for in some regional legislations. We conclude by pointing the need to provide the patient with information with sufficient notice prior to operations, so that he/she can ponder over his/her decision.

  15. "Case Neisser": experimental design, the beginnings of immunology, and informed consent.

    PubMed

    Benedek, Thomas G

    2014-01-01

    In 1892, Albert L. Neisser (1855-1916), the professor of dermatology and venereology at the University of Breslau (Prussia), undertook two series of clinical experiments: one to test whether serum from syphilitic patients had a prophylactic value against contracting syphilis, and the other to test whether such serum had a therapeutic value for syphilitic patients. The first experiment was based on the erroneous scientific hypothesis called "Colles's law," which posited that a fetus that was syphilitic due to the father's disease could in utero immunize its mother against syphilis. Neisser acknowledged that neither experiment achieved its goal. However, when his work was published, Neisser was criticized not for the various errors of experimental design that should have been recognizable to him, but because of his failure to obtain the consent of his non-syphilitic subjects. The political furor that followed led to the first governmental edict to require informed consent of participants in clinical research. This essay examines how Neisser's generally forgotten investigation into therapies for syphilis led to some of the first regulations about informed consent.

  16. Randomization, informed consent and physicians' communication skills in pediatric oncology: a delicate balance.

    PubMed

    Massimo, Luisa M; Wiley, Thomas J

    2005-12-01

    Parents asked to consent to a child's randomization in a pediatric cancer clinical trial are often unprepared to grasp the implications of this scientifically crucial but seemingly unfair process. Physicians must adopt specific communication skills to engage families in open dialogue from the outset in order to elicit truly shared informed consent. Starting from the case of a family with an only child affected by disseminated neuroblastoma, we wish to comment on the problems surfacing in the informed consent process for treatment and research in pediatric oncology that implicate an understanding of bioethical issues and psychological principles. Although the outcome of childhood cancer has improved dramatically over the last 30 years, with overall survival rates now exceeding 70%, there are regretfully still types and stages of cancer carrying a very high risk of death that urgently require new clinical strategies. The response to this need has been the design of experimental protocols that often entail randomized controlled trials (RCT). A large number of these trials concern stage IV neuroblastoma, acute leukemia, rhabdomyosarcoma, and other types of childhood cancers presenting great heterogeneity both in terms of localization and responsiveness to therapy. Most trials for disease relapses also include one or more randomizations. The scientific motivation justifying an RCT is the need to compare and evaluate an innovative protocol (or part thereof) with reference treatment modalities. Nevertheless, the process brings to bear the ethical dilemma of having to weigh the needs of the single afflicted child against the benefit which may ensue for a much larger patient community.

  17. Knowledge and Practices of Obtaining Informed Consent for Medical Procedures among Specialist Physicians: Questionnaire Study in 6 Croatian Hospitals

    PubMed Central

    Jukić, Marko; Kvolik, Slavica; Kardum, Goran; Kozina, Slavica; Tomić, Ana; Juraga

    2009-01-01

    Aim To assess physicians’ knowledge and practices for obtaining patients’ informed consent to medical procedures. Methods An anonymous and voluntary survey of knowledge and practices for obtaining informed consent was conducted among 470 physicians (63% response rate) working in 6 hospitals: 93 specialists in anesthesiology, 166 in internal medicine, and 211 in surgery. Results Only 54% physicians were acquainted with the fact that the procedure for obtaining consent was regulated by the law. Internists and surgeons were better informed than anesthesiologists (P = 0.024). More than a half of respondents (66%) were familiar with the fact that a law on patient rights was passed in Croatia; there were no differences among different specialties (P = 0.638). Only 38% of the physicians were fully informed about the procedure of obtaining consent. Internists and surgeons provided detailed information to the patient in 33% of the cases and anesthesiologists in 16% of the cases (P < 0.050). Internists reported spending more time on informing the patient than anesthesiologists and surgeons (P < 0.001). There were no differences in knowledge and practices for obtaining informed consent between physicians working in university and those working in community hospitals (P ≥ 0.05 for all questions). Conclusion Physicians in Croatia have no formal education on informed consent and implement the informed consent process in a rather formal manner, regardless of the type of hospital or medical specialty. Systemic approach at education and training at the national level is needed to improve the informed consent process. PMID:20017225

  18. Informed consent for HIV testing in a South African hospital: is it truly informed and truly voluntary?

    PubMed Central

    Abdool Karim, Q; Abdool Karim, S S; Coovadia, H M; Susser, M

    1998-01-01

    OBJECTIVE: The purpose of this study was to assess informed consent to human immunodeficiency virus (HIV) testing in a perinatal HIV transmission study in a major referral hospital serving a largely Black population in South Africa. METHODS: First-time antenatal clinic attenders who were randomly selected from those enrolled in the perinatal HIV study (n = 56) answered questionnaires before and after counseling. RESULTS: Knowledge of HIV transmission and prevention, high at the outset, was little improved after counseling. The acceptance rate for HIV testing was high. Despite assurances that participation was voluntary, 88% of the women said they felt compelled to participate in the study. CONCLUSIONS: Informed consent in this setting was truly informed but not truly voluntary. PMID:9551007

  19. 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

  20. Informed consent in implantable BCI research: identification of research risks and recommendations for development of best practices

    NASA Astrophysics Data System (ADS)

    Klein, Eran; Ojemann, Jeffrey

    2016-08-01

    Objective. Implantable brain-computer interface (BCI) research promises improvements in human health and enhancements in quality of life. Informed consent of subjects is a central tenet of this research. Rapid advances in neuroscience, and the intimate connection between functioning of the brain and conceptions of the self, make informed consent particularly challenging in BCI research. Identification of safety and research-related risks associated with BCI devices is an important step in ensuring meaningful informed consent. Approach. This paper highlights a number of BCI research risks, including safety concerns, cognitive and communicative impairments, inappropriate subject expectations, group vulnerabilities, privacy and security, and disruptions of identity. Main results. Based on identified BCI research risks, best practices are needed for understanding and incorporating BCI-related risks into informed consent protocols. Significance. Development of best practices should be guided by processes that are: multidisciplinary, systematic and transparent, iterative, relational and exploratory.

  1. GCP compliance and readability of informed consent forms from an emerging hub for clinical trials

    PubMed Central

    Nair, Satish Chandrasekhar; Ibrahim, Halah

    2015-01-01

    Background: The rapid expansion of trials in emerging regions has raised valid concerns about research subject protection, particularly related to informed consent. The purpose of this study is to assess informed consent form (ICF) compliance with Good Clinical Practice (GCP) guidelines and the readability easeof the ICFs in Abu Dhabi, a potential destination for clinical trials in the UAE. Materials and Methods: A multicenter retrospective cross-sectional analysis of 140 ICFs from industry sponsored and non-sponsored studies was conducted by comparing against a local standard ICF. Flesch-Kincaid Reading Scale was used to assess the readability ease of the forms. Results: Non-sponsored studies had significantly lower overall GCP compliance of 55.8% when compared to 79.5% for industry sponsored studies. Only 33% of sponsored and 16% of non-sponsored studies included basic information on the participants' rights and responsibilities. Flesch-Kincaid Reading ease score for the informed consent forms from industry sponsored studies was significantly higher 48.9 ± 4.8 as compared to 38.5 ± 8.0 for non-sponsored studies, though both were more complex than recommended. Reading Grade Level score was also higher than expected, but scores for the ICFs from the industry sponsored studies were 9.7 ± 0.7, significantly lower as compared to 12.2 ± 1.3 for non-sponsored studies. Conclusion: In spite of the undisputed benefits of conducting research in emerging markets readability, comprehension issues and the lack of basic essential information call for improvements in the ICFs to protect the rights of future research subjects enrolled in clinical trials in the UAE. PMID:25878956

  2. 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

  3. The Readability of Information and Consent Forms in Clinical Research in France

    PubMed Central

    Ménoni, Véronique; Lucas, Noël; Leforestier, Jean François; Dimet, Jérôme; Doz, François; Chatellier, Gilles; Tréluyer, Jean-Marc; Chappuy, Hélène

    2010-01-01

    Background Quantitative tools have been developed to evaluate the readability of written documents and have been used in several studies to evaluate information and consent forms. These studies all showed that such documents had a low level of readability. Our objective is to evaluate the readability of Information and Consent Forms (ICFs) used in clinical research. Methods and Findings Clinical research protocols were collected from four public clinical research centers in France. Readability was evaluated based on three criteria: the presence of an illustration, the length of the text and its Flesch score. Potential effects of protocol characteristics on the length and readability of the ICFs were determined. Medical and statutory parts of the ICF form were analyzed separately. The readability of these documents was compared with that of everyday contracts, press articles, literary extracts and political speeches. We included 209 protocols and the corresponding 275 ICFs. The median length was 1304 words. Their Flesch readability scores were low (median: 24), and only about half that of selected press articles. ICF s for industrially sponsored and randomized protocols were the longest and had the highest readability scores. More than half (52%) of the text in ICFs concerned medical information, and this information was statistically (p<0.05) more readable (Flesch: 28) than statutory information (Flesch: 21). Conclusion Regardless of the field of research, the ICFs for protocols included had poor readability scores. However, a prospective analysis of this test in French should be carried out before it is put into general use. PMID:20485505

  4. 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.

  5. Legislation and informed consent brochures for dental patients receiving amalgam restorations.

    PubMed

    Edlich, Richard F; Cochran, Amy A; Cross, Catherine L; Wack, Courtney A; Long, William B; Newkirk, Anthony T

    2008-01-01

    In 2008, Norway banned the use of mercury for amalgam restorations. Four states in the United States have developed Informed Consent Brochures for amalgam restorations that must be given to their dental patients. The authors describe a patient who had a large cavity in his left lower molar tooth no.18 that had to be removed by an oral surgeon. When the patient went to the oral surgeon, the surgeon told the patient that he would replace the carious tooth with a gold implant. He was not given an Informed Consent Brochure regarding dental restorative materials. The oral surgeon extracted the carious tooth, replacing the tooth with a supposed gold crown implant. On his yearly dental examination, his dentist took an x-ray of his dental implant and explained that the x-ray could not distinguish whether the implant contained either gold or mercury. Consequently, the dentist referred him to a dental clinic in which the dental implant could be removed without mercury contamination of the patient's neurologic system during the extraction of the implant from the root canal. During the removal of the dental restoration, the dentist found build up expanding into the root canal that had a black color. The crown and underlying tooth were sent to ALT BioScience for analysis. Elemental analysis of the crown and underlying tooth confirmed the presence of mercury in the restoration. The patient should have been given an Informed Consent Brochure by the dentist that described the dental restoration that was used in the dental implant.

  6. Informed consent in the ethics of responsibility as stated by Emmanuel Levinas.

    PubMed

    Benito, Javier Jiménez; García, Sonia Ester Rodríguez

    2016-09-01

    In this paper we analyze some of the major difficulties of informed consent (IC). We consider insufficient to base IC on the principle of autonomy. We must not forget that the patient may be in a situation of extreme vulnerability and the good doctor should assume a degree of commitment and responsibility with his/her decisions. Our aim is to introduce the ethics of responsibility of Levinas in practice and theory of IC in order to generate a beneficent medical practice in which the supervision and overseeing of the patient do not undermine his/her autonomy.

  7. Risk communication and informed consent in the medical tourism industry: A thematic content analysis of canadian broker websites

    PubMed Central

    2011-01-01

    the websites. Finally, brokers' roles in follow up care, their prices, and the speed of surgery were the most commonly included business dimensions on the reviewed websites. Conclusion Canadian medical tourism brokers currently lack a common standard of care and accreditation, and are widely lacking in providing adequate risk communication for potential medical tourists. This has implications for the informed consent and consequent safety of Canadian medical tourists. PMID:21943392

  8. Duty to Inform and Informed Consent in Diagnostic Radiology: How Ethics and Law can Better Guide Practice.

    PubMed

    Doudenkova, Victoria; Bélisle Pipon, Jean-Christophe

    2016-03-01

    Although there is consensus on the fact that ionizing radiation used in radiological examinations can affect health, the stochastic (random) nature of risk makes it difficult to anticipate and assess specific health implications for patients. The issue of radiation protection is peculiar as any dosage received in life is cumulative, the sensitivity to radiation is highly variable from one person to another, and between 20 % and 50 % of radiological examinations appear not to be necessary. In this context, one might reasonably assume that information and patient consent would play an important role in regulating radiological practice. However, there is to date no clear consensus regarding the nature and content of-or even need for-consent by patients exposed to ionizing radiation. While law and ethics support the same principles for respecting the dignity of the person (inviolability and integrity), in the context of radiology practice, they do not provide a consistent message to guide clinical decision-making. This article analyzes the issue of healthcare professionals' duty to inform and obtain patient consent for radiological examinations. Considering that both law and ethics have as one of their aims to protect vulnerable populations, it is important that they begin to give greater attention to issues raised by the use of ionizing radiation in medicine. While the situation in Canada serves as a backdrop for a reflective analysis of the problem, the conclusions are pertinent for professional practice in other jurisdictions because the principles underlying health law and jurisprudence are fairly general.

  9. Mandating audio-video recording of informed consent: are we right in enforcing this?

    PubMed

    Agrawal, A R; Joshi, R P; Shah, V

    2014-07-01

    Medicines are the result of experimentation carried out in animals and humans. However, there are numerous instances in the history of medicine where humans were subjected to undue risks and abuses, requiring regulations for their safety. Idea of informed consent has found its presence in medical literature from the times of Hippocratic Oath propagating principles of '...never do harm to anyone' and physician directed care of patients. This was revived in post-world war II era in the form of Nuremberg code and the declaration of Helsinki in response to various debilitating experimentations done on prisoners in concentration camps and elsewhere. Complete information and voluntary participation forms the ethical tenets of these acts and the same has been reflected in various guidelines enacted worldwide, which are sufficient to make sure that patient consent is obtained in fair and just manner. Despite this, there have been undesirable lapses in the conduct of clinical trials. This situation worsens, when intentional lapses in conduct of trial hamper the ability of socially and economically disadvantaged communities in developing countries to make free and informed decision.

  10. Using media to improve the informed consent process for youth undergoing pediatric endoscopy and their parents

    PubMed Central

    Yeh, Debra M.; Chun, Stanford; Terrones, Laura; Huang, Jeannie S.

    2017-01-01

    Background and study aims Youth undergoing pediatric endoscopic procedures and their parents demonstrate suboptimal comprehension of the informed consent (IC) process. We developed informational videos discussing key IC elements for pediatric endoscopy and evaluated their effects on youth and parental comprehension of the IC process. Patients and methods A randomized controlled trial of the video intervention was performed among youth undergoing endoscopy and their parents at an academic children’s hospital. Randomization occurred at the time of enrollment using permutated blocks. Following the IC process with the proceduralist, subjects underwent structured interviews to assess IC comprehension. An Informed Consent Overall Score (ICOS: range 0 – 4) for comprehension was calculated. Results Seventy-seven pairs of children and their parents participated. Intervention recipients (N = 37 pairs) demonstrated higher ICOS scores as compared to control counterparts (mean (standard deviation): 3.6 (0.7) v. 2.9 (0.9), intervention v. control parents, P < 0.0001 and 2.7 (1.1) v. 1.7 (1.1), intervention v. control youth, P < 0.0001). Conclusions A media intervention addressing key elements of the IC process for pediatric endoscopy was effective in improving comprehension of IC for youth undergoing endoscopic procedures and their parents. PMID:28191495

  11. Alternatives of informed consent for storage and use of human biological material for research purposes: Brazilian regulation.

    PubMed

    Marodin, Gabriela; França, Paulo Henrique Condeixa de; Salgueiro, Jennifer Braathen; Motta, Marcia Luz da; Tannous, Gysélle Saddi; Lopes, Anibal Gil

    2014-12-01

    Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms - Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 (NATIONAL GUIDELINES FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 - state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher.

  12. Beyond informed consent: did cancer patients challenge their physicians in the post-World War II era?

    PubMed

    Lerner, Barron H

    2004-10-01

    Historians have debated the degree to which past patients have provided meaningful consent prior to medical interventions. This article, a chart review of 170 patients treated for cancer between 1945 and 1970, adds to this literature by exploring the years when informed consent was being introduced in medical practice. As would be expected in a largely paternalistic era, physicians controlled most of the clinical encounters, even concealing cancer diagnoses. Yet thirty-one (18 percent) of the patients showed some involvement in decision making, either writing restrictions on their consent forms, asking probing questions, or otherwise challenging physicians' orders. Although the overall number of patients studied was small, minority and other ward patients were as likely as white, private patients to speak up. This study concludes that most patients passively assented to treatment, signing consent forms without making any inquiries. But a small group of patients challenged their physicians, leading them to learn more about proposed treatment options and perhaps make more informed decisions. Although motivated in part by the increasing attention to better consent practices, these patients spoke up for other reasons as well, possibly including their basic personalities, prior negative experiences in hospitals, or apprehensiveness regarding specific types of interventions. Further research should explore the factors--beyond the introduction of informed consent--that have historically promoted better dialogue between physicians and patients.

  13. Informed Consent as a Litigation Strategy in the Field of Aesthetic Surgery: An Analysis Based on Court Precedents

    PubMed Central

    2016-01-01

    Background In an increasing number of lawsuits doctors lose, despite providing preoperative patient education, because of failure to prove informed consent. We analyzed judicial precedents associated with insufficient informed consent to identify judicial factors and trends related to aesthetic surgery medical litigation. Methods We collected data from civil trials between 1995 and 2015 that were related to aesthetic surgery and resulted in findings of insufficient informed consent. Based on these data, we analyzed the lawsuits, including the distribution of surgeries, dissatisfactions, litigation expenses, and relationship to informed consent. Results Cases were found involving the following types of surgery: facial rejuvenation (38 cases), facial contouring surgery (27 cases), mammoplasty (16 cases), blepharoplasty (29 cases), rhinoplasty (21 cases), body-contouring surgery (15 cases), and breast reconstruction (2 cases). Common reasons for postoperative dissatisfaction were deformities (22%), scars (17%), asymmetry (14%), and infections (6%). Most of the malpractice lawsuits occurred in Seoul (population 10 million people; 54% of total plastic surgeons) and in primary-level local clinics (113 cases, 82.5%). In cases in which only invalid informed consent was recognized, the average amount of consolation money was KRW 9,107,143 (USD 8438). In cases in which both violation of non-malfeasance and invalid informed consent were recognized, the average amount of consolation money was KRW 12,741,857 (USD 11,806), corresponding to 38.6% of the amount of the judgment. Conclusions Surgeons should pay special attention to obtaining informed consent, because it is a double-edged sword; it has clinical purposes for doctors and patients but may also be a litigation strategy for lawyers. PMID:27689046

  14. The Definition of Placebo in the Informed Consent Forms of Clinical Trials

    PubMed Central

    Hernández, Astrid; Baños, Josep-E.; Llop, Cristina; Farré, Magí

    2014-01-01

    Aim Lack of knowledge concerning the nature of placebo and why it is necessary may influence the participation of patients in clinical trials. The objective of the present study is to review how placebo is described in written information for participants in clinical trials to be evaluated by a Human Research Ethics Committee. Methods All research protocols submitted for evaluation in a Spanish hospital during 2007–2013 were reviewed. The main characteristics of the studies using a placebo were collected. Three authors read each of them to determine how the term “placebo” was explained and if there was any comment on its efficacy and safety. Results Two thousand seven-hundred and forty research protocols were evaluated, of which three hundred and fifty-nine used a placebo. Pharmaceutical companies sponsored most placebo-controlled clinical trials (91.9%), and phase III studies were the commonest (59.9%). Oncology (15.0%), cardiology (14.2%), and neurology (13.1%) made the greatest contributions. A review of the informed consent forms showed that placebo was described in a similar manner in most studies: the explanation was limited to between four and eight words. Very few gave information about the risks of its use or adverse reactions from its administration. None of the studies provided details about the placebo effect. And 23 lacked any information about placebo at all. Conclusions Explanations about placebo in informed consent forms is often scarce, and information about the placebo effect and associated risks are absent. This situation may influence a full understanding of placebo by participants in clinical trials and might reduce their informed decision to participate. PMID:25423149

  15. Informed consent in the NICU setting: an ethically optimal model for research solicitation.

    PubMed

    Golec, Lisa; Gibbins, Sharyn; Dunn, Michael S; Hebert, Philip

    2004-12-01

    Recruiting patients for studies in the Neonatal Intensive Care Unit is a complex endeavour. Much discussion has occurred regarding the optimal recruitment "model" for this environment. This paper discusses current and suggested recruitment models for the NICU setting and presents a systematic approach to the consent process that focuses on the protection and promotion of parental autonomy. The proposed model incorporates several key considerations for an ethically optimal approach to the inclusion of neonates in research: informing parents about research and their rights prior to any solicitation, asking parents if they wish to be approached for research, approaching for one study at a time, assuring the study is relevant to the infants' current clinical status, minimising information overload, allowing parents appropriate time (which will vary from study to study) to consider their choice, and providing a waiting period between subsequent approaches. It is argued that parental ability to make a truly informed choice may be improved when following the proposed model.

  16. Educational and interactive informed consent process for treatment of unruptured intracranial aneurysms.

    PubMed

    Park, Jaechan; Son, Wonsoo; Park, Ki-Su; Kang, Dong-Hun; Lee, Joomi; Oh, Chang Wan; Kwon, O-Ki; Kim, Taesun; Kim, Chang-Hyun

    2017-03-01

    OBJECTIVE For patients with unruptured intracranial aneurysms (UIAs), the information transfer that precedes informed consent needs to be in-depth and detailed, as most patients with a UIA have no symptoms, yet the risks related to treatment are relatively high. Thus, in this study an educational and interactive program was proposed for patients with UIAs to improve the informed consent process and assess the level of comprehension. METHODS A total of 110 patients with UIAs underwent the proposed educational and interactive informed consent (EIIC) process and were enrolled in this study. The EIIC process combines patient education using information booklets, a cartoon book, a video, an initial physician-patient interview, answering a questionnaire, a second physician-patient interview based on the questionnaire results, and finally consent. After the first physician-patient interview that provides the patient with specific information, including his or her angiographic characteristics, medical condition, and recommended treatment, the patient is requested to answer a questionnaire composed of 3 parts: demographic information, including the patient's age, sex, and years of education; 13 medical questions to assess the patient's knowledge about his or her UIA; and an evaluation of the usefulness of the educational resources. The control group consisted of 65 patients from 3 other tertiary university hospitals where the EIIC process was not used. RESULTS The questionnaire scores of the EIIC group ranged from 7 to 13 (mean ± SD: 11.9 ± 1.3) and were significantly higher than those for the controls (10.2 ± 1.9, p < 0.001). The better comprehension of the patients in the EIIC group was remarkable as they were significantly older than those in the control group (62.7 ± 8.3 years vs 55.9 ± 10.5 years, respectively; p < 0.001). For both the EIIC group and the control group, a Pearson correlation analysis revealed a positive correlation (r = 0.232 for the EIIC group, r

  17. Informed consent in human subject research: a comparison of current international and Nigerian guidelines.

    PubMed

    Fadare, Joseph O; Porteri, Corinna

    2010-03-01

    Informed consent is a basic requirement for the conduct of ethical research involving human subjects. Currently, the Helsinki Declaration of the World Medical Association and the International Ethical Guidelines for Biomedical Research of the Council for International Organizations of Medical Sciences (CIOMS) are widely accepted as international codes regulating human subject research and the informed consent sections of these documents are quite important. Debates on the applicability of these guidelines in different socio-cultural settings are ongoing and many workers have advocated the need for national or regional guidelines. Nigeria, a developing country, has recently adopted its national guideline regulating human subject research: the National Health Research Ethics Committee (NHREC) code. A content analysis of the three guidelines was done to see if the Nigerian guidelines confer any additional protection for research subjects. The concept of a Community Advisory Committee in the Nigerian guideline is a novel one that emphasizes research as a community burden and should promote a form of "research friendship" to foster the welfare of research participants. There is also the need for a regular update of the NHREC code so as to address some issues that were not considered in its current version.

  18. [Terms of informed consent for users of dental clinics in Brazil: legal and ethical issues].

    PubMed

    Sales-Peres, Sílvia Helena de Carvalho; Sales-Peres, Arsênio; Eleutério, Adriana Silveira de Lima; de Oliveira, José Luiz Góes; Gigliotti, Mariana Pracucio

    2011-01-01

    The consent of patient before the beginning of any procedure has to be a respected condition, without any exception. It is necessary the patients to be aware of their health status, their specific needs, the intention of each treatment, the alternatives plans (including no treatment), to know their prognostic, risks, consequences, limitations, and to be aware of their responsibilities and those of your dentist, resulting in the success of the treatment. The Informed Consent (TCLE) aims to fortify and to clarify the position of the patient, being established the rights and duties of both parts - patient and professional. The integral knowledge of the treatment will minimize the anxiety of the patient and treatment complications, and promote greater quality of dental services and improve the satisfaction of both dentist and patient. However, there are few articles in Brazil about this, but there are some ethics problems involving dental clinics regarding this document of information for the patient. Therefore, the aim of this work is to carry through a critical revision on the subject demonstrating the importance of the TCLE in the Brazilian dental clinics.

  19. Email-Based Informed Consent: Innovative Method for Reaching Large Numbers of Subjects for Data Mining Research

    NASA Technical Reports Server (NTRS)

    Lee, Lesley R.; Mason, Sara S.; Babiak-Vazquez, Adriana; Ray, Stacie L.; Van Baalen, Mary

    2015-01-01

    Since the 2010 NASA authorization to make the Life Sciences Data Archive (LSDA) and Lifetime Surveillance of Astronaut Health (LSAH) data archives more accessible by the research and operational communities, demand for data has greatly increased. Correspondingly, both the number and scope of requests have increased, from 142 requests fulfilled in 2011 to 224 in 2014, and with some datasets comprising up to 1 million data points. To meet the demand, the LSAH and LSDA Repositories project was launched, which allows active and retired astronauts to authorize full, partial, or no access to their data for research without individual, study-specific informed consent. A one-on-one personal informed consent briefing is required to fully communicate the implications of the several tiers of consent. Due to the need for personal contact to conduct Repositories consent meetings, the rate of consenting has not kept up with demand for individualized, possibly attributable data. As a result, other methods had to be implemented to allow the release of large datasets, such as release of only de-identified data. However the compilation of large, de-identified data sets places a significant resource burden on LSAH and LSDA and may result in diminished scientific usefulness of the dataset. As a result, LSAH and LSDA worked with the JSC Institutional Review Board Chair, Astronaut Office physicians, and NASA Office of General Counsel personnel to develop a "Remote Consenting" process for retrospective data mining studies. This is particularly useful since the majority of the astronaut cohort is retired from the agency and living outside the Houston area. Originally planned as a method to send informed consent briefing slides and consent forms only by mail, Remote Consenting has evolved into a means to accept crewmember decisions on individual studies via their method of choice: email or paper copy by mail. To date, 100 emails have been sent to request participation in eight HRP

  20. Discordance in informed consent response on the basis of demographic factors: brief report.

    PubMed

    Nunez-Wallace, Karen R; Gill, Chandler E; Harrison, Courtney H; Taylor, Henry M; Charles, P David

    2010-06-01

    During an outcomes study of spasticity treatment at a developmental center for 62 residents with profound intellectual disabilities, either botulinum toxin A (BTX-A), intrathecal baclofen (ITB), or both were recommended with physical and occupational therapy. Conservators consented to BTX-A more than ITB (p = .021). Court-appointed conservators were more likely to provide consent for treatment than family members (p = .026). Nonparents consented more than parents (p = .009). Finally, Caucasian conservators were more likely to consent to treatment than African American conservators (p = .036), but ethnicity of the resident did not influence consent. Gender of resident or conservator did not influence rate of consent. This report highlights disparities in surrogate consent giving for individuals with intellectual disabilities and indicates a need for more research to ensure that this vulnerable population has access to appropriate treatments.

  1. Negotiating decisions during informed consent for pediatric Phase I oncology trials.

    PubMed

    Marshall, Patricia A; Magtanong, Ruth V; Leek, Angela C; Hizlan, Sabahat; Yamokoski, Amy D; Kodish, Eric D

    2012-04-01

    During informed consent conferences (ICCs) for Phase I trials, oncologists must present complex information while addressing concerns. Research on communication that evolves during ICCs remains largely unexplored. We examined communication during ICCs for pediatric Phase I cancer trials using a stratified random sample from six pediatric cancer centers. A grounded theory approach identified key communication steps and factors influencing the negotiation of decisions for trial participation. Analysis suggests that during ICCs, families, patients, and clinicians exercise choice and control by negotiating micro-decisions in two broad domains: drug logic and logistics, and administration/scheduling. Micro-decisions unfold in a four-step communication process: (1) introduction of an issue; (2) response; (3) negotiation of the issue; and (4) resolution and decision. Negotiation over smaller micro-decisions is prominent in ICCs and merits further study.

  2. Informed consent in clinical research; Do patients understand what they have signed?

    PubMed

    Villamañán, Elena; Ruano, Margarita; Fernández-de Uzquiano, Enma; Lavilla, Paz; González, Diana; Freire, Mercedes; Sobrino, Carmen; Herrero, Alicia

    2016-05-01

    Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the potential participants in a clinical trial.

  3. 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.

  4. Participant understanding and recall of informed consent for induced pluripotent stem cell biobanking.

    PubMed

    McCaughey, Tristan; Chen, Christine Y; De Smit, Elisabeth; Rees, Gwyneth; Fenwick, Eva; Kearns, Lisa S; Mackey, David A; MacGregor, Casimir; Munsie, Megan; Cook, Anthony L; Pébay, Alice; Hewitt, Alex W

    2016-09-01

    The ability to generate human induced pluripotent stem cells (iPSCs) has opened new avenues for human disease modelling and therapy. The aim of our study was to determine research participants' understanding of the information given when donating skin biopsies for the generation of patient-specific iPSCs. A customised 35-item questionnaire based on previous iPSC consent guidelines was sent to participants who had previously donated samples for iPSC research. The questionnaire asked pertinent demographic details, participants' motivation to take part in iPSC research and their attitudes towards related ethical issues. 234 participants were contacted with 141 (60.3 %) complete responses received. The median duration between recruitment and follow-up questioning was 313 days (range 10-573 days). The majority of participants (n = 129, 91.5 %) believed they understood what a stem cell was; however, only 22 (16.1 %) correctly answered questions related to basic stem cell properties. We found no statistically significant difference in responses from participants with different levels of education, or those with a health sciences background. The poor understanding amongst participants of iPSC research is unlikely to be unique to our study and may impact future research if not improved. As such, there is a need to develop an easily understood yet comprehensive consent process to ensure ongoing ethical progress of iPSC biobanking.

  5. The Information and Consent Process in Patients undergoing Elective ENT surgery: A cross-sectional survey

    PubMed Central

    Georgalas, Christos; Ganesh, Kulandaivelu; Papesch, Eva

    2008-01-01

    Background To assess the importance of different information pathways for patients undergoing elective ENT surgery (General Practitioner, Specialist consultation, pre assessment clinic and consent process as well as printed information material and non medical sources) and to correlate their relative importance with patient and doctor factors Methods – Patients Cross – sectional questionnaire survey 226 consecutive patients undergoing elective non-oncological otolaryngology procedures at a District General Hospital between May and August 2004 Results Overall patients were moderately satisfied with the information they received prior to surgery (score 63/100). Although they were generally satisfied with the quality of information they received at their outpatient consultation and at the preadmission clinic, they were less satisfied with the quality of information provided by their GPs and by the quality of self – obtained information. Most importantly, linear regression modeling showed that the overall level of information could be predicted by three factors: The quality of written information received at the hospital, the quality of self-obtained information and the information provided by the specialist at the time of listing for surgery. While patient's education level was correlated with the information process, the age and gender of the patient as well as the grade of the doctor at the outpatients were not associated with his overall levels of satisfaction. Conclusion Although the impact of the initial outpatient consultation for patients undergoing elective surgery can not be over emphasized, written information provided at the hospital as well as patient – initiated, parallel information pathways are at least as important: It is our duty to recognize them and use them for the patient's advantage. PMID:18798994

  6. Genomic research and data-mining technology: implications for personal privacy and informed consent.

    PubMed

    Tavani, Herman T

    2004-01-01

    This essay examines issues involving personal privacy and informed consent that arise at the intersection of information and communication technology (ICT) and population genomics research. I begin by briefly examining the ethical, legal, and social implications (ELSI) program requirements that were established to guide researchers working on the Human Genome Project (HGP). Next I consider a case illustration involving deCODE Genetics, a privately owned genetic company in Iceland, which raises some ethical concerns that are not clearly addressed in the current ELSI guidelines. The deCODE case also illustrates some ways in which an ICT technique known as data mining has both aided and posed special challenges for researchers working in the field of population genomics. On the one hand, data-mining tools have greatly assisted researchers in mapping the human genome and in identifying certain "disease genes" common in specific populations (which, in turn, has accelerated the process of finding cures for diseases tha affect those populations). On the other hand, this technology has significantly threatened the privacy of research subjects participating in population genomics studies, who may, unwittingly, contribute to the construction of new groups (based on arbitrary and non-obvious patterns and statistical correlations) that put those subjects at risk for discrimination and stigmatization. In the final section of this paper I examine some ways in which the use of data mining in the context of population genomics research poses a critical challenge for the principle of informed consent, which traditionally has played a central role in protecting the privacy interests of research subjects participating in epidemiological studies.

  7. Informed consent practices for surgical care at university teaching hospitals: a case in a low resource setting

    PubMed Central

    2014-01-01

    Background Informed consent in medical practice is essential and a global standard that should be sought at all the times doctors interact with patients. Its intensity would vary depending on the invasiveness and risks associated with the anticipated treatment. To our knowledge there has not been any systematic review of consent practices to document best practices and identify areas that need improvement in our setting. The objective of the study was to evaluate the informed consent practices of surgeons at University teaching Hospitals in a low resource setting. Methods A cross-sectional study conducted at three university teaching hospitals in Uganda. Self-guided questionnaires were left at a central location in each of the surgical departments after verbally communicating to the surgeons of the intention of the study. Filled questionnaires were returned at the same location by the respondents for collection by the research team. In addition, 20 in-depth interviews were held with surgeons and a review of 384 patients’ record files for informed consent documentation was done. Results A total of 132 (62.1%) out of 214 questionnaires were completed and returned. Respondents were intern doctors, residents and specialists from General surgery, Orthopedic surgery, Ear, Nose and Throat, Ophthalmology, Dentistry, Obstetrics and Gynaecology departments. The average working experience of respondents was 4.8 years (SD 4.454, range 0–39 years). 48.8% of the respondents said they obtained consent all the time surgery is done while 51.2% did not obtain consent all the time. Many of the respondents indicated that informed consent was not obtained by the surgeon who operated the patient but was obtained either at admission or by nurses in the surgical units. The consent forms used in the hospitals were found to be inadequate and many times signed at admission before diagnosing the patient’s disease. Conclusions Informed consent administration and documentation for

  8. Exceptions and Exclusions: The Right to Informed Consent for Medical Treatment of People with Psychosocial Disabilities in Europe.

    PubMed

    Waddington, Lisa; Mesherry, Bernadette

    2016-06-01

    This article examines the relevant international law relating to informed consent to treatment for individuals with psychosocial disabilities and reflects on the protection offered in this respect by the European Convention on Human Rights (ECHR) and the Council of Europe Convention on Human Rights and Biomedicine. The article argues that while the UN Convention on the Rights of Persons with Disabilities is beginning to influence case law of the European Court of Human Rights, only 'weak' protection has been afforded to people with psychosocial disabilities by the ECHR and the Court in relation to informed consent for medical treatment.

  9. Doctor-family-patient relationship: the Chinese paradigm of informed consent.

    PubMed

    Cong, Yali

    2004-04-01

    Bioethics is a subject far removed from the Chinese, even from many Chinese medical students and medical professionals. In-depth interviews with eighteen physicians, patients, and family members provided a deeper understanding of bioethical practices in contemporary China, especially with regard to the doctor-patient relationship (DPR) and informed consent. The Chinese model of doctor-family-patient relationship (DFPR), instead of DPR, is taken to reflect Chinese Confucian cultural commitments. An examination of the history of Chinese culture and the profession of medicine in China is used to disclose the deep roots of these commitments. The author predicts that the DFPR model will further develop in China but that it will maintain its Chinese character.

  10. 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.

  11. Confidentiality, informed consent and children's participation in the Saudi biobank governance: a comparative study.

    PubMed

    Alahmad, G H; Dierickx, K

    2014-12-17

    The growth of research biobanks has created many new ethical challenges worldwide. This article outlines and discusses key issues in the governance of Saudi Biobank, a newly established national biobank in Saudi Arabia launched in 2014. The Saudi Biobank project includes human biological samples from participants aged 10-70 years and aims to conduct an extensive study on the influence of genes, environment and lifestyle in common diseases. We examined the strengths and weaknesses of Saudi Biobank's governance as well as the similarities and differences with 4 other biobanks (in the United Kingdom, Iceland, Estonia and Canada). Three different ethical issues are discussed in detail: confidentiality, informed consent and children's participation in research. We evaluated these issues in relation to international ethical guidelines and Islamic law. The insights gained may be useful in developing national biobanking regulations in other Islamic countries, particularly in countries of the Eastern Mediterranean Region.

  12. Corrected Feedback: A Procedure to Enhance Recall of Informed Consent to Research among Substance Abusing Offenders.

    PubMed

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

    2010-01-01

    This study examined the efficacy of corrected feedback for improving consent recall throughout the course of an ongoing longitudinal study. Participants (N = 135) were randomly assigned to either a corrected feedback or a no-feedback control condition. Participants completed a consent quiz 2-weeks after consenting to the host study and at months 1, 2, and 3. The corrected feedback group received corrections to erroneous responses and the no-feedback control group did not. The feedback group displayed significantly greater recall overall and in specific content areas (i.e., procedures, protections, risks/benefits). Results support the use of corrected feedback for improving consent recall.

  13. Procedures of recruiting, obtaining informed consent, and compensating research participants in Qatar: findings from a qualitative investigation

    PubMed Central

    2014-01-01

    Background Very few researchers have reported on procedures of recruiting, obtaining informed consent, and compensating participants in health research in the Arabian Gulf Region. Empirical research can inform the debate about whether to adjust these procedures for culturally diverse settings. Our objective was to delineate procedures related to recruiting, obtaining informed consent, and compensating health research participants in the extremely high-density multicultural setting of Qatar. Methods During a multistage mixed methods project, field observations and qualitative interviews were conducted in a general medicine clinic of a major medical center in Qatar. Participants were chosen based on gender, age, literacy, and preferred language, i.e., Arabic, English, Hindi and Urdu. Qualitative analysis identified themes about recruitment, informed consent, compensation, and other research procedures. Results A total of 153 individuals were approached and 84 enrolled; the latter showed a diverse age range (18 to 75 years); varied language representation: Arabic (n = 24), English (n = 20), Hindi (n = 20), and Urdu (n = 20); and balanced gender distribution: women (n = 43) and men (n = 41). Primary reasons for 30 declinations included concern about interview length and recording. The study achieved a 74% participation rate. Qualitative analytics revealed key themes about hesitation to participate, decisions about participation with family members as well as discussions with them as “incidental research participants”, the informed consent process, privacy and gender rules of the interview environment, reactions to member checking and compensation, and motivation for participating. Vulnerability emerged as a recurring issue throughout the process among a minority of participants. Conclusions This study from Qatar is the first to provide empirical data on recruitment, informed consent, compensation and other research procedures in a general

  14. The need of adequate information to achieve total compliance of mass drug administration in Pekalongan

    NASA Astrophysics Data System (ADS)

    Ginandjar, Praba; Saraswati, Lintang Dian; Taufik, Opik; Nurjazuli; Widjanarko, Bagoes

    2017-02-01

    World Health Organization (WHO) initiated The Global Program to Eliminate Lymphatic Filariasis (LF) through mass drug administration (MDA). Pekalongan started MDA in 2011. Yet the LF prevalence in 2015 remained exceed the threshold (1%). This study aimed to describe the inhibiting factors related to the compliance of MDA in community level. This was a rapid survey with cross sectional approach. A two-stages random sampling was used in this study. In the first stage, 25 clusters were randomly selected from 27 villages with proportionate to population size (PPS) methods (C-Survey). In the second stage, 10 subjects were randomly selected from each cluster. Subject consisted of 250 respondents from 25 selected clusters. Variables consisted of MDA coverage, practice of taking medication during MDA, enabling and inhibiting factors to MDA in community level. The results showed most respondents had poor knowledge on filariasis, which influence awareness of the disease. Health-illness perception, did not receive the drugs, lactation, side effect, and size of the drugs were dominant factors of non-compliance to MDA. MDA information and community empowerment were needed to improve MDA coverage. Further study to explore the appropriate model of socialization will support the success of MDA program

  15. 75 FR 62913 - 30-Day Notice of Proposed Information Collection: Form DS-3053, Statement of Consent or Special...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-13

    ...: Issuance of a Passport to a Minor Under Age 16, OMB Control Number 1405-0129 ACTION: Notice of request for... Collection: Statement of Consent or Special Circumstances: Issuance of a Passport to a Minor Under Age 16... age of 16. The primary purpose of soliciting the information is to ensure that both parents and/or...

  16. Overcoming language barriers in the informed consent process: regulatory and compliance issues with the use of the "short form".

    PubMed

    Lad, Pramod M; Dahl, Rebecca

    2014-01-01

    Language barriers in the informed consent process can be a significant impediment when recruiting non-English speaking subjects into clinical research studies. Regulatory guidelines indicate that the short form procedure be utilized in such circumstances. In this paper, we examine some of the ambiguities in the regulatory framework, the resulting need for institutional policy guidelines, and compliance issues with the short form process.

  17. Reflecting on Earlier Experiences with Unsolicited Findings: Points to Consider for Next-Generation Sequencing and Informed Consent in Diagnostics

    PubMed Central

    Rigter, Tessel; Henneman, Lidewij; Kristoffersson, Ulf; Hall, Alison; Yntema, Helger G; Borry, Pascal; Tönnies, Holger; Waisfisz, Quinten; Elting, Mariet W; Dondorp, Wybo J; Cornel, Martina C

    2013-01-01

    High-throughput nucleotide sequencing (often referred to as next-generation sequencing; NGS) is increasingly being chosen as a diagnostic tool for cases of expected but unresolved genetic origin. When exploring a higher number of genetic variants, there is a higher chance of detecting unsolicited findings. The consequential increased need for decisions on disclosure of these unsolicited findings poses a challenge for the informed consent procedure. This article discusses the ethical and practical dilemmas encountered when contemplating informed consent for NGS in diagnostics from a multidisciplinary point of view. By exploring recent similar experiences with unsolicited findings in other settings, an attempt is made to describe what can be learned so far for implementing NGS in standard genetic diagnostics. The article concludes with a set of points to consider in order to guide decision-making on the extent of return of results in relation to the mode of informed consent. We hereby aim to provide a sound basis for developing guidelines for optimizing the informed consent procedure. PMID:23784691

  18. The student and the ovum: the lack of autonomy and informed consent in trading genes for tuition.

    PubMed

    Papadimos, Thomas J; Papadimos, Alexa T

    2004-07-12

    Rising tuition costs have forced university students to become creative in finding ways to fund their education. Some female university students have decided that ova donation may be an acceptable alternative in which to pay for their tuition. This alternative presents itself because of the insufficient number of ova available for assisted reproduction and emerging stem cell technologies. Young female university students are encouraged by Internet sources and respectable electronic and print media to donate their ova in the cause of assisted reproduction for monetary compensation. While university students generally exhibit autonomy, the constraining influence of their financial predicament compromises the elements of informed consent (voluntariness, competence, capacity, understanding, and disclosure) as to their making an autonomous decision in regard to egg donation. Thus, any moral possibility of giving informed consent is negated. Informed consent can only occur through autonomy. A female university student in need of financial resources to pay for her education cannot make an autonomous choice to trade her genes for tuition. Donated ova are not only needed for assisted reproduction, but for stem cell technologies. While the long-term health of women who donate their ova is of concern (a potential risk of cancer after long term use of ovulation induction), of equal concern is the possibility of a growth in the trade of ova targeting third world and Eastern European women where the precedence for autonomy and informed consent is not well established.

  19. Institutional Review Boards in the University Setting: Review of Pharmaceutical Testing Protocols, Informed Consent and Ethical Concerns.

    ERIC Educational Resources Information Center

    Kobasic, Dena M.

    1988-01-01

    A discussion of the testing of new drugs in campus medical facilities reviews the process of federal approval of investigational new drugs, analyzes the implications of the federally mandated institutional review board, and the issues of informed consent and the ethics of human-subject research on campus. (MSE)

  20. Informed consent, participation in, and withdrawal from a population based cohort study involving genetic analysis

    PubMed Central

    Matsui, K; Kita, Y; Ueshima, H

    2005-01-01

    Design: Descriptive analyses. Setting and participants: The study evaluated two non-genetic subcohorts comprising 3166 people attending for a health checkup during 2002, and two genetic subcohorts comprising 2195 people who underwent a checkup during 2003. Main outcome measurements: Analysis endpoints were differences in participation rates between the non-genetic and genetic subcohorts, differences between providing non-extensive and extensive preliminary information, and changes in participation status between baseline and at 6 months. Results: Participation rates in the genetic subcohorts were 4·7–9·3% lower than those in the non-genetic subcohorts. The odds ratios (OR) of participation in genetic research were between 0·60 and 0·77, and the OR for withdrawal from the research was over 7·70; providing preliminary extensive information about genetic research reduced the withdrawal risks (OR 0·15 for all dependent variables) but worsened participation rates (OR 0·63–0·74). Conclusions: The general population responded sceptically towards genetic research. It is crucial that genetic researchers utilise an informative and educational consent process worthy of public trust. PMID:15994356

  1. Use of Videos Improves Informed Consent Comprehension in Web-Based Surveys Among Internet-Using Men Who Have Sex With Men: A Randomized Controlled Trial

    PubMed Central

    Sanchez, Travis H; Stein, Aryeh D; Stephenson, Rob; Zlotorzynska, Maria; Sineath, Robert Craig; Sullivan, Patrick S

    2017-01-01

    Background Web-based surveys are increasingly used to capture data essential for human immunodeficiency virus (HIV) prevention research. However, there are challenges in ensuring the informed consent of Web-based research participants. Objective The aim of our study was to develop and assess the efficacy of alternative methods of administering informed consent in Web-based HIV research with men who have sex with men (MSM). Methods From July to September 2014, paid advertisements on Facebook were used to recruit adult MSM living in the United States for a Web-based survey about risk and preventive behaviors. Participants were randomized to one of the 4 methods of delivering informed consent: a professionally produced video, a study staff-produced video, a frequently asked questions (FAQs) text page, and a standard informed consent text page. Following the behavior survey, participants answered 15 questions about comprehension of consent information. Correct responses to each question were given a score of 1, for a total possible scale score of 15. General linear regression and post-hoc Tukey comparisons were used to assess difference (P<.001) in mean consent comprehension scores. A mediation analysis was used to examine the relationship between time spent on consent page and consent comprehension. Results Of the 665 MSM participants who completed the comprehension questions, 24.2% (161/665) received the standard consent, 27.1% (180/665) received the FAQ consent, 26.8% (178/665) received the professional consent video, and 22.0% (146/665) received the staff video. The overall average consent comprehension score was 6.28 (SD=2.89). The average consent comprehension score differed significantly across consent type (P<.001), age (P=.04), race or ethnicity (P<.001), and highest level of education (P=.001). Compared with those who received the standard consent, comprehension was significantly higher for participants who received the professional video consent (score

  2. Developing competency in post-graduate students of anaesthesiology for taking informed consent for elective caesarean section

    PubMed Central

    Mehta, Kamla Harshad; Shah, Vandana Saurin; Patel, Kirti Dhirajlal

    2017-01-01

    Background and Aims: Post-graduate medical students (residents) generally lack effective communication skills required to obtain informed consent. The aim of this study was to assess role play and group discussion as teaching/learning tools for improving residents' knowledge on informed consent and competency in communicating while taking informed consent. Methods: This prospective, observational study was conducted on 30 anaesthesia residents. They were first observed while obtaining informed consent and their basic knowledge regarding communication skills was checked with a pre-test questionnaire. Then, lecture and group discussion were carried out to increase the knowledge base, and their knowledge gain was checked by the same questionnaire as a post-test. Communication skills were demonstrated by role play and residents were assessed by direct unobtrusive observation using a checklist. Feedback regarding effectiveness of programme was taken from students. Statistical analyses were done using Microsoft Office Excel and SPSS software. Results: Percentage gain was 122.37% for knowledge domain. For communication skills, mean ± standard deviation for checklist was 8.93 ± 1.43 before role play and it improved to 17.96 ± 1.29 after role play. Regarding effectiveness of role play as a teaching/learning tool, 76.66% of residents said they strongly agreed and 23.33% of residents said they agreed. Likert scale for evaluation of programme was graded 4 or 5 by all residents. Conclusion: The knowledge and communication skills required for obtaining informed consent was improved significantly after role playing. PMID:28250486

  3. Navigating the legal and ethical foundations of informed consent and confidentiality in integrated primary care.

    PubMed

    Hudgins, Cathy; Rose, Sandra; Fifield, Peter Y; Arnault, Steve

    2013-03-01

    This article describes findings from ongoing research and analysis of current literature in addition to discussions with leaders in the field, communications with lawyers and administrators of advocacy and government agencies pertaining to integrated primary care (IPC). Standards of care are established based on a myriad of factors, including professional codes of ethics, case law, state and federal laws, professional standards, existing best practices, current professional guidelines, administrative rules and regulations, and licensing board regulations. Regulations may differ for behavioral health and medical providers, posing challenges in IPC settings. This article provides a review of these regulations, particularly 42CFR Part 2, a federal law governing confidentiality for substance abuse programs, Health Insurance Portability and Accountability Act (HIPAA), and state laws relevant to patient care in IPC settings. On the basis of findings from the study, the authors make recommendations related to patient care practices concerning informed consent and release of information procedures, treatment and warm hand-off protocols, documentation and electronic record keeping, agreements with other providers, and billing.

  4. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

    PubMed Central

    2013-01-01

    Background Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. Purpose To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods. Methods The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique. Results Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for

  5. Bioethics and power: Informed consent procedures in post-socialist Latvia.

    PubMed

    Putniņa, Aivita

    2013-12-01

    This paper explores two lines of development in the donor consent procedures in post-Soviet Latvia. The paper is based on secondary analysis of interview, focus group discussion data, and media and legal text material collected throughout three previously conducted research projects on organ transplantation, population genome project and xenotransplantation focusing on the historical development of the issues of donor consent across these three fields of medical technologies. The paper argues that the quality of consent depends not as much on political and legal change per se as on the strengthening of the position of both medical specialists and donors, facilitating bonds between the two.

  6. Fair Shares and Sharing Fairly: A Survey of Public Views on Open Science, Informed Consent and Participatory Research in Biobanking

    PubMed Central

    Joly, Yann; Dalpé, Gratien; So, Derek; Birko, Stanislav

    2015-01-01

    Context Biobanks are important resources which enable large-scale genomic research with human samples and data, raising significant ethical concerns about how participants’ information is managed and shared. Three previous studies of the Canadian public’s opinion about these topics have been conducted. Building on those results, an online survey representing the first study of public perceptions about biobanking spanning all Canadian provinces was conducted. Specifically, this study examined qualitative views about biobank objectives, governance structure, control and ownership of samples and data, benefit sharing, consent practices and data sharing norms, as well as additional questions and ethical concerns expressed by the public. Results Over half the respondents preferred to give a one-time general consent for the future sharing of their samples among researchers. Most expressed willingness for their data to be shared with the international scientific community rather than used by one or more Canadian institutions. Whereas more respondents indicated a preference for one-time general consent than any other model of consent, they constituted less than half of the total responses, revealing a lack of consensus among survey respondents regarding this question. Respondents identified biobank objectives, governance structure and accountability as the most important information to provide participants. Respondents’ concerns about biobanking generally centred around the control and ownership of biological samples and data, especially with respect to potential misuse by insurers, the government and other third parties. Although almost half the respondents suggested that these should be managed by the researchers’ institutions, results indicate that the public is interested in being well-informed about these projects and suggest the importance of increased involvement from participants. In conclusion, the study discusses the viability of several proposed models

  7. Eyes wide open: the personal genome project, citizen science and veracity in informed consent

    PubMed Central

    Angrist, Misha

    2012-01-01

    I am a close observer of the Personal Genome Project (PGP) and one of the original ten participants. The PGP was originally conceived as a way to test novel DNA sequencing technologies on human samples and to begin to build a database of human genomes and traits. However, its founder, Harvard geneticist George Church, was concerned about the fact that DNA is the ultimate digital identifier – individuals and many of their traits can be identified. Therefore, he believed that promising participants privacy and confidentiality would be impractical and disingenuous. Moreover, deidentification of samples would impoverish both genotypic and phenotypic data. As a result, the PGP has arguably become best known for its unprecedented approach to informed consent. All participants must pass an exam testing their knowledge of genomic science and privacy issues and agree to forgo the privacy and confidentiality of their genomic data and personal health records. Church aims to scale up to 100,000 participants. This special report discusses the impetus for the project, its early history and its potential to have a lasting impact on the treatment of human subjects in biomedical research. PMID:22328898

  8. May Stakeholders be Involved in Design Without Informed Consent? The Case of Hidden Design.

    PubMed

    Pols, A J K

    2016-08-24

    Stakeholder involvement in design is desirable from both a practical and an ethical point of view. It is difficult to do well, however, and some problems recur again and again, both of a practical nature, e.g. stakeholders acting strategically rather than openly, and of an ethical nature, e.g. power imbalances unduly affecting the outcome of the process. Hidden Design has been proposed as a method to deal with the practical problems of stakeholder involvement. It aims to do so by taking the observation of stakeholder actions, rather than the outcomes of a deliberative process, as its input. Furthermore, it hides from stakeholders the fact that a design process is taking place so that they will not behave differently than they otherwise would. Both aspects of Hidden Design have raised ethical worries. In this paper I make an ethical analysis of what it means for a design process to leave participants uninformed or deceived rather than acquiring their informed consent beforehand, and to use observation of actions rather than deliberation as input for design, using Hidden Design as a case study. This analysis is based on two sets of normative guidelines: the ethical guidelines for psychological research involving deception or uninformed participants from two professional psychological organisations, and Habermasian norms for a fair and just (deliberative) process. It supports the conclusion that stakeholder involvement in design organised in this way can be ethically acceptable, though under a number of conditions and constraints.

  9. Eyes wide open: the personal genome project, citizen science and veracity in informed consent.

    PubMed

    Angrist, Misha

    2009-11-01

    I am a close observer of the Personal Genome Project (PGP) and one of the original ten participants. The PGP was originally conceived as a way to test novel DNA sequencing technologies on human samples and to begin to build a database of human genomes and traits. However, its founder, Harvard geneticist George Church, was concerned about the fact that DNA is the ultimate digital identifier - individuals and many of their traits can be identified. Therefore, he believed that promising participants privacy and confidentiality would be impractical and disingenuous. Moreover, deidentification of samples would impoverish both genotypic and phenotypic data. As a result, the PGP has arguably become best known for its unprecedented approach to informed consent. All participants must pass an exam testing their knowledge of genomic science and privacy issues and agree to forgo the privacy and confidentiality of their genomic data and personal health records. Church aims to scale up to 100,000 participants. This special report discusses the impetus for the project, its early history and its potential to have a lasting impact on the treatment of human subjects in biomedical research.

  10. [Benefits from the exercise of autonomy and informed consent: the example of Jehovah's Witnesses].

    PubMed

    Retamales P, Avelino; Cardemil H, Gonzalo

    2009-10-01

    The respect for self-determination has represented a great challenge for the medical community. This debate has resulted in laws, codes of ethics, international treaties, and administrative guidelines, all with the purpose of protecting such right. In the medical field, the "Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine", known as the Oviedo Convention plays a crucial role. The doctrine of Informed Consent (IC) exists to enforce it. This principle is considered as law in some countries. In Chile, the IC is considered in the legal ordinance and in documents that are used as guidelines in the field of ethics. Jehovah s Witnesses invoke such precepts when they demand respect for their decisions. The present article outlines their position regarding blood transfusions and their contribution to the practice of bloodless medicine and surgery, which promotes the respect for patient's self determination. The experience of Jehovah's Witnesses has lead to a dignified treatment of the patient and has promoted a better participation in decision-making, focusing on the patient. All these benefits can be conveyed to other patients, resulting in the protection of the dignity of the individual.

  11. Intelligence, Academic Self-Concept, and Information Literacy: The Role of Adequate Perceptions of Academic Ability in the Acquisition of Knowledge about Information Searching

    ERIC Educational Resources Information Center

    Rosman, Tom; Mayer, Anne-Kathrin; Krampen, Günter

    2015-01-01

    Introduction: The present paper argues that adequate self-perceptions of academic ability are essential for students' realization of their intellectual potential, thereby fostering learning of complex skills, e.g., information-seeking skills. Thus, academic self-concept should moderate the relationship between intelligence and information…

  12. Aspects of informed consent in medical practice in the eastern Mediterranean region during the 17th and 18th centuries.

    PubMed

    Christopoulos, Platon; Falagas, Matthew E; Gourzis, Philippos; Trompoukis, Constantinos

    2007-08-01

    Informed consent is a question of central importance in contemporary medical ethics, and clinical practice is inconceivable without considering the issues it raises. Although it is often vigorously argued that consent, informed or otherwise, is a recent phenomenon and that no sources testify to its existence before the 20th century, it is difficult to accept that a process for regulating the common and fundamental parameters in the relationship between doctor and patient and the planning of treatment had not concerned previous eras. A review of the Registers of the Islamic Court of Candia (Heraklion) in Crete, a series of records that touches on, among other things, matters of medical interest, reveals that the concept of informed consent was not only known during a period that stretched from the mid-17th to the early 19th century, but it was concerned with the same principles that prevail or have been a point of contention today. An extension of this study into other periods may thus provide contemporary researchers with material and information valuable in the discussion of today's bioethical issues.

  13. A process of informed consent for student learning through peer physical examination in pelvic floor physiotherapy practice.

    PubMed

    Delany, Clare; Frawley, Helena

    2012-03-01

    Peer physical examination (PPE) is a method of teaching and learning clinical skills in which students use fellow students as surrogate patients or models. PPE is recognised as useful as an experiential learning method to increase skill development for physiotherapy clinical practice. However students may feel pressured to participate despite discomfort and embarrassment when practising physical examination and treatment skills with their peers. Obtaining students' informed consent to participate in PPE is an important process to address these disadvantages of PPE. This paper proposes a three stage process for obtaining informed consent from postgraduate physiotherapy students learning pelvic floor examination and treatment skills. The process is designed to encourage educators to articulate the ethical issues that are relevant in this area of teaching; to provide information to students to enable them to understand what is involved and to choose to participate, and to offer alternatives to participation through a formalised process of informed consent. These steps mirror students' future obligations and actions when communicating with their patients.

  14. Participants’ understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis

    PubMed Central

    Tam, Nguyen Thanh; Thoa, Le Thi Bich; Long, Nguyen Phuoc; Trang, Nguyen Thi Huyen; Hirayama, Kenji; Karbwang, Juntra

    2015-01-01

    Abstract Objective To estimate the proportion of participants in clinical trials who understand different components of informed consent. Methods Relevant studies were identified by a systematic review of PubMed, Scopus and Google Scholar and by manually reviewing reference lists for publications up to October 2013. A meta-analysis of study results was performed using a random-effects model to take account of heterogeneity. Findings The analysis included 103 studies evaluating 135 cohorts of participants. The pooled proportion of participants who understood components of informed consent was 75.8% for freedom to withdraw at any time, 74.7% for the nature of study, 74.7% for the voluntary nature of participation, 74.0% for potential benefits, 69.6% for the study’s purpose, 67.0% for potential risks and side-effects, 66.2% for confidentiality, 64.1% for the availability of alternative treatment if withdrawn, 62.9% for knowing that treatments were being compared, 53.3% for placebo and 52.1% for randomization. Most participants, 62.4%, had no therapeutic misconceptions and 54.9% could name at least one risk. Subgroup and meta-regression analyses identified covariates, such as age, educational level, critical illness, the study phase and location, that significantly affected understanding and indicated that the proportion of participants who understood informed consent had not increased over 30 years. Conclusion The proportion of participants in clinical trials who understood different components of informed consent varied from 52.1% to 75.8%. Investigators could do more to help participants achieve a complete understanding. PMID:25883410

  15. Knowledge and Informed Decision-Making about Population-Based Colorectal Cancer Screening Participation in Groups with Low and Adequate Health Literacy

    PubMed Central

    Essink-Bot, M. L.; Dekker, E.; Timmermans, D. R. M.; Uiters, E.; Fransen, M. P.

    2016-01-01

    Objective. To analyze and compare decision-relevant knowledge, decisional conflict, and informed decision-making about colorectal cancer (CRC) screening participation between potential screening participants with low and adequate health literacy (HL), defined as the skills to access, understand, and apply information to make informed decisions about health. Methods. Survey including 71 individuals with low HL and 70 with adequate HL, all eligible for the Dutch organized CRC screening program. Knowledge, attitude, intention to participate, and decisional conflict were assessed after reading the standard information materials. HL was assessed using the Short Assessment of Health Literacy in Dutch. Informed decision-making was analyzed by the multidimensional measure of informed choice. Results. 64% of the study population had adequate knowledge of CRC and CRC screening (low HL 43/71 (61%), adequate HL 47/70 (67%), p > 0.05). 57% were informed decision-makers (low HL 34/71 (55%), adequate HL 39/70 (58%), p > 0.05). Intention to participate was 89% (low HL 63/71 (89%), adequate HL 63/70 (90%)). Respondents with low HL experienced significantly more decisional conflict (25.8 versus 16.1; p = 0.00). Conclusion. Informed decision-making about CRC screening participation was suboptimal among both individuals with low HL and individuals with adequate HL. Further research is required to develop and implement effective strategies to convey decision-relevant knowledge about CRC screening to all screening invitees. PMID:27200089

  16. Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China

    PubMed Central

    Wen, Gaiyan; Liu, Xinchun; Huang, Lihua; Shu, Jingxian; Xu, Nana; Chen, Ruifang; Huang, Zhijun; Yang, Guoping; Wang, Xiaomin; Xiang, Yuxia; Lu, Yao; Yuan, Hong

    2016-01-01

    Purpose To explore the readability and content integrity of informed consent forms (ICFs) used in China and to compare the quality of Chinese local ICFs with that of international ICFs. Methods The length, readability and content of 155 consent documents from phase II-IV drug clinical trials from the Third Xiangya Hospital Ethics Committee from November 2009 to January 2015 were evaluated. Reading difficulty was tested using a readability formula adapted for the Chinese language. An ICF checklist containing 27 required elements was successfully constructed to evaluate content integrity. The description of alternatives to participation was assessed. The quality of ICFs from different sponsorships were also compared. Results Among the 155 evaluable trials, the ICFs had a median length of 5286 words, corresponding to 7 pages. The median readability score was 4.31 (4.02–4.41), with 63.9% at the 2nd level and 36.1% at the 3rd level. Five of the 27 elements were frequently neglected. The average score for the description of alternatives to participation was 1.06, and 27.7% of the ICFs did not mention any alternatives. Compared with Chinese local ICFs, international ICFs were longer, more readable and contained more of the required elements (P < 0.05). Conclusion The ICFs used in China were difficult to read for most participants. These forms had poor description of alternatives to participation, and failed to provide a high degree of information disclosure, including an explanation of informed consent, follow-up processing of the data/sample, inclusion/exclusion criteria, double blinding, and unpredictable risks. International ICFs had better readability and content integrity than Chinese local ICFs. More efforts should thus be made to improve the quality of consent documents in China. PMID:27701471

  17. The Limits of Informed Consent for an Overwhelmed Patient: Clinicians' Role in Protecting Patients and Preventing Overwhelm.

    PubMed

    Bester, Johan; Cole, Cristie M; Kodish, Eric

    2016-09-01

    In this paper, we examine the limits of informed consent with particular focus on ways in which various factors can overwhelm decision-making capacity. We introduce overwhelm as a phenomenon commonly experienced by patients in clinical settings and distinguish between emotional overwhelm and informational overload. We argue that in these situations, a clinician's primary duty is prevention of harm and suggest ways in which clinicians can discharge this obligation. To illustrate our argument, we consider the clinical application of genetic sequencing testing, which involves scientific and technical information that can compromise the understanding and decisional capacity of most patients. Finally, we consider and rebut objections that this could lead to paternalism.

  18. Discordance in Informed Consent Response on the Basis of Demographic Factors: Brief Report

    ERIC Educational Resources Information Center

    Nunez-Wallace, Karen R.; Gill, Chandler E.; Harrison, Courtney H.; Taylor, Henry M.; Charles, P. David

    2010-01-01

    During an outcomes study of spasticity treatment at a developmental center for 62 residents with profound intellectual disabilities, either botulinum toxin A (BTX-A), intrathecal baclofen (ITB), or both were recommended with physical and occupational therapy. Conservators consented to BTX-A more than ITB (p = 0.021). Court-appointed conservators…

  19. Communication training for advanced medical students improves information recall of medical laypersons in simulated informed consent talks – a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Informed consent talks are mandatory before invasive interventions. However, the patients’ information recall has been shown to be rather poor. We investigated, whether medical laypersons recalled more information items from a simulated informed consent talk after advanced medical students participated in a communication training aiming to reduce a layperson’s cognitive load. Methods Using a randomized, controlled, prospective cross-over-design, 30 5th and 6th year medical students were randomized into two groups. One group received communication training, followed by a comparison intervention (early intervention group, EI); the other group first received the comparison intervention and then communication training (late intervention group, LI). Before and after the interventions, the 30 medical students performed simulated informed consent talks with 30 blinded medical laypersons using a standardized set of information. We then recorded the number of information items the medical laypersons recalled. Results After the communication training both groups of medical laypersons recalled significantly more information items (EI: 41 ± 9% vs. 23 ± 9%, p < .0001, LI 49 ± 10% vs. 35 ± 6%, p < .0001). After the comparison intervention the improvement was modest and significant only in the LI (EI: 42 ± 9% vs. 40 ± 9%, p = .41, LI 35 ± 6% vs. 29 ± 9%, p = .016). Conclusion Short communication training for advanced medical students improves information recall of medical laypersons in simulated informed consent talks. PMID:23374907

  20. How often are ethics approval and informed consent reported in publications on health research in Cameroon? A five-year review.

    PubMed

    Munung, Nchangwi Syntia; Che, Chi Primus; Ouwe-Missi-Oukem-Boyer, Odile; Tangwa, Godfrey B

    2011-09-01

    We assessed the extent of research ethics approval and informed consent reporting in publications emanating from Cameroon and indexed in PubMed from 2005-2009. In our review of 219 full-length articles, we found that 57.53% reported ethics approval, 70.78% informed consent, and 50.68% both ethics approval and informed consent. Reporting these procedures was more common in randomized clinical trials than in other study designs. Also, 59.52% of the articles on vulnerable populations documented ethics approval and 76.19% documented informed consent. This study also identified some structures for ethics review and recommends some next steps for research on the quality of ethics review in Cameroon.

  1. The risks and benefits of disclosing psychotherapy records to the legal system: What psychologists and patients need to know for informed consent.

    PubMed

    Borkosky, Bruce; Smith, Deirdre M

    2015-01-01

    When psychologists release patient records to the legal system, the typical practice is to obtain the patient's signature on a consent form, but rarely is a formal informed-consent obtained from the patient. Although psychologists are legally and ethically required to obtain informed consent for all services (including disclosure of records), there are a number of barriers to obtaining truly informed consent. Furthermore, compared to disclosures to nonlegal third parties, there are significantly greater risks when records are disclosed to the legal system. For these reasons, true informed consent should be obtained from the patient when records are disclosed to the legal system. A model for informed consent is proposed. This procedure should include a description of risks and benefits of disclosing or refusing to disclose by the psychotherapist, an opportunity to ask questions, and indication by the patient of a freely made choice. Both psychotherapist and patient share decision making responsibilities in our suggested model. The patient should be informed about potential harm to the therapeutic relationship, if applicable. Several recommendations for practice are described, including appropriate communications with attorneys and the legal system. A sample form, for use by psychotherapists, is included.

  2. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study

    PubMed Central

    Schumacher, Andrew; Sikov, William M.; Quesenberry, Matthew I.; Safran, Howard; Khurshid, Humera; Mitchell, Kristen M.

    2017-01-01

    Background Informed consent forms (ICFs) for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies. Methods We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics. Results Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials) were significantly longer (P < .0001) and had lower Flesch ease-of-reading scores (P = .003) than investigator-initiated trials (N = 11). At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011). The scores did not differ significantly by type of cancer therapy (P = .12) or trial sponsor (P = .38). Conclusions Many participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient’s education level or cultural characteristics should be evaluated across socio-demographic groups. Trial registration Clinicaltrials.gov NCT01772511 PMID:28235011

  3. Past, Present, and Future of Informed Consent in Pain and Genomics Research: Challenges Facing Global Medical Community.

    PubMed

    Compagnone, Christian; Schatman, Michael E; Rauck, Richard L; Van Zundert, Jan; Kraus, Monika; Primorac, Dragan; Williams, Frances; Allegri, Massimo; Saccani Jordi, Gloria; Fanelli, Guido

    2017-01-01

    In recent decades, there has been a revision of the role of institutional review boards with the intention of protecting human subjects from harm and exploitation in research. Informed consent aims to protect the subject by explaining all of the benefits and risks associated with a specific research project. To date, there has not been a review published analyzing issues of informed consent in research in the field of genetic/Omics in subjects with chronic pain, and the current review aims to fill that gap in the ethical aspects of such investigation. Despite the extensive discussion on ethical challenges unique to the field of genetic/Omics, this is the first attempt at addressing ethical challenges regarding Informed Consent Forms for pain research as the primary focus. We see this contribution as an important one, for while ethical issues are too often ignored in pain research in general, the numerous arising ethical issues that are unique to pain genetic/Omics suggest that researchers in the field need to pay even greater attention to the rights of subjects/patients. This article presents the work of the Ethic Committee of the Pain-Omics Group (www.painomics.eu), a consortium of 11 centers that is running the Pain-Omics project funded by the European Community in the 7th Framework Program theme (HEALTH.2013.2.2.1-5-Understanding and controlling pain). The Ethic Committee is composed of 1 member of each group of the consortium as well as key opinion leaders in the field of ethics and pain more generally.

  4. Informed consent/assent in children. Statement of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP).

    PubMed

    De Lourdes Levy, Maria; Larcher, Victor; Kurz, Ronald

    2003-09-01

    Informed consent means approval of the legal representative of the child and/or of the competent child for medical interventions following appropriate information. National legal regulations differ in regard to the question when a child has the full right to give his or her autonomous consent. Informed assent means a child's agreement to medical procedures in circumstances where he or she is not legally authorised or lacks sufficient understanding for giving consent competently. Doctors should carefully listen to the opinion and wishes of children who are not able to give full consent and should strive to obtain their assent. Doctors have the responsibility to determine the ability and competence of the child for giving his or her consent or assent. All children, even those not judged as competent, have a right to receive information given in a way that they can understand and give their assent or dissent. This consent/assent process must promote and protect the dignity, privacy and confidentiality of the child and his or her family. Consent or assent is required for all aspects of medical care, for preventive, diagnostic or therapeutic measures and research. Children may effectively refuse treatment or procedures which are not necessary to save their lives or prevent serious harm. Where treatment is necessary to save a life or prevent serious harm, the doctor has the duty to act in the best interest of the child. However, parents may also refuse to consent and in this case national laws and legal mechanisms for resolving disputes may be used.

  5. Improving consent form documentation and introduction of procedure-specific labels in a district general hospital

    PubMed Central

    Bajada, Stefan; Dwamena, Samuel; Abdul, Zabihullah; Williams, Rhodri; Ennis, Owain

    2017-01-01

    Informed consent is an important aspect in patient care. Failings in this area may result in patient dissatisfaction or litigation. The aim of this project was to assess our practice in consenting and institute changes to maintain best practice. A consecutive series of 140 patients undergoing elective and trauma procedures were randomly identified over a nine-month period. The consent forms were reviewed and the following information collected: patient/ consenter details, procedure, legibility, if copy was offered/ given to patient and adequacy of procedure-specific complications listed (scored 0-3). The issues identified included: 25% of consents were not fully legible particularly in the complications section. 62% were noted to have inadequate complications listed (score 0 [>5 risks missing]) when compared to an accepted standard. None of the consent form copies were offered or given to the patients. Focused teaching to juniors as well as procedure-specific complication stickers were implemented to improve the documentation of complications. Following several improvement cycles all consents (100%) were fully legible and had the adequate procedure-specific labels with all complications listed. There was an increase to 38% of consent forms offered to patients. We have asked surgeons in the department to comment on which consent method they prefer and all consenters felt that the procedure-specific labels where easier to read and understand. Departmental education as well as introduction of simple procedure-specific complication stickers has resulted in significant improvements in practice. PMID:28243444

  6. Are open-Label Placebos Ethical? Informed Consent and Ethical Equivocations.

    PubMed

    Blease, Charlotte; Colloca, Luana; Kaptchuk, Ted J

    2016-07-01

    The doctor-patient relationship is built on an implicit covenant of trust, yet it was not until the post-World War Two era that respect for patient autonomy emerged as an article of mainstream medical ethics. Unlike their medical forebears, physicians today are expected to furnish patients with adequate information about diagnoses, prognoses and treatments. Against these dicta there has been ongoing debate over whether placebos pose a threat to patient autonomy. A key premise underlying medical ethics discussion is the notion that the placebo effect necessitates patient deception. Indeed, the American Medical Association guidelines imply that placebo treatment necessary entails a form of deception. As a consequence of this assumption, the fulcrum of debate on the use of placebo treatment has hinged on whether that deception is ever justified. Recently performed experiments with open-label transparently prescribed placebos have begun to challenge the notion that deception is necessary in eliciting the placebo effect and such effects necessarily involve a binary distinction between autonomy and beneficence. In this article we focus on the content of disclosures in distinctive open-label, transparently disclosed placebo studies and inquire whether they might be said to invoke deception in clinical contexts, and if so, whether the deception is unethical. We find that open placebos may be said to involve equivocation over how placebos work. However, drawing on surveys of patient attitudes we suggest that this equivocation appears to be acceptable to patients. We conclude that open placebos fulfil current American Medical Association guidelines for placebo use, and propose future research directions for harnessing the placebo effect ethically.

  7. ARE OPEN-LABEL PLACEBOS ETHICAL? INFORMED CONSENT AND ETHICAL EQUIVOCATIONS

    PubMed Central

    Blease, Charlotte; Colloca, Luana; Kaptchuk, Ted J

    2016-01-01

    The doctor-patient relationship is built on an implicit covenant of trust yet it was not until the post-World War Two era that respect for patient autonomy emerged as an article of mainstream medical ethics. Unlike their medical forebearers physicians today are expected to furnish patients with adequate information about diagnoses, prognoses and treatments. Against these dicta there has been ongoing debate over whether placebos pose a threat to patient autonomy. A key premise underlying medical ethics discussion is the notion that the placebo effect necessitates patient deception. Indeed, the American Medical Association guidelines imply that placebo treatment necessary entails a form of deception. As a consequence of this assumption, the fulcrum of debate on the use of placebo treatment has hinged on whether that deception is ever justified.. Recently performed experiments with open-label transparently prescribed placebos have begun to challenge the notion that deception is necessary in eliciting the placebo effect AND SUCH EFFECTS NECESSARILY INVOLVE A BINARY DISTIINCTION BETWEEN AUTONOMY AND BENEFICIENCE. In this paper we focus on the content of disclosures in distinctive open-label, transparently disclosed placebo studies and inquire whether they might be said to invoke deception in clinical contexts, and if so, whether the deception is unethical. We find that open placebos may be said to involve equivocation over how placebos work. However, drawing on surveys of patient attitudes we suggest that this equivocation appears to be acceptable to patients. We conclude that open placebos fulfil current American Medical Association guidelines for placebo use, and propose future research directions for harnessing the placebo effect ethically. PMID:26840547

  8. Human drugs and biologics; determination that informed consent is NOT feasible or is contrary to the best interests of recipients; revocation of 1990 interim final rule; establishment of new interim final rule. Food and Drug Administration, HHS. Interim final rule; opportunity for public comment.

    PubMed

    1999-10-05

    The Food and Drug Administration (FDA) is revoking its 1990 interim final regulations that permitted the Commissioner of Food and Drugs (the Commissioner) to determine that obtaining informed consent from military personnel for the use of an investigational drug or biologic is not feasible in certain situations related to military combat. FDA also is issuing a new interim final rule addressing waiver of informed consent in military operations. FDA is taking these actions based on its analysis and consideration of all relevant facts, including its evaluation of the Department of Defense's (DOD) experience during the Persian Gulf War, its evaluation of the comments received by the agency in response to the agency's July 31, 1997, request for comments on whether the agency should revise or revoke the interim regulations, and the enactment of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (the Defense Authorization Act). Under the Defense Authorization Act, the President is authorized to waive the Federal Food, Drug, and Cosmetic Act's (the act) informed consent requirements in military operations if the President finds that obtaining consent is infeasible or contrary to the best interests of recipients and on an additional ground that obtaining consent is contrary to national security interests. In light of the enactment of the Defense Authorization Act, with an immediate effective date, and because the President could be called upon to make a waiver determination for military personnel engaged in a specific military operation at any time, the agency believes that it is critical to have in place adequate criteria and standards for the President to apply in making an informed consent waiver determination. Therefore, FDA is issuing a new interim final regulation with an immediate effective date to establish criteria and standards for the President to apply in making a determination that informed consent is not feasible or is contrary to the

  9. A qualitative exploration of the informed consent process in hematopoietic cell transplantation clinical research and opportunities for improvement.

    PubMed

    Raj, M; Choi, S W; Platt, J

    2017-02-01

    Informed consent (IC) struggles to meet the ethical principles it strives to embody in the context of hematopoietic cell transplantation (HCT). Patients often participate in multiple clinical trials making it difficult to effectively inform the participants and fulfill complex regulations. The recent Notice of Proposed Rule Making would make major changes to federal requirements, providing a timely opportunity to evaluate existing practice. Twenty health care professionals within a Midwest Academic Medical Center involved in obtaining IC in the HCT clinic or involved in patient care during or after the IC process were interviewed to understand: (1) how they approached the IC process; (2) how they described a 'successful' IC process; and (3) opportunities for innovation. Narrative and discourse analyses of interviews indicate that providers understand IC to be a collaborative process requiring engagement and participation of providers, patients and caregivers. 'Markers of success' were identified including cognitive, affective and procedural markers focusing on patient understanding and comfort with the decision to participate. Opportunities for innovating the process included use of decision aids and tablet-based technology, and better use of patient portals. Our findings suggest specific interventions for the IC process that could support the process of consent for providers, patients and caregivers.

  10. Factors affecting the process of obtaining informed consent to surgery among patients and relatives in a developing country: results from Pakistan.

    PubMed

    Jahan, F; Roshan, R; Nanji, K; Sajwani, U; Warsani, S; Jaffer, S

    2014-10-12

    Efforts have been made in Pakistan to create ethical guidelines for research and medical practice. This study explored the perceptions of and factors affecting the process of obtaining informed consent to surgery among inpatients and families at a tertiary-care hospital in Karachi. A random sample of 400 post-surgery adult patients answered a pre-tested, structured questionnaire. Overall, 233 patients (58.3%) had signed the surgery consent form themselves, while 167 relatives (41.7%) had signed on behalf of the patient. Perceived factors significantly associated with patients not signing the consent form themselves were: language used (adjusted OR = 4.6), medical terminology used (aOR = 2.7), insufficient time allocation (aOR = 3.8), cultural/traditional reasons (aOR = 1.5) and low education (aOR = 2.4). Inappropriate timing for taking consent and not being informed/asked about consent were not statistically significant factors. Health-care practitioners should encourage patients to sign the consent form themselves.

  11. Digitised audio questionnaire for assessment of informed consent comprehension in a low-literacy African research population: development and psychometric evaluation

    PubMed Central

    Afolabi, Muhammed O; Bojang, Kalifa; D'Alessandro, Umberto; Ota, Martin O C; Imoukhuede, Egeruan B; Ravinetto, Raffaella; Larson, Heidi J; McGrath, Nuala; Chandramohan, Daniel

    2014-01-01

    Objective To develop and psychometrically evaluate an audio digitised tool for assessment of comprehension of informed consent among low-literacy Gambian research participants. Setting We conducted this study in the Gambia where a high illiteracy rate and absence of standardised writing formats of local languages pose major challenges for research participants to comprehend consent information. We developed a 34-item questionnaire to assess participants’ comprehension of key elements of informed consent. The questionnaire was face validated and content validated by experienced researchers. To bypass the challenge of a lack of standardised writing formats, we audiorecorded the questionnaire in three major Gambian languages: Mandinka, Wolof and Fula. The questionnaire was further developed into an audio computer-assisted interview format. Participants The digitised questionnaire was administered to 250 participants enrolled in two clinical trials in the urban and rural areas of the Gambia. One week after first administration, the questionnaire was readministered to half of the participants who were randomly selected. Participants were eligible if enrolled in the parent trials and could speak any of the three major Gambian languages. Outcome measure The primary outcome measure was reliability and validity of the questionnaire. Results Item reduction by factor analysis showed that 21 of the question items have strong factor loadings. These were retained along with five other items which were fundamental components of informed consent. The 26-item questionnaire has high internal consistency with a Cronbach's α of 0.73–0.79 and an intraclass correlation coefficient of 0.94 (95% CI 0.923 to 0.954). Hypotheses testing also showed that the questionnaire has a positive correlation with a similar questionnaire and discriminates between participants with and without education. Conclusions We have developed a reliable and valid measure of comprehension of informed consent

  12. Informed Consent for Whole Genome Sequencing: A Qualitative Analysis of Participant Expectations and Perceptions of Risks, Benefits, and Harms

    PubMed Central

    Tabor, Holly K.; Stock, Jacquie; Brazg., Tracy; McMillin, Margaret J.; Dent., Karin M.; Yu, Joon-Ho; Shendure, Jay; Bamshad, Michael J.

    2012-01-01

    Scientific evidence on the extent to which ethical concerns about privacy, confidentiality, and return of results for whole genome sequencing (WGS) are effectively conveyed by informed consent (IC) is lacking. The aim of this study was to learn, via qualitative interviews, about participant expectations and perceptions of risks, benefits, and harms of WGS. Participants in two families with Miller syndrome consented for WGS were interviewed about their experiences of the IC process and their perceptions of risks, benefits, and harms of WGS. Interviews were transcribed and analyzed for common themes. IC documents are included in the supplementary materials. Participants expressed minimal concerns about privacy and confidentiality with regard to both their participation and sharing of their WGS data in restricted access databases. Participants expressed strong preferences about how results should be returned, requesting both flexibility of the results return process and options for the types of results to be returned. Participant concerns about risks to privacy and confidentiality from broad sharing of WGS data are likely to be strongly influenced by social and medical context. In these families with a rare Mendelian syndrome, the perceived benefits of participation strongly trumped concerns about risks. Individual preferences, for results return, even within a family, varied widely. This underscores the need to develop a framework for results return that allows explicitly for participant preferences and enables modifications to preferences over time. Web-based tools that facilitate participant management of their individual research results could accommodate such a framework. PMID:22532433

  13. Informed consent for whole genome sequencing: a qualitative analysis of participant expectations and perceptions of risks, benefits, and harms.

    PubMed

    Tabor, Holly K; Stock, Jacquie; Brazg, Tracy; McMillin, Margaret J; Dent, Karin M; Yu, Joon-Ho; Shendure, Jay; Bamshad, Michael J

    2012-06-01

    Scientific evidence on the extent to which ethical concerns about privacy, confidentiality, and return of results for whole genome sequencing (WGS) are effectively conveyed by informed consent (IC) is lacking. The aim of this study was to learn, via qualitative interviews, about participant expectations and perceptions of risks, benefits, and harms of WGS. Participants in two families with Miller syndrome consented for WGS were interviewed about their experiences of the IC process and their perceptions of risks, benefits, and harms of WGS. Interviews were transcribed and analyzed for common themes. IC documents are included in the Supplementary Materials. Participants expressed minimal concerns about privacy and confidentiality with regard to both their participation and sharing of their WGS data in restricted access databases. Participants expressed strong preferences about how results should be returned, requesting both flexibility of the results return process and options for the types of results to be returned. Participant concerns about risks to privacy and confidentiality from broad sharing of WGS data are likely to be strongly influenced by social and medical context. In these families with a rare Mendelian syndrome, the perceived benefits of participation strongly trumped concerns about risks. Individual preferences, for results return, even within a family, varied widely. This underscores the need to develop a framework for results return that allows explicitly for participant preferences and enables modifications to preferences over time. Web-based tools that facilitate participant management of their individual research results could accommodate such a framework.

  14. Reassessing the approach to informed consent: the case of unrelated hematopoietic stem cell transplantation in adult thalassemia patients

    PubMed Central

    2014-01-01

    Introduction The informed consent process is the legal embodiment of the fundamental right of the individual to make decisions affecting his or her health., and the patient’s permission is a crucial form of respect of freedom and dignity, it becomes extremely important to enhance the patient’s understanding and recall of the information given by the physician. This statement acquires additional weight when the medical treatment proposed can potentially be detrimental or even fatal. This is the case of thalassemia patients pertaining to class 3 of the Pesaro classification where Allogenic hematopoietic stem cell transplantation (HSCT) remains the only potentially curative treatment. Unfortunately, this kind of intervention is burdened by an elevated transplantation-related mortality risk (TRM: all deaths considered related to transplantation), equal to 30% according to published reports. In thalassemia, the role of the patient in the informed consent process leading up to HSCT has not been fully investigated. This study investigated the hypothesis that information provided by physicians in the medical scenario of HSCT is not fully understood by patients and that misunderstanding and communication biases may affect the clinical decision-making process. Methods A questionnaire was either mailed or given personally to 25 patients. A second questionnaire was administered to the 12 physicians attending the patients enrolled in this study. Descriptive statistics were used to evaluate the communication factors. Results The results pointed out the difference between the risks communicated by physicians and the risks perceived by patients. Besides the study highlighted the mortality risk considered to be acceptable by patients and that considered to be acceptable by physicians. Conclusions Several solutions have been suggested to reduce the gap between communicated and perceived data. A multi-disciplinary approach may possibly help to attenuate some aspects of

  15. [General and ethical considerations for the informed consent process: Guidelines from the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC)].

    PubMed

    Thibert, Jean-Baptiste; Polomeni, Alice; Yakoub-Agha, Ibrahim; Bordessoule, Dominique

    2016-11-01

    Informed consent is not restricted to clinical research and must be applied to high-risk care such as hematopoietic stem cell transplantation. If standardized informed consent might improve inequalities in medical practices between different transplantation centers, it is strongly recommended that it be adapted with an honest dialogue between physicians and patients and physicians and donors. In an attempt to harmonize clinical practices among French hematopoietic stem cell transplantation centers, the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC) held its sixth annual workshop series in September 2015 in Lille. This event brought together practitioners from across the country. The purpose of this paper is to highlight the French law concerning patients' rights and ethical practices for an informed consent process to be applied to care or research.

  16. The Department of Veterans Affairs, Department of Defense, and Kaiser Permanente Nationwide Health Information Network exchange in San Diego: patient selection, consent, and identity matching.

    PubMed

    Bouhaddou, Omar; Bennett, Jamie; Cromwell, Tim; Nixon, Graham; Teal, Jennifer; Davis, Mike; Smith, Robert; Fischetti, Linda; Parker, David; Gillen, Zachary; Mattison, John

    2011-01-01

    The Nationwide Health Information Network allow for the secure exchange of Electronic Health Records over the Internet. The Department of Veterans Affairs, Department of Defense, and Kaiser Permanente, participated in an implementation of the NwHIN specifications in San Diego, California. This paper focuses primarily on patient involvement. Specifically, it describes how the shared patients were identified, were invited to participate and to provide consent for disclosing parts of their medical record, and were matched across organizations. A total 1,144 were identified as shared patients. Invitation letters containing consent forms were mailed and resulted in 42% participation. Invalid consent forms were a significant issue (25%). Initially, the identity matching algorithms yielded low success rate (5%). However, elimination of certain traits and abbreviations and probabilistic algorithms have significantly increased matching rate. Access to information from external sources better informs providers, improves decisions and efficiency, and helps meet the meaningful use criteria.

  17. "They Take Positive People": An Investigation of Communication in the Informed Consent Process of an HIV/AIDS Vaccine Trial in South Africa

    ERIC Educational Resources Information Center

    Watermeyer, Jennifer; Penn, Claire

    2008-01-01

    South Africa is a multilingual, multicultural context that poses communication challenges to health professionals. In a clinical trial, information must be thoroughly understood by participants in order for consent to be informed. Unfortunately, this is not always the case. This pilot study aimed to identify communication successes and breakdowns…

  18. Implementation of the exception from informed consent regulations in a large multicenter emergency clinical trials network: the RAMPART experience.

    PubMed

    Silbergleit, Robert; Biros, Michelle H; Harney, Deneil; Dickert, Neal; Baren, Jill

    2012-04-01

    Clinical trials investigating therapies for acutely and critically ill and injured patients in the earliest phases of treatment often can only be performed under regulations allowing for exception from informed consent (EFIC) for emergency research. Implementation of these regulations in multicenter clinical trials involves special challenges and opportunities. The Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART), the first EFIC trial conducted by the Neurological Emergencies Treatment Trials (NETT) network, combined centralized resources and coordination with retention of local control and flexibility to facilitate compliance with the EFIC regulations. Specific methods used by the NETT included common tools for community consultation and public disclosure, sharing of experiences and knowledge, and reporting of aggregate results. Tracking of community consultation and public disclosure activities and feedback facilitates empirical research on EFIC methods in the network and supports quality improvements for future NETT trials. The NETT model used in RAMPART demonstrates how EFIC may be effectively performed in established clinical trial networks.

  19. Informed consent in clinical practice: pre-registration house officers' knowledge, difficulties and the need for postgraduate training.

    PubMed

    Schildmann, Jan; Cushing, Annie; Doyal, Len; Vollmann, Jochen

    2005-11-01

    In clinical practice consent is often obtained by junior doctors. This study investigates the involvement of pre-registration house officers (PRHOs) in the process of obtaining consent, the supervision they receive and their knowledge on the subject. Some 74% of the PRHOs in post completed the questionnaire; 68% had often or sometimes obtained consent during their year as PRHO; 18% stated that on the occasions when they had obtained consent they were always the only person eliciting consent; 62% of the doctors perceived some lack of knowledge with regard to the nature of the procedure as a difficulty. Despite a comprehensive undergraduate programme in ethics, law and communication there is a need for applied education regarding the clinical procedures for which PRHOs are obtaining consent.

  20. Patient advocacy and patient centredness in participant recruitment to randomized‐controlled trials: implications for informed consent

    PubMed Central

    Tomlin, Zelda; deSalis, Isabel; Toerien, Merran; Donovan, Jenny L.

    2012-01-01

    Abstract Context  With the routinization of evidence‐based medicine and of the randomized‐controlled trial (RCT), more patients are becoming ‘sites of evidence production’ yet, little is known about how they are recruited as participants; there is some evidence that ‘substantively valid consent’ is difficult to achieve. Objective  To explore the views and experiences of nurses recruiting patients to randomized‐controlled trials and to examine the extent to which their recruitment practices were patient‐centred and patient empowering. Design  Semi‐structured in‐depth interviews; audio recording of recruitment appointments; thematic interactional analysis (drawing on discourse and conversation analysis). Setting and participants  Nurses recruiting patients to five publicly funded RCTs and patients consenting to the recording of their recruitment sessions. Main outcome measures  The views of recruiting nurses about their recruitment role; the extent to which nurse–patient interactions were patient‐centred; the nature of the nurses’ interactional strategies and the nature and extent of patient participation in the discussion. Results  The nurses had a keen sense of themselves as clinicians and patient advocates and their perceptions of the trial and its interventions were inextricably linked to those of the patients. However, many of their recruitment practices made it difficult for patients to play an active and informed part in the discussion about trial participation, raising questions over the quality of consent decisions. Conclusion  Nurses working in patient recruitment to RCTs need to reconcile two different worlds with different demands and ethics. Evidence production, a central task in evidence‐based medicine, poses a challenge to patient‐centred practice and more research and relevant training are needed. PMID:22712887

  1. [Information and consent forms for hematopoietic stem cell transplantation donors and recipients: Guidelines from the Franchophone society of bone marrow transplantation and cellular therapy (SFGM-TC)].

    PubMed

    Bruno, Bénédicte; Thibert, Jean-Baptiste; Bancillon, Nelly; Desbos, Anna; Fawaz, Abir; Fournier, Isabelle; Genty, Carole; Issarni, Dominique; Leveille, Sandrine; Premel, Christelle; Polomeni, Alice; Renault, Myriam; Tarillon, Sylvie; Wallart, Anne; Yakoub-Agha, Ibrahim; Bordessoule, Dominique

    2016-11-01

    Within the context of the SFGM-TC's 6th workshop series on the harmonization of clinical practices, our workshop proposes a standardization of the informed consent process for hematopoietic stem cell donors and recipients leading up to an autologous or allogenic transplantation. All informed consent was for bone marrow or peripheral stem cell donors, and mononuclear/lymphocyte donors according to usual procedures. The informed consent for autologous and allogenic related or unrelated adults and pediatric transplantation patients have been included. A first step has been conducted for collecting in advance the informed consent forms used routinely in all francophone transplantation centers. In a second step, a comprehensive version has been re-written by a multidisciplinary team. For the purposes of understanding the risks and advantages, language has been carefully considered and streamlined. In the third step, texts were sent to stem cell transplantation experts, experts at the French biomedical agency (agence de la biomédecine [ABM]), law specialists, members of the ethical committee of the French society of hematology and several transplant recipients to be edited and proofread.

  2. Psychiatric Residents' Needs for Education about Informed Consent, Principles of Ethics and Professionalism, and Caring for Vulnerable Populations: Results of a Multisite Survey

    ERIC Educational Resources Information Center

    Jain, Shaili; Lapid, Maria I.; Dunn, Laura B.; Roberts, Laura Weiss

    2011-01-01

    Objective: The authors examined psychiatric residents' perceived needs for education in informed consent, principles of ethics and professionalism, and treating vulnerable populations. Method: A written survey was distributed to psychiatric residents (N = 249) at seven U.S. residency programs in 2005. The survey contained 149 questions in 10…

  3. Women's Voices in Maternity Care: The Triad of Shared Decision Making, Informed Consent, and Evidence-Based Practices.

    PubMed

    Moore, Jennifer E

    2016-01-01

    The United States is the only industrialized nation that has experienced dramatic increases in the use of maternity interventions resulting in poor birth outcomes. It is speculated that the increased rates of maternal mortality and other outcomes are attributed to the current maternity model of care focused on the overuse of interventions, such as induction of labor, in otherwise healthy pregnant women. The overuse of induction of labor to artificially speed up the birth process has been linked to an increase in preterm and cesarean births. The cost of these interventions and poor outcomes has been substantial. The purpose of this article is to present concepts that demonstrate the challenges and value of informed, shared decision making, informed consent, and women's use of evidence within the context of maternity care. To highlight these important concepts, this article presents original findings from a secondary analysis of data on induction of labor. Findings from this analysis further highlight the importance of including women as part of informed, shared decision making in models of maternity care.

  4. Consent--its medico legal aspects.

    PubMed

    Yadwad, B S; Gouda, H

    2005-10-01

    One of the duties of a doctor towards his patients is to obtain consent before any medical examination. Any such examination without prior consent amounts to an assault on the patient. Consent is defined under Indian Contract Act (because Doctor Patient relationship isa contract) as "two or more persons are said to consent when they agree to the same thing in the same sense." Consent may be implied, expressed or informed depending upon the circumstances. But the consent of the patient is not required in situations like medical emergency, for vaccination etc. If the patient is not medically or legally competent to give consent, the consent of the parents or guardians or any person present at the time with the patient can be taken. Any research on a potential subject, removal of organs for transplantation, publication of information obtained during medical examination also require consent of the concerned person.

  5. A case of informed consent obtained from a patient with terminal cancer and his family using family function by the primary care physician.

    PubMed

    Tsuboi, Keiko; Minegishi, Yukiko; Harada, Toshihide; Ishizaki, Fumiko; Nitta, Kohsaku

    2007-06-01

    We evaluated the contents and characteristics of informed consent obtained by the primary care physician from a male patient with advanced cancer and his family, and clarified the influences of the informed consent on family function. This patient was diagnosed as having advanced cancer at the age of 46 years, underwent surgery/chemotherapy, but died after 4 months at the hospital. Semi-structured interviews were held with the elder daughter of the patient, and notes on the patient's disease, the course of treatment, his family's responses, and the informed consent obtained by the primary care physician were taken during the interview. The informed consent obtained by the primary care physician had the following characteristics: (1) The physician transmitted accurate and detailed information on the treatment methods, side effects, and prognosis by appropriate communication techniques with consideration for the feelings of the patient and his family, and proposed choices so that they could participate in the decision of treatment principles. (2) During the entire course, the primary care physician frequently visited the bedside and encouraged the patient and his family to express their feelings of anxiety and to ask questions, giving continuous emotional support. With the progression of the disease and explanation by the primary care physician, the patient and his family expressed and shared feelings such as grief and powerlessness and supported each another. Gradually, they began to show practical/adaptive coping behavior and could accept the patient's death. Appropriate informed consent obtained by the primary-care physician promoted the family function of this family.

  6. Text-Processing Differences in Adolescent Adequate and Poor Comprehenders Reading Accessible and Challenging Narrative and Informational Text

    ERIC Educational Resources Information Center

    Denton, Carolyn A.; Enos, Mischa; York, Mary J.; Francis, David J.; Barnes, Marcia A.; Kulesz, Paulina A.; Fletcher, Jack M.; Carter, Suzanne

    2015-01-01

    Based on the analysis of 620 think-aloud verbal protocols from students in grades 7, 9, and 11, we examined students' conscious engagement in inference generation, paraphrasing, verbatim text repetition, and monitoring while reading narrative or informational texts that were either at or above the students' current reading levels. Students were…

  7. Information and Communication Technology Profiles of College Students with Learning Disabilities and Adequate and Very Poor Readers

    ERIC Educational Resources Information Center

    Fichten, Catherine S.; Nguyen, Mai N.; King, Laura; Barile, Maria; Havel, Alice; Mimouni, Zohra; Chauvin, Alexandre; Budd, Jillian; Raymond, Odette; Juhel, Jean-Charles; Asuncion, Jennison

    2013-01-01

    We interviewed 58 experts (30 in French, 28 in English) about potentially useful information and communication technologies (ICTs) for Québec college students with a learning disability (LD) and evaluated whether college students with an LD (n = 74), in fact, used these. We also compared ICT use, learning opportunities, and attitudes among three…

  8. The changing nature of consent.

    PubMed

    Trathen, Andrew

    2015-02-01

    Consent is a foundational principle of medical and dental ethics. The importance of the concept has changed over time and it is now viewed as more important than it has ever been, both within the profession and by wider society. This article looks at the nature of consent historically, the changes it has undergone, and some of the contemporary challenges in this area. The philosophical basis of consent is considered, looking at two lines of thought relating to autonomy and prevention of harm. The difficulty and appropriateness of providing 'fully-informed' consent is then considered along with some of the modern problems relating to consumerist culture, and the social changes that have caused them. By looking at consent from a social and philosophical standpoint, we can broaden our thinking to give context to the day-to-day practicalities of obtaining consent in practice. These practicalities are addressed in subsequent articles within this issue of the Primary Dental Journal.

  9. 32 CFR 806b.47 - Rules for releasing Privacy Act information without consent of the subject.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., economy and to avoid redundancy. Unless a system notice specifically excludes a system of records from a... individual or agency that needs the information for compelling health or safety reasons. The...

  10. 32 CFR 806b.47 - Rules for releasing Privacy Act information without consent of the subject.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 8. (e) Exception 5. A recipient for statistical research or reporting. The recipient must give advanced written assurance that the information is for statistical purposes only. Note: No one may use...

  11. Comparison of Two Questionnaires on Informed Consent in "Marginal" Donor Liver.

    PubMed

    Bruzzone, P; Balla, A; Quaresima, S; Seitaj, A; Intini, G; Giannarelli, D; Paganini, A M

    2016-03-01

    The necessity of liver donors has contributed to overcoming the traditional criteria and to propose new ones for the acceptance of livers for transplantation. For this reason expanded or extended criteria donation (ECD) or even overextended criteria for marginal or high-risk organ donors have been developed. Ethical, Legal and Psychological Aspects of Organ Transplantation (ELPAT) and European Liver and Intestine Transplant Association (ELITA) - European Liver Transplantation Registry (ELTR) coordinated the distribution of a previously reported questionnaire that was sent to 53 European liver transplant centers. Criteria were divided based on the response rate. Donor criteria such as steatosis and serum sodium >165 mmol/L, as well as recipient criteria such as previous history of cancer, were not considered contraindications to transplantation in more than 60% of cases. Criteria such as ICU (intensive care unit) stay, body mass index >30, serum bilirubin >3 mg/dL, and HIV infection or critical illness were not considered adequate for transplantation in 30% to 59% of cases. On the other hand, there was no agreement on other extended liver donor and recipient criteria, such as age up to 80 years, serum glutamic oxaloacetic transaminase >90 U/L, serum glutamic pyruvic transaminase >105 U/L, high-risk sex practices, drug users, patients older than 65 years, and patients younger than 65 years, respectively. Criteria such as serum sodium could not be considered ECD criteria. In conclusion, development of more studies and inclusion of more liver transplantation centers are required to confirm these data.

  12. Informed consent v. ITAR: Regulatory conflicts that could constrain commercial human space flight

    NASA Astrophysics Data System (ADS)

    Blount, P. J.

    2010-06-01

    The Human Space Flight Requirements (promulgated by the U.S. Federal Aviation Administration) seek to protect the fledgling commercial space flight industry by shifting risk from the operator to the space flight participants. However, in order to do this effectively the regulations require a great deal of information to be given to the participants. The information required might be extensive enough that it could be considered "technical data" under the International Traffic in Arms Regulations. If this is the case then commercial spaceflight companies will have to get export licenses for non-U.S. participants on their flights which could cause additional costs as well as other problems.

  13. 77 FR 63833 - Equifax Information Services LLC; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... information, like anyone's Social Security number, date of birth, driver's license number or other state...). Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a... Advertising, Inc. and Virtual Lending Source, LLC (collectively ``Direct Lending'') which included,...

  14. 'Is this knowledge mine and nobody else's? I don't feel that.' Patient views about consent, confidentiality and information-sharing in genetic medicine.

    PubMed

    Dheensa, Sandi; Fenwick, Angela; Lucassen, Anneke

    2016-03-01

    In genetic medicine, a patient's diagnosis can mean their family members are also at risk, raising a question about how consent and confidentiality should function in clinical genetics. This question is particularly pressing when it is unclear whether a patient has shared information. Conventionally, healthcare professionals view confidentiality at an individual level and 'disclosure without consent' as the exception, not the rule. The relational joint account model, by contrast, conceptualises genetic information as confidential at the familial level and encourages professionals to take disclosure as the default position. In this study, we interviewed 33 patients about consent and confidentiality and analysed data thematically. Our first theme showed that although participants thought of certain aspects of genetic conditions--for example, the way they affect day-to-day health--as somewhat personal, they perceived genetic information--for example, the mutation in isolation--as familial. Most thought these elements were separable and thought family members had a right to know the latter, identifying a broad range of harms that would justify disclosure. Our second theme illustrated that participants nonetheless had some concerns about what, if any, implications there would be of professionals treating such information as familial and they emphasised the importance of being informed about the way their information would be shared. Based on these results, we recommend that professionals take disclosure as the default position, but make clear that they will treat genetic information as familial during initial consultations and address any concerns therein.

  15. Correlation between doctor's belief on the patient's self-determination and medical outcomes in obtaining informed consent.

    PubMed

    Yoshihara, Keisuke; Takase, Kozo

    2013-03-01

    We employed a questionnaire survey to assess attitudes toward informed consent (IC) among hospital doctors. Based on the result of the correlation analysis, the following two hypotheses were identified. The first hypothesis is that "the doctor's belief that the patient's self-determination is possible promotes cure of illness by obtaining IC." The second hypothesis is that "the doctor's belief that the patient's self-determination is possible has a positive influence on patient's quality of life by obtaining IC." We clarified the rationale for explaining these two hypotheses by applying cross tabulation analysis, discriminant analysis and principal component analysis (PCA). The doctors were divided into two groups in terms of their position on the patient's self-determination. One group of doctors believed the possibility of patient's self-determination, and the other did not. Through our statistical analyses, the characteristics that discriminate these two groups were identified. It was revealed that the former group placed a great importance on the hospitality value, while the latter placed an importance on the service value. Agreement or rejection of the concept of IC has been demonstrated as a key distinguishing factor between the two groups. The results of PCA showed that the doctor's belief on the patient's self-determination in obtaining IC had a significant effect on medical outcomes, and the two above-mentioned hypotheses were revealed.

  16. [Dental and health law 4. The treatment of minors and of adults who are unable to give informed consent].

    PubMed

    Brands, W G; van der Ven, J M; Brands-Bottema, G W

    2013-01-01

    When minors are treated, a complex triangular relationship can emerge among dentist, patient and the individual legally responsible for the patient. Generally speaking, both parents are those legally responsible for a child. This might not be the case if the parents are not married to each other or have divorced, or when there is a question of a child protection ruling. The governing rule is that dentists are required to honour the obligations to the legal representatives thatfollow from the patients' rights concerning the treatment of children under the age of 12. In the case of patients between the ages of 12 and 16, dentists are required to act in accordance with their obligations to both those legally responsible and to the patients. Finally, in the case ofpatients who are 16 and older, dentists are required to act only in accordance with their obligations to the patients. There are, however, various exceptions to this governing rule. One of the most common examples is the patient who is a minor of 16 or older who is unable to determine what is in his own best interest. That criterium is also used in determining the capability to give informed consent in adults.

  17. Informed consent for emergency contraception: variability in hospital care of rape victims.

    PubMed Central

    Smugar, S S; Spina, B J; Merz, J F

    2000-01-01

    There is growing concern that rape victims are not provided with emergency contraceptives in many hospital emergency rooms, particularly in Catholic hospitals. In a small pilot study, we examined policies and practices relating to providing information, prescriptions, and pregnancy prophylaxis in emergency rooms. We held structured telephone interviews with emergency department personnel in 58 large urban hospitals, including 28 Catholic hospitals, from across the United States. Our results showed that some Catholic hospitals have policies that prohibit the discussion of emergency contraceptives with rape victims, and in some of these hospitals, a victim would learn about the treatment only by asking. Such policies and practices are contrary to Catholic teaching. More seriously, they undermine a victim's right to information about her treatment options and jeopardize physicians' fiduciary responsibility to act in their patients' best interests. We suggest that institutions must reevaluate their restrictive policies. If they fail to do so, we believe that state legislation requiring hospitals to meet the standard of care for treatment of rape victims is appropriate. PMID:10983186

  18. Quality assessment of patient leaflets on misoprostol-induced labour: does written information adhere to international standards for patient involvement and informed consent?

    PubMed Central

    Clausen, Jette Aaroe; Rydahl, Eva

    2016-01-01

    Objectives The need for thorough patient information is increasing as maternity care becomes more medicalised. The aim was to assess the quality of written patient information on labour induction. In most Danish hospitals, misoprostol is the first-choice drug for induction in low-risk pregnancies. Misoprostol has been associated with adverse side effects and severe outcomes for mother and child and is not registered for obstetric use in Denmark. Setting Secondary care hospitals in Denmark. Data Patient information leaflets from all hospitals that used misoprostol as an induction agent by June 2015 (N=13). Design Patient leaflets were evaluated according to a validated scoring tool (International Patient Decision Aid Standards instrument, IPDAS), core elements in the Danish Health Act, and items regarding off-label use and non-registered medication. Two of the authors scored all leaflets independently. Outcome measures Women's involvement in decision-making, information on benefits and harms associated with the treatment, other justifiable treatment options, and non-registered treatment. Results Generally, the hospitals scored low on the IPDAS checklist. No hospitals encouraged women to consider their preferences. Information on side effects and adverse outcomes was poorly covered and varied substantially between hospitals. Few hospitals informed about precautions regarding outpatient inductions, and none informed about the lack of evidence on the safety of this procedure. None informed that misoprostol is not registered for induction or explained the meaning of off-label use or use of non-registered medication. Elements such as interprofessional consensus, long-term experience, and health authorities' approval were used to add credibility to the use of misoprostol. Conclusions Central criteria for patient involvement and informed consent were not met, and the patient leaflets did not inform according to current evidence on misoprostol-induced labour. Our findings

  19. A Comparison of the Quality of Informed Consent for Clinical Trials of an Experimental Hookworm Vaccine Conducted in Developed and Developing Countries

    PubMed Central

    Lobato, Lucas; Styczynski, Ashley; Zumer, Maria; Soares, Amanda; Gazzinelli, Maria Flávia

    2017-01-01

    Informed consent is one of the principal ethical requirements of conducting clinical research, regardless of the study setting. Breaches in the quality of the informed consent process are frequently described in reference to clinical trials conducted in developing countries, due to low levels of formal education, a lack of familiarity with biomedical research, and limited access to health services in these countries. However, few studies have directly compared the quality of the informed consent process in developed and developing countries using the same tool and in similar clinical trials. This study was conducted to compare the quality of the informed consent process of a series of clinical trials of an investigational hookworm vaccine that were performed in Brazil and the United States. A standardized questionnaire was used to assess the ethical quality of the informed consent process in a series of Phase 1 clinical trials of the Na-GST-1/Alhydrogel hookworm vaccine that were conducted in healthy adults in Brazil and the United States. In Brazil, the trial was conducted at two sites, one in the hookworm non-endemic urban area of Belo Horizonte, Minas, and one in the rural, resource-limited town of Americaninhas, both in the state of Minas Gerais; the American trial was conducted in Washington, DC. A 32-question survey was administered after the informed consent document was signed at each of the three trial sites; it assessed participants’ understanding of information about the study presented in the document as well as the voluntariness of their decision to participate. 105 participants completed the questionnaire: 63 in Americaninhas, 18 in Belo Horizonte, and 24 in Washington, DC. Overall knowledge about the trial was suboptimal: the mean number of correct answers to questions about study objectives, methods, duration, rights, and potential risks and benefits, was 45.6% in Americaninhas, 65.2% in Belo Horizonte, and 59.1% in Washington, DC. Although there

  20. A Comparison of the Quality of Informed Consent for Clinical Trials of an Experimental Hookworm Vaccine Conducted in Developed and Developing Countries.

    PubMed

    Diemert, David J; Lobato, Lucas; Styczynski, Ashley; Zumer, Maria; Soares, Amanda; Gazzinelli, Maria Flávia

    2017-01-01

    Informed consent is one of the principal ethical requirements of conducting clinical research, regardless of the study setting. Breaches in the quality of the informed consent process are frequently described in reference to clinical trials conducted in developing countries, due to low levels of formal education, a lack of familiarity with biomedical research, and limited access to health services in these countries. However, few studies have directly compared the quality of the informed consent process in developed and developing countries using the same tool and in similar clinical trials. This study was conducted to compare the quality of the informed consent process of a series of clinical trials of an investigational hookworm vaccine that were performed in Brazil and the United States. A standardized questionnaire was used to assess the ethical quality of the informed consent process in a series of Phase 1 clinical trials of the Na-GST-1/Alhydrogel hookworm vaccine that were conducted in healthy adults in Brazil and the United States. In Brazil, the trial was conducted at two sites, one in the hookworm non-endemic urban area of Belo Horizonte, Minas, and one in the rural, resource-limited town of Americaninhas, both in the state of Minas Gerais; the American trial was conducted in Washington, DC. A 32-question survey was administered after the informed consent document was signed at each of the three trial sites; it assessed participants' understanding of information about the study presented in the document as well as the voluntariness of their decision to participate. 105 participants completed the questionnaire: 63 in Americaninhas, 18 in Belo Horizonte, and 24 in Washington, DC. Overall knowledge about the trial was suboptimal: the mean number of correct answers to questions about study objectives, methods, duration, rights, and potential risks and benefits, was 45.6% in Americaninhas, 65.2% in Belo Horizonte, and 59.1% in Washington, DC. Although there

  1. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 7: Informed consent and xenotransplantation clinical trials.

    PubMed

    Vanderpool, Harold Y

    2009-01-01

    This essay explores the meaning and implications of informed consent in xenotransplantation clinical trials from both ethically justifiable and international perspectives. In international and national codes and guidelines involving human subject research and in the laws of many nations, the informed consent of research subjects is obligatory. Its moral foundations include and also extend beyond respect for individual persons as autonomous agents in Western nations. Axioms regarding the value of human life and duties to protect innocent and vulnerable persons from harm, duress, and deceit underlie Western individualism and are broadly shared in many non-Western cultures. Accents on family and/or community consent in China and other nations are compatible with individual consent as long as family and community consent supplement, rather than replace, individual consent. Reflecting its moral foundations, informed consent in medical research is rightly characterized as "voluntary" or "freely given" informed consent because it encompasses researchers' disclosure and subjects' comprehension of all the relevant information about the protocol that reasonable persons would want to know in order to freely and affirmatively enroll in the research. The interplay between these conceptual foundations of informed consent and the realities of xenotransplantation research defines what the nature and functions of consent should be in xenotransplantation clinical trials. Because these trials involve a complex body of medical information, numerous procedures, numerous risks (associated with failure rates, immunosuppression, xenogeneic infections, and so on) and the subject's obligation to abide by extensive national and international precautionary guidelines, informed consent should be enacted as an organized, sequential, thoughtfully paced, jargon-free process of communication. The features and functions of consent forms or consent documents should accord with this process. Rather

  2. Improving Community Understanding of Medical Research: Audience Response Technology for Community Consultation for Exception to Informed Consent

    PubMed Central

    Vohra, Taher; Chebl, Raphe Bou; Miller, Joseph; Russman, Andrew; Baker, Anna; Lewandowski, Christopher

    2014-01-01

    Introduction The Department of Health and Human Services and Food and Drug Administration described guidelines for exception from informed consent (EFIC) research. These guidelines require community consultation (CC) events, which allow members of the community to understand the study, provide feedback and give advice. A real-time gauge of audience understanding would allow the speaker to modify the discussion. The objective of the study is to describe the use of audience response survey (ARS) technology in EFIC CCs. Methods As part of the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART), 13 CC events were conducted. We prepared a PowerPoint™ presentation with 4 embedded ARS questions,according to specific IRB guidelines to ensure that the pertinent information would reach our targeted audience. During 6 CCs, an ARS was used to gauge audience comprehension. Participants completed paper surveys regarding their opinion of the study following each CC. Results The ARS was used with minimal explanation and only one ARS was lost. Greater than 80% of the participants correctly answered 3 of the 4 ARS questions with 61% correctly answering the question regarding EFIC. A total of 105 participants answered the paper survey; 80–90% of the responses to the paper survey were either strongly agree or agree. The average scores on the paper survey in the ARS sites compared to the non-ARS sites were significantly more positive. Conclusion The use of an audience response system during the community consultation aspects of EFIC is feasible and provides a real-time assessment of audience comprehension of the study and EFIC process. It may improve the community’s opinion and support of the study. PMID:25035746

  3. Risk of seizures in transcranial magnetic stimulation: a clinical review to inform consent process focused on bupropion

    PubMed Central

    Dobek, Christine E; Blumberger, Daniel M; Downar, Jonathan; Daskalakis, Zafiris J; Vila-Rodriguez, Fidel

    2015-01-01

    Objective When considering repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder, clinicians often face a lack of detailed information on potential interactions between rTMS and pharmacotherapy. This is particularly relevant to patients receiving bupropion, a commonly prescribed antidepressant with lower risk of sexual side effects or weight increase, which has been associated with increased risk of seizure in particular populations. Our aim was to systematically review the information on seizures occurred with rTMS to identify the potential risk factors with attention to concurrent medications, particularly bupropion. Data sources We conducted a systematic review through the databases PubMed, PsycINFO, and EMBASE between 1980 and June 2015. Additional articles were found using reference lists of relevant articles. Reporting of data follows Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Study selection Two reviewers independently screened articles reporting the occurrence of seizures during rTMS. Articles reporting seizures in epilepsy during rTMS were excluded. A total of 25 rTMS-induced seizures were included in the final review. Data extraction Data were systematically extracted, and the authors of the applicable studies were contacted when appropriate to provide more detail about the seizure incidents. Results Twenty-five seizures were identified. Potential risk factors emerged such as sleep deprivation, polypharmacy, and neurological insult. High-frequency-rTMS was involved in a percentage of the seizures. None of these seizures reported had patients taking bupropion in the literature review. One rTMS-induced seizure was reported from the Food and Drug Administration in a sleep-deprived patient who was concurrently taking bupropion, sertraline, and amphetamine. Conclusion During the consent process, potential risk factors for an rTMS-induced seizure should be carefully screened for and discussed. Data

  4. Improved informed consent documents for biomedical research do not increase patients’ understanding but reduce enrolment: a study in real settings

    PubMed Central

    Paris, Adeline; Deygas, Béatrice; Cornu, Catherine; Thalamas, Claire; Maison, Patrick; Duale, Christian; Kane, Maty; Hodaj, Enkelejda; Cracowski, Jean-Luc

    2015-01-01

    Aims The aim was to evaluate the comprehension of participants of an improved informed consent document (ICD). Method This was a randomized controlled French multicentre study performed in real conditions. Participants were adult patients undergoing screening for enrolment in biomedical research studies, who agreed to answer a validated questionnaire evaluating objective and subjective comprehension scored from 0 (no comprehension) to 100 (excellent comprehension). Patients were provided either the original ICD or an ICD modified in terms of structure and readability. The primary end point was the score of objective comprehension. The secondary end-points were the enrolment rate in the clinical study and patient characteristics associated with the score of objective comprehension. Results Four hundred and eighty-one patients were included, 241 patients in the original ICD group and 240 patients in the modified ICD group. There was no difference between the two groups for the score of objective comprehension (original ICD 72.7 (95% CI 71.3, 74.1) vs. modified ICD 72.5 (95% CI 71.0, 74.0); P = 0.81). However, the rate of enrolment in the clinical study was lower in the group who received the modified ICD (64.4% (95% CI 58.3, 70.5)) than for the original ICD (73.0% (95% CI 67.4, 78.7)) (P = 0.042). Only female gender and high educational level were associated with a better objective comprehension. Conclusions Improving ICDs had no effect on participants’ understanding, whereas the rate of enrolment was lower in this group. In attempts at improving potential participants’ understanding of clinical research information, efforts and future trials should focus on other ways to improve comprehension. PMID:26147763

  5. An audit of consent for allograft use in elective orthopaedic surgery.

    PubMed

    Mullan, C J; Pagoti, R; Davison, H; McAlinden, M G

    2016-04-01

    Introduction Patients receiving musculoskeletal allografts may be at risk of postoperative infection. The General Medical Council guidelines on consent highlight the importance of providing patients with the information they want or need on any proposed investigation or treatment, including any potential adverse outcomes. With the increased cost of defending medicolegal claims, it is paramount that adequate, clear informed patient consent be documented. Methods We retrospectively examined the patterns of informed consent for allograft bone use during elective orthopaedic procedures in a large unit with an onsite bone bank. The initial audit included patients operated over the course of 1 year. Following a feedback session, a re-audit was performed to identify improvements in practice. Results The case mix of both studies was very similar. Revision hip arthroplasty surgery constituted the major subgroup requiring allograft (48%), followed by foot and ankle surgery (16.3%) and revision knee arthroplasty surgery (11.4%) .On the initial audit, 17/45 cases (38%) had either adequate preoperative documentation of the outpatient discussion or an appropriately completed consent form on the planned use of allograft. On the re-audit, 44/78 cases (56%) had adequate pre-operative documentation. There was little correlation between how frequently a surgeon used allograft and the adequacy of consent (Correlation coefficient -0.12). Conclusions Although the risk of disease transmission with allograft may be variable, informed consent for allograft should be a routine part of preoperative discussions in elective orthopaedic surgery. Regular audit and feedback sessions may further improve consent documentation, alongside the targeting of high volume/low compliance surgeons.

  6. An electronic surgical order, undertaking patient education, and obtaining informed consent for regional analgesia before the day of surgery reduce block-related delays

    PubMed Central

    Brooks, Brandon S; Barman, Joydip; Ponce, Brent A; Sides, Alisa; Vetter, Thomas R

    2016-01-01

    Background Obtaining patient informed consent for a regional analgesia block on the day of surgery can result in surgical case delays. We hypothesized that implementing a preoperative electronic surgical order, undertaking patient education, and obtaining informed consent for a regional block in our preoperative assessment clinic prior to the day of surgery would reduce surgical case delays attributed to our regional anesthesia pain service and increase the percentage of patients for whom our regional anesthesia pain service was requested to provide a block. Methods A prospective two-group time-series design, with a nonrandomized, pre- and post-intervention data collection strategy, was applied. Based upon the surgeons’ newly implemented preoperative electronic outpatient orders, patients were identified by our preoperative assessment clinic staff to receive educational materials. The attending anesthesiologist in the preoperative assessment clinic then obtained written informed consent. Block-related delay and utilization data were analyzed with conventional inferential statistics. Results We observed a 14.8% (95% CI: 9.4%, 20.1%; P<0.001) decrease in surgical case delays, attributed to the regional nerve block, in the post- vs pre-intervention group. In addition, there was a 9.9% (95% CI: 4.7%, 15.1%); P<0.001) increase in the proportion of patients for whom a regional nerve block was ordered by our three high-volume orthopedic surgeons in the post- vs pre-intervention time periods. Conclusion When performed before the day of surgery, a surgeon’s electronic order, patient education, and informed consent for regional postoperative analgesia can improve patient throughput, thereby reducing block-related operating room delays. The preoperative assessment clinic can serve as a venue to achieve this goal, thereby adding value by decreasing downstream delays on the day of surgery. PMID:27785096

  7. Using Community-Based Participatory Research Principles to Develop More Understandable Recruitment and Informed Consent Documents in Genomic Research

    PubMed Central

    Skinner, Harlyn G.; Calancie, Larissa; Vu, Maihan B.; Garcia, Beverly; DeMarco, Molly; Patterson, Cam; Ammerman, Alice; Schisler, Jonathan C.

    2015-01-01

    Background Heart Healthy Lenoir is a transdisciplinary project aimed at creating long-term, sustainable approaches to reduce cardiovascular disease risk disparities in Lenoir County, North Carolina using a design spanning genomic analysis and clinical intervention. We hypothesized that residents of Lenoir County would be unfamiliar and mistrustful of genomic research, and therefore reluctant to participate; additionally, these feelings would be higher in African-Americans. Methodology To test our hypothesis, we conducted qualitative research using community-based participatory research principles to ensure our genomic research strategies addressed the needs, priorities, and concerns of the community. African-American (n = 19) and White (n = 16) adults in Lenoir County participated in four focus groups exploring perceptions about genomics and cardiovascular disease. Demographic surveys were administered and a semi-structured interview guide was used to facilitate discussions. The discussions were digitally recorded, transcribed verbatim, and analyzed in ATLAS.ti. Results and Significance From our analysis, key themes emerged: transparent communication, privacy, participation incentives and barriers, knowledge, and the impact of knowing. African-Americans were more concerned about privacy and community impact compared to Whites, however, African-Americans were still eager to participate in our genomic research project. The results from our formative study were used to improve the informed consent and recruitment processes by: 1) reducing misconceptions of genomic studies; and 2) helping to foster participant understanding and trust with the researchers. Our study demonstrates how community-based participatory research principles can be used to gain deeper insight into the community and increase participation in genomic research studies. Due in part to these efforts 80.3% of eligible African-American participants and 86.9% of eligible White participants enrolled in

  8. Donation after cardiocirculatory death: a call for a moratorium pending full public disclosure and fully informed consent

    PubMed Central

    2011-01-01

    Many believe that the ethical problems of donation after cardiocirculatory death (DCD) have been "worked out" and that it is unclear why DCD should be resisted. In this paper we will argue that DCD donors may not yet be dead, and therefore that organ donation during DCD may violate the dead donor rule. We first present a description of the process of DCD and the standard ethical rationale for the practice. We then present our concerns with DCD, including the following: irreversibility of absent circulation has not occurred and the many attempts to claim it has have all failed; conflicts of interest at all steps in the DCD process, including the decision to withdraw life support before DCD, are simply unavoidable; potentially harmful premortem interventions to preserve organ utility are not justifiable, even with the help of the principle of double effect; claims that DCD conforms with the intent of the law and current accepted medical standards are misleading and inaccurate; and consensus statements by respected medical groups do not change these arguments due to their low quality including being plagued by conflict of interest. Moreover, some arguments in favor of DCD, while likely true, are "straw-man arguments," such as the great benefit of organ donation. The truth is that honesty and trustworthiness require that we face these problems instead of avoiding them. We believe that DCD is not ethically allowable because it abandons the dead donor rule, has unavoidable conflicts of interests, and implements premortem interventions which can hasten death. These important points have not been, but need to be fully disclosed to the public and incorporated into fully informed consent. These are tall orders, and require open public debate. Until this debate occurs, we call for a moratorium on the practice of DCD. PMID:22206616

  9. Informed Consent (Clinical Trials)

    MedlinePlus

    ... Partners & Collaborators Spotlight on Scientists Research Areas Cancer Biology Cancer Genomics Causes of Cancer Diagnosis Prevention Screening & ... Collaborators Spotlight on Scientists NCI Research Areas Cancer Biology Cancer Genomics Causes of Cancer Diagnosis Prevention Screening & ...

  10. 77 FR 74044 - 60-Day Notice of Proposed Information Collection: Statement of Consent: Issuance of a U.S...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-12

    ... Under Age 16 ACTION: Notice of request for public comment. SUMMARY: The Department of State is seeking... under Age 16. OMB Control Number: 1405-0129. Type of Request: Revision of a Currently Approved..., ``Statement of Consent: Issuance of a U.S. Passport to a Minor under Age 16'', is used in conjunction with...

  11. 78 FR 36815 - 30-Day Notice of Proposed Information Collection: Statement of Consent: Issuance of a U.S...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... Under Age 16 ACTION: Notice of request for public comment and submission to OMB of proposed collection... of a U.S. Passport to a Minor under Age 16. OMB Control Number: 1405-0129. Type of Request: Revision... on the DS-3053, ``Statement of Consent: Issuance of a U.S. Passport to a Minor under Age 16'',...

  12. Consent procedures in pediatric biobanks

    PubMed Central

    Giesbertz, Noor AA; Bredenoord, Annelien L; van Delden, Johannes JM

    2015-01-01

    The inclusion of children's samples in biobanks brings forward specific ethical issues. Guidelines indicate that children should be involved in the consent procedure. It is, however, unclear how to allocate an appropriate role for children. Knowledge of current practice will be helpful in addressing this issue. Therefore, we conducted an international multiple-case study on the child's role in consent procedures in pediatric biobanks. Four biobanks were included: (1) LifeLines, (2) Prevention and Incidence of Asthma and Mite Allergy (PIAMA), (3) Young-HUNT3 and (4) the Oxford Radcliffe Biobank contribution to the Children's Cancer and Leukaemia Group tissue bank (ORB/CCLG). Four themes linked to the child's role in the consent procedure emerged from the multiple-case study: (1) motives to involve the child, (2) informing the child, (3) the role of dissent, assent and consent and (4) voluntariness of children to participate. We conclude that biobank characteristics influence the biobank's motives to include children in the consent procedure. Moreover, the motives to include children influence how the children are involved in the consent procedure, and the extent to which children are able to make voluntary decisions as part of the consent procedure. This insight is valuable when designing pediatric biobank governance. PMID:25537361

  13. 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.

  14. Diverse perceptions of the informed consent process: implications for the recruitment and participation of diverse communities in the National Children's Study.

    PubMed

    Lakes, Kimberley D; Vaughan, Elaine; Jones, Marissa; Burke, Wylie; Baker, Dean; Swanson, James M

    2012-03-01

    We examined the experiences, perceptions, and values that are brought to bear when individuals from different ethnic and cultural backgrounds consider participating in health research. Fifty-three women from Latino, Asian American, Middle Eastern, or Non-Latino, White backgrounds participated in seven English or Spanish focus groups facilitated by trained investigators using a standard protocol. Investigators described the National Children's Study (NCS) and then asked questions to elicit potential concerns, expectations, and informational needs. Group sessions were audio-recorded, transcribed verbatim, and analyzed using qualitative thematic methods. A major theme that emerged during focus groups was participant self-identification as a member of a cultural group or community when raising issues that would influence their decision to participate in research. A related theme was the belief by some that communities may differ in the ease of participation in the NCS. Identified themes related to the informed consent process included perceived risks, anticipated burden, perceived benefits, informational needs, and decision-making strategies. Although themes were shared across groups, there were cultural differences within themes. Findings indicated that individuals from diverse backgrounds may have different perspectives on and expectations for the research process. To effectively recruit representative samples, it will be important to address a range of issues relevant for informed consent and to consider the impact of participation on both individuals and communities.

  15. Diverse Perceptions of the Informed Consent Process: Implications for the Recruitment and Participation of Diverse Communities in the National Children’s Study

    PubMed Central

    Vaughan, Elaine; Jones, Marissa; Burke, Wylie; Baker, Dean; Swanson, James M.

    2013-01-01

    We examined the experiences, perceptions, and values that are brought to bear when individuals from different ethnic and cultural backgrounds consider participating in health research. Fifty-three women from Latino, Asian American, Middle Eastern, or Non-Latino, White backgrounds participated in seven English or Spanish focus groups facilitated by trained investigators using a standard protocol. Investigators described the National Children’s Study (NCS) and then asked questions to elicit potential concerns, expectations, and informational needs. Group sessions were audio-recorded, transcribed verbatim, and analyzed using qualitative thematic methods. A major theme that emerged during focus groups was participant self-identification as a member of a cultural group or community when raising issues that would influence their decision to participate in research. A related theme was the belief by some that communities may differ in the ease of participation in the NCS. Identified themes related to the informed consent process included perceived risks, anticipated burden, perceived benefits, informational needs, and decision-making strategies. Although themes were shared across groups, there were cultural differences within themes. Findings indicated that individuals from diverse backgrounds may have different perspectives on and expectations for the research process. To effectively recruit representative samples, it will be important to address a range of issues relevant for informed consent and to consider the impact of participation on both individuals and communities. PMID:21671109

  16. Actions Needed to Ensure Scientific and Technical Information is Adequately Reviewed at Goddard Space Flight Center, Johnson Space Center, Langley Research Center, and Marshall Space Flight Center

    NASA Technical Reports Server (NTRS)

    2008-01-01

    This audit was initiated in response to a hotline complaint regarding the review, approval, and release of scientific and technical information (STI) at Johnson Space Center. The complainant alleged that Johnson personnel conducting export control reviews of STI were not fully qualified to conduct those reviews and that the reviews often did not occur until after the STI had been publicly released. NASA guidance requires that STI, defined as the results of basic and applied scientific, technical, and related engineering research and development, undergo certain reviews prior to being released outside of NASA or to audiences that include foreign nationals. The process includes technical, national security, export control, copyright, and trade secret (e.g., proprietary data) reviews. The review process was designed to preclude the inappropriate dissemination of sensitive information while ensuring that NASA complies with a requirement of the National Aeronautics and Space Act of 1958 (the Space Act)1 to provide for the widest practicable and appropriate dissemination of information resulting from NASA research activities. We focused our audit on evaluating the STI review process: specifically, determining whether the roles and responsibilities for the review, approval, and release of STI were adequately defined and documented in NASA and Center-level guidance and whether that guidance was effectively implemented at Goddard Space Flight Center, Johnson Space Center, Langley Research Center, and Marshall Space Flight Center. Johnson was included in the review because it was the source of the initial complaint, and Goddard, Langley, and Marshall were included because those Centers consistently produce significant amounts of STI.

  17. The use of high definition video modules for delivery of informed consent and wound care education in the Mohs Surgery Unit.

    PubMed

    Migden, Michael; Chavez-Frazier, Arianne; Nguyen, Tri

    2008-03-01

    The use of video in the informed consent process has been well documented in the literature to improve patient satisfaction, understanding, comprehension, and to decrease anxiety. At the MD Anderson Mohs Surgery Unit, we use high-definition (HD) audiovisual (AV) modules to assist with the delivery of informed consent and to educate patients on the subject of postoperative wound care. The purpose of this work was to develop HD-AV media to inform patients of the risks, benefits, and alternatives of Mohs surgery before they are asked to sign the consent form and to educate patients on basic wound care after Mohs Surgery. The use of a HD virtual surgeon and nurse in the videos educates the patient, allowing the surgeon and nursing staff to attend to other patients within the Mohs Surgery Unit. Using HD digital recording equipment, we captured real-time HD-AV media to explain the risks, alternatives, and benefits of Mohs surgery (surgeon explanation) and to give detailed instructions for postoperative wound care (nurse explanation). Once captured, HD modules were created and stored on a central University of Texas-MD Anderson Cancer Center server in the Texas Medical Center approximately 1 mile from the Mohs Surgery Unit. The full-screen HD modules are accessed on demand at the point of need with the use of standard institutional computers within any of the Mohs's center's examination/surgical suites. An early evaluation of this quality improvement initiative was performed to measure patient satisfaction, efficiency, and efficacy of the videos followed by physician/nurse discussion compared with physician/nurse discussion alone. Early evaluation of HD-AV modules used for the delivery of informed consent and postoperative wound care in the MD Anderson Mohs surgery Unit revealed that patient satisfaction was maintained and that this medium was preferred by patients in the video group over physician/nurse discussion alone. The HD modules allowed increased efficiency and

  18. Consent in escrow

    PubMed Central

    Van der Loos, Kiah I.; Longstaff, Holly; Virani, Alice; Illes, Judy

    2014-01-01

    Disasters such as flash flooding, mass shootings, and train and airplane accidents involving large numbers of victims produce significant opportunity for research in the biosciences. This opportunity exists in the extreme tails of life events, however, during which decisions about life and death, valuing and foregoing, speed and patience, trust and distrust, are tested simultaneously and abundantly. The press and urgency of these scenarios may also challenge the ability of researchers to comprehensively deliver information about the purposes of a study, risks, benefits, and alternatives. Under these circumstances, we argue that acquiring consent for the immediate use of data that are not time sensitive represents a gap in the protection of human study participants. In response, we offer a two-tiered model of consent that allows for data collected in real-time to be held in escrow until the acute post-disaster window has closed. Such a model not only respects the fundamental tenet of consent in research, but also enables such research to take place in an ethically defensible manner. PMID:27774181

  19. Use of Mobile Devices and the Internet for Multimedia Informed Consent Delivery and Data Entry in a Pediatric Asthma Trial: Study Design and Rationale

    PubMed Central

    Blake, Kathryn; Holbrook, Janet T.; Antal, Holly; Shade, David; Bunnell, H. Timothy; McCahan, Suzanne M.; Wise, Robert A.; Pennington, Chris; Garfinkel, Paul; Wysocki, Tim

    2015-01-01

    Introduction Phase III / IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be noninferior and will be less expensive compared to a traditional pediatric asthma trial. Materials/Methods Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs. Results Participants have been enrolled in the streamlined and traditional trials and recuitment is ongoing. Conclusions This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases. PMID:25847579

  20. Comparison of Closed-Ended, Open-Ended, and Perceived Informed Consent Comprehension Measures for a Mock HIV Prevention Trial among Women in Tanzania

    PubMed Central

    MacQueen, Kathleen M.; Chen, Mario; Ramirez, Catalina; Nnko, Soori E. A.; Earp, Kelly M.

    2014-01-01

    Verifying participant comprehension continues to be a difficult ethical and regulatory challenge for clinical research. An increasing number of articles assessing methods to improve comprehension have been published, but they use a wide range of outcome measures including open-ended, closed-ended, and self-perceived measures of comprehension. Systematic comparisons of different measures have rarely been reported. This study evaluated the likely direction of bias observed when using open-ended, closed-ended, and perceived ease of comprehension measures among women administered a mock informed consent process in Mwanza, Tanzania. Participants were randomized to either a closed-ended or an open-ended assessment of comprehension, administered the consent process for a hypothetical HIV prevention trial in Kiswahili, and then administered a comprehension assessment, per their randomization. They were then asked how easy or hard it was to understand each of the informed consent components measured in the comprehension assessment. Women in the closed-ended arm had significantly higher overall comprehension scores than in the open-ended arm. Perceived scores were significantly higher when compared to both open-ended and close-ended scores within arms but were similar between arms. Findings highlight the importance of comprehension assessments in complex clinical trials that go beyond asking participants if they understand or have any questions. They also indicate the need for continued exploration of objective measures of comprehension in international clinical research settings, so that points in need of clarification can be efficiently and effectively identified and addressed. Such measures would reduce burdens on both staff and participants that result from well-intentioned but potentially unnecessary time spent explaining in unwarranted detail things already understood. PMID:25157899