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Sample records for industry informed consent

  1. [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.

  2. Informed Consent

    PubMed Central

    Manion, F.; Hsieh, K.; Harris, M.

    2015-01-01

    Summary Background Despite efforts to provide standard definitions of terms such as “medical record”, “computer-based patient record”, “electronic medical record” and “electronic health record”, the terms are still used interchangeably. Initiatives like data and information governance, research biorepositories, and learning health systems require availability and reuse of data, as well as common understandings of the scope for specific purposes. Lacking widely shared definitions, utilization of the afore-mentioned terms in research informed consent documents calls to question whether all participants in the research process — patients, information technology and regulatory staff, and the investigative team — fully understand what data and information they are asking to obtain and agreeing to share. Objectives This descriptive study explored the terminology used in research informed consent documents when describing patient data and information, asking the question “Does the use of the term “medical record” in the context of a research informed consent document accurately represent the scope of the data involved?” Methods Informed consent document templates found on 17 Institutional Review Board (IRB) websites with Clinical and Translational Science Awards (CTSA) were searched for terms that appeared to be describing the data resources to be accessed. The National Library of Medicine’s (NLM) Terminology Services was searched for definitions provided by key standards groups that deposit terminologies with the NLM. Discussion The results suggest research consent documents are using outdated terms to describe patient information, health care terminology systems need to consider the context of research for use cases, and that there is significant work to be done to assure the HIPAA Omnibus Rule is applied to contemporary activities such as biorepositories and learning health systems. Conclusions “Medical record”, a term used extensively

  3. 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.

  4. 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. PMID:16939165

  5. 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 ...

  6. [Informed consent].

    PubMed

    Rodríguez, C R; González Parra, E; Martínez Castelao, A

    2008-01-01

    - Basic law 41/2002 on patient autonomy regulates the rights and obligations of patients, users and professionals, as well as those of public and private health care centers and services. This regulation refers to patient autonomy, the right to information and essential clinical documentation. - This law establishes the minimum requirements for the information the patient should receive and the decision making in which the patient should take part. Diagnostic tests are performed and therapeutic decisions are taken in the ACKD unit in which patient information is an essential and mandatory requirement according to this law. PMID:19018748

  7. Guideline 2: Informed Consent.

    ERIC Educational Resources Information Center

    American Journal on Mental Retardation, 2000

    2000-01-01

    The second in seven sets of guidelines based on the consensus of experts in the treatment of psychiatric and behavioral problems in mental retardation (MR) focuses on informed consent. Guidelines cover underlying concepts, usual components, informed consent as a process, information to include, what to provide, when to obtain informed consent, and…

  8. Informed consent and routinisation.

    PubMed

    Ploug, Thomas; Holm, Soren

    2013-04-01

    This article introduces the notion of 'routinisation' into discussions of informed consent. It is argued that the routinisation of informed consent poses a threat to the protection of the personal autonomy of a patient through the negotiation of informed consent. On the basis of a large survey, we provide evidence of the routinisation of informed consent in various types of interaction on the internet; among these, the routinisation of consent to the exchange of health related information. We also provide evidence that the extent of the routinisation of informed consent is dependent on the character of the information exchanged, and we uncover a range of causes of routinisation. Finally, the article discusses possible ways of countering the problem of routinisation of informed consent.

  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. The research process: informed consent.

    PubMed

    Summers, S

    1993-12-01

    Informed consent is a vital part of the research proposal and study. Informed consent is based on principles of autonomy ie, individuals have a right to full disclosure of information in order to make an informed decision and to assume responsibility for the consequences of their decision. Informed consent also contains a legal element whereby failure to obtain it is considered negligence and/or battery. Conducting studies when patients are medicated, ill, or very young or very old require special steps to verify that subjects are fully informed. It is important that PACU nurses pay particular attention to the informed consent process when planning and conducting research studies.

  11. [Informed consent: a pragmatic view].

    PubMed

    Lomnici, Zoltán

    2006-04-01

    The overall goal of this study is a short introduction into the Hungarian legal basis, and practical circumstances of informed consent trough the cases of the Data Protection Commissioner of Hungary, the Supreme Court of Hungary, and the Constitutional Court. The author begins by describing the basic law with an introduction to the dogmatic background of informed consent, as a common law category. [corrected].

  12. 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.

  13. Informed consent in pediatric research.

    PubMed

    Leibson, Tom; Koren, Gideon

    2015-02-01

    Pediatric drug research is gradually becoming more and more accepted as the norm for assessing whether a drug is safe and efficacious for infants and children. The process of informed consent and assent for these trials presents a major challenge. The aim of this review is to map historical, ethical and legal aspects relevant to the challenges of informed consent in the setting of pediatric drug research. The impact of age, level of maturity and life circumstances on the process of obtaining informed consent as well as the relations between consent and assent are discussed. There appears to be a lack of regulatory clarity in the area of pediatric clinical trials; while numerous statements have been made regarding children's rights to autonomy and their ability to care for themselves and for younger ones, the ever changing status of adolescence is still difficult to translate to informed consent. This may delay scientific and clinical advancement for children who are at the very junction of being independent and not needing parental permission. Obtaining consent and assent for pediatric clinical trials is a delicate matter, as both parent and child need to agree to participate. The appropriate transfer of information to guardians and the children, especially concerning potential risks and benefits, is at the heart of informed consent, as it serves to protect both patient and physician. As many adults lack health literacy, one must ensure that guardians receive relevant information at a level and in forms they can understand regarding the trials their children are asked to participate in.

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

    PubMed Central

    2011-01-01

    Background Medical tourism, thought of as patients seeking non-emergency medical care outside of their home countries, is a growing industry worldwide. Canadians are amongst those engaging in medical tourism, and many are helped in the process of accessing care abroad by medical tourism brokers - agents who specialize in making international medical care arrangements for patients. As a key source of information for these patients, brokers are likely to play an important role in communicating the risks and benefits of undergoing surgery or other procedures abroad to their clientele. This raises important ethical concerns regarding processes such as informed consent and the liability of brokers in the event that complications arise from procedures. The purpose of this article is to examine the language, information, and online marketing of Canadian medical tourism brokers' websites in light of such ethical concerns. Methods An exhaustive online search using multiple search engines and keywords was performed to compile a comprehensive directory of English-language Canadian medical tourism brokerage websites. These websites were examined using thematic content analysis, which included identifying informational themes, generating frequency counts of these themes, and comparing trends in these counts to the established literature. Results Seventeen websites were identified for inclusion in this study. It was found that Canadian medical tourism broker websites varied widely in scope, content, professionalism and depth of information. Three themes emerged from the thematic content analysis: training and accreditation, risk communication, and business dimensions. Third party accreditation bodies of debatable regulatory value were regularly mentioned on the reviewed websites, and discussion of surgical risk was absent on 47% of the websites reviewed, with limited discussion of risk on the remaining ones. Terminology describing brokers' roles was somewhat inconsistent across

  15. Placebo Effects and Informed Consent.

    PubMed

    Alfano, Mark

    2015-01-01

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

  16. Informed consent for obesity surgery.

    PubMed

    Mason, E E; Hesson, W W

    1998-08-01

    A patient cannot consent to an operation without being adequately informed. There are a number of different operations in use today for treatment of severe obesity. The variations are designed to (1) limit food intake and/or (2) create malabsorption. The surgeon has a duty, according to the law of informed consent, to provide all of the information necessary for a reasonable person to decide whether to consent to the operation recommended. Changes in anatomy, function and risk therefore need to be explained. When only limitation of intake is planned, as in vertical banded gastroplasty (VBG), the patient should know how large the pouch will be and how the outlet will be stabilized. When both intake restriction and malabsorption are planned, as in Roux-en-Y gastric bypass (RGB), or biliopancreatic diversion (BPD), the patient should know whether there will be a larger pouch (less restriction) and a short common channel (more malabsorption) as in BPD or a smaller pouch and less malabsorption. Patients should know that if they have an operation that uses maximum malabsorption to bring weight to a nearly normal level, the risk of malnutrition will be increased, which may require further hospitalization and possible operative treatment. When the duodenum is to be bypassed, the patient should know that this will impair iron and calcium absorption, and that access to this area for radiologic and endoscopic procedures may not be possible. Simple drawings can be used to explain what is planned and how the operation will determine body weight, side-effects, and risk.

  17. [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

  18. [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

  19. 21 CFR 50.25 - Elements of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Elements of informed consent. 50.25 Section 50.25... OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided...

  20. 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... OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. Using informed consent to save trust.

    PubMed

    Eyal, Nir

    2014-07-01

    Increasingly, bioethicists defend informed consent as a safeguard for trust in caretakers and medical institutions.This paper discusses an ‘ideal type’ of that move. What I call the trust-promotion argument for informed consent states:1. Social trust, especially trust in caretakers and medical institutions, is necessary so that, for example,people seek medical advice, comply with it, and participate in medical research.2. Therefore, it is usually wrong to jeopardise that trust.3. Coercion, deception, manipulation and other violations of standard informed consent requirements seriously jeopardise that trust.4. Thus, standard informed consent requirements are justified.This article describes the initial promise of this argument, then identifies challenges to it. As I show, the value of trust fails to account for some common sense intuitions about informed consent. We should revise the argument, common sense morality, or both.

  13. Collective informed consent and decision power.

    PubMed

    Varelius, Jukka

    2009-03-01

    It has been suggested that, in addition to individual level decision-making, informed consent procedures could be used in collective decision-making too. One of the main criticisms directed at this suggestion concerns decision-making power. It is maintained that consent is a veto power concept and that, as such, it is not appropriate for collective decision-making. This paper examines this objection to collective informed consent. It argues that veto power informed consent can have some uses in the collective level and that when it is not appropriate the decision power a concerned party ought to have in connection with an arrangement should be made relative to the interest she has at stake in it. It concludes that the objection examined does not undermine collective informed consent.

  14. 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.

  15. 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.

  16. 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... Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent... following: (1) A written consent document that embodies the elements of informed consent required by §...

  17. 7 CFR 1c.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Documentation of informed consent. 1c.117 Section 1c... Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent... following: (1) A written consent document that embodies the elements of informed consent required by §...

  18. 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.

  19. [Informed consent with special emphasis on Croatia].

    PubMed

    Vucemilo, Luka; Babić-Bosanac, Sanja; Altarac, Silvio; Borovecki, Ana

    2014-01-01

    Respecting the informed consent and its implementation is one of the fundamental components of high-quality health care. This article discusses the informed consent with an overview of Croatian and international legal documents and scientific studies dealing with this issue. Based on the review of the literature it can be concluded that this is an important issue that contains several key components that should be observed and investigated. It is necessary to evaluate the purposefulness and quality of the implementation of the informed consent, to systematically examine respect of the patients' right to information regarding the medical procedure during treatment, to explore decision-making model in the physician-patient encounter in Croatian hospitals, to determine the content and amount of information shared between physicians and patients, to determine the content and readability of consent forms and written patient information on the medical procedure. In order to assure higher quality of the implementation of the informed consent it is necessary to define by law a list of medical procedures that require written consent and to uniform consent forms for the same medical procedures country-wide.

  20. [Informed consent with special emphasis on Croatia].

    PubMed

    Vucemilo, Luka; Babić-Bosanac, Sanja; Altarac, Silvio; Borovecki, Ana

    2014-01-01

    Respecting the informed consent and its implementation is one of the fundamental components of high-quality health care. This article discusses the informed consent with an overview of Croatian and international legal documents and scientific studies dealing with this issue. Based on the review of the literature it can be concluded that this is an important issue that contains several key components that should be observed and investigated. It is necessary to evaluate the purposefulness and quality of the implementation of the informed consent, to systematically examine respect of the patients' right to information regarding the medical procedure during treatment, to explore decision-making model in the physician-patient encounter in Croatian hospitals, to determine the content and amount of information shared between physicians and patients, to determine the content and readability of consent forms and written patient information on the medical procedure. In order to assure higher quality of the implementation of the informed consent it is necessary to define by law a list of medical procedures that require written consent and to uniform consent forms for the same medical procedures country-wide. PMID:24988746

  1. [Informed consent: going through the motions?].

    PubMed

    Shiber, Shachaf; Glezerman, Marek

    2014-02-01

    We review the concept of informed consent in clinical medicine and in research. Informed consent is a complex practice designed to protect the legal rights of the patient, to maintain ethics in support of the patient's autonomy to arrive at his own decisions related to medical interventions, to ensure appropriate quality of care, and to build trust between the physician and the patient regarding medical procedures, medication or clinical research. It must be borne in mind that the patient's signature on a document of informed consent does not automatically imply comprehension. Physicians need to provide the information about the patient's condition, and in the case of research, they need to provide an exhaustive explanation related to benefits and the risks of the research project for the patient and to society. Physicians need to be available to readily answer patients' questions. Signing an informed consent form should not become a mere bureaucratic procedure of "going through the motions". Without emphasis on delivering understandable and relevant information, tailored to the recipient and clarifying that explanations have been properly understood, informed consent becomes but a bureaucratic burden. There is an urgent need to complete the process of conveying information by a structured mechanism aimed to ensure adequate comprehension. Only then will the process of obtaining informed consent become meaningful.

  2. The changing face of informed consent.

    PubMed

    Main, B G; Adair, S R L

    2015-10-01

    All healthcare professionals are required to gain a patient's consent before proceeding with examination, investigation or treatment. Gone are the days when consent was about protecting the professional. Following a recent landmark Supreme Court case, 'informed' consent is now embedded in UK law. Patients have the right to high-quality information that allows them to be involved in making decisions about their care. Dentists have a duty of care to provide this information and guide their patients through the process. This paper reviews key ethical, legal, and professional guidance available to dentists about informed consent and concludes by discussing how shared decision-making is a model of healthcare delivery with much to offer dentist and patient alike. PMID:26450244

  3. 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.

  4. Informed consent & ethical issues in paediatric psychopharmacology.

    PubMed

    Malhotra, Savita; Subodh, B N

    2009-01-01

    Issues relating to informed consent and ethics in paediatric psychopharmacology limit research in this population. Children vary in their levels of cognitive development, and presence of psychiatric disorder may further impair their ability to give informed consent. In decisional impairment subjects, various methods used for consent are assent/dissent; inclusion of advance directives; and/or alternative decision-makers. India is emerging as a new market for clinical trials in recent years. Moreover, in India the sociocultural realities are different from those in the western countries making it necessary for professionals to be cautious in conducting drug trials. In this review, issues regarding informed consent in children and adolescent with psychiatric diagnosis are discussed for information, discussion and debate by professionals, parents, society and legal experts to create awareness and to facilitate development of guidelines that are appropriate and applicable to the Indian system.

  5. Participant observation, informed consent and ethical approval.

    PubMed

    Moore, Lucy; Savage, Jan

    2002-01-01

    Participant observation raises particular ethical issues in the health care context, especially in terms of ensuring informed consent. Lucy Moore and Jan Savage outline the specific dilemmas raised by participant observation in one practice setting and the difficulties experienced in complying with a predetermined process designed for gaining fully informed consent. Their experience suggests that, instead of fully formulating this process in advance of fieldwork, researchers need to be able to respond to the circumstances they find in the field.

  6. Informed consent: an international researchers' perspective.

    PubMed

    Rivera, Roberto; Borasky, David; Rice, Robert; Carayon, Florence; Wong, Emelita

    2007-01-01

    We reported 164 researchers' recommendations for information that should be included in the informed consent process. These recommendations were obtained during training workshops conducted in Africa, Europe, and the United States. The 8 elements of informed consent of the US Code of Federal Regulations were used to identify 95 items of information ("points"), most related to benefits and research description. Limited consensus was found among the 3 workshops: of the 95 points, only 27 (28%) were identified as useful by all groups. These points serve as a springboard for identifying information applicable in different geographic areas and indicate the need for involving a variety of individuals and stakeholders, with different research and cultural perspectives, in the development of informed consent, particularly for research undertaken in international settings.

  7. 21 CFR 50.27 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Documentation of informed consent. 50.27 Section... PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.27 Documentation of informed consent. (a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written...

  8. 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

  9. Informed Consent and Cluster-Randomized Trials

    PubMed Central

    Dawson, Angus

    2012-01-01

    We argue that cluster-randomized trials are an important methodology, essential to the evaluation of many public health interventions. However, in the case of at least some cluster-randomized trials, it is not possible, or is incompatible with the aims of the study, to obtain individual informed consent. This should not necessarily be seen as an impediment to ethical approval, providing that sufficient justification is given for this omission. We further argue that it should be the institutional review board’s task to evaluate whether the protocol is sufficiently justified to proceed without consent and that this is preferable to any reliance on community consent or other means of proxy consent. PMID:22390511

  10. Informed Consent in Social Work Ethics Education: Guiding Student Education with an Informed Consent Template

    ERIC Educational Resources Information Center

    Burkemper, Ellen M.

    2004-01-01

    This article proposes the use of an informed consent template for educating social work students. The elements of informed consent, derived primarily from the National Association of Social Workers' "Code of Ethics", are operationalized in the template. The suggestion is that instructors will use the template for classroom instruction and require…

  11. Autonomy and informed consent: a mistaken association?

    PubMed

    Kristinsson, Sigurdur

    2007-09-01

    For decades, the greater part of efforts to improve regulatory frameworks for research ethics has focused on informed consent procedures; their design, codification and regulation. Why is informed consent thought to be so important? Since the publication of the Belmont Report in 1979, the standard response has been that obtaining informed consent is a way of treating individuals as autonomous agents. Despite its political success, the philosophical validity of this Belmont view cannot be taken for granted. If the Belmont view is to be based on a conception of autonomy that generates moral justification, it will either have to be reinterpreted along Kantian lines or coupled with a something like Mill's conception of individuality. The Kantian interpretation would be a radical reinterpretation of the Belmont view, while the Millian justification is incompatible with the liberal requirement that justification for public policy should be neutral between controversial conceptions of the good. This consequence might be avoided by replacing Mill's conception of individuality with a procedural conception of autonomy, but I argue that the resulting view would in fact fail to support a non-Kantian, autonomy-based justification of informed consent. These difficulties suggest that insofar as informed consent is justified by respect for persons and considerations of autonomy, as the Belmont report maintained, the justification should be along the lines of Kantian autonomy and not individual autonomy. PMID:17333491

  12. Dimensions of informed consent to treatment.

    PubMed

    Dickens, B M; Cook, R J

    2004-06-01

    Modern law approaches patients' consent to treatment not only through liability for unauthorized touching, namely criminal assault and/or civil (non-criminal) battery, but also through liability for negligence. Physicians must exercise appropriate skill in conducting procedures, and in providing patients with information material to the choices that patients have to make. The doctrine of informed consent serves the ethical goal of respecting patients' rights of self-determination. Information is initially pitched at the reasonable, prudent person in the patient's circumstances, and then fine-tuned to what is actually known about the particular patient's needs for information. Elements to be disclosed include the patient's prognosis if untreated, alternative treatment goals and options, the success rate of each option, and its known effects and material risks. Risks include medical risks, but also risks to general well-being such as economic and similar reasonable interests. Consent is a continuing process, not an event or signed form.

  13. 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....117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  14. 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... SUBJECTS § 1028.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB...

  15. 38 CFR 16.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... PROTECTION OF HUMAN SUBJECTS § 16.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form... elements of informed consent required by § 16.116. This form may be read to the subject or the...

  16. 22 CFR 225.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Documentation of informed consent. 225.117....117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  17. 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...) § 97.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed...

  18. 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... PROTECTION OF HUMAN SUBJECTS § 690.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent...

  19. Simplifying informed consent for biorepositories: Stakeholder perspectives

    PubMed Central

    Beskow, Laura M.; Friedman, Joelle Y.; Hardy, Natalie C.; Lin, Li; Weinfurt, Kevin P.

    2011-01-01

    Purpose Complex and sometimes controversial information must be conveyed during the consent process for participation in biorepositories, and studies suggest that consent documents in general are growing in length and complexity. As a first step toward creating a simplified biorepository consent form, we gathered data from multiple stakeholders about what information was most important for prospective participants to know when making a decision about taking part in a biorepository. Methods We recruited 52 research participants, 12 researchers, and 20 institutional review board representatives from Durham and Kannapolis, NC. These subjects were asked to read a model biorepository consent form and highlight sentences they deemed most important. Results On average, IRB representatives identified 72.3% of the sentences as important; researchers selected 53.0%, and participants 40.4% (P = 0.0004). Participants most often selected sentences about the kinds of individual research results that might be offered, privacy risks, and large-scale data sharing. Researchers highlighted sentences about the biorepository's purpose, privacy protections, costs, and participant access to individual results. IRB representatives highlighted sentences about collection of basic personal information, medical record access, and duration of storage. Conclusion The differing mandates of these three groups can translate into widely divergent opinions about what information is important and appropriate to include a consent form. These differences could frustrate efforts to move simplified forms—for biobanking as well as for other kinds of research—into actual use, despite continued calls for such forms. PMID:20697289

  20. Informed Consent for Web Paradata Use

    PubMed Central

    Couper, Mick P.; Singer, Eleanor

    2013-01-01

    Survey researchers are making increasing use of paradata – such as keystrokes, clicks, and timestamps – to evaluate and improve survey instruments but also to understand respondents and how they answer surveys. Since the introduction of paradata, researchers have been asking whether and how respondents should be informed about the capture and use of their paradata while completing a survey. In a series of three vignette-based experiments, we examine alternative ways of informing respondents about capture of paradata and seeking consent for their use. In all three experiments, any mention of paradata lowers stated willingness to participate in the hypothetical surveys. Even the condition where respondents were asked to consent to the use of paradata at the end of an actual survey resulted in a significant proportion declining. Our research shows that requiring such explicit consent may reduce survey participation without adequately informing survey respondents about what paradata are and why they are being used. PMID:24098312

  1. [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. PMID:26039500

  2. Understood consent versus informed consent: a new paradigm for obtaining consent for pediatric research studies.

    PubMed

    Isles, Alan F

    2013-01-01

    All too often the informed consent process is viewed by members of research teams as a challenge of getting a parent or young person's signature on a form. Informed consent is, however, much more than a signed form. Rather, it is a process, often iterative, in which the parent or young person is given sufficient information about a study in order that they can make a truly informed decision about participation. Substantial effort is required in producing appropriately formatted and readable documents using plain language at about Grade 6 or 12-year old reading level. Achieving truly understood consent involves the researcher spending significant one-on-one time with the parent or young person explaining in simple language what is proposed and then using so-called repeat-back techniques to test the understanding of the participants. This is critically important if the research involves randomization to different treatments or use of a placebo arm and, in particular if the research involves more than minimal risk. PMID:24400284

  3. Informed consent in Malaysia: an overview.

    PubMed

    Che Ngah, Anisah

    2005-01-01

    The right of a person to control his body is a concept that has long been recognized in Malaysia under the law of torts. The purpose of requiring informed consent is to preserve that right in medical decision-making. Informed Consent is a relatively new concept in medical litigation cases. However in the late 1990's, it has become one of the important claims under negligence made against the doctor for failure to disclose relevant information to patients in respect of the treatment proposed. Whether Malaysia has begun to recognize patient's right to decision-making is yet to be seen. Furthermore the social-cultural relationship between doctors and patients had to be considered. In this respect, the researcher had conducted interviews with doctors and patients to gauge their reaction towards a shared process of decision-making, which is the central issue in the doctrine of informed consent. Findings suggest that in society where primary health care is the main thrust to achieve health for all, the possibility of recognition of the rights of patients to receive information before making decisions about treatment appears remote. The findings also underscore the importance of incorporating aspects of informed consent as part of providing quality service to patients. PMID:16637139

  4. Some observations on informed consent in non-therapeutic research.

    PubMed Central

    Garnham, J C

    1975-01-01

    The quality of the consent obtained from 41 volunteer subjects in eight experiments is evaluated. Five subjects (all physicians) gave informed consent; 22 subjects gave partially informed consent; and 14 subjects merely gave consent. It is argued that 'informed' consent is obtainable only from medically trained people, and that lip service to this concept in laymen should cease. The concept of medical competence should instead be introduced and a personal medical referee appointed to adjudicate on behalf of the volunteer. PMID:765462

  5. [Informed consent in health legislation of Mexico].

    PubMed

    López-de la Peña, X A

    1996-01-01

    This paper deals with informed consent in Mexican Health Legislation in the context of a contract regulated by the Mexican Civil Code, in which a patient capable of making a thoughtful decision agrees to a specific plan of medical management and has received sufficient information, in a clear and explicit manner so that he/she can make a decision and in consequence agrees, or does not agree, to a course of action and to its consequences, under the Nuremberg Code. In Mexico, informed consent has recently been incorporated into health care legislation, and is basically oriented toward the field of medical research, while in other medical procedures, a legal authorization, and not an informed consent form is required, as with surgical procedures such as definitive fertility control (e.g. vasectomy or fallopian tube ligation). We emphasize the necessity of the adding of informed consent to Mexican health legislation in general, substituting it for other terms to legalize medical action, such as authorization, permission, dispositioned compliance, acceptance or approval-all of which have an essentially different and limited connotation, and are not Patient's Rights legal protector mechanisms, from our point of view. PMID:9011521

  6. 42 CFR 441.257 - Informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Informed consent. 441.257 Section 441.257 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... without loss or withdrawal of any federally funded program benefits to which the individual might...

  7. 28 CFR 512.16 - Informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., determines the research project or data-collection instrument is of a sensitive nature. (d) A researcher who... Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE GENERAL MANAGEMENT AND ADMINISTRATION RESEARCH Research § 512.16 Informed consent. (a) Before commencing a research project...

  8. 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…

  9. 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. PMID:27587444

  10. 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.

  11. 45 CFR 690.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 690.117 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION... (c) of this section, informed consent shall be documented by the use of a written consent form..., the consent form may be either of the following: (1) A written consent document that embodies...

  12. 45 CFR 690.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 690.117 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION... (c) of this section, informed consent shall be documented by the use of a written consent form..., the consent form may be either of the following: (1) A written consent document that embodies...

  13. Informed consent: can we educate patients?

    PubMed

    Askew, G; Pearson, K W; Cryer, D

    1990-10-01

    Previous reports have shown consent to be 'short' of informed in many cases. One hundred patients, including a control group, were interviewed between 2 and 7 days after their operations. Those given an information sheet before the operation had a better recall of their operations than the controls, the overall awareness being 97 and 69% respectively. This may have medico-legal implications but further studies are required.

  14. 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. PMID:26399672

  15. 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.

  16. 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

  17. 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... (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of...

  18. 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) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of...

  19. 38 CFR 16.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... informed consent. 16.116 Section 16.116 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.116 General requirements for informed consent. Except as... covered by this policy unless the investigator has obtained the legally effective informed consent of...

  20. 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.

  1. Informed consent: patient's right or patient's duty?

    PubMed

    Hull, R T

    1985-05-01

    The rule that a patient should give a free, fully-informed consent to any therapeutic intervention is traditionally thought to express merely a right of the patient against the physician, and a duty of the physician towards the patient. On this view, the patient may waive that right with impunity, a fact sometimes expressed in the notion of a right not to know. This paper argues that the rule also expresses a duty of the patient towards the physician and a right of the physician against the patient. The argument turns, first, on the truism that a physician has no obligation to commit a battery, or unauthorized touching, and, second, on the thesis that a patient necessarily cannot consent to something that is unknown to him. The conclusion is drawn that a patient is not free to receive treatment voluntarily without knowledgeably authorizing it.

  2. 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. PMID:27587443

  3. Communication and informed consent in elderly people.

    PubMed

    Giampieri, M

    2012-02-01

    Physician-patient relationship is the key-point for an optimal management of any medical procedure. Before performing any diagnostic or therapeutic procedure, clinical communication with patients is necessary. It should regard the nature and purpose of a proposed procedure including potential risks and benefits. During physician-patient communication, alternatives, as well as the risks and benefits of not receiving or undergoing a procedure should also be disclosed. Thus, a complete physician-patient clinical communication is the basis of "shared decision-making" and plays a clinical-therapeutic role in the informed consent process in order to improve patient care. Informed consent is a delicate process of communication between a patient and physician necessary for patient authorization for any medical intervention. The success of achieving good informed consent procedure depends on the strength of the relationship between the doctor and the patient. For this reason, the traditional paternalistic relationship, in which decisions were made by the doctor, is no longer appropriate. Therefore, the use of a model which allows for a greater patient involvement in the decision making process is fundamental. This approach allows for a clearer impact on patient values. The aspects of the procedure related to these values, combined with the technical and scientific considerations of the doctor, are the basis of a shared decision making process, in which the patient is actively involved. Therefore, an informed consent is not simply the acquisition of the patient's signature, but a real process based on the dialogue between doctor and patient. This dialogue is particularly delicate in some circumstances, such as geriatric medicine and anesthesiology. Seeking consent is part of a respectful relationship with an older person. Adults are almost always considered capable of making personal healthcare decisions. Older adults should also be considered capable of handling their own

  4. Informed-Consent Issues with Adolescent Health Behavior Research

    ERIC Educational Resources Information Center

    Olds, R. Scott

    2003-01-01

    Objective: To identify the informed-consent issues when conducting adolescent health behavior research. Methods: A literature review was conducted across diverse academic fields about the informed-consent issues that were relevant to adolescent health behavior research. Results: Issues included defining consent, assent and permission, minimal…

  5. Ethical issues in informed consent with substance abusers.

    PubMed

    McCrady, B S; Bux, D A

    1999-04-01

    Alcohol and drug abusers present issues that complicate the informed consent process. The present study examined the practices of federally funded clinical investigators in obtaining informed consent from alcohol and drug abusers. Ninety-one (51%) researchers completed a 27-item survey on informed consent issues. The majority of investigators (57%) recruited participants susceptible to coercion; most used procedures to minimize coercion. Two thirds of researchers used objective means to determine competence to give consent and comprehension of consent forms. Virtually all investigators had policies to deal with suicidality, homicidality, or reports of child abuse; less than 1/2 informed participants of these limits to confidentiality. Almost 50% of investigators had dealt with intoxicated or suicidal participants; 12% had encountered homicidal participants; and 23% had encountered child abuse or neglect. Half of the sample used collateral data sources; about 1/2 of these obtained written informed consent from collaterals. Guidelines for informed consent with substance abusers are suggested. PMID:10224728

  6. Informed consent: Enforcing pharmaceutical companies' obligations abroad.

    PubMed

    Lee, Stacey B

    2010-01-01

    The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, multinational pharmaceutical companies, the United States government and courts, and the media, have played a significant role in defining these obligations. This article examines how such obligations have developed through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust obligations appear, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement by an international tribunal or through one universally adopted code of ethics. This article argues that, rather than continuing to pursue an untenable international approach, the Alien Torts Statute (ATS) offers a viable enforcement mechanism, at least for US-based pharmaceutical companies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceutical companies and research and academic institutions) for informed consent misconduct. Substantive human rights protections are vital in order to ensure that every person can realize the "right to health." This article concludes that by building on the federal appellate court's ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in US courts, a mechanism can be created for enforcing not only substantive informed consent, but also human rights protections.

  7. Informed consent, confidentiality, and subject rights in clinical trials.

    PubMed

    Smith-Tyler, June

    2007-05-01

    The informed consent process is designed to inform the subject of the risks, rights, and benefits of participation in a clinical research trial. Informed consent, while not always necessary, is a critical component of ethical research involving human subjects. This article includes an overview of two sets of regulations regarding informed consent found in the Code of Federal Regulations (CFR) Titles 21 and 45: 21 CFR 50 and 56, the Food and Drug Administration Regulations, and 45 CFR 46, where applicable, the Department of Health and Human Services Regulations. Also included in this discussion are the general requirements of informed consent; challenging issues regarding informed consent; determining and obtaining informed consent in research involving vulnerable subjects (e.g., children, critically ill patients); the use of genetic information; confidentiality and privacy of subject information; and compensation for injury during a research study. Examples of acceptable and unacceptable (exculpatory) informed consent language are also provided as they may pertain to commercial gain, confidentiality, and compensation for injury. The goal of this article is to provide the clinical researcher with an explanation of the legal requirements for informed consent in clinical research. The researcher faces many challenges in implementing effective informed consent beyond the federal regulations.

  8. Informed Consent-Uninformed Participants: Shortcomings of Online Social Science Consent Forms and Recommendations for Improvement.

    PubMed

    Perrault, Evan K; Nazione, Samantha A

    2016-07-01

    As informed consent forms continue to lengthen, are these lengthening forms helping to create better informed participants? The aim of this research was to determine whether the length of consent forms affected reading frequency and comprehension, and to provide recommendations on how to improve consent forms in the social sciences so they are more likely to be read. A quasi-experiment was conducted using actual consent forms at two liberal arts schools, one requiring a long form (463 words, n = 73) and one requiring a shorter form (236 words, n = 57). Participants exposed to the shorter form reported fully reading, or at least skimming the form more frequently than those exposed to the longer form. Those exposed to the shorter form also comprehended more of the form's information. The majority of participants indicated consent forms need to be shortened if researchers want future participants to be more likely to read these forms' contents. Additional recommendations are discussed. PMID:27329533

  9. Disclosing Information in Interview Introductions: Methodological Consequences of Informed Consent.

    ERIC Educational Resources Information Center

    Sobal, Jeff

    1982-01-01

    Varying amounts of information about the interview, interviewer and research can be provided to potential respondents during the interview introduction. Two studies in a large eastern center city may be interpreted as supporting greater disclosure to ensure informed consent by the respondent, thus improving the public image of survey research.…

  10. Consent for audio-video recording of informed consent process in rural South India

    PubMed Central

    Chauhan, Ramesh Chand; Purty, Anil J.; Singh, Neelima

    2015-01-01

    Introduction and Objectives: In recent times, audio-video (A-V) recording of consent process for all the study subjects entering a clinical trial has been made mandatory. A-V recording of informed consent process is a big challenge due to confidentiality and the sociocultural environment in India. It is important to find out the acceptability for A-V recording of the consent process and reasons for refusal, if any to address this new challenge. Materials and Methods: A descriptive survey was done among 150 residents of a rural community of South India. Acceptability for A-V recording of consent process was assessed among those who had given the informed written consent for participation in the study. An attempt to find the factors determining the refusal was also made. Results: More than one-third (34%) of the study subjects refused to give consent for A-V recording of consent process. Not interested in recording or don’t like to be recorded (39%) were the most common reasons to refuse for A-V recording of consent process. The refusal was higher among female and younger age-group adult subjects. Socioeconomic status was not found to be significantly associated with refusal to consent for A-V recording. Conclusion: Refusal for A-V recording of consent process is high in the South Indian rural population. Before any major clinical trial, particularly a field trial, an assessment of consent for A-V recording would be helpful in recruitment of study subjects. PMID:26229752

  11. [Prerequisites and limits of informed consent].

    PubMed

    Peintinger, M

    2001-01-01

    The process of getting an "informed consent" is based on judicial necessity as well as on the relationship between the patient and his doctor, which has been changing remarkably over the last years. In this alliance the idea of autonomy increases, while the paternal treatment is loosing its influence continuously. Although patients have the right to decide, they also need competence in order to make a decision. Many circumstances may be responsible for a corruption of this competence. A communication based on appreciation, empathy and authenticity is able to discover such circumstances and fight against them. This kind of communication is able to prevent communication gaps, even when severe or dangerous realities have to be verbally expressed. Despite the judicial necessity the healing power of communication should get a more central place in therapy.

  12. Intensive care patients' evaluations of the informed consent process.

    PubMed

    Clark, Paul Alexander

    2007-01-01

    This study examines the informed consent process from the perspective of intensive care patients. Using the largest single-method database of patient-derived information in the United States, we systematically outlined and tested several key factors that influence patient evaluations of the intensive care unit (ICU) informed consent process. Measures of information, understanding, and decision-making involvement were found to predict overall patient satisfaction and patient loyalty intentions. Specific actions supportive of ICU informed consent, such as giving patients information on advance directives, patient's rights, and organ donation, resulted in significantly higher patient evaluation scores with large effect sizes. This research suggests that the effectiveness of the informed consent process in the ICU from the patient's perspective can be measured and evaluated and that ICU patients place a high value on the elements of the informed consent process. PMID:17704678

  13. Informed consent: a study of the OR consenting process in New Zealand.

    PubMed

    Agnew, Joanne; Jorgensen, Diane

    2012-06-01

    The outcome of the informed consenting process should be that patients are knowledgeable about their future procedure, but there is no guarantee that signing the informed consent form means that patients have understood the information that their health care providers have given to them. To evaluate the informed consenting process in an OR direct admissions department of a city hospital in New Zealand, we interviewed 18 surgical patients. We transcribed the audiotaped interviews and analyzed the data using a general inductive approach derived from Grounded Theory. Our analysis indicated that educational information was not always based on patients' previous knowledge or understanding, although most patients understood the surgical consenting process to be complete after they met with the physician and signed the form. Our study highlights that although patients spoke with their physicians and nurses, there was still a lack of understanding. Perioperative nurses are in a prime position to reinforce informed consent. They should actively support the consenting process and be proactive in collaborating with patients and physicians to ultimately ensure that the patient has every opportunity to make an informed decision. PMID:22633383

  14. Informed consent: corner stone in ethical medical and dental practice.

    PubMed

    Kakar, Heena; Gambhir, Ramandeep Singh; Singh, Simarpreet; Kaur, Amarinder; Nanda, Tarun

    2014-01-01

    Progress in health care technologies has enabled patients to be better informed about all aspects of health care. Patients' informed consent is a legal regulation and a moral principle which represents patients' rights to take part in the clinical decisions concerning their treatment. With increasing awareness among the patients, the concept of informed consent is also evolving in developing countries like India. It is important for the medical and dental practitioners to have a written and signed informed consent from their patients before performing any invasive or irreversible procedures. Informed consent is also needed when providing medical care to children, foreign patients, and incorporating images of the patients while conducting medical and dental research. The present review addresses some of the vital issues regarding informed consent when providing medical and dental care with current review of the literature. PMID:24791241

  15. 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...

  16. 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...

  17. 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...

  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. 14 CFR 1230.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 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...

  20. 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...

  1. 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…

  2. 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...

  3. 10 CFR 745.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false General requirements for informed consent. 745.116 Section 745.116 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being...

  4. 10 CFR 745.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false General requirements for informed consent. 745.116 Section 745.116 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being...

  5. 10 CFR 745.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false General requirements for informed consent. 745.116 Section 745.116 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being...

  6. 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...

  7. 10 CFR 745.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false General requirements for informed consent. 745.116 Section 745.116 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being...

  8. 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...

  9. 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...

  10. 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...

  11. 10 CFR 745.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false General requirements for informed consent. 745.116 Section 745.116 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being...

  12. 14 CFR 1230.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 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...

  13. 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...

  14. 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. PMID:27269752

  15. Counseling Programs' Informed Consent Practices: A Survey of Student Preferences

    ERIC Educational Resources Information Center

    Pease-Carter, Cheyenne; Minton, Casey A. Barrio

    2012-01-01

    This study examined 115 master's-level counseling students' preferences for content, timing, and method of programmatic informed consent. Students rated the majority of items as moderately or extremely important to receive, and they indicated a desire for the informed consent to be facilitated through a combination of both oral and written methods…

  16. Informed consent in community-based oral health research.

    PubMed

    Singh, Shenuka

    2014-11-01

    The ethical principle of respect for persons presents multiple dimensions to stimulate debate around issues related to informed consent for participation, data management, confidentiality and privacy. The informed consent process is built on a continuum involving a comprehensive explanation of the proposed study; and the declaration of consent (the right to withdraw from at anytime from the study without any negative consequences). All research involving human participants carry a certain level of risk (physical or informational) and it is not possible for the researcher to know all the consequences of participation before a study commences. This presentation will focus around the key issues of information, consent' and competence in relation to community-based oral health research and outlines some of debates in the informed consent process.

  17. Experiences with obtaining informed consent for genomic sequencing.

    PubMed

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

    2015-11-01

    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.

  18. 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.

  19. Informed Consent for Electroconvulsive Therapy--Finding Balance.

    PubMed

    Mankad, Mehul

    2015-09-01

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

  20. 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

  1. Informed patient consent--historical perspective and a clinician's view.

    PubMed

    Kour, N W; Rauff, A

    1992-02-01

    Informed patient consent, in this day and age, is usually taken for granted, poorly understood, and inadequately practised. Historically, informed patient consent is relatively new to medical practice, as there was no such consent during the times of the ancient Egyptians, the ancient Greeks or Romans. The culture of individual rights as part of a social trend and evolution of human civilisation with landmarks such as the American Revolution two centuries ago also brought along greater patient awareness of their health and persons as well as their rights in the investigations, treatment and research of their illnesses. The rationale and elements in the practice of informed patient consent is part of this trend. However, there are moral and legal dilemmas involved. Discussion is needed, and though the practice of such consent may sometimes be difficult, the spirit of its application should never be compromised.

  2. 15 CFR 27.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Documentation of informed consent. 27.117 Section 27.117 Commerce and Foreign Trade Office of the Secretary of Commerce PROTECTION OF HUMAN... record linking the subject and the research would be the consent document and the principal risk would...

  3. 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.

  4. Informed Consent in Decision-Making in Pediatric Practice.

    PubMed

    Katz, Aviva L; Webb, Sally A

    2016-08-01

    Informed consent should be seen as an essential part of health care practice; parental permission and childhood assent is an active process that engages patients, both adults and children, in their health care. Pediatric practice is unique in that developmental maturation allows, over time, for increasing inclusion of the child's and adolescent's opinion in medical decision-making in clinical practice and research. This technical report, which accompanies the policy statement "Informed Consent in Decision-Making in Pediatric Practice" was written to provide a broader background on the nature of informed consent, surrogate decision-making in pediatric practice, information on child and adolescent decision-making, and special issues in adolescent informed consent, assent, and refusal. It is anticipated that this information will help provide support for the recommendations included in the policy statement. PMID:27456510

  5. Surgeons' Silence: A History of Informed Consent in Orthopaedics

    PubMed Central

    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. PMID:17907443

  6. 76 FR 256 - Informed Consent Elements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

    .... References I. Introduction In the Federal Register of December 29, 2009 (74 FR 68750), FDA issued a notice of... anxiety upon reading consent forms; (2) unnecessarily burdens or overwhelms participants because it does... responsibility of investigators (74 FR 68750 at 68752). Clinical research (as opposed to clinical practice)...

  7. 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

  8. 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

  9. 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....

  10. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 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....

  11. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 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....

  12. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 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....

  13. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 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....

  14. 32 CFR 219.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as...

  15. 45 CFR 690.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in...

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

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... HUMAN SUBJECTS § 1028.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this...

  17. 16 CFR 1028.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... HUMAN SUBJECTS § 1028.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this...

  18. 15 CFR 27.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... OF HUMAN SUBJECTS § 27.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this...

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

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... HUMAN SUBJECTS § 1028.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this...

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

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... OF HUMAN SUBJECTS § 27.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this...

  1. 32 CFR 219.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as...

  2. 16 CFR 1028.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... HUMAN SUBJECTS § 1028.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this...

  3. 32 CFR 219.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as...

  4. 15 CFR 27.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... OF HUMAN SUBJECTS § 27.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this...

  5. 45 CFR 690.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in...

  6. 45 CFR 690.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in...

  7. 32 CFR 219.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as...

  8. 15 CFR 27.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... OF HUMAN SUBJECTS § 27.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this...

  9. 32 CFR 219.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as...

  10. 45 CFR 690.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in...

  11. 16 CFR 1028.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... HUMAN SUBJECTS § 1028.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this...

  12. Informed Consent at Gunpoint: When Psychiatry Affects Gun Ownership.

    PubMed

    Candilis, Philip J; Khurana, Gagandeep; Leong, Gregory B; Weinstock, Robert

    2015-06-01

    As states take more steps to connect patients' gun ownership to their mental health, psychiatrists are being asked to provide mental health information after clinical interviews as well as after confiscation. This move into the patient-physician relationship raises new questions about how psychiatrists should obtain informed consent when interviews may result in reports to legal authorities. Consent warnings are already practiced more in the breach than in the observance and informed consent is imperfect at its best. In communities torn by controversies surrounding gun control, vehement political views will further influence these established themes to result in unprecedented pressures on patient confidentiality. This analysis draws on new movements in ethical theory and behavioral medicine that go beyond balancing principles to question the use of psychiatry in firearm reporting, and support a vigorous practice of informed consent to protect both individuals and the communities they live in.

  13. Understanding, interests and informed consent: a reply to Sreenivasan.

    PubMed

    Bromwich, Danielle

    2015-04-01

    It is widely agreed that the view of informed consent found in the regulations and guidelines struggles to keep pace with the ever-advancing enterprise of human subjects research. Over the last 10 years, there have been serious attempts to rethink informed consent so that it conforms to our considered judgments about cases where we are confident valid consent has been given. These arguments are influenced by an argument from Gopal Sreenivasan, which apparently shows that a potential participant's consent to research participation can be perfectly valid even if she fails to understand the risk-benefit profile of the study. I argue that Sreenivasan's argument fails. The set of clinical trials that is supposed to be ethical in the face of this kind of ignorance is empty. However, I argue that his argument is nonetheless instructive in allowing us to identify three important but neglected areas for future conceptual research on informed consent. I close by arguing that research on these identified questions promises to yield a defensible view of consent, lessen the burden of ambiguity on researchers attempting to obtain consent to research participation, and facilitate socially valuable research.

  14. Can informed consent to research be adapted to risk?

    PubMed

    Bromwich, Danielle; Rid, Annette

    2015-07-01

    The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical benefits for the individual research participant. Furthermore, current proposals do not address the concern that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorisation. In this paper, we show how the standard view of informed consent--consent as autonomous authorisation--can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk.

  15. Audio-video recording of informed consent process: Boon or bane

    PubMed Central

    Kulkarni, Niranjan G.; Dalal, Jeroze J.; Kulkarni, Tejashree N.

    2014-01-01

    The Drugs Technical Advisory Board has recommended inclusion of audio-video (AV) recording of the informed consent process while conducting clinical trials in India. It is included as draft rule in the gazette of India notification dated 7th June 2013. This will soon become a law. There are many anticipated advantages of AV recording like reliability, transparency, and improvement in quality of conduct of informed consent process. However, at the same time the industry will need to address challenges in infrastructure, maintaining confidentiality, cost implication, and so on. AV recording will help reassure the government and community about standards maintained by the industry/institute while conducting informed consent process, thereby increasing society's faith in clinical research. PMID:24551580

  16. Audio-video recording of informed consent process: Boon or bane.

    PubMed

    Kulkarni, Niranjan G; Dalal, Jeroze J; Kulkarni, Tejashree N

    2014-01-01

    The Drugs Technical Advisory Board has recommended inclusion of audio-video (AV) recording of the informed consent process while conducting clinical trials in India. It is included as draft rule in the gazette of India notification dated 7(th) June 2013. This will soon become a law. There are many anticipated advantages of AV recording like reliability, transparency, and improvement in quality of conduct of informed consent process. However, at the same time the industry will need to address challenges in infrastructure, maintaining confidentiality, cost implication, and so on. AV recording will help reassure the government and community about standards maintained by the industry/institute while conducting informed consent process, thereby increasing society's faith in clinical research. PMID:24551580

  17. [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

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

    PubMed

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

    2016-08-01

    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.

  19. 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

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

    PubMed

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

    2016-08-01

    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

  1. Autonomy, privacy and informed consent 2: postnatal perspective.

    PubMed

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

    The nursing and healthcare ethics literature over the past 10 years has focused on issues of patient autonomy and patient rights. Despite the growing volume of literature exploring such topics, there is little empirical work investigating what is actually happening in clinical nursing or midwifery practice in relation to patient autonomy, privacy or informed consent, from the perspective of either patients or staff. This four-part series reports the results of a Scottish study that formed part of a multisite comparative research project funded by the European Commission, investigating issues of patient autonomy, privacy and informed consent. This article, the second of four, explores the issues of autonomy, privacy and informed consent in maternity care. The research questions asked were: (1) What is the perception of mothers' autonomy, privacy and informed consent in Scottish NHS hospitals, from the point of view of both mothers and midwives? (2) Are there differences in the perceptions of mothers and midwives on these issues? Data were collected by a self-completion questionnaire for mothers (n = 243) and staff (n = 170) on postnatal units in both district general and university teaching hospital. Results indicated that there are differences between the perceptions of mothers and midwives in relation to mothers' autonomy, privacy and informed consent. Most differences were found in the information-giving and decision-making elements of autonomy.

  2. 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.

  3. The informed consent process in randomised controlled trials: a nurse-led process.

    PubMed

    Cresswell, Pip; Gilmour, Jean

    2014-03-01

    Clinical trials are carried out with human participants to answer questions about the best way to diagnose, treat and prevent illness. Participants must give informed consent to take part in clinical trials that requires understanding of how clinical trials work and their purpose. Randomised controlled trials provide strong evidence but their complex design is difficult for both clinicians and participants to understand. Increasingly, ensuring informed consent in randomised controlled trials has become part of the clinical research nurse role. The aim of this study was to explore in depth the clinical research nurse role in the informed consent process using a qualitative descriptive approach. Three clinical research nurses were interviewed and data analysed using a thematic analysis approach. Three themes were identified to describe the process of ensuring informed consent. The first theme, Preparatory partnerships, canvassed the relationships required prior to initiation of the informed consent process. The second theme, Partnering the participant, emphasises the need for ensuring voluntariness and understanding, along with patient advocacy. The third theme, Partnership with the project, highlights the clinical research nurse contribution to the capacity of the trial to answer the research question through appropriate recruiting and follow up of participants. Gaining informed consent in randomised controlled trials was complex and required multiple partnerships. A wide variety of skills was used to protect the safety of trial participants and promote quality research. The information from this study contributes to a greater understanding of the clinical research nurse role, and suggests the informed consent process in trials can be a nurse-led one. In order to gain collegial, employer and industry recognition it is important this aspect of the nursing role is acknowledged.

  4. [From informed to shared: the developing process of consent].

    PubMed

    Casari, E F; Massimo, L M E

    2002-06-01

    Based on the respect of the four well known ethical principles "autonomy, non-maleficence, beneficence and justice", of clinical cognitive psychology, social psychology and bioethics, and in the light of moral values, we wish to comment the clinical problems involving informed consent for diagnostic procedures, treatment and research in pediatrics. Studies of the issues in attitudes and shared consent in the clinical management involving children, their parents and the therapeutic team are still limited. Our suggestion is to manage the process of informed consent as a negotiated "shared consent" originated from the cognitive social representation theory, and taking into consideration the evolutive characteristics of the cognitive processes in children and adolescents, the ego defence mechanisms, the coping behaviour activated in the relationship among the pediatric patient, his/her family and the physicians. Many parents told us that the informed consent process is helpful though often confusing. Satisfaction was not related to ethnicity or education level. They found discussions more helpful than the consent documents. The more difficult process concerned their understanding of the concept of randomisation and the request of their consent to this procedure. The model we suggest has also the aim to give adequate and honest informations to children and adolescents through a continuous dialogue with the physician, until this become a routine part of their life in hospital care, to avoid confusion, to satisfy any request and curiosity, to be honest and helpful with any answer. We strongly believe that medical students, and in particular pediatricians, must be trained on "communication" and that they need to acquire, in addition to their medical capability, a good knowledge on this topic, including ethics and relational aspects. In our opinion, pediatricians must become expert also in the following topics: "Problem-related Learning", "The Family System Health Model

  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. PMID:26732319

  6. Legal briefing: informed consent in the clinical context.

    PubMed

    Pope, Thaddeus Mason; Hexum, Melinda

    2014-01-01

    This issue's "Legal Briefing" column covers recent legal developments involving informed consent.1 We covered this topic in previous articles in The Journal of Clinical Ethics.2 But an updated discussion is warranted. First, informed consent remains a central and critically important issue in clinical ethics. Second, there have been numerous significant legal changes over the past year. We categorize recent legal developments into the following 13 categories: (1) Medical Malpractice Liability, (2) Medical Malpractice Liability in Wisconsin, (3) Medical Malpractice Liability in Novel Situations, (4) Enforcement by Criminal Prosecutors, (5) Enforcement by State Medical Boards, (6) Enforcement through Anti-Discrimination Laws, (7) Statutorily Mandated Disclosures Related to End-of-Life Counseling, (8) Statutorily Mandated Disclosures Related to Aid in Dying, (9) Statutorily Mandated Disclosures Related to Abortion, (10) Statutorily Mandated Disclosures Related to Telemedicine, (11) Statutorily Mandated Disclosures Related to Other Interventions, (12) Statutorily Mandated Gag and Censorship Laws, (13) Informed Consent in the Research Context. PMID:24972066

  7. 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

  8. Implications of late complications from adhesions for preoperative informed consent

    PubMed Central

    Rajab, Taufiek Konrad; Ahmad, Umar Naeem; Kelly, Edward

    2010-01-01

    Summary The process of informed consent is a critical aspect of the doctor–patient relationship. Doctors have a professional duty to provide patients with sufficient information if a treatment is associated with a significant risk. NHS guidelines advise doctors to mention risks that occur more frequently than 1–2% or risks that are serious even if the likelihood is very small. In the case of abdominal and pelvic surgery, risks can broadly be divided into early and late complications. Early complications, such as bleeding and infection, have a close temporal relationship with the operation. Such complications are routinely mentioned during the consent process. In contrast, postoperative adhesions cause changes in the normal anatomy that can adversely affect function many years and even decades after the original operation, leaving patients at lifelong risk for late complications. These late adhesive complications, namely bowel obstruction, mechanical female infertility and chronic pain, are often neglected during the consent process. However, the risks to patients from late adhesive complications are serious and well in excess of the accepted threshold where it could be considered a breach in the duty of care not to inform patients. This is reflected by a number of claims against the NHS based on consent issues regarding late adhesive complications of surgery. Therefore, late complications of surgery from adhesions should be included in the pre-operative consent process. This would decrease litigation costs but more importantly also underpins the doctor–patient relationship. PMID:20610617

  9. 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

  10. 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

  11. 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

  12. 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.

  13. Theory and practice of informed consent in the Czech Republic.

    PubMed

    Krizova, Eva; Simek, Jiri

    2007-05-01

    The large-scale change of Czech society since 1989 has involved the democratic transformation of the health system. To empower the patient was one important goal of the healthcare reform launched immediately after the Velvet Revolution. The process has been enhanced by the accession of the Czech Republic to the European Union and the adoption of important European conventions regulating the area. The concept of informed consent and a culture of negotiation are being inserted into a traditionally paternalistic culture. Our article describes the current situation on the issue of the communication of information on state of health and treatment, and on the question of the participation of the patient in decisions on treatment. We present empirical results of a public opinion survey on this issue. The results show a still prevailing submissive attitude towards the physicians, despite the fact that the concept of informed consent has become more and more publicly familiar (42% of respondents gave the completely correct answer regarding informed consent). The impact of age, education and sex on answers to the questionnaire was analysed. Men, younger and more educated respondents were more likely to show the autonomous attitude, whereas women, older and less educated people tended to show the traditional submissive attitude. Further, our article raises the question of the cultural and historical background within which the current ethically and legally binding norms (products of western democracies, in fact) are interpreted. The question is how far cultural modifications are tolerable in the practical implementation of universal ethical constructs (informed consent).

  14. 42 CFR 50.204 - Informed consent requirement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Informed consent requirement. 50.204 Section 50.204 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL... funded program benefits to which the individual might be otherwise entitled: (2) A description...

  15. 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.

  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... 7 Agriculture 1 2010-01-01 2010-01-01 false General requirements for informed consent. 1c.116 Section 1c.116 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS §...

  17. 7 CFR 1c.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... may involve a human being as a subject in research covered by this policy unless the investigator has... 7 Agriculture 1 2012-01-01 2012-01-01 false General requirements for informed consent. 1c.116 Section 1c.116 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS §...

  18. 22 CFR 225.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., no investigator may involve a human being as a subject in research covered by this policy unless the... 22 Foreign Relations 1 2013-04-01 2013-04-01 false General requirements for informed consent. 225.116 Section 225.116 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF...

  19. 28 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., no investigator may involve a human being as a subject in research covered by this policy unless the... 28 Judicial Administration 2 2011-07-01 2011-07-01 false General requirements for informed consent. 46.116 Section 46.116 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF...

  20. 45 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Section 46.116 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a...

  1. 45 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Section 46.116 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a...

  2. 49 CFR 11.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... investigator may involve a human being as a subject in research covered by this policy unless the investigator... 49 Transportation 1 2013-10-01 2013-10-01 false General requirements for informed consent. 11.116 Section 11.116 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS §...

  3. 7 CFR 1c.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... may involve a human being as a subject in research covered by this policy unless the investigator has... 7 Agriculture 1 2011-01-01 2011-01-01 false General requirements for informed consent. 1c.116 Section 1c.116 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS §...

  4. 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... 49 Transportation 1 2010-10-01 2010-10-01 false General requirements for informed consent. 11.116 Section 11.116 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS §...

  5. 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... 28 Judicial Administration 2 2010-07-01 2010-07-01 false General requirements for informed consent. 46.116 Section 46.116 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF...

  6. 7 CFR 1c.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... may involve a human being as a subject in research covered by this policy unless the investigator has... 7 Agriculture 1 2013-01-01 2013-01-01 false General requirements for informed consent. 1c.116 Section 1c.116 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS §...

  7. 22 CFR 225.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., no investigator may involve a human being as a subject in research covered by this policy unless the... 22 Foreign Relations 1 2010-04-01 2010-04-01 false General requirements for informed consent. 225.116 Section 225.116 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF...

  8. 28 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., no investigator may involve a human being as a subject in research covered by this policy unless the... 28 Judicial Administration 2 2013-07-01 2013-07-01 false General requirements for informed consent. 46.116 Section 46.116 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF...

  9. 22 CFR 225.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., no investigator may involve a human being as a subject in research covered by this policy unless the... 22 Foreign Relations 1 2012-04-01 2012-04-01 false General requirements for informed consent. 225.116 Section 225.116 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF...

  10. 49 CFR 11.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... investigator may involve a human being as a subject in research covered by this policy unless the investigator... 49 Transportation 1 2012-10-01 2012-10-01 false General requirements for informed consent. 11.116 Section 11.116 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS §...

  11. 49 CFR 11.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... investigator may involve a human being as a subject in research covered by this policy unless the investigator... 49 Transportation 1 2011-10-01 2011-10-01 false General requirements for informed consent. 11.116 Section 11.116 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS §...

  12. 22 CFR 225.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., no investigator may involve a human being as a subject in research covered by this policy unless the... 22 Foreign Relations 1 2011-04-01 2011-04-01 false General requirements for informed consent. 225.116 Section 225.116 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF...

  13. 28 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., no investigator may involve a human being as a subject in research covered by this policy unless the... 28 Judicial Administration 2 2012-07-01 2012-07-01 false General requirements for informed consent. 46.116 Section 46.116 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF...

  14. 49 CFR 11.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... investigator may involve a human being as a subject in research covered by this policy unless the investigator... 49 Transportation 1 2014-10-01 2014-10-01 false General requirements for informed consent. 11.116 Section 11.116 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS §...

  15. 28 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., no investigator may involve a human being as a subject in research covered by this policy unless the... 28 Judicial Administration 2 2014-07-01 2014-07-01 false General requirements for informed consent. 46.116 Section 46.116 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF...

  16. 22 CFR 225.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., no investigator may involve a human being as a subject in research covered by this policy unless the... 22 Foreign Relations 1 2014-04-01 2014-04-01 false General requirements for informed consent. 225.116 Section 225.116 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF...

  17. 45 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Section 46.116 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a...

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

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... may involve a human being as a subject in research covered by this policy unless the investigator has... 7 Agriculture 1 2014-01-01 2014-01-01 false General requirements for informed consent. 1c.116 Section 1c.116 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS §...

  19. 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…

  20. 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. PMID:24865264

  1. 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…

  2. 40 CFR 26.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or... policy, no investigator may involve a human being as a subject in research covered by this policy unless... from liability for negligence. (a) Basic elements of informed consent. Except as provided in...

  3. 45 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.116 General requirements... being as a subject in research covered by this policy unless the investigator has obtained the legally...) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section,...

  4. 45 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.116 General requirements... being as a subject in research covered by this policy unless the investigator has obtained the legally...) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section,...

  5. 40 CFR 26.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or... policy, no investigator may involve a human being as a subject in research covered by this policy unless... from liability for negligence. (a) Basic elements of informed consent. Except as provided in...

  6. 15 CFR 27.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false General requirements for informed consent. 27.116 Section 27.116 Commerce and Foreign Trade Office of the Secretary of Commerce PROTECTION... description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of...

  7. Autonomy, privacy and informed consent 4: surgical perspective.

    PubMed

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

    This is the fourth article in a four-part series that considers the issues of patient autonomy, privacy and informed consent. The article discusses these issues in the context of surgical patients and their nurses. There is an abundance of references to issues of autonomy and informed consent within the healthcare literature, although there are few empirical studies investigating these issues within practice. The issue of privacy has been somewhat less explored than that of autonomy or consent, particularly in the UK literature. This article reports the findings of a Scottish study that formed part of a multisite comparative study funded by the European Commission. A convenience sample of surgical patients (n = 282) and their nurses (n = 260) participated in the study. Data were collected by means of a self-completion questionnaire for both patients and nursing staff. Results indicated that there are significant differences in patient and staff perceptions on issues of patient autonomy, privacy and informed consent. However, the most marked difference in perceptions of patients and staff were found on the information-giving element of the autonomy subscale. Implications for nursing practice, education and research are highlighted.

  8. 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)...

  9. 21 CFR 50.25 - Elements of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Elements of informed consent. 50.25 Section 50.25 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)...

  10. 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)...

  11. 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…

  12. 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

  13. Understanding informed consent for participation in international health research.

    PubMed

    Jegede, Ayodele S

    2009-08-01

    To participate in health research, there is a need for well-administered informed consent. Understanding of informed consent, especially in international health research, is influenced by the participants' understanding of information and the meaning attached to the information communicated to them regarding the purpose and procedure of the research. Incorrect information and the power differential between researcher and participants may lead to participants becoming victims of harmful research procedures. Meningitis epidemics in Kano in early 1996 led to a response from drug companies, especially Pfizer, as well as humanitarian workers from Médecins Sans Frontiers, which resulted in an unethical trial. Pfizer's drug trial during the epidemics has left a lasting controversy, which has yet to be resolved. This paper examines the key issues surrounding the controversy, discusses the context of informed decision-making, the ethical issues and implications of the incident, and concludes with some recommendations. Relevant texts, journals, Internet materials, newspaper articles and documentary materials on the conduct of the Pfizer's Trovan trial have been consulted. Four types of action (act intuitively, act rationally, act ignorantly, and act contextually - based on information provided) are identified as possible options for decision making. Participants most likely acted in ignorance due to poor understanding of the information contained in the verbal informed consent administered, thereby raising ethical issues. It is concluded that health research ethics committees have an important role to play nationally and locally in overseeing research, and in avoiding future occurrences. PMID:18637943

  14. 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. 
. PMID

  15. Consenting to donation: an examination of current practices in informed consent for tissue donation in the US

    PubMed Central

    Siminoff, Laura A.

    2012-01-01

    Informed consent is the primary moral principle guiding the donation of human tissue for transplant purposes. When patients’ donation wishes are not known, family members making the decision about tissue donation should be provided with requisite information needed to make informed donation decisions. Using a unique dataset of 1,016 audiotaped requests for tissue obtained from 15 US tissue banking organizations, we examined whether the information provided to families considering tissue donation met current standards for informed consent. The results indicated that many elements of informed consent were missing from the donation discussions, including the timeframe for procurement, autopsy issues, the involvement of both for-profit and nonprofit organizations, and the processing, storage and distribution of donated tissue. A multiple linear regression analysis also revealed that nonwhites and family members of increased age received less information regarding tissue donation than did younger, white decision makers. Recommendations for improving the practice of obtaining consent to tissue donation are provided. PMID:22395736

  16. 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.

  17. Informed consent and the limits of confidentiality.

    PubMed

    Haggerty, L A; Hawkins, J

    2000-06-01

    Investigators encounter many legal and ethical issues when they conduct research on partner abuse. Balancing abused women's rights to privacy with legally mandated reporting requirements involves considerable thought and planning. Failure to protect participants may result in escalation of abuse as well as loss of children to protective services. Various perspectives on maintaining participant privacy while conforming to legal mandates to report child abuse, homicidality, and suicidality are discussed. The role of confidentiality certificates in providing legal immunity for researchers and the method of obtaining the certificates are presented. In addition, the authors describe the strategies for participant protection that are implemented in a federally funded study of abuse, women's self-care, and pregnancy outcomes. The decision to clearly and specifically inform abused women of the limits of confidentiality allows participants to make informed decisions about disclosures, but may result in diminished recruitment. PMID:10826257

  18. Informed consent and the limits of confidentiality.

    PubMed

    Haggerty, L A; Hawkins, J

    2000-06-01

    Investigators encounter many legal and ethical issues when they conduct research on partner abuse. Balancing abused women's rights to privacy with legally mandated reporting requirements involves considerable thought and planning. Failure to protect participants may result in escalation of abuse as well as loss of children to protective services. Various perspectives on maintaining participant privacy while conforming to legal mandates to report child abuse, homicidality, and suicidality are discussed. The role of confidentiality certificates in providing legal immunity for researchers and the method of obtaining the certificates are presented. In addition, the authors describe the strategies for participant protection that are implemented in a federally funded study of abuse, women's self-care, and pregnancy outcomes. The decision to clearly and specifically inform abused women of the limits of confidentiality allows participants to make informed decisions about disclosures, but may result in diminished recruitment.

  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. 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. PMID:11070641

  1. 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.

  2. Patient and parent understanding of informed consent in orthodontics.

    PubMed

    Mortensen, Micah G; Kiyak, H Asuman; Omnell, Lena

    2003-11-01

    In both medical and dental settings, researchers have found that patients do not adequately comprehend the information given during informed consent discussions, especially the less educated, low-income patients. Because of the importance of patient compliance with orthodontic treatment regimens, this study examined patient and parent understanding of the child's Phase I orthodontic treatment in a public dental clinic with ethnically diverse, low-income patients. Interviews were conducted with 29 children (ages 6-12) and their parents or guardians at the orthodontic case presentation appointment. The orthodontist explained the reasons for treatment, the orthodontic procedures to be used, the risks, the alternatives, and patient and parent responsibilities during treatment; the session was audiotaped. Interviews were conducted immediately after this discussion and the results compared with the orthodontists' presentations. In general, both children and parents recalled significantly fewer reasons for treatment (1.10, 1.66, and 2.34 items, respectively), procedures (1.55, 1.59, and 2.45, respectively), risks associated with treatment (0.66, 1.48, and 4.66, respectively), and responsibilities of the child during treatment (2.21, 2.07, and 3.38, respectively) than what the orthodontist had told them. They were also less likely to recall the reasons, procedures, and risks that were most frequently cited by the orthodontist. These findings raise concerns about the effectiveness of current informed consent techniques with public health populations, especially the low recall rates within 30 minutes of the case presentations. Low recall of risks by children and their parents, particularly for critical risks such as relapse, caries, and periodontal problems, raises concerns about treatment compliance, success, and more importantly, the effectiveness of the informed consent process itself. Future research should focus on methods to improve the informed consent process among

  3. 76 FR 55390 - Guidance on Exculpatory Language in Informed Consent, Draft

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... HUMAN SERVICES Guidance on Exculpatory Language in Informed Consent, Draft AGENCY: Office for Human... the availability of a draft guidance entitled, ``Guidance on Exculpatory Language in Informed Consent... Language in Informed Consent document to the Division of Policy and Assurances, Office for Human...

  4. How does national culture affect citizens' rights of access to personal health information and informed consent?

    PubMed

    Cockcroft, Sophie; Sandhu, Neelam; Norris, Anthony

    2009-09-01

    Two widely discussed and debated aspects of health law literature are 'informed' consent to medical treatment and the right of access to personal health information. Both are tied to the larger subject of patients' rights, including the right to privacy. This article looks at the issue of informed consent internationally, and goes further to explain some of the inequalities across the world with respect to informed consent and patients' rights legislation via an analysis of the take-up of key legislative attributes in patient consent. Specifically, the effect that national culture, as defined by the GLOBE variables, has on the rate and pattern of adoption of these consent elements is analysed using binary logistic regression to provide evidence of the existence or otherwise of a cultural predicate of the legislative approach. The article concludes by outlining the challenges presented by these differences.

  5. Informed consent for HPV vaccination: a relational approach.

    PubMed

    Gottvall, Maria; Tydén, Tanja; Larsson, Margareta; Stenhammar, Christina; Höglund, Anna T

    2015-03-01

    The aim of this study was to explore the relational aspects of the consent process for HPV vaccination as experienced by school nurses, based on the assumption that individuals have interests related to persons close to them, which is not necessarily to be apprehended as a restriction of autonomy; rather as a voluntary and emotionally preferred involvement of their close ones. Thirty Swedish school nurses were interviewed in five focus groups, before the school based vaccination program had started in Sweden. The empirical results were discussed in light of theories on relational autonomy. The school nurses were convinced that parental consent was needed for HPV vaccination of 11-year-old girls, but problems identified were the difficulty to judge when a young person is to be regarded as autonomous and what to do when children and parents do not agree on the decision. A solution suggested was that obtaining informed consent in school nursing is to be seen as a deliberative process, including the child, the parents and the nurse. The nurses described how they were willing strive for a dialogue with the parents and negotiate with them in the consent process. Seeing autonomy as relational might allow for a more dialogical approach towards how consent is obtained in school based vaccination programs. Through such an approach, conflicts of interests can be made visible and become possible to deal with in a negotiating dialogue. If the school nurses do not focus exclusively on accepting the individual parent's choice, but strive to engage in a process of communication and deliberation, the autonomy of the child might increase and power inequalities might be reduced.

  6. 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. PMID:27587448

  7. 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.

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

    PubMed

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

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

  9. 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

  10. 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.

  11. The problem of informed consent in emergency medicine research

    PubMed Central

    Foex, B

    2001-01-01

    The CRASH Trial (Corticosteroid Randomisation After Significant Head injury), which started in April 1999 hopes to answer the question of whether or not there is any benefit to giving high dose corticosteroids after significant head injuries. To do this patients are randomised to receive either the standard care for head injuries, as defined by the receiving hospital, or standard care plus a 48 hour infusion of corticosteroids. This is to be started within eight hours of injury, preferably as soon as possible. As all eligible patients will have a reduced level of consciousness informed consent has been deemed unnecessary. In this review the issue of consent in human experimentation is presented with a special emphasis on the problems faced in emergency medicine research, and the way these have been tackled. PMID:11354212

  12. The influence of informed consent content on study participants’ contraceptive knowledge and concerns

    PubMed Central

    Stephenson, Rob; Grabbe, Kristina; Vwalika, Bellington; Ahmed, Yusuf; Vwalika, Cheswa; Haworth, Alan; Fuller, Laurie; Liu, Fong; Chomba, Elwyn; Allen, Susan

    2011-01-01

    Objectives Little is known about how the information presented in the informed consent process influences study outcomes among participants. This paper examines how the content of the informed consent document may influence baseline levels of knowledge among study participants. Methods We examined the influence of the content of informed consent documents on reported contraceptive knowledge and concerns among two groups of sero-discordant and HIV concordant positive couples enrolled in research projects at an HIV research center in Lusaka, Zambia. Results We found significant differences in the reporting of both contraceptive knowledge and concerns between couples viewing consent forms that included detailed information on contraception and those viewing consent forms without the detailed information. Conclusions The protection of human subjects is vital. The future challenge, however, lies in creating informed consent documents that can find the balance between ensuring that participants give truly informed consent, and educating participants in ways that compromise the assessment of the impact of behavioral interventions. PMID:21331352

  13. 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.

  14. 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.

  15. Informed consent to breech birth in New Zealand.

    PubMed

    Powell, Rhonda; Walker, Shawn; Barrett, Alison

    2015-07-24

    The authors note significant room for improvement in facilitating informed consent in the management of breech presentation. New Zealand maternity care providers, including midwives, general practitioners and specialist obstetricians, have legal duties to provide full and unbiased information about risks and benefits of all relevant treatment options. In the case of breech presentation, such options include the interventions of external cephalic version or planned caesarean section, as well as the option to decline intervention and proceed with a planned vaginal breech birth. Information should be presented in a balanced and accessible way and not limited to the provider's personal preferences. Women have legal rights to make an informed choice, to give or refuse consent, to a second opinion and to co-operation among providers. The right of competent persons to refuse medical treatment, including the right to refuse caesarean section, is well established. Clinical policies therefore should include appropriate and non-coercive care for women who choose to birth their breech-presenting baby vaginally, compliance with such policies should be the norm, and consideration should be given to any institutional reforms or educational priorities needed to achieve this. PMID:26367363

  16. Research and the IRB: When Consent Information Refers to Risk and to Deception.

    ERIC Educational Resources Information Center

    Finney, Phillip D.

    An experiment which varied indications about the possibility of psychological risk and deception in consent information provided to subjects prior to participation in Asch's (1952) line-judgment task is presented. The number of erroneous line-judgments (conformity) made by subjects across five consent treatments and a no-consent control group were…

  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. Distinctions in Disclosure: Mandated Informed Consent in Abortion and ART.

    PubMed

    Daar, Judith

    2015-01-01

    Enactment of mandated pre-procedure disclosures in abortion and assisted reproductive technology (ART) services has swelled in recent years. Calls to equally regard these mandates as neutral tools in furtherance of patient protection fail to acknowledge key substantive and structural differences in these reproduction-affecting mandates. While ART mandates permit physicians to use their medical judgment to protect presumptively vulnerable egg donors and gestational carriers, abortion disclosures impart scientifically suspect messaging aimed at dissuading women from pursuing pregnancy termination. These and other distinctions counsel in favor of regarding and analyzing abortion and ART mandated disclosures as separate and distinguishable informed consent tools.

  19. Putting the 'informed' into 'consent': a matter of plain language.

    PubMed

    Green, J B; Duncan, R E; Barnes, G L; Oberklaid, F

    2003-12-01

    Health professionals frequently write at the same level for lay readers as they write for peers. In relation to health research and ethical requirements to provide written explanation of studies, this can complicate the notion of informed consent. Plain language information statements need to be clearly understood by research subjects if the ethics process for research approval is to fulfil its objective. Many delays in gaining ethics approval for child-related research are caused by substandard plain language statements (PLS). We describe specific issues for information statements for research with children, young people and their parents/guardians, particularly in consideration of the literacy capabilities of the general population. We highlight the usefulness of everyday language when explaining research and science in writing to families, and present some guidelines for writing PLS that have emerged from the introduction of a plain language service by an Ethics in Human Research Committee. PMID:14629504

  20. 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. PMID:21424464

  1. Pharmaceutical information systems and possible implementations of informed consent - developing an heuristic

    PubMed Central

    2012-01-01

    Background Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use. Analysis The paper analyses 1) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context. Results and Conclusion Based on the analysis a heuristic is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system. The danger of routinisation of consent is identified. The Danish pharmaceutical information system raises issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed in relation to routinisation of consent. PMID:23157854

  2. Informed consent procedure for clinical trials in emergency settings: the Polish perspective.

    PubMed

    Iwanowski, Piotr S

    2007-09-01

    Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients' to give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants. Whereas the Declaration of Helsinki, Good Clinical Practice guideline, Additional Protocol to the European Bioethical Convention concerning Biomedical Research, as well as appropriate regulations adopted by the Food and Drugs Administration (USA) allow waivers from participants' consent or deferred consent for emergency research, the regulations of most European Community countries following the Clinical Trial Directive (2001/20/EC) do not give space for a deferred consent or a waiver from consent for adult patients (unless surrogate consent is made use of). This is even more confusing in case of Poland, where conflicting regulations on a waiver from a participant's consent in emergency research exist and the regulations on surrogate consent of temporarily incompetent adults are too restrictive and authorise only the guardianship courts to consent, which is not or hardly feasible in practice. European Community regulations need to be amended to allow for implementation of the deferred consent or waivers from consent for emergency research in order to enable ethical research of emergency conditions that should become a large part of important public health priorities. PMID:18210227

  3. 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. PMID:27523956

  4. 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.

  5. 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. PMID:25156698

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

    PubMed Central

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

    2012-01-01

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

  7. A tiered-layered-staged model for informed consent in personal genome testing.

    PubMed

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

    2013-06-01

    In recent years, developments in genomics technologies have led to the rise of commercial personal genome testing (PGT): broad genome-wide testing for multiple diseases simultaneously. While some commercial providers require physicians to order a personal genome test, others can be accessed directly. All providers advertise directly to consumers and offer genetic risk information about dozens of diseases in one single purchase. The quantity and the complexity of risk information pose challenges to adequate pre-test and post-test information provision and informed consent. There are currently no guidelines for what should constitute informed consent in PGT or how adequate informed consent can be achieved. In this paper, we propose a tiered-layered-staged model for informed consent. First, the proposed model is tiered as it offers choices between categories of diseases that are associated with distinct ethical, personal or societal issues. Second, the model distinguishes layers of information with a first layer offering minimal, indispensable information that is material to all consumers, and additional layers offering more detailed information made available upon request. Finally, the model stages informed consent as a process by feeding information to consumers in each subsequent stage of the process of undergoing a test, and by accommodating renewed consent for test result updates, resulting from the ongoing development of the science underlying PGT. A tiered-layered-staged model for informed consent with a focus on the consumer perspective can help overcome the ethical problems of information provision and informed consent in direct-to-consumer PGT.

  8. 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

  9. Researchers' Views on Informed Consent for Return of Secondary Results in Genomic Research

    PubMed Central

    Appelbaum, Paul S.; Fyer, Abby; Klitzman, Robert L.; Martinez, Josue; Parens, Erik; Zhang, Yuan; Chung, Wendy K.

    2014-01-01

    Purpose Prior studies suggest that genomic investigators generally favor offering to return at least some secondary findings to participants and believe that participants' preferences should determine the information they receive. We surveyed investigators to ascertain their views on 4 models of informed consent for this purpose: traditional consent, staged consent, mandatory return, and outsourced consent. Methods We performed an online survey of 198 US genetic researchers, drawn from our subject pool for an earlier study, on views regarding return of secondary results. Potential participants were identified through the NIH RePORTER database and abstracts from the 2011 American Society of Human Genetics meeting. Results Under circumstances in which resource constraints are not an issue, approximately a third of respondents would endorse either staged consent or traditional consent; outsourced consent and mandatory return are favored by only a small minority. However, taking resource constraints into account, roughly half the sample would favor traditional consent, with support for staged consent dropping to 13%. Conclusion Traditional approaches to consent, despite their liabilities, are seen as most viable under current circumstances. However, there is considerable interest in staged consent, assuming the infrastructure to support it can be provided. PMID:25503499

  10. 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

    ... Informed Consent for Pediatric Clinical Trials SUMMARY: In compliance with the requirement of Section 3506... information on the proposed project, contact: Ms. Victoria Pemberton, Clinical Trials Specialist, National... Informed Consent for Pediatric Clinical Trials, 0925-New, National Heart, Lung, and Blood Institute...

  11. 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

    ... Equifax Information Services LLC; Analysis of Proposed Consent Order To Aid Public Comment AGENCY: Federal... INFORMATION section below. Write ``Equifax Info Services, File No. 102 3252'' on your comment and file your... from Equifax Information Services LLC (``Equifax''). The proposed consent order has been placed on...

  12. Informed consent in China: status quo and its future.

    PubMed

    Dai, Qingkang

    2003-01-01

    Informed consent is one of the fundamental rights of a patient. However it used to be ignored in mainland China and was neither academically discussed nor a matter of practical concern until recent years. Paternalism was dominant in the practice of traditional Chinese medicine which was intensely influenced by Confucianism. The historic medical paternalism was reinforced under communism and the planned economy due to the communist beliefs. But is has been frequently challenged in recent years with patients' awakening awareness of rights and the advent of rights-defending litigation culture in the course of the transformation to market economy. Nevertheless, the current Chinese laws lag behind this patients' awakening awareness and litigation culture. The resulting deficiency in Chinese laws governing medical relations has created dilemmas and chaos in the resolution of medical disputes. In conclusion, the author appeals for the amendment of Chinese law and tries to point out how it should be amended.

  13. 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

  14. 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

  15. 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.

  16. Ethical issues in genetic research: disclosure and informed consent.

    PubMed

    Reilly, P R; Boshar, M F; Holtzman, S H

    1997-01-01

    As research to correlate genetic status with predisposition to disease has accelerated, so has the concern that participation in such studies creates the risk of genetic discrimination and emotional distress. There is a need to broaden disclosure during the consent process to ensure that potential subjects understand these risks and other issues and to address them in the consent form. We describe the broad approach that we have taken in regard to disclosure and consent in gene mapping studies.

  17. SIDCER informed consent form: principles and a developmental guideline.

    PubMed

    Koonrungsesomboon, Nut; Laothavorn, Junjira; Chokevivat, Vichai; Hirayama, Kenji; Karbwang, Juntra

    2016-01-01

    The quality of informed consent forms (ICFs) remains an issue in clinical research. The lengthy and complicated ICFs currently being used lower research participants' ability to read and understand the information provided therein. In collaboration with the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), we have developed the SIDCER ICF, which could be of value in improving the quality of the ICFs. The three principles underlying the SIDCER ICF were: (i) an ICF contains all the required regulatory elements; (ii) an ICF provides only such information as is relevant for the subject's decision-making; and (iii) an ICF presents information in a simple format that conveys relevant information to the target population. The SIDCER ICF template, with its instructions, was then structured to assist an investigator in developing an enhanced ICF according to the three principles. The applicability of the SIDCER ICF was tested using a phase I study protocol, and a variety of experts with a special interest in ethics and clinical research were invited to evaluate the comprehensiveness of the three-page ICF for the phase I study. The SIDCER ICF template was refined and finalised in accordance with the results and comments from the experts. PMID:27009426

  18. 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.

  19. [Survey on informed consent about operative mortality in urologic surgery in Japan].

    PubMed

    Mitsuzuka, Koji; Ishidoya, Shigeto; Saito, Seiichi; Ohyama, Chikara; Arai, Yoichi

    2008-08-01

    A questionnaire about informed consent of operative death was mailed, and a total of 38 institutes answered the questions. Informed consent of operative death was likely to be obtained from only when the operation had been considered at high risk. Most of the urologists surveyed never obtained such informed consent for transurethral resection, prostate biopsy, extracorporeal shockwave lithotripsy, and nephrostomy. About half of them did not consider it necessary to explain the operative death of these procedures to patients in future. The percentage of death was informed to patients only in one institute. Japanese urologists seem to obtain informed consent of operative death at their discretion, according to the risk of each procedure. These results will provide important information about informed consent of operative death.

  20. [The Nice CHU biobank experience to collect patients' informed consent for research context (2004-2009)].

    PubMed

    Hofman, Véronique; Bonnetaud, Christelle; Gaziello, Marie Clotilde; Ilie, Marius; Lassalle, Sandra; Butori, Catherine; Lerda, Nathalie; Selva, Eric; Gavric-Tanga, Virginie; Castillo, Laurent; Guevara, Nicolas; Santini, José; Pop, Daniel; Vénissac, Nicolas; Mouroux, Jérôme; Chabannon, Christian; Hofman, Paul

    2010-10-01

    Over the last 10 years, significant financial support from the French National Institute of Cancer (INCa), the Ministry of Health (DGOS), and the Health and Research National Institute (Inserm) helped biobanks--of which tumour banks represent a prominent example of hospital-based infrastructures--to improve their operations, and in some instances to adopt the rules of Biological Ressource Centers as defined by OECD. Nowadays, the use of biological samples of human origin is strictly subordinated to regulations that integrate bioethical principles. However, in spite of the establishment of these regulations, requirement to obtain an authorisation and/or to register the biological collections with the Ministry of Research, many uncertainties persist. While French regulations mandate that samples can be used for research as long as patients did not oppose to such use, many biobank curators face practical and theoretical issues when establishing a Material Transfer Agreement with scientists, due to the lack of harmonization between national regulations--particularly due to a different perception of privacy and free will in anglo-american and other countries--and different demands on the side of private industry or editorial boards of scientific journals. The goal of this article is (1) to describe the procedure followed to collect patients' informed consent at the Biobank of CHU de Nice and (2) to assess the number of obtained consents in comparison to the number of collected samples between 01/09/2004 and 31/12/2009, the number of consents obtained before or after collecting the samples, and the number of patients' refusal to collect their biological resources. This balance-sheet is settled for the three major collections (thoracic, thyroid and head and neck tissues) from the Biobank of CHU de Nice. Results show that 88 % of consents were obtained during this period (82 % in a prospective manner and 6 % in a retrospective manner). Refusal was notified by writing in

  1. 76 FR 64945 - Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-19

    ... products are manufactured by branded pharmaceutical companies and marketed and sold under a non-brand label... an additional year. Par is a New Jersey-based generic pharmaceutical company with 115 active products... Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent...

  2. 77 FR 12590 - Winchester Industries; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ... Winchester Industries; Analysis of Proposed Consent Order To Aid Public Comment AGENCY: Federal Trade.... The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and... public record for a period of thirty (30) days. The following Analysis to Aid Public Comment...

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

    PubMed

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

    2010-03-01

    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.

  4. 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…

  5. 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…

  6. Negotiating Informed Consent with Children in School-Based Research: A Critical Review

    ERIC Educational Resources Information Center

    Gallagher, Michael; Haywood, Sarah L.; Jones, Manon W.; Milne, Sue

    2010-01-01

    The methods literature on research with children recognises the challenges of negotiating informed consent with this group. Special "child-friendly" techniques are advocated to overcome these challenges. We argue that, upon closer inspection, research with children foregrounds more fundamental problems with informed consent that are not easily…

  7. Towards a standardised informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Evaluation) project—study protocol for a nationwide prospective cohort study

    PubMed Central

    Kortram, Kirsten; Spoon, Emerentia Q W; Ismail, Sohal Y; d'Ancona, Frank C H; Christiaans, Maarten H L; van Heurn, L W Ernest; Hofker, H Sijbrand; Hoksbergen, Arjan W J; Homan van der Heide, Jaap J; Idu, Mirza M; Looman, Caspar W N; Nurmohamed, S Azam; Ringers, Jan; Toorop, Raechel J; van de Wetering, Jacqueline; Ijzermans, Jan N M; Dor, Frank J M F

    2016-01-01

    Introduction Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed consent procedures for live donor nephrectomy vary per centre, and even per individual healthcare professional. The basis for a standardised, uniform surgical informed consent procedure for live donor nephrectomy can be created by assessing what information donors need to hear to prepare them for the operation and convalescence. Methods and analysis The PRINCE (Process of Informed Consent Evaluation) project is a prospective, multicentre cohort study, to be carried out in all eight Dutch kidney transplant centres. Donor knowledge of the procedure and postoperative course will be evaluated by means of pop quizzes. A baseline cohort (prior to receiving any information from a member of the transplant team in one of the transplant centres) will be compared with a control group, the members of which receive the pop quiz on the day of admission for donor nephrectomy. Donor satisfaction will be evaluated for all donors who completed the admission pop-quiz. The primary end point is donor knowledge. In addition, those elements that have to be included in the standardised format informed consent procedure will be identified. Secondary end points are donor satisfaction, current informed consent practices in the different centres (eg, how many visits, which personnel, what kind of information is disclosed, in which format, etc) and correlation of donor knowledge with surgeons' estimation thereof. Ethics and dissemination Approval for this study was obtained from the medical ethical committee of the Erasmus MC, University Medical Center, Rotterdam, on 18 February 2015. Secondary approval has been obtained from the local ethics committees in six participating centres. Approval in the

  8. 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

  9. 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. PMID:23038801

  10. [Intracerebral aneurysm--treatment options, informed consent, and legal aspects].

    PubMed

    Burkhardt, Jan-Karl; Burkhardt, Werner Friedrich; Zinn, Pascal Olivier; Bozinov, Oliver; Bertalanffy, Helmut

    2011-01-01

    All medical subspecialties and, in particular, high-tech field neurosurgery are subject to continuous change in therapeutic concepts due to novel treatment options emerging through research and evolution in the field. Hence, the question arises if the patient's informed consent needs to be adjusted in the face of multiple therapeutic options with different configurations of risk/benefit relationships. In this paper we discuss different therapeutic scenarios with regard to ruptured intracerebral aneurysms (RIA) and unruptured intracerebral aneurysms (UIA), and we advise the medical doctor involved in the process. Indeed, experienced neurosurgeons and endovascular interventionalists are very familiar with the management of these scenarios; likewise, interns, residents, and otherwise affiliated physicians may be faced with these situations. In general, asymptomatic and mentally capacitated patients as well as legal guardians of minor patients and of mentally incapacitated patients with incidental aneurysms and more than one therapeutic option need to be accurately informed about the advantages and disadvantages of the treatment options available to them. In case of emergency or when treating a mentally disabled patient who is incapable of making a sound judgment and has no legal guardian, the attending doctor will have to choose the best possible treatment option. PMID:21958620

  11. 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.

  12. 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

  13. Why we should not seek individual informed consent for participation in health services research

    PubMed Central

    Cassell, J; Young, A

    2002-01-01

    Ethics committees now require that individuals give informed consent to much health services research, in the same way as for clinical research. This is misguided. Existing ethical guidelines do not help us decide how to seek consent in these cases, and have allowed managerial experimentation to remain largely unchecked. Inappropriate requirements for individual consent can institutionalise health inequalities and reduce access to services for vulnerable groups. This undermines the fundamental purpose of the National Health Service (NHS), and ignores our rights and duties as its members, explored here. Alternative forms of community consent should be actively pursued. PMID:12356960

  14. Why we should not seek individual informed consent for participation in health services research.

    PubMed

    Cassell, J; Young, A

    2002-10-01

    Ethics committees now require that individuals give informed consent to much health services research, in the same way as for clinical research. This is misguided. Existing ethical guidelines do not help us decide how to seek consent in these cases, and have allowed managerial experimentation to remain largely unchecked. Inappropriate requirements for individual consent can institutionalise health inequalities and reduce access to services for vulnerable groups. This undermines the fundamental purpose of the National Health Service (NHS), and ignores our rights and duties as its members, explored here. Alternative forms of community consent should be actively pursued.

  15. 78 FR 59943 - Submission for OMB Review; 30-Day Comment Request; Interactive Informed Consent for Pediatric...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-30

    ...; Interactive Informed Consent for Pediatric Clinical Trials SUMMARY: In compliance with the requirement of... information on the proposed project contact: Victoria Pemberton, Clinical Trials Specialist, NHLBI, 6701... for Pediatric Clinical Trials, 0925-New, National Heart, Lung, and Blood Institute (NHLBI),...

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

    PubMed Central

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

    2016-01-01

    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. PMID:26767117

  17. 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.

  18. Informed Consent for Research in a Nursing Home: Processes and Issues.

    ERIC Educational Resources Information Center

    Cohen-Mansfield, Jiska; And Others

    1988-01-01

    Examined difficulty of obtaining valid informed consent from participants in research with older persons. Of 470 nursing home residents asked to participate in nonrisk study, 406 agreed. High consent rate was attributed to perception of research significance, presentation format, and absence of risk or pain. (Author/NB)

  19. 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...

  20. The Effects of Enhanced Informed Consent in a Pro-Life Pregnancy Counseling Center.

    ERIC Educational Resources Information Center

    Mardirosian, Kathryn; And Others

    1990-01-01

    Investigated effects of enhanced informed consent condition on attitudes of female clients (n=60) toward a counselor, counseling situation, and decision making in a pro-life pregnancy center. Results suggest enhanced consent did not lead to increased or decreased decisions to abort nor to differential attitudes toward counselor or setting.…

  1. A jurisdictional review of the legislation governing informed consent by chiropractors across Canada

    PubMed Central

    Boucher, Pierre B.; Brousseau, Danica; Chahine, Sarah

    2016-01-01

    The objective of this jurisdictional review is to provide summary information pertaining to the regulation of chiropractors in Canadian provinces and territories on the topic of informed consent. Our review shows that two provinces have legislated for all healthcare professions: Ontario and Prince Edward Island. Two chiropractic regulatory bodies (New Brunswick and, Newfoundland and Labrador) have adopted the Canadian Chiropractic Association Code of Conduct. All chiropractic regulatory bodies of the other provinces and Yukon have adopted their own specific dispositions regarding informed consent. Chiropractors in Prince Edward Island, Saskatchewan and Québec must obtain informed consent in writing. PMID:27069269

  2. 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

  3. Patient or physician safety? Physicians' views of informed consent and nurses' roles in an Indonesian setting.

    PubMed

    Susilo, Astrid Pratidina; Nurmala, Ira; van Dalen, Jan; Scherpbier, Albert

    2012-05-01

    Informed consent is a reflection of patients' autonomy in health decision-making. The main responsibility lies with the doctor. In practice, the nurses' contributions matter as well. This paper presents a case study that explored physicians' perceptions of the existing informed consent process, their suggestions for improvement and their views on the nurses' roles in this process. A two-phase approach was conducted. First, six physicians with different expertise were interviewed. Second, after attending presentations about informed consent and physician-patient relationship principles, 32 physicians were asked to complete an open-ended questionnaire. Data were analyzed by two independent coders and emerging themes were compared. The results of the questionnaires and the interviews were triangulated. Of 32 physicians attending the presentations, 24 (75%) completed the questionnaire. The results indicate that physicians perceive patients, physicians and the hospital as main factors influencing the process of informed consent. Physicians' misinterpretation of informed consent principles, (mis)perceptions regarding patients and their family, and deficient hospital policy and support challenge the informed consent process. Physicians value nurses' roles, provided nurses have sufficient clinical knowledge, sound comprehension of informed consent principles and effective communication skills.

  4. A tiered-layered-staged model for informed consent in personal genome testing.

    PubMed

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

    2013-06-01

    In recent years, developments in genomics technologies have led to the rise of commercial personal genome testing (PGT): broad genome-wide testing for multiple diseases simultaneously. While some commercial providers require physicians to order a personal genome test, others can be accessed directly. All providers advertise directly to consumers and offer genetic risk information about dozens of diseases in one single purchase. The quantity and the complexity of risk information pose challenges to adequate pre-test and post-test information provision and informed consent. There are currently no guidelines for what should constitute informed consent in PGT or how adequate informed consent can be achieved. In this paper, we propose a tiered-layered-staged model for informed consent. First, the proposed model is tiered as it offers choices between categories of diseases that are associated with distinct ethical, personal or societal issues. Second, the model distinguishes layers of information with a first layer offering minimal, indispensable information that is material to all consumers, and additional layers offering more detailed information made available upon request. Finally, the model stages informed consent as a process by feeding information to consumers in each subsequent stage of the process of undergoing a test, and by accommodating renewed consent for test result updates, resulting from the ongoing development of the science underlying PGT. A tiered-layered-staged model for informed consent with a focus on the consumer perspective can help overcome the ethical problems of information provision and informed consent in direct-to-consumer PGT. PMID:23169494

  5. Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension.

    PubMed

    Sanchini, Virginia; Reni, Michele; Calori, Giliola; Riva, Elisabetta; Reichlin, Massimo

    2014-04-01

    We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials.

  6. Informed consent revisited: a doctrine in the service of cancer care.

    PubMed

    Schachter, Madeleine; Fins, Joseph J

    2008-10-01

    Informed consent traditionally has been viewed as a safeguard for the protection of patients' decisional autonomy. While informed consent is a critical means for the protection of the patient's dominion over the integrity of his body, exclusive consideration of the doctrine as a safeguard for patients eclipses the doctrine's significant benefits for the therapeutic endeavor. Undertaking a thorough informed consent process helps the physician avoid the unilateral burdens of paternalism; furthers compliance with the doctor's legal obligations, ethical duties, and clinical responsibilities; and, as importantly, enhances the collaborative treatment enterprise. When informed consent is viewed narrowly and solely as a protective device for patients' rights, the physician may be less likely to engage the patient in ongoing discussions. Important opportunities may be missed to elicit additional clinical information, assess psychosocial concerns, and reiterate the commitment to collaboration and patient autonomy. PMID:18849321

  7. 45 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 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 resulting... linking the subject with the research, and the subject's wishes will govern; or (2) That the...

  8. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 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...

  9. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 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...

  10. 45 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 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 resulting... linking the subject with the research, and the subject's wishes will govern; or (2) That the...

  11. 10 CFR 745.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written... research would be the consent document and the principal risk would be potential harm resulting from a... subject with the research, and the subject's wishes will govern; or (2) That the research presents no...

  12. 22 CFR 225.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...'s legally authorized representative. When this method is used, there shall be a witness to the oral... 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...

  13. 38 CFR 16.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... subject or the subject's legally authorized representative. When this method is used, there shall be a...: (1) That the only record linking the subject and the research would be the consent document and the... asked whether the subject wants documentation linking the subject with the research, and the...

  14. 38 CFR 16.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... subject or the subject's legally authorized representative. When this method is used, there shall be a...: (1) That the only record linking the subject and the research would be the consent document and the... asked whether the subject wants documentation linking the subject with the research, and the...

  15. 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

  16. Knowledge and awareness of informed consent among orthodontists and patients: A pilot study

    PubMed Central

    Alagesan, Anitha; Vaswani, Vina; Vaswani, Ravi; Kulkarni, Uma

    2015-01-01

    Aim: Despite fixed professional opinion of what might constitute optimal treatment, patients must be informed of the various treatment options available in orthodontics to manage their clinical problem. The purpose of this study was to compare and evaluate the knowledge and awareness among practicing orthodontists and patients with regard to informed consent in clinical practice and research. Materials and Methods: Twenty-five orthodontists and 25 patients were enrolled in a questionnaire study which was descriptive and cross-sectional in the nature. The questionnaire focused on the following aspects; contents of informed consent, at what age and who can give consent. Results: The study showed a majority of orthodontists (79.14%) were aware of knowledge regarding informed consent when compared to patients(35.14%). Conclusion: The overall result showed the huge gap that exists between orthodontists and patients and thus making it categorical for patients to be more involved in the decision-making process. PMID:26604580

  17. 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.

  18. "Not Tied Up Neatly with a Bow": Professionals' Challenging Cases in Informed Consent for Genomic Sequencing.

    PubMed

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

    2016-02-01

    As the use of genomic technology has expanded in research and clinical settings, issues surrounding informed consent for genome and exome sequencing have surfaced. Despite the importance of informed consent, little is known about the specific challenges that professionals encounter when consenting patients or research participants for genomic sequencing. We interviewed 29 genetic counselors and research coordinators with considerable experience obtaining informed consent for genomic sequencing to understand their experiences and perspectives. As part of this interview, 24 interviewees discussed an informed consent case they found particularly memorable or challenging. We analyzed these case examples to determine the primary issue or challenge represented by each case. Challenges fell into two domains: participant understanding, and facilitating decisions about testing or research participation. Challenges related to participant understanding included varying levels of general and genomic literacy, difficulty managing participant expectations, and contextual factors that impeded participant understanding. Challenges related to facilitating decision-making included complicated family dynamics such as disagreement or coercion, situations in which it was unclear whether sequencing research would be a good use of participant time or resources, and situations in which the professional experienced disagreement or discomfort with participant decisions. The issues highlighted in these case examples are instructive in preparing genetics professionals to obtain informed consent for genomic sequencing.

  19. Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative.

    PubMed

    Lentz, Jennifer; Kennett, Michele; Perlmutter, Jane; Forrest, Annemarie

    2016-07-01

    Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Broad consensus among sponsors, research staff, study participants, and advocates indicate that the current process could be improved to enhance participants' understanding of study-related information and meet the needs of individuals. The Clinical Trials Transformation Initiative (CTTI) convened a project to identify problems in the current process and to formulate recommendations for improvement. A literature review, expert interviews, and multi-stakeholder meeting were conducted to identify barriers and develop solutions for a more effective informed consent process. Four key topics were the foundation of the recommendations: 1) defining an effective informed consent process, 2) training research staff, 3) improving the informed consent document, and 4) exploring the use of electronic consent. The ideal informed consent process involves an ongoing, interactive conversation between the participant and knowledgeable, responsive research staff who were trained in best practices. The informed consent process should be supported by a tiered informed consent document that provides critically relevant information to aid in the decision to participate in a study. Adoption of the CTTI informed consent recommendations should lead to a more participant-centric informed consent process. Participant involvement better meets the needs of participants and benefits the clinical trial enterprise by promoting a research culture that encourages informed participation in clinical studies.

  20. Zambian court issues groundbreaking decision concerning HIV testing without informed consent.

    PubMed

    Patel, Priti

    2010-10-01

    HIV testing is a critical component in the response to HIV. Human rights law requires that it include informed consent, pre- and post-test counselling, and guaranteed confidentiality of test results. In this article, based on her presentation at AIDS 2010, Priti Patel discusses a precedent-setting case in Zambia in which two former members of the Zambian Air Force were subjected to HIV testing without their consent.

  1. Patient information, consents and privacy protection scheme for an information system dedicated to pervasive developmental disorders.

    PubMed

    Ben Said, Mohamed; Robel, Laurence; Messiaen, Claude; Craus, Yann; Jais, Jean Philippe; Golse, Bernard; Landais, Paul

    2014-01-01

    Patients explicit and unambiguous information, patients consents and privacy protection are reviewed in this article, in the frame of the deployment of the information system TEDIS dedicated to autism spectrum disorders. The role of the Delegate to the Protection of Data is essential at this stage. We developed a privacy protection scheme based on storing encrypted patients personal data on the server database and decrypting it on the Web browser. It tries to respond to the end-users request to manage nominative data in a human readable form and to meet with privacy protection framework.

  2. 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.

  3. Ethical issues in bipolar disorders pedigree research: privacy concerns, informed consent, and grounds for waiver.

    PubMed

    Parker, Lisa S

    2002-02-01

    Focusing on bipolar disorders research, this article considers ethical issues of informed consent and privacy arising in genetic pedigree research at two stages: the construction of tentative pedigrees to determine family eligibility for study and, subsequently, the enrollment of subjects in and conduct of the family study. Increasing concern to protect the privacy of family members of primary subjects or probands, following ethical controversy over a survey study at Virginia Commonwealth University, has led some researchers and Institutional Review Boards (IRBs) to apply informed consent requirements to those represented on a tentative pedigree at the initial stage of research. This article analyzes the possible benefits, risks, and burdens to prospective subjects of seeking prospective consent for pedigree construction at this initial stage. It argues that the likely risk-benefit ratio favors granting a waiver of consent requirements for this stage of pedigree research and presents grounds for IRBs to grant such a waiver. The article closes by considering particular ethical concerns that should be addressed in the informed consent discussion when enrolling subjects in pedigree studies of bipolar disorder, including concerns about subjects' competence to consent, management of interim and incidental findings, and issues particular to psychiatric research.

  4. Ethical considerations for informed consent in infertility research: The use of electronic health records

    PubMed Central

    Wells, Kristen J.; Gordon, Janna R.; Su, H. Irene; Plosker, Shayne; Quinn, Gwendolyn P.

    2015-01-01

    The growing use of electronic health records (EHRs) in healthcare provides rich opportunities for biomedical research. Using EHRs, massive quantities of patient data can be extracted for research without the need to recruit patients, schedule study visits, or rely on self-reporting. However, this innovation poses significant concerns about patient privacy and confidentiality of data. Patients receiving infertility treatment may be particularly vulnerable to data breaches, as their EHRs often include sensitive health information about themselves, their partner, and their offspring. Helping patients with infertility to make informed decisions about sharing data is crucial, yet little is known about best practices for obtaining informed consent to use EHR data for research. This commentary reviews possible options for obtaining informed consent for EHR use among patients seeking fertility services. In addition, this commentary summarizes the limited research available on patient preferences for informed consent practices. PMID:27066591

  5. 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

  6. The informed consent aftermath of the genetic revolution. An Italian example of implementation.

    PubMed

    Artizzu, Federica

    2008-06-01

    A great part of human genetics research is carried out collecting data and building large databases of biological samples that are in a non-anonymous format. These constitute a valuable resource for future research. The construction of such databases and tissue banks facilitates important scientific progress. However, biobanks have been recognized as ethically problematic because they contain thousands of data that could expose individuals and populations to discrimination, stigmatization and psychological stress if misused. Informed consent is regarded as a cornerstone in the protection of personal autonomy in research involving human subjects. Yet in recent years this fundamental concept has been overwhelmed by the genomic revolution. From a general overview of international literature, it seems evident that informed consent issues have come into sharp focus, in particular in relation to the twin issues of time extension (blanket versus specific/repeated consent) and personal extension (group consent). After an introduction on obtaining informed consent in the context of genetic research, this paper addresses the apparent lack of a single, universal model of obtaining informed consent among populations involved in genetic research and it argues for the need to develop an ethical framework tailored to the specific features of each project. In order to support this theory of contextualizing, the case of a private biotechnology company, SharDNA is presented. The present paper explores the management of its biobank, developed from a genetic research project carried out on isolated populations living on the Italian island of Sardinia. In particular, the paper highlights how the company is tackling the problem of informed consent and other ethical requirements for genetic research, such as the respect of individual privacy, the population approach and the existing Italian legal regulatory framework.

  7. Informed consent for human genetic and genomic studies: a systematic review.

    PubMed

    Khan, A; Capps, B J; Sum, M Y; Kuswanto, C N; Sim, K

    2014-09-01

    As genetic and genomic studies grow in scale, there are ethical concerns related to the collection and use of genetic information. The emergence of large public databases potentially redefine the terms of participation in genetic and genomic research, and suggests the changing application of traditional ethical principles such as privacy or consent. For this study, we wanted to see whether such developments are reflected in the informed consent processes in human genetic and genomic studies. Therefore, we performed a systematic review of the empirical studies that examined informed consent involving large genetic databases in human genetic and genomic studies, grouped the identified issues related to the different stakeholders (including subjects, researchers, and institutional review boards) and discussed the limitations and implications of these findings. Major themes related to the place of bioethical considerations, procured tissues, people involved, process of informed consent and study procedures. Frequently raised issues included confidentiality of participants, documentation of informed consent, public attitudes, future use of participant samples or data, and disclosure of results. Awareness and attention to these bioethical issues as well as assiduousness in managing these concerns in genetic/genomic research would further strengthen and safeguard the rights, safety and well-being of genetic research participants.

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

    PubMed Central

    Fisher, Jill A.

    2011-01-01

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

  9. 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.

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

    PubMed

    Milinkovic, Igor; Majstorovic, Biljana

    2014-12-01

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

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. [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.

  17. 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

  18. Sub-orbital commercial Human space flight and informed consent in the United States

    NASA Astrophysics Data System (ADS)

    Carminati, Maria-Vittoria « Giugi »; Griffith, Doug; Campbell, Mark R.

    2013-12-01

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

  19. 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

  20. 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.

  1. 34 CFR 99.30 - Under what conditions is prior consent required to disclose information?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... information? (a) The parent or eligible student shall provide a signed and dated written consent before an educational agency or institution discloses personally identifiable information from the student's education... a parent or eligible student so requests, the educational agency or institution shall provide him...

  2. 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…

  3. 46 CFR Exhibit No. 2 to Subpart S... - Respondent's Consent Form for Informal Adjudication

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... the above-numbered claim in accordance with subpart S (46 CFR 502) of the Commission's informal... 46 Shipping 9 2014-10-01 2014-10-01 false Respondent's Consent Form for Informal Adjudication No. Exhibit No. 2 to Subpart S of Part 502 Shipping FEDERAL MARITIME COMMISSION GENERAL AND...

  4. A consumer perspective on informed consent and third-party issues.

    PubMed

    Terry, S F; Terry, P F

    2001-01-01

    Our two children were diagnosed with a rare genetic disorder, which led us to establish a research foundation. This led to in-depth consideration of issues surrounding informed consent from a consumer perspective. Third-party issues arose as central to the formulation of ethical policy in the establishment of a blood and tissue bank and an epidemiologic study. We suggest that a number of myths--privacy is possible, samples can be stripped of identifiers, humans are subjects, voluntary informed consent is attainable, genetics is about the individual only, genetic information is different than other medical information, research is altruistic, the public will learn truths about genetic research via media, and research is culturally competent--make it difficult to resolve the issues intrinsic to informed consent. A number of important elements could make policy decisions less complicated. These include conducting culturally competent research; conveying noncoercive hope, not hype; contacting the voluntary informant only; asking the informant to extend contact to other family members; requiring a comprehensive informed consent process for all contacted; and engaging in state-of-the-art data protections. There is a need for a "Genomic Hippocratic Oath," creating an ethical basis for research similar to the one vowed by health care professionals. Establishing ethical policies as a result of the collaboration of policy makers, researchers, and consumers will allow research to progress ethically at a rapid rate. If regulations are oppressive, they will thwart research; if they are too lenient, participants will not receive protections needed to participate safely.

  5. Case two: A Kantian approach to the morality of blood substitute clinical trials without informed consent.

    PubMed

    Fields, Keota

    2008-01-01

    Clinical trials in a number of countries are now underway to evaluate experimental, non-human blood substitute. One scenario calls for the blood substitute to be available on board emergency vehicles. This allows first responders the opportunity to provide transfusion support at an accident site and on the way to the hospital. However, many of the patients who would most benefit from the use of this material may be unconscious and unable to comprehend or sign an informed consent. One possible solution would be to eliminate the need for informed consent. PMID:18507310

  6. Consent in severely disabled children: informed or an infringement of their human rights?

    PubMed

    Rowse, Vicki L

    2007-03-01

    In this article the issue of consent in children is examined with particular reference to disabled children and young people. It is demonstrated that gaining informed consent from disabled children is still a long way off and that the issues are not clear. The law delivers contradictory rulings, parents and families are becoming more vocal in challenging doctors, and the courts are becoming increasingly involved in decision-making on treatment options. The Human Rights Act 1998 is becoming more prominent in informing these decisions. The article concludes that these developments may not be in the best interests of disabled children and that strategies are needed to help them communicate their views.

  7. 77 FR 29983 - Federal Acquisition Regulation; Information Collection; Subcontract Consent

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-21

    ... policy when subcontracting. The Government requires a contractor to provide certain information (e.g... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF DEFENSE... information provided. FOR FURTHER INFORMATION CONTACT: Mr. Karlos Morgan, Procurement Analyst, Contract...

  8. Assessment of a decision aid to assist genetic testing research participants in the informed consent process.

    PubMed

    Sorenson, J R; Lakon, C; Spinney, T; Jennings-Grant, T

    2004-01-01

    Limited attention has been given to applying decision-making theories from psychology to the content and process of informed consent in genetic testing research. Data are presented from a study that developed and assessed a psychological theory-based decision aid as part of the informed consent process. This innovative approach assisted at-risk women in assessing the consequences of participating in a research project that offered them free hemophilia A genetic carrier testing. Results suggest: (1) the decision aid can be incorporated into the consent process with few problems; (2) women of varying educational backgrounds can complete the decision aid; (3) while women consider many consequences of genetic testing, their primary focus is on the implications for their family; and (4) this is in marked contrast to the typical benefit-harm statements prepared by researchers for genetic testing.

  9. 76 FR 36989 - Medical Devices; Exception From General Requirements for Informed Consent

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances..., biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate...: I. Background A. Overview of Final Rule In the Federal Register of June 7, 2006 (71 FR 32827),...

  10. Realizing Informed Consent in Times of Controversy: Lessons from the SUPPORT Study.

    PubMed

    Morse, Robert J; Wilson, Robin Fretwell

    2016-09-01

    This Essay examines the elegantly simple idea that consent to medical treatment or participation in human research must be "informed" to be valid. It does so by using as a case study the controversial clinical research trial known as the Surfactant, Positive Pressure, and Oxygenation Randomized Trial ("SUPPORT"). The Essay begins by charting, through case law and the adoption of the common rule, the evolution of duties to secure fully informed consent in both research and treatment. The Essay then utilizes the SUPPORT study, which sought to pinpoint the level of saturated oxygen that should be provided to extremely low birth weight infants to demonstrate modern complexities and shortcomings of the duty to secure informed consent. This Essay shows how the duty is measured by foreseeability of risks and benefits in human research and why federal regulators believed the trade-offs in risk and benefits from differing oxygen levels administered in the support study were foreseeable. It then explores the contours of the duty to secure informed consent when applied to researchers who also serve as treating physicians, highlighting how common law duties differ in jurisdictions that apply the professional standard and those that apply the patient-centered material risk standard. This Essay provides new insight into what the law must do to make real the notion that [e]very human being of adult years and sound mind has a right to determine what shall be done with his body." PMID:27587446

  11. 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…

  12. 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.

  13. 46 CFR Exhibit No. 2 to Subpart S... - Respondent's Consent Form for Informal Adjudication

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... the Settlement Officer to determine the above-numbered claim in accordance with subpart S (46 CFR 502... 46 Shipping 9 2013-10-01 2013-10-01 false Respondent's Consent Form for Informal Adjudication No. Exhibit No. 2 to Subpart S of Part 502 Shipping FEDERAL MARITIME COMMISSION GENERAL AND...

  14. 46 CFR Exhibit No. 2 to Subpart S... - Respondent's Consent Form for Informal Adjudication

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... the Settlement Officer to determine the above-numbered claim in accordance with subpart S (46 CFR 502... 46 Shipping 9 2012-10-01 2012-10-01 false Respondent's Consent Form for Informal Adjudication No. Exhibit No. 2 to Subpart S of Part 502 Shipping FEDERAL MARITIME COMMISSION GENERAL AND...

  15. Perceptions of Academic Health Science Research Center Personnel Regarding Informed Consent Processes and Therapeutic Misconception

    PubMed Central

    Atz, Teresa W.; Sade, Robert M.; Williams, Pamela H.

    2015-01-01

    Introduction Instrumentation exists to measure voluntariness and misunderstanding in informed consent processes. However, research personnel’s perspectives about using instrumentation to measure therapeutic misconceptions in research participants has not been reported. We designed a workshop to promote research personnel knowledge of emerging instrumentation and to study the perceptions of research personnel regarding such instruments. Methods and Findings Two nationally recognized experts who have developed psychometric instruments to measure aspects of informed consent presented their recent findings to research personnel of the Medical University of South Carolina at a one-day workshop. Following the presentations, workshop attendees divided into two focus groups and shared their perceptions regarding the presentation content. Inductive thematic analysis detected themes related to informed consent processes including: investigator/provider role clarity; investigator transparency; therapeutic misconception; and screening subjects for understanding. Conclusion Our findings suggest future directions in applied, proactive empirical research to better understand investigator perceptions and practices related to transparency in research, and to develop instrumentation to detect risks to the integrity of informed consent in order to promote voluntariness and autonomy and minimize therapeutic misconception in research practices. PMID:24625182

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. REALIZATION OF INFORMED CONSENT AS ONE OF PATIENT’S RIGHTS: CURRENT SITUATION IN AZERBAIJAN

    PubMed Central

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

    2016-01-01

    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. PMID:27434222

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

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... the Settlement Officer to determine the above-numbered claim in accordance with subpart S (46 CFR 502... 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...

  3. 46 CFR Exhibit No. 2 to Subpart S... - Respondent's Consent Form for Informal Adjudication

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... the Settlement Officer to determine the above-numbered claim in accordance with subpart S (46 CFR 502... 46 Shipping 9 2011-10-01 2011-10-01 false Respondent's Consent Form for Informal Adjudication No. Exhibit No. 2 to Subpart S of Part 502 Shipping FEDERAL MARITIME COMMISSION GENERAL AND...

  4. 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.

  5. Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative.

    PubMed

    Lentz, Jennifer; Kennett, Michele; Perlmutter, Jane; Forrest, Annemarie

    2016-07-01

    Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Broad consensus among sponsors, research staff, study participants, and advocates indicate that the current process could be improved to enhance participants' understanding of study-related information and meet the needs of individuals. The Clinical Trials Transformation Initiative (CTTI) convened a project to identify problems in the current process and to formulate recommendations for improvement. A literature review, expert interviews, and multi-stakeholder meeting were conducted to identify barriers and develop solutions for a more effective informed consent process. Four key topics were the foundation of the recommendations: 1) defining an effective informed consent process, 2) training research staff, 3) improving the informed consent document, and 4) exploring the use of electronic consent. The ideal informed consent process involves an ongoing, interactive conversation between the participant and knowledgeable, responsive research staff who were trained in best practices. The informed consent process should be supported by a tiered informed consent document that provides critically relevant information to aid in the decision to participate in a study. Adoption of the CTTI informed consent recommendations should lead to a more participant-centric informed consent process. Participant involvement better meets the needs of participants and benefits the clinical trial enterprise by promoting a research culture that encourages informed participation in clinical studies. PMID:27327780

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 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 the... research must be informed of the identity of the pesticide and the nature of its pesticidal function....

  7. 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.

  8. Researching the intoxicated: informed consent implications for alcohol and drug research.

    PubMed

    Aldridge, Judith; Charles, Vikki

    2008-03-01

    This article considers the informed consent process in relation to carrying out research with intoxicated participants in 'field' research settings. There is little discussion in the literature of the potential problems that the intoxication of research participants may pose to research. Intoxication is a potential problem for all researchers but is heightened in field research that takes place in settings where participants are likely to be intoxicated, such as licensed venues, in drug consumption rooms, or police custody suites. The risks to research participants that intoxication poses should not be resolved by electing not to do research with intoxicated participants; it is argued that these risks can be managed to some extent, and are offset by the benefits of such research. Moreover, intoxication (and the impairment of cognitive functions relevant to valid informed consent) may not always be identifiable through behavioural or biochemical methods of detection. The search for accurate and field-practical methods for identifying intoxication amongst participants is useful, but not the only strategy for researchers who want to ensure the validity of the consent process. Suggestions are provided for devising research protocols that acknowledge and accept intoxication of research participants and attempt to protect them. One solution is to side-step identification of intoxication per se as a strategic objective in the consent process, and turn instead to established methods for ensuring that information has been understood by potential research participants.

  9. 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.

  10. Simple genetics language as source of miscommunication between genetics researchers and potential research participants in informed consent documents.

    PubMed

    Morgenstern, Justin; Hegele, Robert A; Nisker, Jeff

    2015-08-01

    Informed consent is based on communication, requiring language to convey meanings and ensure understandings. The purpose of this study was to investigate the use of language in informed consent documents used in the genetics research funded by Canadian Institutes of Health Research and Genome Canada. Consent documents were requested from the principal investigators in a recent round of funding. A qualitative content analysis was performed, supported by NVivo7™. Potential barriers to informed consent were identified, including language that was vague and variable, words with both technical and common meanings, novel phrases without clear meaning, a lack of definitions, and common concepts that assume new definitions in genetics research. However, we noted that difficulties in comprehension were often obscured because the words used were generally simple and familiar. We conclude that language gaps between researcher and potential research participants may unintentionally impair comprehension and ultimately impair informed consent in genomics research. PMID:24751688

  11. [Secondary use of human tissue: consent and better information required].

    PubMed

    Vermeulen, Eric; Geesink, Ingrid; Schmidt, Marjanka K; Steegers, Chantal; Verhue, Dieter; Brom, Frans W A; Aaronson, Neil K; van Leeuwen, Flora E

    2009-01-01

    Human tissue remaining after diagnostic procedures is important for use in scientific research. This 'secondary use' of tissue is regulated by the Dutch Medical Treatment Contracts Act and the Code of Conduct for Proper Secondary Use of Human Tissue of the Dutch Federation of Biomedical Scientific Societies. Patients have the right to opt-out of further use of their residual tissue, but the procedures for objection and the provision of information involved are not regulated by statute. Dutch patients have a positive attitude to further use of human tissue for other purposes. They prefer, however, a procedure in which they are informed verbally by their health professional about research with residual tissue. The information can be brief and is best provided early in the treatment. Administrative and technical modifications of the current registration systems are necessary to support the opting-out procedure in practice. By taking the preferences of patients into account, trust in medical practice can be maintained.

  12. 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.

  13. A consumer perspective on informed consent and third-party issues.

    PubMed

    Terry, S F; Terry, P F

    2001-01-01

    Our two children were diagnosed with a rare genetic disorder, which led us to establish a research foundation. This led to in-depth consideration of issues surrounding informed consent from a consumer perspective. Third-party issues arose as central to the formulation of ethical policy in the establishment of a blood and tissue bank and an epidemiologic study. We suggest that a number of myths--privacy is possible, samples can be stripped of identifiers, humans are subjects, voluntary informed consent is attainable, genetics is about the individual only, genetic information is different than other medical information, research is altruistic, the public will learn truths about genetic research via media, and research is culturally competent--make it difficult to resolve the issues intrinsic to informed consent. A number of important elements could make policy decisions less complicated. These include conducting culturally competent research; conveying noncoercive hope, not hype; contacting the voluntary informant only; asking the informant to extend contact to other family members; requiring a comprehensive informed consent process for all contacted; and engaging in state-of-the-art data protections. There is a need for a "Genomic Hippocratic Oath," creating an ethical basis for research similar to the one vowed by health care professionals. Establishing ethical policies as a result of the collaboration of policy makers, researchers, and consumers will allow research to progress ethically at a rapid rate. If regulations are oppressive, they will thwart research; if they are too lenient, participants will not receive protections needed to participate safely. PMID:11803770

  14. 77 FR 56644 - Federal Acquisition Regulation; Information Collection; Subcontract Consent

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-13

    ... effectiveness with which the contractor spends Government funds, and complies with Government policy when... current policy and sound business judgment. The information provides the Government a basis for granting... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF...

  15. Specimen Collection for Induced Pluripotent Stem Cell Research: Harmonizing the Approach to Informed Consent

    PubMed Central

    Lowenthal, Justin; Lipnick, Scott; Rao, Mahendra

    2012-01-01

    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. PMID:23197820

  16. Tailoring the process of informed consent in genetic and genomic research.

    PubMed

    Rotimi, Charles N; Marshall, Patricia A

    2010-01-01

    Genomic science and associated technologies are facilitating an unprecedented rate of discovery of novel insights into the relationship between human genetic variation and health. The willingness of large numbers of individuals from different ethnic and cultural backgrounds to donate biological samples is one of the major factors behind the success of the ongoing genomic revolution. Although current informed consent documents and processes demonstrate a commitment to ensuring that study participants are well informed of the risks and benefits of participating in genomic studies, there continues to be a need to develop effective new approaches for adequately informing participants of the changing complexities of the scientific and ethical issues that arise in the conduct of genomics research. Examples of these complexities in genomic research include more widespread use of whole-genome sequencing technologies, broad sharing of individual-level data, evolving information technology, the growing demand for the return of genetic results to participants, and changing attitudes about privacy and the expansion of genomics studies to global populations representing diverse cultural, linguistic and socio-economic backgrounds. We highlight and briefly discuss the importance of ten core scientific, cultural and social factors that are particularly relevant to tailoring informed consent in genomic research, and we draw attention to the need for the informed consent document and process to be responsive to the evolving nature of genomic research.

  17. Last call for informed consent: confused proxies in extra-emergency conditions.

    PubMed

    Vyshka, Gentian; Seferi, Arsen; Myftari, Kreshnik; Halili, Vera

    2014-01-01

    Informed consent has become a part of medical practice in Albania only recently, during a time when there has been a substantial increase in claims of malpractice. Its original aim was to provide patients with information to help them make decisions on particular health interventions. We describe the case of a patient who developed an unexpected surgical complication and desperately needed a second intervention, and the futility of obtaining informed consent in the setting of a medical emergency. The circumstances of the emergency might turn out to be too complicated and confusing for the proxies. The, role of proxies is not defined in the Albanian laws and bylaws. Seeking and eventually obtaining the necessary signatures and permissions in an emergency cannot be justified because the lack of time in such circumstances might be a major obstacle to sound and comprehensive communication, and lack of communication could give rise to mistrust, with all its potential consequences.

  18. Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India

    PubMed Central

    Joglekar, Neelam S.; Deshpande, Swapna S.; Sahay, Seema; Ghate, Manisha V.; Bollinger, Robert C.; Mehendale, Sanjay M.

    2013-01-01

    Background Optimum comprehension of informed consent by research participants is essential yet challenging. This study explored correlates of lower comprehension of informed consent among 1334 participants of a cohort study aimed at estimating HIV incidence in Pune, India. Methods As part of the informed consent process, a structured comprehension tool was administered to study participants. Participants scoring ≥90% were categorised into the ‘optimal comprehension group’, whilst those scoring 80–89% were categorised into the ‘lower comprehension group’. Data were analysed to identify sociodemographic and behavioural correlates of lower consent comprehension. Results The mean ± SD comprehension score was 94.4 ± 5.00%. Information pertaining to study-related risks was not comprehended by 61.7% of participants. HIV-negative men (adjusted OR [AOR] = 4.36, 95% CI 1.71–11.05) or HIV-negative women (AOR = 13.54, 95% CI 6.42–28.55), illiteracy (AOR= 1.65, 95% CI 1.19–2.30), those with a history of multiple partners (AOR = 1.73, 95% CI 1.12–2.66) and those never using condoms (AOR = 1.35, 95% CI 1.01–1.82) were more likely to have lower consent comprehension. Conclusions We recommend exploration of domains of lower consent comprehension using a validated consent comprehension tool. Improved education in these specific domains would optimise consent comprehension among research participants. PMID:24029848

  19. 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.

  20. 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.

  1. Initial evaluation of the Consent Support Tool: a structured procedure to facilitate the inclusion and engagement of people with aphasia in the informed consent process.

    PubMed

    Jayes, Mark; Palmer, Rebecca

    2014-04-01

    This study evaluated the Consent Support Tool (CST), a procedure developed to identify the optimum format in which to present research information to people with different severities of aphasia, in order to support their understanding during the informed consent process. Participants were a convenience sample of 13 people with aphasia who had mixed comprehension ability. The CST was used to profile each participant's language ability and identify an information format that should maximize her/his understanding. Next, participants were shown information presented in three formats: standard text and two 'aphasia-friendly' versions providing different levels of support. Participants' understanding of the information was measured for each format. The format recommended by the CST was compared with the format observed to maximize understanding for each participant. The CST accurately predicted the optimum format for 11/13 participants and differentiated people who could understand fully with support from those who could not in 12/13 cases. All participants interviewed (10/10) found the adapted formats helpful and 9/10 preferred them to the standard version. These findings suggest that the CST could usefully support researchers to determine whether a person with aphasia is likely to be able to provide informed consent, and which information format will maximize that individual's understanding. The CST and different information formats are available as Supplementary Appendices to be found online at http://www.informahealthcare.com/doi/abs/10.3109/17549507.2013.795999 . PMID:23826849

  2. Initial evaluation of the Consent Support Tool: a structured procedure to facilitate the inclusion and engagement of people with aphasia in the informed consent process.

    PubMed

    Jayes, Mark; Palmer, Rebecca

    2014-04-01

    This study evaluated the Consent Support Tool (CST), a procedure developed to identify the optimum format in which to present research information to people with different severities of aphasia, in order to support their understanding during the informed consent process. Participants were a convenience sample of 13 people with aphasia who had mixed comprehension ability. The CST was used to profile each participant's language ability and identify an information format that should maximize her/his understanding. Next, participants were shown information presented in three formats: standard text and two 'aphasia-friendly' versions providing different levels of support. Participants' understanding of the information was measured for each format. The format recommended by the CST was compared with the format observed to maximize understanding for each participant. The CST accurately predicted the optimum format for 11/13 participants and differentiated people who could understand fully with support from those who could not in 12/13 cases. All participants interviewed (10/10) found the adapted formats helpful and 9/10 preferred them to the standard version. These findings suggest that the CST could usefully support researchers to determine whether a person with aphasia is likely to be able to provide informed consent, and which information format will maximize that individual's understanding. The CST and different information formats are available as Supplementary Appendices to be found online at http://www.informahealthcare.com/doi/abs/10.3109/17549507.2013.795999 .

  3. 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.

  4. 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. PMID:24664856

  5. 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. PMID:27471590

  6. 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. PMID:23718722

  7. 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

  8. 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.

  9. Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study

    PubMed Central

    Abay, Serebe; Addissie, Adamu; Davey, Gail; Farsides, Bobbie; Addissie, Thomas

    2016-01-01

    Background Informed consent is a key component of bio-medical research involving human participants. However, obtaining informed consent is challenging in low literacy and resource limited settings. Rapid Ethical Assessment (REA) can be used to contextualize and simplify consent information within a given study community. The current study aimed to explore the effects of social, cultural, and religious factors during informed consent process on a proposed HPV-serotype prevalence study. Methodology A qualitative community-based REA was conducted in Adigudom and Mynebri Kebeles, Northern Ethiopia, from July to August 2013. Data were collected by a multi-disciplinary team using open ended questions concerning informed consent components in relation to the parent study. The team conducted one-to-one In-Depth Interviews (IDI) and Focus Group Discussions (FGDs) with key informants and community members to collect data based on the themes of the study. Tape recorded data were transcribed in Tigrigna and then translated into English. Data were categorized and thematically analyzed using open coding and content analysis based on pre-defined themes. Results The REA study revealed a number of socio-cultural issues relevant to the proposed study. Low community awareness about health research, participant rights and cervical cancer were documented. Giving a vaginal sample for testing was considered to be highly embarrassing, whereas giving a blood sample made participants worry that they might be given a result without the possibility of treatment. Verbal consent was preferred to written consent for the proposed study. Conclusion This rapid ethical assessment disclosed important socio-cultural issues which might act as barriers to informed decision making. The findings were important for contextual modification of the Information Sheet, and to guide the best consent process for the proposed study. Both are likely to have enabled participants to understand the informed consent

  10. 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

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

    PubMed

    Levy, Neil

    2016-02-01

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

  12. 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.

  13. Talking more about talking cures: cognitive behavioural therapy and informed consent.

    PubMed

    Blease, C R

    2015-09-01

    Cognitive behavioural therapy (CBT) has risen to prominence as an orthodox treatment option which is commonly recommended to patients with anxiety and depressive disorders. Mainstream healthcare institutions (including the National Health Service in the UK (NHS) and National Institute for Mental Health (NIMH)) assume that CBT works by helping patients to challenge and overcome 'faulty cognition'. Even if we accept the empirical evidence which shows that CBT (like other forms of psychotherapy) is a beneficial treatment there are still problems with this therapy: mainstream medicine and psychotherapy are continuing to ignore established research that CBT does not work according to its core theoretical tenets. This paper presents evidence that psychotherapy is entrenched in such conventional 'wisdom' and that practitioners are failing to meet their own codified requirement of informed consent. I examine ethical arguments for and against upholding current informed consent procedures and focus, in particular, on the relationship between respect for patient autonomy and the duty of beneficence. I argue that (so far) there are no strong grounds for the claim that patient autonomy undermines therapeutic outcome. The modest conclusion of this paper is that psychotherapy (including CBT) needs to begin to adapt informed consent procedures to comply with ongoing scientific research into its efficacy.

  14. 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.

  15. Optimizing informed consent in living liver donors: Evaluation of a comprehension assessment tool.

    PubMed

    Gordon, Elisa J; Mullee, Jack; Butt, Zeeshan; Kang, Joseph; Baker, Talia

    2015-10-01

    Adult-to-adult living liver donation is associated with considerable risks with no direct medical benefit to liver donors (LDs). Ensuring that potential LDs comprehend the risks of donation is essential to medically and ethically justify the procedure. We developed and prospectively evaluated the initial psychometrics of an "Evaluation of Donor Informed Consent Tool" (EDICT) designed to assess LDs' comprehension about the living donation process. EDICT includes 49 true/false/unsure items related to LD informed consent. Consecutive LDs undergoing evaluation at 1 academic medical center from October 2012 to September 2014 were eligible for participation in pretest/posttest interviews. Medical records were reviewed for postdonation complications. Twenty-seven LDs participated (96% participation rate). EDICT demonstrated good internal consistency reliability at pretest, 2 days before donating (Cronbach's α = 0.78), and posttest, 1 week after donating (α = 0.70). EDICT scores significantly increased over time (P = 0.01) and demonstrated good test-retest reliability (r = 0.68; P < 0.001). EDICT was associated with race/ethnicity (P = 0.02) and relationship to the recipient (P = 0.01; pretest), and income (P = 0.01) and insurance (P = 0.01; posttest), but not with decisional conflict, preoperative preparedness, satisfaction, or decisional regret (pretest and posttest). Donor complications did not impact postdonation EDICT scores. In conclusion, EDICT has promising measurement properties and may be useful in the evaluation of informed consent for potential LDs. PMID:25990592

  16. 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

  17. [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.

  18. [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. PMID:23809780

  19. Informed Consent

    MedlinePlus

    ... State Legislative Action Center Leadership & Advocacy Summit 2017 Leadership & Advocacy Summit 2016 Webinars Practice Management Practice Management Practice Management CPT Coding Bulletin Articles ...

  20. Timing invitations to participate in clinical research: preliminary versus informed consent.

    PubMed

    Iltis, Ana Smith

    2005-02-01

    This article addresses the impact of the potential conflict between the roles of physicians who are both clinicians and researchers on the recruitment of persons into research trials. It has been proposed (1) that a physician breaches inter-role confidentiality when he or she uses information gathered in his or her clinical role to inform patients about trials for which they may be eligible and (2) that clinician-researchers should adopt a model of preliminary consent to be approached about research prior to commencing a clinical relationship. This article argues that even if we grant the legitimacy of inter-role confidentiality (which is open to question), there are circumstances in which other obligations physicians bear override the obligation of inter-role confidentiality. Moreover, it is argued that the practice of preliminary consent is morally suspect and that such consent cannot be deemed valid. The article concludes with a series of recommendations of ways in which the legitimate concern regarding the conflicting roles of clinician-researchers can be addressed in the recruitment stage of research.

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. Counseling for women requesting sterilization: a comprehensive program designed to insure informed consent.

    PubMed

    Shapiro-Steinberg, L; Stiglitz Neamatalla, G

    1979-01-01

    This paper describes the counseling program implemented by a social worker and a family planning counselor for female clinic patients requesting sterilization. Rather than limiting counseling to the guidelines for informed consent established by New York City law, a comprehensive approach is utilized. The program combines the provision of information regarding the procedure and contraceptive alternatives, with an opportunity for individuals to examine the psychosocial components of their request for sterilization. It is the authors' assessment that such comprehensive counseling is essential to provide individuals with the full assistance they need in making the decision to eliminate reproductive capacity, and that legal guidelines should be expanded accordingly.

  6. Alternatives to project-specific consent for access to personal information for health research: Insights from a public dialogue

    PubMed Central

    Willison, Donald J; Swinton, Marilyn; Schwartz, Lisa; Abelson, Julia; Charles, Cathy; Northrup, David; Cheng, Ji; Thabane, Lehana

    2008-01-01

    Background The role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues. Methods We conducted seven day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly. Results Broad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research. Conclusion Because no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than

  7. The doctrine of informed consent: a tale of two cultures and two legal traditions.

    PubMed

    Walter, P

    1999-01-01

    In this article, the author compares and contrasts the notion of informed consent in medical decision making in the Western legal system with the traditional Jewish biblical legal system. Walter critically examines the philosophical underpinnings of disease and medical healing in both legal systems, and describes the practical consequences that emanate from the different ideologies in terms of the individual's rights of choice of treatment. She explains that the Western system is predicated on notions of individual autonomy and self determination. Patients therefore have the autonomous ability to select and direct their own medical therapy. By contrast, the traditional biblical system of law is based on the concept that the body does not belong to the individual. Instead, the body is given to man by God as a trust to respect and preserve. Therefore, the individual patients "has no absolute right to control his body and ... he has no real decision making power as to medical treatment choices." In the Jewish biblical tradition, consent is not necessary for obviously beneficial or obviously non-beneficial procedures; consent is only necessary in decisions with uncertain outcomes or when making choices between equal options. Patients are encouraged to seek the counsel of religious authorities and to conform to rabbinical interpretations of the traditional Jewish law.

  8. “Negotiorum Gestio” in Family Medicine, Informed Consent Obtainment, and Disciplinary Responsibility

    PubMed Central

    Birkeland, Søren

    2016-01-01

    Introduction. Negotiorum gestio (NG) denotes an action where a person well intendedly acts on behalf of another without obtaining the latter's prior consent. In broad terms, NG-like actions have played a considerable role in health care provision. In some settings, health care delivery with only little or presumed patients' consent has been the rule rather than the exception. However, bioethical principles regarding patient autonomy and obtainment of the patient's informed consent (IC) before intervention are now increasingly materialized in the law of many countries. Aim. To study legal consequences of NG in family medicine and IC handling options. Methods. Case law examination. Results. A disciplinary board case is described concerning a family doctor conducting unlawful NG by not coming up to legal IC requirements. Discussion and Conclusion. The practical and legal implications of IC and possible role of novel Shared Decision-Making approaches in coming up to regulation and bioethical demands are discussed. It is concluded that a doctor may run an unnecessary legal risk when conducting NG in decision-competent patients and furthermore it is suggested that novel Shared Decision-Making approaches could help in obtaining a rightful and practicable IC. PMID:27110401

  9. Informed consent in research to improve the number and quality of deceased donor organs.

    PubMed

    Rey, Michael M; Ware, Lorraine B; Matthay, Michael A; Bernard, Gordon R; McGuire, Amy L; Caplan, Arthur L; Halpern, Scott D

    2011-02-01

    Improving the management of potential organ donors in the intensive care unit could meet an important public health goal by increasing the number and quality of transplantable organs. However, randomized clinical trials are needed to quantify the extent to which specific interventions might enhance organ recovery and outcomes among transplant recipients. Among several barriers to conducting such studies are the absence of guidelines for obtaining informed consent for such studies and the fact that deceased organ donors are not covered by extant federal regulations governing oversight of research with human subjects. This article explores the underexamined ethical issues that arise in the context of donor management studies and provides ethical guidelines and suggested regulatory oversight mechanisms to enable such studies to be conducted ethically. We conclude that both the respect that is traditionally accorded to the prior wishes of the dead and the possibility of postmortem harm support a role for surrogate consent of donors in such randomized controlled trials. Furthermore, although recipients will often be considered human subjects under federal regulations, several ethical arguments support waiving requirements for recipient consent in donor management randomized controlled trials. Finally, we suggest that new regulatory mechanisms, perhaps linked to existing regional and national organ donation and transplantation infrastructures, must be established to protect patients in donor management studies while limiting unnecessary barriers to the conduct of this important research. PMID:20975549

  10. Trouble in the gap: a bioethical and sociological analysis of informed consent for high-risk medical procedures.

    PubMed

    Jordens, Christopher F C; Montgomery, Kathleen; Forsyth, Rowena

    2013-03-01

    Concerns are frequently raised about the extent to which formal consent procedures actually lead to "informed" consent. As part of a study of consent to high-risk medical procedures, we analyzed in-depth interviews with 16 health care professionals working in bone-marrow transplantation in Sydney, Australia. We find that these professionals recognize and act on their responsibility to inform and educate patients and that they expect patients to reciprocate these efforts by demonstrably engaging in the education process. This expectation is largely implicit, however, and when it is not met, this can give rise to trouble that can have adverse consequences for patients, physicians, and relationships within the clinic. We revisit the concept of the sick role to formalize this new role expectation, and we argue that "informed" consent is a process that is usually incomplete, despite trappings and assumptions that help to create the illusion of completeness.

  11. 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. PMID:27269736

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

    PubMed

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

    2014-01-01

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

  13. 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.

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

    PubMed Central

    2013-01-01

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

  15. 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. PMID:27021386

  16. Volume-outcome disparities and informed consent: what should surgeons disclose?

    PubMed

    Stell, Lance K

    2014-10-01

    It has been repeatedly shown that higher procedure volumes, by hospital and by physician, are associated with better outcomes. Buttressed by large-scale selective service purchasing, surgical care for many volume-sensitive operations has been regionalized. However, the implications of outcome disparity data for obtaining valid patient consent remain uncertain. When the first large scale outcome study appeared showing empirically that outcomes are volume-related, two prominent bioethicists promptly insisted that such information was material to a reasonable patient's decision whether and where to have a volume-sensitive operation and that surgeons at low-volume hospitals should disclose it. More recently, two surgical oncologists have reiterated that argument, most especially when patients are making decisions about pancreatic or esophageal resections. This proposal tantalizingly appeals to the concept of patient empowerment, supposedly showing appropriate respect for the patient's interest in self-determination by having his surgeon (or physician), rather than others, outline for him personally the risks and benefits associated with surgical care delivered at different hospitals. But on the contrary, a surgeon's conducting a truthful, non-misleading, non-confusing informed consent discussion of statistical outcome disparities in the relentlessly shrinking time typically allowed for this conversation is unrealistic as a general requirement. The traditional approach to informed consent is simpler, less fraught and preferable. By law, a surgeon who is licensed to practice independently and who evidences willingness to examine and to offer an operation to a patient conveys (1) an implicit standard of care assurance, and (2) a fiduciary assurance. In other words, it goes without saying that the surgeon holds it out to the patient that s/he possesses the training and skill necessary to perform the offered service with reasonable skill and safety as measured by the

  17. 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. PMID:24942306

  18. Readability of informed consent documents (1987-2007) for clinical trials: a linguistic analysis.

    PubMed

    Sand, K; Eik-Nes, N L; Loge, J H

    2012-10-01

    We investigated the readability of informed consent documents linguistically and compared old and new ICDs. Twenty ICDs (ten from 1987-1992 and ten from 2006-2007) were included. The Evaluative Linguistic Framework (ELF) was used to analyze the texts. The ELF evaluates the following items: main themes, order of themes, rhetorical functions, the relationship between reader and writer, metadiscourse, headings, expert terminology, and visual aspects. An ICD is considered readable if it achieves the goal of inviting the reader to participate and explaining the implication of participation. The new ICDs were more readable than the old ones, as they were more oriented towards research, contained instructions about how to consent, and provided clear contact information. Aspects that reduced the readability of the new ICDs were the large number of topics, details, and actors presented. The readability of the old ICDs was enhanced by fewer topics, a clear presentation of the involved actors, and brevity. However, their readability was reduced by the inclusion of a vast amount of information about the reader's diagnosis and treatment.

  19. 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.

  20. 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

  1. 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.

  2. Taking part in a pharmacogenetic clinical trial: assessment of trial participants understanding of information disclosed during the informed consent process

    PubMed Central

    2013-01-01

    Background This study is the first to examine the understandings that participants have of the consent process in a pharmacogenetic trial of anti-depressant medication. Methods This was a qualitative cross sectional study. There were 76 participants residing in London, Mannheim, Arhuus and Poznan. Results Only one quarter of participants (none in Poznan) could articulate the concept of pharmacogenetics. Heritability and testing medication were also given as the purpose of the trial. Most participants had not appreciated harms that could derive from the trial. Even when shown the consent sheet, participants were confused about DNA profiling. There was evidence that participants appreciated weekly contact with researchers. Most said they would participate in a trial again but would like choice over the intervention they were assigned to. Conclusion Participants in this study showed a poor level of informed consent. Although this is not the first time this argument has been made, it is in the case of a pharmacogenetic trial. Further work should investigate the associations between extraneous factors such as information and social support on beneficial or untoward outcomes of antidepressant treatment. PMID:24025622

  3. 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

  4. 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

  5. e-Consent design and implementation issues for health information managers.

    PubMed

    Grain, Heather

    2004-01-01

    This article outlines and discusses a number of e-consent issues concerning an individual's access to information held in electronic health records. Through research conducted with general practices and health consumers, the following issues have been identified: limitation of health professionals' access to records; the ability of the individuals to limit access to their records and to indicate the circumstances within which access would be permitted; the degree of the health professional's awareness of restricted or total access to a patient's record; audit trails through which an individual can track the path of a record; and the individual's nomination of an agent authorised to control access to their record. These issues affect system developments and Health Information Managers, and key challenges to Health Information Managers in the electronic health record environment are also highlighted.

  6. Informed consent in the psychosis prodrome: ethical, procedural and cultural considerations.

    PubMed

    Morris, Sarah E; Heinssen, Robert K

    2014-01-01

    Research focused on the prodromal period prior to the onset of psychosis is essential for the further development of strategies for early detection, early intervention, and disease pre-emption. Such efforts necessarily require the enrollment of individuals who are at risk of psychosis but have not yet developed a psychotic illness into research and treatment protocols. This work is becoming increasingly internationalized, which warrants special consideration of cultural differences in conceptualization of mental illness and international differences in health care practices and rights regarding research participation. The process of identifying and requesting informed consent from individuals at elevated risk for psychosis requires thoughtful communication about illness risk and often involves the participation of family members. Empirical studies of risk reasoning and decisional capacity in young people and individuals with psychosis suggest that most individuals who are at-risk for psychosis can adequately provide informed consent; however ongoing improvements to tools and procedures are important to ensure that this work proceeds with maximal consideration of relevant ethical issues. This review provides a discussion of these issues in the context of international research efforts. PMID:25403748

  7. Medical Comics as Tools to Aid in Obtaining Informed Consent for Stroke Care

    PubMed Central

    Furuno, Yuichi; Sasajima, Hiroyasu

    2015-01-01

    Abstract Informed consent has now become common in medical practice. However, a gap still exists between doctors and patients in the understanding of clinical conditions. We designed medical comics about “subarachnoid hemorrhage” and “intracerebral hemorrhage” to help doctors obtain informed consent intuitively, quickly, and comprehensively. Between September 2010 and September 2012, we carried out a questionnaire survey about medical comics with the families of patients who had suffered an intracerebral or subarachnoid hemorrhage. The questionnaire consisted of 6 questions inquiring about their mental condition, reading time, usefulness of the comics in understanding brain function and anatomy, pathogenesis, doctor's explanation, and applicability of these comics. The results showed that 93.8% responders would prefer or strongly prefer the use of comics in other medical situations. When considering the level of understanding of brain function and anatomy, pathology of disease, and doctor's explanation, 81.3%, 75.0%, and 68.8% of responders, respectively, rated these comics as very useful or useful. We think that the visual and narrative illustrations in medical comics would be more helpful for patients than a lengthy explanation by a doctor. Most of the responders hoped that medical comics would be applied to other medical cases. Thus, medical comics could work as a new communication tool between doctors and patients. PMID:26131830

  8. Medical Comics as Tools to Aid in Obtaining Informed Consent for Stroke Care.

    PubMed

    Furuno, Yuichi; Sasajima, Hiroyasu

    2015-07-01

    Informed consent has now become common in medical practice. However, a gap still exists between doctors and patients in the understanding of clinical conditions. We designed medical comics about "subarachnoid hemorrhage" and "intracerebral hemorrhage" to help doctors obtain informed consent intuitively, quickly, and comprehensively.Between September 2010 and September 2012, we carried out a questionnaire survey about medical comics with the families of patients who had suffered an intracerebral or subarachnoid hemorrhage. The questionnaire consisted of 6 questions inquiring about their mental condition, reading time, usefulness of the comics in understanding brain function and anatomy, pathogenesis, doctor's explanation, and applicability of these comics.The results showed that 93.8% responders would prefer or strongly prefer the use of comics in other medical situations. When considering the level of understanding of brain function and anatomy, pathology of disease, and doctor's explanation, 81.3%, 75.0%, and 68.8% of responders, respectively, rated these comics as very useful or useful.We think that the visual and narrative illustrations in medical comics would be more helpful for patients than a lengthy explanation by a doctor. Most of the responders hoped that medical comics would be applied to other medical cases. Thus, medical comics could work as a new communication tool between doctors and patients.

  9. To tell the truth, the whole truth, may do patients harm: the problem of the nocebo effect for informed consent.

    PubMed

    Wells, Rebecca Erwin; Kaptchuk, Ted J

    2012-01-01

    The principle of informed consent obligates physicians to explain possible side effects when prescribing medications. This disclosure may itself induce adverse effects through expectancy mechanisms known as nocebo effects, contradicting the principle of nonmaleficence. Rigorous research suggests that providing patients with a detailed enumeration of every possible adverse event-especially subjective self-appraised symptoms-can actually increase side effects. Describing one version of what might happen (clinical "facts") may actually create outcomes that are different from what would have happened without this information (another version of "facts"). This essay argues that the perceived tension between balancing informed consent with nonmaleficence might be resolved by recognizing that adverse effects have no clear black or white "truth." This essay suggests a pragmatic approach for providers to minimize nocebo responses while still maintaining patient autonomy through "contextualized informed consent," which takes into account possible side effects, the patient being treated, and the particular diagnosis involved.

  10. 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.

  11. Informing egg donors of the potential for embryonic research: A survey of consent forms from US IVF clinics

    PubMed Central

    Schaefer, G. Owen; Sinaii, Ninet; Grady, Christine

    2013-01-01

    Objective To understand whether and to what extent US in vitro fertilization (IVF) clinics inform egg donors that resultant embryos initially intended to be implanted for reproductive purposes may in fact be used for research instead. Design 470 US IVF were asked to respond to a questionnaire and provide a copy of the egg donor consent form(s) used at the clinic. Setting 470 US IVF clinics listed in a Centers for Disease Control and Prevention database; only forms from clinics that both accepted donor eggs and provided excess embryos for research were analyzed for content. Main Outcome Measures Responses to the questionnaire, demographic data from a Centers for Disease Control and Prevention database and the content of egg donor consent forms. Results Of 222 US IVF clinics who responded to our query, 100 clinics both accepted donor eggs and provided some excess embryos for research. We received 66 consent forms from these 100 clinics, which showed that although most egg donor consent forms inform donors that they will not have control over embryos resulting from their eggs, 30% inform them that some embryos may be used for research, and even fewer mention stem cell research. Conclusion Egg donors in the US, including some who may have a moral objection to research and stem cell research, are not being informed that embryos created with their donated eggs may in fact be used for these purposes. This can be corrected with the inclusion of succinct, non-technical language in egg donor consent forms. PMID:22196714

  12. 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. PMID:24671866

  13. 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.

  14. 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.

  15. 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

    2016-01-01

    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. PMID:27145389

  16. The influence of objective prognostic information on the likelihood of informed consent for decompressive craniectomy: a study of Australian anaesthetists.

    PubMed

    Honeybul, S; O'Hanlon, S; Ho, K M; Gillett, G

    2011-07-01

    The aim of this study was to assess the influence of detailed prognostic information on the likelihood of informed consent for decompressive craniectomy for severe traumatic brain injury. The study was a simulation exercise, asking anaesthetists to give opinions as if they themselves were the injured party. Anaesthetists were chosen as they represent a distinct group likely to be familiar with the procedure and the decision-making process, but not necessarily aware of the longer-term outcomes. A two-part structured interview was used. Seventy-five anaesthetists were shown three cases of differing severity of traumatic brain injury. A visual analogue scale (1 to 10) was used to assess the strengths of their opinion. Initially they were asked their opinion with no predictive outcome data. They were then shown the prediction of an unfavourable outcome (Glasgow Outcome Scale severely disabled, vegetative state or dead) and the observed outcome at 18-month follow-up from a cohort of 147 patients (who had had a decompressive craniectomy for severe traumatic brain injury in Perth, Western Australia between the years 2004 and 2008). The opinions of the participants before and after seeing the prediction outcome data were compared. The participants' preferences to consent to the procedure changed after being informed of the predicted risks of unfavourable outcomes (P values < 0.01). The changes in attitude appeared to be independent of age group, amount of experience in caring for similar patients and religious background. These findings suggest that access to objective information on risks of unfavourable outcomes may influence opinions in relation to consent for decompressive craniectomy for traumatic brain injury. PMID:21823386

  17. Information Services of Maritime Industry

    NASA Astrophysics Data System (ADS)

    Palazov, Atanas; Stefanov, Asen

    2015-04-01

    The ultimate goal of modern oceanography is an end user oriented product. Beneficiaries are the governmental services, coast-based enterprises and research institutions that make use of the products generated by operational oceanography. Direct potential users and customers are coastal managers, shipping, offshore industry, ports and harbours, fishing, tourism and recreation industry, and scientific community. Indirect beneficiaries, through climate forecasting based on ocean observations, are food, energy, water and medical suppliers. Five general classes of users for data and information are specified: (1) operational users that analyze the collected data and produce different forecasts serving to impose regulation measures; (2) authorities and managers of large-scale projects needing timely oceanographic information, including statistics and climatic trends; (3) industrial enterprises, safety of structures and avoiding of pollution; (4) tourism and recreation related users aiming protection of human health; (5) scientists, engineers, and economists carrying out special researches, strategic design studies, and other investigations to advance the application of marine data. The analysis of information received during the extensive inquiry among all potential end users reveals variety of data and information needs encompassing physical, chemical, biological and hydrometeorological observation. Nevertheless, the common requirement concerns development of observing and forecasting systems providing accurate real-time or near-real time data and information supporting decision making and environmental management. Availability of updated information on the actual state as well as forecast for the future changes of marine environment are essential for the success and safety of maritime operations in the offshore industry. For this purpose different systems have been developed to collect data and to produce forecasts on the state of the marine environment and to provide

  18. First-in-human cell transplant trials in Parkinson's disease: The need for an improved informed consent process.

    PubMed

    de Melo-Martín, Inmaculada; Hellmers, Natalie; Henchcliffe, Claire

    2015-08-01

    First-in-human clinical trials of innovative medical procedures, such as cell transplantation for Parkinson's disease, present a variety of ethical challenges. In an era of rapidly developing stem cell technologies likely to be translated into clinical trials over the next few years, it is critical that ethical concerns be fully considered. One important undertaking is ensuring that research participants give free and truly informed consent. This will necessitate adequate disclosure of risks and benefits at a time when these are incompletely defined; ensuring understanding of a complex research protocol when there is significant possibility of therapeutic misconception; and careful determination of capacity for informed consent in patients with a neurodegenerative disorder that is known to affect cognition. Here we call attention to the ethical issues that researchers conducting these types of trials will face when trying to obtain a genuinely informed consent, and we suggest possible solutions.

  19. 7 CFR 1219.15 - Industry information.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., AND INFORMATION Hass Avocado Promotion, Research, and Information Order Definitions § 1219.15 Industry information. Industry information means information, programs, and activities that are designed to increase... 7 Agriculture 10 2010-01-01 2010-01-01 false Industry information. 1219.15 Section...

  20. 7 CFR 1219.15 - Industry information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 10 2014-01-01 2014-01-01 false Industry information. 1219.15 Section 1219.15..., AND INFORMATION Hass Avocado Promotion, Research, and Information Order Definitions § 1219.15 Industry information. Industry information means information, programs, and activities that are designed to...

  1. 7 CFR 1219.15 - Industry information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 10 2012-01-01 2012-01-01 false Industry information. 1219.15 Section 1219.15..., AND INFORMATION Hass Avocado Promotion, Research, and Information Order Definitions § 1219.15 Industry information. Industry information means information, programs, and activities that are designed to...

  2. 7 CFR 1219.15 - Industry information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 10 2011-01-01 2011-01-01 false Industry information. 1219.15 Section 1219.15..., AND INFORMATION Hass Avocado Promotion, Research, and Information Order Definitions § 1219.15 Industry information. Industry information means information, programs, and activities that are designed to...

  3. 7 CFR 1219.15 - Industry information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 10 2013-01-01 2013-01-01 false Industry information. 1219.15 Section 1219.15..., AND INFORMATION Hass Avocado Promotion, Research, and Information Order Definitions § 1219.15 Industry information. Industry information means information, programs, and activities that are designed to...

  4. 7 CFR 1215.8 - Industry information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 10 2013-01-01 2013-01-01 false Industry information. 1215.8 Section 1215.8... Industry information. Industry information means information and programs that will lead to the development of new markets, new marketing strategies, or increased efficiency for the popcorn industry,...

  5. 7 CFR 1209.9 - Industry information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 10 2013-01-01 2013-01-01 false Industry information. 1209.9 Section 1209.9... Definitions § 1209.9 Industry information. Industry information means information and programs that will lead... enhance the image of the mushroom industry....

  6. 7 CFR 1215.8 - Industry information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 10 2012-01-01 2012-01-01 false Industry information. 1215.8 Section 1215.8... Industry information. Industry information means information and programs that will lead to the development of new markets, new marketing strategies, or increased efficiency for the popcorn industry,...

  7. 7 CFR 1215.8 - Industry information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 10 2011-01-01 2011-01-01 false Industry information. 1215.8 Section 1215.8... Industry information. Industry information means information and programs that will lead to the development of new markets, new marketing strategies, or increased efficiency for the popcorn industry,...

  8. 7 CFR 1209.9 - Industry information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 10 2011-01-01 2011-01-01 false Industry information. 1209.9 Section 1209.9... Definitions § 1209.9 Industry information. Industry information means information and programs that will lead... enhance the image of the mushroom industry....

  9. 7 CFR 1215.8 - Industry information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 10 2014-01-01 2014-01-01 false Industry information. 1215.8 Section 1215.8... Industry information. Industry information means information and programs that will lead to the development of new markets, new marketing strategies, or increased efficiency for the popcorn industry,...

  10. 7 CFR 1209.9 - Industry information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 10 2012-01-01 2012-01-01 false Industry information. 1209.9 Section 1209.9... Definitions § 1209.9 Industry information. Industry information means information and programs that will lead... enhance the image of the mushroom industry....

  11. 7 CFR 1209.9 - Industry information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 10 2014-01-01 2014-01-01 false Industry information. 1209.9 Section 1209.9... Definitions § 1209.9 Industry information. Industry information means information and programs that will lead... enhance the image of the mushroom industry....

  12. 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. PMID:27465453

  13. 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.

  14. Ethical challenges in the care of persons with hepatitis C infection: a pilot study to enhance informed consent with veterans.

    PubMed

    Geppert, Cynthia M A; Dettmer, Elizabeth; Jakiche, Antonie

    2005-01-01

    Psychiatric and addictive disorders are often considered contraindications to hepatitis C virus (HCV) treatment. In this pilot study, the ability of 30 veterans to provide informed consent for combined antiviral HCV therapy was examined with a mental health assessment protocol specifically geared to evaluate capacity in this area. The results showed that subjects lacked essential knowledge regarding the course of the disease and the nature of antiviral treatment despite receiving prior counseling. Informed consent assessments of candidates for HCV treatment may identify deficits that are responsive to intervention, thereby allowing patients with comorbid psychiatric and addictive disorders to receive effective HCV treatment. PMID:16145183

  15. 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.

  16. 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. PMID:27491250

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

    PubMed

    Alahmad, G H; Dierickx, K

    2014-11-01

    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. PMID:25601806

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

    PubMed

    Alahmad, G H; Dierickx, K

    2014-11-01

    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.

  19. 7 CFR 1220.112 - Industry information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 10 2014-01-01 2014-01-01 false Industry information. 1220.112 Section 1220.112... CONSUMER INFORMATION Soybean Promotion and Research Order Definitions § 1220.112 Industry information. The term industry information means information and programs that will lead to the development of...

  20. 7 CFR 1220.112 - Industry information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 10 2013-01-01 2013-01-01 false Industry information. 1220.112 Section 1220.112... CONSUMER INFORMATION Soybean Promotion and Research Order Definitions § 1220.112 Industry information. The term industry information means information and programs that will lead to the development of...

  1. 7 CFR 1220.112 - Industry information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 10 2012-01-01 2012-01-01 false Industry information. 1220.112 Section 1220.112... CONSUMER INFORMATION Soybean Promotion and Research Order Definitions § 1220.112 Industry information. The term industry information means information and programs that will lead to the development of...

  2. 7 CFR 1220.112 - Industry information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 10 2011-01-01 2011-01-01 false Industry information. 1220.112 Section 1220.112... CONSUMER INFORMATION Soybean Promotion and Research Order Definitions § 1220.112 Industry information. The term industry information means information and programs that will lead to the development of...

  3. Informed consent, vulnerability and the risks of group-specific attribution.

    PubMed

    Schrems, Berta M

    2014-11-01

    People in extraordinary situations are vulnerable. As research participants, they are additionally threatened by abuse or exploitation and the possibility of harm through research. To protect people against these threats, informed consent as an instrument of self-determination has been introduced. Self-determination requires autonomous persons, who voluntarily make decisions based on their values and morals. However, in nursing research, this requirement cannot always be met. Advanced age, chronic illness, co-morbidity and frailty are reasons for dependencies. These in turn lead to limited abilities or opportunities for decision-making and self-determination. Exclusion of vulnerable people from research projects would disadvantage them by not covering their needs, which would violate the ethical principles of justice and beneficence. Commonly, vulnerability is attributed to social groups. The consequence for individuals, attributed as belonging to such a vulnerable group, is that the principles of respect for autonomy, justice and beneficence are subordinated to the principle of non-maleficence, understood as avoiding the risk to cause more harm than good. In addition, group-specific attribution could lead to stigmatizing because labelling a person as deviation from a norm violates integrity. For clinical nursing research, the question arises how the protection of vulnerable people could be granted without compromising ethical principles. The concept of relational ethics provides a possible approach. It defines vulnerability as the relation between a person's health status and the extent to which this person is dependent on the researcher and the research context. Vulnerability is not attributed solely to a person but to a situation, meaning the person is viewed in context. By combining vulnerability as a context-related and situational concept with existing approaches of informed consent, the different ethical principles can be balanced and preserved at every step

  4. Achieving Informed Consent for Cellular Therapies: A Preclinical Translational Research Perspective on Regulations versus a Dose of Reality.

    PubMed

    Anderson, Aileen J; Cummings, Brian J

    2016-09-01

    A central principle of bioethics is "subject autonomy," the acknowledgement of the primacy of the informed consent of the subject of research. Autonomy requires informed consent - the assurance that the research participant is informed about the possible risks and benefits of the research. In fact, informed consent is difficult when a single drug is being tested, although subjects have a baseline understanding of the testing of a pharmacological agent and the understanding that they can stop taking the drug if there were an adverse event. However, informed consent is even less easily achieved in the modern arena of complex new molecular and cellular therapies. In this article, we argue that as science confronts new issues such as transplantation of stem cell products, which may live within the participant for the rest of their lives, researchers must carefully consider and constantly re-examine how they properly inform subjects considering participation trials of these novel therapeutic strategies.For example, the manufacture of a vial of a cell product that consists of a collection of growing cells is very different than the production of a vial of identical pills, which can be presumed to be identical. The scientific concepts on which these cellular approaches are based may seem alien and incomprehensible to a research subject, who thinks of a clinical trial as simply the selection and testing of the most efficacious pharmaceutical agent already proven to work in preclinical animal studies. The research subject would be wrong. PMID:27587445

  5. [Informed consent for standard procedures and for clinical research in paediatric anaesthesia].

    PubMed

    Murat, I; Sabourdin, N; Balestrat, E; Louvet, N

    2013-01-01

    This short review is aimed at describing the particularities of consent in paediatric patients. For routine procedures, the consent of one of the parents is required whereas both parents should sign the consent for research protocols. In case of difficulties such as Jehovah witnesses or parental opposite opinions, doctors should ask the question to the judge in charge of protection of children. Consent or at least assent of minors enrolled in research protocols should be obtained provided their maturity is sufficient to understand correctly the purpose of clinical research. PMID:23183134

  6. 7 CFR 1260.125 - Industry information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 10 2011-01-01 2011-01-01 false Industry information. 1260.125 Section 1260.125... Promotion and Research Order Definitions § 1260.125 Industry information. Industry information means... efficiency, and activities to enhance the image of the cattle industry....

  7. 7 CFR 1260.125 - Industry information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 10 2013-01-01 2013-01-01 false Industry information. 1260.125 Section 1260.125... Promotion and Research Order Definitions § 1260.125 Industry information. Industry information means... efficiency, and activities to enhance the image of the cattle industry....

  8. 7 CFR 1260.125 - Industry information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 10 2014-01-01 2014-01-01 false Industry information. 1260.125 Section 1260.125... Promotion and Research Order Definitions § 1260.125 Industry information. Industry information means... efficiency, and activities to enhance the image of the cattle industry....

  9. 7 CFR 1260.125 - Industry information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 10 2012-01-01 2012-01-01 false Industry information. 1260.125 Section 1260.125... Promotion and Research Order Definitions § 1260.125 Industry information. Industry information means... efficiency, and activities to enhance the image of the cattle industry....

  10. Patient and public attitudes towards informed consent models and levels of awareness of Electronic Health Records in the UK

    PubMed Central

    Riordan, Fiona; Papoutsi, Chrysanthi; Reed, Julie E.; Marston, Cicely; Bell, Derek; Majeed, Azeem

    2015-01-01

    Background The development of Electronic Health Records (EHRs) forms an integral part of the information strategy for the National Health Service (NHS) in the UK, with the aim of facilitating health information exchange for patient care and secondary use, including research and healthcare planning. Implementing EHR systems requires an understanding of patient expectations for consent mechanisms and consideration of public awareness towards information sharing as might be made possible through integrated EHRs across primary and secondary health providers. Objectives To explore levels of public awareness about EHRs and to examine attitudes towards different consent models with respect to sharing identifiable and de-identified records for healthcare provision, research and planning. Methods A cross-sectional questionnaire survey was administered to adult patients and members of the public in primary and secondary care clinics in West London, UK in 2011. In total, 5331 individuals participated in the survey, and 3157 were included in the final analysis. Results The majority (91%) of respondents expected to be explicitly asked for consent for their identifiable records to be accessed for health provision, research or planning. Half the respondents (49%) did not expect to be asked for consent before their de-identified records were accessed. Compared with White British respondents, those from all other ethnic groups were more likely to anticipate their permission would be obtained before their de-identified records were used. Of the study population, 59% reported already being aware of EHRs before the survey. Older respondents and individuals with complex patterns of interaction with healthcare services were more likely to report prior awareness of EHRs. Individuals self-identifying as belonging to ethnic groups other than White British, and those with lower educational qualifications were less likely to report being aware of EHRs than White British respondents and

  11. 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

  12. Improving Validity of Informed Consent for Biomedical Research in Zambia Using a Laboratory Exposure Intervention

    PubMed Central

    Zulu, Joseph Mumba; Lisulo, Mpala Mwanza; Besa, Ellen; Kaonga, Patrick; Chisenga, Caroline C.; Chomba, Mumba; Simuyandi, Michelo; Banda, Rosemary; Kelly, Paul

    2014-01-01

    Background Complex biomedical research can lead to disquiet in communities with limited exposure to scientific discussions, leading to rumours or to high drop-out rates. We set out to test an intervention designed to address apprehensions commonly encountered in a community where literacy is uncommon, and where complex biomedical research has been conducted for over a decade. We aimed to determine if it could improve the validity of consent. Methods Data were collected using focus group discussions, key informant interviews and observations. We designed an intervention that exposed participants to a detailed demonstration of laboratory processes. Each group was interviewed twice in a day, before and after exposure to the intervention in order to assess changes in their views. Results Factors that motivated people to participate in invasive biomedical research included a desire to stay healthy because of the screening during the recruitment process, regular advice from doctors, free medical services, and trust in the researchers. Inhibiting factors were limited knowledge about samples taken from their bodies during endoscopic procedures, the impact of endoscopy on the function of internal organs, and concerns about the use of biomedical samples. The belief that blood can be used for Satanic practices also created insecurities about drawing of blood samples. Further inhibiting factors included a fear of being labelled as HIV positive if known to consult heath workers repeatedly, and gender inequality. Concerns about the use and storage of blood and tissue samples were overcome by a laboratory exposure intervention. Conclusion Selecting a group of members from target community and engaging them in a laboratory exposure intervention could be a useful tool for enhancing specific aspects of consent for biomedical research. Further work is needed to determine the extent to which improved understanding permeates beyond the immediate group participating in the intervention

  13. 38 CFR 17.32 - Informed consent and advance care planning.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...-authorized consent form is valid for a period of 60 calendar days. If, however, the treatment plan involves... documentation so long as the course of treatment proceeds as planned, even if treatment extends beyond the 60...) Close friend. (f) Consent for patients without surrogates. (1) If none of the surrogates listed...

  14. 38 CFR 17.32 - Informed consent and advance care planning.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...-authorized consent form is valid for a period of 60 calendar days. If, however, the treatment plan involves... documentation so long as the course of treatment proceeds as planned, even if treatment extends beyond the 60...) Close friend. (f) Consent for patients without surrogates. (1) If none of the surrogates listed...

  15. Intervention Research with Youths at Elevated Risk for Suicide: Meeting the Ethical and Regulatory Challenges of Informed Consent and Assent

    ERIC Educational Resources Information Center

    King, Cheryl A.; Kramer, Anne C.

    2008-01-01

    Intervention research with youths at elevated risk for suicidal behavior and suicide--a vulnerable and high risk population--presents investigators with numerous ethical challenges. This report specifically addresses those challenges involving the informed consent and assent process with parents/guardians and youths. The challenges are delineated…

  16. 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.

  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. Reflecting on earlier experiences with unsolicited findings: points to consider for next-generation sequencing and informed consent in diagnostics.

    PubMed

    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

    2013-10-01

    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.

  19. 20 CFR 401.110 - Disclosure of personal information in nonprogram records without the consent of the subject of...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... made from our nonprogram records, e.g., administrative and personnel records, without your consent... be disclosed under the Freedom of Information Act, 5 U.S.C. 552, and 20 CFR part 402. (c) For a... other value to warrant its continued preservation by the United States Government, or for evaluation...

  20. 20 CFR 401.110 - Disclosure of personal information in nonprogram records without the consent of the subject of...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... made from our nonprogram records, e.g., administrative and personnel records, without your consent... be disclosed under the Freedom of Information Act, 5 U.S.C. 552, and 20 CFR part 402. (c) For a... other value to warrant its continued preservation by the United States Government, or for evaluation...

  1. 20 CFR 401.110 - Disclosure of personal information in nonprogram records without the consent of the subject of...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... made from our nonprogram records, e.g., administrative and personnel records, without your consent... be disclosed under the Freedom of Information Act, 5 U.S.C. 552, and 20 CFR part 402. (c) For a... other value to warrant its continued preservation by the United States Government, or for evaluation...

  2. 20 CFR 401.110 - Disclosure of personal information in nonprogram records without the consent of the subject of...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... made from our nonprogram records, e.g., administrative and personnel records, without your consent... be disclosed under the Freedom of Information Act, 5 U.S.C. 552, and 20 CFR part 402. (c) For a... other value to warrant its continued preservation by the United States Government, or for evaluation...

  3. 20 CFR 401.110 - Disclosure of personal information in nonprogram records without the consent of the subject of...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... made from our nonprogram records, e.g., administrative and personnel records, without your consent... be disclosed under the Freedom of Information Act, 5 U.S.C. 552, and 20 CFR part 402. (c) For a... other value to warrant its continued preservation by the United States Government, or for evaluation...

  4. 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...

  5. 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

  6. Lethal autonomy: the malfunction of the informed consent mechanism within the context of prenatal diagnosis of genetic variants.

    PubMed

    Dunne, C; Warren, C

    1998-01-01

    In this article, Cara Dunne and Catherine Warren challenge the current role of genetic counselors in advising expectant mothers about potential genetic defects of their fetuses. They show that genetic counselors sometimes provide one-sided negative information to women undergoing prenatal diagnosis of genetic variants. This biased information promotes abortion of what are considered "defective" fetuses. The misleading information provided by the genetic counselors and the termination of the pregnancies is akin to the eugenics movement. The authors describe the early 20th century eugenics movement, explore the origin and development of the Human Genome Project, analyze the current role of genetic counseling, and explain the importance of the informed consent process to the exercise of autonomy. Dunne and Warren conclude by offering methods by which to restructure the informed consent mechanism to offer a more balanced assessment of the risks and benefits associated with genetic disability.

  7. 7 CFR 1220.112 - Industry information.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE SOYBEAN PROMOTION, RESEARCH, AND CONSUMER INFORMATION Soybean Promotion and Research Order Definitions § 1220.112 Industry information. The... markets, new marketing strategies, or increased efficiency for the soybean industry, and activities...

  8. 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

  9. 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.

  10. Individual genetic and genomic research results and the tradition of informed consent: exploring U.S. review board guidance

    PubMed Central

    Simon, Christian M.; Shinkunas, Laura; Brandt, Debra; Williams, Janet K.

    2015-01-01

    Background Genomic research is challenging the tradition of informed consent. Genomic researchers in the United States, Canada, and parts of Europe are encouraged to use informed consent to address the prospect of disclosing individual research results (IRRs) to study participants. In the U.S., no national policy exists to direct this use of informed consent, and it is unclear how local Institutional Review Boards (IRBs) may want researchers to respond. Objective and Methods To explore publicly accessible IRB websites for guidance in this area, using summative content analysis. Findings Three types of research results were addressed in 45 informed consent templates and instructions from 20 IRBs based at centers conducting genomic research: 1) IRRs in general 2) incidental findings (IFs), and 3) a broad and unspecified category of, “significant new findings” (SNFs). IRRs were more frequently referenced than IFs or SNFs. Most documents stated that access to IRRs would not be an option for research participants. These nondisclosure statements were found to coexist in some documents with statements that SNFs would be disclosed to participants if related to their willingness to participate in research. The median readability of template language on IRRs, IFs, and SNFs was greater than a 9th grade level. Conclusion IRB guidance may downplay the possibility of IFs, and contain conflicting messages on IRR nondisclosure and SNF disclosure. IRBs may need to clarify why separate IRR and SNF language should appear in the same consent document. The extent of these issues, nationally and internationally, needs to be determined. PMID:22361295

  11. 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

  12. 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.

  13. Practical Communication Guidance to Improve Phase I Informed Consent Conversations and Decision-Making in Pediatric Oncology

    PubMed Central

    Johnson, Liza-Marie; Leek, Angela C.; Drotar, Dennis; Noll, Robert B.; Rheingold, Susan R.; Kodish, Eric D.; Baker, Justin N.

    2015-01-01

    Background It can be difficult to explain pediatric Phase I oncology trials to families of children with refractory cancer. Parents may misunderstand the information presented to them, and physicians may assume that certain topics are covered in the informed consent document and need not be discussed. Communication models can help to ensure effective discussions. Methods Suggestions for improving the informed consent process were first solicited from Phase I study clinicians via questionnaire. Eight parents who had enrolled their child on a Phase I pediatric oncology trial were recruited for an advisory group designed to assess the clinicians’ suggestions and make additional recommendations for improving informed consent for pediatric Phase I trials. Results A Phase I Communication Model was designed to incorporate the suggestions of clinicians and families. It focuses on education of parents/families about Phase I trials at specific time points during a child’s illness, but specifically at the point of relapse. We also present an informative Phase I fact sheet that can be distributed to families. Conclusions Families who will be offered information about a Phase I clinical trial can first receive a standardized fact sheet explaining the general purpose of these early-phase clinical trials. Parental understanding may be further enhanced when oncologists address key themes, beginning at diagnosis and continuing through important decision points during the child’s illness. This model should be prospectively evaluated. PMID:25873253

  14. [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. PMID:20011949

  15. Parent Participation and Physician-Parent Communication During Informed Consent in Child Leukemia

    PubMed Central

    Cousino, Melissa; Hazen, Rebecca; Yamokoski, Amy; Miller, Victoria; Zyzanski, Stephen; Drotar, Dennis

    2011-01-01

    OBJECTIVE: In this study we evaluated the effectiveness of a physician-directed intervention at enhancing positive physician behaviors and communication strategies during informed consent conferences (ICCs) for pediatric acute leukemia clinical trials. PATIENTS AND METHODS: Physicians at 2 large pediatric hospitals were recruited to participate in a physician-directed intervention (PDI), which included 1 full-day seminar and successive half-day booster sessions. ICCs were then observed, audiotaped, coded, and analyzed to evaluate the effectiveness of the intervention. Data also were collected at 2 control sites. Between 2003 and 2007, 59 ICCs were observed and analyzed. RESULTS: Significant group differences were found in physician rapport-building behaviors. Physicians in the PDI + booster session group engaged in greater rapport-building than did physicians in the PDI group who did not attend booster sessions and physicians in the control group. No group differences were detected for physician partnership-building. In addition, parents in the PDI + booster session group engaged in more general communication and study-related communication, and mothers in the PDI groups asked significantly more questions per minute than did mothers in the control group. CONCLUSIONS: These results provide support for the effectiveness of the PDI at enhancing positive physician behaviors. Booster-session attendance is a critical component of physician-directed interventions to improve parental participation and physician-parent communication during ICCs. PMID:22065265

  16. 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.

  17. 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

  18. 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.

  19. The Challenges of Research Informed Consent in Socio-Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo.

    PubMed

    Kalabuanga, Marion; Ravinetto, Raffaella; Maketa, Vivi; Muhindo Mavoko, Hypolite; Fungula, Blaise; Inocêncio da Luz, Raquel; Van Geertruyden, Jean-Pierre; Lutumba, Pascal

    2016-08-01

    In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio-cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of socio-economic vulnerability. To ensure children's protection, consent is required by the parents or, in their absence, by a legally mandated representative. In our setting, children's responsibility is often entrusted permanently or temporarily to relatives or friends without a tribunal mandate. Hence, a notion of 'culturally acceptable representative' under supervision of the local Ethics Committee may be more suitable. To ensure protection of illiterate subjects, an independent witness is required to confirm that the consent was freely given. However, in low-literacy contexts, potential witnesses often don't have any previous relationship with patient and there may be power-unbalance in their relationship, rather than genuine dialogue. In poor communities, trial participation may be seen as an opportunity to secure access to healthcare. Poverty may also lead to 'competition' to access the research-related benefits, with a risk of disturbance at societal or household level. Adjusting consent procedures to sociocultural and socioeconomic realities is essential for fulfilling the underlying ethical principles. This requires a collaborative dialogue between researchers, regulators and ethics committees.

  20. 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

  1. Investigating the informed consent process, therapeutic misconception and motivations of Egyptian research participants: a qualitative pilot study.

    PubMed

    Mansour, H; Zaki, N; Abdelhai, R; Sabry, N; Silverman, H; El-Kamary, S S

    2015-03-01

    Few studies have explored the informed consent process among research participants in developing countries. This study aimed to evaluate the informed consent process, therapeutic misconception and motivation for participation among Egyptians participating in clinical trials. In a cross-sectional qualitative pilot study 103 participants in 10 clinical trials responded to a questionnaire. Over 90% agreed they had time to ask questions and received adequate information about the risks prior to consenting. All participants thought the research and the drug would improve their condition; only 46.1% were aware of receiving a non-approved experimental drug and 21.3% of being randomized. Reasons for participation included: better treatment (100%), to benefit society & advance science (85.4%), to receive free drugs (42.6%) and medical care (43.6%), to get hospitalized (15.8%) and to receive money or gifts (4.9%). Investigators need to emphasize the distinction between research and clinical care to address the high rate of therapeutic misconception. PMID:26074215

  2. Investigating the informed consent process, therapeutic misconception and motivations of Egyptian research participants: a qualitative pilot study.

    PubMed

    Mansour, H; Zaki, N; Abdelhai, R; Sabry, N; Silverman, H; El-Kamary, S S

    2015-05-19

    Few studies have explored the informed consent process among research participants in developing countries. This study aimed to evaluate the informed consent process, therapeutic misconception and motivation for participation among Egyptians participating in clinical trials. In a cross-sectional qualitative pilot study 103 participants in 10 clinical trials responded to a questionnaire. Over 90% agreed they had time to ask questions and received adequate information about the risks prior to consenting. All participants thought the research and the drug would improve their condition; only 46.1% were aware of receiving a non-approved experimental drug and 21.3% of being randomized. Reasons for participation included: better treatment (100%), to benefit society & advance science (85.4%), to receive free drugs (42.6%) and medical care (43.6%), to get hospitalized (15.8%) and to receive money or gifts (4.9%). Investigators need to emphasize the distinction between research and clinical care to address the high rate of therapeutic misconception.

  3. [Informed Consent in the Humanization of the Cesarean: A Preliminary Study].

    PubMed

    Castaño Molina, M Ángeles; Carrillo Navarro, Francisco; Pastor, Luis Miguel

    2016-01-01

    The informed consent (IC) is a process based on dialogue between the professional and the patient in which he freely decides on possible interventions in their health. This is applicable to caesarean delivery and if it meets a number of conditions will help to improve the process of ″humanization″ of birth. The overall objective of this study is to analyze preliminarily in several hospitals in the Region of Murcia the IC in caesarean delivery. To this end, we have revised the documents of IC and we studied who, where, when and how the IC process is done. The results show that all hospitals are based on the same document, and although the documents take into account all the elements of a IC, do not indicate the date of their design or subsequent revisions. It does not contemplate the risks and complications that caesarean section can have on the newborn, mother, and mother-child relationship later. It is noted that the document of IC normally is delivers by gynecologist in the consultation, when intervention is programmed, although it are sometimes nurses, who after admission to the hospital give it to sign the patient. In urgent caesarean sections, there are some hospitals that in life-threatening situation, do not offer the document of IC to women. In others, it is offered hastily by the gynecologist or midwife. In conclusion, the IC is a process which used correctly, favors the relationship between women and health professionals in the intervention of cesarean section. Although this process and the documents of IC examined in our study, have presented many positive aspects, the humanization of caesarean could be increased improving with the preparation and updating of these documents and coordinating the various professionals.

  4. [Informed Consent in the Humanization of the Cesarean: A Preliminary Study].

    PubMed

    Castaño Molina, M Ángeles; Carrillo Navarro, Francisco; Pastor, Luis Miguel

    2016-01-01

    The informed consent (IC) is a process based on dialogue between the professional and the patient in which he freely decides on possible interventions in their health. This is applicable to caesarean delivery and if it meets a number of conditions will help to improve the process of ″humanization″ of birth. The overall objective of this study is to analyze preliminarily in several hospitals in the Region of Murcia the IC in caesarean delivery. To this end, we have revised the documents of IC and we studied who, where, when and how the IC process is done. The results show that all hospitals are based on the same document, and although the documents take into account all the elements of a IC, do not indicate the date of their design or subsequent revisions. It does not contemplate the risks and complications that caesarean section can have on the newborn, mother, and mother-child relationship later. It is noted that the document of IC normally is delivers by gynecologist in the consultation, when intervention is programmed, although it are sometimes nurses, who after admission to the hospital give it to sign the patient. In urgent caesarean sections, there are some hospitals that in life-threatening situation, do not offer the document of IC to women. In others, it is offered hastily by the gynecologist or midwife. In conclusion, the IC is a process which used correctly, favors the relationship between women and health professionals in the intervention of cesarean section. Although this process and the documents of IC examined in our study, have presented many positive aspects, the humanization of caesarean could be increased improving with the preparation and updating of these documents and coordinating the various professionals. PMID:27637198

  5. 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

  6. 7 CFR 1260.125 - Industry information.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE BEEF PROMOTION AND RESEARCH Beef Promotion and Research Order Definitions § 1260.125 Industry information. Industry information means information and programs that will lead to the development of new markets, marketing strategies,...

  7. 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.

  8. 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…

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... education record of a student without the consent required by § 99.30 if the disclosure meets one or more of the following conditions: (1)(i)(A) The disclosure is to other school officials, including teachers... of another school, school system, or institution of postsecondary education where the student...

  10. 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.

  11. Development of a tiered and binned genetic counseling model for informed consent in the era of multiplex testing for cancer susceptibility

    PubMed Central

    Bradbury, Angela R.; Patrick-Miller, Linda; Long, Jessica; Powers, Jacquelyn; Stopfer, Jill; Forman, Andrea; Rybak, Christina; Mattie, Kristin; Brandt, Amanda; Chambers, Rachelle; Chung, Wendy K.; Churpek, Jane; Daly, Mary B.; Digiovanni, Laura; Farengo-Clark, Dana; Fetzer, Dominique; Ganschow, Pamela; Grana, Generosa; Gulden, Cassandra; Hall, Michael; Kohler, Lynne; Maxwell, Kara; Merrill, Shana; Montgomery, Susan; Mueller, Rebecca; Nielsen, Sarah; Olopade, Olufunmilayo; Rainey, Kimberly; Seelaus, Christina; Nathanson, Katherine L.; Domchek, Susan M.

    2016-01-01

    Purpose Multiplex genetic testing, including both moderate- and high-penetrance genes for cancer susceptibility, is associated with greater uncertainty than traditional testing, presenting challenges to informed consent and genetic counseling. We sought to develop a new model for informed consent and genetic counseling for four ongoing studies. Methods Drawing from professional guidelines, literature, conceptual frameworks, and clinical experience, a multidisciplinary group developed a tiered-binned genetic counseling approach proposed to facilitate informed consent and improve outcomes of cancer susceptibility multiplex testing. Results In this model, tier 1 “indispensable” information is presented to all patients. More specific tier 2 information is provided to support variable informational needs among diverse patient populations. Clinically relevant information is “binned” into groups to minimize information overload, support informed decision making, and facilitate adaptive responses to testing. Seven essential elements of informed consent are provided to address the unique limitations, risks, and uncertainties of multiplex testing. Conclusion A tiered-binned model for informed consent and genetic counseling has the potential to address the challenges of multiplex testing for cancer susceptibility and to support informed decision making and adaptive responses to testing. Future prospective studies including patient-reported outcomes are needed to inform how to best incorporate multiplex testing for cancer susceptibility into clinical practice. PMID:25297947

  12. 7 CFR 1215.8 - Industry information.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POPCORN PROMOTION, RESEARCH, AND CONSUMER INFORMATION Popcorn Promotion, Research, and Consumer Information Order Definitions § 1215.8... of new markets, new marketing strategies, or increased efficiency for the popcorn industry,...

  13. Intervention research with youths at elevated risk for suicide: meeting the ethical and regulatory challenges of informed consent and assent.

    PubMed

    King, Cheryl A; Kramer, Anne C

    2008-10-01

    Intervention research with youths at elevated risk for suicidal behavior and suicide--a vulnerable and high risk population--presents investigators with numerous ethical challenges. This report specifically addresses those challenges involving the informed consent and assent process with parents/guardians and youths. The challenges are delineated in the context of pertinent laws and regulatory requirements, and guidelines are suggested for their practical resolution. These are illustrated with case examples from NIMH-funded intervention trials. Through the sharing of such methodological information, intervention researchers can support each other in conducting ethical research in a manner that does not unduly compromise scientific rigor.

  14. 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.

  15. Informed consent for clinical trials in acute coronary syndromes and stroke following the European Clinical Trials Directive: investigators' experiences and attitudes

    PubMed Central

    Iwanowski, Piotr; Budaj, Andrzej; Członkowska, Anna; Wąsek, Wojciech; Kozłowska-Boszko, Beata; Olędzka, Urszula; Masełbas, Wojciech

    2008-01-01

    Background During clinical trials in emergency medicine, providing appropriate oral and written information to a patient is usually a challenge. There is little published information regarding patients' opinions and competence to provide informed consent, nor on physicians' attitudes towards the process. We have investigated the problem of obtaining consent from patients in emergency-setting clinical trials (such as acute coronary syndromes (ACS) and stroke) from a physicians' perspective. Methods A standardised anonymous 14-item questionnaire was distributed to Polish cardiac and stroke centres. Results Two hundred and fourteen informative investigator responses were received. Of these investigators, 73.8% had experience with ACS and 25.2% had experience with acute stroke trials (and 1% with both fields). The complete model of informed consent (embracing all aspects required by Good Clinical Practice (GCP) and law) was used in 53.3% of cases in emergency settings, whereas the legal option of proxy consent was not used at all. While less than 15% of respondents considered written information to have been fully read by patients, 80.4% thought that the amount of information being given to emergency patients is too lengthy. Although there is no legal obligation, more than half of the investigators sought parallel consent (assent) from patients' relatives. Most investigators confirmed that they would adopt the model proposed by the GCP guidelines: abbreviated verbal and written consent in emergency conditions with obligatory "all-embracing" deferred consent to continue the trial once the patient is able to provide it. However, this model would not follow current Polish and European legislation. Conclusion An update of national and European regulations is required to enable implementation of the emergency trial consent model referred to in GCP guidelines. PMID:18644120

  16. Drug Information Residency Rotation with Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Cramer, Richard L.

    1986-01-01

    Program objectives of a drug information rotation at the Upjohn Company include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of…

  17. Misusing informed consent: a critique of limitations on research subjects' access to genetic research results.

    PubMed

    Banks, T M

    2000-01-01

    Express denials of access to genetic research results are being drafted into consent instruments. Some commentators suggest that the principle of beneficence can justify such a denial of access. This paper provides an ethical and legal critique of the use of consent instruments to disclaim responsibility for on-going disclosure by genetic researchers. Currently, the law of torts provides only weak protection for on-going disclosure for research subjects. The most substantive rights are to be found in the law of fiduciary obligations. The author concludes that, notwithstanding arguments to the contrary, there should be a presumption of disclosure in genetic research, unless the research subject elects otherwise. The author outlines one possible exception to this general presumption.

  18. Readability and Understanding of Informed Consent Among Participants With Low Incomes: A Preliminary Report.

    PubMed

    Ittenbach, Richard F; Senft, Elizabeth C; Huang, Guixia; Corsmo, Jeremy J; Sieber, Joan E

    2015-12-01

    With passage and implementation of the Affordable Health Care Act, more vulnerable segments of the U.S. population will now have access to regular health care and increased opportunities to participate in biomedical research. Yet, access to new groups brings with it new responsibilities for investigators, most importantly, reducing burdens for participants. Data collected through this small pilot study suggest several preliminary but potentially important findings when working with adults from low-income populations: First, while all participants read some parts of the consent forms (55%), only a minority reported reading the entire form (45%); second, 73% of participants reported understanding the study very well whereas only 27% reported understanding the study "a little"; third, there was a slight reported advantage of the simplified form over the regular form; however, this difference varied by section. Relatedly, other research has shown a high incidence of persons reading none of the consent form, but signing a statement that they have read and understood the study. Why does this occur? What are we teaching people when we request that they sign a consent form they have chosen not to read? What are the ethical and regulatory implications? Embedded ethics studies such as this one, although pilot and preliminary in nature, offer a number of advantages, such as stimulating additional scientific inquiry as well as challenging established institutional practices. PMID:26564942

  19. Consent and widespread access to personal health information for the delivery of care: a large scale telephone survey of consumers' attitudes using vignettes in New Zealand

    PubMed Central

    Whiddett, Dick; Hunter, Inga; McDonald, Barry; Norris, Tony; Waldon, John

    2016-01-01

    Objectives In light of recent health policy, to examine factors which influence the public's willingness to consent to share their health information in a national electronic health record (EHR). Design Data were collected in a national telephone survey in 2008. Respondents were presented with vignettes that described situations in which their health information was shared and asked if they would consent to such sharing. The subset, consisting of the 18 vignettes that covered proving care, was reanalysed in depth using new statistical methods in 2016. Setting Adult population of New Zealand accessible by telephone landline. Participants 4209 adults aged 18+ years in the full data set, 2438 of which are included in the selected subset. Main outcome measures For each of 18 vignettes, we measured the percentage of respondents who would consent for their information to be shared for 2 groups; for those who did not consider that their records contained sensitive information, and for those who did or refused to say. Results Rates of consent ranged from 89% (95% CI 87% to 92%) for sharing of information with hospital doctors and nurses to 51% (47% to 55%) for government agencies. Mixed-effects logistic regression was used to identify factors which had significant impact on consent. The role of the recipient and the level of detail influenced respondents' willingness to consent (p<0.0001 for both factors). Of the individual characteristics, the biggest impact was that respondents whose records contain sensitive information (or who refused to answer) were less willing to consent (p<0.0001). Conclusions A proportion of the population are reluctant to share their health information beyond doctors, nurses and paramedics, particularly when records contain sensitive information. These findings may have adverse implications for healthcare strategies based on widespread sharing of information. Further research is needed to understand and overcome peoples' ambivalence towards

  20. Information Resource Management for Industrial Information Officers.

    ERIC Educational Resources Information Center

    Dosa, Marta

    This paper argues that the function of educational programs is to convey a sense of reality and an understanding of the open-endedness of information needs and situations; only such a reality orientation can instill the necessary flexibility in information professionals for effectively managing change. There is a growing consensus among…