Prevailing ethical thinking about informed consent to clinical research is characterized by theoretical confidence and practical disquiet. On the one hand, bioethicists are confident that informed consent is a fundamental norm. And, for the most part, they are confident that what makes consent to research valid is that it constitutes an autonomous authorization by the research participant. On the other hand, bioethicists are uneasy about the quality of consent in practice. One major source of this disquiet is substantial evidence of (...) the “therapeutic misconception”—the tendency of patient-subjects in clinical trials to confuse participating in research with receiving personalized medical care. This .. (shrink)

One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal regulations require that the “risks to (...) subjects” be “reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge” to be gained from the .. (shrink)

Introduction While quizzing during informed consent for research to ensure understanding has become commonplace, it is unclear whether the quizzing itself is problematic for potential participants. In this study, we address this issue in a multinational HIV prevention research trial enrolling injection drug users in China and Thailand. Methods Enrolment procedures included an informed consent comprehension quiz. An informed consent survey followed. Results 525 participants completed the informed consent survey (Heng County, China=255, Xinjiang, China=229, Chiang Mai, Thailand=41). Mean age was (...) 33 and mean educational level was 8 yrs. While quizzing was felt to be a good way to determine if a person understands the nature of clinical trial participation (97%) and participants did not generally find the quiz to be problematic, minorities of respondents felt pressured (6%); anxious (5%); bored (5%); minded (5%); and did not find the questions easy (13%). In multivariate analysis, lower educational level was associated with not minding the quizzing (6–10 yrs vs 0–5 yrs: OR=0.27, p=0.03; more than 11 yrs vs 0–5 yrs: OR=0.18, p=0.03). There were also site differences (Heng County vs Xinjiang) in feeling anxious (OR=0.07; p=<0.01), not minding (OR=0.26; p=0.03), being bored (OR=0.25; p=0.01) and not finding the questions easy (OR=0.10; p=<0.01). Conclusions Quizzing during the informed consent process can be problematic for a minority of participants. These problems may be associated with the setting in which research takes place and educational level. Further research is needed to develop, test and implement alternative methods of ensuring comprehension of informed consent. Trial Registration clinicaltrials.gov number NCT00270257. (shrink)

According to the standard view of informed consent, a prospective subject's consent to participate in a research study is invalid if the individual fails to comprehend the information about the study standardly disclosed to him. I argue that this involves three mistakes. First, the standard view confuses an ethical aspiration with a minimum ethical standard. Second, it assigns the entire responsibility for producing comprehension in study participants to the investigators. Most importantly, the standard view requires the termination of many otherwise (...) perfectly ethical research studies. This last conclusion follows from appreciating a pervasive phenomenon that is known as the "therapeutic misconception." I argue that a prospective subject's consent to participate in research can be perfectly valid even if he or she does not comprehend the information that investigators are required to disclose. Furthermore, I explain that this alternative view does not in the least compromise the vital goal of ensuring the protection of subjects in research. (shrink)

Objective Some researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries. To evaluate this assumption, we reviewed the available data on the quality of consent in both settings. Methods We conducted a comprehensive PubMed search, examined bibliographies and literature reviews, and consulted with international experts on informed consent in order to identify studies published from 1966 to 2010 that used quantitative methods, surveyed participants or parents of paediatric participants (...) in actual trials, assessed comprehension and/or voluntariness, and did not involve testing particular consent interventions. Forty-seven studies met these criteria. We compared data about participant comprehension and voluntariness. The paucity of data and variation in study methodology limit comparison and preclude statistical aggregation of the data. Results and Discussion This review shows that the assertion that informed consent is worse in developing countries than in developed countries is a simplification of a complex picture. Despite the limitations of comparison, the data suggest that: (1) comprehension of study information varies among participants in both developed and developing countries, and comprehension of randomisation and placebo controlled designs is poorer than comprehension of other aspects of trials in both settings; and (2) participants in developing countries appear to be less likely than those in developed countries to say they can refuse participation in or withdraw from a trial, and are more likely to worry about the consequences of refusal or withdrawal. (shrink)

Implants and drugs with animal and human derived content are widely used in medicine and surgery, but information regarding ingredients is rarely obtainable by health practitioners. A religious perspective concerning the use of animal and human derived drug ingredients has not thoroughly been investigated. The purpose of this study was to clarify which parts of the medical and surgical treatments offered in western world-hospitals that conflicts with believers of major religions.

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

Background Informed consent is a requirement for all research. It is not, however, clear how much information is sufficient to make an informed decision about participation in research. Information on an online questionnaire about childhood development was provided through an unfolding electronic participant sheet in three levels of information. Methods 552 participants, who completed the web-based survey, accessed and spent time reading the participant information sheet (PIS) between July 2008 and November 2009. The information behaviour of the participants was investigated. (...) The first level contained less information than might be found on a standard PIS, the second level corresponded to a standard PIS, and the third contained more information than on a standard PIS. The actual time spent on reading the information provided in three incremental levels and the participants' evaluation of the information were calculated. Results 77% of the participants chose to access the first level of information, whereas 12% accessed the first two levels, 6% accessed all three levels of information and 23% participated without accessing information. The most accessed levels of information were those that corresponded to the average reading times. Conclusion The brief information provided in the first level was sufficient for participants to make informed decisions, while a sizeable minority of the participants chose not to access any information at all. This study adds to the debate about how much information is required to make a decision about participation in research and the results may help inform the future development of information sheets by providing data on participants' actual needs when deciding about questionnaire surveys. (shrink)

This is the third volume of Joel Feinberg's highly regarded The Moral Limits of the Criminal Law, a four-volume series in which Feinberg skillfully addresses a complex question: What kinds of conduct may the state make criminal without infringing on the moral autonomy of individual citizens? In Harm to Self, Feinberg offers insightful commentary into various notions attached to self-inflicted harm, covering such topics as legal paternalism, personal sovereignty and its boundaries, voluntariness and assumptions of risk, consent and its counterfeits, (...) coercive force, incapacity, and choice of death. (shrink)

In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions.

Few issues affecting the therapeutic professions are as much discussed and as little understood as informed consent. This book, written from the combined perspectives of a physician, a lawyer, and a social scientist, is the first reference work to provide a concise overview of informed consent with particular emphasis on the practical issues facing professionals. After introducing the ethical theories behind this principle, the authors describe the history and current status of the law, detailing all legal requirements for practitioners. They (...) consider the problems faced when these theories and laws are applied in a clinical setting, offering suggestions for simplifying the interaction between doctor and patient and for making it clinically meaningful. The stress throughout is on ways to improve practitioners' performance in meeting these ethical and legal mandates. The book will be valuable for all professionals working in areas where issues of informed consent are likely to arise, including medicine, mental health care, social work, dentistry and law. (shrink)

Institutional review boards and researchers have struggled to ensure that subjects receive sufficient information to make knowledgeable decisions about study participation. But the quality of the consent forms that are a key component of this process has rarely been evaluated. We reviewed 215 consent forms approved by an IRB serving a major academic department from 1978–2002 and discovered two trends: greater consistency in the description of risks, and an increase in the length of consent forms. However, despite data indicating that (...) length and comprehension are inversely related, length of consent forms increased linearly. The findings demonstrate the dilemma in attempting to provide information on consent forms that is simultaneously accurate and concise. (shrink)