Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant’s consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked (...) to evaluate the importance of the information again, panelists’ opinions shifted dramatically in the direction of requiring that less information be understood. Follow-up interviews indicated significant uncertainty about defining a threshold of understanding and what should happen when prospective participants are unable to grasp key information. These findings have important implications for urgently needed discussion of whether... (shrink)

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

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)

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.

This book approaches ethical and legal issues in medicine from the patient's viewpoint and argues that many patients do not want the full burden of decision making that contemporary bioethics has thrust upon them.