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Informed consent is a central topic in contemporary biomedical ethics. Yet attempts to set defensible and feasible standards for consenting have led to persistent difficulties. In Rethinking Informed Consent in Bioethics, first published in 2007, Neil Manson and Onora O'Neill set debates about informed consent in medicine and research in a fresh light. They show why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethically better. They argue that consent needs distinctive communicative transactions, by which other obligations, prohibitions, and rights can be waived or set aside in controlled and specific ways. Their book offers a coherent, wide-ranging and practical account of the role of consent in biomedicine which will be valuable to readers working in a range of areas in bioethics, medicine and law

Informed consent has emerged as an issue both of great importance & substantial uncertainty & confusion. Examined are some of the conceptual & practical complexities of informed consent; some implications of empirical knowledge are suggested. Among the issues considered are the purposes of informed consent, ethical vs legal functions of informed consent, the distinction between informed consent & consent forms, & whether informed consent is an ideal that can never be achieved. Informed consent is presently not a reliable method of protecting Ss & patients from harm because of limited commitment of professionals to the concept itself, the tendency for procedures to be substituted for substance, the dependence of the quality of consent on many factors, including the characteristics of the Ss or patients, and the tendency of human Ss review committees to confine their attention to consent forms rather than to the process by which consent is sought, & lack of knowledge about how to judge r1sks, benefits, & the selection of research Ss. Modified HA.

Informed consent has emerged as an issue both of great importance and substantial uncertainty and confusion. This paper examines some of the conceptual and practical complexities of informed consent and suggests some impli cations of our empirical knowledge about consent. Among the issues considered are the purposes of informed consent, ethical versus legal functions of informed consent, the dis tinction between informed consent and consent forms, and whether informed consent is an ideal that can never be achieved. It is argued that informed consent is presently not a reliable method of protecting subjects and patients from harm because of limited commitment of professionals to the concept of informed consent, the tendency for procedures to be substituted for substance, the dependence of the quality of consent on many factors, including the characteristics of the subjects or patients, and the tendency of human subjects review committees to confine their attention to consent forms rather than to the process by which consent is sought.

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

Purpose: Enrolling traumatic brain injury (TBI) patients with an inability to provide informed consent in research is challenging. Alternatives to patient consent are not sufficiently embedded in European and national legislation, which allows procedural variation and bias. We aimed to quantify variations in informed consent policy and practice. Methods: Variation was explored in the CENTER-TBI study. Policies were reported by using a questionnaire and national legislation. Data on used informed consent procedures were available for 4498 patients from 57 centres across 17 European countries. Results: Variation in the use of informed consent procedures was found between and within EU member states. Proxy informed consent (N = 1377;64%) was the most frequently used type of consent in the ICU, followed by patient informed consent (N = 426;20%) and deferred consent (N = 334;16%). Deferred consent was only actively used in 15 centres (26%), although it was considered valid in 47 centres (82%). Conclusions: Alternatives to patient consent are essential for TBI research. While there seems to be concordance amongst national legislations, there is regional variability in institutional practices with respect to the use of different informed consent procedures. Variation could be caused by several reasons, including inconsistencies in clear legislation or knowledge of such legislation amongst researchers.