The Limits of Consent: A socio-ethical approach to human subject research in medicine

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Since its inception as an international principle to protect the welfare of patients and volunteers taking part in medical research, informed consent has become increasingly important within healthcare. Despite its ubiquitous status, there are a number of scholars who are beginning to question whether consent is adequate for contemporary biomedical research. The Limits of Consent considers a number of criticisms that have been levelled at the prominence given to autonomy, a central tenet underpinning the rationale for informed consent in Western bioethics. It raises questions about how quickly and easily this principle has been adopted, and how appropriate it is for those actively engaged in research. In the context of genetic research, for example, the individual's overriding right of autonomy to give consent to research could have huge implications for other members of their families.

The Limits of Consent questions the assumption that informed consent protects or facilitates individual autonomy, and discusses empirical studies which suggest that gaining a truly informed consent can be difficult to achieve in practice. With the expectation of treatment and guidance from the physician, how much is the process of consent governed by social norms and expectations? The Limits of Consent focuses upon three principal areas within biomedical research: clinical trials, genetic research, and research with those who may have impaired capacity to consent. It is a truly multi-disciplinary book, incorporating perspectives from medicine, law, philosophy and sociology.

The Limits of Consent is a fascinating exploration of the inadequacies of consent, and will appeal to those in the fields of bioethics, socio-legal studies, sociology, and health law. Policy makers, research ethics committee members, and those healthcare professionals with an interest in medical ethics, will also find the book of interest.

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Product Details

  • ISBN-13: 9780199231461
  • Publisher: Oxford University Press
  • Publication date: 3/25/2009
  • Pages: 256
  • Product dimensions: 6.30 (w) x 9.30 (h) x 2.80 (d)

Meet the Author

Oonagh Corrigan's areas of research include informed consent, clinical trials, genetics and medical education. In 2007 she held a Leverhulme Trust visiting abroad fellowship at the University of British Columbia, and has previously held lectureship positions in Sociology at the Universities of Cambridge and Plymouth. She is editor of the journal Medical Studies. Dr Kathy Liddell is a Lecturer in Law at the University of Cambridge and a Fellow of Downing College. She teaches intellectual property, medical law and ethics, and torts, which complements her research on the regulatory frameworks that govern and provide incentives for medical research. She studied law and science at the University of Melbourne, bioethics at Monash University and completed her doctorate of law at the University of Oxford. She is Deputy Director of the Law Faculty's Centre for Intellectual Property and Information Law.
John McMillan is responsible for designing and teaching the ethics curriculum at the Hull Yok Medical School. Prior to this appointment he held posts at the Universities of Cambridge, Oxford and Otago where he taught ethics to philosophy and medical students. He is a program director for the Institute of Applied Ethics at the University of Hull. Martin Richards is Leverhulme Emeritus Fellow at the University of Cambridge. Until his retirement in 2005 he was Director of the Centre for Family Research at Cambridge University, which he founded in 1968. His current research concerns genetic and reproductive technologies and family life. He is Vice Chair of the UK Biobank Ethics and Governance Council and a member of the Law and Ethics Committee of the Human Fertilisation and Embryology Authority. He was a member of the Human Genetics Commission (1998-2005) and has served on working parties of the Nuffield Council on Bioethics. Charles Weijer is a leading authority on research ethics. He is a philosopher and physician and holds the Canada Research Chair in Bioethics at the University of Western Ontario. His research, immediately recognizable for its relevance to important social issues and philosophical rigor, has broadly influenced scholarly discourse and the practice of clinical research. Especially influential is his work on the ethics of benefits and harms in research, research in developing countries, and research involving communities. He served as a consultant to the Joint United Nations Programme on HIV/AIDS, the US Institute of Medicine, President Clinton's National Bioethics Advisory Commission, the World Health Organization, and the World Medical Association. Dr Weijer was elected a Fellow of the Hastings Center (2002), Fellow of the Royal College of Physicians and Surgeons of Canada (2002), Fellow of the American College of Physicians (2007), and Fellow of the Canadian Academy of Health Sciences (2007).

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Table of Contents

Contributors xi

Introduction Oonagh Corrigan John McMillan Charles Weijer 1

1 Informed consent in medical research - a procedure stretched beyond breaking point? Søren Holm Søren Madsen 11

2 Trust and exploitation in clinical research Paul B. Miller Charles Weijer 25

3 Consent and private liability in clinical research Paul B. Miller Josephine Johnston 39

4 The decision to decline to enrol in a clinical trial: a blind spot in the literature on decision-making for research participation Clare Snowdon Diana Elbourne Jo Garcia 57

5 Beyond a rebarbative commitment to consent Kathleen Liddell 79

6 The normative status of the requirement to gain an informed consent in clinical trials: comprehension, obligations, and empirical evidence Angus Dawson 99

7 Is there an obligation to participate in medical research? Stephen John 115

8 Consenting older adults: research as a virtuous relationship Julian C. Hughes Erica Haimes Lorraine Summerville Karen Davies Joanna Collerton Thomas B.L. Kirkwood 133

9 Towards supported decision-making in biomedical research with cognitively vulnerable adults Philip Bielby 151

10 Is consent sufficient? A case study of qualitative research with men with intellectual disabilities Margaret Ponder Helen Statham Nina Hallowell Martin Richards 171

11 Consent to genetic testing: a family affair? Nina Hallowell 185

12 Cultural authority of informed consent: indigenous participation in biobanking and salmon genomics focus groups Michael Burgess James Tansey 199

Consent and beyond: some conclusions Kathleen Liddell Martin Richards 213

Index 229

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