Informed Consent in Medical Research

This is a comprehensive discussion of the ethical issues involved in informing patients on their rights and participation in medical research and treatment. With 30 chapters contributed by internationally recognised medical ethicists, Informed Consent provides an authoritative reference on a subject of major importance in medical ethics

Len Doyal FRSA FRSocMed is emeritus professor of medical ethics at Queen Mary, University of London and a medical ethicist. He was born in Atlanta, Georgia in 1944 and studied philosophy and sociology at Georgia State University, earning his undergraduate degree in 1966. Jeffrey S. Tobias is the editor of Informed Consent in Medical Research, published by Wiley.

Contributors

ix

Foreword

xi

Richard Smith

Introduction

xv

Len Doyal

Jeffrey S Tobias

Part 1 Informed consent and medical research: a historical perspective

1

(60)

The Nuremberg Code and the Helsinki Declaration

3

(4)

A historical introduction to the requirement of obtaining informed consent from research participants

7

(8)

Baruch A Brody

Human guinea pigs and the ethics of experimentation: the BMJ's correspondent at the Nuremberg medical trial

15

(5)

Paul Weindling

Henry K Beecher and Maurice Pappworth: informed consent in human experimentation and the physicians' response

20

(8)

Paul J Edelson

Extracts from Pappworth and Beecher

28

(21)

Introduction to Beecher's ``Ethics and clinical research''

28

(1)

Len Doyal

Ethics and clinical research

29

(8)

Henry K Beecher

Commentary on ``Ethics and clinical research''

37

(1)

John P Bunker

An introduction to Pappworth's Human Guinea Pigs

38

(1)

Jeffrey S Tobias

Human Guinea Pigs

39

(8)

MH Pappworth

Commentary on Human guinea pigs

47

(2)

Stephen Lock

Learning from unethical research

49

(12)

Paul McNeill

Naomi Pfeffer

Part 2 The BMJ debate: informed consent in medical research

61

(78)

Informed consent: the intricacies

63

(3)

Richard Smith

Evaluation of a stroke family care worker: results of a randomised controlled trial

66

(9)

Martin Dennis

Suzanne O'Rourke

Jim Slattery

Trish Staniforth

Charles Warlow

No consent means not treating the patient with respect (commentary)

73

(1)

Sheila AM McLean

Why we didn't ask patients for their consent (commentary)

74

(1)

Martin Dennis

Does HIV status influence the outcome of patients admitted to a surgical intensive care unit? A prospective double blind study

75

(11)

Satish Bhagwanjee

David JJ Muckart

Prakash M Jeena

Prushini Moodley

Failing to seek patient consent to research is always wrong (commentary)

81

(1)

Rajendra Kale

Laxmi-Kunj

Why we did not seek informed consent before testing patients for HIV (commentary)

82

(1)

Satish Bhagwanjee

David JJ Muckart

Prakash M Jeena

Prushini Moodley

No simple and absolute ethical rule exists for every conceivable situation (commentary)

83

(3)

YK Seedat

Journals should not publish research to which patients have not given fully informed consent - with three exceptions

86

(6)

Len Doyal

BMJ's present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct

92

(5)

Jeffrey S Tobias

Responses to Chapters 7-11: letters to the BMJ

97

(26)

Informed consent: one standard for research, another for clinical practice

97

(1)

Richard Smith

Letters

98

(21)

Personal view

119

(4)

Kulsum Winship

Other perspectives following the BMJ articles and correspondence

123

(16)

Informed consent: edging forwards (and backwards)

123

(3)

Richard Smith

Informed consent: a response to recent correspondence

126

(2)

Len Doyal

Changing the BMJ's position on informed consent would be counterproductive

128

(1)

Jeffrey S Tobias

Informed consent - a publisher's duty

129

(1)

Mary Warnock

Trial subjects must be fully involved in design and approval of trials

130

(1)

Lisa Power

Studies that do not have informed consent from participants should not be published

131

(2)

Heather Goodare

Thrombolytic treatment for acute ischaemic stroke: consent can be ethical

133

(4)

Richard I Lindley

Informed consent and research

137

(2)

David Benatar

Solomon R Benatar

Part 3 Informed consent and the regulation of medical research

139

(108)

International regulation, informed consent and medical research

141

(25)

The UK perspective

141

(7)

CM Foster

A perspective from the USA and Canada

148

(7)

Eric M Meslin

The European perspective

155

(11)

Richard Nicholson

Informed consent, medical research and the competent adult

166

(7)

Sheila AM McLean

Informed consent and clinical research with children

173

(9)

Jonathan Montgomery

Informed consent and clinical research in psychiatry

182

(11)

Phil Fennell

Informed consent and surgical research

193

(10)

Alan G Johnson

Informed consent and genetic research

203

(8)

Ruth Chadwick

Informed consent and HIV: public health versus private lives

211

(11)

Rebecca Bennett

Informed consent and research on assisted conception

222

(8)

Bobbie Farsides

Heather Draper

Informed consent for access to medical records for health services research

230

(10)

Brian Hurwitz

Informed consent, medical research, and healthy volunteers

240

(7)

SM Louise Abrams

GA Browning

Part 4 The limits of informed consent in medical research: rights, duties, skills

247

(60)

Informed consent and human rights in medical research

249

(8)

Ann Sommerville

`Fully' informed consent, clinical trials, and the boundaries of therapeutic discretion

257

(9)

Raanan Gillon

Double standards on informed consent to treatment

266

(10)

Iain Chalmers

Richard I Lindley

Rights and responsibilities of individuals participating in medical research

276

(7)

John Harris

Simon Woods

Informed consent in medical research: the consumer's view

283

(8)

Naomi Pfeffer

The role of effective communication in obtaining informed consent

291

(8)

Angela Hall

Informed consent and medical education

299

(8)

Chris Ward

Part 5 Conclusion

307

(20)

The moral importance of informed consent in medical research: concluding reflections

309

(9)

Len Doyal

Contemporary challenges in clinical research: paying lip service to informed consent, or a genuine shift of gear?

318

(9)

Jeffrey S Tobias

Index

327

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Informed Consent in Medical Research

Summary

Author Biography

Table of Contents

Supplemental Materials