Informed Consent in Medical Research

by Doyal, Len; Tobias, Jeffrey S.

• ISBN13: 9780727914866
• ISBN10: 0727914863
• Edition: 1st
• Format: Hardcover
• Copyright: 2000-12-19
• Publisher: BMJ Books

Summary

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

Author Biography

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.

Table of Contents

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