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Informed Consent in Medical Research
  1. R Ashcroft

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    Edited by L Doyal, J S Tobias. BMJ Books, 2001, £50.00 (hb), pp 336. ISBN 0-7279-1486-3

    Debates over research ethics have until recently revolved around two related questions: the voluntary, informed consent of subjects, and the appropriate relationship between risk and benefit to subjects in the experiment. Recently more attention has been paid to issues of justice in research studies, especially in the international arena, and to issues of the scientific and financial probity of researchers. Yet these new foci augment rather than supplant the traditional focus on consent, since arguably “the rights and wellbeing of the subject take precedence over the interests of science and society”, as the Declaration of Helsinki (still) puts it.

    Clinically the difficulties of obtaining the informed consent of subjects to participation in research remain one of the more difficult barriers to research. Recently this issue has become more fraught in non-clinical research also, with complex debates over consent to the use and reuse of clinical information or stored tissue samples in epidemiological and genetic research. The trade-off between public interest in the development of epidemiological research and the rights of individuals to decline participation in such research remains precarious. The possibility that a surgeon might need to explain not only randomisation and equipoise between surgical procedures, but also the possible commercial exploitation of tissue samples extracted from surgical waste gives most thoughtful people pause at the difficulty of this process and the complex way in which scientific, therapeutic, and commercial elements are entwined in it willy nilly. The need for a general guidebook to the range of practical ethical problems in consent in research is profound, since most books and articles cover at most a small subgroup of research studies, usually from the points of view of research design or review, rather than from practice, patient, or consumer perspectives.

    In 1997 the BMJ published two studies in which the consent of subjects had not been obtained prospectively, and at the same time published critical commentaries on these papers. It then invited two debate papers to argue the question of whether the BMJ should refuse to publish papers based on research where the informed consent of the participants had not been obtained, subject to some very stringent rules about exceptional cases. The two papers were written by Len Doyal and Jeffrey Tobias, respectively a Professor of medical ethics and a senior medical oncologist. There followed an unprecedently large correspondence on the issue. It was not accidental that 1997 was the 50th anniversary of the Nuremberg doctors’ trial and the famous code on human experimentation which was written in its wake.

    This book reproduces the controversy from the pages of the BMJ in full, which in itself makes for a useful documentary casebook. What makes this book worthy of wide consideration is the wealth of additional material. Part 1 of the book reproduces the Nuremberg Code and the 1996 version of the Declaration of Helsinki, together with classic material by Henry Beecher and Maurice Pappworth on “human guinea pigs” and some valuable historical articles setting this material in context. Part 2 reproduces the articles and correspondence from the BMJ. Part 3 contains reviews of the “state of the art” on informed consent in research in a variety of contexts, including research with children, genetics research and access to patients’ records for research purposes. Part 4 reviews the moral role of informed consent and how better to achieve both consent and respect for its importance, in particular through education, consumer involvement and communications skills. The book concludes with closing remarks by the editors.

    The reader interested in the complexities of current debates on consent in research will find this a very valuable guide. The chapters are rather brief, which make philosophical depth difficult to achieve. The cumulative effect of reading 32 short articles can be exhaustion and confusion. Taken individually, however, the articles are on the whole very well written and informative. The reader has a sense—unusually in a work of this kind—of an evolving debate and a growth in sensitivity of the contending parties to each others’ positions and the rationales underlying them. Some of the articles are likely to be classics in their own right, and all of them are stimulating. For this reason, the book transcends the “occasional” character of its source material, and is likely to have a long life in the reading lists and the libraries of researchers, doctors, and research ethics committees.

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