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by Len Doyal and Jeffrey S. Tobias (editors)
BMJ Books, 2001
Review by Rachel Cooper on Oct 10th 2002

Informed Consent in Medical Research

Problems related to informed consent are seldom out of the news. There is a consensus that informed consent is required for medical treatment or experimentation, and yet the scandals keep coming: At Alder Hey parents are shocked to discover that the hearts of their dead babies have been removed for experimentation; “Miss B” is kept on a life support machine despite her insistence that she wants to die in peace; in North Staffordshire babies are allotted to an experimental ventilator, babies die as a result, and there are allegations that the original consent forms were forged.

Despite the popular interest in questions of consent, the existing literature on informed consent is sparse and often pitched at a low level. It's hard to find anything that says much more than "Informed consent – it's a good thing". Informed Consent in Medical Research goes some way to fill this gap. Articles in the collection address a vast range of problems concerning informed consent, and many are thoughtful and provocative. I have no doubt that the book will soon come to be considered essential reading for anyone with a serious interest in medical ethics.

The book centres on the controversy provoked by the British Medical Journal's decision to publish two papers reporting studies in which consent was not obtained from participants. Both papers were published in 1997, alongside commentaries explaining why the journal had decided to publish them. Following publication the B.M.J. found itself swamped with letters, with correspondents arguing with equal passion that consent is always necessary, or that sometimes experimentation without consent is permissible. Impressed by the interest taken in the case, the B.M.J. decided to produce a collection addressing the issues in depth.

Informed Consent in Medical Research contains the papers that sparked the controversy, along with the commentaries and some of the letters subsequently published in the B.M.J. Also included in the collection are seventeen commissioned papers discussing various issues and problems, and selections from two classic works detailing abusive experiments from the 1960s, M.H.Pappworth's Human Guinea-Pigs and Henry Beecher's "Ethics and Clinical Research". The range of the collection is impressive. Predictably, contributors discuss the special problems posed by experimentation on children, on the elderly, and on the mentally ill. But papers also discuss new issues raised by genetic research, and by assisted contraception, and practical problems with ensuring that subjects have understood the information they have been given. Many of the papers are excellent, but others are dull and repetitive. The good material ensures that Informed Consent in Medical Research is a useful book, but more vicious editing could have greatly improved it.

Of the good material, highlights include papers by John Harris and Simon Woods, and Iain Chalmers and Richard Lindley.

Harris and Woods argue that citizens have a moral duty to participate in medical research. Medical research is a good, and as people should wish to leave the world a better place than they joined it, they should be willing to participate in experimentation. Furthermore, those who do not participate can be condemned as free riders; they enjoy the fruits of previous subjects' sacrifices without doing their bit. Harris and Woods claim that the obligation to participate in research holds even when research is risky. As a society we expect citizens to risk life and limb to fight for their country when required, why should we not also expect individuals to take on the risks of research for the public good? The debates over informed consent, Harris and Woods argue, have paid to much attention to the rights of subjects and not enough attention to their responsibilities.

Chalmers and Lindsey argue that participating in research is generally in the interest of subjects. Rather than being viewed as a sacrifice, participation in experimentation should be seen as a benefit. Generally it is assumed that experimentation is riskier than conventional treatment. It is for this reason that higher standards of informed consent are required for research than for treatment. Chalmers and Lindsey argue convincingly that this is wrong-headed. Much medical treatment is at least as dangerous as much research. Experimenters are required to follow strict protocols, and will be alert for any side effects or problems. Before human trials are permitted they must have sound reasons for thinking that the experimental treatment may help and is unlikely to harm. In contrast many conventional treatments have not been conclusively shown to be effective and regular doctors are less likely to notice or deal with problems. Research subjects do not have to be altruistic, but should sign up out of self-interest.

To sum up, Informed Consent in Medical Research is a large and varied collection of articles. Many are worth reading, and some are excellent, but others should be skipped by all but reviewers. Still, the good material included in the book ensures that it will be of value to all those interested in issues surrounding consent, whether they are medical practitioners or lay people.


© 2002 Rachel Cooper

Rachel Cooper is a lecturer in philosophy in the Department of Interdisciplinary Human Studies, Bradford University, U.K.

Informed Consent in Medical Research