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