Informed Consent in Medical Research
By Len Doyal and Jeffrey S. Tobias. BMJ Books, 2000. HB £50.00, 334 pp. ISBN 0‐7279‐1486‐3
This book arose from a debate in the British Medical Journal in 1997 around the question of whether medical journals should publish reports of research where informed consent had not been obtained from the participants in the research. Two such studies, a randomized controlled trial of a stroke family support worker in Scotland, and a study of the correlation between HIV status and outcome in patients admitted to an intensive care unit in South Africa, were published with critical commentaries and justification by the authors of their decision not to obtain consent. The editors of this book, Len Doyal and Jeffrey Tobias contributed to the debate with papers taking opposing views on the issue of informed consent in medical research, and the BMJ readership responded to the debate in the correspondence pages with an unprecedented number of letters to the Journal. This book expands the debate and sets it in an historical context.
An impressive number of ethicists, lawyers and clinicians have contributed thoughtful and easily accessible papers. A welcome innovation for an ethics book is the contribution of papers by patient and lay ‘experts’ reminding us that this is more than an academic debate between ivory tower ethicists and researchers. Tensions between the different ethical principles that inform the conduct of medical research is a recurring theme throughout the book. On one hand there is the moral imperative of respect for persons that underpins both our intuitive assertion that people should not be subjects of research without giving consent, and the numerous guidelines on medical research including the Nuremberg Code and the Declaration of Helsinki. On the other hand there is the duty of the clinician to provide the best medical care for current and future patients, and the responsibility of society to ensure that scarce resources are spent on effective treatments. Sheila McLean, among others, argues that if obtaining informed consent invalidates the outcome of the research then ‘the question should be not how much information can be withheld but whether the research should be done in the first place’. Len Doyal allows for certain exceptions to the requirement for informed consent, but his reasons for allowing these exceptions and not others are challenged by other authors. The practical difficulties of obtaining fully informed consent to research, particularly from vulnerable and sick patients, are explored by several authors and the different standards for research and clinical practice with regard to consent arehighlighted by Iain Chalmers and Richard Lindley.
Historical and contemporary examples remind us of the dangers of over enthusiastic researchers disregarding informed consent and treating their patients as means rather than ends. An eloquent personal account of unwittingly taking part in a clinical trial which led to severe physical harm is given by Kulsum Winship in which she reminds scientists and clinicians that when they have academic arguments about clinical research they are dealing with peoples' lives. An overriding theme emerging from many of the papers in this book is the pressing need to involve current and future patients in all aspects of medical research including identifying the research questions, study design and ethical review. Public information and education about research is also called for by Brian Hurwitz in his paper on accessing medical records for research.
The book is presented in four distinct sections: historical perspective, the BMJ debate, regulation of research and a final section containing papers exploring the limits of informed consent in medical research. The historical context is clearly presented in a number of papers that emphasize the fact that harmful experimentation on humans did not only occur in Nazi Germany and that researchers in both the US and UK have regularly breached ethical standards relating to informed consent to research in the years since Nuremberg. The section centres on two seminal accounts of unethical medical research practices written by Maurice Pappworth and Henry Beecher in the 1960s. These two papers are both illuminating and disturbing and their importance cannot be emphasized too much. However, one of my few criticisms of this book is that some of the other papers in this section refer extensively to Pappworth and Beecher giving a rather repetitious feel to the whole section.
The second section represents the BMJ debate of 1997 thus bringing the debate to the present. The focus on two specific studies and the inclusion of readers' letters gives the debate an immediacy and relevance that engages the readers, whatever their position. Section three provides a good overview of national and international regulations of medical research as well as chapters on specific areas such as research with children. The final section expands the discussion further and includes excellent papers on informed consent and human rights, the consumer's view, the importance of communication and the need for increased focus on informed consent in medical education.
This book is an accessible and rich resource for all those taking part in medical research, and those involved in ethical review of research. There is a wide range of views articulated in the collection of papers but the overall message is clear. Respect for research participants is fundamental to ethical medical research and informed consent should be accepted as an a priori requirement for ethical research. Any exception to this requirement should have a strong moral justification. Present and future patients should be collaborators in medical research rather than subjects. Their active involvement will lead to not only more ethical research, but also better research.
Anne Slowther, Research Fellow, Ethox Centre, University of Oxford, Oxford, UK