The Ethics of Medical Research on Humans

Claire Foster divides her book into three broad sections. The first introduces the ethical challenges of research, the balance between the need to know and the needs to benefit and to avoid harm. She follows this introductory material with her own way of considering ethics. A short transition leads to a final section which—as books on ethics should—provides cases against which to test the framework she proposes. Foster chooses a form of limited ethical pluralism as her model. She suggests that our ethical consideration of research should be driven by three kinds of morality. First is a consequentialist goal-based morality which requires that we consider the goal of the research, the scientific validity and appropriateness of the methods proposed, and the ways in which the results will be disseminated. Second is a deontological duty-based morality, based on both natural law theory and Kantian categorical imperatives. Under this heading, we need always to consider the primary obligation of the medical person to act in the best interests of and for the benefit of each and every patient. Third is a right-based morality, again deontological in origin, which demands respect for the autonomy of each patient, an observance of criteria for informed consent, and a respect for confidentiality. Foster argues that this three-part model will remind us to balance our considerations, and that each moral system alone may lead us into error. Her examples are generally good ones. Various aspects of transplantation (including xenotransplantation and embryo technology), investigations of alternative medical practice and the influence of pharmaceutical companies on publication content and practice provide examples of the use of goal-based thinking. Placebo controls and non-therapeutic research are examined closely in terms of duty-based morality. Problems with consent and confidentiality provide opportunities to apply right-based morality. The concluding section discusses how the three approaches can be combined, and how they may fail, and gives a brief history of research ethics committees and a critique of their strengths and weaknesses. But the book is not a total success. The first and most fundamental drawback is Foster's curious selectivity in her moral models. She argues strongly that her form of moral pluralism will encourage people to think of countervailing moral arguments when they judge research proposals. I think she is right, but I am not clear why her approach will make such thinking any more thorough than, say, principlism. Foster admits that her approach will never solve all the dilemmas we may encounter in research ethics. Ethics, by its very nature, cannot make such promises. I am not a principlist by conviction or practice, but it seems to me that the conflicting issues Foster identifies with placebos, for example, are made just as evident by considering the principles of autonomy, beneficence, non-maleficence and justice as they are by thinking in terms of goals, duties and rights. Similarly, I am left wondering why feminist ethics, discourse ethics, and even some forms of virtue ethics are not pressed into service. Ethical pluralism has much to recommend it, and there are great practical advantages to breaking from the constraints of consequentialism and principlism, which still dominate a good deal of bioethical thought and writing. My point is that Foster perhaps does not go far enough, nor does her analysis of examples demonstrate that her three-fold ethics produces greater clarity or thoroughness than other approaches. My second criticism is less serious. It is not really clear to me what Foster's audience is meant to be. There is a section in chapter 2, on research methodology, that would be useful to non-scientific members of research ethics committees, but it would be familiar territory for those who do research. Yet she writes ‘This book has been addressed primarily to the moral agent, that is, the researcher, and not to the research ethics committee, although it is every bit as relevant to the latter as to the former. ’ It is indeed relevant to the ethics committee, and it seems to be addressed to an audience unfamiliar with both ethics and science. There are also a few factual errors. On p. 73, Foster claims that one of the big problems for transplant recipients is ‘graft versus host disease’, which she defines as ‘the recipient's immune system developing resistance to the donor's organ. ’ It is, of course, just the opposite—the phenomenon of the donor organ producing immunity against the tissues of the host, and is seen particularly in the recipients of bone-marrow transplants for leukaemia. The common problem is host versus graft disease, usually called rejection. On p.74, she refers to the graveyards of World War I in France as ‘crematoria’, perhaps conflating the graveyards with the crematoria at the World War II extermination camps. On balance, the book can be recommended for anyone taxed with judging the ethical aspects of medical research. But I would suggest that those who read it should keep their minds open to other modes of ethical thought.