W(h)ither Informed Consent? Research Ethics from Nuremberg to Now
The Harold T. Shapiro Lecture on Ethics, Science, and Technology
Alexander M. Capron, University Professor, Scott H. Bice Chair in Healthcare Law, Policy and Ethics, and Professor of Medicine and Law, University of Southern California
The concept of autonomy—a bedrock of liberal societies—is manifested in research with human beings through the doctrine of informed consent. The first principle in the so-called “Nuremberg Code,” set forth in the judgment passed in 1947 by the court that tried the physicians who experimented on Nazi concentration camp inmates, proclaims that “the voluntary consent of the human subject is absolutely essential.” In the 1970s, consent requirements for research—as well as medical care—became more detailed and demanding. Yet the adequacy of consent is seldom actually examined in a regulatory context, perhaps because many physician-researchers doubt the feasibility of obtaining it, and an increasing amount of research is now being conducted without obtaining the advance, voluntary, and informed consent of the people being studied. Is this where informed consent is headed, and, if so, ought we to be concerned?
Alexander M. Capron is a University Professor at the University of Southern California, where he occupies the Scott H. Bice Chair in Healthcare Law, Policy and Ethics at the Gould School of Law, is a Professor of Medicine and Law at the Keck School of Medicine, and co-directs USC’s Pacific Center for Health Policy and Ethics. He previously taught at Yale and Georgetown Universities and at the University of Pennsylvania. Professor Capron served as the Executive Director of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1979-83), as Chair of the Biomedical Ethics Advisory Committee of the US Congress (1987-90), as a member of the National Bioethics Advisory Commission (1996-2001), and as the World Health Organization’s first Director of Ethics, Trade, Human Rights and Health Law (2002-06). He has written and edited a dozen books and more than 250 scholarly articles and chapters. Professor Capron received his L.L.B. from Yale Law School and his B.A. from Swarthmore College.