YALE LAW SCHOOL P.O. Box 208215 New Haven, Connecticut 06520-8215 JAY KATZ Elizabeth K. Dollard Professor Emeritus of Law, Medicine, and Psychiatry Harvey L. Kar Professorial Lecturer in Law and Psychoanalysis 203 432 4958 203 432 8260 FAX June 16, 1994 To: Advisory Committee on Human Radiation Experiments From: Jay Katz As background materials for my comments on the history of research regulations, consider skimming the following articles (in this order if you are pressed for time): 1. The Consent Principle of the Nuremberg Code: Its Significance Then and Now. (The title says it all.) 2. Informed Consent - Must It Remain A Fairy Tale? Since the informed consent requirements for human experimentation are an offshoot of the informed consent doctrine for therapeutic settings, it might be helpful to have some idea about where informed consent came from and its present status. 3. "Ethics and Clinical Research" Revisited - A Tribute to Henry K. Beecher. This article provides some more information about the contemporary beginnings of the ethics of human experimentation. Historical accounts, as you well know, are always a mix of objective and subjective impressions. I can only give you my version of this history. The Consent Principle of the Nuremberg Code: Its Significance Then and Now Informed Consent - Must It Remain a Fairy Tale? "Ethics and Clinical Research" Revisited. A Tribute to Henry K. Beecher