This grant will support career development in the area of research ethics, with particular attention to the ethics of clinical trials involving children as subjects. Over its 3 year term, the PI. a physician, historian, and experienced clinical investigator, will pursue two general goals, research and practice, with the guidance of his mentor, Prof. David J Rothman, Professor of History and Social Medicine and Director of the Center for the Study of Society and Medicine. The practice segment will involve participation in a variety of Center and medical school activities in ethics teaching and consultation. The research segment involves carrying out a historical analysis of six examples of clinical trials in which children were research subjects: the trial of diphtheria antitoxin treatment (1895), the Salk vaccine trial (1954), the development of therapy for childhood leukemia (1955-60), the introduction of phototherapy for neonatal jaundice (1970s), the Extracorporeal Membrane Oxygenator (1980s), and the use of Azidothymidine to prevent perinatal HIV transmission. Studies will include not only published and unpublished research materials, but also newspaper and magazine treatments of these studies, analysis of the ethical issues as understood at the time by physicians, by commentators in medical ethics and by the general public. The practical strategies used in these trials offer us guidance as we define the ethical standards for future research involving children.
