Children as Research Subjects

Michael A. Grodin, M.D., FAAP, is a Medical Ethicist, Professor of Health Law, Pediatrics, Socio-Medical Sciences and Community Medicine, Adjunct Professor of Philosophy, and Director of the Program in Medical Ethics at Boston University Schools of Medicine, Public Health and the College of Liberal Arts. He has been Chairman of the Institutional Review Board of the Department of Health and Hospitals of the City of Boston for 10 years, and is a member of the National Committee on Bioethics of the American Academy of Pediatrics. He is co-editor of The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation (Oxford, 1992) Leonard H. Glantz, J.D., is a lawyer, Associate Director and Professor of Health Law at Boston University School of Public Health, and Professor of Socio-Medical Sciences and Community Medicine at Boston University School of Medicine. Mr. Glantz was an advisor to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the area of legal issues concerning research with children, and has been a member of Institutional Review Boards for 15 years.

I. History
1: Historical Overview: Pediatric Experimentation, S. Lederer, M. Grodin
II. Science
2: Scientific Issues in Biomedical Research with Children, R. Kauffman
3: Scientific Issues in Psychosocial and Educational Research with Children, G. Koocher
III. Ethics
4: Ethics of Exposing Children to Risks in Research, D. Brock
IV. Law
5: The Law of Human Experimentation with Children, L. Glantz
V. Practical Problems
6: Children's Involvement in Research Participation Decisions: Psychological Considerations, L. Weithorn, D. Scherer
7: Assessment of Risk to Children, E. Wender
8: Vulnerable Children, R. Cooke
Codes of Ethics: Nuremburg Code; WHO Declaration of Helsinki IV; Federal Policy for the Protection of Human Subjects: Notices and Rules; Points to Consider in Proposing or Reviewing Research Involving Children