Human Subjects Research Regulation ─ Perspectives on the Future

The current framework for the regulation of human subjects research emerged largelyin reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and theTuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework,combining elements of paternalism with efforts to preserve individual autonomy, has remainedfundamentally unchanged for decades. Yet, as this book documents, it has significant flaws --including its potential to burden important research, overprotect some subjects and inadequatelyprotect others, generate inconsistent results, and lag behind developments in how research isconducted. Invigorated by the U.S. government's first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers in thisfield from ethics, law, medicine, and public policy to discuss how to make the system better. Theresult is a collection of novel ideas -- some incremental, some radical -- for the future ofresearch oversight and human subject protection.

After reviewing the history ofU.S. research regulations, the contributors consider such topics as risk-based regulation; researchinvolving vulnerable populations (including military personnel, children, and prisoners); therelationships among subjects, investigators, sponsors, and institutional review boards; privacy,especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigmshifts.

ContributorsAdam Braddock, Alexander Morgan Capron,Ellen Wright Clayton, I. Glenn Cohen, Susan Cox, Amy L. Davis, Hilary Eckert, Barbara J. Evans, NirEyal, Heidi Li Feldman, Benjamin Fombonne, Elisa A. Hurley, Ana S. Iltis, Gail H. Javitt, GregKoski, Nicole Lockhart, Holly Fernandez Lynch, Michael McDonald, Michelle N. Meyer, Osagie K.Obasogie, Efthimios Parasidis, Govind Persad, Rosamond Rhodes, Suzanne M. Rivera, Zachary M. Schrag,Seema K. Shah, Jeffrey Skopek, Laura Stark, Patrick Taylor, Anne Townsend, Carol Weil, Brett A.Williams, Leslie E. Wolf

I. Glenn Cohen is Professor at Harvard Law School, where he is also Faculty Codirector of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. Holly Fernandez Lynch is Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics and author of Conflicts of Conscience in Health Care: An Institutional Compromise (MIT Press).