The Harvard Law School Library staff invites you to join a book talk and panel discussion in celebration of the launch of Professor I. Glenn Cohen and Holly Fernandez Lynch’s co-edited volume from the MIT Press, Human Subjects Research: Perspectives on the Future.
This edited volume stems from the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics‘ 2012 annual conference, which brought together leading experts in a conversation about whether and how the current system of human subjects research regulation in the U.S. ought to change to fit evolving trends, fill substantial gaps, and respond to identified shortcomings.
Please join us for a discussion of the book, pending efforts to amend federal research regulations, and some of the biggest unresolved questions in this space.
“The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee 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 remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsistent results, and lag behind developments in how research is conducted. 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 this field from ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protection.
After reviewing the history of U.S. research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts.” — MIT Press
Book talk panelists include:
I. Glenn Cohen, J.D., Professor of Law and Faculty Director of the Petrie-Flom Center, Harvard Law School (co-editor);
Holly Fernandez Lynch, J.D., M.Bioethics, Executive Director of the Petrie-Flom Center (co-editor);
Barbara E. Bierer, M.D., Professor of Medicine, Harvard Medical School and Brigham and Women’s Hospital; Harvard Catalyst; Multi-Regional Clinical Trials Center at Harvard;
![michelle 6[1]](http://etseq.law.harvard.edu/wp-content/uploads/2014/09/michelle-61.jpg)
Michelle N. Meyer, J.D., Ph.D., Assistant Professor and Director of Bioethics Policy, Union Graduate College – Icahn School of Medicine at Mt. Sinai Bioethics Program.
Wednesday, October 22, 2014, 12:00 noon.
Harvard Law School, Langdell Caspersen Room. (Directions).
Sponsored by the Harvard Law School Library.
Free and open to the public. Lunch will be served.