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Introduction to: 'Human Subjects Research Regulation: Perspectives on the Future'

Human Subjects Research Regulation: Perspectives on the Future (I. Glenn Cohen & Holly Fernandez Lynch eds., MIT Press 2014)

9 Pages Posted: 4 Aug 2014  

I. Glenn Cohen

Harvard Law School

Holly Fernandez Lynch

Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania

Date Written: July 28, 2014

Abstract

This introduction to "Human Subjects Research Regulation: Perspectives on the Future" summarizes the book's contents and explains its contribution in charting new ways of thinking about human subject research and the law and ethics of its regulation. Here is a description of the book itself:

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.

Keywords: human subjects research, regulation, common rule, genetics, law, paternalism, belmont report, tissue banking, consent, IRB, pediatric populations, prisoners, privacy, employment, military, risk regulation

Suggested Citation

Cohen, I. Glenn and Lynch, Holly Fernandez, Introduction to: 'Human Subjects Research Regulation: Perspectives on the Future' (July 28, 2014). Human Subjects Research Regulation: Perspectives on the Future (I. Glenn Cohen & Holly Fernandez Lynch eds., MIT Press 2014). Available at SSRN: https://ssrn.com/abstract=2473261

I. Glenn Cohen (Contact Author)

Harvard Law School ( email )

1525 Massachusetts Avenue
Griswold Hall 503
Cambridge, 02138
United States

Holly Fernandez Lynch

Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania ( email )

423 Guardian Drive
Philadelphia, PA 19104
United States

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