by Holly Fernandez Lynch, JD, MBioethics, Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

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 US Public Health Service Syphilis Study at Tuskegee, conducted by US 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, it has significant flaws—including its potential to burden important research, lag behind developments in how research is conducted, overprotect some subjects and inadequately protect others, and generate inconsistent results.

A new book from the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, titled Human Subjects Research Regulation: Perspectives on the Future, documents some of the issues that persist with the current system of research regulation. Invigorated by the US government’s first steps toward change in over twenty years, Human Subjects Research Regulation, which was co-edited by myself and the Center’s faculty director I. Glenn Cohen, JD, brings together the leading thinkers in the fields of 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 protections.

The edited volume stems from the Petrie-Flom Center’s 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 US ought to change to fit evolving trends, fill substantial gaps, and respond to identified shortcomings. After reviewing the history of US research regulations and the 2011 Advance Notice of Proposed Rulemaking for revision to the “Common Rule”—in a chapter by PRIM&R’s own Elisa A. Hurley, PhD, and Amy Davis, JD, MPH—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 IRBs; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts.  

The book is currently available from MIT Press and Amazon, and its introduction can be downloaded for free here. We will be hosting a book discussion at Harvard Law School on October 22 (in Wasserstein Hall Room 2009 from 12-1:30pm), and in Baltimore on December 5 at PRIM&R’s 2014 Advancing Ethical Research Conference.

We hope to see you there!