Revised 'Common Rule' Shapes Protections For Research Participants

Health Aff (Millwood). 2017 May 1;36(5):784-788. doi: 10.1377/hlthaff.2017.0307.

¹ Barbara E. Bierer (bbierer@bwh.harvard.edu) is faculty co-director of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center); director of the Regulatory Foundations, Ethics and Law Program, Harvard Catalyst; and a professor of Medicine at Brigham and Women's Hospital and Harvard Medical School, in Boston, Massachusetts. Mark Barnes is a partner at Ropes and Gray LLP, a visiting lecturer at Yale Law School, and faculty co-director of the MRCT Center. Holly Fernandez Lynch is executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and faculty in the Harvard Medical School Center for Bioethics.

Abstract

Investigators and institutions have begun to prepare for new federal protections of study participants set to take effect in 2018.

Keywords: Clinical Research; Common Rule; Human research; OHRP; Regulations.

Project HOPE—The People-to-People Health Foundation, Inc.