Revised 'Common Rule' Shapes Protections For Research Participants.

Barbara E Bierer Mark Barnes Holly Fernandez Lynch

Health Aff (Millwood)

Barbara E. Bierer 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.

Published: May 2017

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

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http://dx.doi.org/10.1377/hlthaff.2017.0307	DOI Listing

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