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Revised 'Common Rule' Shapes Protections For Research Participants

Barbara E Bierer1, Mark Barnes1, Holly Fernandez Lynch1

  • 1Barbara 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.

Health Affairs (Project Hope)
|May 3, 2017
PubMed
Summary

Investigators are preparing for new federal protections for study participants, which were implemented in 2018. This ensures enhanced safety and ethical standards in research involving human subjects.

Keywords:
Clinical ResearchCommon RuleHuman researchOHRPRegulations

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