Revised ‘Common Rule’ Shapes Protections For Research Participants image

Health Affairs, May 2017, Vol. 36, No. 5
By Barbara E. Bierer, Mark Barnes and Holly Fernandez Lynch (Executive Director)

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From the article:

Research with human participants funded by most federal agencies is governed by a set of rules and procedures designed to protect study participants while enabling the advancement of important biomedical and social science research. These regulations are formally known as the Federal Policy for the Protection of Human Subjects and are often referred to as the “Common Rule” because they are held in common by many different federal agencies and departments. The regulations are based on the foundational ethical principles of respect for persons, beneficence, and justice. They require, for example, voluntary and informed consent by participants and review and approval by an Institutional Review Board (IRB) of studies before they commence.

Since the current version of the Common Rule was adopted in 1991, the experience of researchers, institutions, and participants has identified multiple gaps in protections, on the one hand, and gross inefficiencies and overregulation, on the other. To address these issues, on January 19, 2017, the Department of Health and Human Services, together with fifteen other federal departments and agencies, issued final revisions to the Common Rule. They are the first comprehensive revisions in more than twenty-five years.

The revised final rule differs in several key measures from the 2015 Notice of Proposed Rule Making, the preceding step in the administrative process, which garnered nearly 2,200 comments. The revised rule attempts to modernize the protections of human participants in research, simultaneously increasing flexibility with respect to review and oversight of research and decreasing administrative burden. Some possibility remains that the Trump administration will reverse or further modify the rule. However, institutions, investigators, funders, and sponsors have little choice but to begin addressing its implications and implementation now, given that most of the rule’s provisions will go into effect January 19, 2018. In what follows, we highlight high-priority issues to be addressed in advance of the effective date, as well as implications for participants in human research. [...]

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bioethics health law policy holly fernandez lynch human subjects research regulation research