While the NPRM might do much to reduce the number of projects requiring IRB review, it would do little to improve the quality of review for those projects for which it is still required. This is a retreat from the more ambitious plans of the 2011 advance notice of proposed rulemaking.
[Cross-posted from Institutional Review Blog]
Zachary M. Schrag, editor of the Institutional Review Blog, will contribute to Bill of Health’s symposium on the 2015 notice of proposed rulemaking (NPRM) on human subjects regulations.
Zach is a professor of history at George Mason University. He has been involved with human subjects regulations’ impact on the humanities and social sciences since 2004, working as both an advocate and scholar.
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- “You Can’t Ask That.” Washington Monthly, September/October 2014.
- “What Is This Thing Called Research?” in Human Subjects Research Regulation: Perspectives on the Future, eds. I. Glenn Cohen and Holly Fernandez Lynch. Cambridge: MIT Press, 2014.
- “Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board.” Report of a subcommittee of the American Association of University Professors Committee A on Academic Freedom and Tenure. With Judith Jarvis Thomson, Catherine Elgin, David A. Hyman, Jonathan Knight, and B. Robert Kreiser. Published, September 2012. Final version, March 2013.
- “The Case Against Ethics Review in the Social Sciences.” Research Ethics 7 (2011): 120–131.