An Assessment of the Human Subjects Protection Review Process for Exempt Research

44 J. Law, Medicine, & Ethics 481 (2016)

11 Pages Posted: 11 Jul 2015 Last revised: 28 Mar 2022

See all articles by Jonathan Loe

Jonathan Loe

University of Arizona, James E. Rogers College of Law, Students

D. Winkelman

University of Arizona - James E. Rogers College of Law

Christopher T. Robertson

Boston University; University of Arizona - James E. Rogers College of Law; Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Date Written: July 10, 2015

Abstract

Medical and public health research includes surveys, interviews, and biospecimens--techniques that do not present substantial risks to subjects. Consequently, this research is exempt from regulation under the Federal Common Rule. Nevertheless, at many institutions, exempt research is frequently subject to the same regulatory process that is required for non-exempt research, requiring the consumption of time and resources for review by Institutional Review Board members or staff. The federal government has indicated an intention to reform and centralize this system, but has not yet specified the form that it will use instead. By examining the policies of the top 50 research institutions, this article assesses institutional practices surrounding exempt research, quantifies the extent of exempt-research review requirements, documents a problem of "over-compliance," and makes recommendations for reform.

Keywords: Ethics, Research, Compliance, Institutional Review Boards, Human Subjects Protections

Suggested Citation

Loe, Jonathan and Winkelman, D. and Robertson, Christopher T., An Assessment of the Human Subjects Protection Review Process for Exempt Research (July 10, 2015). 44 J. Law, Medicine, & Ethics 481 (2016), Available at SSRN: https://ssrn.com/abstract=2629491

Jonathan Loe

University of Arizona, James E. Rogers College of Law, Students

Tucson, AZ
United States

D. Winkelman

University of Arizona - James E. Rogers College of Law ( email )

P.O. Box 210176
Tucson, AZ 85721-0176
United States

Christopher T. Robertson (Contact Author)

Boston University ( email )

765 Commonwealth Avenue
Boston, MA 02215
United States
6179100649 (Phone)
02215 (Fax)

University of Arizona - James E. Rogers College of Law ( email )

P.O. Box 210176
Tucson, AZ 85721-0176
United States

Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics ( email )

23 Everett Street
Cambridge, MA 02155
United States

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