Clearing Complexity from the Common Rule NPRM

3 Journal of Law & the Biosciences 257 (2016)

24 Pages Posted: 8 Nov 2016

See all articles by Christi J. Guerrini

Christi J. Guerrini

Baylor College of Medicine; University of Houston Law Center Intellectual Property and Information Law Institute

Amy L. McGuire

Baylor College of Medicine

Mary Anderlik Majumder

Center for Medical Ethics and Health Policy, Baylor College of Medicine

Date Written: June 15, 2016

Abstract

On September 8, 2015, the U.S. Department of Health and Human Services proposed major changes to the regulations known as the Common Rule, whose purpose is to protect human subjects in federally funded research. The proposed changes have been criticized as unduly burdening the conduct of research. While some of the proposed changes are supported by legitimate practical, legal, or ethical considerations, we believe that others lack compelling justification. This article addresses those unjustified changes that we view as especially problematic, focusing on the proposed disparate treatment of secondary research involving data and secondary research involving biospecimens across a number of provisions. The primary rationale for this disparate treatment is that individuals have a strong autonomy interest in the research use of their biospecimens that does not extend to their private information. We explain why this and other justifications do not hold up to scrutiny and how the proposed changes will introduce new layers of complexity to the conduct of research while incentivizing behaviors that undermine the Common Rule's effectiveness and integrity. We conclude by recommending the removal of these unjustified complexities from the regulations that ultimately are adopted.

Keywords: NPRM, Common Rule, Research Ethics, Biospecimens, Health Data

Suggested Citation

Guerrini, Christi J. and McGuire, Amy L. and Majumder, Mary Anderlik, Clearing Complexity from the Common Rule NPRM (June 15, 2016). 3 Journal of Law & the Biosciences 257 (2016). Available at SSRN: https://ssrn.com/abstract=2858520

Christi J. Guerrini (Contact Author)

Baylor College of Medicine ( email )

One Baylor Plaza
Apt 510
Houston, TX TX - Texas 77057
United States

HOME PAGE: http://https://www.bcm.edu/people/view/christi-guerrini-j-d/b1e79844-9aa9-11e4-907f-005056b104be

University of Houston Law Center Intellectual Property and Information Law Institute ( email )

4604 Calhoun Road
Houston, TX 77204-6060
United States

Amy L. McGuire

Baylor College of Medicine ( email )

One Baylor Plaza
Apt 510
Houston, TX TX - Texas 77030
United States

Mary Anderlik Majumder

Center for Medical Ethics and Health Policy, Baylor College of Medicine ( email )

One Baylor Plaza
Houston, TX TX - Texas 77030
United States

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