Are Changes to the Common Rule Necessary to Address Evolving Areas of Research? A Case Study Focusing on the Human Microbiome Project

Journal of Law, Medicine & Ethics, Vol.. 41, No. 2, p. 454, Summer 2013

U of Maryland Legal Studies Research Paper No. 2013-35

Posted: 10 Jul 2013

See all articles by Diane E. Hoffmann

Diane E. Hoffmann

University of Maryland Francis King Carey School of Law

J. Fortenberry

Independent

Jacques Ravel

University of Maryland School of Medicine, Institute for Genome Studies

Date Written: 2013

Abstract

This article examines ways in which research conducted under the Human Microbiome Project, an effort to establish a “reference catalogue” of the micro-organisms present in the human body and determine how changes in those micro-organisms affect health and disease, raise challenging issues for regulation of human subject research. The article focuses on issues related to subject selection and recruitment, group stigma, and informational risks, and explores whether: (1) the Common Rule or proposed changes to the Rule adequately address these issues and (2) the Common Rule is the most appropriate vehicle to provide regulatory oversight and guidance on these topics.

The publisher prohibits posting of the article to repositories and personal webpages. Access to the full text is available at the publisher's website.

Keywords: human subjects research, biomedical research

Suggested Citation

Hoffmann, Diane E. and Fortenberry, J. and Ravel, Jacques, Are Changes to the Common Rule Necessary to Address Evolving Areas of Research? A Case Study Focusing on the Human Microbiome Project (2013). Journal of Law, Medicine & Ethics, Vol.. 41, No. 2, p. 454, Summer 2013, U of Maryland Legal Studies Research Paper No. 2013-35, Available at SSRN: https://ssrn.com/abstract=2291983

Diane E. Hoffmann (Contact Author)

University of Maryland Francis King Carey School of Law ( email )

500 West Baltimore Street
Baltimore, MD 21201-1786
United States

J. Fortenberry

Independent ( email )

Jacques Ravel

University of Maryland School of Medicine, Institute for Genome Studies ( email )

655 West Baltimore Street
College Park, MD 20742
United States

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