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Article
Are Changes to the Common Rule Necessary to Address Evolving Areas of Research? A Case Study Focusing on the Human Microbiome Project
Faculty Scholarship
  • Diane E. Hoffmann, University of Maryland Francis King Carey School of Law
  • J. Dennis Fortenberry
  • Jacques Ravel
Document Type
Article
Publication Date
7-1-2013
Keywords
  • human subjects research,
  • biomedical research
Comments

The publisher prohibits posting of the article to repositories and personal webpages. Access to the full text is available at the publisher's website: http://onlinelibrary.wiley.com/doi/10.1111/jlme.12055/pdf (DOI: 10.1111/jlme.12055).

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.

Journal
41 Journal of Law, Medicine & Ethics 454 (2013).
Citation Information
41 Journal of Law, Medicine & Ethics 454 (2013).