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

Document Type


Publication Date

Summer 2013


human subjects research, biomedical research


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


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.

Publication Citation

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


Bioethics and Medical Ethics | Health Law and Policy