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

Overview of attention for article published in The Journal of Law, Medicine & Ethics, January 2021
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Title
Are Changes to the Common Rule Necessary to Address Evolving Areas of Research? A Case Study Focusing on the Human Microbiome Project
Published in
The Journal of Law, Medicine & Ethics, January 2021
DOI 10.1111/jlme.12055
Pubmed ID
Authors

Diane E. Hoffmann, J. Dennis Fortenberry, Jacques Ravel

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.

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Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 41 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United States 1 2%
Unknown 40 98%

Demographic breakdown

Readers by professional status Count As %
Researcher 9 22%
Professor > Associate Professor 6 15%
Student > Ph. D. Student 5 12%
Student > Bachelor 4 10%
Professor 3 7%
Other 8 20%
Unknown 6 15%
Readers by discipline Count As %
Agricultural and Biological Sciences 11 27%
Nursing and Health Professions 4 10%
Psychology 3 7%
Biochemistry, Genetics and Molecular Biology 3 7%
Medicine and Dentistry 3 7%
Other 8 20%
Unknown 9 22%