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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

Published online by Cambridge University Press:  01 January 2021

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

The proposed changes to the Common Rule, described in the recent Advanced Notice of Proposed Rulemaking (ANPRM), come more than 20 years after the U.S. Department of Health and Human Services adopted the Rule in 1991. Since that time, human subjects research has changed in significant ways. Not only has the volume of clinical research grown dramatically, this research is now regularly conducted at multiple collaborative sites that are often outside of the United States. Research takes place not only in academic medical centers, but also at outpatient clinics, community hospitals, and other nontraditional venues. In addition, technological advances, such as sophisticated computer software programs, the Internet, social media, new research methods, and mobile applications have exponentially increased the volume of data available and the possibilities for accessing, analyzing, and sharing that data.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 41 , Issue 2 , Summer 2013 , pp. 454 - 469
Copyright
Copyright © American Society of Law, Medicine and Ethics 2013

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