January 2013

In December, the National Research Council (NRC) appointed a 12-person panel to address possible revisions to the Common Rule for the protection of human subjects in research, last revised in 1991. AERA Executive Director Felice Levine, an expert on research ethics, was invited to serve on the panel.

The Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences is charged with operating on a fast track to hold workshops and produce a summary report. Assuming sufficient funding, a consensus report will be prepared to further inform efforts to update the Common Rule. The first Information-Gathering and Workshop-Planning Meeting will be held on January 14–15, followed by a two-day workshop in March.

The panel, led by  Susan Fiske of Princeton University, will consider issues such as the appropriateness of the Common Rule for various behavioral and social science research methods, for information and psychological risks, and for the consent process and facilitation of informed decisions. At this stage, the project is funded by the National Science Foundation’s Directorate for Social, Behavioral, and Economic Sciences and Directorate for Education and Human Resources.

Over many years, there has been growing recognition of the need to examine the Code of Federal Regulations for the Protection of Human Subjects (45CFR46). In July 2011, the Office of the Secretary of the Department of Health and Human Services, in coordination with the Office of Science and Technology Policy, issued an advance notice of proposed rulemaking (ANPRM) requesting general and specific comments in seven areas on some 74 questions.

In October 2011, extensive comments were provided in the Social and Behavioral Science White Paper on Advance Notice for Proposed Rulemaking, submitted by 22 organizations. Levine was senior author of the white paper.

Levine has served on the National Human Research Protections Advisory Committee of the U.S. Department of Health and Human Services. She was on the National Research Council panel on Putting People on the Map: Protecting Confidentiality with Linked Social-Spatial Data and chaired the NRC workshop on Protecting Student Records and Facilitating Education Research.