NRC Panel Issues Recommendations on Common Rule
 
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January 2014
 
A National Research Council (NRC) panel released a
report this month urging that federal regulations that protect human research subjects clarify the review process for social and behavioral science research. AERA Executive Director Felice J. Levine served on the NRC-appointed 16-person panel, which was charged in December 2013 with reviewing proposed regulations outlined in the Advance Notice of Proposed Rulemaking issued by the U.S. Department of Health and Human Services.

The report’s key recommendations included:

  • Defining “human subjects research”—research that would be subject to the full review process—as involving direct interaction with a living individual or obtaining identifiable private information about the individual.

  • Clarifying that research which relies on publicly available information or information that can be observed in public contexts should not be considered “human subjects research,” as long as the individuals whose information is used have no reasonable expectation of privacy.

  • Outlining three distinct categories of research studies: excused research, expedited review research, and full review research. Expedited review research—or research that might otherwise qualify as excused but may need further consideration—should be considered the default category of social and behavioral science research that is not in the excused category.

Advances in technology and availability of online data have changed the landscape for human subjects research. The strict regulations set forth in the 1991 Federal Policy for the Protection of Human Subjects—popularly called the “Common Rule”—were designed to protect human subjects of biomedical and behavioral studies; however, a great deal of social and behavioral science research poses minimal risk to subjects and may not merit the full institutional review board process.

Public Briefing on January 30
The committee that wrote the report will present a public briefing on its recommendations for an audience representing federal agencies, research institutions, professional and advocacy associations, and other stakeholders. The briefing will be held on January 30, 2014, from 1:30 p.m. to 3:30 p.m. (EST) at the National Academies’ Keck Center, Room 100, 500 Fifth Street NW, Washington, D.C.

RSVP online or view the webcast of the event at www.nationalacademies.org.

Related Article:

NRC Panel to Examine Common Rule,” AERA Highlights, January 2013

 
 
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