Improved Regulations to Protect Human Research Subjects Would Reduce Burden on IRBs While Better Protecting Study Participants


Proposed updates to federal regulations that protect human research subjects need additional clarification when applied to the social and behavioral sciences, says a new report from the National Research Council.  Fordham University Center for Ethics Education Director Dr. Celia B. Fisher was a member of the committee and an author of the report.

The report reviews an Advance Notice of Proposed Rulemaking (ANPRM) from the U.S. Department of Health and Human Services (HHS), issued in July 2011 to strengthen protection for human subjects, and recommends how best to ensure those protections while promoting effective social and behavioral science research and also respecting the different contexts and processes of biomedical research.

Last updated in 1991, the Federal Policy for the Protection of Human Subjects, popularly known as the Common Rule, outlines basic regulations for participation of human subjects in biomedical and behavioral research. Since that update, however, rapid advances in technology and the increasing volume of data available on individuals have changed the landscape for investigators and Institutional Review Boards (IRBs).  The ANPRM addresses how the Common Rule may need to be revised to more effectively protect research subjects and promote important research.

To first determine if research activities fall within the scope of the Common Rule, the report recommends that HHS define “human subjects research” as a systematic investigation designed to develop or contribute to generalizable knowledge that involves direct interaction or intervention with a living individual or that involves obtaining identifiable private information about an individual.  Only research that fits this definition should be subject to IRB procedures and the Common Rule.

Building on this definition, HHS should also clarify that research which relies on publicly available information, information in the public domain, or information that can be observed in public contexts does not meet the definition of human subjects research — regardless of whether the information is personally identifiable — as long as individuals whose information is used have no reasonable expectation of privacy. This includes digital data, some types of administrative records, and public-use data files that have been certified as protected against disclosure.

Once defined as “human subjects research,” studies should be put in one of three review categories — excused research, expedited review, or full review — already outlined in the ANPRM.

“The recommendations of the committee, if adopted, will ensure adequate protections for participants in social behavioral research, and at the same time, reduce unnecessary barriers to research that can contribute to population health and welfare,” said Dr. Fisher.

For more information on the report, please read the full National Academy of Sciences press release.

The committee that authored the report will hold a public briefing on Thursday, January 30 from 1:30 to 3:30 p.m. EST in Room 100 of the National Academies’ Keck Center, 500 Fifth St. N.W., Washington, D.C. Those who cannot attend may view a webcast of the event.

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