February 2014 Issue • Volume 42 • Issue 2

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From the Executive Officer
sally hillsman

Sally T. Hillsman,
ASA Executive
Officer

Consensus on the Common Rule: Proposed Revisions to Human Subjects Regulations Would Benefit Social Sciences

On January 30, 2014, the National Research Council held a public forum to discuss its newest consensus study, Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences.i The report represents a major step forward in efforts to bring the voices and needs of social science researchers to the policy discussions concerning revisions to the regulations that govern human subjects research. Federal Policy for the Protection of Human Subjects, known as the Common Rule, outlines basic regulations that aim to protect individuals who participate in biomedical and behavioral research.

A Long Road

The ASA has worked for decades to bring attention to the failure of human-subjects regulations to make distinctions between the realities and risks involved in social and behavioral science research as compared to the level of risk often present for human subjects in bio-medical research.ii ASA has not been alone in this effort. The final report of the Advisory Committee on Human Radiation Experiments, established by President Bill Clinton, addressed the impact of this failure in its final report (1995). According to historian Zachary Schrag, “the… report noted that one of the problems of the IRB system as it existed was that IRBs spent too much time reviewing minimal risk research, leaving them insufficient time to review truly risky studies” (2010: 130).

In 2011 another opportunity arose for the ASA to respond to the disjuncture between social science research and human subjects regulations. In July of that year the U.S. Department of Health and Human Services (HHS) issued an Advanced Notice of Proposed Rule Making (ANPRM) concerning plans to make significant changes the Common Rule with the aim of more effectively protecting human subjects and promoting important research. Three months later the ASA joined 21 other scholarly associations in publishing the Social and Behavioral Sciences White Paper on the ANPRM. The White Paper commended HHS for recognizing the need to modernize the Common Rule but expressed concern regarding a number of the proposed changes, including applying HIPPA Privacy Standards to all research data, which would expand federal oversight of social science research, rather than limit it.

A Committee to Address ANPRM

ASA then helped fund a two-day public event at the National Academy of Sciences, titled “Revisions to the ‘Common Rule’ in Relation to the Behavioral and Social Sciences Workshop.” The results of that workshop led to the formation of a committee (including sociologists Robert Groves, former Director of Census and current Provost at Georgetown University; Felice Levine, former ASA Executive Officer and current AERA Executive Director; and Yonette Thomas, University of Miami and Association of American Geographers) charged with writing a consensus report on the ANPRM. The group’s charge included identifying issues in the ANPRM of particular concern to the social and behavioral sciences, providing guidance on how to address those issues, and identifying areas where research would be needed to identify best practices for the implementation of new human-subjects regulations.

In the words of the committee’s chair, Susan Fiske (Princeton University), the fact that a consensus report was released a mere six months later was “practically a miracle.” If not an indication of divine intervention, it was certainly an indication of the urgency and importance the committee members felt regarding the need to improve human-subjects regulations as they apply to the social and behavioral sciences.

The consensus report includes many recommendations that, if adopted by HHS, will significantly improve the functioning of Institutional Review Boards vis a vis the work of sociologists and other social scientists. To begin, the report defines 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 obtaining identifiable private information about an individual.” Thus, information available in the public domain or observed in public contexts would not be human-subjects research and would not be subject to IRB review. This would include many forms of large-scale data such as Twitter records, public Facebook posts, or entries on blogs or electronic comment boards.

Recommendations

For research that does fit within the definition of human-subjects research, the report follows the ANPRM in supporting the creation of three categories of IRB oversight. This would involve adding to the two current categories of “Expedited Review” and “Full Review” a new category of “Excused Research.” Studies that involve only minimal risk, primarily of an informational character, would be included in this new category. Examples of research activities within the new category include the use of pre-existing data or “benign” interventions such as surveys, focus groups, and educational tests. Researchers conducting studies of this type would be required to register their study with an IRB, describe their activities and consent processes, and provide a data protection plan. They would then be free to start their project a week later. A small sample of registered studies will be audited by the receiving IRBs to assure compliance.

The current category of “Expedited Review” would be expanded to allow studies involving children and adolescents to be considered for less than full board review.  The report further recommends that “Expedited Review” be the default procedure for social and behavioral science research that is not excused. The “Full Review” category is then reserved for studies where “the probability is high that participants will experience a greater-than-minimal risk of harm and… that risk cannot be mitigated by risk-minimizing procedures.”iii The Report recommends that full board reviews occur on a monthly basis and that IRBs provide feedback to researchers within 10 days of the review.


Additionally, the report makes useful recommendations regarding protecting privacy and security of data, informed consent, handling multi-site studies with a single IRB, establishing an appeals process for IRB decisions, and encourages additional research on the actual functioning and impact of IRBs on human-subjects research.


As heartening as the National Academies report recommendations may be, there is no assurance that these changes will be reflected in any changes to the federal guidelines. If such changes are to occur, federal law requires that HHS issue a Notice of Proposed Rule Making, followed by a period of public comment. As you consider the benefits of membership in the American Sociological Association, you can add the assurance that ASA will, in concert with professional associations from across the behavioral and social sciences, work for updates to the Common Rule that address the disjuncture between social science research and human subjects regulations as they are currently written—a project that is central to our mission of advancing sociology as a scientific discipline and profession serving the common good. For more information on this topic, there will be a session at the Annual Meeting in San Francisco, titled “Consensus Study: Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences,” Yonette Thomas and Felice Levine as presenter.

References

Sally T. Hillsman is the Executive Officer of ASA. She can be reached by email at executive.office@asanet.org.

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