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ResourcesHuman Research EthicsCommon Rule Reform – A Botched Job – Network Blogger (Robert Dingwall | January 2017)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Common Rule Reform – A Botched Job – Network Blogger (Robert Dingwall | January 2017)

 


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US social scientists have long complained about the impact of the Common Rule, the main federal regulation governing the ethical review of biomedical and behavioral research by Institutional Review Boards (IRBs). This was first enacted in 1991 and last revised in 2005. In 2011, the relevant federal agencies announced a review, leading to the publication of revised regulations on the very last day of the Obama presidency. An international policy community has closely followed these US debates because of their influence on the frameworks for ethical regulation established elsewhere.

A 2014 report of the National Research Council of the National Academies (NRC) and by the draft regulations issued for consultation in 2016 raised hopes of sensible reform. The final drafting, however, seems to have been distracted by a major controversy over access to biospecimens. There are also signs of haste to enact regulations before the change of administration. Biomedical agendas have once again crowded out proper consideration of social science concerns.

The NRC set out a coherent approach that appropriately identified virtually all social science research as minimal risk. It should be ‘excused’ from ethical regulation on the basis that participants were well able to judge the risk and make their own decisions. A small number of experimental or intervention studies might require IRB review but everything else should just be registered. Specific consent should not be required for most studies – it could be inferred from willingness to fill in a survey or continue with an interview or focus group. Observations in public spaces, including social media, would also be ‘excused,’ as would most re-use of administrative data sets. ‘Vulnerable groups’ would no longer be listed but assumed normally to be capable of judging their own best interests. This approach was largely adopted by the draft regulations, which substituted the term ‘excluded’ for ‘excused’. IRBs would lose their jurisdiction over most social science research, unless it fell within narrow criteria or they could justify calling it in from the registration documents. There were still uncertainties about the status of participant observation or ethnography, but the approach was broadly welcomed by the community.

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