[Cross-posted from the Institutional Review Blog, as part of the Bill of Health’s symposium on the 2015 notice of proposed rulemaking (NPRM) on human subjects regulations.]
The notice of proposed rulemaking (NPRM) promises long-sought relief for historians, journalists, and biographers. For these groups, the goal will be to ensure that the proposed rules are enacted as currently written.
Organizations representing anthropologists, sociologists, political scientists, and other social scientists have largely tried to make peace with IRB regulations, often counseling members to submit to IRB review and serve on IRBs. Historians, by contrast, have been almost uniform in our opposition to regulation, and since 2000, we have argued that our work should not be subject to rules written for “generalizable research.” In 2003, OHRP endorsed that position, but then distanced itself at the first challenge from IRB offices. Read More