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.
Now, the NPRM promises to eliminate the ambiguity. As it explains, it
outlines eleven specific types of activities that will be outside the scope of the regulations. These activities will therefore not have to satisfy any regulatory requirements, nor is it expected (unlike exempt research) that they will undergo any type of review process to determine this status. The exclusions will eliminate uncertainty regarding some activities that are not research, and identify some activities that arguably might be judged to be research, but whose contribution to public welfare is so imperative that they should proceed without having to satisfy the regulatory requirements. The exclusions also identify certain research activities that are sufficiently low- risk and nonintrusive that the protections provided by the regulations are an unnecessary use of time and resources, whereas the potential benefits of the research are substantial.
History makes this first set of exclusions, concerning the “some activities that are not research.” As the NPRM explains,
While the NPRM does not propose to modify the definition of “research”, it does propose to explicitly exclude oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information or biospecimens is collected.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.