Sizeable Response on Review Board Issue

The federal Office of Human Research Protections (OHRP) received a large response to their request for comment on research methods subject to institutional review boards (IRBs). Dr. Zachary Schrag, an assistant professor at George Mason University, reports that more than half of the 65 responses to the OHRP’s request asked for an exclusion of oral history research methods.

Staff at OHRP provided Schrag with copies of all the comments submitted (at his request), and he posted them at Institutional Review Blog last week. In addition to the AHA’s response requesting the exclusion of oral history, the other comments reflected the wide diversity of the profession, ranging from graduate students to department chairs, and including academics and public historians.

The original federal request consisted of two parts—a specific proposal to amend Expedited Review Category 5 “to clarify that the category includes research involving materials that were previously collected for either nonresearch or research purposes.” The AHA’s response noted that this seemed likely to extend IRB intrusion over new areas of archival collection and research, and a number of the other comments reiterated that concern.

OHRP also invited comments on Category 7 of the policy, which first included “oral history” among the research methods subject to review. Regrettably, the AHA was among the organizations that supported this change back in 1998. At the time, staff and officers here thought this change could help stem a growing number of cases in which review boards engaged in seemingly arbitrary interventions in oral history research. In practice, however, the change simply extended the number of review boards claiming oversight, failed to improve the level of expertise or policies brought to bear on oral history research, thereby increasing the number of arbitrary intrusions into oral history research. As the comments to this federal request and a series of reports from AHA indicate, oral history projects are typically being reviewed by unqualified members of review boards trying to force oral history methods to abide by inappropriate categories of biomedical research.

Given the complexities of the bureaucratic process for such requests, staff at OHRP could not offer a precise schedule for when or how the office might implement these changes. They indicate that the next steps in any proposed change are likely to focus on implementing the changes proposed for Category 5. If OHRP chooses to make any changes to Category 7, they will likely be the subject of a separate proposal for change and another round of comment and review.

We hope AHA members will keep a close eye on this issue in the coming month (and years), and in the interim, will continue to engage administrators and review boards at their institutions, seeking clear policies and appropriate criteria for oral history.

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