An Update on the Exclusion of Oral History from IRB Review
Since August 26, 2003, when the Office for Human Research Protection concurred in a policy statement developed jointly by the American Historical Association and the Oral History Association regarding the application of federal regulations governing research on human subjects to oral history, most campus-based oral history projects have been able to proceed with their interviews without submitting protocols for review by an Institutional Review Board. (The policy statement can be found at the website below).
We are aware, however, of several memos in circulation in which IRB representatives have raised questions about the standing of the policy statement or suggested hypothetical cases in which oral history projects might still be subject to review.
We are pleased to report that after a conference call on January 7, 2004, the Office for Human Research Protection confirmed its concurrence with the existing policy statement. On January 8, Dr. Michael Carome, the Associate Director for Regulatory Affairs, stated the following in an email to us:
“To summarize from OHRP's perspective, OHRP yesterday reaffirmed its concurrence with your policy statement that oral history interviewing activities, in general, are not designed to contribute to generalizable knowledge and therefore do not involve research as defined by Department of Health and Human Services (HHS) regulations at 45 CFR 46.102(d) and do not
need to be reviewed by an institutional review board (IRB). OHRP has tried consistently to confirm this concurrence whenever it receives inquiries about this matter from representatives of IRBs or other institutional officials.”
Some of the confusion seems to have arisen around the concepts of “research” and “generalizable knowledge.” While oral history clearly involves historical research and interviews can lend themselves to generalizations, oral historians’ standard operating procedures do not fit the type of research defined by federal regulations: “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Individually-tailored interviews with the narrator’s informed consent do not meet this definition of “research.” Nor do they contribute to “generalizable knowledge,” even if conducted with people identified with a common group, theme or event, and whether or not the interviewer or other researchers might draw some historical generalizations from the multiple interviews. The interviews must be designed specifically to produce generalizable knowledge in the scientific sense (as detailed in paragraph two of the August 26th policy statement.)
Interview projects that meet the above federal definition should be submitted for IRB review. Those that do not are not subject to review.
We hope that this will clarify matters.
Linda Shopes, Pennsylvania Historical and Museum Commission
Don Ritchie, Senate Historical Office
Division of History
Pennsylvania Historical & Museum Commisison
COmmonwealth Keystone Building - PL
400 North St.
Harrisburg, PA 17120-0053
For information purposes only; I cannot respond to individual requests for advice on oral history and human subjects review issues.
Send comments and questions to H-Net
Webstaff. H-Net reproduces announcements that have been submitted to us as a
free service to the academic community. If you are interested in an announcement
listed here, please contact the organizers or patrons directly. Though we strive
to provide accurate information, H-Net cannot accept responsibility for the text of
announcements appearing in this service. (Administration)