Editor's Note: Because of varying interpretations of the recent decision to exclude oral history from the purview of Institutional Review Boards, Linda Shopes (Pennsylvania Historical and Museum Commission) and Donald Ritchie (U.S. Senate Historical Office), who represented the AHA and the Oral History Association, respectively, in discussions with the Office for Human Research Protection on the subject, provide a clarification.

Since August 26, 2003, when the Office for Human Research Protection (OHRP) concurred in a policy statement developed jointly by the AHA 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 http://omega.Dickinson.edu/organizations/oha/org_irb.html).

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. In an e-mail dated January 8, 2004, Michael Carome, the associate director for regulatory affairs at the OHRP, stated 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 received 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 26, 2003, policy statement).

Interview projects that meet with the above federal definition should be submitted for IRB review. Those that do not are not subject to review.

—Linda Shopes (Pennsylvania Historical and Museum Commission)

—Donald Ritchie (U.S. Senate Historical Office)