�������������������������� An Update on the Exclusion of Oral History from IRB Review

 

������������������������������������������������������ Linda Shopes and Don Ritchie

 

����������� 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 on the OHA�s website: http://www.dickerson.edu/oha.

����������� Some IRBs, however, have raised questions about the policy statement and have circulated memoranda that suggest hypothetical cases in which oral history would still be subject to review.The memos purport to reflect the views of the Office for Human Research Protection, but in fact they seriously misinterpret the OHRP�s position.

����������� As representatives of the OHA and AHA, we participated in a conference call with Dr. Michael Carome on January 7, 2004, the OHRP�s associate director for regulatory affairs, who reaffirmed his agency�s continued concurrence in the 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 officers.�

����������� 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 a narrators� 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 multiple interviews.The interviews must be designed specifically to produce generalizable knowledge in the scientific sense.

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