In general, the UConn IRB agrees that oral history interviews are not designed to contribute to generalizable knowledge and are therefore not subject to IRB review. However, at the present time, the Office for Human Research Protections has not issued formal guidance regarding oral history and the federal regulations. Therefore, at its meeting of January 18, 2005, the IRB determined that studies involving the use of oral histories would be reviewed by the IRB and that a determination would be made, on a case-by-case basis, as to whether the research meets the definition of research specified in the federal regulations. Until formal federal guidance is issued, the IRB would like to provide researchers with the following research scenarios 1 as examples of research that would or would not require IRB review.
Oral history activities, such as open ended interviews, that ONLY document a specific historical event or the experiences of individuals without an intent to draw conclusions or generalize findings would NOT constitute “research” as defined by HHS regulations 45 CFR part 46.
Example: An oral history video recording of interviews with holocaust survivors is created for viewing in the Holocaust Museum. The creation of the video tape does NOT intend to draw conclusions, inform policy, or generalize findings. The sole purpose is to create a historical record of specific personal events and experiences related to the Holocaust and provide a venue for Holocaust survivors to tell their stories.
Systematic investigations involving open ended interviews that are designed to develop or contribute to generalizable knowledge (e.g., designed to draw conclusions, inform policy, or generalize findings) WOULD constitute “research” as defined by HHS regulations at 45 CFR part 46.
Example: An open ended interview of Gulf War veterans to document their experiences and to draw conclusions about their experiences to help the VA evaluate VA health benefit policy for these veterans.
Oral historians and qualitative investigators may want to create archives for the purpose of providing a resource for others to do research. Since the intent of the archive is to create a repository of information for other investigators to conduct research as defined by 45 CFR part 46, the creation of such an archive WOULD constitute research under 45 CFR part 46.
Example: Open ended interviews are conducted with surviving Negro League Baseball players in order to create an archive for future research. The creation of such an archive would constitute research under 45 CFR part 46 since the intent is to collect data for future research.
Oral history research that does meet the definition of research is likely to qualify for review by the expedited mechanism (rather than meet the criteria for exemption because the interviews are generally audio or videotaped). Therefore, such research must be submitted to the IRB using the IRB-1 protocol application. The IRB will determine whether a study involving oral history receives exempt, expedited or full board review as defined by the federal regulations.
Researchers are encouraged to contact Research Compliance Services, or a member of the IRB, with questions pertaining to oral history research and IRB review prior to completing a protocol application.
1The scenarios were taken from a workshop presented by Tracy Arwood, Clemson University and Helen McGough, University of Washington held at the 2007 Social, Behavioral, Educational Research Conference. The scenarios were taken from a December 2003 e-mail exchange with Michael Carome, Associate Director Regulatory Affairs, OHRP and Lori Bross, Assistant to the Vice President for Research – Research Compliance, The Graduate School, Office of Research Compliance, Northern Illinois University, DeKalb, IL. For the full text of this exchange, read New York University’s Clarification on Oral History.