A decision regarding whether oral history (or similar activities) are subject to IRB oversight is based on the prospective intent of the investigator and the definition of "research" under HHS regulations at 45 CFR 46.102(d): "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."
General principles for evaluating Oral History type activities:
1. Oral history activities that only document a specific historical event or the experiences of individuals without intent to draw conclusions or generalize findings would not constitute "research" as defined by HHS regulations 45 CFR part 46.
Example: The creation of a video of interviews with holocaust survivors is created for viewing in the Holocaust Museum. The sole purpose is to create a historical record of personal events and experiences related to the Holocaust. There is no intent to inform policy, draw conclusions, or generalize the experiences of these individuals to a larger population. Therefore, this activity does not meet the definition of research and does not require IRB review.
2. 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: Qualitative interviews of Gulf War veterans to document their experiences and to demonstrate the need for additional research and facilities for the treatment of traumatic brain injuries. The intent here is to draw conclusions, inform policy, and/or generalize findings.
3. Oral historians and qualitative investigators may want to create archives for the purpose of providing a resource for others to do research. Such a repository of information meets the definition of “research” because it includes “research development.”
Example: Qualitative interviews are conducted with Negro League Baseball players in order to create an archive for future researchers. The creation of such an archive would constitute research under 45 CFR part 46 because the intent is to collect data for future research.
Investigators are advised submit a Determination Form to the IRB Office prior to initiating an oral history project.
Policy approved June 4th 2013.