Oral History/Ethnography Research Guidance

This guidance is for research using oral history methods for data collection to help determine if IRB review is required. It is based on communications between other universities’ IRBs and Dr. Michael Carrome, Associate Director for Regulatory Affairs at the Office for Human Research Protections (OHRP). These communications were designed to clarify statements that OHRP made to the Oral History Association and the American Historical Association in 2003.

Oral history is a method for data collection, and, analogous to the method of sampling blood, the intended purpose (i.e., goal) for using this method dictates whether its use falls under the federal regulations that cover protections of human research subjects and operations of IRBs (i.e., Department of Health and Human Services regulations at 45 CFR 46). Blood samples taken solely for medical reasons do not fall under 45 CFR 46. However, just as when blood sampling methods are used to collect information that will be analyzed to contribute to generalized knowledge, when oral history procedures are used to that end, that research does meet the definition of research under 45 CFR 46.102(d) and must be reviewed by the IRB. The information and examples below further illustrate this point.

General Principles for Evaluating Goals of Oral History Methods for IRB Review

Oral History Goals Requiring IRB Review

  • 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 45 CFR part 46.

Example: An open ended interview of surviving Gulf War veterans to document their experiences and to draw conclusions about their experiences, inform policy, or generalize findings.

  • Creation of archives by oral historians and qualitative investigators to provide 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 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 Goals Excluded from IRB Review

  • Oral history activities, such as open ended interviews, that ONLY document a specific historical event or the experiences of individuals with no intent to draw conclusions or generalize findings WOULD NOT constitute research" as defined by 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 videotape 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. [However, if a researcher wanted to use Holocaust Museum data which identified individuals, he or she would have to apply to the IRB.]

For determining whether interviews having other goals or classroom interview research requires IRB review, see the following entries in the UM Policy Directory:

Approved by IRB 9/6/06