In 2003, the Office of Human Research Protections within the U.S. Department of Health and Human Services issued a letter explaining 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).” This means that because oral history usually focuses on the particulars of specific people, times, and places—instead of attempting to build knowledge and theories that can be generalized (applied to other people, times, situations, and places)—oral history is not subject to IRB review. This does not mean that using oral history methods always makes IRB review unnecessary, because whether this OHRP policy applies to a specific project depends on the scholar’s intent. Using oral history methods within a systemic investigation that seeks generalizable conclusions about living people is likely to constitute “human subjects research” as defined in federal law.
Not sure whether your oral history project involves "human subjects research"? If you want help assessing your project, just ask.
These examples, from Columbia University’s IRB policy, illustrate the distinction:
A. Oral History Activities Not Considered “Human Subjects Research”
Oral history activities, such as interviews that serve only to document an individual’s life history or general reflections on past events are not considered “human subjects research.”
Example: Veterans Oral History Project
A student is planning a dissertation on the long term social impact of the Vietnam War on American culture. The student wants to conduct life histories of a group of veterans for the sake of documenting the broad meaning of the war in the rest of their lives. The interviews will be contributed to the Veterans Oral History Project at the Smithsonian Institution which offers professional training to oral historians, the costs of which were underwritten by Congress. To ensure that oral histories are conducted in a professional manner the student will follow the protocols and guidance developed for this project by the Smithsonian, as well as the guidelines of the national Oral History Association.
The above project does not require IRB approval because based on the information provided in the example the information collected from the interviews is not a systematic investigation (it is not intended to address a hypothesis). Furthermore, it is neither intended nor likely to contribute to generalizable knowledge. Other details, such as the external financial support for the oral history activity and following the OHA or sponsor’s guidelines are irrelevant in determining whether IRB approval is required by the Columbia IRB. Of course, the conduct of oral histories by Columbia faculty, staff, or students should follow the OHA guidelines.
B. Oral History Activities Considered "Human Subjects Research"
Systematic investigations involving open-ended interviews that are designed to develop or contribute to generalizable knowledge (e.g., designed to draw conclusions in an effort to address a hypothesis or serve to collect pilot data for a future "research" study) WOULD constitute "research" as defined by HHS regulations at 45 CFR Part 46, and therefore does need to be submitted for IRB review.
Example: Long-term Post-Traumatic Stress Disorder in Vietnam War Veterans
A faculty member is planning to conduct oral histories to gain an understanding of the impacts of the Vietnam War on post-traumatic stress disorder. The faculty member wants to work with a veterans Post-Traumatic-Stress-Disorder [PTSD] support group to take life histories to see how the war influenced the rest of the veterans' lives. The group agrees in writing to allow the faculty member to meet with the members as a part of the group, and individually. One goal of the research, in addition to understanding general ways in which the war affected the subsequent lives of soldiers, is to make assessments that will allow the faculty member to predict what kinds of exposure in war situations leads to the development of PTSD. In order to prepare for this analysis, the faculty member will consult published research done on PTSD with reference to Vietnam veterans, and will use PTSD related materials specific to the individuals in the group. While the veterans want to contribute their memories to the national Veterans oral history project run by the Smithsonian, they want to keep specific information which would link PTSD material to their life histories private. The faculty member and/or the psychiatrist who runs the group plans to use the data collected through these life histories to prepare a scientific presentation.
The above project does require prospective IRB approval because, based on the information provided, the information that will be collected from the interviewees will be designed to contribute to generalizable knowledge.
The veterans' interest to keep specific information which would link PTSD material to their life histories private is irrelevant to the determination that this project needs IRB approval. Such consideration would be taken by the OHRO office even for projects that do not require IRB approval.