In September, 2003, the Office of Human Research Protections (DHHS) issued a letter to the Pennsylvania Historical and Museum Commission concerning the need for review of oral history being collected by the Commission. This letter has led some New York University investigators, among many others, who make use of oral history in research to ask for clarification of OHRP's position as it affects the need for investigators to apply to the University Committee on Activities Involving Human Subjects (UCAIHS), NYU's Institutional Review Board (IRB), for review and approval of such work.
In response to an inquiry on this topic from Northeastern Illinois University, Dr. Michael Carome of the DHHS Office of Human Research Protections issued, on Dec. 1, 2003, a clarification of the Pennsylvania decision as it might apply to other situations. This clarification makes it clear that investigators are likely to continue to need UCAIHS approval for projects involving human subjects. The following excerpt from Dr. Carome's response to NIU details the circumstances under which oral history does or does not need IRB review and approval:
General Principles for Evaluating Oral History Type Activities
- 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 surviving Gulf War veterans to document their experiences and to draw conclusions about their experiences, inform policy, or generalize findings.
- 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.
Until the regulations governing the use of human subjects in research are revised or OHRP changes the policies cited above, investigators at the University should continue to apply to the UCAIHS for review and approval of all activities involving human subjects. Dissertations or theses that include human subjects are by definition considered to be research and are therefore required to be reviewed by the UCAIHS. Investigators requiring advice on how to categorize a particular project involving oral history should contact the UCAIHS staff.