While oral history is typically not considered human research, the prospective intent of the investigator and the definition of “research” under the federal regulations needs to be taken into account. Per federal regulation, research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

Specifically, the consideration of human research and the requirement for IRB review hinges upon whether:

• The activity involves a prospective research plan which incorporates data collection, including qualitative data, and data analysis to answer a research question; AND
• The activity is designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study population), inform policy, or generalize findings.

General principles for evaluating whether oral history type activities are human research and require IRB review:

• Oral history activities, such as open-ended interviews, 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 federal regulation.
• 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 federal regulation.
• 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 federal regulation.