There are often questions and misconceptions regarding the need for IRB approval of oral history projects. The MSU IRB provides the following information as a resource for individuals who are unsure as to whether their projects require IRB approval.
The IRB defines as its purview those projects which meet the definition of human subjects research from the Common Rule, that is those projects that are conducted for the purpose of contributing to generalizable knowledge.
Oral history projects, as in any other field, require IRB approval when the project meets the regulatory definitions for human subjects research. The relevant definitions from the regulations (45 CFR 46.102, https://www.hhs.gov/ohrp/regulations-and-policy#46.102) are included below:
(l) Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.
(e)(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator associated with the information.
Consistent with any other method of inquiry, only those oral history projects that meet the regulatory definition of research found at 45 CFR 46.102(l) fall under the purview of the IRB. For example, while a survey conducted for research purposes qualifies as human subjects research and would require IRB approval prior to its administration, a survey conducted strictly for institutional effectiveness would not qualify as human subjects research and would not need IRB approval. Likewise, an oral history project conducted for research purposes would require IRB approval.
As always, please feel free to contact a member of the HRPP staff if you have any questions or if we can be of any assistance.