If a research proposal involves oral histories and is not defined as research under federal regulations, what action would the IRB take?

If a research proposal involves oral histories and is not defined as research under federal regulations, what action would the IRB take?

• A. The IRB will not review this study because it is not research as defined by the federal regulations.
• B. The IRB will approve the study as exempt.
• C. The IRB will require consent from participants.
• D. The IRB will request additional privacy safeguards.

Answer: (A)

When an activity isn’t defined as human subjects research under the federal rules, the IRB does not review it. The IRB’s job is to oversee research involving people as defined by 45 CFR 46, and if the oral histories proposal falls outside that definition, there’s no regulatory trigger for IRB oversight. That’s why no review, exemption determination, consent requirements, or IRB-imposed privacy safeguards apply in this scenario. If the project later shifts into something that meets the regulatory definition of research, the IRB would then become involved.

When an activity isn’t defined as human subjects research under the federal rules, the IRB does not review it. The IRB’s job is to oversee research involving people as defined by 45 CFR 46, and if the oral histories proposal falls outside that definition, there’s no regulatory trigger for IRB oversight. That’s why no review, exemption determination, consent requirements, or IRB-imposed privacy safeguards apply in this scenario. If the project later shifts into something that meets the regulatory definition of research, the IRB would then become involved.