If your study needs IRB review, the next step is to identify the level of review required—full board review, expedited review, or exempt from further review.
The level of review will reflect the level of risk to the subject, which is compared to “minimal risk” as defined by the Code of Federal Regulations:
- "Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." (45.CFR.46.102(j))(included in the Common Rule).
Following the language of the regulation and common practice, our IRB requires that both the probability and magnitude of harm be low for risk to be assessed to be minimal.
Studies that entail greater than minimal risk require full IRB review, while minimal risk studies may be eligible for expedited review or may even be certified by the IRB to be exempt from further IRB review. Full board reviews take the longest, since the full IRB must meet to reach a decision, and in particular does not convene during breaks in the academic year.
Recorded Interviews: A Caution
Social researchers commonly wish to conduct and record interviews, often by using technologies like Zoom. If the risk is minimal, which can depend on both the subject matter and the recording method used, there are circumstances in which the research may be exempt from further IRB review. In other situations, an expedited review may be required, again if risk is minimal. In either of the above cases, even if the identity of the interviewee were revealed, the magnitude of harm would be small. On the other hand, it could be that, even though the probability of a breach of confidentiality is low, the harm caused by such a breach would be great. Thus, if interviewees could be exposed to serious social, economic, legal, or other risks, were their identities to be revealed, then there is greater than minimal risk, and a full board review would be required.
As noted above, the method of recording can affect the level of risk, given that modern technologies have increased the likelihood that a determined party in possession of a recording could discover the identity of the interviewee, even if their identity is not openly revealed in the interview. For example, Zoom creates two recordings—an m4a audio recording and an mp4 audio-video recording. The latter is more likely to be able to be used to reveal the identity of the interviewee than the former, although nowadays there are risks in both cases. A research protocol that specifies that the audio-video recording will be deleted and that the audio recording will be retained only as long as is required to make a transcription of the interview will entail a lower level of risk to interviewees than if the audio-video recording is to be retained and utilized in the research, all else equal.