Exemptions Don't Come to PRIM&R's Mind

In October, PRIM&R hosted a webinar on "Protecting Human Subjects in Qualitative Research: Ethical Considerations for IRBs and Researchers," hosted by Julie Simpson, director of research integrity services at the University of New Hampshire.

A follow up question, just posted the PRIM&R Blog, suggests that Simpson is unfamiliar with the Common Rule:

AS: Under what circumstances might qualitative research not require IRB review?
JS: None come to mind at this time. If the activity is research and it involves human subjects, then it needs IRB review.

Of course, 45 CFR 46.101 lists several circumstances in which human subjects research does not require IRB review, some of them--particularly (b)(2) and (b)(3)--of enormous importance to qualitative researchers.

To be sure, OHRP is primarily responsible for discouraging institutions from recognizing the exemptions. But it is a pity to see PRIM&R spread such misinformation.