Exempt research is research that does not need to be approved by the IRB. The Ochsner IRB written procedures assign the role of deciding whether research is exempt to the IRB Chair. Deciding that research is exempt is not something investigators should do on their own. Information needs to be entered into the IRB's electronic application system, called ERSA. If the research is exempt, the determination will be issued through the ERSA system. If not deemed exempt, the application will be assigned for expedited or full panel review as appropriate. FDA-regulated clinical investigations are never exempt from IRB review.
Research exemption requirements
1. There is no intervention or interaction with a living person that would not be occurring or would be occurring in some other fashion but for this research AND there is no identifiable private data/information obtained for the research in a form that can be associated with an individual (i.e., the identity of the subject is or may readily be ascertained or associated with the information). [45 CFR 46.102(f)]
OR
2. The research uses solely existing data or specimens (i.e., already on the shelf and collected prior to the research for a purpose other than the proposed research) AND either
a. The data or specimens are publicly available
OR
b. The information will be recorded by the investigator in such a way that it cannot be linked to the subject
[45 CFR 46.101(b)(4)]
OR
3. Research involving survey or interview procedures with adult subjects unless the information obtained is recorded in such a manner that the subjects can be identified, and the information obtained could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. [45 CFR 46.101(b)(2)]
Note that survey and interview research involving children is not exempt but rather requires full IRB review.
There are a few other exempt categories that federal regulations allow, though most will not apply to medical research.