Research Determined to be Exempt from Continuing Review
The Word Exempt is Misleading
Investigators sometimes think the word exempt means that their protocol is exempt from review and determination, but that is not the case. A determination of Exempt means that the research protocol is approved and exempt from Continuing Review. The OHRP is very clear that it is a conflict of interest for investigators to make the determination that their own research is exempt from continuing review. It is MSU Denver's position that only the IRB Chair and IRB Members registered with the OHRP are eligible to make a determination of exempt.
From Health and Human Services, Office of Human Research Protections:
The regulations do not specify who at an institution may determine that research is exempt under 45 CFR 46.101(b). However, OHRP recommends that, because of the potential for conflict of interest, investigators not be given the authority to make an independent determination that human subjects research is exempt. (For more on this issue, see also Must there be review by someone other than the investigator before a research study is determined to be exempt?). Institutions should implement exemption policies that most effectively address the local setting and programs of research. OHRP recognizes that this may result in a variety of configurations of exemption authority, any of which are acceptable assuming compliance with applicable regulations.
In developing policies and procedures addressing exemption, OHRP recommends that institutions consider the following:
OHRP notes that the HHS retains final authority as to whether a particular human subjects research study conducted or supported by HHS is exempt from the HHS regulations (45 CFR 46.101(c)).
Determination of level of review, including determinations of not human subjects research or exempt from continuing review occurs when the Request for Review is found to be complete and ready for review. See the flow chart below for the Initial Determination process.