Determination of Exempt Status
The federal guidance clearly states that it is a conflict of interest for investigators to make the determination that their own research is exempt from requirements of the Common Rule. Therefore, like many other institutions, it is the IRB's policy that any research involving human subjects or identifiable private data be submitted for to the HSPP for IRB review, and that the IRB will make the determination of exempt status, not the researcher.
The Word Exempt is Misleading
Investigators sometimes think the word "exempt" means that their protocol does not have to be submitted to the IRB for review and determination, but that is not the case. A determination of "exempt" means that the research protocol is exempt from regulatory requirements of the Common Rule (45 CFR 46), the federal regulations that govern the conduct of human subjects research. However, theses studies must still meet institutional standards. At MSU Denver all human subjects research must be reviewed by the IRB and is held to same standard of ethical conduct.
Studies that qualify for an exempt determination involve research activities that pose less than minimal risk to participants and fall within six defined categories in the Common Rule. Studies that are determined exempt do not require continuing or final review by the IRB. If modifications are proposed to exempt research, a modification application must be submitted for IRB review and approval prior to implementing any changes to the study.
The submission requirements are the same for all levels of IRB review, including exempt determinations. The reviewer(s) must be given sufficient information to assess risks to participants. Therefore, the quality and clarity of your submission materials will affect the reviewer's ability to determine if your proposed research is exempt.
Please consult with the HSPP staff if you have any questions about the review process or whether your study may be exempt.