3. My study fits into one of the Exempt categories listed under the revised Common Rule. Do I need to submit a protocol to the UMass IRB for review?

Yes. UMass IRB/HRPO reviews all exempt protocols so a submission is required.

A determination of "exempt" means the proposed research activity meets one of the exemption criteria and thus is exempt from the federal regulations that govern the conduct of human subjects research, Common Rule (45 CFR 46).  However, a research activity determined as “Exempt”, must still be reviewed by the IRB and conducted in accordance with the ethical principles outlined in the Belmont Report: respect for persons, beneficence, and justice. Researchers must also comply with all applicable state and local regulations.

 

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