The Common Rule (32 CFR 219)
provides for exemptions from IRB review for certain Categories of minimal risk studies. If a protocol meets the
criteria for one or more of these exempt studies, then an IRB review is not necessary. The investigators, however, must comply with all of the provisions
of The Common Rule as they pertain to the protection of human subjects of their research protocol.
If, upon reviewing 32 CFR 219.101(b),
you believe that your protocol meets the criteria for one or more of the exempt categories, then complete the
Request for Exempt Determination Review template and submit it, along with all
supporting documents, to our office via IRBNet.
Investigators are not permitted to begin work on a protocol under the assumption that it is exempt from IRB review until a formal determination
from this office has been received.
