What is: a) exempt determination; b) full Board review; and c) expedited review?
• A protocol may be determined to be exempt from IRB review if all procedures fall into one or more of 6 specific categories of research, see CFR45 46.101(b). (http://www.hhs.gov/ ohrp/humansubjects/guidance/45cfr46.htm#46.101). A designated IRB reviewer makes this decision; the protocol is not reviewed further by the IRB. • Expedited review is appropriate for a protocol that presents not greater than minimal risk to subjects, and all procedures fall into one or more of 9 specific categories (http://www.hhs.gov/ ohrp/humansubjects/guidance/expedited98.htm). The IRB chair or designated IRB reviewer makes this decision; the protocol is not reviewed at a convened meeting of the IRB. (i.e., expedited or full board review) • Full Board review is required for all protocols that are not eligible for exemption or expedited review. The protocol is reviewed at a convened meeting of the IRB, at which a majority of members are present. Recommendation for action must be voted upon, and a majority m
