Who determines if my research protocol is exempt, expedited or requires full board review?
This determination is made by the IRB chair or administrator upon submission of your research protocol. First, your proposal must be considered minimal risk to qualify for exemption or expedited review. There are certain additional criteria that your research must meet to be considered exempt or to qualify for expedited review. The rules for exempt research are delineated in 32 CFR 219.101(b). The criteria for research that qualifies for expedited review can be found on the OHRP web site at: http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm.
