Research activities in the Review Category of exempt

Generally, research that does not propose to disrupt or manipulate subjects' normal experience, or incorporate any form of intrusive procedures, may be declared exempt from IRB review (the complete federal regulations regarding exempt research is available in Title 45 CFR 46.101(b) at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101(b)). Major considerations when determining if an exemption from review is appropriate include level of risk and the presence or absence of deceptive procedures.

MINIMAL RISK means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.

Projects involving more than minimal risk must be presented for full board review. Further, any degree of deception disqualifies a study from exempted review.

Note: Although investigators should request on IRB Form I the level of review they feel is appropriate for their project, the IRB Chair, in consultation with committee members if necessary, will determine whether a proposal will fall into the Exempt, Expedited, or Full-Board Review category.