Minimal Risk (Expedited) Review
Minimal Risk generally means that the probability and magnitude of physical or psychological harm anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life, or in routine medical, dental, or psychological examinations. In order to be considered Minimal Risk, research must meet this definition and fall within one or more of the federally-defined categories that qualify for “Expedited” review. The definition of “minimal risk” is somewhat different for research involving prisoners of the Department of Defense.
Under an expedited review procedure, (see SOP Expedited Review) the review may be carried out by the IRB chair or by one or more experienced reviewers designated by the chair from among members of the IRB. The WORKSHEET Expedited Review Eligibility is a tool that describes the expedited categories and additional details about the definition of “minimal risk”.