A procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. An IRB may use the expedited review procedure to review either or both of the following:
- Some or all of the research appearing on the list of categories of research and found by the reviewer(s) to involve no more than minimal risk,
- Minor changes in previously-approved research during the period for which approval is authorized.
The following criteria must be met in order for research to be considered for expedited review:
- The research activities must present no more than minimal risk to human subjects. 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 examinations or tests.
- All of the research activities involve only procedures listed in one or more of the research categories established in the Federal Register. The categories in this list apply regardless of the age of subjects, except as noted. Categories one (1) through (7) pertain to both initial and continuing IRB review.
For additional information regarding expedited review categories, see OHRP Guidance and OHRP Decision Chart #8.