According to federal regulations, expedited review of a new, proposed study by an IRB (Institutional Review Board) may be used when the study involves no more than minimal risk to the human subjects and fits into one or more of the specific categories of research eligible for expedited review as defined by the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The expedited review procedure is reserved for research activities that present minimal risk and for minor changes in previously approved research during the approval period. The review can be conducted by the IRB chairperson or an experienced reviewer and carries all the authorities of the IRB except the authority to disapprove the study. The criteria for approval remain the same as for a full IRB review. Expedited review is not applicable if the study involves greater than minimal risk or does not meet the allowable categories specified federally. In summary, the best description according to federal regulations is:
- The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified by federal regulations.
This is consistent across multiple federal guidelines and IRB policies.
