Expedited Review

Expited Review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

Department of Health and Human Services (DHHS) regulations (45 CFR 46.110) recognize that there are certain categories of research which involve procedures which pose no more than minimal risks to subjects and for which clear standards can be set.

a.    The Secretary, DHHS, has established, and published as a Notice in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure.

b.    (b) An IRB may use the expedited review procedure to review either or both of the following:

(1) some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk,

(2) minor changes in previously approved research during the period (of one year or less) for which approval is authorized.

Accordingly, research studies which fall under one of these categories will be reviewed by the Chair of the IRB and/or one or more experienced IRB member/s selected by the Chair. These categories, as determined by the IRB, may not apply to pregnant women, children, prisoners, mentally disabled persons, and other classes of subjects considered vulnerable.

If the application is approved by the expedited procedure, it will be reported to the IRB as a review and acknowledged agenda item at the next convened meeting. The IRB is likely to approve the expedited review action but has the option of requesting more information, requiring modification of the protocol, or disapproving the project.

Click here to download: Expedited Review Request Form