EXPEDITED RESEARCH PROTOCOLS
Research activities that present no more than minimal risk to human subjects may be reviewed by the IRB through the Expedited Review Procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45.CFR.46.102(j))(Common Rule).
To be eligible for expedited review, the research activities must be limited to those described in one or more of nine (9) federally-defined Expedited Review Categories. The activities listed in these categories should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
Applicability of Expedited Review Categories
- The review procedure is limited to research activities that present no more than minimal
risk to human subjects, and involve only procedures listed in one or more of the nine
(9) Expedited Review Categories.
- The procedure may not be used where identification of the subjects and/or their responses
would reasonably place them at risk of criminal or civil liability or be damaging
to the subjects' financial standing, employability, insurability, reputation, or be
stigmatizing, unless reasonable and appropriate protections will be implemented so
that risks related to invasion of privacy and breach of confidentiality are no greater
than minimal.
- The review procedure may not be used for classified research involving human subjects.
- Categories one (1) through seven (7) pertain to both initial and continuing IRB review.
Categories eight (8) and nine (9) pertain only to continuing IRB review.
- The categories apply regardless of the age of subjects, except where noted.
- The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.
Expedited Review Procedure
The requirements for review of research using expedited procedures are identical to review by the convened board with two exceptions:
- Instead of review by the Full Board, the Chair or an experienced member of the IRB designated by the Chair reviews the research and may request modifications and approve the research; an
- The Chair or his/her designee cannot disapprove the research.
How to Submit
Submit a new protocol in Kuali Research and select Expedited Research under “Protocol Type.” The IRB Chair or designee will determine if the research qualifies for expedited review. Additional instructions for submitting a study for review by the expedited procedure are available in the Kuali Quick Guide - Expedited / Full Board Research.
Resources
Use the following resources (as applicable) to submit an initial application for a study that meets the regulatory criteria for expedited research:
- Protocol Templates
- Informed Consent Form Templates
- Supplemental Application for International Research - Complete and submit this form if your project involves conduct of research outside the United States.
