Research reviewed by an expedited review process means that one or more qualified reviewers designated by the chairperson reviews the submission rather than a review at a convened (Full Board) IRB meeting. Expedited review in this manner is in accordance with the requirements set forth in 45 CFR 46.110 and 21 CFR 56.110.
There are no deadlines for IRB applications qualifying for Expedited Review and the IRB has the authority to recommend or require revisions to the submitted materials during the course of the review. For information regarding submitting to the IRB for expedited review visit the IRB Forms and Submission Requirements webpage.
An expedited review process can be used, when appropriate, for the initial review of a research study, when minor changes are proposed (expedited amendment review) and for continuing review (expedited continuation review).
What research qualifies for expedited review?
To qualify for Expedited Review, the research must meet both of the following:
- Presents no more than minimal risk to research participants;
- Involves only research activities listed in one or more of the nine available research categories listed below.
About expedited review:
- The criteria for IRB approval, including standard requirements for informed consent (or its waiver or alterations) apply to expedited review in the same manner as for full board review.
- The activities listed in the categories below should not be deemed to be of minimal risk simply because they are included in the 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 participants.
- The expedited review procedure may not be used where identification of the participants and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the participants' 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.