110.1 Organization Policy on Expedited Review of Proposed Research

January 2019

It is the policy of the Organization that any IRB designated to conduct review of research may use an expedited review process.  An expedited review process may be used only in accord with DHHS and FDA regulations; therefore, only research that meets the regulatory definition of research involving no more than minimal risk, meets all applicability criteria in the document “Categories Of Research That May Be Reviewed By The Institutional Review Board (IRB) Through An Expedited Review Procedure” published by DHHS and FDA in the Federal Register and that involves procedures that are listed in one or more of the categories in this document are eligible for an expedited review process. 

An expedited review process may be conducted for initial new applications, continuing review applications, or proposed minor changes in previously approved research.  OHSR shall provide examples to researchers and IRB members regarding proposed changes in research that would qualify as a minor change eligible for expedited review.  (See Guidance: “Changes in Research”).

An expedited review may be conducted by any member on the designated IRB reviewer list, with the exception of research involving a drug, biologic, or CAM, which must be reviewed by the P&T member.  Members will be added to the designated member list when the IRB Chair determines the member has sufficient experience and training to conduct such reviews.  See Organization Policy No. 107.3. “Training and Evaluation of IRB Members and Chairs.” The Organization grants the primary reviewer conducting the expedited review process the authority to take action on a protocol in accord with Policy 109.5.  A primary reviewer conducting an expedited review is not authorized to disapprove an application per Policy No. 109.6(a).  New applications, continuing review applications, or proposed changes in already approved research that a reviewer finds at expedited review may not be approvable must be referred for discussion at a convened meeting. 

A list of all actions taken through an expedited review process will be provided to the IRB at a convened meeting.  Any member of the IRB may request re-review of research approved using an expedited process.  If such a request is made, the project will be scheduled for convened meeting discussion.