Expedited Change of Protocol Guidance
Version Date: December 1, 2012
This document provides guidance to researchers and others regarding expedited review of minor changes of protocols as conducted by the Health Sciences Institutional Review Boards (HS IRBs). The Common Rule(45 CFR 46.110) and FDA regulations (21 CFR 56.110) allow for the review under expedited procedures of "minor changes in previously approved research during the period (of one year or less) for which approval is authorized" by the IRB Chair or designated experienced IRB member. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that they may not disapprove the research. Any expedited approvals must be reported to the full IRB.
Criteria for Expedited Review of Changes of Protocol
The HS IRBs typically limit expedited review of changes to those that are minimal risk or administrative in nature AND:
- Represent minor clarifications of study procedures previously approved by the convened IRB,
- do not significantly change the study design, AND
- do not alter the risk/benefit ratio of the study.
In addition, the HS IRBs will typically review changes to non-exempt medical records studies under expedited procedures unless the PI is being changed, significant changes are being made to the aims or purpose, and/or changes are such that the study will no longer qualify as a non-exempt medical record study.
Please see the Expedited Changes Examples table for specific examples of what changes may be reviewed under expedited procedures and when such changes may require full IRB review.
Criteria for Referring Expedited Changes for Full IRB Review
At its discretion, the HS IRBs office may refer changes submitted as expedited for full IRB review. This may occur for reasons such as (but not limited to) the following:
- The change does not meet the criteria for expedited review provided above.
- The change requires assessment by one or more medical reviewers.
- The change is for a study that enrolls prisoners.
- The change requires input from other committees on campus (e.g., conflict of interest, RDRC) or consultants (e.g., legal services).
The change involves multiple revisions of changes that may individually qualify for expedited review:
- But collectively represent a substantial change to the study.
- Numerous changes have been made to a study within the previous 6 months, such that reassessment of the full scope and purpose of the study may be warranted.