565. Amendment Reviews, Expedited

Updated July 13, 2021

A project reviewed as an expedited category may have any amendments reviewed in Expedited Review if the study continues to be eligible for expedited review (see Department of Health and Human Services (DHHS) website for a listing of categories of research that may be reviewed by expedited review procedure).

Amendments to projects initially approved through Full Committee Review may be reviewed by expedited procedures if the IRB Chair or Expedited Reviewer determines the proposed changes are minor/editorial or the new or amended activities are eligible for Expedited Review as specified by DHHS (as referenced above).

For Expedited Review, a qualified IRB member is assigned to review the amendment request. The IRB member comprehensively reviews the materials submitted in the amendment package, previous versions of any newly amended documents if necessary, and other relevant approved project documents in IRBNet (or those flagged by Research Integrity staff); and completes the relevant review worksheets. Research Integrity staff may assign additional reviewers or a consultant if additional expertise is required (for more information, see IRB policy for reviewer assignment).

Amendment Review Materials

As specified in IRB policy for overview of requirements for amendments and submitting amendments, investigators requesting IRB approval for an amendment must submit an amendment request form and updated versions of all amended documents. The amendment request form asks for information about and justification for the amendments being requested, including the specific documents that are being changed.

See the online Human Research Protection Program (HRPP) Policy Manual for more information about review materials and worksheets.

Considerations for Amendment Review

The amendment review focuses on the following:

• effect of the amendments on the DHHS criteria for IRB approval (at 45 CFR 46.111);
• effect of the amendments (including any related significant new findings) on participants’ willingness to continue participation;
• need for and when warranted, processes to inform participants of the changes; and
• whether each amendment is consistent with ensuring participants’ continued welfare.

See the online HRPP Policy Manual for information about reviewer recommendations and documentation.

Changes in approved research that are initiated without prior IRB to eliminate apparent immediate hazards to a participant are promptly reported to the IRB as problems, assessed according to IRB policy, and if warranted, reviewed as possible noncompliance, Unanticipated Problem, or for suspension or termination of IRB approval.

Possible Actions for Expedited Review of Amendments

The range of possible actions for expedited amendments include Approved, Approved with Conditions, or Deferred (as described in IRB policy regarding IRB Actions).

If an Expedited Reviewer determines that an amendment cannot be approved, the package is referred for Full Committee Review at the next available IRB meeting. Expedited Reviewers have the additional option of referring any amendment request for Full Committee Review, for example if the amendment disqualifies a project from eligibility for Expedited Review, increases risks to greater than minimal, or substantially and negatively alters the relationship between risks and benefits.