564. Amendment Reviews, Full Committee

Updated July 13, 2021

The University IRB uses a primary reviewer system for Full Committee Review (for more information, see reviewer assignment in the online Human Research Protection Program (HRPP) Policy Manual).

Amendments to projects initially approved by Full Committee Review continue to be reviewed at convened meetings unless changes are limited to addition or removal of study personnel or performance sites, or are minor or editorial. Minor changes are those that do not materially increase the risks or decrease the benefits of the study, nor materially decrease scientific merit.

Amendment Review Materials

As specified in the online HRPP Policy Manual 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.

The Primary Reviewer 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. IRB members (including alternate members) voting during the meeting are expected to review the same materials as the Primary Reviewer.

See the online 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 any significant new findings that arise from the amendment review that might relate to participants’ willingness to continue participation and when warranted, processes to inform participants of these findings;
• consistency of requested changes with ensuring participants’ continued welfare;

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.

Primary Reviewer Presentation

During the convened meeting, the Primary Reviewer summarizes the research as needed to provide context for the requested amendments. The Primary Reviewer describes the amendments and presents her/his/their questions or concerns about the effects of the amendments on the continuation of the research and participants’ continued welfare.

If the assigned Primary Reviewer is unexpectedly absent from the meeting, at the discretion of the Chair a written commentary from the Primary Reviewer may be submitted and presented for discussion, or another IRB member who is present at the meeting may assume the responsibilities of the Primary Reviewer if the Chair determines the member has the requisite knowledge and expertise and is sufficiently familiar with the materials submitted for review.

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

Possible IRB Actions

The range of possible actions for amendments include Approved, Approved with Conditions, Deferred, or Not Approved (of Disapproved) (as described in IRB policy regarding IRB Actions).

A decision to not approve an amendment request would apply only to the proposed amendments, not to the project as previously approved. Investigators would be notified that the proposed changes are unacceptable and may not be initiated.

Approval Periods and Expiration Dates

Approval dates for amendments do not affect approval periods, or expiration dates unless the IRB determines the amendment increases risks such that the approval period should be reduced. In this case, the expiration date would be adjusted to reflect the new approval period.