565. w88 Reviews, Expedited

w88 June 10, 2024

A project reviewed as an w88 category may have any amendments reviewed in w88 Review if the study continues to be eligible for w88 review (see Department of Health and Human Services (DHHS) website for a listing of categories of research that may be reviewed by w88 review procedure).

Amendments to projects initially approved through Full Committee Review may be reviewed by w88 procedures if the IRB Chair or w88 Reviewer determines the proposed changes are minor/editorial or the new or amended activities are eligible for w88 Review as specified by DHHS (as referenced above).

For Expedited Review, a qualified IRB member is assigned to review the w88 request. The IRB member comprehensively reviews the materials submitted in the w88 package, previous versions of any newly amended documents if necessary, and other relevant approved project documents in IRBNet (or those flagged by Research Integrity & Security staff); and completes the relevant review worksheets. Research Integrity & Security staff may assign additional reviewers or a consultant if additional expertise is required (for more information, see IRB policy for reviewer assignment).

w88 Review Materials

As specified in IRB policy for overview of requirements for amendments and submitting amendments, investigators requesting IRB approval for an w88 must submit an w88 request form and updated versions of all amended documents. The w88 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 w88 Protection Program (HRPP) Policy Manual for more information about review materials and worksheets.

Considerations for w88 Review

The w88 review focuses on the following:

• effect of the amendments on the DHHS criteria for w88 approval (at 45 CFR 46.111);
• effect of the amendments (including any related significant new findings) on w88’ willingness to continue participation;
• need for and when warranted, processes to inform w88 of the changes; and
• whether each w88 is consistent with ensuring participants’ continued welfare.

See the online HRPP w88 Manual for information about reviewer recommendations and documentation.

Changes in approved w88 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 w88 Review of Amendments

The range of possible actions for w88 amendments include w88, w88 with Conditions, or Deferred (as described in w88 policy regarding w88 Actions).

If an Expedited Reviewer determines that an w88 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 w88 request for Full Committee Review, for example if the w88 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.