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Full Board Review

Studies that involve more than minimal risk require review at full board IRB meeting (also referred to as Convened Review). The research requires approval from a majority of those members. The committee discusses the study and determines whether the Criteria of Approval for Human Subject Research are met, and makes a decision to approve, approve with stipulations, defer, or disapprove the study.

The ability to schedule a study for review is related to the pre-review response time, the IRB's meeting agenda, and expertise that may be required for the review. Once a study is reviewed by the IRB, the IRB analyst will communicate any changes requested by the committee and will work with you to resolve any issues.

Examples of Research That Require Full Board Review

  • Clinical procedures with drugs, devices, or biologics, or innovative research into new medical or surgery procedures
  • Complex research design requiring the expertise of multiple board members to evaluate
  • Deception
  • IRB analyst, board member, or designee determines risks are greater than minimal
  • Vulnerable populations, particularly prisoners

The Full Board Review Process

The IRB has 6 panels total that review “more than minimal risk” items:

Once a submission is assigned to the next available meeting, the reviewer may request additional information ahead of the meeting. The analyst facilitating the meeting will log a comment in the submission history conveying any clarifications or edits to the investigators. The investigators may respond to the clarifications or edits by uploading updated documents in a comment before the meeting.

Within one week after the meeting, the analyst will send a letter indicating one of the following:

  • Approval: This letter indicates nothing else is needed and you may proceed using the protocol or other documents uploaded in the submission.
  • Modifications Required to Secure Approval: This letter will include minor modifications required to the submission before the submission can be approved. Once the modifications are made and submitted, the analyst will review the submission and send the approval letter.
  • Deferral: This letter indicates that there are outstanding clarifications required involving the study design or risk. Once the submission is updated with the requested changes from the panel, the submission will need to return to panel for review. Please note that the submission must return to the same panel that originally reviewed it.