Institutional Review Board

PURPOSE

The University of Utah Institutional Review Board (IRB) must conduct a comprehensive assessment of all submitted research proposals to determine whether the studies meet the minimum criteria for approval. This SOP describes the assigned reviewer system used by the University of Utah IRB.

SCOPE

This policy applies to the members of the University of Utah IRB.

POLICY

A thorough evaluation of all research proposals submitted for review is conducted by IRB members allowing the IRB to determine if the study meets the minimum criteria for initial approval (see IRB SOP 403: Initial Review – Criteria for IRB Approval) and the minimum criteria for continuing approval (see IRB SOP 404: Continuing Review). IRB members review changes in approved research during the period for which approval has already been given to determine if the study meets minimum criteria for ongoing review (see IRB SOP 405: Review of Amendments to Research Studies).

At a minimum, all members of a convened board are expected to be familiar with all IRB applications scheduled for review in advance of convened board meetings. Board members are expected to be familiar with the agenda and items (as described above) for the meeting they will attend.

Additionally, the IRB relies upon an assigned reviewer system. A primary reviewer is assigned to each application (e.g., new study, continuing review, amendment, report form, etc.) reviewed at the convened board. A secondary reviewer may be assigned to new studies reviewed at the convened board as outlined in IRB SOP 302: Administrative Review and Distribution of Materials. For studies eligible for expedited review, the primary reviewer is a designated expedited reviewer. Assigned reviewers must complete applicable board member checklists in the University of Utah Electronic Research Integrity and Compliance Administration system (ERICA).

Assigned IRB reviewers perform an in-depth review of all documentation and materials submitted by the IRB staff and investigator. Assigned reviewers may be required to review additional material requested by the IRB for the purpose of study approval.

Comments are not limited to the assigned reviewer(s). All members of the IRB have access to the submitted documents and may provide comments regarding any proposed research. Any board member, at his/her discretion, can request any of (but are not limited to) the following:

• Ad hoc consultant review;
• Any additional necessary information beyond what has been provided by the investigator;

PROCEDURES

1. Primary Reviewers
   Primary reviewers are required to review all submitted documents in advance of convened meetings in enough depth to be familiar with and be prepared to discuss the application. The Primary reviewer is responsible for presenting findings, providing an assessment of the merits and safety of the protocol, reviewing the consent process (in the absence of a secondary review), and recommending specific actions to the IRB.  The primary reviewer leads the discussion of the study at the convened meeting.
   1. For studies qualifying for expedited review, the designated expedited reviewer is expected to perform an in-depth review of all documents submitted by the investigator. The expedited reviewer documents the applicable expedited category in the board member checklist. If the expedited reviewer determines the study does not qualify for an expedited review, the expedited reviewer notifies the IRB staff. The study is then referred to the convened board for review.
2. Secondary Reviewers
   The secondary reviewer, if assigned, is expected to review all submitted documents in advance of the meeting. The secondary reviewer is responsible for reviewing the consent process outlined in the application , and add to the discussion as necessary.
3. Board Member Checklists
   Each assigned reviewer is responsible for documenting findings in the board member checklist. The assigned reviewer determines whether the study meets the minimum criteria for initial approval, the minimum criteria for continuing approval, or the minimum criteria for ongoing review. Additional checklists are required when a study necessitates additional consideration by the IRB (e.g., the study involves a vulnerable group, use of a medical device, use of an investigational drug, etc.). Completed board reviewer checklists are submitted in ERICA, becoming part of the electronic record and forming the basis for communication to the investigator.
4. Notification of IRB Review
   The IRB staff notifies the investigator of the IRB’s determination within seven business days of the convened board meeting. For studies reviewed using expedited review procedures, the IRB staff notifies the investigator of the IRB’s determination within seven business days of the expedited review. The written notification includes the IRB’s decision with requested revisions or requested clarification, when applicable.
5. Review of Requested Revisions
   Based on the terms of approval at the time of initial review, the IRB will review the investigator’s response to requested revisions as outlined in SOP 407: IRB Actions to Approve or Disapprove Research Action. Final approval will not be granted until all the board or expedited reviewer recommendations and requests are appropriately addressed.