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SOP 019: Full Board Review

1. Purpose

This SOP describes the process for the review of protocols requiring Full Board IRB review and approval.

2. Overview

A thorough evaluation of all research proposals submitted for review is conducted by IRB members allowing the IRB to determine if the protocol application meets the minimum criteria for initial approval (see SOP 007: Criteria for IRB Approval) and for continuing approval (See SOP 030: Continuing Review of Approved Research). IRB members review changes in approved research during the period for which approval has already been given to determine if the protocol application meets the minimum criteria for ongoing review (See SOP 028: Post-Approval Submissions).

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

Additionally, the IRB relies upon an assigned reviewer system (as described in SOP 006: IRB Meeting Conduct). A primary reviewer is (typically, and whenever possible) assigned to each application or item on the agenda to be reviewed by the convened board. A secondary reviewer may be assigned to protocols reviewed at the convened meeting.

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

Comments are not limited to the assigned reviewer(s). All members of the convened committee have access to the submitted documents and may provide comments regarding any proposed research. Any board member or WVU OHRP staff member, at their discretion, can request (but are not limited to) the following:

    • Ad hoc and/or ex officio consultant review;
    • Any additional necessary information beyond what has been provided by the investigator; and
    • Third-party verification of information submitted by the investigator.

3. Procedures for full IRB Review

3.1. WVU OHRP staff are authorized by the IO and WVU OHRP Director to complete a preliminary review of submitted protocol materials to determine completeness and accuracy. OHRP staff assign protocols to IRB members (primary reviewers) for review paying close attention to the protocol’s scientific discipline, the potential reviewer’s area of expertise, and representation for vulnerable populations involved in the research.

3.2. Primary reviewers are required to perform an in-depth review of all submitted documents in advance of convened meetings to be familiar with, and prepared to discuss, the protocol. Primary reviewers are most often responsible for presenting their findings, providing an assessment of the merits and safety of the protocol, reviewing the consent process, and recommending specific actions to the IRB. If the primary reviewer cannot attend the meeting, they must provide detailed comments to the IRB Chair or Vice Chair to present on their behalf. If present, the primary reviewer should lead the discussion of the protocol at the convened meeting.

3.3. Secondary reviewers, if assigned, are expected to review all submitted documents in advance of the meeting, are responsible for reviewing the consent process outlined by the protocol, and should add to the discussion as necessary.

3.4. Each assigned reviewer’s findings are documented either in the meeting minutes or within the WVU electronic protocol submission system via completion of applicable reviewer forms. After discussion and review of the primary (and if needed, secondary) reviewer’s findings, the IRB determines whether the protocol application meets the minimum criteria for initial approval, the minimum criteria for continuing approval, or the minimum criteria for ongoing review. Additional checklists may be required when a protocol application necessitates additional considerations (e.g., the research involves a vulnerable group, use of a medical device, use of an investigational drug, or funding that requires specific findings beyond minimum criteria for approval).

3.5. Notification of IRB Review: The WVU OHRP staff notifies the investigator of the IRB’s determination within seven (7) business days of the convened board meeting. Written notification includes the IRB’s decision with requested revisions or requested clarification, when applicable.

3.6. 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 008: IRB Determinations. Final approval will not be granted until all of the IRB’s recommendations and requests are appropriately and adequately addressed. Final approval will be granted by a vote of IRB members present at the meeting.

4. References

WVU Policies:
SOP 007: IRB Approval Criteria
SOP 008: IRB Determinations
SOP 028: Post-Approval Submissions
SOP 030: Continuing Review of Approved Research

Federal Regulations:
21 CFR 56.109
45 CFR 46.109

Element II.2.E