Full Board Operating Procedures
Overview: Full Board Review is the default review process for protocols, however, most studies fall into a category that does not require a Full Board Review. Studies that do not require Full Board Review:
· Quality Improvement / Quality Insurance (QI/QA) Protocols
· Protocols that meet the requirements for Exemption
· Non-Exempt studies that meet the criteria for Expedited review.
· SI = Student Investigator
· PI = Principal Investigator
When: Full Board IRB reviews will occur at regularly scheduled IRB meetings. A protocol review takes precedence over other IRB work previously scheduled for the meeting time. IRB meetings occur between September and April. However, the IRB will meet in August, or May, if needed to accomplish a review. The Principal Investigator (PI) should plan for these meeting times if they anticipate submitting a protocol requiring Full Board Review.
Protocol Submission / Dissemination: A protocol that requires Full Board IRB Review must be submitted a minimum of two weeks prior to the meeting at which it will be reviewed. The IRB Chair will confirm that the study requires a Full Board Review. The IRB Chair and IRB Administrator will confirm that all materials have been properly submitted, and the protocol will be distributed to all members for review prior to the scheduled meeting. Members who will be unable to attend the review meeting are encouraged to submit any comments or concerns to the IRB Chair prior to the scheduled meeting at which the study will be reviewed.
Meeting Requirements: A Full Board Review must include a quorum of IRB members. In accordance with Federal guidelines, the IRB must include one member whose primary expertise is not in a scientific area. The makeup of the IRB Board must be in accordance with the IRB policies and procedures as stated elsewhere.
There may be situations where the Gonzaga IRB is not capable of reviewing a protocol, for example if a prisoner advocate is required for studies with prisoners. Another potential example is a drug study that would require specific medical expertise to review. In these cases, a study may need to be referred to a private IRB external to GU for proper review. The IRB Chair will make the determination if the study will require external review and will communicate this information to the PI.
Invitations to Principal Investigator and Student Investigators: The PI and any SIs will be invited to attend the meeting at which their protocol will be reviewed. This will provide an opportunity for the IRB to ask any clarifying questions directly to the investigators. If they are unable to attend in person, they will be invited to participate remotely (ex: video conference, conference call, etc.)
Conduct of the Meeting: The meeting will typically involve a structured format:
· First 10-15 minutes: The IRB Chair will commence the meeting as a closed session. The Chair will solicit any feedback or questions about the protocol from the IRB members. The Chair will also relay any questions/concerns that were submitted via email from members who could not attend.
· Next 10-15 minutes: The PI and Sis will be invited in to address any questions or to clarify the protocol. The IRB Chair will facilitate the Q&A period. After questions have been sufficiently answered, the PI and SIs will be excused from the meeting.
· Next 10-15 minutes: The closed session will resume. The IRB Chair will open discussion to collate any concerns the board may have.
· Final: The IRB Chair will request a vote, after summarizing the options, as listed below.
The vote may be for approval, conditional approval with minor revisions, or for disapproval requiring resubmission. If conditional approval is granted the IRB Chair may obtain approval from the board to review the minor revisions once completed her/himself to grant study approval. If the board does not grant the Chair authority to review the revisions, then the board will need to review the revisions. The vote on approval of the revisions may be accomplished via email or another electronic means. Otherwise, the board can review changes at the next scheduled meeting prior to granting approval.
The outcome of the Full Board Review will be communicated to the PI and SIs by the IRB. In the case of conditional approval with minor revisions, the needed revisions will be clearly communicated, and the PI and SIs will be asked to submit an updated protocol. Once revisions are completed and submitted, the Chair will grant full study approval. If the board does not grant the Chair authority to review the revisions, then the board will need to review the revisions. The vote on approval of the revisions may be accomplished via email or another electronic means. Otherwise, the board can review changes at the next scheduled meeting prior to granting approval.
The outcome of the Full Board Review will be communicated to the PI and SIs by the IRB. In the case of conditional approval with minor revisions, the needed revisions will be clearly communicated, and the PI and SIs will be asked to submit the revised protocol.