Full Board Protocols

If a protocol doesn't meet the qualifications for exemption or expedited review, the protocol needs to be reviewed by the full board. The full board meets twice per month and your protocol will be assigned to the next available meeting. See Full Board Meeting for more information about the board meeting cycle. 

Once the protocol is reviewed, you will receive a notice regarding the board's determination. See Board Determinations for more information about the various determinations and how to respond. 

When a protocol is reviewed in a full board meeting, ongoing review also happens in full board meetings with a couple of exceptions. If the study is in the "data analysis only" phase of the study or if the protocol is modified and the modification qualifies the protocol for exemption or expedited review, the protocol will receive expedited review. 

    Maintaining a Full Board Protocol
    • Modifications: Your protocol should always reflect your study's practice and if it doesn't, you need to modify the protocol. Full board modifications are reviewed at the full board meeting so please consider grouping modifications into one submission. If you are changing personnel, use the Personnel Management Tool instead of submitting a modification for this change. 
    • Continuation Review: Full board protocols require an annual continuation review. You will receive an email notification one month prior to your protocol's expiration with information about how to submit a continuation. Failure to submit a continuation before the protocol expires will result in noncompliance and study closure. 
    • Unexpected Event Report: Research doesn't always go according to plan and if that happens, you may need to submit an unexpected event report.  
    • Study Closure: Once a study is complete, the protocol needs to be closed. Allowing a protocol to expire is not the same as closing the study.