Scientific Advisory and Review Committee

Investigator-initiated protocols that meet any of the following conditions will receive a SARC review:

• More than minimal risk with no previous independent review of scientific merit 
• Previous independent review of scientific merit, but protocol has undergone substantial change since the time of review (e.g., change in the aims, hypotheses, experimental design, or sample size)
• Protocols supported by a Career Development Award or other mentored mechanism (e.g. NIH K award)
• Protocols requesting a CTRC Microgrant 

**The COMIRB reserves the right to send any IIT through SARC review, even if the protocol does not meet the above criteria.**

The review process is designed to ensure quality research according to the following criteria:

• Scientific merit, including scientific premise, testable hypotheses, appropriate experimental approach, sample size justification, and appropriate data analysis plan
• Study design feasibility
• Realistic accrual rate for completion within a practical time frame

When a protocol is submitted to the Human Subjects Research (HSR) Portal, the portal team reviews the protocol to determine if a SARC review is required prior to COMIRB submission. If a SARC review is required, the protocol is routed to the SARC Coordinator who will schedule the protocol for review and contact the study team regarding the review details. Once a protocol has received SARC approval, the study team is issued an HSR Portal clearance letter, permitting them to submit the protocol to COMIRB for review. Notification of SARC approval is sent to the study team via OnCore. SARC approved documentation is uploaded to OnCore and InfoEd.

**JIT submissions: If a protocol has a JIT request, the portal team will issue portal clearance immediately so that the protocol can be submitted to the IRB for approval. However, the protocol may still require SARC review and will be reviewed at the next available SARC meeting. Once SARC approval has been obtained, the study team will have to submit the SARC approved protocol as an amendment to COMIRB.

If your study involves a cancer-related question or cancer population, submit your protocol to the Cancer Center specific Protocol Review and Monitoring System (PRMS) portal .