Scientific Advisory and Review Committee

The Scientific Advisory and Review Committee (SARC) serves as the scientific review board for the Colora‚Äčdo Multiple Institutional Review Board (COMIRB) to review non-oncology, investigator-initiated trials (IITs).

The SARC performs scientific and feasibility reviews of new research protocols for investigator-initiated clinical research at CU Denver Anschutz, UCHealth, CHCO or DHHA that has not had an independent review for scientific merit.

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.

 

 
1. HSR Portal
  • Study team submits protocol to HSR portal
  • Portal team assesses protocol for SARC review and routes protocol to SARC if review required
2. SARC
  • Protocol reviewed by SARC
  • PI revises protocol per SARC stipulations/recommendations
  • Revised protocol approved by SARC
  • SARC approval sent to study team via OnCore
3. COMIRB
  • Portal team sends portal clearance email to study team
  • Study team submits SARC approved protocol to COMIRB for review

 

**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.

 

 
1. HSR Portal
  • Study team submits protocol to HSR Portal, indicating an NIH JIT request
  • Portal team assesses protocol for SARC review and routes protocol to SARC if review required
  • Portal team issues portal clearance email to study team
  • Study team submits protocol to COMIRB
2. SARC
  • Protocol reviewed by SARC
  • PI revises protocol per SARC stipulations/recommendations
  • Revised protocol approved by SARC
  • SARC approval sent to study team via OnCore
3. COMIRB
  • Study team submits amendment to COMIRB with SARC approved protocol

 

Submission DeadlineMeeting DateMeeting Location
03/11/202003/19/2020Nighthorse Campbell Native Health, M24-Combo-304/305
03/27/202004/06/2020Barbara Davis Center Main Conf Room (M20-2104)
04/15/202004/23/2020Nighthorse Campbell Native Health, M24-Combo-304/305
04/24/202005/04/2020Barbara Davis Center Main Conf Room (M20-2104)
05/13/202005/21/2020Nighthorse Campbell Native Health, M24-Combo-304/305
05/22/202006/01/2020Barbara Davis Center Main Conf Room (M20-2104)
06/10/202006/18/2020Nighthorse Campbell Native Health, M24-Combo-304/305
06/26/202007/06/2020Barbara Davis Center Main Conf Room (M20-2104)
07/15/202007/23/2020Nighthorse Campbell Native Health, M24-Combo-304/305
07/24/202008/03/2020Barbara Davis Center Main Conf Room (M20-2104)
08/12/202008/20/2020Nighthorse Campbell Native Health, M24-Combo-304/305
08/21/202008/31/2020Barbara Davis Center Main Conf Room (M20-2104)
09/9/202009/17/2020Nighthorse Campbell Native Health, M24-Combo-304/305
09/25/202010/05/2020Barbara Davis Center Main Conf Room (M20-2104)
10/14/202010/22/2020Nighthorse Campbell Native Health, M24-Combo-304/305
10/23/202011/02/2020Barbara Davis Center Main Conf Room (M20-2104)
11/11/202011/19/2020Nighthorse Campbell Native Health, M24-Combo-304/305
11/27/202012/07/2020Barbara Davis Center Main Conf Room (M20-2104)
12/29/202012/17/2020Nighthorse Campbell Native Health, M24-Combo-304/305

 

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 found here.