The multi-institutional CICATS Institutional Review Board (IRB) serves as the IRB of record and the HIPAA Privacy Board for CICATS research. The Board is one of several UConn Health panels approved under the UConn Health Federal Wide Assurance (FWA) with the Office of Human Research Protection (under Department of Health and Human Services).
The CICATS IRB standardizes regulatory functions across CICATS partner organizations with the local requirements checklist and providing investigators from those institutions or agencies, with a single point of IRB submission for eligible multi-site or single site clinical and translational research studies that use CICATS resources or services.
CICATS IRB Eligibility
CICATS investigators from the following institutions may be eligible to have their research studies reviewed by the CICATS IRB if their project meets the CICATS requirements:
- UConn Health
- UCONN Storrs
- Connecticut Children’s Medical Center
- Hartford Hospital
- The Jackson Laboratory
- Saint Francis Hospital and Medical Center
- Hospital of Central Connecticut
- Hospital for Special Care
- Institute for Community Research
- Hispanic Health Council
- Community Health Center Association of Connecticut
- Community Health Center Inc.
These partner/affiliate institutions have signed a Reliance Agreement with UConn Health Human Subjects Protection Program (HSPP) for the CICATS IRB Panel. Review by the CICATS IRB cannot be purchased for non-CICATS projects.
Eligibility review is required by the CICATS Regulatory Core and investigators planning to use the CICATS IRB should discuss their project details with Linda Burian, CICATS Regulatory Specialist, prior to submitting a CICATS IRB application.
CICATS IRB Requirements
1. Research must meet the definition of CICATS research and all of the following must apply:
- CICATS research includes basic, clinical or community research focused on transforming scientifically grounded discoveries into treatments, diagnostics, practices, policies or other applications that benefit human health;
- The research is supported by CICATS resources, or utilizes CICATS services (including regulatory support, investigator advocate, statistics), or involves collaboration with CICATS partners/affiliates as co-investigators; and,
- The research is likely to result in peer-reviewed articles, innovative discoveries, practical applications and extramural funding (preferably NIH funding).
2. Principal Investigators (PI’s) must qualify as CICATS Investigators and all of the following must apply:
- The investigator has a UConn Health or UConn faculty (employee) appointment, or has confirmation as an Investigator (employee with CV filed) from a CICATS partner or affiliate organization (that has a signed cooperative agreement) and certification of training in human research protection;
- The investigator has registered with CICATS and is conducting CICATS research (1.a); and,
- The investigator is qualified to serve as the Principal Investigator on the project and accepts scientific, ethical and financial oversight of the research per federal regulations and institutional policy.
3. The research project may be a previously reviewed and/or approved study by an IRB Panel from a CICATS partner/affiliate institution or other external IRB, if requesting facilitated review approval for collaborative purposes. This type of application will be reviewed on a case-by-case basis. Projects that have been previously denied by any other IRB cannot be submitted.
CICATS IRB Submission Process
Regulatory Specialists assist with the communications of the partnering institution IRBs, agreement process and the navigation of the UConn Health IRB submission system to support investigators as much as possible.
The CICATS IRB panel meets as needed (click here for schedule and deadlines) for full board reviews submitted through the UConn Health Integrated Research Information System (IRIS) electronic submission process.
Panel members have experience reviewing all types and levels of research including: translational research, informatics projects, social behavioral research and research involving vulnerable populations and children.
Expedited reviews are conducted by the chair or primary panel reviewer once received in the Uconn Health IRIS system. Expedited studies have no deadlines and can be submitted anytime once reviewed for completeness by the Regulatory Specialists. Question about exempt or non-human subjects research determinations? These also can be discussed with the Regulatory Specialists.
The CICATS IRB may also conduct a facilitated review for a CICATS partner IRB approved study when appropriate if including or adding CICATS resources, services or partner collaborative site(s) to an already approved study. These studies will be accepted for review on a case by case basis.
CICATS IRB Panel Members
Jyoti Chhabra, Ph.D., Senior Scientist and Project Manager, Research Program, Hartford Hospital
Jane Comerford, J.D., retired from Attorney General’s Office
Francis DiMario, Jr. M.D., Division of Pediatric Neurology, Connecticut Children’s Medical Center
Jayesh Kamath, M.D., Ph.D., Associate Professor, Psychiatry
Julian Ford, Ph.D., Professor, Psychiatry, UConn Health, Chair
Joan Levine, MPH, Research Compliance, UConn Storrs
Kim Radda, R.N., M.A., Director of Research Administration, Institute for Community Research
Catherine Wilcox, M.Div., Pastoral Services, UConn Health
Linda Burian, MS, CCRP
CICATS Lead Regulatory Specialist