When reviewing proposed studies, the Institutional Review Board (IRB) works very closely with several other offices and committees. The interaction between the IRB and these various departments or committees is described below. The descriptions are limited to this interaction and are not representative of the entire function of the department or committee. The IRB application checklist directs the investigator as to when to contact these various departments or committees.
Financial Conflict of Interest in Research Committee (FCOIC): On an annual basis, all investigators are required to disclose significant financial interests to the FCOIC. The FCOIC will determine if a conflict of interest exists. If so, the FCOIC institutes a conflict of interest management plan. The FCOIC provides the IRB with copies of such plans. Investigators must also disclose any conflicts of interest within each IRB application. This ensures 1) that any conflict of interest is being addressed in accordance with the management plan and 2) that any new conflicts that develop during the course of the year are addressed. Investigators are encouraged to become familiar with the individual financial conflict of interest in research policy. Investigators may contact Gus Fernandez-Wolff in the Office of the Vice President for Research for additional information.
Environmental Health and Safety (EHS): Investigators proposing a research study that will use ionizing radiation, non-ionizing radiation, biological material, or hazardous chemicals must obtain a Risk Assessment Report from EHS. Investigators may contact Steve Jacobs for additional information.
HealthONE in Research: When a clinical research study will utilize HealthONE (UConn Health’s electronic medical record system) for scheduling, billing, or ordering the HealthONE Command Center is responsible for building the profile of that study within the system. The study build submission form must be completed and submitted to the Command Center for this to occur. Questions should be directed to HealthONEResearch@uchc.edu.
Institutional Biosafety Committee (IBC): Investigators must obtain approval from the IBC prior to seeking local IRB approval for research studies that deal with recombinant DNA. Investigators may contact Ron Wallace in the Office of Research Safety for additional information.
Office of Clinical and Translational Research (OCTR): Investigators proposing a research study that is sponsored by an external source, typically an industry sponsor, must have a fully executed contract in place. When the sponsor is providing for subject injury, the IRB must receive the final contract prior to granting final IRB approval. Both the OCTR and the IRB will verify that language regarding subject injury is consistent between the consent form and the contract. Studies that will generate charges, whether sponsored or investigator originated, must also have an approved budget in place, confirmation that it is in process, or confirmation from the budget office that a budget workbook is not necessary. Investigators may contact Paul Hudobenko, Cherron Payne or Keith Gulick for more information.
Sponsored Program Services (SPS): Investigators proposing a study that is grant supported or funded by a private non-profit agency will need to route the proposal through SPS. The IRB must review all funded grant applications. In general, federal grant applications will require IRB review once the determination is made that funding will occur. At such time investigators must submit a complete IRB application, in addition to the grant application, to the IRB. Non-federal grant applications typically require that IRB review occur prior to a funding decision having been made. Investigators may contact Paul Hudabenko for additional information.
Stem Cell Research Oversight (SCRO) Committee: UConn’s Stem Cell Research Oversight Committee (SCRO) provides oversight of all ethical issues related to the derivation and research use of human stem cell lines at all schools, colleges, campuses, and research arms of UConn regardless of the source of funding, and reviews all proposals submitted by University investigators for funds from the State of Connecticut. The SCRO Committee will ensure that sensitive research is well-justified and that inappropriate research is not conducted. Review by the SCRO Committee will supplement but not replace the usual reviews for compliance with federal, state, and local regulations (e.g., reviews by IACUC, IRB, IBC, etc.). Investigators may contact Ellen Ciesielski for additional information.