When reviewing proposed studies, the Human Subjects Protection Program (HSPP), in particular the Institutional Review Board component, works very closely with several other offices and committees that are not part of the HSPP. The interaction between the HSPP 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 directs the investigator as to when to contact these various departments or committees.
Stem Cell Research Oversight (SCRO) Committee: The University of Connecticut’s Stem Cell Research Oversight Committee (UC-SCRO) shall provide 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 the University of Connecticut regardless of the source of funding, and shall review all proposals submitted by University investigators for funds from the Connecticut Stem Cell Research Grant Project. The UC-SCRO committee will ensure that sensitive research is well-justified and that inappropriate research is not conducted. Review by the UC-SCRO Committee will supplement but not replace the usual reviews for compliance with federal, state, and local regulations (e.g. reviews by animal care committees, Institutional Review Boards, Biological Safety Committees, etc.).
Institutional Biosafety Committee: Investigators must obtain approval from the Institutional Biosafety Committee (IBC) prior to seeking IRB approval for research studies that deal with recombinant DNA. Investigators may contact Ron Wallace in the Office of Research Safety for additional information.
Environmental Health and Safety: 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 the Office of Research Safety. Investigators may contact Steve Jacobs for additional information.
Office of Clinical and Translational Research: 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. The IRB will verify that language regarding subject injury is consistent between the consent form and the contract. Investigators may contact Judi Kulko for more information. 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.
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 the Office of the Vice President for Research, Sponsored Program Services. 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.
Conflict of Interest Committee: On an annual basis all investigators are required to disclose financial interests in sponsors to the Conflict of Interest Committee (CIC). The CIC will determine if a conflict of interest exists. If so, the CIC may either prevent the investigator from doing research funded by that sponsor or institute a conflict of interest management plan. The management plan may require the investigator to disclose the financial interests to research subjects. The CIC 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 (pdf). Investigators may contact Gus Fernandez in the Office of the Vice President for Research for additional information.
Human Subjects Protection Program (HSPP) Executive Council: This committee acts as an advisory board to the Director of the Human Subjects Protection Office. The committee discusses policies, regulations and issues related to human subject protections. It is comprised of the staff of the HSPO and IRB Office, the Research Subject Advocate, a faculty representative and representatives from the 1) Institutional Review Board panels, 2) Office of Research Administration and Finance, and 3) Office of Research Compliance. Legal Counsel is invited to attend on an as needed basis. The committee meets on a quarterly basis. Investigators who would like an issue brought forth to the committee should contact Deb Gibb in the HSPO.