There are two Institutional Review Board (IRB) panels constituted at UConn Health. Institutional policy number 2002-42, Review and Approval of Research Involving Human Subjects (PDF), assigns authority and responsibility to the IRBs. Panels 1 and 2 meet once per month. With the following exception, studies requiring full board review are assigned to a panel based on the submission date of the initial application.
- Any study proposing to involve prisoners must be assigned to Panel 02 which has a prisoner advocate as a member.
Once a study is assigned to a panel it remains under the oversight of that same panel for the life of the study. The IRB Office is located on the 5th floor of the L Building.
Federal regulations (e.g. 45 CFR 46, 21 CFR 50 and 56) require that the IRB review and approve any non-exempt research involving human participants, or exempt research that requires limited IRB review, prior to it being started and that, in the majority of cases, legally effective informed consent of the subject or the subject’s legally authorized representative is obtained prior to any involvement in the study. At UConn Health the IRB is also responsible for determining if research meets criteria for exemption.
Vested with an ethical imperative to safeguard the rights and welfare of human subjects in research studies, the IRB reviews protocols to assure that the research activities proposed include no unnecessary risks, minimize potential risks to subjects, and that overall potential benefit to the subject, or to society, is reasonable in relation to the risks. The Board also measures the importance and significance of the scientific knowledge potentially gained against risks to study subjects.
“Risks to subjects are minimized by:
- using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk;
- and whenever appropriate using procedures already being performed on the subjects for diagnostic or therapeutic purposes.”
The IRB examines and approves all proposed informed consent forms to ensure that subjects are provided with a clear and complete explanation of the study and its potential benefits and risks. When applicable, the IRB also ensures that additional protections afforded under regulation to children, pregnant women, and prisoners have been addressed.
In general, the membership of IRB meets on the first, and third working Mondays of each month; applications requiring review by the full IRB are due 12 working days prior to the meeting. Applications requesting exempt status or expedited review may be submitted at any time. Once approved, when continuing review is a requirement protocols must be reviewed at least annually. All studies, including exempt studies, are subject to audit by the Research Compliance Monitor.
Finally, approval for emergency and therapeutic use of investigational new drugs (IND’s) must be obtained from the IRB.