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Human Subjects Research

Institutional Review Board (IRB) and Human Research Protection Program (HRPP)

 

The primary purpose of the UConn Human Research Protection Program (HRPP) is to enforce the regulations which govern the protection of research participants. Within the HRPP, the UConn Institutional Review Board (IRB) is responsible for the review of all research involving human participants conducted by faculty, students and staff at the UConn Storrs campus, the four regional campuses, the School of Social Work, and the School of Law. The IRB works with the University research community to help ensure that human subjects are treated with dignity, adequately protected from risk of harm, and voluntarily give informed consent to participate in research, in accordance with the ethical principles established in the Belmont Report: Respect for Persons, Beneficence and Justice. These principles require the balancing of risks to subjects against the scientific knowledge to be gained and the potential benefits to subjects and society. The IRB has at least five members of varying backgrounds in order to provide complete and adequate review of human research. The Board also includes at least one member who is not affiliated with the institution and one member who is not a scientist.

The IRB is governed by federal regulations Title 45, Part 46, Protection of Human Subjects that dictate the scope and purpose of IRB activities. The regulations (revised July 19, 2018) have been adopted by 20 federal agencies and thus have come to be known as the “Common Rule.” The Office of Human Research Protection (OHRP) is the federal administrative agency that monitors the IRB and its activities. The University has a contract with the OHRP (called an “assurance” or “assurance of compliance”) that allows investigators to conduct federally conducted or supported research using human subjects. This assurance specifies the University’s responsibilities and must be approved by OHRP. The UConn-Storrs Federal wide Assurance (FWA) is identified as FWA00007125 and expires on March 27, 2024. The UConn-Storrs IRB (IRB00000036) is registered with OHRP and is identified as IRB Organization Number IORG0000027 and the registration expires on March 21, 2022.

The Food and Drug Administration (FDA) also protects human research subjects through its investigational drug and device regulations. Both the OHRP and the FDA (21 CFR 50 and 21 CFR 56) monitor human research subjects protections through educational efforts, site visits, and reporting requirements. Both have the authority to suspend research for failure to adhere to the regulations. In accordance with federal regulations and institutional policy, the IRB also has the authority to approve, require modifications, monitor, and disapprove research (funded or not) that is not being conducted in accordance with the IRB’s decisions, conditions, and requirements, or that has been associated with unexpected serious harm to subjects.

The IRB Office consists of the IRB Program Director, two IRB Program Specialists and Post Approval Monitor. The IRB staff reports to the Director of Research Compliance Services, who reports directly to the Associate Vice President for Research Integrity and Regulatory Affairs, the assurance signatory Institutional Official (IO) for the institution.