About the IRB at Storrs-UConn

1.1 - The IRB's Responsibility
1.2 - The IRB's Regulatory Authority
1.3 - Assurances & IRB Registration
1.4 - IRB Membership
1.5 - The Office of Research Compliance (ORC)

1.1 The IRB's Responsibility

The responsibility of the UConn-Storrs IRB is to work with the university research community to help make sure that:

• Ensure that human subjects engaged in research are treated with dignity;
• Ensure that human subjects are adequately protected from risk of harm; and,
• Ensure that all human subjects give informed consent to participate in research.

The IRB also follows the ethical principals found in the Belmont Report and codified in "The Common Rule" set out in 45 CFR 46, subpart A. It also follows subparts B-D of 45 CFR 46.

The IRB reviews and approves research protocols before any work is started and reviews ongoing research periodically to help investigators ensure the continued protection of subjects. In addition, the IRB reviews all changes to research protocols before implementation. In accordance with federal regulations, the IRB has the authority to suspend or terminate approval of research 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.

1.2 The IRB's Regulatory Authority

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 Office of Human Research Protection (OHRP) is the federal administrative agency that monitors the IRB and its activities. The Food and Drug Administration (FDA) also protects human research subjects through its investigational drug and device regulations. Both the OHRP and the FDA 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.

1.3 Assurances and IRB Registration

The University has a contract with the federal government (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 the federal Office of Human Research Protection (OHRP).

• The UConn-Storrs Federalwide Assurance (FWA) is identified as FWA00007125 and expires on October 19, 2010.
• The UConn-Storrs IRB is registered with OHRP and is identified as IRB Organization Number (IORG #): IRB00000036.

Multi-site projects that are federally funded (i.e., NIH, DHHS, etc.) must have an appropriate assurance for each research site. Investigators should be aware of the type of assurance held at outside research sites and be prepared to initiate the assurance process, if necessary. This includes research both in and outside of the United States. Investigators should also be aware that federal funding agencies will not make research funds available unless all research sites have an assurance approved by OHRP. The Office of Research Compliance (ORC) can assist investigators and ensure that the appropriate assurances have been obtained for all research sites. (see also Research Conducted in a Foreign Country)

(Note: Investigators seeking funding from the National Institutes of Health (NIH) must also satisfy the NIH training requirement before an approved study may be initiated. For more information on the NIH training requirements go to: http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp)

1.4 IRB Membership

The IRB is composed of University faculty, staff and the local community. The individual members contribute the professional competency necessary to review specific research activities representing a broad range of disciplines through experience and expertise. In addition, the IRB seeks diversity in race, gender and cultural backgrounds to promote sensitivity to community attitudes and respect for the rights and welfare of human subjects.

1.5 The Office of Research Compliance

The Office of Research Compliance (ORC) provides central administration to the IRB and serves as the primary point of contact for all IRB-related issues. The ORC communicates with investigators regarding IRB decisions, maintains IRB records and facilitates on-going auditing of approved protocols. The ORC also offers faculty consultation on protocol preparation and general compliance issues, as well as the following services:

• Pre-review of protocols and consent forms to identify potential problems and suggest ways to address them before full IRB review (includes a discussion of risks and benefits, informed consent, recruiting subjects, advertising, privacy and confidentiality);
• Individual and departmental education/training on the protection of human research subjects;
• Assistance with the use of IRB guidelines and research forms;
• Preparation of needed documents (Certification or Assurances); and,
• Resolution of research-related problems with external funding agencies.