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Human Subjects Research

Responsibility of the Institutional Review Board

The responsibility of the UConn Institutional Review Board (IRB) is to work with the University research community to help ensure that human subjects engaged in research are treated with dignity, adequately protected from risk of harm, and voluntarily give informed consent to participate in research.

Before any work may begin on a research protocol, the IRB must review and approve the research. The IRB also reviews ongoing research at least annually 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.

The UConn IRB  is responsible for the review of all human subjects research conducted at or by the UConn-Storrs campus, the four regional campuses, the School of Law and the School of Social Work. The IRB seeks to create a collaborative relationship with the research community to assure that research with human subjects is conducted in accordance with legal requirements and 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 also focuses on the informed consent process to assure that subject participation in research is voluntary.

Who must apply?

All UConn faculty, student (graduate and undergraduate), and staff planning to conduct “research with human participants” must file an application and receive IRB approval BEFORE starting to advertise, recruit or conduct research procedures. See When Submission to the IRB is Required and Pilot Research and Protocol Development in the IRB Policies and Procedures document.

When Submission to the IRB is Required

A protocol application must be submitted to the IRB for any study for which research is the intent and the researcher proposes to use or involve any of the following:

  • identifiable data collected for non-research purposes (e.g., academic or medical records);
  • interaction (communication or interpersonal contact between investigator and participant) through interviews, surveys, and other forms of communication;
  • intervention (physical procedures by which data are gathered and manipulations of the participant or the participant’s environment that are performed for research purposes);
  • student research projects conducted as part of Research Methods Courses;
  • access to medical records and data through the medical information systems;
  • pathological specimens (directly identifiable or identifiable via codes);
  • diagnostic specimens (directly identifiable or identifiable via codes).

The IRB reviews projects when the research:

  • is sponsored by the institution;
  • is conducted by or under the direction of an employee or agent of the institution in relation to his/her institutional responsibilities;
  • is conducted by or under the direction of an employee or agent of the institution using resources of the institution; or
  • involves the use of the institution’s non-public information (i.e. alumni, students, staff, etc.) to identify or contact human research participants or prospective participants.

Is it human subject research?

Human Subject Research is defined by the Federal Regulations and determined by the IRB Chair or the Chair’s designee. See Human Participant Research Determination in the IRB Policies and Procedures document.

IRB 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 regulations have been adopted by 20 federal agencies and have thus 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 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.

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 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 expires on March 21, 2022.

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. Research Integrity and Compliance Services can assist investigators and ensure that the appropriate assurances have been obtained for all research sites. See also Research Conducted in a Foreign Country