Human Subjects Research and the Institutional Research Board, Policy on

Title: Human Subjects Research and the Institutional Research Board, Policy on
Policy Owner: Office of the Vice President for Research
Applies to: Faculty, Staff, Students
Campus Applicability: UConn Storrs, five Regionals, and School of Law
Effective Date: February 16, 2011
For More Information, Contact Office of the Vice President for Research
Contact Information: (860) 486-4164
Official Website: http://research.uconn.edu/

 

The University of Connecticut-Storrs Institutional Review Board is responsible for the review of all human subjects research conducted at or by the UConn-Storrs Campus, the five regional campuses, the School of Law and the School of Social Work. This policy includes research conducted by faculty, staff, and students.  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 of 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.

The IRB’s Responsibility

The responsibility of the UConn-Storrs IRB is to work with the University research community to help make sure 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.

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.

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 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 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.

Assurances and IRB Registration

UConn has a contract with the federal government (called an “assurance”) 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) www.hhs.gov/ohrp/.