PROTECTION OF HUMAN SUBJECTS IN RESEARCH THE UNIVERSITY OF NORTH CAROLINA AT GREENSBORO
(Approved by the Chancellor, August, 1978)(Revised March 1982, August 1989, and June 7, 2007)
The University of North Carolina at Greensboro fosters a research environment that promotes respect for the rights and welfare of individuals recruited for, or participating in, research conducted by or under the auspices of the University in the review and conduct of research. Actions by the University will be guided by the principles (i.e., respect for persons, beneficence, and justice) set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (often referred to as the Belmont Report) and will be performed in accordance with the Department of Health and Human Services (HHS) policy and regulations in 45 CFR 46 (also known as the “Common Rule”). The actions of the University will also conform to all other applicable federal, state, and local laws and regulations.
The Chancellor has designated the Director for the Office of Research Compliance as the Institutional Official who has overall responsibility for the University’s human research protection program. The duties of the Institutional Official are as follows:
- Be responsible for compliance with institutional policies and all applicable regulations for the protection of human participants.
- Be the signatory authority for the Federal-wide Assurance to the Office of Human Research Protections.
- Provide support to the human research protections program within the means of the institution.
In the performance of these duties, the Institutional Official has the authority to delegate such activities as may be necessary in order to fulfill these duties.
To conduct its responsibility effectively, the University maintains an Institutional Review Board ( IRB) to review research protocols involving human participants. The IRB is an autonomous administrative body established to protect the rights and welfare of human research participants recruited to participate in research activities conducted under the auspices of the University. The IRB has the following authority:
- To approve, require modifications to secure approval, or disapprove all research activities overseen and conducted under the auspices of the University;
- To suspend or terminate approval of research not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants;
- To observe, or have a third party observe, the consent process; and
- To observe, or have a third party observe, the conduct of the research.
All IRB approved research studies are subject to ongoing review, which must be conducted at least once annually by the IRB. If approval by the IRB lapses, all research activity must stop unless the IRB finds that there is an over-riding safety concern or ethical issue involved such that it is in the best interests of individual participants to continue participating in the research interventions or interactions.
The IRB has jurisdiction over all human participant research conducted under the auspices of the institution, regardless of funding source. Research under the auspices of the institution includes research conducted at this institution, conducted by or under the direction of any employee or agent of this institution (including students) in connection with his or her institutional responsibilities, conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or involving the use of this institution's non-public information to identify or contact human participants.
No one at the University (including the Chancellor) shall approve the implementation of any research protocol nor may anyone override the decision of the IRB concerning a research protocol that has been disapproved by the IRB.
All institutional and non-institutional performance sites for the University, domestic or foreign, will be obligated by this policy to conform to ethical principles which are at least equivalent to those of this institution or as may be determined by the Department of Health and Human Services (DHHS) Secretary.
The Institutional Official and the IRB shall adopt operating procedures to implement this policy. These procedures shall serve as the governing procedures for the conduct and review of all human research conducted under the auspices of the University.
IRB Standard Operating Procedures Click Here