Title
University of North Carolina at Chapel Hill Policy on Research Involving Human Participants
Introduction
Purpose
This policy establishes the Human Research Protection Program (HRPP) as the body responsible for ensuring UNC-Chapel Hill conducts human subjects research that is ethical and that complies with all relevant laws and regulations.
Scope of Applicability
This policy applies to all human subjects research conducted under the auspices of UNC-Chapel Hill. This means:
- any human subjects research performed under the direction of University faculty, staff, students or other trainees in connection with their UNC-Chapel Hill affiliations;
- any human subjects research in UNC-Chapel Hill facilities or using UNC-Chapel Hill resources; and
- any use of non-public individually identifiable information created or maintained by UNC-Chapel Hill.
The following people are responsible for knowing this policy and acting in accordance with its requirements:
- all UNC-Chapel Hill personnel who conduct human subjects research (including faculty, students, visiting scholars, and trainees); and
- individuals acting on behalf of UNC-Chapel Hill.
This policy supplements the requirements and procedures for UNC-Chapel Hill Human Research Protection Program (HRPP) operations specified in Office of Human Research Ethics (OHRE) policies and standard operating procedures.
Policy
Policy Statement
UNC-Chapel Hill is committed to conducting research with the highest regard for the welfare of human subjects. Accordingly, UNC-Chapel Hill upholds and adheres to the ethical principles of respect for persons, beneficence, and justice, set forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research. In addition, UNC-Chapel Hill conducts human subjects research in compliance with applicable federal and state laws.
UNC-Chapel Hill has established a Human Research Protection Program (the "HRPP"), an institution-wide program coordinated by the Office of Human Research Ethics (OHRE). The HRPP and OHRE together are responsible for ensuring the ethical and equitable treatment of all human subjects participating in research conducted under the auspices of UNC-Chapel Hill.
The UNC-Chapel Hill HRPP is composed of the Institutional Official (IO), research administrators, research compliance functions, researchers and research staff, and research review committees such as the Institutional Review Board (IRB), the Institutional Biosafety Committee (IBC), the Conflict of Interest (COI) Committee, and others. The policy statements below establish UNC-Chapel Hill’s commitment to protecting the rights, safety, and welfare of human subjects.
IRB Independence
UNC-Chapel Hill maintains the independence of its IRBs. Attempts to unduly influence IRB staff or IRB members, including chairs or vice chairs, should be reported to the OHRE Director, IO, or Chancellor, as appropriate. Attempts by the IO to influence IRB chairs, members, and/or staff should be reported to the Chancellor.
IRB Authority
UNC-Chapel Hill may review any human subjects research protocol and has the right to disapprove or terminate approval of a research protocol that has been approved by the IRB. However, no one at UNC-Chapel Hill may approve the implementation of human subjects research requiring an IRB approval that has been rejected by the IRB.
UNC-Chapel Hill IRBs and other duly constituted relied-upon IRBs are granted authority through federal regulations to review research proposals and take any of the following actions:
- Approve,
- Require modifications to secure approval,
- Disapprove,
- Suspend or terminate approval, and/or
- Observe or have a third party observe the consent processes or the conduct of research.
IO in Charge of the HRPP
At UNC-Chapel Hill, the Vice Chancellor for Research is the IO. The IO is responsible for oversight and the compliant operation of the UNC-Chapel Hill HRPP.
Creation and Dissemination of Policies
UNC-Chapel Hill OHRE policies are developed, implemented, and managed by OHRE, in partnership with other components of the HRPP, including the Conflict of Interest Office, the Office of Clinical Trials, and the Office of University Counsel.
Exceptions
None.
Definitions
Human Subjects Research - Any activity that meets the definition of "research" and involves "human subjects" as defined in federal regulations.
Institutional Review Board (IRB) - A board designated by UNC-Chapel Hill to review, approve the initiation of, and conduct periodic reviews of research involving human subjects. The primary purpose of the IRB is to protect the rights, safety, and welfare of the human subjects.
Related Requirements
External Regulations and Consequences
University Policies, Standards, and Procedures
Contact Information
UNC-Chapel Hill OHRE
Email: Irb_questions@unc.edu