POLICIES FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH
THE UNIVERSITY OF NORTH CAROLINA AT PEMBROKE
Purpose
The University of North Carolina at Pembroke is concerned that no research be done under its jurisdiction which exposes persons who participate as subjects or respondents to unreasonable risks to their health, general well-being or privacy.
Specifically, the University is concerned that all research development. and related activities involving the use of human subjects:
(2) use as subjects only persons who have freely given informed consent; and
(3) provide benefits to the subject or advance knowledge to the extent that any risk involved is judged acceptable.
Procedures
All research involving human subjects at the University is subject to review. Two types of review procedures are available, depending on the funding sources for the research:
A. research explicitly contracted through federal or state funds shall be reviewed by the Institutional Review Board for Research Involving Human Subjects (IRB), using the Department of Health and Human Services (DHHS) guidelines (See Code of Federal Regulations 45 CFR 46).
B. research which does not involve such contracts shall be reviewed in the manner specified below. This category includes nonfunded research of faculty and students.
2. Each department shall submit a copy of its review process to the IRB for approval. Departmental procedures and guidelines, any guidelines provided by the disciplines national association, and sample copies of forms used in the review process should be included. To be approved, departmental review procedures must provide the same protection to human subjects as does DHHS policy (See Code of Federal Regulations 45 CFR 46 - particularly Subpart A, Section 46:111).
3. If an academic department decides not to establish a departmental review process, its faculty and students will have proposals reviewed by the IRB.
4. Each department should maintain a permanent file for all proposals that have been reviewed. Copies of approved proposals shall be forwarded to the IRB. The IRB will examine the proposals that it receives and may review any proposal it chooses. The IRB will maintain a permanent file of all proposals that it receives.
5. Faculty and students may submit proposals directly to the IRB. A signed copy of such a proposal upon which the IRB acts shall be sent to the appropriate departmental committee for its permanent file and a copy shall be placed in the permanent file of the IRB. The IRB will send the signed copy of the proposal to the department chair for departments that do not establish review processes.
6. A departmental review committee may request that the IRB review proposals where it deems such review to be appropriate.
B. Should repeated resubmissions to the departmental review committee fail to result in approval, the proposal may be submitted to the IRB.
C. There is no appeal beyond the IRB for a proposal judged to have inadequate safeguards for the rights and welfare of human subjects; authority to override approval given by the IRB is held by the Chancellor.
The members of the IRB will be appointed by the Provost/Vice Chancellor for Academic Affairs. The IRB will be composed of the Coordinator of Faculty Grants and four faculty members, two of whom will be experienced in human subjects research and one of whom shall be from a nonscientific area such as ethics, religion, literature, history, etc. Only one member may come from any academic department. For review of contracted research, a sixth member who is not otherwise affiliated with The University of North Carolina at Pembroke and who is not part of the immediate family of a person who is affiliated with the University shall be appointed. No member of the IRB or of a departmental review committee may vote on the approval of a proposal that she/he submitted.
NOTE:
Committee members, applicants for review, and others concerned with the policy should familiarize themselves with Code of Federal Regulations 45 CFR 46.