Regulatory Documents
The documents listed below are commonly needed regulatory or informational documents for the University of North Carolina at Chapel Hill Office of Human Research Ethics (OHRE) and the Institutional Review Boards (IRBs). Access to other related documents can be found on our links page.
- Federal Wide Assurance (FWA) -- The University of North Carolina at Chapel Hill has committed to uphold regulatory and ethical standards through a Federal Wide Assurance approved by the federal Office for Human Research Protections (OHRP). Our agreement with OHRP is FWA4801; here is our registration record at OHRP (OHRP no longer provides paper copies of these agreements).
- Statement of Compliance -- The statement of compliance (PDF document) attests that the Institutional Review Boards at the University of North Carolina at Chapel Hill, administered by the Office of Human Research Ethics, are organized and operate according to applicable laws and regulations governing research involving human subjects.
- OHRE Standard Operating Procedures (SOP) -- The University of North Carolina at Chapel Hill Institutional Review Board Standard Operating Procedures (SOP) (PDF document) describes the policy and procedures that guide the IRBs at our University. This manual is directed to IRB chairs and members, the staff of the Office of Human Research Ethics and other affiliated persons, and includes policies and procedures applicable to these persons in their capacities with the IRB.
- IRB Member Rosters -- There are six IRB committees (rosters), four for the Biomedical IRB and one each for the Public Health-Nursing IRB and the Behavioral IRB.