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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; to view our OHRP registration records, click registration record at OHRP (OHRP no longer provides paper copies of these agreements) and follow these steps: 1) on the search form, a) at the Institution/Organization Name field, enter "U of North Carolina at Chapel Hill"; b) at the Document field, select "Assurances (FWA)"; c) at the FWA Number field, enter "00004801"; and d) click the Search button. 2) on the Office of Human Research Protections (Current Data) screen, beneath the Institution column click the link "U of North Carolina at Chapel Hill." 3) On the Assurance Information screen, select 100 Results per page, click Go and scroll to the bottom of the page.
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.
Standard Operating Procedures (SOP) -- The University of North Carolina at Chapel Hill Human Research Protection Program Standard Operating Procedures (SOP) (PDF document) describes the policies and procedures that govern human subjects research at this University. These are intended for use by IRB chairs and members, the staff of the Office of Human Research Ethics and investigators and research team members.
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.