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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). Also included on this page is information about proposed regulatory reforms, and UNC comments to these proposals. Access to other related documents can be found on our Resources page.

Standard Operating Procedures (SOP)
The University of North Carolina at Chapel Hill Human Research Protection Program Standard Operating Procedures (SOP) 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.
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 (FWA) approved by the federal Office for Human Research Protections (OHRP). Our assurance with OHRP is FWA #4801. OHRP no longer provides paper copies of these agreements.

Click here for the OHRP database and follow the steps below to view our OHRP assurance records:

  1. Click the TAB FOR “FWAs”;
  2. Enter “4801” in the FWA number field; and
  3. Click the Search button.

Statement of Compliance
The statement of compliance 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. Click here for a statement explaining that IRB approval documents do not carry signatures (effective March 2, 2011).

IRB Member Rosters
There are six IRBs (rosters): A, B, C, D, E, and F.
21 CFR Part 11 for IRBIS
Compliance Statement regarding UNC’s electronic IRB information system (IRBIS).

  • Proposed Regulatory Reforms