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.
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:
- Click the TAB FOR “FWAs”;
- Enter “4801” in the FWA number field; and
- Click the Search button.
- Proposed Regulatory Reforms
- Updates to the Common Rule
- UNC comments on proposed NPRM changes January 2016
- Full NPRM as published in Federal Register
- UNC comments on proposed ANPRM changes Oct 2011
- Full ANPRM as published in Federal Register
- NEJM article explaining proposed changes in ANPRM
- UNC comments to Presidential Commission May 2011