How to Request a Reliance Agreement

Guidance DocumentRequesting Reliance on an External IRB or Extending UNC IRB Oversight to an External Group or Individual

A reliance agreement may be required when you are collaborating with researchers external to UNC who are engaged in research. This document describes how to complete the IRBIS application to request one of the following:

  •  UNC provide IRB oversight for institutions, groups or organizations external to UNC
  •  UNC provide IRB oversight for individuals (whose collaboration is NOT on behalf of an external institution, group or organization) external to UNC
  •  UNC rely on an Institutional IRB
  •  UNC rely on an Independent/Commercial IRB
  •  UNC rely on the NCI CIRB

The UNC Institutional Profile

The UNC Institutional Profile contains basic information about the UNC IRB and institutional processes and requirements when reliance agreements are being considered or negotiated with collaborating sites.

Reliance documents for collaborations with organizations or institutions

These are samples of the forms the IRB uses to document reliance arrangements. The UNC Reliance Team will be responsible for preparing these forms when specific reliance requests are made. They are provided here for informational purposes, and should not be completed by the study team unless during consultation with the Reliance Team.

Reliance documents for collaborating individuals

These forms are fillable pdf’s and may be used by the research team.

Requesting Reliance on a Commercial IRB

Instructional Website: Requesting reliance on a Commercial IRB

UNC allows investigators to utilize a commercial IRB for industry-sponsored, multi-center, clinical research studies for which one of the following approved commercial IRBs have been appointed as the commercial IRB by the Sponsor or CRO and the commercial IRB has already approved the study.

  • WIRB-Copernicus
  • Advarra (created by merger of Chesapeake IRB and Schulman IRB in 2017)
  • Sterling
  • Quorum