Throughout this document “institution” refers to the University of Wisconsin-Madison. The institution’s IRB also serves as the reviewing IRB for University Hospital and Clinics (UWHC) so the information in this manual applies to human research conducted at the institution and UWHC. For information on UWHC affiliates (e.g., UnityPoint Health-Meriter, Swedish American) and VA reliance issues, see the “Other” section below.


Purpose

This document, HRP-806 – RELIANCE MANUAL, is designed to guide you through policies and procedures related to human research overseen by the institution’s IRBs when it serves as the reviewing IRB for external individuals or institutions. This manual also provides guidance on when the institution relies on an external IRB.

Along with this manual, we encourage you to review current Human Research-related policies, SOPs, Worksheets, Checklists, and Templates located in the Human Research Protection Program (HRPP) Toolkit Library. This manual includes references to the relevant documents throughout. To ensure you are always referencing the most current version of Toolkit and related documents, please access them in real time from the Toolkit Library rather than downloading and storing them on your computer.

Reliance and Navigation Team (RELIANT)

The HRPP Reliance and Navigation Team (RELIANT) assists researchers with collaborative research issues, including single IRB review, ceding IRB review, and working with external personnel. We facilitate the process for executing reliance agreements when needed as well as supporting researchers working with a commercial IRB or the NCI CIRB. We also assist study teams with navigating the institutional requirements outside the IRB review process that may apply to their study. Collaborative research issues and reliance arrangements can be complex, so we encourage you to consult with us (irbreliance@wisc.edu) early in your grant preparation and/or study design process.