How to Draft Consent and Authorization Documents for Relying Sites

February 2019

This document provides a general framework for study teams to follow when drafting consent and authorization documents for sites for which UW-Madison will serve as the reviewing IRB. (These are also called relying or local sites.) The regulatory landscape for single IRB (sIRB) review is evolving, so the framework provided below is only general guidance. The specific process for each relying site may differ depending on their local requirements. Study teams are encouraged to contact the HS IRBs Reliance Team (irbreliance@wisc.edu) with any questions.

For guidance on listing relying sites in the IRB application and obtaining IRB approval for them, see How to List and Obtain IRB Approval for Relying Sites.

Step 1: Develop Template Documents

Each relying site enrolling subjects will have its own consent and, if applicable, authorization documents. Template documents are created using UW-Madison template forms, which are later customized to develop site-specific forms including each site’s institutionally required language.

Step 2: Obtain IRB Approval for the Template Documents

Upload template consent (including combined consent/authorization) documents in the initial review application as follows:

Upload template authorization documents in the initial review application as follows, only if relying sites require a standalone authorization form:

Step 3: Work with Relying Site Study Team on Cede Request and Site Documents

After the HS IRBs have approved the template documents, the UW study team will reach out to the relying site study team to begin the cede request process at the relying site. As part of the cede request process, the relying site study team will provide its own IRB with the site-specific consent/authorization documents that will be used at that site. The relying site’s IRB will then review the site-specific documents to ensure they meet its institutional requirements.

To create these site specific documents, the relying site study team will use the HS IRBs’ approved consent and, if applicable, authorization document templates. The relying site study team will:

Step 4: Obtain Approval for a Site and Site Documents

After the cede request is in progress at the relying site and the site’s IRB has indicated that the consent/authorization documents for that site meet its requirements, the UW-Madison study team will need to formally add the site and obtain approval for site documents as follows:

Note: A full change of protocol may be needed for the regular or sIRB application if the site being added is not already listed in the application.

Step 5: Distribute Approved Study Documents to Relying Sites

The UW-Madison study team is responsible for distributing approved study documents to relying sites. Study teams can use email or a web-based platform of their choosing to distribute approved study documents.