How to Draft Consent and Authorization Documents for Relying Sites
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 (firstname.lastname@example.org) 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.
- Consent template, including combined consent-authorization forms
- Start with the UW-Madison template form
- If your study requires multiple consent and/or assent documents, then multiple templates should be created
- Include brackets or other placeholder text in the following sections of the template:
- Contact information for the study team at the relying site
- Costs to subjects, if this will differ for relying sites
- Compensation for research-related injury
- Authorization template, if a relying site requires a standalone authorization form
- Start with the UW-Madison template form UNLESS the relying site requires its own authorization form be used
- The HS IRBs will accept site-specific authorization forms in lieu of following UW-Madison’s template
- If your study requires multiple authorization documents, then multiple templates should be created
Step 2: Obtain IRB Approval for the Template Documents
Upload template consent (including combined consent/authorization) documents in the initial review application as follows:
- Regular initial review application:
- Consent templates should be uploaded on the consent: overview page, in response to question 6.5. Please clearly indicate that the document is a template by including “TEMPLATE” in the name of the document
- sIRB initial review application:
- Consent templates should be uploaded on the consent: overview page in response to the consent template question
Upload template authorization documents in the initial review application as follows, only if relying sites require a standalone authorization form:
- Regular and sIRB initial review application:
- Template authorization forms should be uploaded on the HIPAA authorization page and clearly labeled as a template by including “TEMPLATE” in the name of the document
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:
- Revise the consent template using track changes to include its site-specific language in the three areas of the consent template with placeholder language
- ONLY these three areas of the consent template can be revised by the relying site. If the relying site requires additional revisions, the relying site IRB must contact the HS IRBs reliance team to discuss.
- If a standalone authorization form is required by the relying site, the relying site study team will revise the HS IRBs’ approved authorization document using track changes to include site-specific language OR provide an authorization document for the relying site using that’s site’s preferred format.
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:
- Regular application: Study teams should submit an expedited change and upload the site-specific documents in the relevant pages of the application (e.g., consent: overview page). All changes from the approved template must be tracked.
- sIRB application: Study teams will submit an “add a site” form for the site being added. Within that form, the study team will upload the site specific documents where prompted in the add a site form.
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.