After the template documents have been approved by the IRB, we recommend following the steps below. Please note, however, that each relying site may have a different process so these steps are only recommendations.

Step 1: Working with the relying site study team, create consent and, if applicable, authorization forms for each site. To create site-specific documents, the relying site study team will use the UW-Madison 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. Generally, ONLY these three areas of the consent template can be revised by the relying site: contact information for the local PI and for local concerns or complaints about the research, study costs, and compensation for injury.
  • If the relying site requires additional revisions other than these three areas (e.g., to address state law requirements), the relying site IRB must contact RELIANT to discuss before proceeding. RELIANT staff will not review consent or authorization documents for relying site if they have extensive revisions and RELIANT has not been previously consulted.
  • If a standalone authorization form is required by the relying site, the relying site study team will revise the UW-Madison’s approved authorization document using track changes to include site-specific language OR provide an authorization document for the relying site using that site’s preferred format.

Step 2: The relying site study team should begin the cede request process at their institution. As part of this process, the relying site study team will provide its own IRB with the site-specific consent/authorization documents that you have created with them. The relying site’s IRB will then review the site-specific documents to ensure they meet its institutional requirements.

• If the relying site’s IRB has questions about the site-specific documents, these should be directed to that site’s study team. The relying site study team should consult with you – as the lead study team – in addressing questions raised by the relying site IRB.
• In the event the relying site’s IRB has significant concerns, you may contact RELIANT for assistance. (Do not ask the relying site study team to contact us directly; this will complicate communication moving forward.)
• Note: At this stage in the process, RELIANT and the relying site’s IRB are typically already in contact and working on any needed reliance agreement.

Step 3: After the cede request has been reviewed by the relying site’s IRB and it has indicated to their study team that the consent/authorization documents are acceptable, you will need to formally add the site to your study and obtain approval for site documents as follows:

• Protocol-Based and Non-Protocol-Based applications:
  • Submit an expedited change and upload the site-specific documents in the relevant pages of the application.
  • All changes to the approved template must be tracked.
• sIRB application:
  • Submit an “add a site” form for the site being added. Within that form, you will upload the site-specific documents where prompted.
  • All changes to the approved template must be tracked.

After UW-Madison’s IRB has approved the change to add the site and its documents, it will stamp the site-specific consent documents. As the lead study team, you are responsible for then distributing these documents to the relying site. Note: Subject enrollment at relying sites cannot begin until the consent-documents for those sites have been approved by the UW-Madison IRB and a reliance-agreement completed.