As the lead study team, you will need to develop consent and other template documents. Each relying site enrolling participants will have its own consent and, if applicable, authorization documents and these will be based on the template documents you create. 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.

To draft the consent template, start with the UW-Madison template form (HRP 502-TEMPLATE CONSENT DOCUMENT). If your study requires multiple consent and/or assent documents, then you need to create a template for each document. Relying site study teams will only be able to edit a few areas of the template to include their required institutional language. (Other edits may be allowed if the
relying site has, for example, language required by state law.) To indicate which areas of the consent template may be edited, include brackets or other placeholder text in the following:

• Contact information for the study team at the relying site
• Contact information for concerns or complaints about the research
• Costs to participants, if this will differ for relying sites
• Compensation for research-related injury

If a relying site requires a standalone authorization form rather than including that language in the consent document, start with the UW-Madison authorization template form (see the HIPAA website) UNLESS the relying site requires its own authorization form be used. (The IRB will accept site-specific authorization forms in lieu of following UW-Madison’s template, if required.) If your study requires multiple authorization documents, then multiple templates should be created.

Consent and authorization templates must be approved by the IRB before you can provide them to the relying site study team. Upload template consent (including combined consent/authorization) documents in the initial review application as follows:

• Protocol-Based and Non-Protocol-Based applications
  • Consent templates should be uploaded where indicated in the application. Please clearly label the document by including “TEMPLATE” in the name of the document. This will ensure that the template document is not stamped by the IRB.
• sIRB application:
  • Consent templates should be uploaded in response to the consent template question.
• For all application types, template authorization forms should be uploaded in the application where requested and clearly labeled by including “TEMPLATE” in the name of the document.