This section of the Reliance Manual covers how to prepare a study protocol and site supplement and how to write consent and authorization documents.

Prepare Study Protocol and Site Supplement

In the cede application, you will be asked to upload the IRB-approved study protocol or, if no study protocol is available, a copy of the IRB-approved application. The lead study team will need to provide you with this document. Whichever document you use, it will need to clearly describe the role of UW-Madison/UWHC in the study. This is important because the institution cannot cede IRB review without knowing what study activities will be occurring here, including who from UW-Madison/UWHC will be involved in the study. RELIANT uses this information to assess whether the study qualifies for ceded review and to identify any institutional requirements that must be met before study activities can commence at UW-Madison/UWHC, as applicable.

If neither the IRB-approved study protocol or application describe UW-Madison/UWHC’s role in the study, you will need to complete HRP-508-TEMPLATE SITE SUPPLEMENT and upload this in your cede application. This will provide RELIANT with the information needed for its review process. Some sections of the site supplement may not apply to your study and you may edit the document as needed.

Write UW-Madison Authorization Documents

If your study requires use of a HIPAA authorization form, the lead study team should provide you with an authorization template or authorization language included in a combined consent and authorization template. Either format is acceptable. If a separate authorization form will be used for the study, you should only need to make minimal revisions to reflect the UW-Madison PI and contact information. If the reviewing IRB/lead study team does not provide a template authorization form, you should use the UW-Madison templates.

Regardless of the format, RELIANT will review authorization language to confirm the required elements are present. For more information on required authorization elements, see HRP-834 – WORKSHEET – Institutional Requirements for Ceded Studies and HRP-502c – INSTITUTIONAL CONSENT LANGUAGE mentioned above.