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 Consent Documents
If you will be enrolling participants at UW-Madison/UWHC sites, you will need to draft a consent document with required UW-Madison language. We recommend the following process when drafting consent documents for external IRB review:
- The UW-Madison consent document should be based on the IRB-approved consent template provided by the sponsor or lead study team.
- We advise against revising a consent template that is not yet approved by the reviewing IRB as it is likely to request revisions to the template during its review process.
- In the event you are not provided with a consent template, you may use UW-Madison’s template (HRP-502-TEMPLATE CONSENT DOCUMENT).
- Revise the consent document to include UW-Madison institutionally required language. See HRP-502c-INSTITUTIONAL CONSENT LANGUAGE for the specific language that needs to be included.
- When you submit your request to cede IRB review, upload the UW-Madison consent document in the application. We will review this along with the other documents you provide.
- The IRB of record is responsible for reviewing and approving the UW-Madison consent document. The reviewing IRB may request your consent document as either part of the reliance process or after reliance has been approved. Practices vary by institution, so please consult with your lead study team as to when the UW-Madison consent document needs to be submitted.
- You cannot use the UW-Madison consent document until it is approved by the reviewing IRB. The lead study team should provide you with the UW-Madison approved consent document or provide instructions on how you obtain it.