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.