Documents

Purpose

Guidance on the comparison of the research consent form and the research budget with the clinical trials contract between the sponsor funding the research and the UW.  This comparison ensures consistency and compliance in the consent form with respect to:

• Who is paying for the research procedures, services, and items; and
• What payments are made to research subjects for participation and/or expenses; and
• Who is paying for treatment of "on-site" adverse events or subjects injuries, including any conditions or limitations to such payment; and
• Medicare rules about Medicare being a secondary payer (Medicare Secondary Payer rule).