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Outline of the Endorsement Process

Submission of projects for review by the VA - The Endorsement Process

New projects may be submitted to the VA R&D Committee first, to the IRB first, or to both committees simultaneously, depending on the nature of the project, the relative involvement of both institutions, and the committee schedules.  For all projects:

• The two committees review schedules are independent
• Initial review of the VA R&D Committee may result in a deferral, disapproval, or endorsement of the project
• If the project is endorsed by the R&D committee this will be communicated to the study team and to the IRB
• Endorsement by the VA R&D Committee signifies that the submitted iteration of the research project meets the needs and requirements of the Madison VA.   However, it is not an approval of the final version of the protocol which may still be in the process of completing IRB requested modifications
• Final approval can only be granted by the R&D Committee after the IRB completes its review and approval of the project
• Once the IRB approves the study, this approval will be communicated to the study team and to the VA R&D Committee
• The R&D Committee will give a final review of the project as reviewed and approved by the IRB, and this iteration may then receive final approval by the VA R&D Committee
• Informed consent forms related to the project will only be released by the IRB after final VA R&D approval is received
• Study procedures, including recruiting, may only be initiated after final VA R&D Committee approval documentation has been received by the study team

If the project is already an approved UW protocol that the study team wishes to expand to the VA:

• Either the current PI must be qualified to conduct research at the Madison VA or a VA Responsible Investigator must be appointed as part of the study team
• A change of protocol will need to be submitted to the UW IRB system
• An application for VA R&D review must be completed and submitted to the VA Research Service
• All above review steps for project approval must be completed prior to the initiation of any research procedures related to the VA portion of the project

Only once final R&D Committee approval has been given, will the research be considered VA approved research.