Office of Research & Development |
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The Mayo Clinic IRB has worked with ORD and ORO on establishing a mechanism for VHA Facilities to rely upon the Mayo Clinic IRB to participate in the expanded access program: Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19.
In order for your VA Facility to register to participate in the program, the following must occur:
i. Page 1: Type in the name of your VHA Facility in the fillable box at the top of page
ii. Page 2: Type in the name of your Medical Center Director and give the form to the Medical Center Director to sign; the form can be signed
iii. Retain a copy for your files and send a copy of the signed and dated agreement by email to ORD and ORO; a confirmation of receipt will be sent.
ORO: Priscilla.Craig@va.gov
ORD: Sarah.Rule@va.gov
i. Please put “VA” as the first two letters when your research office is registering your VA
ii. Several VA Facilities have already registered to rely on Mayo Clinic’s IRB for this program without prior VHA approval. ORD is aware that some of the VA Facility registrations to rely upon the Mayo Clinic IRB occurred without the VA Facility’s research office’s knowledge. These VA Facilities do not need to repeat the registration process; however, these VA Facilities must follow all requirements for submitting the Concurrence with the Office of Research and Development (ORD) Agreement with Mayo Clinic Institutional Review Board (IRB) For Mayo Clinic IRB Oversight. ORD policy does not permit VA Facilities to add IRBs to its Human Research Protection Program without ORD approval (VHA Directive 1200.05, Paragraph 5.f.(9).
Additional Information from ORD on the Mayo Clinic Convalescent Plasma expanded program is located on the ORD COVID-19 SharePoint site. The ORD COVID-19 SharePoint site is located at https://dvagov.sharepoint.com/sites/vacovhacomm/admin/projects/covid19 and is accessible within VA; it is not an external site.