Mayo Clinic IRB Information

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:

1. The CRADO has signed an Authorization Agreement Between the Mayo Clinic Institutional Review Board and the Veterans Health Administration (VHA) Office of Office of Research and Development. A copy of the Agreement is included in this communication. Your VA Facility must sign and date the form included in the email titled: “Concurrence with the Office of Research and Development (ORD) Agreement with Mayo Clinic Institutional Review Board (IRB) For Mayo Clinic IRB Oversight”.

   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

2. The VA research office is responsible for registering your VA Facility into the program. Information about the convalescent plasma expanded access program is located at https://www.uscovidplasma.org/. Please go tohttps://redcap2.mayo.edu/redcap/surveys/?s=T9WEANE38T to register your VA Facility into the the program.

   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).

3. Updating Federalwide Assurances: Your facility does not need to update your FWA to add the Mayo Clinic

4. Facility policies to use the Mayo Clinic IRB: A standard operating policy has been placed on the VA ORD-COVID-19 SharePoint site at https://dvagov.sharepoint.com/sites/vacovhacomm/admin/projects/covid19. Please check this site frequently as updates are made often to the SOP.

5. VA Physicians/Principal Investigators from your VA Facility are required to register AFTER your VA Facility has registered. Please go to https://www.uscovidplasma.org/#why and registration entered by going to:https://redcap2.mayo.edu/redcap/surveys/?s=N44T8M9PED.

6. Patients are registered AFTER both the VA facility and VA Physician/Principal Investigators from your VA Facility have registered. Information can be found at https://www.uscovidplasma.org/#why and patient registration information entered by going to:https://redcap2.mayo.edu/redcap/surveys/?s=R3DHR7X8N4.

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.