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IMPORTANT INFORMATION ON EXPIRATION OF COVID-19 EXCEPTIONS
To Principal Investigators/Study Chairs:
On Jun 2nd, the CRADO published guidance on the lifting of the ORD administrative hold of non-critical, in-person interactions. Each VA facility (Chief of Staff) is required to create a plan and submit a memo to ORD stating that the facility is ready to lift the administrative hold. Once that memo is submitted to ORD, a 30 calendar-day “clock” begins. It is important that your ACOS alert you when that document is submitted.
All study procedures listed as COVID-19 exceptions as detailed on any VA Central IRB Forms 127a, COVID-19, Reporting of Protocol Exceptions Due to COVID-19 Safety Precautions, submitted for your study will expire at the end of that 30 days. The 30 days may be different for each site participating in your protocol. If you want those exceptions to continue permanently, then an amendment must be submitted prior to the end of the 30 days for the first site that has the ORD hold lifted.
Please reference the link under the “Important Links” menu options titled COVID-19 Exceptions for additional information that we hope will help you understand the potential impacts and requirements of this lifting of the ORD hold:
If you have any questions concerning the above guidance, please e-mail the VA Central IRB general mailbox at vacentralirb@va.gov.
Purpose: The purpose of the VA Central IRB is two-fold. First and foremost its purpose is to enhance the quality of human research protection in multi-site human research projects by performing appropriate ethical and scientific review while ensuring local issues are addressed. The second is to enhance the efficiency of these reviews across participating sites.
VA Facilities: Each VA facility that plans to use the VA Central IRB must add the VA Central IRB to its Federalwide Assurance (FWA) and sign a Memorandum of Understanding (MOU) with the VHA Central Office (VHACO) Human Research Protection Program (HRPP). The MOU clearly delineates the respective roles and responsibilities of each entity. The local VA has ultimate responsibility for its HRPP. Instructions for adding the VA Central IRB as an IRB of Record are also included on this website, as are the VA Central IRB SOPs and forms. Guidance for local facilities in updating their own SOPs to incorporate use of the VA Central IRB is also available.
In addition, any affiliated Nonprofit Research and Education Corporation (NPC) for a VA site that has entered into an MOU with the VHACO HRPP, should also sign the MOU and update its FWA to add the VA Central IRB as an IRB of Record.
VA Investigators: Investigators whose studies are being funded by VA ORD should consult the applicable ORD funding service to determine whether their study should be submitted to the VA Central IRB or to each site's local IRB.
Investigators whose studies will be reviewed by the VA Central IRB should contact the VA Central IRB Administrator, whose contact information is available below, as far in advance of the planned submission as possible to obtain the most current information about submission procedures. Application forms and other information concerning the operations of the VA Central IRB can also be found on this website under the Important Links box on the right-hand side of this page.
VA Central IRB Administrative Staff
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Annette Anderson VA Central IRB Administrator 202-443-5649 Annette.anderson3@va.gov |
Lindsey Martin SharePoint and MOU Coordinator 202-443-5653 Lindsey.Martin2@va.gov |
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Hector Ramirez VA Central IRB Manager 202-443-5656 hector.ramirez@va.gov |
Angela Foster CATS Manager/ SharePoint Coordinator Angela.Foster@va.gov |
| Kendra Clarke VA Central IRB Manager 202-443-5766 Kendra.Clarke2@va.gov |
Erica Aulik CATS Manager/ SharePoint Coordinator Erica.Aulik@va.gov |
| Rishima Weston VA Central IRB Manager 202-443-5642 Rishima.weston@va.gov |
Samantha McBride VA Central IRB Admin Support 202-443-5742 Samantha.mcbride@va.gov |
| Mary Eckart VA Central IRB Manager 216-215-7945 Mary.Eckart@va.gov |
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Christie O'Brien VA Central IRB Manager 202-443-5660 christie.o'brien@va.gov |
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Michele McGee VA Central IRB Manager 202-443-5651 Michele.mcgee@va.gov |
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Chelle Yin VA Central IRB Manager Chelle.Yin@va.gov |
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VA Central IRB Toll Free Number: 1-877-254-3130
VA Central IRB E-mail Address: vacentralirb@va.gov
SOP 105 Continuing Review Requirements