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VA Central IRB Requirements for Reporting of Protocol Changes Due to Taking Safety Precautions for the COVID-19 Virus
Per the March 6, 2020, ORD Guidance on Implementing COVID-19 Clinical Screening and Study Modifications, the VA Central IRB Form 127a, Reporting of Protocol Exceptions Due to COVID-19 Safety Precautions, should be used to meet the reporting requirement to the IRB if your study team makes any changes to approved protocol procedures under this guidance. If your study team is not planning to make any changes to approved protocol procedures as a result of the COVID-19 virus, no report needs to be submitted.
ONE report should be submitted per study listing all precautions to combat COVID-19 that local study teams take that deviate from currently approved protocol procedures. Local study teams will only need to submit a separate report if different or additional precautions at that site will be taken that deviate from approved procedures. Reports will be acknowledged, reviewed, and posted to the VA Central IRB SharePoint site and a notice sent to both the PI/SC and LSI study teams with the link.
Submission instructions are detailed at the end of the form. In addition, study teams should follow any local R&D Committee reporting requirements.
If you have any questions concerning submission procedures or whether you need to submit a report, please contact your assigned VA Central IRB Manager or the VA Central IRB Administrator, Annette Anderson, at Annette.anderson3@va.gov or at 202-443-5649. You also may call the VA Central IRB toll free number at 202-254-3130.
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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VA Central IRB Toll Free Number: 1-877-254-3130
VA Central IRB E-mail Address: vacentralirb@va.gov