VA Central Institutional Review Board (IRB)
Important Notice About Upcoming Changes in VA Central IRB Policies and Procedures
As many of you may know, the Common Rule for the protection of human subjects has been revised and contains significant changes in how IRBs will review and oversee research. These changes will go into effect on January 21, 2019, and all studies approved after that date must conform to the revised Rule. Studies approved prior to that date will be grandfathered under the old Rule unless transitioned to the new Rule.These changes have required substantial revisions to VA Central IRB SOPS and forms. We are now beginning to upload the revised versions of the forms and will soon begin loading the revised SOPs. Meanwhile, we have begun to accept new studies again with the caveat that they will be reviewed under the revised Common Rule provisions and not approved until after the implementation date. Meanwhile, we have taken down all the outdated SOPs and will be replacing the forms as they are finalized. Look at the "WHAT's NEW" section of the website to see the latest additions.
As always, before preparing an application for submission to the VA Central IRB, please contact the VA Central IRB Administrator at Annette.anderson3@va.gov or at 202-443-5649 to discuss the submission first as all multisite studies cannot be accepted for review.
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 |
Mary Eckart VA Central IRB Manager 216-215-7945 Mary.Eckart@va.gov |
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Hector Ramirez VA Central IRB Manager 202-443-5656 hector.ramirez@va.gov |
Soundia A. Duche, MA, MS Program Analyst 202-443-5658 Soundia.duche@va.gov |
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Christie O'Brien VA Central IRB Manager 202-443-5660 christie.o'brien@va.gov |
Erica Doruska ACCESS Manager/SharePoint Coordinator Erica.Doruska@va.gov |
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Lindsey Martin SharePoint and MOU Coordinator 202-443-5653 Lindsey.Martin2@va.gov |
Kendra Clarke VA Central IRB Manager 202-443-5766 Kendra.Clarke2@va.gov |
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Pauline Cilladi-Rehrer Administrative Officer, PRIDE 202-443-5607 Pauline.Cilladi-Rehrer@va.gov |
Michele McGee VA Central IRB Manager 202-443-5651 Michele.mcgee@va.gov |
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Rishima Weston VA Central IRB Admin Support 202-443-5642 Rishima.weston@va.gov |
VA Central IRB Toll Free Number: 1-877-254-3130
VA Central IRB E-mail Address: vacentralirb@va.gov
What's New!
New:
- Form 127: Request for an Exception to an Approved Protocol (127KB, MSWord)
- Form 144: Amendment to Memorandum Of Understanding (MOU) - DOE Laboratories (145KB, MSWord)
Updated:
- Form 108: Principal Investigator/Study Chair New Project Application (703KB, MSWord)
- Form 115a: Application for Continuing Review — Principal Investigator/Study Chair (390KB, MSWord)
- Form 115b: Application for Continuing Review — Local Site Investigator (1.6MB, MSWord)
- Form 116: Request to Amend or Modify an Approved Project (601KB, MSWord)
- Form 134a: Change in Principal Investigator/Study Chair (563KB, MSWord)
- Form 143: Amendment to Memorandum of Understanding (MOU) (146KB, MSWord)
Important Links
- Current Fee Schedule
(102KB, MSWord)
The VA Central IRB does not charge for review of VA-funded or other federally funded research involving human subjects, but it does charge for review of non-federally funded human subjects research. The Baltimore Research and Education Foundation (BREF) currently handles all billing issues for the VA Central IRB. If you have any billing questions, please contact Caroline Zink at 410-605-7000. - Forms
Important VA Central IRB Forms - IRB Composition
- FAQ (313 KB, PDF)
- Meeting Dates:
2018 (399 KB, MSWord)
2019 (395 KB, MSWord)
- Investigators and Local VA Sites
- PowerPoint Presentations
- Research Participants or Potential Participants (42KB, MSWord)
- Standard Operating Procedures (SOPs)
- VA Facilities Listing the VA Central IRB as an IRB of Record (214KB, PDF)
Questions about the R&D website? Email the Web Team.
Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.
Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.