The VA Central IRB and the 2018 Common Rule Requirements
The 2018 Common Rule requirements are now in effect. All new projects submitted to the VA Central IRB for review must conform to these requirements and VA Central IRB forms have been changed to reflect these. All forms required for submission of new studies, requesting amendments or modifications, limited IRB review for exemption requests, and continuing review approval have been uploaded to this website. There are two model versions of the informed consent form. One is a combined informed consent and HIPAA authorization and the other a stand-alone consent form.
The VA Central IRB is currently not accepting studies requesting the use of broad consent. However, In May 2019 the VA Central IRB did begin transitioning certain specified studies approved prior to the implementation of the 2018 requirements to the new requirements if studies were in data analysis and all interventions and follow-up had ended or if the studies were data use only studies.
Finally, the VA Central IRB is planning for the renewal of its Memorandum of Understanding (MOU) with VA local facilities and it is also planning implementation of a second panel. More information about these initiatives will be forthcoming so please check this box periodically for updates.
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
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 |
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 |
Christie O'Brien VA Central IRB Manager 202-443-5660 christie.o'brien@va.gov |
Erica Aulik CATS Manager/ SharePoint Coordinator Erica.Aulik@va.gov |
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 |
Pauline Cilladi-Rehrer Administrative Officer, ORPP&E 202-443-5607 Pauline.Cilladi-Rehrer@va.gov |
Michele McGee VA Central IRB Manager 202-443-5651 Michele.mcgee@va.gov |
Rishima Weston VA Central IRB Admin Support 202-443-5642 Rishima.weston@va.gov |
Angela Foster CATS Manager/ SharePoint Coordinator Angela.Foster@va.gov |
VA Central IRB Toll Free Number: 1-877-254-3130
VA Central IRB E-mail Address: vacentralirb@va.gov