Investigators and Local VA Sites

Office of Research & Development

Investigators and Local VA Sites



Federalwide Assurance (FWA) and Memorandum of Understanding (MOU)

In order for a local VA facility to be a participating site in a research project that is reviewed by the VA Central IRB, the VA Central IRB must be listed as one of the facility's IRBs of Record on the local facility Federalwide Assurance (FWA). The local facility must also enter into a Memorandum of Understanding (MOU) with the VHA Central Office Human Research Protections Program (HRPP).

The same is true for a local VA facility's Non-Profit Corporation (NPC), if one is associated with the facility. Since NPCs often hire personnel to work on projects overseen by the VA Central IRB and often manage research funds for the study team when outside funding is received, the VA Central IRB should be listed as an IRB of Record on the NPC FWA as well. The MOU is between the local VA facility, the VHA Central Office and the local NPC. If an NPC covers more than one local VA facility, the NPC will need to sign all applicable MOUs. For facilities that do not have an affiliated NPC, there is an MOU template that does not include the NPC as a signatory.

The MOU between VA facilities and the VHA Central Office was recently revised and updated to reflect changes in VA and VA Central IRB polices and to provide additional clarifications in some sections, such as reporting to the VA Central IRB by local Research Compliance Officers (RCOs). Although there were no substantive changes in procedures, the MOU does not indicate that the VA Central IRB is reviewing a wider range of studies, in addition to ORD funded multisite studies to include designated industry sponsored studies and studies from other governmental agencies such as DoD. The revised MOU templates, with and without an NPC, can be found by clicking on the links below.

top


Submitting a New Study Application to the VA Central IRB


What projects are submitted to the VA Central IRB?

The VA Central IRB mainly reviews ORD-funded VA research projects that have more than one VA site engaged in human subjects research. The VA Central IRB will also review single site pilot studies that, if successful, will eventually have multiple VA sites engaged in human subjects research. The applicable ORD Funding service should be consulted if you have a question concerning whether your study should be submitted to the VA Central IRB.

Studies funded by other sources may be considered for review by the VA Central IRB on a case-by-case basis.

How do I submit a new project to the VA Central IRB?

The VA Central IRB Application process involves two steps. The first step pertains to the submission of the protocol and supporting documents by the Principal Investigator/Study Chair (PI/SC). In addition, the PI/SC submits all waiver requests if they apply to the entire study, as well as model informed consent documents, HIPAA authorizations, and recruitment materials as applicable. The second step involves the submission of Local Site Investigator (LSI) Applications once the PI/SC application has been approved.

All VA Central IRB Application forms can be found by clicking on the forms link on this website. Prior to filling out any of the listed forms, the PI/SC or Study Coordinator should contact the VA Central IRB Administrator at 202-443-5649 to discuss submission deadlines, potential participating sites, and application procedures.

The VA Central IRB also has an optional pre-review process. Drafts of the applicable forms and protocol can be submitted and a courtesy pre-review will be performed by one of the staff or by the VA Central IRB Administrator. This pre-review is not a determination of the VA Central IRB and is meant to assist the study team in ensuring the application will be complete at the time of submission. To request a pre-review, please contact the VA Central IRB Administrator.

Below is a more detailed description of the two-step submission process:

Step 1: Submission and review of Principal Investigator/Study Chair (PI/SC) New Project Application

The PI/SC completes a VA Central IRB Form 108, PI/SC New Project Application, as well as all associated forms and documents. The VA Central IRB Form 108 was designed to be self-explanatory but if you have any questions on any areas of the application, please do not hesitate to call a member of the VA Central IRB staff for assistance. Once the VA Central IRB Form 108 and all other associated documents and forms are complete, call the VA Central IRB Administrator at 202-443-5649 to obtain access to the VA Central IRB secure SharePoint site and to have a folder created for upload of the application documents.

Upon submission of the documents on the SharePoint site, send an e-mail message to or call the VA Central IRB Administrator to indicate that the initial submission is complete. The VA Central IRB Administrator will assign a VA Central IRB Manager to the study. The assigned VA Central IRB Manager will serve as your main point of contact for all VA Central IRB actions related to the study.

The VA Central IRB Manager will perform an administrative review. Depending upon the type of project submitted, additional reviewers from the VA Central IRB will be assigned. At a minimum, the study will receive a review by the Regulatory Advisor to the VA Central IRB, the Privacy Officer Representative, the Information Security Officer Representative, and at least one voting member of the VA Central IRB. If the study is scheduled to be reviewed by the convened IRB, a Secondary Reviewer and an Informed Consent Reviewer may also be assigned. All comments will be consolidated as much as possible and forwarded to the PI/SC or designee via encrypted e-mail for response. However, in the interest of not holding up communications, some reviewer comments may be forwarded separately depending upon receipt. If the study is reviewed at a convened IRB meeting, a letter indicating the determinations made by the IRB, as well as any required modifications, will be forwarded.

Upon approval of the PI/SC Application, or approval contingent upon required minor modifications if the study was reviewed by the convened IRB, the study advances to the next step.

Step 2: Submission of Local Site Investigator (LSI) Applications

After a PI/SC Application has been approved under expedited review procedures, or approved contingent upon required minor modification if reviewed by the convened IRB, LSI Applications, VA Central IRB Forms 104, may be submitted by each Local Site Investigator.

The LSI Application mirrors the PI/SC Application. There are standard sections for study staff and site-specific information. If the LSI does not plan to deviate from the approved PI/SC Application, in many sections, this can just be stated and no further information needs to be completed. If the LSI plans to deviate from the approved PI/SC Application, all deviations must be detailed and justified on the application. Approved model forms should be used and site-specific demographic information completed as appropriate. Any deviations made from approved wording must be indicated through the use of the "track changes" function, and justification provided within the application. LSI Applications should also include changes made in response to any requested modifications to the PI/SC Application as applicable.

LSI Applications must be submitted to the PI/SC study team for review prior to upload to the VA Central IRB SharePoint site. This upload can be done by the PI/SC study team and/or the Local Site Study Coordinator. The PI/SC study team must inform the VA Central IRB Manager for the study via phone or e-mail that LSI Applications have been submitted.

LSI Applications will be reviewed after the comments that were solicited from the local sites to the approved PI/SC Application are reviewed by the VA Central IRB. Upon review of local site comments, additional modifications may be required in the PI/SC and/or LSI Applications. These additional modifications will be detailed for the investigators in writing.

A simplified flowchart detailing the entire VA Central IRB application and review process can be found by clicking on the below Microsoft Publisher file:

Flowchart detailing the entire VA Central IRB application (587KB, Microsoft Publisher file)

top


What Must be Reported to the VA Central IRB

For those studies that are overseen by the VA Central IRB, local facilities participating in those studies must report the same information described in VHA requirements to the VA Central IRB as they would report to their local IRB if the local IRB was serving as the IRB of Record for the study. The types of issues that must be reported include but are not limited to:

  • All unanticipated serious adverse events
  • Unanticipated or unexpected problems in research involving risks to subjects or others
  • Protocol deviations or violations
  • Modifications or amendments
  • A Change in PI of main study or a change of a Local Site Investigator
  • Addition of Local Site Investigator and/or additional sites
  • Participant complaints
  • Incarceration of a participant
  • New information that indicates a change to the risks or potential benefits of the project

Click on the link below for a Table of Reporting Requirements. This table indicates the type of issue that must be reported, a description of what constitutes the reportable issue, what VA Central IRB form to use to make the report if applicable, and the time frame in which the report must be submitted.

Table of Reporting Requirements (68KB, PDF)

The VA Central IRB forms referenced in the table can be found under the Forms link on this website. Additional details concerning reporting procedures can also be found on the SOP link on this website.

In addition, audits conducted by the local facility Research Compliance Officer must also be forwarded to the VA Central IRB for review. These include the routine yearly informed consent audits and the tri-annual regulatory audits. The routine audits can be forwarded with the continuing review report if there are no issues (e.g., noncompliance that may be serious or continuing) that need to be brought to the attention of the VA Central IRB prior to continuing review. All other audit reports should be forwarded as they are completed and/or received.

A copy of audits conducted by any other VA or external entity must also be forwarded to the VA Central IRB upon receipt, such as the results of a SMART audit or an audit by ORO, the FDA, OIG, or OHRP concerning a specific study.

Any further questions concerning what must be reported to the VA Central IRB can be forwarded to va.central.irb@va.gov or you can call the Program for Research Integrity and Development (PRIDE) toll free number at 877-254-3130.

top


Important Information for VA Central IRB Local Site Liaisons

A Local Site Liaison is appointed for each VA facility that lists the VA Central IRB as an IRB of Record on the facility's Federalwide Assurance (FWA). This Local Site Liaison serves as the main point of contact between the local VA facility and the VA Central IRB and is given access to the VA Central IRB secure SharePoint site for all studies involving their local site for which the VA Central IRB is serving as the IRB of Record. All Local Site Liaisons are highly encouraged to read the Memorandum of Understanding their local facility signed with the VHA Central Office HRPP to use the VA Central IRB as one of the facility's IRBs of Record.

A handout detailing the responsibilities of the Local Site Liaisons, what the Local Site Liaisons can expect from the VA Central IRB and its Administrative staff, and more information on the use of the VA Central IRB SharePoint site can be found by clicking on the following link:

It is extremely important that any changes in the appointed VA Central IRB Local Site Liaisons made by the Medical Facility Directors be immediately reported to the VA Central IRB Administrator to ensure that important communications with the site from the VA Central IRB are sent to the appropriate local site appointees. Anyone having any questions concerning the role and responsibilities of the VA Central IRB should contact the VA Central IRB Administrator whose contact information is listed on the VA Central IRB Home Page.

top



Important Information for Local Site Research Compliance Officers (RCOs)

RCO responsibilities regarding the VA Central IRB are essentially the same as for their local IRBs in regard to studies that are approved and overseen by the VA Central IRB as on IRB of Record for the RCO’s site. An Information Sheet that can be printed out and serve as a useful guide concerning what is expected of the local RCO, what the local RCO can expect from the VA Central IRB, and the use and structure of the VA Central IRB SharePoint site can be found here:

New RCOs should find out who is serving as the VA Central IRB Liaison for their specific site. The Liaison can assist the RCO in obtaining access to the VA Central IRB SharePoint site, which contains copies of the approved documents for studies overseen by the VA Central IRB. RCOs having questions concerning the operations of the VA Central IRB can contact the VA Central IRB Administrator whose contact information is listed on the VA Central IRB Home Page.

top



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.