VACO Central IRB and Local VA Facilities: 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 local facility must also enter into a Memorandum of Understanding (MOU) with the VHA Central Office Human Research Protections Program (HRPP), and rewrite its SOPs to incorporate the processes for using the VA CIRB. Both ORO and ORD must approve changes in the facilities IRB relationships, so the MOU will be reviewed by each.
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 NPC will also need to execute an MOU. For this reason, ORD has two versions of the VA CIRB MOU, one of which includes the NPC as a third party. If an NPC covers more than one local VA facility, the NPC will need to sign all applicable VA CIRB MOUs. For facilities that do not have an affiliated NPC, there is an MOU template that does not include the NPC as a signatory.
Requesting a Change in IRB Arrangements
ORD policy requires that the VA Medical Center Director request approval from the Chief Research and Development Officer (CRADO) approval when the VA facility wants to establish a new HRPP, change its IRB(s) of Record, or wants its internal IRB to serve as an IRB of Record for a non-VA entity if allowed by ORD policy.
VA Facilities wishing to change IRB arrangements for a single or multiple studies must submit the ORD application form: Institutional Review Board (IRB) Reliance Request Form.
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 Forms and Templates in IRBNet. 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 on an annual basis at the end of the calendar year.
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 firstname.lastname@example.org or you can call the Office of Research Protections, Policy, and Education (ORPP&E) toll free number at 877-254-3130.
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. 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.
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 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 of IRBNet can be found here:
New RCOs should find out who is serving as the VA Central IRB Liaison for their specific site. 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. The VA Central IRB will assist the RCOs with obtaining access to IRBNet which contains copies of the approved documents for studies overseen by the VA Central IRB.