Conducting VA Research; HRP-318 Additional Federal Agency Criteria; VA Research and Development staff (VHAMADRDCOORDINATOR@va.gov)

The UW IRB may serve as the IRB of record for the William S. Middleton Memorial Veterans Hospital (or Madison VA) human subjects research. A research project may be categorized as VA research if: 

•     It recruits or enrolls subjects through the Madison VA 
•     It involves the use of Madison VA medical records or specimens obtained from the Madison VA 
•     Study personnel will be engaged in research under their VA appointment 
•     The project is supported by VA funds 

Other considerations: 

• Limited use of VA facilities or space (e.g., use of office same for administrative tasks, use of lab space for storage of data or samples) may impact the VA status of the study.  If study teams select this option on the VA page of their application, the application will be routed to the VA prior to pre-review and the VA will determine if their proposed use of space impacts the VA status. 
• Likewise, enrollment of VA patients to a UW study may not lead to the project being classified as VA research.  If study teams select this option on the VA page of their application, the application will be routed to the VA prior to pre-review and the VA will determine if the recruitment activities at the VA impacts the VA status.

The VA RDC applies the regulatory requirements derived from the Veterans Health Administration (VHA), e.g., VHA Directive 1200.05(2), VA Central Office (VACO), VA Office of Research and development (ORD), Department of Veteran Affairs (DVA) Chief Research and Development Officer (CRADO) to: 

•     Determine if research belongs at Madison VA 
•     Consider safety/ethical issues in light of subcommittee (IRB) recommendations 
•     Evaluate the quality, design, feasibility, and scientific standards of the study 
•     Consider facilities, budget, etc. 
•     Verify that VA-specific requirements are met. Examples may include: 
  •     The project fits VA needs and is consistent with the VA mission. The project is relevant to VA patients / veterans. 
  •     If the inclusion of non-VA-patients is proposed, their inclusion is consistent with meeting the VA mission.  
  •     The plans for information security and privacy meet with VA expectations and are approvable. 
  •     Any VA Pharmacy requirements have been met. 

For initial reviews, the VA RDC’s endorsement review should address the issues below, but IRB analysts should be aware of these requirements in case they come up as part of a change of protocol. Study teams can be referred to the Conducting VA Research section of the Investigator Manual. 

Key Personnel on VA Studies 

The VA has restrictions on the individuals who can conduct VA research, interact with VA subjects, and access VA records. Individuals listed as key personnel would typically be expected to have a VA appointment. If the study team proposes inclusion of a non-VA study team member, refer them to the VA Research Office. The inclusion of non-VA personnel on a VA study can involve complex and time-consuming VA process, and VA approval is not guaranteed.  

• Personnel who are not “engaged” in the VA component per OHRP guidelines can be removed from the VA application. UW and/or non-VA researchers who are not engaged in the VA-site component could receive access to relevant data through the VA study’s specification of data sharing, with the engagement of such non-VA researchers covered through a separate (UW) application and protocol.  The VA-specific protocol should describe the data sharing in detail (e.g., who will receive the data, the type of data that will be shared, and the rationale for sharing it). 
• Regulatory Coordinators from the Clinical Trials Institute (CTI) may not be considered engaged in research by the VA. According to the VA, if a person falls under the “Admin Only” category, they are exempt from certain trainings. The only VA training required of “Admin Only” personnel is the PDF version of the VA training, “Privacy and Information Security Awareness and Rules of Behavior”. The VA RDC can confirm the engagement status of CTI staff. Contact Mina Herreman at Mina.Herreman@va.gov or the VHAMADRDCOORDINATOR@va.gov.

Combining UW and VA Research

Combining UW and VA applications is not allowed. If research activities will be conducted at both the UW and VA, the UW and VA components of the research must be submitted as separate ARROW applications with UW- and VA-specific protocols.  

Multicenter studies

Multicenter studies involving the VA site require a VA-site protocol. Study teams are encouraged to use HRP-508 Site Supplement protocol template to describe activities occurring locally. The VA has not fully implemented single IRB mandates. In cases when the VA does allow review by an external IRB, the cede process is managed by the VA. 

Bank and Repository Considerations

The VA considers the maintenance of subject contact information, PHI, or any other study-derived data to constitute the creation of a research database or data repository. Study teams should address this in their protocol by including the information requested in the banking section of the Biomedical Protocol Template, or the more detailed info in the Registry and Repository Template. 

Per VACO clarification, a VA bank/repository involves the use of VA facilities and/or oversight by VA personnel. A VA bank / repository MAY require the creation of a separate and distinct protocol and application. Study teams should check with VA RDC staff. 

VA samples can be banked at non-VA repositories as long as the repository has appropriate IRB approval in place. For example, the banking of samples from a VA-site study that were provided to UW investigators for future unspecified research would be approved under an associated UW application/protocol. 

Data shared with a repository or banked at a non-VA site for future use is no longer considered to be ‘VA data.’ The disclosure of PHI must be addressed in the VA study’s HIPAA form. The VA RDC has objected to the sharing of directly identifiable data in the past (e.g., coded data where the recipient has access to information connecting codes to names).  

Transfers of data to any repository must meet VA privacy and information security requirements. 

Off-site, non-VA repositories should be not-for-profit. 

Data Storage Considerations

VA data may not be stored at UW; however, copies of the data can be shared with UW researchers and be stored at UW. The VA research site must store all research records and data, including original and signed consent forms, subject data collection instruments, etc. All records, regardless of format, must be maintained in accordance with VA requirements.  

Recruitment Considerations

Activities preparatory to research only encompass the time to prepare the protocol and ends when the protocol is submitted to the IRB. See the Use of Preparatory to Research section of the Investigator Manual for allowable activities.  Other activities are likely to require HIPAA authorization or a waiver. 

Initial contact with potential subjects must be made in person or through a recruitment letter. Exceptions to this requirement apply to cases where there is written documentation that the subject is willing to be contacted by telephone about the study in question or a specific kind of research as outlined in the study (e.g., through participation in a VA recruitment registry), or a potential subject calls the study team in response to an advertisement.  

Recruitment letters that don’t come from the potential subject’s clinician should be cosigned by the Madison VA Chief of Staff.

See the Changes of Protocol of the Staff Manual for more information.

IRBs reviewing VA research include VA representatives, and the VA Research Compliance Officer (RCO) regularly attends an advisor/observer. However, a VA representative does not need to be present when a VA item is reviewed by the full board.

Study teams must upload the VA endorsement letter to the VA page of the ARROW application before they submit the application to the IRB. 

Submissions reviewed by the full board are approved with an administrative hold. If the VA RDC requests changes when the study is this state, the study team should submit a change of protocol to address the requested changes. 

Consent documents should not be finalized until the administrative hold has been lifted. 

See the Lifting an Administrative Hold process, within the Post Meeting Processing section, for post VA approval processing.