VA research is defined as research conducted by investigators (serving on VA compensated, WOC, or IPA appointments) while on VA time or on VA property. Research that qualifies as VA research may be funded by the VA, by other sponsors, or be unfunded. Use of VA space that is rented by the University does not apply.

The R&D committee may grant permission for some non-VA studies — i.e., those that do NOT fall into the criteria above — to conduct the following limited activities involving the VA:

• Recruitment of Veterans to a study not focused on Veteran health
• Conduct of administrative or sample processing activities at the VA (e.g. use of office or lab space under UW-Madison appointment) that do not involve interaction or intervention with study subjects

Any of the above activities must first be approved by the VA R&D committee, but studies limited to these activities at or with the VA are NOT considered VA human subjects research and will not be subject to continued VA oversight beyond the initial approval, absent a specific request for information about the study by the VA. Questions about whether an activity falls into one of the above categories should be directed to the VA RDC.

Studies recruiting veterans directly to non-VA studies, with prior RDC approval, should include the following language in any recruiting documents, flyers, and advertisements that are associated with this protocol:

• “This is not VA research, will not be conducted by the VA, has not been reviewed by VA’s Institutional Review Board, and is not endorsed by the VA. The VA is not responsible for any costs incurred by a Veteran if the Veteran enters the study as a research subject. The announcement is being provided for information only.”

No recruitment materials may be posted in VA facilities without approval from the VA.

Pre-screening of records or clinic appointments to identify eligible participants is a VA research activity and is therefore not permitted when recruiting veterans to non-VA studies. Sharing of contact information for a potentially eligible VA patient by a VA clinician or other VA employee with a UW study team may only be done with written authorization of the VA patient using VA Form 10-5345. The above template language for recruitment materials should be inserted into the open text box on Form 10-5345 titled “Type and Extent of Material Released.”

In all other cases, UW Consent and HIPAA templates should be used (rather than VA) and should include the following language:

• “This is not a VA study. Any information you provide the study team will not be kept by the VA. All information pertaining to this study will be obtained and kept by the xxx study team. As a Veteran, your VA clinical care will not be impacted in any way by participating in this study. Your care will continue as usual whether you join the study or not.”
• “We may share information collected about you for this study with the VA.”
• The rest of this form should be standard UW language.

Recruitment of veterans from the William S. Memorial VA Hospital must follow VA recruitment guidelines, including the use of email for research purposes.