Promoting Partnerships To Improve Veterans’ Health

From the General Counsel’s Office - Derwood J. Haskell, General Counsel

29 Nov 2022 10:15 AM | Anonymous member (Administrator)

From the General Counsel’s Office - Derwood J. Haskell, General Counsel

Hello to member nonprofit Title 38 corporations (NPCs) leadership and staff. In this column, I want to update you on some of the work I have been doing and alert you to trends I am seeing that might serve as guidance in your practice.

A common referral I receive from NPCs is a request for advice on subawards to the NPC involving commitments of VA data and/or VA intellectual property (IP). Under VHA Directive 1206, Use of a Cooperative Research and Development Agreement, NPCs are “highly encouraged” but not mandated to use a VA CRADA template for subawards originating from a federal agency. Most NPCs do not add VA as a party to federal subawards on the standard Federal Demonstration Partnership form, nor do the NPCs typically consult VA OGC Specialty Team Advising Research (STAR), unless there is novel language that raises a concern. One example is language that commits data or IP arising from performance of the statement of work to the pass through entity (PTE) for its use. Since it is VA and not the NPC that is conducting the research, the data and intellectual property derived from the research is VA property, not NPC property. If you have a federal subaward that has language such as, “the PTE may use data and intellectual property for its own internal research and non-commercial purposes,” or any similar clause, please consult me or your STAR attorney. The NPCs are not agencies or instrumentalities of the United States and do not have legal authority to make commitments of VA data or VA IP. 38 U.S.C. §7361(d)(2). I will try and negotiate that language out of the subaward. If the PTE will not agree to remove the language, STAR will have to be consulted and VA added as a party and signatory to the subaward.

Some of the interesting referrals I am working on at the moment include: Master Service Agreements between NPCs and vendors, one for research subject compensation and the other for blood sample analysis; two SWOG clinical trial agreement templates; a potential substantial donation of company stock to an NPC; a problem with NPC matching retirement fund contributions; research subject injury during an MRI procedure and a claim against the NPC; nonpayment of funds due by a CRADA collaborator; and help facilitating a significant multisite clinical trial. On the advocacy front, we are still waiting for distribution of the revised VHA Directive 1200.17 to the NPCs for comment. We are asking that the mandatory requirement for financial officers be deleted and for NPC authority to manage quality improvement and innovation CRADAs. Also, there still has been no legislative action to cure the dually appointed personnel compensation problem created by the U.S. Department of Justice’s opinion on 18 U.S.C. §209. VHA is aware of the §209 problem and consulting congressional staff to seek a solution.

Please do not hesitate to reach-out to me for assistance. It is my privilege to work with you.

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