Washington, DC - May 10, 2023 - NAVREF would like to welcome our newest staff member, Elizabeth Stout. Elizabeth will be joining the team as the Project Administrator while she continues to pursue her graduate degree in Mass Communication and specializing in Public Interest Communications. She earned double majors in Political Science and Anthropology, a minor in Innovation, and a certificate in International Relations at the University of Florida during her undergraduate career. Before she moved to Washington D.C., Elizabeth grew up in South Florida and attended Marjory Stoneman Douglas High School. There, on February 14, 2018, Elizabeth survived a deadly mass school shooting in which 17 people were killed and 17 were injured. With adequate care and resources, Elizabeth overcame her PTSD after battling it for over four years and ultimately found her passion for advocacy.

Have you heard of Valde-Falsum? Neither have we. Happy April Fool's Day!!!

But in real news, the 31st NAVREF Annual Conference webpage and registration is live!!! This year our theme will center around Vikings as we will be "Exploring New Horizons"!

Click here to take a look at this year's preliminary program.

VA’s Office of Research and Development (ORD) is currently centralizing the HR processes for Research, with a new system called the Human Resource Management and Consulting Services (HRMACS – “HR MAX”).

As you may already be aware, ORD plans to implement WOC, IPA and Affiliate centralization towards the March/April timeframe. During this transition, many concerns from our members were brought to our attention.  NAVREF has taken these considerations and formed a workgroup to actively collaborate with ORD to alleviate these issues.

NAVREF’s workgroup, comprised of Ron Hakes, Cary Zink, and Katrina Washburn, began by meeting with Tony Laracuente, Director of Field Operations in ORD, to discuss policy concerns regarding WOC/IPA/Affiliate HR centralization.  Mr. Laracuente, a former NPC Executive Director himself, expressed his understanding of the needs of NPC operations and was open to addressing the issues raised by the NAVREF membership.

While in this meeting, some clarity regarding badging and the new HRMACS came to fruition. HRMACS clearly distinguishes three (3) categories of appointments: affiliate, contractor, and employee. Employee is defined as those who have VA-paid, WOC or an IPA appointment.  The intent of HRMACS is to increase the efficiency in obtaining these appointments and to allow for a smoother, less burdensome transition between them. IPA appointments still require that a person work for the non-federal facility for 90 days prior to issuing the agreement - the 90-day rule is still in effect!

NPC’s, ED’s, and their administrative staff - who do not conduct VA work - will be issued Affiliate appointments. These appointments are issued badges that allow them access to the VA facility and computer systems. An OGC opinion on this is available from NAVREF for those needing additional information.

At this time, no changes to your current HR processes are require unless initiated by your site’s HR Service.

Ultimately, NAVREF will actively continue to communicate with ORD as the transition to a Centralized HR continues to unfold.

We encourage members to please contact us with any questions you have regarding the HR webinar and the transition to centralizing HR appointments.  

Earlier this week Director of Field Operations, Tony Laracuente, presented on both Without Compensation Employments and Intergovernmental Personnel Agreements. The presentation has been shared and can be accessed here.

As we head into the new year, we have an exciting piece of news for you to end the year on. The VIPER Act has passed Congress and was signed into law on December 23!

The VIPER Act addressed the issue of “209” which by a Department of Justice interpretation, impacted research studies conducted by VA employees who had compensated appointments and who also conducted VA Research outside their VA tour of duty at the VA Facility on Without Compensation (WOC) appointments. While there was no compensation from the VA, these VA employees received compensation from the University or the VA Nonprofit Corporation (VA NPC) for this work. This practice was considered a violation of 18 U.S.C. § 209 by the DOJ. Thus, VA compensated employees who conducted VA Research outside their VA tour of duty could not be compensated by a non-Federal entity to work on VA research unless the State Treasury exception applies, even if they held a separate WOC appointment. 

With the passage of the VIPER Act, the restriction on dually appointed personnel (DAPs) receiving compensation from NPCs and universities has been removed in law. This will once again allow DAPs (appointments at VA and the university) to be paid for approved research at VA. At this point, the VA Office of Research and Development is preparing specific guidance on how the VIPER Act will impact VA Research as a whole since additional provisions were included in the original legislation, however NPCs can begin planning on paying their DAPs and removing any barriers on their end for a smooth reimplementation of the original practice of paying DAPs.

Happy New Year and we look forward to providing more guidance on the other provisions of VIPER as they now come out from the agency-level! 

Written by: Priscilla West, MPH

The NAVREF Industry Partner Consortium (IPC) held three meetings during the past year.  An Executive Committee for the IPC was developed to help focus and prioritize the broad interests of the group.  The charter members of the Executive Committee include: Peggy Bradley (Executive Director, Biomedical Research and Education Foundation of Southern Arizona), Angie Smith (Executive Director, North Florida Foundation for Research and Education), Caroline Zink (Executive Director, Baltimore Research and Education Foundation), Sean Cunningham (Janssen), Theresa Devens (Eisai), and Allyson Gage (Cohen Veterans Bioscience).

At the most recent IPC meeting in Miami on December 6-7, conversations continued about decentralized clinical trials (DCTs), and how they might best work for VA sites.  Decentralized clinical trials are characterized by less dependence on traditional clinical research infrastructure, and more on virtual communication tools like telemedicine, patient-driven communication devices, home health visits (or visits at ancillary facilities closer to the patient’s home), and direct mailing of study medications and other study materials to the patient’s home.  The Covid pandemic led to strong interest in developing DCT methods, and the IPC is discussing how some of these methods might improve veteran access to clinical trials and their satisfaction with the research experience. 

The IPC Miami meeting also included a discussion about consistent access to VA data to provide support to NAVREF members, VA researchers and clinical trial sponsors in the following areas:

• ·        Identification of prospective study sites for new or expanding studies
• ·        Prescreening potential study subjects for existing studies

We will move forward with contracting with the VINCI program to provide these services for NAVREF members.  During the first year, it will be important to establish the level and scope of demand so that we can best tailor services for future years. 

Our IPC industry colleagues identified the need for a VA clinical trial ‘Playbook,’ describing the VA processes for reviewing and approving clinical research in lay terms (including a dictionary of VA research-related acronyms).  A big thank you to Katrina Washburn (Executive Director of the South Florida Veterans Affairs Foundation for Research and Education), who volunteered to take the lead on drafting this document.

The Miami IPC meeting wrapped up with a discussion about how we can best support diversity and equity in VA clinical trials, including gender, race, and geographic distribution/rurality of study subjects.  Industry partners noted that the US Food and Drug Administration also has strong interests in promoting equal access to clinical studies.  There was unanimous support for this effort, and we will be reaching out to other government and nonprofit agencies to assist us in developing effective strategies to strengthen equity in clinical trials access and participation.

Written by: Peter Martin, Program Support Specialist

In tandem with scouting for the 2023 NAVREF Conference venue, this trip also  served to be the introductory site visit for the new NAVREF staff members in their first years of service: Marlon Ferguson, CEO; Peter Martin, program support specialist. Warmly greeted by Nadine Rogers, Executive Director of the Center for Veterans Research and Education, and her staff, we were able to discuss how we could be of assistance to their work, before getting a tour of their facilities and some insight into their projects. To integrate a bit of wow factor, we were shown motion capture demonstration by Dr. John Looft. We would like to thank CVRE for their hospitality and their excellent showcase of the innovation and commitment to our mission.

Written by: Peter Martin, NAVREF Program Support Specialist

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.

dhaskell@navref.org

The VIPER Act has garnered some progress last week as it moved through the house by roll call vote at the request by Virginia Congressman, Rep. Bob Good. The bill passed the house with a final vote of 381-39. It now heads to the Senate where NAVREF will be working closely with the Senate VA Committee leadership to bringing the bill to the final steps of becoming law.

The VIPER Act was first introduced in October 2021 and aims to improve the VA Medical and Prosthetic Research program by providing additional authority and resources for VA research.

The legislation would add stability and efficiency for the VA research program by formally authorizing VA’s Office of Research and Development and excluding VA research from the Paperwork Reduction Act requirements, better aligning VA with other federal research agencies. The VIPER Act will also work to enhance the diversity of the VA research workforce, increasing scientific opportunities and leading to improved health care for veterans.

The bill also includes provisions to:

• End the Section 209 interpretation by the DOJ.
• Expand the VA’s hiring authority for certain classes of research occupations, including data scientists and statisticians.
• Create a career development award grant program for researchers at smaller universities.
• Mandate a Government Accountability Office study on the retention of VA clinician-scientists and the productivity of their research.