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THE NAVREF "ICYMIT"

Your On-Going News Feed

The NAVREF "In Case You Missed It (ICYMIT)" is where you can find updates and announcements from NAVREF and stakeholders alike. Refer to this page if you want more in depth information on topics found in your weekly email briefs.

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  • 18 Jan 2023 4:28 PM | Peter Martin (Administrator)
    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.
  • 31 Dec 2022 9:58 AM | Anonymous member (Administrator)

    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! 


  • 19 Dec 2022 10:39 AM | Anonymous member (Administrator)

    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.


  • 29 Nov 2022 10:46 AM | Anonymous member (Administrator)

    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.

  • 29 Nov 2022 10:39 AM | Anonymous member (Administrator)

    Written by: Peter Martin, NAVREF Program Support Specialist

    Minneapolis-St. Paul Area | Explore Minnesota

    With the 2022 NAVREF conference seemingly still in our rearview mirror, we have been steadfast in our preparations for next year’s conference. We are excited to share that our planning committee has been formed and the next host city has been decided. For those who do not know, the 2023 conference will be held in the land of 10,000 lakes, in the great city of Minneapolis.

    Earlier this month, the full-time staff at NAVREF had the privilege to be able to convene in the twin cities and begin scouting venues. Throughout this visit we were able to learn about the rich history and culture of the area as a parallel to our constant traversal of the city’s different neighborhoods. We are confident in saying that this is an ideal conference destination, with ideally located venues and a lot of activities to offer.

    We are happy to introduce a diverse and deep planning committee with a lot of new faces inspired by the last conference and some experienced members returning as well.

    2023 Conference Planning Committee:
    • Peggy Bradley— Executive Director, Biomedical Research and Education Foundation of Southern Arizona
    • Pamela Capone—Executive Director, McGuire Research Institute
    • Julie Gouda, MD-- Executive Director, Midwest Veterans’ Biomedical Research Foundation
    • Lori Gould— Executive Director, Central New York Research Corporation
    • Jeremy Greene, MS— Executive Director, Arizona Veterans Research and Education Foundation
    • Jacob Lindheimer, PhD— Associate Chief of Staff/ Research, Madison VA Medical Center
    • Jennifer Mock— Finance & Operations Manager, Veterans Health and Research Foundation
    • Felix Oliver— Executive Director, Institute for Clinical Research, Inc.
    • Christiane Perry— Contracts & Grants Post Award Manager
    • Mary Reeder— Grants Administration, Tampa VA Research and Education Foundation
    • Angie Smith, MPH— Executive Director, North Florida Foundation for Research & Education
    • Jenni Waters— Operations Manager, Salem Research Institute
  • 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.

    dhaskell@navref.org

  • 21 Nov 2022 8:47 AM | Anonymous member (Administrator)

    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.


  • 11 Nov 2022 8:58 AM | Anonymous member (Administrator)

    Written by Maryam Azarion, STAR 

    OGC STAR has been billing VA NPCs for the same rate for the past ten years. Effective January 1, 2023, OGC will have a new rate and billing schedule. The new rates were captured based on reviewing the cumulative legal work and the need to simplify existing rates. These rates were negotiated and finalized in coordination with the NAVREF Board and STAR. They are valid for 2 years.  To discuss this forthcoming change, and to address any questions about billing, NAVREF will be hosting two Town Hall calls.  These calls are scheduled for November 7th at noon and November 16th at 1pm Eastern. Please contact NAVREF if you need the webinar link.

    Attachment Download - Attorney Fee SOP (October 2022)

  • 25 Oct 2022 10:32 AM | Anonymous member (Administrator)

    Written by Peter Martin, NAVREF Program Support Specialist

    Have you explored the possibilities of Public Service Loan Forgiveness? Although much of the attention has been geared towards general student loan relief plan, we would be remiss if we did not bring attention to the end of the PSLF extension and PSLF accessibility in general. 

    For those that do not know, currently, public servants with any type of federal loan, can retroactively apply their payments to the 120 total payments (10 years’ worth of payments) required for forgiveness. This includes payments from federal loans that are not direct loans, late payments to federal loans, payments that did not meet the minimum amount, and payments towards federal loan from employment prior to public service(Federal Student Aid). Outside of the current expanded benefits, the Student Borrower Protection Center estimates that out of the 9 million borrowers that are eligible to benefit from PSLF, only 15% have filed the paperwork to follow their progress (Student Borrower Protection Agency).  

    PSLF has the potential to be useful for hiring and retention, two subjects that are often challenge areas for many NPCs. By encouraging and helping employees apply, employers will also be creating a culture that prioritizes the interests of employees. Thus, NPCs can add an entirely new avenue of service to their missions, especially as a sector that employs veterans, former hospital workers, and others public servants. 

    Implementation of PSLF assistance at your NPC: 

    • Easy access to certification of years of employment 

    • To apply for PSLF, applicants will need to certify their time in public service. Employers will be required to fill a form on behalf of their employees that are applying. 

    • As and ED, make sure that your office or your Human Resources director has the resources on hand to assist employees 

    • Both sites below are good starting points for those tackling their student loans 

    • Make PSLF a staple of your onboarding process: When starting a new job, loan forgiveness may not always be a something new employees think about when starting in a new position. 

    • Remember that your do not have to be an expert, but you should be familiar with the process. Use he guide below to familiarize yourself with potential form of assistance and share it with your employees. 

    Beyond this expanded period of loan forgiveness, PSLF will still be available, and the unfortunate reality is that much of the vital information is not reaching those in debt. Many loan servicers fail to provide information on programs such as PSLF.  

    If you have not yet taken advantage of the PSLF expansion, we encourage you to find out more through the links below: 

    PSLF Explained- Youtube Video 
    White House- Public Student Loan Forgiveness 
    PSLF Help tool- studentaid.gov 


  • 26 Aug 2022 2:36 PM | Peter Martin (Administrator)

    Fiscal Year 2022 (FY22) pre-announcement for the Department of Defense (DOD) program managed by the Congressionally Directed Medical Research Programs (CDMRP).

    The Toxic Exposures Research Program is a new CDMRP program that will allow the research community to improve scientific understanding and pathobiology of toxic exposures, efficiently assess comorbidities, and speed the development of treatments, cures, and preventions. This message is being sent to individuals subscribed to multiple applicable programs to ensure widest dissemination.

    FY22 Pre-announcement released:

    New! Toxic Exposures Research Program

    https://cdmrp.army.mil/pubs/press/2022/22terppreann

    ·       Investigator Initiated Research Award

    ·       Translational Research Award

    • ·       Translational Research Award – Partnership Option
    • ·       Clinical Trial Award
    • ·       Clinical Trial Award-Partnership Option

    …………………………………………………………………………….

    A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at Caution-https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Funding Opportunities/Program Announcements and General Application Instructions which can be found on the Grants.gov website (https://Grants.gov).  A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using Assistance Listing (formerly CFDA) Number 12.420.

    New for FY22: The applicant organization must be registered as an entity in SAM (https://www.sam.gov/SAM/ ) and receive confirmation of an “Active” status before submitting an application through Grants.gov.  As published in the Federal Register 10 July 2019 (https://www.federalregister.gov/documents/2019/07/10/2019-14665/unique-entity-id-standard-for-awards-management), the Unique Entity Identifier for awards management generated through SAM will replace the Data Universal Numbering System (DUNS) number as of April 2022. CDMRP has transitioned to use of the Unique Entity Identifier (SAM) and will utilize the latest SF 424 which includes the UEI. The DUNS will no longer be accepted.

    For email notification when CDMRP funding opportunities are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).

    For more information on types of funding opportunities offered and application strategies review the CDMRP Webinar Series: https://cdmrp.army.mil/pubs/Webinars/webinar_series .


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