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NAVREF News Center

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  • 1 Dec 2020 10:10 AM | Anonymous member (Administrator)
    1. Legislative:  Congress gets back to work this week.  First order of business—funding the federal government beyond the Continuing Resolution which expires on December 11th.  Other possible legislation before the end of the year includes a pandemic supplemental and a veterans package.
    1. Research Information Security Toolkit:  The OIT Research Support Division (RSD) reached out to the Office of Research Protections, Policy, and Education (ORPP&E) to collaboratively publish a toolkit on Information Security Reviews.  Click here to access this and other ORPP&E toolkits: https://www.research.va.gov/programs/ orppe/education/tools.cfm
    2. Donations:  the CARES Act included some lesser known provisions that increase the tax deductibility of donations.  Read more here: https://www.501c3.org/the-cares-act-increases-donation-tax-deductibility/
    3. Newsletter:  we are seeking NPC success stories to include in the NAVREF Newsletter to be published on Dec 22nd.  Please contact us to share any successes you have achieved in 2020, no matter how small!
    4. Calendar Items: 
    Dec 10, 1pm ET           NAVREF Webinar:       Understanding your HR Options, presented by TriNet (https://attendee.gotowebinar.com/register/209415594360924688)


  • 24 Nov 2020 11:32 AM | Anonymous member (Administrator)

    We have 6 items of interest for you this week:

    1. Despite the short week, we will still be hosting our NPC Discussion Groups on Tuesday from 3-4pm ET and on Wednesday from 1:30-2:30pm ET and 3-4pm ET.  You can attend any of the three at https://www.gotomeet.me/NAVREF/navref-video-conference-room
    1. Indirect cost rates and the direct cost distribution base are about to become publicly available (effective FY2022).  OMB issued a memo on Nov 12 (attached) about how this will occur:

    "On August 13, 2020,4 0MB published an update to the Guidance for Grants and Agreements in Title 2 of the Code of Federal Regulations (2 CFR) which requires the publication of the federally negotiated indirect rate, distribution base, and rate type for a non-Federal entity on an OMB-designated Federal website. This memorandum designates USASpending.gov as the official Federal website to display the federally negotiated indirect rate, distribution base, and rate type for a non-Federal entity receiving federal Financial Assistance awards.  Effective FY2022, cognizant agencies must report this information by non-Federal entity to a central location for display on USASpending.gov recipient profiles. Additionally, agencies must begin reporting indirect cost by total dollar amount by award with their Federal Assistance Broker Submission (F ABS) data to the DATA Act broker. Within fifteen days of issuance of this memorandum, 0MB, in accordance with Section 6 of the GREAT Act and in partnership with the Grants Standards setting agency, will convene a working group to provide recommendations on a set of common standard data elements for award agreements, otherwise known as notice of awards (NOA), and information related to grant awards and indirect costs. The Grants Data Standards Element Working Group will further inform what data elements are needed to link this information to recipient data in SAM. 8 Pub. L. No. 116-103 § 6(b). indirect cost rates."

    1. Clinical Repurposing Funding Opportunity. The global nonprofit Cures Within Reach recently launched the Clinical Repurposing for Veterans Initiative.  The program’s goal is to identify new medical treatments for already approved medications and devices to impact high-priority health concerns for veterans and active military. Cures Within Reach is launching its Clinical Repurposing for Veterans Initiative with a Request for Proposals (RFP) specifically for repurposing research in any disease area that will benefit veterans. Investigator-initiated proposals can come from any US-based institution, and at least one project will be selected to receive a $50,000 grant from Cures Within Reach and its funding partner, the Kahlert Foundation for a clinical repurposing trial. Additional details are in the attached press release or at cureswithinreach.org.  
    2. The U.S. Department of Veterans Affairs’ (VA) announced VA Chief Research and Development Officer, Rachel Ramoni, Ph.D., has been selected as the first recipient of the Above and Beyond Award from the Women in Science Forum of the Prostate Cancer Foundation (PCF).
    • Ramoni received the award for advancing biomedical research and clinical trials for veterans with prostate cancer and contributing to the fight against COVID-19.  To support better prostate cancer care for veterans, the department established the VA Precision Oncology Program for Cancer of the Prostate (POPCaP) in partnership with the PCF. The program aims to deliver precision cancer care to all veterans, including those who live in remote rural areas. There are currently 12 hubs in the POPCaP network distributed across the U.S.  Under Ramoni's stewardship, the VA Office of Research and Development has implemented policies that have streamlined research efforts, especially for multi-site clinical trials. In some cases, this has reduced the start-up time for clinical trials from several months to a matter of weeks.  In addition to advancing precision oncology research, Ramoni promotes diversity within the VA research enterprise and has been instrumental in mentoring women researchers in VA. See full press release at https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5572
    1. SCRS Offers Upcoming Webinar:  Key Strategies for Effective Oncology Clinical Trial Budgeting
    • December 3, 2020 @ 12:00 PM ET  -  Join Kathleen Hurtado, R.Ph., Director, Office of Research Administration, Cancer Treatment Centers of America, for a session that will dive into the policies and business rules that must be in place to support optimal budget development. Kathleen will review strategies for effective budget negotiations, determination of cost and necessary reimbursements, and working with transparency and how FMV comes into play.  Register here: https://customer28911c419.portal.membersuite.com/events/ViewEvent.aspx?contextID=fbf07b1c-0078-cc91-d848-634f9347538a
    1. Calendar Items: 


  • 3 Nov 2020 10:44 AM | Anonymous member (Administrator)

    Our NAVREF partnership with the Association of Clinical Research Professionals (ACRP) is in its fourth year and currently offers over 25 online training modules to our members. These courses come at no cost to our members. To get started, NPCs just need to sign up their personnel by sending NAVREF an email with their information.

    One of the courses offered by ACRP is the Informed Consent Simulation. Don't let this be a missed opportunity! The general research community is practically kicking down ACRP's door to take this course....and they have to pay $239 per person to take the class! NAVREF members with access will get to take this course for free!

    Contact the NAVREF office for more information or questions about the ACRP partnership. 

  • 28 Oct 2020 8:42 AM | Anonymous member (Administrator)

    Billing and reimbursement of services provided by VAMCs to externally sponsored research grants

    NAVREF prepared this analysis to advise members regarding (1) the recent memo from VA ORD (attached) that specifies rates for billing VAMC services on research awards at the Medicare rate less 10%, as well as (2) questions from the field regarding such billings. We considered situations that might occur at NPCs, taking into account the ORD memo, the VHA Handbook, the OMB Uniform Guidance and the new FASB pronouncement on contributed services.

    We deal with the following questions:

    ·       Can a NPC reimburse a VAMC for clinical services provided to patients on NPC-administered research grants?

    Yes.

    Per Handbook 1200.17: (b)(2) “Reimbursement. NPCs may reimburse VA for salaries and other costs incurred by VA in the conduct of VA-approved research projects or education activities.”

    ·       Which services can be billed, and which cannot?

    MRIs and similar tests and studies provided to research grants can be billed but not certain other medical services.

    Per “background” in ORD memo:  "VA Research and Education Non-Profit Corporations (“NPCs”) administer clinical research studies sponsored by non-VA entities, including industry. There are currently more than seventy (70) NPCs across the nation, many of which participate in the same clinical trials. These studies often include the use of VA clinical services, such as laboratory tests (e.g. blood counts and urinalyses), radiologic studies (e.g. chest X-rays and CT scans), and other diagnostic tests (e.g. EKGs, echocardiograms, pulmonary function tests). Each VA is to be reimbursed for only those tests that are performed outside of the “customary care” as described in VHA Handbook 1200.17, as authorized by Title 38.”

    Per 38 CFR 17.102: "Except as provided in § 17.101[ [which details types of charges for medical care, not research], charges at the indicated rates shall be made for Department of Veterans Affairs hospital care or medical services . . . as follows...:

    (g)  Furnished for research purposes.  Charges will not be made for medical services, including transportation, furnished as part of an approved Department of Veterans Affairs research project, except that if the services are furnished to a person who is not eligible for the services as a veteran, the medical care appropriation shall be reimbursed from the research appropriation at the same rates used for billings under paragraph (b) of this section."

    Per 38 U.S. Code § 1701 - Definitions: "(6)The term “medical services” includes, in addition to medical examination, treatment, and rehabilitative services, the following:

    (A)  Surgical services.

    (B)  Dental services and appliances as described in sections 1710 and 1712 of this title.

    (C)  ) Optometric and podiatric services.

    (D)  ) Preventive health services.

    1


    (E)  Noninstitutional extended care services, including alternatives to institutional extended care that the Secretary may furnish directly, by contract, or through provision of case management by another provider or payer.

    (F)  ) In the case of a person otherwise receiving care or services under this chapter—

    (i)  wheelchairs, artificial limbs, trusses, and similar appliances;

    (ii)  special clothing made necessary by the wearing of prosthetic appliances; and

    (iii)  other supplies or services as the Secretary determines to be reasonable and necessary.

    (G)  Travel and incidental expenses pursuant to section 111 of this title.

    (H)  Chiropractic services."

    Diagnostic procedures such as MRIs are not covered by that definition and so may be billed to research grants.

    ·       Is the VAMC required to bill for such services?

    No. We are not aware of a law or regulation that would require that investigator effort, or tests and studies like MRIs, must be billed. The memo says only that "Each VA is to be reimbursed for only those tests that are performed outside of the “customary care” as described in VHA Handbook 1200.17, as authorized by Title 38.” This doesn’t say it must be reimbursed.

    The question may be moot in the future. The VA is implementing Cerner electronic health record, and the system may dictate that VAMC’s account for all services by billing or other actions. The Nonprofit Program Office recommends that when your site goes live, you spend time with those individuals entering the data into the Cerner PowerTrials system to avoid being overbilled or underbilled.

    ·       What rates should the VAMC use in such billings?

    Medicare less 10%, once the rates are incorporated into Cerner EHR.

    Per the cover letter on the ORD memo:  "At the December 12, 2019, Nonprofit Program Oversight Board meeting, the board voted to use the Medicare Rate minus 10% for research-related tests performed outside of “customary care” after reviewing the National Pricing Recommendation from the Charge Delineation Work Group. It may take some effort and training of those involved in clinical trials to assure that the billing takes place at the appropriate rate for each test or study.

    ·       If there is a billing, which appropriation should get the credit—research or medical care?

    The appropriation for medical care.

    Per Handbook 1200.17: “A VA medical facility may retain and use funds provided to it by an NPC. Such funds must be credited to the applicable VA appropriation account and available for account purposes without fiscal year limitations as provided for in 38

    U.S.C. 7364(b)(3)."

    Per the cover letter to the recent ORD memo:  2. Accordingly, VA Medical Center’s (VAMC) shall be reimbursed by the Office of Research and Development for only those


    research-related tests, as part of sponsored clinical trials, that are performed outside of the “customary care” as described in VHA Handbook 1200.17, VA Nonprofit Research and Education Corporations Authorized by Title 38 U.S.C. These funds may also be accepted by VAMC’s without fiscal year limitations.”

    ·       Can the NIH and other federal sponsors pay for research services provided by the VAMC?

    Yes. There is no restriction in the NIH Grants Policy Statement on charges for services from federal entities.  NIH and other federal sponsors have not raised objections to NPCs including reimbursement for services provided by VAMCs (purely for research purposes) in their project budgets. Charges for salaries (e.g., an hourly rate for a specialist) are limited by GPS 17.3 and 17.6, however.

    ·       If the research project is administered by a NPC or by an academic affiliate, is the NPC or the affiliate required to reimburse the VAMC service by service in order to bill the sponsor?

    No, a service-by-service reimbursement is not required. However, the NPC should be able to demonstrate (i) that a service took place, (ii) that, if billed by the VAMC, the charge was priced at no more than Medicare less 10% rate, and (iii) that money was flowing in and out of an agency account held for the VAMC and not simply accumulating on the NPC’s balance sheet.

    In accordance with applicable rules, regulations and sponsor policy, NPCs should make all reasonable efforts to work with VAMCs to facilitate billing the NPCs for research- related costs on sponsored projects and to establish systems to ensure that the NPCs liability to the VAMCs is captured in a productive and compliant manner. In the event that the VAMCs do not bill the NPCs for research costs incurred on sponsored awards, a recommended practice is for the NPC to create a liability account to be used at the discretion of the VAMC and in accordance with applicable rules, regulations and policies.

    ·       What if the VAMC donates the service to the NPC-administered award? Are such donations appropriate?

    Yes.

    For effort, per VHA Handbook 1200.17:

    "11 PROVIDING AND FUNDING ADMINISTRATIVE AND RESEARCH SERVICES

    b. Reimbursement and Compensation Related to Approved Research Projects or Education Activities.

    (1)  VA Employees. VA employees may be assigned as part of their VA duties to work on VA-approved research projects or education activities for which an NPC is the flexible funding mechanism.


    (2)  Reimbursement. NPCs may reimburse VA for salaries and other costs incurred by VA in the conduct of VA-approved research projects or education activities. A VA medical facility may retain and use funds provided to it by a[n] NPC."

    For services, per VHA Handbook 1200.17

    11. a. “Use of VA Resources or Time to Support Management or Other Operations of an NPC. (5) VA Resources that Incidentally Further NPC Purposes. The NPC may receive any incidental benefits that result from VA employees using VA resources to carry out their official duties to promote VA research and education missions. The VA medical facility also may provide the NPC with space for its activities.”

    So, as noted above, VAMC employees may work on VA-approved NPC projects, and there appears to be no requirement for billing or reimbursement.  The VA may also donate “incidental” services.

    ·       Must the NPC report the contribution of such services on its statement of activities?

    Yes.

    Per FASB (ASU) 2020-07 § 958-605-50-1B "An entity (NFPs and business entities) that receives contributed services shall describe the programs or activities for which those services were used, including the nature and extent of contributed services received for the period and the amount recognized as revenues for the period. Entities are encouraged to disclose the fair value of contributed services received but not recognized as revenues if that is practicable. The nature and extent of contributed services received can be described by nonmonetary information, such as the number and trends of donated hours received or service outputs provided by volunteer efforts, or other monetary information, such as the dollar amount of contributions raised by volunteers. Disclosure of contributed services is required regardless of whether the services received are recognized as revenue in the financial statements.”

    ·       Would that contribution then be recognized as an expense?

    Yes, if it is recognized as a cost by the NPC.

    ·       Could effort or services contributed by the VAMC be charged to a federal sponsor?

    No.

    Per the OMB Uniform Guidance:

    § 200.434 Contributions and donations.

    (a)  Costs of contributions and donations, including cash, property, and services, from the non-Federal entity to other entities, are unallowable.

    (b)  The value of services and property donated to the non- Federal entity may not be charged to the Federal award either as a direct or indirect (F&A) cost.


    ·       Could effort or services contributed by the VAMC be charged to a non-federal sponsor under a CRADA, for example?

    Yes, there is no such requirement in the Uniform Guidance that applies to CRADAs, but as noted above, an NPC might not want to include such charges in the award budget when they had no intention of paying for them.

    ·       How would services contributed by the VAMC be treated in the NPC’s indirect cost proposal?

    If indirect, they would be excluded from the pool, since under Uniform Guidance §

    200.434 (a) and (b) they are unallowable; if direct, under § 200.434 (e), they would be in the base if “material” in value and “significant” to the calculation.

    Per OMB Uniform Guidance § 200.434

    (e)  The following provisions apply to nonprofit organizations. The value of services donated to the nonprofit organization utilized in the performance of a direct cost activity must be considered in the determination of the non-Federal entity’s indirect cost rate(s) and, accordingly, must be allocated a

    proportionate share of applicable indirect costs when the following circumstances exist:

    (1)  The aggregate value of the services is material;

    (2)  The services are supported by a significant amount of the indirect costs incurred by the non-Federal entity.


  • 6 Oct 2020 1:04 PM | Anonymous member (Administrator)
    1. NAVREF is proud to announce we are partnering with LIG Solutions, LLC, a subsidiary of Lighthouse Insurance Group, to establish a Partnership Health Member Benefit Program.  A formal announcement and detailed information will be forthcoming, but please block your calendars on October 15, 2-3pm ET for an introductory webinar presentation.
    1. See attached ORD COVID-19 Update from ORD. Please note the webinars highlighted in the “Upcoming Events” portion of this update.
    1. NIH Update - On Sep 30, 2020 Dr. Larry Tabak, Principal Deputy Director of the NIH, participated in a virtual Alliance Member Update with Research America! Key takeaways from the discussion: 
    • Many NIH Institutes and Centers (ICs) are extending application deadlines; most are considering grant extensions and cost supplements triggered by the pandemic on a case-by-case basis; they face tough choices (made all the more so now by the lack of emergency supplemental research funding).
    • In October, NIH will field a survey designed to solicit feedback from extramural scientists and research organizations on the challenges they are facing.
    • Peer review is taking place remotely; this practice may continue beyond the pandemic.
    • NIH will likely initially reduce grant amounts for FY21, as has been common during other Continuing Resolutions.
    1. Legislative Update
    • A.      On Oct. 1, 2020, the president signed H.R. 8337, a continuing resolution to fund the government until Dec. 11, 2020.
    • B.      On Sep 30, 2020, The House Veterans Affairs Committee (HVAC) held a hearing to review the Department of Veterans Affairs’ (VA) intention to go live on October 24 with its new EHR system, from Cerner. VA witnesses emphasized they are fully ready for that date, with employees trained and Cerner support staff in place. VA EHR modernization lead John Windom also told the committee the Department has enough money for its plans throughout the coming fiscal year. The pandemic has delayed the program’s implementation, but the VA expects to still finish within the ten-year timeline.
    1. Upcoming calendar events:                    
    • Oct 6-22                      SCRS Global Site Solutions Summit (virtual)

    • Oct 15, 2-3pm ET        NAVREF Webinar: “Group and Individual Health Coverage Overview,” presented by LIG Solutions

    • Oct 22                          NAVREF Webinar “Fundraising Registration 101: Why, Who, Where and How to Comply with State Laws

    • Oct 28-29                    VHA Innovation Experience (virtual)


  • 29 Sep 2020 1:47 PM | Anonymous member (Administrator)
    1. The NAVREF Annual Conference sessions are still available for all registered attendees.  Please check out those sessions you missed the first time!  Additionally, the survey instruments are still open, please help us gather feedback:
    1. The overall survey on Survey Monkey consists of 10 questions and less than 5 minutes of your time.  Go to: https://www.surveymonkey.com/r/NAVREF2020
    2. The session surveys are on your NAVREF App. Go to the Schedule tab, click on the session you attended, click on “Leave Feedback”, rate the session and the presenter on a 1-to-5 scale and add any additional comments—that’s all!

     

    1. Note that ORD has approved the Sterling IRB as the third commercial IRB that may be used by VA facilities participating in cooperative research activities.
    1. New Requirements for Gifts-in-Kind.  Last week, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2020-07, Not-for-Profit Entities (Topic 958): Presentation and Disclosures by Not-for-Profit Entities for Contributed Financial Assets.  The new standard aims to increase transparency and improve disclosures related to in-kind gifts of nonfinancial assets.  The standard will require that in-kind gifts be presented separately in the revenue section on the Statement of Activities, and will require additional disclosures including:

    •   Disaggregation by type of nonfinancial contribution received;

    • A description of any donor restrictions on the use of the gift;
    • Whether the gift was used or was monetized (converted to cash);
    • If used, a description of the programs or other activities in which the gift was used; and
    • A description of the method used to determine the fair value of the gift, including the principal or most advantageous market used to arrive at the fair value measure.

    The ASU is effective for annual periods beginning after July 15, 2021. The standard is required to be applied on a retrospective basis and early adoption is permitted.

    1. Legislative Update – Last Wednesday, the House unanimously passed S. 785, the Commander John Scott Hannon Veterans Mental Health Care Improvement Act, sending it to the President’s desk to be signed into law. The Senate-crafted bill addresses a wide range of mental health and suicide prevention measures, including opening the care aperture for more veterans.  It also include two provisions supported by NAVREF to solidify the ACT for Veterans initiative:
    • Sec. 704 – to allow sponsored clinical research of VA to use accredited commercial IRBs
    • Sec. 705 – to establish within the VA Office of Information and Technology an Office of Research Reviews to perform centralized security reviews and complete security processes for approved research sponsored outside the VA, with a focus on multi-site clinical trials.

     

    Upcoming calendar events:                         

    • Oct 5, 12-4pm ET                      NAVREF Quarterly Board of Directors Meeting (virtual)
    • Oct 6-22                                     SCRS Global Site Solutions Summit (virtual)
    • Oct 22                                         NAVREF Webinar “Fundraising Registration 101: Why, Who, Where and How to Comply with State Laws
    • Oct 28-29                                VHA Innovation Experience (virtual)

  • 22 Sep 2020 9:28 AM | Anonymous member (Administrator)

    From Mr. Rick Starrs, NAVREF CEO:

    It was great to see many of you virtually last week at the Annual Conference.  I hope everyone enjoyed a refreshing weekend.  We have 6 items of interest for you this week:

    1. Thanks to all of you who attended the NAVREF Annual Conference last week—we had a total of 416 attendees, nearly doubling our previous record!  See attached press release.  The conference materials—recorded sessions and slides—will be available to all registrants for another 30 days, so don’t hesitate to check out the sessions you missed or download desired documents.  Please take the time to help us plan future events by completing our conference surveys:
    1. The overall survey on Survey Monkey consists of 10 questions and less than 5 minutes of your time.  Go to: https://www.surveymonkey.com/r/NAVREF2020
    1. The session surveys are on your NAVREF App. Go to the Schedule tab, click on the session you attended, click on “Leave Feedback”, rate the session and the presenter on a 1-to-5 scale and add any additional comments—that’s all!

     

    1. The Office of Management and Budget recently issued its Final Guidance on amendments to its Uniform Guidance.  Courtesy of NAVREF Board Member Bob Forrester, attached is a summary of those changes (which will be effective November 12, 2020.  Thank you Bob!
    1. See attached ORD COVID-19 Update from ORD.
    1. We do not yet have a determination from OGC on the way ahead for using contracted personnel from staffing agencies.  You may continue to use staffing agencies such as Medix Staffing Solutions for hiring permanent NPC employees.
    1. Legislative Update - Both the House and Senate are in session this week.  The passing of Supreme Court Justice Ruth Bader Ginsburg complicates an already full agenda including the need for a continuing resolution to avoid a government shutdown, the next COVID-19 relief package, and the possibility of a disaster relief package for communities across the country impacted by wildfires and hurricanes.  

     

    1. Upcoming calendar events:                    
    • Sep 25-28                                   SWOG Cancer Research Network Conference (virtual)
    • Sep 28, 10:30-12pm ET            Non-Profit Oversight Board Quarterly Meeting (virtual)
    • Oct 5, 12-4pm ET                    NAVREF Quarterly Board of Directors Meeting (virtual)
    • Oct 6-22                                      SCRS Global Site Solutions Summit (virtual)
    • Oct 22                                                   NAVREF Webinar “Fundraising Registration 101: Why, Who, Where and How to Comply with State Laws”
    • Oct 28-29                                             VHA Innovation Experience (virtual)


     


  • 21 Sep 2020 1:11 PM | Anonymous member (Administrator)

    (Washington, D.C., September 16, 2020) - The National Association of Veterans’ Research and Education Foundations (NAVREF) held its sixth annual awards event on September 16th, honoring NAVREF members and staff nominated by their peers for demonstrating excellence in support of research and education for Veterans. The award ceremony was hosted by NAVREF CEO Rick Starrs in conjunction with NAVREF’s 28th Annual Conference.

    The 2020 winners included Ms. Amy Kimball, MBA, of the Boston VA Research Institute (BVARI), who was awarded NAVREF’s prestigious Barbara West Award for Distinguished Service. Other awardees included Ms. Elaine Staats, MPH, Director of Sponsored Research at the Palo Alto Veterans Institute for Research (PAVIR) in Palo Alto, California, and Ms. Margaret Tiktin, DNP, CNP, MBA, Director, Clinical Research Center, at the VA Northeast Ohio Healthcare System in Cleveland.

    Ms. Kimball was recognized for her outstanding service and dedication both to her nonprofit corporation (NPC) and to NAVREF. She has served as Chief Executive Officer at BVARI for the last three years. In that short time, she has revamped strategy, restructured staffing to align with BVARI’s business model, reduced the reliance on Intergovernmental Personnel Act appointments, and effectively leveraged national and local relationships to improve performance. She generously shares her knowledge and expertise with other NPC leaders in a compassionate, confident, and professional manner. She provided several best practice models and strategic approaches to problem solving that other NPCs have used to improve their systems. Ms. Kimball demonstrates the persistence, passion, and strategic understanding necessary to excel in this highly complex environment.

    Ms. Staats took home the NAVREF Board of Directors Award for her comprehensive leadership and management of PAVIR's extensive sponsored research program. She has supervised the growth of PAVIR's research program to more than $30 million annually through effective collaboration with her local Chief of Staff and Research offices and with VA Central Office’s R&D Service, General  Counsel and CRADA offices; she is also PAVIR's principal liaison with Stanford University, responsible for compliance with the affiliation agreement. Ms. Staats manages these complex relationships in a steady, calm, engaging and resourceful manner and has deservedly earned the confidence and respect of her colleagues in each of these institutions and offices. She is widely regarded as an expert in her field and routinely advises other NPC and VA personnel on all things related to sponsored research.

    Ms. Tiktin was awarded the Best Practice and Innovation Award for the tremendous value she added to NAVREF’s Clinical Trial Committee over the last year. She provided expert insight and understanding as the Committee developed guidelines for leading multi-site industry-sponsored studies. She helped identify those skills and attributes a site needs to successfully lead. Ms. Tiktin’s selfless contribution of time, effort, and expertise exemplified the spirit of collaboration between VA and NAVREF to advance the health of veterans.

  • 26 Aug 2020 3:06 PM | Anonymous member (Administrator)

    We caught up with the National Association of Veterans’ Research and Education Foundations (NAVREF) to learn more about how the VA has been collaborating with the biotech industry and government agencies to accelerate COVID-19 research and improve veterans’ access to clinical trials.

    VA Research has been working to improve collaboration with industry,particularly through the ACT for Veterans Initiative, which works to improve access to clinical trials among military veterans.

    VA jumped in the COVID-19 fight, participating in a number of industry-sponsored studies for therapeutics including tocilizumab with Hoffman-La Roche and sarilumab with Regeneron, which are both used in arthritis care. 

    In addition to participating in Operation Warp Speed and ACTIV, the VA also partnered with the Departments of Energy and Health & Human Services to coordinate and share health data, research, and expertise on COVID-19 therapeutics and vaccines

    And VA’s Million Veteran Program (MVP) is collecting information about participants’ experiences, which could provide insight into the influence of race and ethnicity on disease susceptibility, severity, and outcomes since MVP’s population is around 20% African American and 7% Hispanic.

    And it’s not just about COVID-19. VA is funding a phase 2 clinical trial exploring whether degarelix, a treatment used against prostate cancer, may improve clinical outcomes, as one example.

    The bottom line? We need all kinds of collaboration to beat COVID-19. “Our industry is moving forward at an incredibly fast pace, and part of the reason is because of the unprecedented collaboration we’re seeing across the industry and with key government and nongovernmental partners,” as BIO’s Dr. Michelle McMurry-Heath recently said.


  • 22 Jul 2020 9:36 AM | Anonymous member (Administrator)
    1. The 28th NAVREF Annual Conference is open for registration at www.navref.org.  This year’s virtual event will run from 12-4pm ET on September 14-16th with 5 plenary sessions, 12 breakout sessions, several “On Demand” sessions, and a variety of networking opportunities with colleagues and sponsors.  Register now for up to 3 individuals ($200) or up to 8 individuals ($400) from your site.  In addition to CEO/EDs and senior staff, NPCs should include ACOS-Rs and consider other research service staff as attendees within your group.  Please contact Hawk with any questions, htran@navref.org.   
    1. Reminder:  NAVREF annual membership renewal/enrollment ran from June 1-30.  Thank you to all of you who renewed for 2020-2021.  We are ahead of last year’s pace with only 10 NPCs remaining—to those of you who have not yet contacted us, please complete and return the 2020-2021 membership renewal packet with your most recent IRS form 990.  Due to the pandemic, NAVREF is offering flexible payment arrangements for anyone in need.
    1. ORD COVID-19 Update – attached is the most current weekly update from ORD.  Most relevant for NPCs are pages 5-6 under “New Research Opportunities” related to Vaccine and therapeutic trials and the ACTIV site survey. 
    1. Upcoming training sessions:               Thu, Jul 23, 1pm ET; Incorporating Grants and Grant Strategy into your Organization
    1. PPP Forgiveness:  see attached message from Non Profit Quarterly offering a complimentary webinar for nonprofit financial leaders who have received a Paycheck Protection Program (PPP) loan and want to prepare effectively to seek loan forgiveness.  The webinar will be presented live on Thursday, July 23rd 2020 from 3:00 - 4:00PM ET and the recording will be made available 2-3 days after.
    1. As NAVREF members, you each have full membership with the Society for Clinical Research Sites (SCRS).  Please see attached message highlighting how to take advantage of your valuable SCRS benefits.
    1. Working Together in the Public Interest: Over 20 of the largest global pharmaceutical companies, joined by WHO and other multilateral organizations, have created a billion-dollar fund to support antibiotic R&D by smaller companies. The AMR Action Fund aims to reverse the dangerously fragile antibiotic pipeline. For background on AMR, go to www.amractionfund.com.
    1. Check out the attached chart from the Adult Vaccine Access Coalition (AVAC) showing how the current vaccine development process is accelerating vaccine development to prevent COVID-19.


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