ISHLT Novel Approaches for FDA Cleared Preservation Systems in Donation After Circulatory Death (DCD) Heart Transplantation Research Grant

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The purpose of this grant is to fund clinical research into novel techniques to expand the donor pool by making the recovery and transportation of DCD organs more cost-effective (reducing costs and/or improving outcomes). This research will focus on the use of FDA cleared hypothermic (4-8°C) preservation systems.

Published evidence has shown that the use of FDA cleared 4-8°C hypothermic preservation systems in Donation After Brain Death (DBD) heart recovery leads to both reduction in post-operative complications and reduction in overall transplant costs. DCD represents an expanding area of potential donors; however, costs and logistic burdens can be prohibitive for transplant programs. New technique innovations such as normothermic regional perfusion have the potential to address some of these cost burdens. Additionally, research in liver transplantation has demonstrated the benefits of “back-to-base” approaches towards the use of normothermic machine perfusion as a stationary tool post-hypothermic preservation. This grant aims to support proposals to improve equity of access to DCD hearts through the use of FDA cleared or equivalent, advanced hypothermic preservation for transportation in conjunction with innovative approaches at either end of the transplantation process.

Purpose

This grant will fund research that:

  • Has the potential to reduce the cost of DCD heart transplantation.
  • Utilizes FDA cleared hypothermic preservation systems for preservation during transportation of organs.
  • Innovates through either novel techniques or approaches at the DONOR site or RECIPIENT site, to enable access and evaluation of DCD hearts transported by hypothermic preservation.
    • Both in-situ and ex-situ organ management and evaluation approaches will be considered.
  • Research proposals should be either clinical or translational in nature, and consideration will be given for immediate applicability to clinical practice.

Basic science exploratory research and use of non-FDA cleared products, drugs or therapeutics will not be considered.

Grant Details

One grant of up to $75,000 will be awarded for two years.

Eligibility Requirements
Academic Appointment and Institutional Resources:
  1. The applicant must either have an academic appointment or clinical appointment or may be in training at an accredited institution.
  2. An individual who applies for a research grant while still in training must have been offered and accepted a faculty position that will begin on or before initiation of the grant OR submit a letter of institutional commitment from a division or department chair at the institution at which the research will be conducted, if still in training at initiation of the grant.
ISHLT Membership
  1. The applicant must be an active member of ISHLT or have submitted a completed membership application by 30 September, 2024.
Previous ISHLT Funding/Funding from Other Sources
  1. There are no restrictions on past or current funding.
  2. The applicant may be a past or current recipient of an ISHLT Fellowship or Faculty Development research grant.
  3. The applicant may currently hold career development awards, mentoring awards, or other independent research awards.
  4. If the applicant is currently receiving funding for a project similar to the topics described in this request for applications, the applicant must explain how the funds of the grant would not overlap with the funds of the other research support.
Miscellaneous
  1. Applicants who have a substantial relationship with Paragonix that would present a real or perceived conflict of interest if awarded this grant must first contact ISHLT to declare the conflict before submitting an application. Examples of a substantial relationship with an industry partner include: board member, member of advisory council, consultant, lecturer, etc.
  2. Employees of Paragonix cannot submit an application.
  3. Upon disclosure, the Grants and Awards Committee will determine if the individual can still submit an application and will notify the individual in a timely manner. /li>
Funding Stipulations / Grant Policies

Please review these guidelines and terms prior to completing your application. If you are ultimately awarded a grant, you will sign a letter of agreement (LOA) stating that you agree to these funding guidelines and terms, and the LOA will be co-signed by your institution’s grants/research office.

  1. Research is anticipated to begin between January and December of the grant year.
  2. Funding in the amount of $75,000 (inclusive of both direct and indirect costs) will be provided for the research project.
  3. Funding will not be released until visa status is confirmed (if applicable).
  4. The grant is intended to provide salary support for the researcher, other study personnel, statistical support, supplies/materials, animals, publication costs and travel related costs for abstract presentation and up to 10 percent of the grant budget for institutional overhead. No other costs are permitted.
  5. The grant will be paid in multiple installments to the recipient’s institution. First installment (50% of funds) will be paid at the beginning of grant work; the second installment (25%) will be paid mid-award (after receipt of a grant progress report) and the final installment (25%) will be paid after receipt of a final report.
  6. Grant funding is generally not transferable from one recipient to another; transfer may be considered under compelling circumstances (e.g., the grantee leaves the institution and does not request a transfer of the grant, or the grantee requires an extended medical leave).
  7. If the grantee relocates and requests to move the grant to the new institution, the Grants and Awards Committee will determine if the grant can be transferred to the recipient’s new location, or if the grant must be surrendered and any remaining funds returned. If the grant is surrendered, a final report will still be required.
  8. If the grantee relocates and does not request a transfer of the grant to the new institution, the current institution (i.e., department chair or division chair and Office of Sponsored Research) may select a new PI. The Grants and Awards Committee will determine if the grant can be continued at the current institution.
  9. The applicant must acknowledge the grant as a funding source in all manuscripts and presentations derived from the funded research using the following statement: “This work was supported by a grant from Paragonix and the International Society for Heart and Lung Transplantation.” Copies of such publications must be submitted to ISHLT.
  10. Pursuant to regulations of the federal Physician Payment Sunshine Act (included in the Affordable Care Act), NPI numbers will be collected from grant recipients (if applicable), and tax ID numbers collected from the recipients’ institutions (if applicable). All payments will be reported to the Centers for Medicare and Medicaid Services Open Payments system, as payments from ISHLT represent indirect transfers of value from the funding pharmaceutical company.
  11. Reports are required at the following intervals depending on the term of the grant, and continuation of funding is contingent upon completion of these reports:
      Mid-award progress report due one year after research start date.
    1. Final report within 30 days of the conclusion of the grant term.
      1. A final report is required even if the grant is surrendered for any reason prior to conclusion of the grant term.
Review Process and Notification
  1. Selection of the grant recipient will be made by an expert review committee. The Grants and Awards Committee will work with the Interdisciplinary Networks and Professional Communities to identify the experts who will review the applications. In case of a very close or tie scores, the ISHLT Grants and Awards Committee will make the final decision. Consultation from expert reviewer(s) may be requested.
  2. Grants will be scored on the basis of study aims, significance, innovation, research approach, feasibility of obtaining relevant data, and prior work, as well as other factors.
  3. All applicants will be notified as to whether or not they have been selected to receive the research grant by 15 November.
  4. For the individual selected, the term of the grant will be two years beginning between January – December of the grant year.