Key Dates

Related Announcements

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Issued by

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The National Heart, Lung, and Blood Institute (NHLBI) seeks input on research opportunities and gaps related to the potential to address the shortage of hearts and lungs for transplantation in order to treat individuals with end-stage heart or lung disease. NHLBI invites comments from researchers, patient advocacy groups, patients, healthcare providers, ethicists and other stakeholders.

Background Information

Despite advances in medical and surgical management of heart and lung failure, as well as the growing potential for long term support with a wide array of medical devices, the waiting lists for available organs for heart and lung transplantation remain substantial, and many people die while awaiting transplants. Although procurement of solid organs for transplantation has historically been done following declaration of the donor’s death by neurological criteria, in an effort to increase the pool of donor organs many centers performing transplantation of abdominal organs have instituted protocols to allow donation following circulatory declaration of death (DCDD). NHLBI is interested in identifying and understanding research gaps that could be addressed in order to understand whether and how DCDD could be employed to address the shortage of heart and lung donors.

Information Requested

This RFI is intended to seek input, perspectives, and comments from the broad community on scientific opportunities, critical needs and outstanding questions related to addressing the shortage of donor hearts and lungs for transplantation using DCDD. Comments may include but are not limited to the following concerns:

Gaps and opportunities in basic research:

• Research in resuscitation science, critical care medicine, and other fields to improve understanding of the timing of death following controlled withdrawal of life support in adults, children, and infants, and technological advances that may permit more precise determination of when death has occurred. Information regarding the duration of time following DCDD in which there remains the potential for restoration of circulation, either spontaneously (autoresuscitation) or with intervention.
• Research in organ preservation and extracorporeal recovery, particularly as it applies to hearts and lungs procured following DCDD.
• Research in potential alternatives to transplantation of heart and lungs from deceased donors, including advances in xenotransplantation, and technology including ventricular assist devices, among other technologies, and their potential to offset the demand for donor organs.

Gaps and opportunities in implementation science research:

• Understanding the current practices of both controlled and uncontrolled DCDD for all solid organs, the scientific basis for them and ongoing clinical research activities.
• Identification of obstacles to the uptake of DCDD, the institutional and practical barriers, and the cost-effectiveness of DCDD.
• Identifying misinformation, mistrust, and active disinformation, especially in communities of color, that lead to low participation in organ donation.

Gaps and opportunities in normative and empirical bioethics research:

• Gaps in understanding of public comprehension and acceptance of practices surrounding declaration of death and organ donation in general, and of DCDD in particular. Understanding how to best explain these practices to the families of potential donors in a manner that allows true informed consent, and understanding what sort of community engagement should occur, both prior to adaptation of new practices in the conduct of DCDD research, and over time as scientific understanding and organ donation policy evolve.
• Gaps in understanding of the attitudes, judgments and beliefs of health care personnel regarding determination of death and organ donation in general, and of DCDD practices in particular; judgments and beliefs of health care personnel regarding the use of different DCDD techniques including (but not limited to) reintubation of and reestablishment of ventilation in a deceased donor, use of cardiopulmonary bypass and various regional reperfusion techniques in a deceased donor, and how these practices are explained to potential donors and families.

How to Submit a Response

All responses to this RFI must be submitted electronically by November 30, 2021 to the following webpage:

https://rfi.grants.nih.gov/?s=615ca0d310290000ae006a62

Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in responses. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.

We look forward to your input and hope that you will share this RFI document with your colleagues.

Inquiries

Please direct all inquiries to:

Catherine Burke, MA
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0562
Email: burkec@nhlbi.nih.gov

Kathleen N. Fenton, MD, MS
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-6523
Email: Kathleen.Fenton@nih.gov

Denis Buxton, Ph.D
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0515
Email: buxtond@nhlbi.nih.gov