American Heart Association and Enduring Hearts
Translational Research Awards in Pediatric Heart Transplantation

Program Description and Eligibility

The American Heart Association (AHA) and Enduring Hearts (EH) share common priorities and interests in investing in biomedical research. Together, AHA and EH have established this jointly funded Request for Proposals (RFP) for the AHA/EH Translational Research Awards in Pediatric Heart Transplantation (PHT).

EH was founded in 2013 with a mission to fund research to increase longevity and improve the quality of life for children with transplanted hearts. In collaboration with its partners, founder and donors, EH has invested over $10 million for ˜ 60 investigator-initiated novel projects making it the largest nonprofit funded solely dedicated to pediatric heart transplant research.

The AHA was founded in 1924 and its mission is to be a relentless force for a world of longer, healthier lives. The AHA has invested more than $5 billion in research, making it the largest nonprofit funder of cardiovascular and cerebrovascular research outside the federal government.

Purpose
This award is intended to fund investigators who are committed to conducting research directly related to improving the life expectancy and quality of life of pediatric heart transplant recipients. These Translational Science Awards (TSAs) will further the potential for clinical translation of highly impactful basic, clinical, population, and/or technological sciences to the listed research priorities (below) relevant to Pediatric Heart Transplantation (PHT).

Objectives
To advance the translation of innovative research projects toward clinical applications for PHT recipients.

• Proposals must be based on available evidence and how the proposed project will advance that evidence toward the listed research priorities (below). The combination and integration of the evidentiary foundations of the proposed translational research project could include evidence from the following:  basic sciences, clinical, population-based and/or behavioral sciences.
• Projects must include a Primary Principal Investigator (PI) from a field directly related to PHT, with published evidence from prior research projects.
• This award fosters collaborations between established and early- or mid-career investigators. Applications by existing collaborators are permitted, provided that the proposed project has not been previously funded.
• Proposals must address how the proposed project meets diversity, equity and inclusion goals for investigators and clinical participants.

Research Priorities
To improve the longevity and the quality of PHT recipients’ lives by:

1. Integrating longitudinal non-invasive surveillance protocols, methods, technologies and/or biomarkers with clinical care strategies for accurate pre-onset indicators and early detection of Cardiac Allograft Vasculopathy (CAV), acute cellular rejection (ACR) and/or antibody-mediated rejection (AMR) in PHT.
2. Developing and validating clinical application(s) of novel immunotherapies, novel targets for immunosuppression, and/or improving methods for determining the optimal levels of immunosuppression to prevent CAV, AMR, and/or ACR while reducing/eliminating secondary conditions due to immunosuppression (e.g., kidney injury, opportunistic infections, etc.) after PHT.
3. Developing experimental models, preferably human cell-based, to identify the underlying mechanism(s) of, and/or novel therapies for, and/or the prevention of, CAV in PHT recipients.
4. Developing and validating technologies for improving medication compliance and/or home self-detection of early CAV, antibody-mediated and/or rejection in adolescent heart transplant recipients.

Preference will be given to proposals that:

• Include or will clearly lead to clinical trials and/or applications for PHT recipients;
• Develop new or significantly enhance strategies, innovations, and/or technologies for PHT recipients;
• Perform power analyses and propose to achieve enrollment goals, statistical power, and/or to meet FDA requirements using multiple pediatric centers;
• Involve clinical trials that include primary pediatric patient data from the Pediatric Heart Transplant Society (PHTS).

Disciplines
The AHA maintains dedicated peer review committees by award type and subject, and EH maintains diverse reviewers with a broad range of clinical and scientific expertise. Awards are open to all academic and health professionals. EH and AHA encourage inclusive and diverse applicants and proposals that include women and candidates from racial and ethnic groups underrepresented in science and medicine. A statement to that must be included in the LOI and invited proposals.

Before beginning a proposal, review the information on academic disciplines, eligibility and requirements that apply to all AHA research awards at  AHA Application Resources.

Target Audience

• The primary PI must work in research directly related to PHT.
• The primary PI must be an AHA Professional Member:  https://professional.heart.org/en/partners  (Note: This requirement does not apply to collaborating investigators, consultants, fellows or others who are not the primary PI.)
• The primary PI must hold a faculty/staff appointment at their sponsoring institution.
• The primary PI must be an independent researcher (i.e., must meet their institution’s eligibility to apply for independent awards). This award is not intended for individuals in research training or fellowship positions.
• The primary PI’s institution must be designated as the U.S. institution of record, agreeing to sponsor the application and accept award payments, and ensure that annual progress reports and expenditure reports are submitted to AHA and will be shared with EH.
• At least one collaborating investigator must be an early-career (assistant professor or equivalent) or mid-career (associate professor equivalent) investigator.
• Each investigator must hold an MD, PhD, DO, or equivalent post-baccalaureate terminal degree.
• Collaborating investigators may be from the PI’s sponsoring institution or from a different institution.
• Collaborating investigators may be from different disciplines and/or areas of expertise.

• Salary and fringe benefits of the PI, collaborating investigators, consultants and other personnel with faculty appointments, commensurate with percent effort.
• Project-related expenses such as salaries for technical personnel essential to conducting the project.  Supplies, equipment, computers, travel (including international travel, if needed), human subjects’ recruitment and reimbursement costs, publication costs, including open access fees, etc.
• Costs for Pediatric Heart Transplant Study, if applicable, to collect and report a study’s primary PHT patient data.

Award duration:  Four years, with an option to request up to 12 months no-cost extension (for data analyses and publications) if there is a documented and approved need. Any no-cost extension request must be reviewed and approved in advance.

Required Pre-proposal (Letter of Intent)

• Pre-proposals are due by 3 p.m. Central Time on Thursday, September 28, 2023. Note: The Proposal Central system will shut down at 3 p.m. Central Time. Early submission is encouraged. The applicant has the final responsibility for submitting the completed pre-proposal.
• Pre-proposals must be submitted through Proposal Central:  https://professional.heart.org/en/research-programs/aha-proposalcentral
• For specific application instructions, see the AHA Application Instructions (PDF)
• A pre-proposal is required to ensure responsiveness to this program and to ensure applicants meet the above-specified requirements of the award.
• After reviewing the pre-proposal, AHA will contact the applicants to let them know if they will be invited to submit a full proposal. Only invited applicants will be permitted to submit a full proposal.

• A letter (three pages maximum) describing an innovative research proposal that addresses this RFP and the research priorities listed, plus the preliminary evidence and its clinical translation to PHT recipients.
  • Refer to page setup/formatting requirements on page 10 of the AHA Application Instructions (PDF) for specific information. Failure to comply may result in withdrawal of the pre-proposal.
• A biosketch from the primary PI. 
  • Refer to the section titled “Biographical Sketch” on page 31 of the AHA Application Instructions (PDF) for specific instructions.

Updates for New Research Proposals

International Applicants - Did you know?

For ALL research programs – including fellowships – applicants are not required to reside in the United States for any period before applying for AHA funding. However, AHA research awards are limited to U.S.-based non-profit institutions, including medical, osteopathic, and dental schools, veterinary schools, schools of public health, pharmacy schools, nursing schools, universities and colleges, public and voluntary hospitals and others that can demonstrate the ability to conduct the proposed research. Acceptable visa types and additional information may be found here.

Use of Large Language Models and Generative AI in Proposals & Peer Review

Applicants:
The AHA permits the use of a large language model (LLM – e.g. ChatGPT) or a generative artificial intelligence tool to create and/or edit content in research proposals submitted for funding. This information must be disclosed at the time of submission. Disclosure of this information does not impact peer review. Should this information not be disclosed accurately, and use of these tools is identified, the proposal may be administratively withdrawn.

Peer Reviewers:
The AHA DOES NOT permit the use of a large language model (LLM – e.g. ChatGPT) or an artificial intelligence tool to generate and/or edit content in peer review critiques. Uploading any portion of a research proposal into a large language model (LLM – e.g. ChatGPT) or an artificial intelligence tool to assist in writing a critique of the proposal is explicitly prohibited as it is a violation of the AHA’s Peer Reviewer Certification Statement (to include confidentiality, non-disclosure, and conflict of interest).

Biosketch Addition: Inclusive, safe, diverse environment

All applicants (excluding fellows) are to include a statement in the Personal Statement section of their biographical sketch that explicitly states how they contribute to a safe, inclusive, and diverse work environment. In addition, mentors on Fellowships, Career Development Awards, and Diversity Supplements should complete recognized training specific to sexual and gender-based harassment.

Change to AHA Open Data Policy

For awards beginning in FY 23-24, the AHA has modified its Open Data Policy to align with the NIH’s new timeline for data sharing, effective for proposals submitted to the AHA after July 1, 2023. More on AHA Open Science Policies can be found here.

Revised AHA Open Data Policy: The AHA requires certain applicants to include a data sharing plan with the proposal. Any factual data that is needed for independent verification of research results must be made freely and publicly available in an AHA-approved repository as soon as possible, and no later than the time of an associated publication or the end of the award period (and any no-cost extension), whichever comes first.

* Existing awards are subject to the policy in place when the award agreement was signed. If a new award agreement is required (e.g., change of PI, change of institution) award is subject to policies in place at the time the agreement is signed.

Supporting Rheumatic Heart Disease Research

The AHA is helping to support a broader approach to research funding focused on Rheumatic Heart Disease. To that effect, the AHA is committing to funding research in this specific area across all scientific disciplines (basic, clinical, and population) within any current AHA programs. No additional pre-proposal or proposal materials are necessary outside of individual AHA program criteria; awardees will be designated from the existing applicant pool within each program.