Heart Transplantation Research Network Planning Grant

• Proposals must be received no later than 3 p.m. Central Time on the deadline date. Early submission is encouraged. The American Heart Association does not accept late proposal submissions, grant extension requests, or have an appeals process.
• Before beginning an application, see the Heart Association Application Resources page for requirements that apply to all Association research awards. Also view research Policies and Statements.
• Proposals must be submitted electronically via ProposalCentral. The system will open eight weeks prior to the application deadline to complete the proposal and upload required documents. Applicants can create required documents in advance; refer to the Application Instructions (PDF). All submissions require the signature of a designated institutional representative.
• Applicants must be American Heart Association Professional Members at the time of proposal submission. Join or renew when preparing an application in ProposalCentral, or by phone at +1-888-242-2453 or 214-570-5935. Membership processing may take 3-5 days; do not wait until the application deadline to renew or join. The Association expects all mentors associated with training/mentored research awards to maintain active Association Professional Membership, as well.

The American Heart Association announces a Request for Proposals (RFP) for a planning grant opportunity through its Heart Transplantation Research Network.

The first heart transplant was performed in 1967, one of the most extraordinary feats of modern medicine. The system that supports it, however, has failed to evolve significantly since then, with none of the astonishing novel therapies we see being developed in other areas of medicine. Despite decades of innovation in almost all the other cardiovascular spheres, heart transplant care remains fragmented, inequitable, and frustratingly stagnant. Patients face ongoing cardiac rejection with imprecise methods to detect the immunologic process, potentially toxic immunosuppressive regimens which have not been updated substantially for two decades, and inconsistent outcomes—especially among Black recipients and pediatric populations. Data are siloed, research is underfunded, and quality improvement is virtually nonexistent. The majority of clinical practice guideline recommendations are driven by consensus rather than an evolving catalog of evidence.

The American Heart Association has launched a bold, multi-phase initiative to transform heart transplantation care across the United States, a transformation in treatment built on three pillars:

A Global Heart Transplant Data Infrastructure - In collaboration with key transplant organizations, the American Heart Association will manage a comprehensive heart transplant database, designed not as a static registry, but as a dynamic, harmonized data platform to drive research, quality improvement, and policy change.

A Research Network for Breakthrough Science - We have launched a research network focused on rejection detection, remote monitoring, viral load surveillance, and innovative, safer therapies. This network will be the sandbox for high-impact studies, including planning grants for clinical trials in immune tolerance, and chronic rejection.

A Quality Improvement Infrastructure - Modeled after our Get With The Guidelines® success, we will build a scalable Quality Improvement (QI) framework to standardize transplant care, reduce disparities, and improve long-term outcomes. This will drive system-wide change.

Opportunity

This Request for Proposals is designed to provide support for the development of a detailed trial protocol and grant to be submitted to a federal agency or other major funder focused on developing and testing ways in which diagnostic or therapeutic interventions can improve health outcomes. Investigators funded through this RFP will be provided with salary and other support over the course of 12 months to:

• Optimize and finalize trial design;
• Draft a grant proposal to a federal agency or other major funder;
• Finalize a protocol and manual of procedures;
• Establish a research team;
• Develop tools for data management and research oversight;
• Prepare other items needed for the submission and conduct of a rigorous trial to address therapeutic and management gaps in heart transplantation, including any preparatory steps for IND submission if required.
• If needed, a regulatory strategy must be included.

The primary deliverable at the end of this grant period should be a rigorous and highly competitive proposal for funding of >$3M to include federal and related agencies (NIH, PCORI, ARPA-H, USDA, and others) or state agencies. Proposals for industry or foundation support may also be submitted, but the planning grant proposal should provide justification for such sources of support.

Science Focus Areas of Interest

The goal of this RFP is to provide support for investigators to dedicate time to fully develop a competitive grant proposal that tests the efficacy of observations or interventions in improving health outcomes in heart transplant patients.

Specific areas of clinical focus may include, but are not limited to:

• Immune tolerance
• Chronic rejection
• Infection prevention
• Prevention of malignancy
• Prevention of coronary allograph vasculopathy
• Development of predictive biomarkers or surrogate endpoints

Another focus area of interest:

• Incorporation of artificial intelligence or other technologies to cost-effectively provide personalization at scale

Target Agencies and Funders for the Final Proposal Submission

Applicants should provide details of where they intend to submit the final proposal that will be developed during the planning grant year. They should provide details of any RFPs under which these proposals may be submitted. These target funders may include federal and related agencies (NIH, PCORI, ARPA-H, USDA, and others) or state agencies. Non-governmental funders may also be identified (e.g., foundations with substantial capacity and history of funding clinical trials, industry partners). If submitting proposals for industry or foundation support, the planning grant proposal should provide justification for such sources of support. Letters of support from potential collaborating organizations or funders where it is feasible are welcome but not required.

• At the time of proposal submission, the applicant must hold an MD, PhD, DO, DVM, DDS, DNP, or equivalent post-baccalaureate doctoral degree.

• Heart Association 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.

• Applicants are not required to reside in the United States for any period before applying for American Heart Association funding. However, applicants must have one of the following designations at the time of proposal submission – not award start date, depending on career stage and each individual’s situation. An awardee must maintain one of the designations listed below throughout the duration of the award. Please consult with your institution’s grant officer.
  • U.S. citizen
  • Permanent resident
  • Pending permanent resident (must have filed Form I-485 for permanent resident status and obtained an I-797C Notice of Action that the application has been received by USCIS and case is pending)
  • H1-B Visa - temporary worker in a specialty occupation
  • O-1 Visa - temporary worker with extraordinary abilities in the sciences
  • TN Visa - NAFTA Professional
  • DACA - Deferred Action for Childhood Arrivals

All applicants are required to self-register as peer reviewers with the American Heart Association and select two distinct scientific keywords that accurately reflect their areas of expertise. By registering, applicants consent to being contacted regarding future peer review opportunities and are strongly encouraged to participate as availability permits.

Equitable health for all is a core value of the American Heart Association; all applicants are encouraged to incorporate this vital perspective into their proposals. In addition, the Association believes that including individuals of all backgrounds is an essential component to driving its mission. We strongly encourage applications by individuals who have faced special challenges or obstacles to their careers and those who have experienced varied and non-traditional career trajectories.

• This program places no limit on eligibility based on career stage (excluding fellows/trainees, they are not eligible for this funding mechanism), academic rank or discipline. It requires only evidence of employment at a qualified institution.
• While no minimum percent effort is specified, the principal investigator must demonstrate that adequate time will be devoted to ensuring successful completion of the proposed project.

Award: $100,000 over a 12-month funding period, including up to ten (10) percent institutional indirect costs.

• The Heart Association does not require use of the NIH salary cap.
• The award may be used for salary and fringe benefits of the principal investigator and collaborating investigator(s), consistent with percent effort, and for project-related expenses, such as salaries of technical personnel essential to the conduct of the project, supplies, equipment, computers/electronics, travel (including international travel), volunteer subject costs, data management, and publication costs, etc.
• Up to $25,000 of this award amount can be dedicated to the acquisition of additional data, information and/or other necessary resources during the planning grant year, with appropriate justification.

Duration: One year. No-cost extensions are not allowed, and the awards are non-renewable.

Number of Awards: The American Heart Association anticipates awarding up to 10 awards.

Total Award Amount: $100,000

Awardees will be selected based on scientific merit and alignment with this RFP.

The Heart Association reserves the right to determine the final award amount for competitive projects based on need and potential impact.

An applicant may submit a maximum of one Heart Transplantation Research Network Planning Grant.

Required Documents and Page Limits

Applicant:

1. Proposed Research Plan (5 pages) - Please detail the plan to further develop and finalize a full final clinical trial protocol and budget for a definitive, rigorous, appropriately powered randomized clinical trial to test heart transplantation management interventions. The proposal submitted for this award must include the following elements, but will not itself be the full clinical trial protocol:
   
   • Rationale for the proposed trial;
   • Preliminary trial design; intervention, including plans for dose, duration, frequency;
   • Primary and secondary endpoints and outcome measures;
   • Plan for recruitment;
   • Feasibility estimates;
   • Plan for incorporating lived experience of participants into study design;
   • Statistical design and sample size estimates;
   • Timeline and milestones for the planning year.
   • Statement of additional data, information, and resources that will be needed and acquired during the planning year.
   
   
2. Statement of Qualifications of the PI and study team (1 page)


3. Target Agencies and Funders for the Final Proposal Submission (1 page)


4. Applicant Biosketch


5. Research Project Environment Form (DOCX) (2 pages)


6. Budget Justification Form (DOCX) (2 pages)


7. Literature Cited (4 pages)


8. Vertebrate Animal Subjects (if applicable, no page limit)

 

Third Party Personnel:

1. Collaborating Investigator's Biosketch


2. Collaborating Investigator's Letter (2 pages)


3. Consultant's Letter (2 pages)

 

Proposals will also require the following items to be entered into form fields in ProposalCentral. They are listed here for applicant awareness:

• Project Summary - Write a concise description or abstract describing the work proposed. This should be as brief as possible, since you also will be required to upload a separate pre-proposal document. Note: This field will not accept any special characters or keystrokes (e.g., β, π, etc.).
  
  
• Non-Scientist Summary - Enter a description of the project that is written to be understood by non-scientists. This information may be reviewed by people who do not have scientific or medical backgrounds. Be clear and avoid technical and scientific terms, when possible. When formulating your lay summary, it might help to imagine that you are explaining your work to a new acquaintance who does not work in the science field. NOTE: It is incumbent upon the applicant to make a clear link between the proposed project and the mission of the American Heart Association.

 

Format/Type Requirements

You must comply exactly with the American Heart Association's format/type requirements and page limits. Failure to comply will result in the administrative withdrawal (disqualification) of the proposal.

• Documents must be single-spaced.
• No more than 15 characters per inch (cpi) or an average of no more than 15 cpi (cpi includes symbols, punctuation, and spaces).
• No less than ¾” page margins on all four sides.
• Maximum of 50 lines per page.
• Arial Font style, 12-point font size for Windows users; Helvetica Font style, 12-point font size for Macintosh users.
• Only Portable Document Format (PDF) files are accepted.

To avoid unintentional formatting violations, applicants are advised to avoid adding page numbers, line numbering, headers and footers, signatures, letterhead, etc.

Applicants should avoid scanning as a method to convert Word Documents into PDFs. A better approach is to convert the Word Document to a PDF using Microsoft Word’s Save As or Export function. Should that option not be available to the applicant and an alternative PDF conversion tool is used, applicants are responsible for ensuring the converted PDF adheres to the formatting requirements.

Figures, images, and charts are allowed. All must be legible and fit within the ¾” margin requirements.

Internet web site addresses (URLs) may not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Moreover, reviewers are cautioned not to directly access an Internet site, as it could compromise their anonymity. The only place a URL may be used is in the biographical sketch as described in the instructions for that form.

Note: The ProposalCentral electronic system will reject a document that exceeds the page limit and documents not in compliance with the above format/type requirements. The American Heart Association has the responsibility to make final determination of conformance to format requirements and the authority to withdraw applications. This decision is final and not subject to appeal.

Peer review for this program may be conducted using a distributed peer review approach (Merrifield and Saari, Astronomy and Geophysics, 50, 4.2, 2009). Distributed peer review, in which those submitting proposals also serve as reviewers of others’ proposals submitted under the same call for applications, relies on the principles of a traditional peer review panel: academic integrity, rigor, transparency, and a desire to advance the best science. As opposed to traditional peer review, distributed peer review capitalizes on the expertise of the applicant pool and incentivizes timely review in fairness to all applicants. Additionally, this peer review mechanism exposes applicants to new ideas and could foster new potential collaborations.

All applicants who submit a proposal will be required to serve as a peer reviewer within this program and will be assigned 6-10 proposals for review. By agreeing to the program terms at the time of proposal submission, the principal investigator agrees concurrently to serve as a peer reviewer within this program and meet all peer review expectations and requirements. Principal investigators will declare conflicts of interest and will only be assigned proposals for which they do not have an institutional or individual conflict; PIs (reviewers) are bound by all other requirements associated with peer review. PIs will be provided ~30 days to complete review and scoring of the proposals to which they are assigned.

Only peer reviewers who complete their assigned reviews and record their scores in a timely fashion will in turn have their own proposal considered for funding. Brief written critiques to include bulleted strengths and weaknesses are required. Principal investigators who have not completed their reviews nor submitted their scores by the stated deadline will have their proposals withdrawn and returned as not in compliance with the program announcement, and they will not receive scores should any have been completed for their proposal. Peer review will require submission of scores using ProposalCentral; there will be no peer review panel discussions or meetings. All other Heart Association Peer Review processes apply. Following the receipt of all peer reviewed comments, a committee of Heart Association science leadership will convene to make final determinations on the awardees.

Peer Review Scoring Criteria:

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

The Association uses a 1-9 score scale and Peer Review Guidance. Reviewers are required to provide brief, bulleted written feedback on each proposal reviewed. To judge the merit of the proposal, reviewers will score proposals according to the following criteria:

Non-Scientist Summary: How well written is the Non-Scientist Summary in explaining to a non-scientist audience the research proposed, the questions being asked and how they will be answered, and the importance and impact of this work? Does it relay how the proposal supports the mission of the Heart Association’s Heart Transplant Network?

Investigator and Team: Is the investigator appropriately trained, productive, and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator (applicant) and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Does the investigator have a record of diligence, commitment, and productivity that warrants support? Do investigators have partnerships or relationships in place that could be leveraged to bring in potential partners?

Environment: Does the environment in which the work will be done contribute to the probability of success? Does the proposal benefit from unique features of the investigative environment or subject populations, or employ useful collaborative arrangements?

Significance: Does the planned study address the core concern of this RFP, namely testing ways to achieve improvements in clinical outcomes in cardiac transplantation? Does the planned study use input from the lived experiences of participants or practitioners to guide program design (either historical, or as part of the current study)? If the aims of the proposal are achieved, how will scientific knowledge, clinical practice, and equitable health be advanced? What will be the effect of these studies on the concepts, methods and technologies that drive this field?

Approach: Are the conceptual framework, design, methods, and analyses of the ultimate planned trial adequately developed, well-integrated, well-reasoned and feasible (as determined by preliminary data) and appropriate to the aims of the proposal? The assessment of preliminary data should be put into perspective so that bold new ideas and risk-taking by investigators are encouraged rather than stymied. Does the applicant acknowledge potential challenges and problem areas and consider alternative tactics and mitigation? How does the proposal consider the lived experience of participants and strive to center that in the proposal?

Innovation: Is the proposal original and innovative? For example: Does the proposal challenge existing paradigms and address an innovative hypothesis or critical barrier to progress in the field? Does the proposal develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? How does the proposal achieve the goals of working with diverse populations and capturing the lived experience of participants?

Impact: How does this proposal ensure that the resulting award will produce significant impact on the field? Proposals for research funding will be assessed for their potential impact on the field of cardiac transplantation, and on the applicant’s ability to effectively describe the proposal and its potential outcomes to non-scientists.

Interim Assessment: Awardees must report progress against milestones on a quarterly basis. Progress assessment may take the form of a required written report in addition to video conferencing, phone calls, and/or face-to-face visits. Reporting will be focused on the achievement of stated milestones as indicated in the project timeline. The Heart Association reserves the right to request additional updates, site visits, or reporting.

Public Access: The Heart Association’s public access policy requires that all journal articles resulting from Association funding, including journal articles that are a result of a funded grant designed under an Association-funded planning grant, be made freely available in PubMed Central (PMC) and attributed to a specific Association award within twelve (12) months of publication. It is the responsibility of the awardee to ensure journal articles are deposited into PMC.

Institutional Eligibility / Location of Work:
American Heart Association 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. Proposals will not be accepted for work with funding to be administered through any federal institution or work to be performed by a federal employee, except for Veterans Administrations employees.

Use of Artificial Intelligence and/or Large Language Models:
The American Heart Association permits the use of a large language model (LLM – e.g. ChatGPT) or an artificial intelligence tool to generate 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.

The American Heart Association 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 of 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).

Open Data:
Any factual data that is needed for independent verification of research results must be made freely and publicly available in a Heart Association-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. For more information on the above policies, see the American Heart Association's Open Science Policy webpage.

Preregistration:
The American Heart Association requires preregistration for any funded clinical trials and encourages preregistration for any studies that make an inferential claim from a sampled group or population, as well as studies that are reporting and testing hypotheses. After a project is completed, protocols and preregistration analysis plans can be used in conjunction with the final study and analysis by researchers seeking to replicate, reproduce, and build upon findings. See American Heart Association's preregistration information.

Other:
The projects described can have no scientific or budgetary overlap with other funded work. The applicant/awardee and institution are responsible for compliance with all Heart Association research award policies and guidelines for the duration of any awards they may receive. Visit the Research Programs Awards Policies page for more information on this topic: Policies and Standards Governing American Heart Association Research Awards