NHLBI Program Project Applications (P01 - Clinical Trials Optional) | PAR 18 405

Frequently Asked Questions (FAQs)

What is this funding opportunity?

This opportunity is the NHLBI Program Project Applications (P01 - Clinical Trials Optional) funding opportunity (PAR 18-405), an NIH discretionary grant that supports large, coordinated research programs aligned with the mission and priorities of the National Heart, Lung, and Blood Institute (NHLBI).

Which NIH Institute is offering this P01 opportunity?

The opportunity is offered through the National Heart, Lung, and Blood Institute (NHLBI), which is part of the National Institutes of Health (NIH).

What kind of grant mechanism is a P01 (Program Project Grant)?

A P01 is designed to fund a collaborative, multi-project research program where the combined work is expected to produce outcomes greater than what the individual projects could accomplish if funded separately. The model emphasizes active coordination and scientific integration across projects.

Are clinical trials required?

No. Clinical trials are allowed but not required under this FOA. Applicants can propose basic, translational, clinical, or mixed portfolios, depending on what best addresses the central research theme or question.

What scientific areas are within scope for this FOA?

The scope is broad across cardiovascular, pulmonary, hematologic, and sleep research. It includes both fundamental mechanisms and disease-focused studies involving the heart, blood and lymphatic vessels, lungs, and blood.

Does the FOA allow research in transfusion medicine and blood resources?

Yes. The FOA explicitly welcomes areas such as transfusion medicine and blood resources, as long as the overall program addresses NHLBI priorities.

Are implementation science and health disparities research included in the scope?

Yes. The FOA explicitly welcomes implementation science and health disparities research, provided the overall program is aligned with NHLBI priorities and fits within the program project structure.

Is translational research supported under this P01?

Yes. Translational research is explicitly welcomed, as long as the proposed program fits within NHLBI priorities and is organized as a tightly integrated P01 program.

How many research projects are required in a P01 application?

Applicants must propose at least three interrelated research projects that are scientifically connected and organized around a single, clearly defined biomedical theme or complex research question.

Do the projects just need to be related, or do they need to be integrated?

The expectation is thematic integration, not just topical similarity. The projects should actively interact, inform one another, and demonstrate real scientific synergy around a unified theme.

What is meant by "a single, clearly defined biomedical theme or complex research question"?

Within this FOA, the P01 program should be built around one central theme or complex question that ties the projects together. The projects should be designed so that progress in one meaningfully supports or advances the others.

Can an application include shared cores?

Yes. Applicants may include shared core units when justified. Cores are meant to create economy of effort, space, and equipment by centralizing shared capabilities that support multiple projects.

What kinds of functions can cores provide?

Examples described include centralized specialized methods, shared instrumentation, data resources, clinical coordination functions, or other cross-cutting capabilities that directly support multiple projects in the program.

Are cores required?

The information provided indicates cores are optional: applicants may include shared cores when justified to support multiple projects and improve efficiency and productivity.

Does NHLBI encourage new scientific directions in P01 programs?

Yes. A notable emphasis in this FOA is encouragement of new scientific directions within P01 programs, including innovative and forward-looking program concepts.

Does this FOA encourage participation by investigators who have not traditionally received NHLBI support?

Yes. NHLBI views the P01 mechanism as a way to bring in scientists who have not traditionally received NHLBI support, as part of stimulating innovative, collaborative programs.

Can an Early Stage Investigator (ESI) lead a project within a P01?

Yes. Applicants have the option to include a research project led by an Early Stage Investigator (ESI), as a structured way to integrate newer investigators into a major collaborative effort while maintaining program coherence and rigor.

Is the P01 described as a leadership training environment?

Yes. The FOA frames the program environment as a training ground for leadership, helping emerging scientific leaders learn how to organize and manage a complex, multi-project research program.

Who is eligible to apply (U.S. organizations)?

Eligibility spans a wide range of organization types, including various levels of government (state, county, city/township, special districts), independent school districts, public housing authorities/Indian housing authorities, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations other than small businesses, and small businesses.

Are specific institution types like HBCUs, HSIs, and Tribal colleges included as eligible applicants?

Yes. The FOA highlights additional eligible categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are listed among the additional eligible categories.

Are U.S. territories or possessions included as eligible applicants?

Yes. U.S. territories or possessions are listed among the additional eligible categories.

Are tribal governments or organizations eligible?

Yes. The FOA includes tribal governments or organizations, including Indian/Native American Tribal Governments other than federally recognized entities in the categories specified.

Can a foreign (non-U.S.) organization apply directly as the applicant?

No. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply directly for this opportunity.

Can a U.S. applicant include a foreign component in the project?

Yes. While foreign organizations cannot apply directly, foreign components are permitted when they meet the NIH definition in the NIH Grants Policy Statement and are scientifically justified and compliant with NIH policy.

Are non-domestic components of U.S. organizations eligible to apply?

No. Non-domestic components of U.S. organizations are not eligible to apply, based on the information provided.

What is the funding instrument and activity category?

The funding instrument is a grant, and the activity category is health.

Which CFDA numbers are associated with this opportunity?

The FOA is issued under CFDA numbers 93.233, 93.837, 93.838, 93.839, and 93.840, reflecting NHLBI research domains supported by the Institute.

What are the dates mentioned for this opportunity?

The source record notes a creation date of 2017-10-20 and an original closing date of 2020-12-02.

Should applicants rely on the dates shown in the source record?

No. The information provided notes that applicants typically need to verify current submission dates, budgets, and updated policies by checking the live FOA and NIH guidance, since P01 opportunities may use standard receipt cycles or updated reissues.

What type of team or application is this FOA best suited for?

This FOA is best suited for teams proposing a tightly integrated, multi-project program with a strong unifying theme, clear evidence of synergy across projects, and, where appropriate, shared cores that make the collaboration more efficient and scientifically productive.