Opportunity Information: Apply for PA 25 305
The NIH Research Project Grant (Parent R01 Clinical Trial Required), funding opportunity number PA 25 305, is a discretionary NIH grant that supports a clearly defined, stand-alone research project led by one or more investigators. The intent is to fund a discrete, specified, and circumscribed body of work that fits the scientific expertise of the research team and advances knowledge in areas aligned with NIH priorities. What makes this particular Parent R01 distinct is that it requires the application to include at least one clinical trial, meaning the proposed research must involve a prospective assignment of human participants (or groups) to an intervention or condition with the goal of evaluating effects on biomedical or behavioral outcomes. In practical terms, applicants need to be prepared to justify the clinical trial rationale, describe the intervention and outcomes, and address the full set of clinical trial expectations typically required by NIH (such as participant protections, safety monitoring, and trial-related oversight).
This opportunity is designed to be broad and flexible, but the proposed project must match the programmatic interests of one or more participating NIH Institutes and Centers (ICs). Because it is a parent funding announcement, it is not limited to a narrow disease area or a single scientific topic; instead, it functions as an umbrella mechanism for investigator-initiated ideas, as long as those ideas fall within the mission space of an NIH IC that is participating in the announcement. Applicants typically benefit from aligning the project aims and clinical trial focus with an ICs priorities and, when appropriate, communicating with relevant NIH program staff to confirm fit before submitting.
Eligibility is expansive and includes a wide range of domestic and non-domestic organizations. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities and Indian housing authorities; Native American tribal organizations that are not federally recognized tribal governments; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations (other than small businesses); small businesses; and other organizations as allowed by NIH policy. The announcement explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; regional organizations; U.S. territories or possessions; non-domestic (non-U.S.) entities (foreign organizations); and Indian/Native American tribal governments other than federally recognized entities. This breadth is meant to encourage participation across many institutional settings, including community-centered and minority-serving organizations and international research groups, when appropriate for the science and trial design.
Administratively, the sponsoring agency is the National Institutes of Health, and the funding instrument is a grant under the Research Project Grant (R01) framework. The opportunity lists multiple CFDA numbers (now commonly referenced as Assistance Listing numbers), reflecting that many NIH Institutes and Centers may use this parent announcement to support projects that fall under their respective portfolios. The opportunity was created on 2024-12-18, and the listed original closing date is 2028-01-07, indicating it is intended to remain open across multiple receipt cycles over several years rather than as a one-time solicitation. The notice does not specify an award ceiling or expected number of awards in the provided source data, which is common for NIH parent announcements because award sizes and volumes vary by Institute/Center priorities, available appropriations, and the merit of applications received.
Overall, this funding opportunity is best understood as a standard, investigator-initiated NIH R01 pathway with one major requirement: the application must propose at least one clinical trial. Applicants should plan a strong hypothesis-driven or outcome-driven research project with a well-justified clinical trial component, ensure alignment with an NIH Institute or Center mission, and demonstrate the operational readiness to conduct a trial (including recruitment, human subjects protections, data management, and monitoring appropriate to the level of risk).Apply for PA 25 305
- The National Institutes of Health in the education, environment, food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "NIH Research Project Grant (Parent R01 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.143, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.361, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.859, 93.865, 93.866, 93.867, 93.879.
- This funding opportunity was created on 2024-12-18.
- Applicants must submit their applications by 2028-01-07.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Frequently Asked Questions (FAQs)
What is the NIH Research Project Grant (Parent R01 Clinical Trial Required) opportunity?
This opportunity is an NIH discretionary grant under the Research Project Grant (R01) framework that supports a clearly defined, stand-alone research project led by one or more investigators. It is intended to fund a discrete, specified, and circumscribed body of work that matches the scientific expertise of the research team and advances knowledge in areas aligned with NIH priorities.
What is the funding opportunity number?
The funding opportunity number (FON) is PA 25 305.
What makes this Parent R01 different from other Parent R01 announcements?
This Parent R01 requires the application to include at least one clinical trial. In other words, the proposed research must include a study that prospectively assigns human participants (or groups) to an intervention or condition to evaluate effects on biomedical or behavioral outcomes.
Does my application have to include a clinical trial?
Yes. This announcement specifically requires at least one clinical trial as part of the proposed project.
How does NIH define a clinical trial for this opportunity?
The clinical trial definition provided here is a prospective assignment of human participants (or groups) to an intervention or condition with the goal of evaluating effects on biomedical or behavioral outcomes.
What practical clinical trial details should applicants be prepared to include?
Applicants should be prepared to justify the clinical trial rationale, describe the intervention and outcomes, and address NIH clinical trial expectations such as participant protections, safety monitoring, and trial-related oversight.
Is this opportunity limited to a specific disease area or research topic?
No. As a parent funding announcement, it is broad and flexible and functions as an umbrella mechanism for investigator-initiated ideas, as long as the project aligns with the mission and programmatic interests of one or more participating NIH Institutes and Centers (ICs).
Do I need to align my project with an NIH Institute or Center (IC)?
Yes. The proposed project must match the programmatic interests of one or more participating NIH ICs. Applicants often benefit from aligning project aims and the clinical trial focus with an IC's priorities.
Should applicants communicate with NIH program staff before submitting?
The opportunity notes that applicants may benefit from communicating with relevant NIH program staff, when appropriate, to confirm programmatic fit before submitting.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What is the funding instrument?
The funding instrument is a grant under the Research Project Grant (R01) framework.
What types of organizations are eligible to apply?
Eligibility is broad and includes many domestic and non-domestic organizations, including government entities, higher education institutions, nonprofit and for-profit organizations, small businesses, tribal entities and organizations, and other organizations as allowed by NIH policy.
Are U.S. state, county, city, township, or special district governments eligible?
Yes. State governments, county governments, city or township governments, and special district governments are listed as eligible applicants.
Are independent school districts eligible?
Yes. Independent school districts are included as eligible applicants.
Are colleges and universities eligible?
Yes. Both public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible.
Are nonprofit organizations eligible?
Yes. Nonprofit organizations with or without 501(c)(3) status are eligible, with a note that the listing excludes institutions of higher education within those nonprofit categories.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) and small businesses are both listed among eligible applicants.
Are federally recognized Native American tribal governments eligible?
Yes. Federally recognized Native American tribal governments are included as eligible applicants.
Are Native American tribal organizations that are not federally recognized tribal governments eligible?
Yes. Native American tribal organizations that are not federally recognized tribal governments are listed as eligible.
Are non-federally recognized Indian/Native American tribal governments eligible?
Yes. Indian/Native American tribal governments other than federally recognized entities are explicitly highlighted as eligible in the opportunity description.
Are minority-serving institutions (MSIs) specifically encouraged or included?
Yes. The announcement explicitly highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly highlighted as eligible applicant types.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly highlighted as eligible.
Are foreign (non-U.S.) organizations eligible to apply?
Yes. Non-domestic (non-U.S.) entities (foreign organizations) are explicitly listed as eligible applicants.
Are eligible federal agencies able to apply?
Yes. Eligible federal agencies are explicitly highlighted among eligible applicant types.
Are regional organizations eligible?
Yes. Regional organizations are explicitly highlighted as eligible applicant types.
Are there specific Assistance Listing (CFDA) numbers associated with this opportunity?
The opportunity lists multiple CFDA numbers (now commonly referenced as Assistance Listing numbers). This reflects that multiple NIH Institutes and Centers may use this parent announcement to support projects in their respective portfolios.
When was this funding opportunity created?
The opportunity was created on 2024-12-18.
What is the listed original closing date?
The listed original closing date is 2028-01-07.
Does the long open period mean it is a one-time solicitation?
No. The listed closing date indicates it is intended to remain open across multiple receipt cycles over several years rather than being a one-time solicitation.
Is there an award ceiling listed?
No award ceiling is specified in the provided information. This can be common for NIH parent announcements because award sizes can vary by Institute/Center priorities, available appropriations, and the merit of applications received.
Is the expected number of awards listed?
No. The provided information does not specify an expected number of awards, which is common for NIH parent announcements due to variability across participating Institutes and Centers.
What kind of research project is NIH expecting under this R01?
The opportunity is intended for a clearly defined, stand-alone project with a well-justified clinical trial component, designed to advance knowledge in areas aligned with NIH priorities and the mission space of a participating NIH Institute or Center.
What operational readiness areas are emphasized for the clinical trial component?
Applicants are expected to demonstrate readiness to conduct a trial, including recruitment planning, human subjects protections, data management, and monitoring appropriate to the level of risk.
Is the project required to be investigator-initiated?
Yes. This parent announcement is described as an umbrella mechanism for investigator-initiated ideas, provided they align with a participating NIH Institute or Center's mission.
Can the project be led by more than one investigator?
Yes. The opportunity states that the project may be led by one or more investigators.
What is the core intent of the R01 mechanism in this announcement?
The intent is to support a discrete, specified, and circumscribed body of work that fits the research team's expertise and advances scientific knowledge, with the key added requirement that at least one clinical trial is included.
Browse more opportunities from the same category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Next opportunity: Rehabilitation Research and Training Center (RRTC) on Employment Policy
Previous opportunity: DE-FOA-0003535 Request for Information (RFI): Defining Sustainable Maritime Fuels in the United States
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for PA 25 305
Applicants also applied for:
Applicants who have applied for this opportunity (PA 25 305) also looked into and applied for these:
| Funding Opportunity |
|---|
| NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) Apply for PA 25 301 Funding Number: PA 25 301 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required) Apply for PA 25 303 Funding Number: PA 25 303 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Intervention Research to Improve Native American Health (R01 Clinical Trial Optional) Apply for PAR 25 379 Funding Number: PAR 25 379 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Support for Research Excellence (SuRE) Award (R16 Clinical Trial Not Allowed) Apply for PAR 25 414 Funding Number: PAR 25 414 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $100,000 |
| Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship for Students at Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30) Apply for PA 25 425 Funding Number: PA 25 425 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32) Apply for PA 25 423 Funding Number: PA 25 423 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship for Students at Institutions with NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30) Apply for PA 25 426 Funding Number: PA 25 426 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31) Apply for PA 25 422 Funding Number: PA 25 422 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Support for Research Excellence First Independent Research (SuRE-First) Award (R16 - Clinical Trial Not Allowed) Apply for PAR 25 415 Funding Number: PAR 25 415 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $125,000 |
| Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed) Apply for PAR 25 322 Funding Number: PAR 25 322 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "PA 25 305", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.