Grant Details

GRANT OVERVIEW

Grant name and funding organization

NIH Research Project Grant (Parent R01 Clinical Trial Required)

National Institutes of Health (NIH)

Total funding amount and duration

Funding amount is not limited but must reflect the actual needs of the proposed project.

Maximum project period is 5 years.

Primary objective and mission statement

To support discrete, specified projects that include at least one clinical trial.

To foster fundamental discoveries and innovative research strategies that improve health.

Key stakeholders and beneficiaries

Investigators and researchers in health-related fields.

Participating NIH Institutes and Centers.

ELIGIBILITY CRITERIA

Organization Requirements

Eligible organization types include higher education institutions, nonprofits, for-profit organizations, local and state governments, and tribal governments.

Nonprofits can be with or without 501(c)(3) status.

Foreign organizations are also eligible to apply.

Geographic Scope

Open to U.S. and non-U.S. entities.

Foreign components of U.S. organizations are allowed.

Project Requirements

Projects must propose at least one clinical trial.

Research must align with the scientific missions of participating NIH Institutes and Centers.

Financial Requirements

Application budgets are not limited but must reflect actual project needs.

No cost-sharing is required.

Timeline Requirements

Applications are due by 5:00 PM local time of the applicant organization.

Key dates include application due dates and review cycles.

Previous Funding Considerations

Applicants may submit more than one application, provided each is scientifically distinct.

Duplicate applications are not accepted.

APPLICATION PROCESS

Required documentation and materials

Applications must follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide.

Specific forms and documents must be submitted electronically.

Evaluation criteria and scoring system

Applications are evaluated for scientific and technical merit.

Review criteria include significance, innovation, rigor, and feasibility.

Review process and timeline

Applications undergo peer review and are assigned to appropriate NIH Institutes or Centers.

Selection criteria and priorities

Funding decisions are based on scientific merit, availability of funds, and relevance to program priorities.

SPECIAL CONSIDERATIONS

Unique aspects or requirements

All applications must propose clinical trials.

Some NIH Institutes only accept mechanistic studies.

Potential challenges or limitations

Applicants must ensure compliance with all application instructions to avoid delays or rejection.

Strategic alignment opportunities

Applicants are encouraged to contact relevant NIH staff for guidance on aligning projects with NIH interests.

Competitive advantages or disadvantages

Strong emphasis on innovative research can provide a competitive edge.

KEY INSIGHTS AND RECOMMENDATIONS

Critical success factors

Clear alignment with NIH scientific missions.

Strong research design and methodology.

Common pitfalls to avoid

Submitting duplicate applications.

Failing to comply with application guidelines.

Strategic recommendations for applicants

Engage with NIH staff early in the application process.

Ensure all registrations are completed before submission.

Competitive positioning advice

Highlight innovative aspects of the proposed research.

Grant Details

health clinical trial research biomedical nonprofit higher education for-profit government innovation funding
NIH Research Project Grant (Parent R01 Clinical Trial Required)
PA-25-305
NIH Grants
EDU NGO ENTERPRISE PUBLIC OTHER
US AF AL DZ AS AD AO AI AQ AG AR AU AT BY BE BG CA CN HR CY CZ DK EG EE FI FR GE DE GI GR HU IS IE IL IT JP LV LI LT LU MK MY MT MX MD NL NZ NO PL PT QA RO SA SC SG SK SI ES SE CH TR UA AE UK VA VG VI
RESEARCH_DEVELOPMENT
False
None
None
None
USD
None
True
True
To improve health outcomes through innovative research.
Research findings and clinical trial results.
Jan. 7, 2028, 10 p.m.
March 2025
Application forms as specified in the How to Apply - Application Guide.
True
Peer review based on scientific and technical merit.
Significance and innovation of the proposed research.
Rigor and feasibility of the proposed approach.
Potential impact on health outcomes.
False
False
Grant
Compliance with NIH Grants Policy Statement.
Annual progress reports and financial statements.
Payments based on milestones and project needs.
Compliance with federal regulations and NIH policies.
None specified.