Funder: National Institutes of Health (NIH)
Due Dates: May 25, 2024 (Expired) | See NIH Guide for current opportunities
Funding Amounts: Budgets are not limited but must reflect actual project needs; maximum project period 5 years; total project period limit of 10 years for P01 grants.
Summary: Supports collaborative, interdependent neurological research projects that achieve greater scientific impact together than individually.
Key Information: Clinical trials of new interventions are NOT appropriate; mechanistic human studies allowed; multi-project application with minimum three interrelated projects required.
Description
This funding opportunity announcement (FOA) from the National Institute of Neurological Disorders and Stroke (NINDS) supports Program Project Grants (P01) designed to fund investigator-initiated research programs consisting of three or more highly interdependent projects. These projects must share a unifying, well-defined research goal or theme relevant to the NINDS mission. The program aims to foster synergistic collaboration among outstanding scientists who might not otherwise collaborate, producing results beyond what individual projects could achieve separately.
The P01 mechanism is intended for research programs where the combined efforts of multiple projects and shared core facilities provide significant scientific advantages. The program project director (PD/PI) is expected to provide scientific and administrative leadership, ensuring integration and coordination of the projects.
Clinical trials designed to test safety, efficacy, or effectiveness of interventions (e.g., phase I-III trials) are not appropriate for this FOA. Instead, mechanistic human studies or trials designed to understand biological or behavioral processes are allowed. Investigators planning clinical trials should consult NINDS clinical trial-specific funding opportunities.
Applications must demonstrate:
- A clear, overarching research goal to which each project contributes essentially.
- Scientific and administrative leadership by a qualified PD/PI with substantial effort.
- At least three interdependent research projects, each meritorious on its own and essential to the program.
- Collaborative and synergistic interactions among projects and cores.
- Inclusion of investigators from diverse disciplines or expertise areas.
- Compliance with NIH scientific rigor and transparency guidelines.
The FOA encourages applications from diverse teams, including underrepresented groups in biomedical research.
Due Dates
This FOA expired on May 8, 2024. The last application due date was May 25, 2024. Researchers should consult the NIH Guide for Grants and Contracts for current and reissued opportunities, such as PAR-24-169.
Funding Amount
- Budgets are not limited but must reflect the actual needs of the proposed project.
- Maximum project period is 5 years.
- Total project period for all NINDS P01 grants (including renewals) is limited to 10 years.
- Applications requesting $500,000 or more in direct costs in any year must contact NINDS at least 6 weeks prior to submission.
- NINDS rarely accepts applications requesting more than $1 million in direct costs per year.
Eligibility
Eligible Applicants
- Public and private institutions of higher education, including minority-serving institutions.
- Nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education).
- For-profit organizations, including small businesses.
- State, county, city, township, and special district governments.
- Federally recognized and other Native American tribal governments.
- Eligible federal agencies and U.S. territories or possessions.
Ineligible Applicants
- Foreign (non-U.S.) institutions and non-domestic components of U.S. organizations are not eligible.
- Foreign components of U.S. organizations are allowed.
Eligible Individuals
- Any individual with the necessary skills, knowledge, and resources to carry out the proposed research.
- Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and those from disadvantaged backgrounds are encouraged to apply.
- Multiple PD/PIs are allowed under NIH policy.
Other Requirements
- Applicant organizations and PD/PIs must have all required registrations (DUNS, SAM, eRA Commons, Grants.gov).
- Cost sharing is not required.
Application Process
- Applications must be submitted electronically via ASSIST or institutional system-to-system solutions.
- Follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide.
- Applications must include an Overall component plus at least three interdependent Research Projects.
- Include Administrative and Research Core components as appropriate.
- Use the latest NIH FORMS-H application packages for submissions due on or after January 25, 2023.
- Include a Data Management and Sharing Plan in the Overall component.
- Human subjects research must comply with NIH policies, including use of the PHS Human Subjects and Clinical Trials Information form.
- Applications proposing human fetal tissue research must comply with NIH fetal tissue policies and provide required assurances.
- Letters of support, resource sharing plans, and other required attachments must be included as specified.
- Applications requesting $500,000+ direct costs in any year require prior approval from NINDS.
- Consult NINDS Scientific/Research staff early in the planning process.
Review Criteria
Applications will be evaluated for scientific and technical merit by NINDS convened Scientific Review Groups using the following criteria:
Overall Impact
- Likelihood to exert a sustained, powerful influence on the research field.
- Scientific merit and interdependence of projects.
- Quality of supporting cores.
- Administrative structure and leadership.
Significance
- Importance of the problem or barrier addressed.
- Added value of the program project structure.
- For clinical trials: scientific rationale and necessity.
Investigators
- Qualifications and expertise of PD/PI(s) and collaborators.
- Leadership ability and commitment.
- Evidence of collaboration and diversity.
Innovation
- Novelty of concepts, approaches, or methodologies.
- Enhancement of innovation by combining projects and cores.
- For clinical trials: innovative design elements.
Approach
- Soundness of strategy, methodology, and analyses.
- Plans to address rigor and potential problems.
- Thematic cohesion and justification of interrelationships.
- Adequacy of administrative and organizational structure.
- For clinical trials: appropriateness of design, recruitment, data management, and ethical considerations.
Environment
- Institutional support and resources.
- Unique features enhancing probability of success.
- Commitment to diversity and inclusion.
Additional Review Considerations
- Study timeline (for clinical trials).
- Protections for human subjects.
- Inclusion of women, minorities, and individuals across the lifespan.
- Use of vertebrate animals.
- Biohazards.
- Resource sharing plans.
- Authentication of key biological/chemical resources.
- Budget justification.
Award Administration
- Awards are subject to NIH Grants Policy Statement terms and conditions.
- Just-in-Time information may be requested prior to award.
- Clinical trials must be registered and results reported on ClinicalTrials.gov.
- Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required.
- Data and safety monitoring plans are required for clinical trials.
- Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements apply as appropriate.
- Prior approval is required for pilot projects involving clinical trials or greater than minimal risk.
- Recipients must comply with federal civil rights laws and NIH policies on harassment, discrimination, and data sharing.
- Reporting requirements include annual Research Performance Progress Reports (RPPR) and Federal Financial Reports.
- Subaward reporting and integrity disclosures are required as per federal regulations.
Contact Information
Additional Information
- This FOA has been reissued as PAR-24-169.
- Applicants are encouraged to consult NINDS staff early for guidance on budget and program fit.
- All applications must comply with NIH policies on data management, sharing, and human subjects protections.
- The FOA and application guide provide detailed instructions on multi-project application structure and required components.
- The program supports diverse teams and encourages inclusion of underrepresented groups in biomedical research.
External Links