New Approaches for Measuring Brain Changes Across Longer Timespans (R01 Clinical Trial Optional)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for biomedical researchers and institutions seeking NIH R01 research funding to develop and validate novel methodologies for measuring neurobiological changes over extended longitudinal periods. Eligible applicants include academic research institutions, medical schools, teaching hospitals, and nonprofit research organizations with appropriate infrastructure and experience in clinical neuroscience research. The grant supports investigator-initiated research projects that advance measurement science in brain imaging, neurobiological markers, or related assessment tools. Activities supported include research design and methodology development, longitudinal neuroimaging studies, validation studies for new measurement approaches, and optional clinical trial components. U.S. institutions and domestic researchers are the primary focus, though some international collaboration may be permitted. Applicants must demonstrate scientific merit, feasibility, and institutional research capacity.
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Program description
The purpose of this funding opportunity is to encourage multidisciplinary investigators to develop new approaches or apply existing approaches in novel ways to measure brain activity, connectivity, genomics, or other aspects across the age spectrum of neurodevelopment. The overarching goal is to extend our understanding of brain development and aging, including studies of the neurodevelopmental origins of later health and disease. Research can include healthy human participants of any age, specific clinical groups such as those with cognitive, motor, or affective regulation challenges, and/or animal research on these domains of function. The studies can focus on longitudinal neuroanatomical or functional changes at any level, including genetics/genomics, single cells, connectomics, neural population activity patterns, and others. This funding opportunity is intended to encourage technological and conceptual innovation to improve repeated measures across longer epochs of the lifespan, to better predict outcomes at later ages.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- NIH Form SF-424 (R&R) with institutional routing
- Project narrative (15 pages typical for R01, may vary by institute)
- Specific aims (1 page maximum)
- Research strategy (4–6 pages)
- Preliminary data and feasibility section
- Bibliography/references
- Detailed budget and budget justification
- Biographical sketches (NIH format) for all key personnel
- Facilities and resources section
- Letters of support/collaboration from partners
- IRB approval or IRB exemption letter (if human subjects involved)
- Data management and sharing plan
- Resource sharing plans (if applicable)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.396 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$76,358,174
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$48,037,195
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$47,629,682
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$45,540,324
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$43,304,433
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$38,522,746
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$38,308,314
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$31,389,631
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$31,228,587
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$31,069,673
Top States by Funding
- NY 17 awards $283.5M
- CA 17 awards $198.0M
- MA 18 awards $189.8M
- TX 6 awards $130.2M
- TN 7 awards $102.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.396). How funding has trended year over year.
| 2024 | $892,571,343 | |
| 2025 | $935,620,177 | |
| 2026 est. | $580,131,000 |
FAQ
Who is eligible to apply for this R01 grant?
Eligible applicants include faculty researchers at universities, medical schools, teaching hospitals, and nonprofit research institutions. Postdoctoral fellows, graduate students, and early-career scientists may apply as principal investigators with appropriate institutional support. Foreign organizations may apply but must have a domestic partnering institution.
What is the typical funding range for this type of R01 grant?
R01 grants from NIH typically provide $250,000–$500,000 in annual direct costs, though actual amounts vary by project scope and agency guidelines. Budget requests must align with reasonable project scope and institutional indirect cost rates.
Are clinical trials required for this grant?
Clinical trials are optional. The grant supports methodology development and validation studies, which may or may not include human subject testing. Applicants should clarify their clinical trial plans early in the application process.
What is the typical timeline for NIH R01 review and award?
NIH typically takes 4–6 months from submission to funding decision after scientific review. Once approved, projects typically have a 5-year funding period, though phased funding and no-cost extensions are possible.
How competitive is this grant program?
R01 grants are highly competitive, with success rates typically in the 20–25% range across NIH institutes. Strong preliminary data, clear innovation, and experienced research teams significantly improve competitiveness. Early consultation with your NIH program officer is recommended.
💡 Tips for applicants
- Start with a strong preliminary data section demonstrating feasibility of your measurement approach. NIH reviewers prioritize evidence that your methodology works before full-scale implementation.
- Clearly articulate the innovation: explain what measurement challenges exist and how your approach meaningfully advances the field beyond current standards. Be specific about limitations of existing tools and how you address them.
- If including clinical trials, submit a statistical analysis plan and power calculation upfront. The optional trial component adds complexity, so justify why it strengthens your specific aims.
- Engage your NIH program officer early (6–8 weeks before deadline). They can provide feedback on approach fit, reviewer expectations, and funding probability before you invest heavily in writing.
- Build a realistic timeline with clear milestones for each year of the 5-year project. Longitudinal studies require careful project management plans that demonstrate you understand the practical challenges of subject retention and data quality over time.
⚠️ Common mistakes
Applications often fail because they lack sufficient preliminary data showing the measurement approach works in their target population. Reviewers need evidence of technical validation before committing five years of funding. Additionally, many proposals underestimate the time and resources required for longitudinal research, including subject retention, data quality assurance, and regulatory compliance. Applicants should also avoid overstating novelty without clearly positioning the work within the existing literature.
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