BRAIN Initiative: Exploratory Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (R61 Basic Experimental Studies with Humans Required) | RFA DC 24 001

Opportunity Information: Apply for RFA DC 24 001

The NIH BRAIN Initiative funding opportunity "Exploratory Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain" (R61; Basic Experimental Studies with Humans Required) supports early-stage, high-impact human neuroscience projects that take advantage of rare access to the living human brain during clinically necessary invasive procedures. The core idea is to use intracranial recording and stimulation in precisely localized brain structures to answer fundamental questions about how the human brain works, while acknowledging that individual clinical sites often have too few eligible participants and too many logistical constraints to run large, statistically powered experiments on their own. This opportunity is designed to push teams to organize across sites and disciplines so that data can be aggregated, methods can be aligned, and meaningful conclusions can be reached despite small per-site sample sizes.

The R61 mechanism signals that NIH is looking for exploratory, milestone-driven work focused on feasibility and proof-of-principle rather than a fully mature, large-scale program from day one. Applicants are expected to propose planning and early development activities that demonstrate a credible path toward later, more definitive studies. If these exploratory efforts succeed, they are intended to position the team for a subsequent, larger "Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain" effort described in the companion FOA (RFA-NS-22-041). In practical terms, this means the R61 project should be structured to de-risk the hardest parts of doing invasive human neuroscience, such as harmonizing protocols across hospitals, validating that an experimental paradigm can be executed in the operating room or epilepsy monitoring unit, establishing data quality and reproducibility, and showing that the team can recruit, coordinate, and analyze in a way that supports later statistical power.

A major emphasis is on building diverse, integrated, multidisciplinary teams that can cross typical boundaries between clinicians and researchers. Competitive projects will usually involve close collaboration among neurosurgeons, epileptologists or functional neurosurgery teams, cognitive neuroscientists, biomedical engineers, computational modelers, statisticians, and neuroethicists, along with strong infrastructure for data management. NIH is explicitly encouraging work that maximizes the unique scientific opportunities created by direct access to brain tissue and circuits in vivo, including the ability to record neural activity with high temporal and spatial resolution and to perturb neural circuits with stimulation to test causal hypotheses.

Scientifically, the FOA encourages approaches that are not just descriptive but are guided by clear theoretical constructs and, where appropriate, quantitative mechanistic models. The intent is to move beyond collecting intracranial signals as an end in itself and toward studies that link recordings and stimulation to interpretable models of computation, circuit dynamics, or behavior. Because human invasive studies are often opportunistic and time-limited, strong applications will likely show careful experimental design tailored to clinical workflows, with well-justified tasks, stimulation parameters, analysis plans, and strategies to handle variability across patients, devices, and sites.

A defining feature of this program is the consortium expectation. Awardees will participate in a working group coordinated by NIH with the goal of developing consensus standards of practice. This includes practical standards (for example, consistent metadata, electrode localization practices, stimulation reporting, and quality control) and explicit attention to neuroethical considerations, which are especially important when research is conducted in the context of medical care and involves direct brain intervention. Awardees are also expected to collect and provide data that can support ancillary studies and to help aggregate and standardize datasets for dissemination to the broader scientific community. In other words, the program is not only funding individual projects; it is also trying to build a coordinated ecosystem where datasets and methods become more interoperable, enabling future discovery and reuse.

The opportunity is offered as a discretionary grant by the National Institutes of Health and is listed under Funding Opportunity Number RFA-DC-24-001. It aligns with multiple NIH program areas as reflected in the CFDA numbers provided (93.173, 93.213, 93.242, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867), which signals that the scientific scope can span several neuroscience-relevant domains. The original application closing date is 2025-09-19. The listing does not specify an award ceiling or expected number of awards in the provided text, so applicants would need to consult the full FOA for budget structure, project period details, and any milestone or go/no-go requirements typical of R61 awards.

Eligibility is broad and includes many U.S.-based organization types: state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, faith-based or community-based organizations, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, it draws a clear line on foreign participation: non-U.S. (non-domestic) entities and foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible. However, "foreign components" as defined in the NIH Grants Policy Statement are allowed, meaning a U.S. applicant may include certain well-justified foreign elements within the project under NIH policy, even though a foreign organization cannot be the applicant.

Overall, this R61 opportunity is aimed at teams that can responsibly and rigorously leverage invasive clinical access to the human brain to produce interpretable, model-informed neuroscience, while also doing the difficult coordination work needed to standardize practices and share high-value data. The program is as much about building the collaborative scaffolding for scalable human intracranial research as it is about any single experiment, with the expectation that successful exploratory efforts will unlock more definitive, follow-on studies.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "BRAIN Initiative: Exploratory Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (R61 Basic Experimental Studies with Humans Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173, 93.213, 93.242, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2023-03-31.
• Applicants must submit their applications by 2025-09-19. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

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