BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01 Clinical Trial Required) | RFA NS 19 001

Opportunity Information: Apply for RFA NS 19 001

The National Institutes of Health (NIH) funding opportunity "BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01 Clinical Trial Required)" (Funding Opportunity Number RFA-NS-19-001) supports ambitious human neuroscience studies that take advantage of rare, high-value clinical situations where neurosurgical procedures allow direct recording from, and stimulation of, precisely targeted brain structures. The central idea is that invasive recordings and stimulation in patients can reveal brain function with a level of anatomical and physiological precision that noninvasive methods often cannot reach. At the same time, these studies are typically limited by small patient cohorts, site-specific protocols, and the practical constraints of clinical care, which makes it hard to run complex experiments and even harder to combine results across sites in a statistically powerful way. This program is designed to overcome those barriers by encouraging larger, integrated efforts that can produce robust, generalizable findings.

The award mechanism is a U01 cooperative agreement, meaning projects are expected to operate with substantial NIH scientific involvement and coordination rather than functioning as fully independent investigator-initiated grants. Because the opportunity is labeled "Clinical Trial Required," applicants must propose work that meets NIH’s definition of a clinical trial, and they should be prepared for the associated requirements around human subjects protections, trial registration, oversight, and reporting. The overall goal is to enable high-impact, in vivo research in humans by building multi-disciplinary teams that can execute sophisticated experimental protocols in the context of invasive neurosurgical access, while still respecting patient safety, clinical workflow, and ethical boundaries.

A major emphasis of this RFA is on team science and cross-disciplinary integration. The NIH is explicitly seeking diverse, integrated, multi-disciplinary groups that can bridge neuroscience, neurosurgery, neurology, psychiatry, engineering, computation, biostatistics, ethics, and related fields as needed for the proposed aims. Applicants are encouraged to move beyond single-site, single-lab studies by developing coordinated approaches that can be implemented across patients and potentially across institutions. The expectation is that these teams will ask "high-impact questions in human neuroscience" that are uniquely addressable through invasive access, rather than simply repeating what could be learned through noninvasive imaging or animal models.

Scientific rigor and interpretability are also highlighted in the description. Projects should be guided by clear theoretical constructs and, where appropriate, quantitative and mechanistic models. In practice, this points toward proposals that do more than describe correlations in neural activity. Competitive projects would be expected to articulate hypotheses grounded in theory, define measurable variables and outcomes, and use modeling or other quantitative frameworks to connect neural recordings and stimulation effects to cognitive, sensory, motor, or clinical phenomena. The focus on mechanistic understanding reflects the broader BRAIN Initiative objective of explaining how neural circuits generate function, and how perturbing those circuits changes behavior or symptoms.

Another defining feature of the opportunity is its consortium-based structure. Awardees will participate in a NIH-coordinated consortium work group intended to develop and align "consensus standards of practice." This includes not only technical and analytic standards (for example, approaches to harmonizing recording parameters, stimulation protocols, metadata, and outcome measures), but also explicit attention to neuroethical considerations. Because invasive human neuroscience intersects with sensitive issues such as consent under clinical vulnerability, privacy risks from neural data, incidental findings, and the boundaries between research and clinical intervention, the program builds shared ethical practice into its collaborative framework. Participation in the consortium also involves generating data that can support ancillary studies and contributing to aggregation and standardization efforts so that datasets can be disseminated and reused by the broader scientific community.

Eligibility is broad and includes many common domestic applicant categories: state, county, city or township governments; 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; tribal organizations (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The RFA also calls out additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are not eligible to apply as applicant organizations; however, non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined in the NIH Grants Policy Statement, which means a U.S.-based applicant can include certain international elements when justified and compliant with NIH policy.

Administratively, the opportunity is categorized as a discretionary program, with the funding instrument listed as a cooperative agreement. The activity category is shown under Education, Health, Income Security and Social Services, and multiple CFDA numbers are associated with the opportunity (93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.313, 93.853, 93.865, 93.866, 93.867), reflecting the NIH’s multi-institute participation typical of BRAIN-related efforts. The original closing date listed is 2021-10-29, and the funding opportunity was created on 2018-08-28. The award ceiling and expected number of awards are not specified in the provided source text, so applicants would normally need to consult the full RFA and NIH guide notices for budget expectations, consortium scope, and any institute-specific priorities.

In plain terms, this grant opportunity is meant for teams that can responsibly leverage invasive clinical neurosurgical access to answer major questions about how the human brain works, while building shared methods and shared datasets that outlive any single project. It rewards proposals that combine careful experimental design, strong quantitative thinking, and a serious plan for harmonization, ethics, and data sharing through an NIH-run consortium model.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.313, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2018-08-28.
• Applicants must submit their applications by 2021-10-29. (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.

Apply for RFA NS 19 001

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