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.Apply for RFA NS 19 001
- 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.
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Frequently Asked Questions (FAQs)
What is the name of this NIH funding opportunity?
The opportunity is titled "BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01 Clinical Trial Required)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-NS-19-001.
What is this program trying to support, in plain language?
This program supports ambitious human neuroscience studies that use rare, high-value clinical situations where neurosurgical procedures allow direct recording from, and stimulation of, precisely targeted brain structures. The aim is to generate robust, generalizable findings by moving beyond small, isolated studies toward larger, more integrated efforts.
Why does the NIH emphasize invasive neural recording and stimulation?
Because invasive approaches in patients can reveal brain function with anatomical and physiological precision that noninvasive methods often cannot reach, especially when recording from or stimulating specific brain structures during neurosurgical access.
What kinds of clinical situations is this opportunity designed around?
It is designed around clinical care scenarios where patients already have neurosurgical access that permits direct recording and/or stimulation of targeted brain structures, enabling in vivo research in humans while respecting patient safety and clinical workflow.
What are the main barriers this program is trying to overcome?
The description highlights common constraints in invasive human neuroscience, including small patient cohorts, site-specific protocols, and practical limits imposed by clinical care. These issues can make complex experiments difficult and can also make it challenging to combine results across sites with strong statistical power.
What is the award mechanism?
The award mechanism is a U01 cooperative agreement.
What does a "U01 cooperative agreement" mean for applicants?
A cooperative agreement indicates substantial NIH scientific involvement and coordination. Projects are expected to operate with NIH participation rather than functioning as fully independent investigator-initiated grants.
Is a clinical trial required?
Yes. The opportunity is labeled "Clinical Trial Required," meaning the proposed work must meet the NIH definition of a clinical trial.
What does "Clinical Trial Required" imply from an administrative and compliance standpoint?
Applicants should be prepared for clinical trial-related requirements described in the opportunity summary, including human subjects protections, trial registration, oversight, and reporting.
What is the overall scientific goal of this RFA?
The goal is to enable high-impact, in vivo research in humans by building multidisciplinary teams capable of executing sophisticated experimental protocols during invasive neurosurgical access, while maintaining ethical boundaries, patient safety, and alignment with clinical workflow.
What does NIH mean by "high-impact questions in human neuroscience" here?
The RFA emphasizes questions that are uniquely addressable through invasive access in humans, rather than studies that mainly repeat findings that could be achieved through noninvasive imaging or animal models.
How important is team science to this opportunity?
Team science is a major emphasis. NIH is seeking diverse, integrated, multidisciplinary groups that can bridge relevant domains as needed for the project aims.
What disciplines are specifically called out as relevant for teams?
The opportunity explicitly mentions integration across areas such as neuroscience, neurosurgery, neurology, psychiatry, engineering, computation, biostatistics, ethics, and related fields as needed for the proposed aims.
Does the program encourage multi-site or cross-institution collaboration?
Yes. 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.
What does the RFA say about scientific rigor and interpretability?
Projects are expected to be guided by clear theoretical constructs and, where appropriate, quantitative and mechanistic models. The description points toward proposals that go beyond reporting correlations and instead articulate theory-grounded hypotheses, measurable variables and outcomes, and quantitative frameworks linking recordings and stimulation effects to relevant phenomena.
Is purely correlational analysis discouraged?
The summary indicates a preference for mechanistic understanding rather than only describing correlations in neural activity. Competitive projects are expected to connect neural measures and perturbations to interpretable constructs and outcomes.
What does "mechanistic understanding" mean in the context of this opportunity?
It refers to explaining how neural circuits generate function and how perturbing those circuits (for example, through stimulation) changes behavior or symptoms, consistent with broader BRAIN Initiative objectives described in the opportunity.
Is there a consortium component?
Yes. Awardees will participate in an NIH-coordinated consortium work group.
What is the consortium expected to do?
The consortium work group is intended to develop and align "consensus standards of practice," including technical and analytic standards (such as harmonizing recording parameters, stimulation protocols, metadata, and outcome measures) and explicit attention to neuroethical considerations.
What kinds of standards are mentioned as targets for harmonization?
The description includes harmonization of recording parameters, stimulation protocols, metadata, and outcome measures, along with shared technical and analytic approaches.
How does neuroethics factor into the consortium and project expectations?
Neuroethical considerations are built into the collaborative framework. The summary notes sensitivity around issues such as consent under clinical vulnerability, privacy risks from neural data, incidental findings, and boundaries between research and clinical intervention.
What data sharing or dataset expectations are described?
The opportunity indicates that participation includes generating data that can support ancillary studies, contributing to aggregation and standardization efforts, and enabling dissemination and reuse of datasets by the broader scientific community.
Does this opportunity emphasize reuse and broader community value of the data?
Yes. The summary explicitly describes aggregation, standardization, dissemination, and reuse so that datasets can support ancillary studies and serve the broader scientific community beyond a single project.
Who is eligible to apply as an applicant organization?
Eligibility is broad and includes, among others: 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.
Are minority-serving institutions and specific organization types mentioned as eligible?
Yes. The RFA calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.
Are foreign (non-U.S.) institutions eligible to apply as the applicant organization?
No. Foreign institutions (non-U.S. entities) are not eligible to apply as applicant organizations.
Can a U.S.-based applicant include international or non-U.S. components?
Yes. Non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined in the NIH Grants Policy Statement, meaning a U.S.-based applicant can include certain international elements when justified and compliant with NIH policy.
What is the funding instrument type?
The funding instrument is a cooperative agreement.
How is this opportunity categorized administratively?
It is categorized as a discretionary program, with the activity category shown under Education, Health, Income Security and Social Services.
Which CFDA numbers are associated with this opportunity?
The summary lists multiple CFDA numbers: 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.313, 93.853, 93.865, 93.866, and 93.867.
When was this funding opportunity created?
The opportunity was created on 2018-08-28.
What closing date is listed in the provided information?
The original closing date listed is 2021-10-29.
Are the award ceiling and expected number of awards provided?
No. The award ceiling and expected number of awards are not specified in the provided source text. The summary notes that applicants would normally consult the full RFA and NIH guide notices for budget expectations, consortium scope, and any institute-specific priorities.
What kind of applicant approach seems most aligned with the RFA summary?
Based on the description, the most aligned approach is a coordinated, multidisciplinary team effort that can run sophisticated invasive human neuroscience protocols during neurosurgical access, incorporate strong quantitative and mechanistic framing, participate in NIH consortium standard-setting, and contribute harmonized, reusable datasets while prioritizing ethics and patient safety.
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