Opportunity Information: Apply for RFA DC 27 004

The NIH BRAIN Initiative funding opportunity titled "Exploratory Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (R61 Clinical Trial Not Allowed)" supports early, feasibility-focused projects that take advantage of rare clinical situations where the human brain can be accessed directly during medically indicated invasive procedures. The core idea is to use intracranial recordings and stimulation in precisely localized brain structures to study, in living humans, how single neurons and coordinated neural ensembles operate within organized networks to produce internal mental states such as sensation, perception, emotion, thought, and memory, and how those neural dynamics relate to observable behaviors, including motor and social behavior.

This is an exploratory, planning-and-development style award. Applicants are expected to propose research aimed at establishing feasibility and generating early-stage evidence or methods that could realistically enable a later, larger follow-on project (for example, a subsequent research project grant application) focused on invasive human neural recording and stimulation. In other words, the work should be positioned as a critical first step: developing approaches, pipelines, experimental paradigms, analytic frameworks, and practical workflows that make high-impact invasive human neuroscience more doable, more rigorous, and more scalable. Projects are expected to maximize the scientific value of direct brain access created by neurosurgical contexts, emphasizing innovative in vivo human neuroscience that cannot be achieved with noninvasive tools alone.

A major emphasis of the program is that studies should be guided by clear theoretical constructs and, where appropriate, quantitative and mechanistic models. This signals that NIH is looking for more than descriptive correlations; the opportunity is meant to encourage projects that can test specific hypotheses about neural computation and circuit function, using modeling and quantitative analysis to connect neural activity patterns to cognition and behavior. The announcement also highlights the importance of multidisciplinary teams, including newly formed teams as well as established collaborations, reflecting the practical reality that invasive human neuroscience typically requires close integration of clinical expertise, engineering and device know-how, cognitive and systems neuroscience, computational modeling, statistics, and ethics.

Awardees will not operate in isolation. Funded recipients will join a consortium working group coordinated by NIH. Through this consortium structure, teams will collaborate on identifying consensus standards of practice for invasive human recording and stimulation research, including neuroethical considerations that arise when studying the human brain in clinical settings. The consortium also expects participants to contribute data in ways that enable ancillary studies, and to support aggregation and standardization of datasets so that results can be disseminated and reused by the wider scientific community. Practically, this means applicants should anticipate shared expectations around data organization, metadata capture, documentation, and harmonized methods, as well as active participation in collaborative discussions about best practices and responsible conduct.

The award mechanism is an R61 and explicitly does not allow clinical trials, so proposed activities must fit within a non-clinical-trial research framework even though they occur in clinical environments. The focus is on using opportunities created by invasive procedures to answer neuroscience questions and develop enabling capabilities, not on testing interventions for patient outcomes in a way that meets the NIH definition of a clinical trial.

Key administrative details from the notice include a grant funding instrument, an award ceiling of $700,000, and an expectation of around five awards. The opportunity is listed under Funding Opportunity Number RFA-DC-27-004, with an original closing date of February 11, 2027, and it is administered by NIH. A wide range of applicant organizations are eligible, including many U.S. public entities (such as state, county, city, and special district governments), public and private institutions of higher education, tribal governments and eligible tribal organizations, nonprofits (with or without 501(c)(3) status), and for-profit organizations (including small businesses). However, non-U.S. entities are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible. At the same time, foreign components, as defined in the NIH Grants Policy Statement, are allowed, which generally means certain international collaborations can be included in a compliant way without the foreign organization serving as the applicant institution.

Overall, this NOFO is designed to seed the next wave of rigorous, ethically grounded invasive human neuroscience by funding teams to prove feasibility, build the methodological and analytical foundations, and contribute to shared standards and shared data resources, all aimed at clarifying how coordinated activity across neurons and networks generates the experiences and behaviors that define human brain function.

  • The National Institutes of Health in the health 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 Clinical Trial Not Allowed)" 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, 93.853, 93.865, 93.866, 93.867.
  • This funding opportunity was created on 2026-05-04.
  • Applicants must submit their applications by 2027-02-11.
  • Each selected applicant is eligible to receive up to $700,000.00 in funding.
  • The number of recipients for this funding is limited to 5 candidate(s).
  • 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 DC 27 004

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FAQs: NIH BRAIN Initiative - Exploratory Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (R61 Clinical Trial Not Allowed)

What is this funding opportunity?

This NIH BRAIN Initiative opportunity supports exploratory, feasibility-focused research that uses rare clinical situations where the human brain can be accessed directly during medically indicated invasive procedures. It is intended to help teams establish early-stage feasibility, methods, and evidence for invasive human neuroscience projects.

What is the official Funding Opportunity Number (FON)?

The Funding Opportunity Number is RFA-DC-27-004.

What award mechanism is being used?

The award mechanism is an R61.

Are clinical trials allowed under this opportunity?

No. This is an R61 "Clinical Trial Not Allowed" opportunity, so proposed activities must fit within a non-clinical-trial research framework even if they take place in clinical environments.

What kind of projects is NIH trying to support here?

NIH is looking for early, planning-and-development style projects that use invasive intracranial recording and stimulation in precisely localized brain structures to study how single neurons and coordinated neural ensembles operate within networks to produce internal mental states (for example sensation, perception, emotion, thought, and memory) and how those neural dynamics relate to observable behaviors (including motor and social behavior).

What is the central scientific idea behind the NOFO?

The core idea is to take advantage of direct brain access available during medically indicated neurosurgical contexts to study neural activity in living humans at a resolution and specificity not achievable with noninvasive tools alone, and to use that access to develop enabling methods and workflows for high-impact invasive human neuroscience.

What does "exploratory" mean in the context of this R61?

It means the work is expected to focus on establishing feasibility and generating early-stage evidence, methods, or capabilities that could realistically enable a later, larger follow-on project (for example, a subsequent research project grant application) focused on invasive human neural recording and stimulation.

What kinds of deliverables or foundations are applicants expected to build?

Applicants are expected to develop approaches and practical foundations such as pipelines, experimental paradigms, analytic frameworks, and workflows that make invasive human neuroscience more doable, more rigorous, and more scalable, while maximizing the scientific value of direct brain access.

Why does the NOFO emphasize that this work cannot be done with noninvasive tools alone?

The opportunity is specifically designed to support innovative in vivo human neuroscience that leverages intracranial recordings and stimulation in precisely localized brain structures, emphasizing scientific questions and enabling methods that are not achievable using only noninvasive approaches.

How important are theory and modeling in proposed studies?

They are a major emphasis. Studies are expected to be guided by clear theoretical constructs and, where appropriate, quantitative and mechanistic models. This signals an interest in projects that move beyond descriptive correlations toward testing specific hypotheses about neural computation and circuit function.

Is NIH looking for purely descriptive studies?

The NOFO highlights an emphasis on clear theoretical constructs and quantitative/mechanistic models, suggesting NIH is looking for more than descriptive correlations and is encouraging hypothesis-driven work that connects neural activity patterns to cognition and behavior using modeling and quantitative analysis.

What types of expertise are expected on project teams?

The NOFO emphasizes multidisciplinary teams, reflecting the reality that invasive human neuroscience typically requires integration of clinical expertise, engineering and device know-how, cognitive and systems neuroscience, computational modeling, statistics, and ethics. Newly formed teams as well as established collaborations are encouraged.

Will awardees be expected to participate in a consortium?

Yes. Funded recipients will join a consortium working group coordinated by NIH.

What does participation in the NIH consortium working group involve?

Through the consortium structure, teams will collaborate on identifying consensus standards of practice for invasive human recording and stimulation research, including neuroethical considerations that arise when studying the human brain in clinical settings.

What are the data sharing expectations described in the NOFO?

The consortium expects participants to contribute data in ways that enable ancillary studies and to support aggregation and standardization of datasets so results can be disseminated and reused by the wider scientific community. Applicants should anticipate shared expectations around data organization, metadata capture, documentation, and harmonized methods.

Does the NOFO mention neuroethics?

Yes. The consortium working group will address neuroethical considerations that arise when studying the human brain in clinical settings, and participants are expected to engage in discussions about best practices and responsible conduct.

What is the maximum award amount (award ceiling)?

The notice lists an award ceiling of $700,000.

How many awards does NIH expect to make?

The notice states an expectation of around five awards.

When is the closing date for this opportunity?

The original closing date is February 11, 2027.

Which federal agency administers this opportunity?

The opportunity is administered by the National Institutes of Health (NIH).

Who is eligible to apply?

A wide range of U.S. applicant organizations are eligible, including U.S. public entities (such as state, county, city, and special district governments), public and private institutions of higher education, tribal governments and eligible tribal organizations, nonprofits (with or without 501(c)(3) status), and for-profit organizations (including small businesses).

Are non-U.S. organizations eligible to apply as the applicant institution?

No. Non-U.S. entities are not eligible to apply.

Are non-U.S. components of U.S. organizations eligible?

No. Non-U.S. components of U.S. organizations are not eligible.

Are foreign components allowed at all?

Yes. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. This generally means certain international collaborations can be included in a compliant way without the foreign organization serving as the applicant institution.

What kinds of human research settings does this NOFO assume?

The NOFO is built around rare clinical situations where the human brain can be accessed directly during medically indicated invasive procedures, enabling intracranial recording and stimulation in living humans.

What is the relationship between the research and the clinical procedure?

The focus is on using opportunities created by medically indicated invasive procedures to answer neuroscience questions and develop enabling capabilities, rather than testing interventions for patient outcomes in a way that meets the NIH definition of a clinical trial.

What is the overall goal of the NOFO?

The NOFO is designed to seed the next wave of rigorous, ethically grounded invasive human neuroscience by funding teams to prove feasibility, build methodological and analytical foundations, and contribute to shared standards and shared data resources aimed at clarifying how coordinated neural activity generates human experiences and behaviors.

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