RFA-DC-27-004: BRAIN Initiative Exploratory Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (R61)
NIH BRAIN Initiative award for exploratory human neuroscience using direct intracranial recording with or without stimulation, with clinical trials not allowed, up to $700,000 in direct costs per year and a 3-year maximum project period.
RFA-DC-27-004: BRAIN Initiative Exploratory Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (R61)
At a glance
| Field | Detail |
|---|---|
| Opportunity type | NIH Notice of Funding Opportunity (NOFO) |
| Activity code | R61 Phase 1 Exploratory/Developmental Grant |
| Notice title | RFA-DC-27-004: BRAIN Initiative: Exploratory Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (R61 Clinical Trial Not Allowed) |
| Focus | Fundamental human neuroscience using direct intracranial recording with or without stimulation |
| Posted | 2026-05-04 |
| Open date | 2026-05-09 |
| First receipt date | 2026-06-09, now passed |
| Current receipt date | 2027-02-11 at 5:00 PM local time of the applicant organization |
| Notice expiration | 2027-02-12 |
| Funds announced | Estimated $6 million in total costs per receipt date |
| Expected awards | Approximately 5 awards per receipt date |
| Budget cap | Up to $700,000 in direct costs per year, excluding facilities and administrative costs for consortia |
| Project period | Up to 3 years |
| Clinical trials | Not allowed |
| Why applicants submit | To answer high-impact human neuroscience questions through exploratory, feasibility-oriented research and coordinated data collection |
The first receipt date for this notice, 2026-06-09, has passed. The official announcement also lists 2027-02-11 as a second receipt date, so the opportunity remains usable for applicants preparing for that date. This page is not a historical-only entry: the front matter carries the upcoming published date, while the body records the earlier date for context. Applications are due by 5:00 PM local time of the applicant organization, and the notice expires on 2027-02-12.
Program purpose and fit
The National Institute on Deafness and Other Communication Disorders (NIDCD), together with NIH BRAIN Initiative partners, uses this R61 NOFO to support exploratory human neuroscience made possible by invasive clinical procedures. The announcement is built around direct intracranial recording, with or without stimulation, in precisely localized brain structures. Its scientific aim is to study how activity in single cells and neuronal ensembles within organized networks relates to sensations, perceptions, emotions, thoughts, memories, and observable motor or social behavior.
The opportunity is a fit for a clearly framed fundamental question that cannot be answered adequately without direct intracranial access. A proposal should connect the question to a theoretical or conceptual framework, explain the computational models or analytical methods that will drive interpretation, and show how the team will obtain interpretable data during limited clinical access windows. Multisite teams may be appropriate when combining sites is necessary to assemble enough participants, harmonize methods, or address a question with greater statistical strength.
This is not a therapeutic efficacy mechanism. The NOFO does not allow clinical trials, and it is not intended for explicitly disease-related research. A project may produce knowledge relevant to nervous-system disorders, but its central contribution should be a fundamental neuroscience result rather than a test of whether a treatment improves a patient outcome. Teams should also distinguish this research mechanism from separate BRAIN efforts supporting new device development or regulatory approval.
The award is exploratory, but “exploratory” does not mean underspecified. Reviewers will need to see why the access opportunity is real, how recording or stimulation will be performed, what data will be collected, and how the analysis will distinguish a meaningful result from an artifact. Projects should also explain how methods and data can be harmonized across sites when more than one institution participates.
Supported work and boundaries
The official announcement expects applications to propose fundamental human neuroscience using direct intracranial recording with or without stimulation technologies. Relevant work can include questions about neural representations, circuit dynamics, perception, memory, decision-making, emotion, movement, or social behavior when the research design requires the unique access created by an invasive procedure. The work should make clear what the procedure enables that non-invasive measurements, retrospective data, or animal work alone cannot provide.
The notice also expects recipients to join an NIH-coordinated consortium working group. That group will address consensus standards of practice, including neuroethical considerations, collection of data for ancillary studies, and aggregation and standardization for wider dissemination. A team therefore needs a credible plan for shared methods, curation, analysis, and communication, not just a strong experiment at one site.
Several project types are outside the call’s stated purpose:
- a clinical trial or a study whose main endpoint is therapeutic efficacy;
- explicitly disease-related research rather than a fundamental neuroscience question;
- device development or regulatory approval as the primary deliverable;
- a proposal that does not require direct intracranial recording or stimulation;
- a study that omits neuroethical considerations or the required team management plan; and
- a plan that cannot explain how limited clinical opportunities will produce feasible, interpretable data.
Human-subjects research is allowed when it is not a clinical trial and follows the notice’s requirements. The application must address consent, risk communication, device maintenance and removal, the relationship between clinical and research roles, therapeutic misconception, undue influence, participant capacity, compensation, and care for patients after the study. These are core design issues in this call, not material to add after the scientific plan is complete.
Award amount and project structure
The issuing institute and partner components intend to commit an estimated $6 million in total costs for approximately 5 awards per receipt date. That estimate is not a guaranteed award amount for an individual applicant. A project budget may not exceed $700,000 in direct costs in any single year, excluding facilities and administrative costs for consortia. The maximum project period is 3 years, although the proposed scope should determine the requested period.
Within that ceiling, applicants should explain the actual needs of the study. A credible budget may need to cover clinical coordination, participant-facing procedures, device or recording support, data acquisition and curation, secure storage, statistical or computational analysis, cross-site harmonization, regulatory support, and the personnel needed for neuroethical oversight. A multisite proposal should identify which costs belong to each participating organization and should not assume that the annual limit can be exceeded because the project has several sites.
The NOFO does not require cost sharing. The funding instrument is a grant, and the allowed application types are New, Resubmission, and Revision. The “Clinical Trial?” designation is “Not Allowed,” although activities involving human subjects that are not clinical trials may be proposed.
Eligibility and collaboration rules
Eligible applicant categories include public and private higher education institutions; nonprofits with or without 501(c)(3) status; small businesses and other for-profit organizations; state, county, city or township, and special district governments; federally recognized and other tribal governments; eligible federal agencies; U.S. territories or possessions; independent school districts; public housing authorities; Native American tribal organizations; faith-based or community-based organizations; and regional organizations.
Non-domestic foreign organizations are not eligible to apply, and non-domestic components of U.S. organizations are not eligible. Foreign components, as defined by NIH policy, are allowed. However, the notice says that applications involving foreign subawards or subcontracts will be deemed noncompliant and will not be considered for funding. Unfunded international collaboration, foreign consultants, and procurement of unique equipment or supplies from foreign vendors are treated differently in the notice, but the proposed funding path must be checked carefully before submission.
Each PD/PI must have an eRA Commons account and a personal profile linked to a valid ORCID ID. The applicant organization must complete and maintain the required registrations before submission. Registration can take 6 weeks or more, and the notice states that a registration delay is not a valid reason for a late submission.
How to apply for the current receipt date
- Confirm that the organization and every funded collaboration fit the eligibility rules. Remove any foreign subaward or subcontract from the funding plan, and document any allowed foreign component or unfunded collaboration.
- Complete active SAM registration and obtain the organization’s UEI. Register the organization in eRA Commons and Grants.gov, and ensure that each PD/PI has the required eRA Commons account and linked ORCID ID.
- Build the scientific team around the access opportunity. The notice encourages integrated teams that may include clinicians, scientists, device engineers, mathematicians, statisticians, data scientists, regulatory experts, and ethics specialists.
- Prepare the application using the NIH Research (R) Instructions and the program-specific requirements in this NOFO. Use NIH ASSIST, an institutional system-to-system solution, or Grants.gov Workspace.
- Include the required one-page PDF “Team management plan” as a separate Other Attachment. It must describe the organizational structure, show an organizational chart, explain leadership governance and communications, set out decision-making and conflict-resolution processes, address publication and authorship policies, establish a Scientific Steering Group, and describe how investigators will work across disciplinary boundaries. An application without this attachment is incomplete and will not be reviewed.
- In the Research Strategy, explain the fundamental neuroscience question, the theoretical or conceptual framework, computational models and analytical methods, why direct intracranial access is necessary, and how recruitment, methods, collection, curation, and analysis will be harmonized across sites where appropriate.
- Address the required human-subjects and neuroethics issues. Include consent methods that reduce coercion, undue influence, and therapeutic misconception; explain device maintenance and removal; describe the clinical investigator and research investigator roles; and provide a long-term plan for patients after the study period when appropriate.
- Submit through Grants.gov and complete the tracking process in eRA Commons. The deadline for the current listed receipt date is 2027-02-11 at 5:00 PM local time of the applicant organization. Submit early enough to correct system errors before the deadline.
The first listed receipt date, 2026-06-09, should not be used as the live deadline. It is retained here only to explain the notice’s two-date schedule. The application target for this page is 2027-02-11, and the notice expires on 2027-02-12.
What a competitive application should make easy to understand
The reviewer should be able to trace a clean line from clinical access to a fundamental question, from the question to a measurable neural or behavioral observation, and from that observation to an analysis that can test the proposed explanation. The application should state what is recorded or stimulated, when the opportunity occurs, how the signal is synchronized with behavior or task events, what quality controls are applied, and how missing or site-specific data will be handled.
The proposal should also show that the team can operate across disciplines. The one-page management plan is not a formality: it is the place to show who makes scientific decisions, how sites communicate, how conflicts are handled, how authorship is determined, and how a Scientific Steering Group will monitor progress. For a multisite study, the research plan should make recruitment, protocol harmonization, data dictionaries, curation, analysis, and sharing responsibilities concrete.
Neuroethics should be integrated with the study design. Explain how participants will understand the difference between clinical care and research, how consent will be obtained without pressure, and what will happen to an indwelling device or related hardware at the end of approved research activities. Include a long-term patient-care plan when the project creates a continuing obligation. A proposal that leaves these issues to a generic institutional review board statement is incomplete under this notice.
Applicant checklist
- Confirm the 2027-02-11 receipt date and the 5:00 PM local-time deadline.
- Confirm eligible organization status and remove foreign subawards or subcontracts.
- Complete SAM, UEI, Grants.gov, and eRA Commons registrations before submission.
- Verify an eRA Commons account and linked ORCID ID for every PD/PI.
- Secure a realistic clinical access pathway and define the recording or stimulation protocol.
- State the fundamental neuroscience question and why direct intracranial access is necessary.
- Prepare the required one-page team management plan with an organizational chart and Scientific Steering Group.
- Include the required theoretical, computational, analytical, recruitment, harmonization, and data-management details in the Research Strategy.
- Address consent, undue influence, therapeutic misconception, device maintenance or removal, and long-term patient care.
- Check the annual $700,000 direct-cost limit and the maximum 3-year project period.
- Submit through NIH ASSIST, institutional system-to-system submission, or Grants.gov Workspace, then track the application in eRA Commons.
Frequently asked questions
Is the opportunity closed because 2026-06-09 passed?
No. That was the first receipt date. The same official NOFO lists 2027-02-11 as the second receipt date, so the current page carries 2027-02-11 as its deadline. The notice expires on 2027-02-12.
How much can an applicant request?
The annual budget may not exceed $700,000 in direct costs, excluding facilities and administrative costs for consortia. The maximum project period is 3 years. NIH and partner components estimate $6 million in total costs for approximately 5 awards per receipt date, but that estimate is not a promise to fund a particular application at a fixed amount.
Can a clinical trial be proposed?
No. The funding opportunity is marked Clinical Trial Not Allowed. Human-subjects research may be included when it is not a clinical trial and the proposal meets the notice’s scientific and neuroethical requirements.
Can organizations outside the United States apply?
No. Foreign organizations and non-domestic components of U.S. organizations are not eligible to apply. Foreign components may be allowed, but foreign subawards and subcontracts are prohibited for this NOFO and would make an application noncompliant.
What is the required team management plan?
It is a separate PDF Other Attachment of no more than 1 page. It must cover the team structure and organizational chart, governance, communications, scientific decision-making, conflict resolution, publication and authorship policies, a Scientific Steering Group, and plans to help investigators work across disciplinary boundaries. Missing this item makes the application incomplete and not eligible for review.
Who should be contacted with program questions?
The announcement lists the Research Opportunities in Humans Program at NIDCD as the scientific/research contact and gives BRAINeROH@ninds.nih.gov. Application-system questions go to the eRA Service Desk or Grants.gov Support Center, while grants-management questions go to NIDCD Grants Management.