BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (R01 Clinical Trial Not Allowed)

Open Posted

Opportunity number
RFA-NS-28-010
Agency
Applications due
Award size
Not on record

Opportunity facts

Funding instrument
Cooperative Agreement
Category
  • Health
Eligible applicants
  • City/Township Governments
  • Public or Indian Housing Auth.
  • Tribal Organizations (Not Federally Recognized)
  • Other
  • Non-501(c)(3) Nonprofits
  • Higher Education Inst. (Private)
  • State Governments
  • Small Businesses
  • For Profit Organizations
  • County Governments
  • 501(c)(3) Nonprofits
  • Independent School Districts
  • Higher Education Inst. (Public)
  • Tribal Governments (Federally Recognized)
  • Special District Governments
Points of contact

Opportunity details come from Grants.gov. Updated .

About this opportunity

Written by GovTribe AI ·

The National Institute of Neurological Disorders and Stroke (NINDS), in partnership with ten other NIH institutes and centers, is soliciting applications for transformative mechanistic research on human brain function using invasive neural recording and stimulating technologies, with an application due date of February 8, 2029. Clinical trials are not allowed under this opportunity.

Eligible applicants include higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, state and local governments, Indian tribal governments (federally recognized and non-federally recognized), special district governments, federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Foreign organizations are not eligible; however, foreign components of U.S. organizations, unfunded international collaborations, and foreign consultants are permitted. Applicants may not propose foreign subawards or subcontracts.

The opportunity will utilize the U01 activity code (cooperative agreement). NINDS intends to commit approximately $8 million total to fund approximately five awards per receipt date. Project periods do not exceed five years, and anticipated direct costs generally do not exceed $1 million per award.

Applications must propose fundamental neuroscience research investigating how dynamic neural activity generates internal experiences (sensations, perceptions, emotions, thoughts, memories) and observable behaviors by leveraging invasive surgical procedures providing direct brain access. Proposed studies should employ rigorous, mechanistic, and innovative approaches guided by theoretical constructs or quantitative models. Complementary experimental models or systems strengthening mechanistic understanding are encouraged. All program directors and principal investigators must commit at least 2.4 person-months throughout the award period and maintain valid ORCID IDs in eRA Commons.

Mandatory application components include a one-page Team Management Plan addressing organizational structure, governance, and decision-making; a Data Management and Sharing Plan compliant with BRAIN Initiative requirements; and detailed neuroethical considerations addressing informed consent, FDA risk assessment, device maintenance and removal, and long-term patient care. Funded investigators must participate in a NIH-coordinated consortium working group establishing consensus standards, standardizing data collection and sharing, and addressing neuroethical considerations. Travel costs for up to two key personnel to attend the BRAIN Initiative Biennial Conference are allowable budget items.

Review criteria emphasize significance and innovation of high-impact human neuroscience questions; rigor and feasibility of mechanistic approaches including appropriate sample sizes and justification for human patient cohorts and invasive procedures; and expertise of interdisciplinary teams comprising clinicians, scientists, device engineers, data scientists, regulatory specialists, and ethics experts.

The opportunity is assigned to parent grant programs including Mental Health Research Grants (CFDA 93.242), Alcohol Research Programs (93.273), Drug Use and Addiction Research Programs (93.279), Child Health and Human Development Extramural Research (93.865), Research Related to Deafness and Communication Disorders (93.173), Discovery and Applied Research for Technological Innovations to Improve Human Health (93.286), Extramural Research Programs in the Neurosciences and Neurological Disorders (93.853), 21st Century Cures Act - Brain Research through Advancing Innovative Neurotechnologies (93.372), Aging Research (93.866), Research and Training in Complementary and Integrative Health (93.213), and Vision Research (93.867).

Synopsis

This funding opportunity supports transformative, mechanistic research aimed at understanding how the human brain functions. Applications should seek to reveal how the dynamic activity of individual neurons and ensembles of neurons within spatially organized brain networks gives rise to internal experiences, such as sensations, perceptions, emotions, thoughts, and memories, as well as to observable motor and social behaviors.
To achieve fundamental mechanistic insights into human brain function, proposed studies are expected to leverage opportunities made possible by invasive surgical procedures in humans, such as intracranial recording or stimulation. These investigations may be enhanced by incorporating complementary experimental models or systems that provide access to knowledge, techniques, or resources not otherwise available in human neuroscience research. Such integration is encouraged to strengthen the mechanistic understanding of human brain function and to connect discoveries across species and biological scales. This program builds on cutting-edge advances enabled by the BRAIN Initiative and the broader neuroscience community.
Projects supported through this opportunity are expected to produce transformative outcomes by the end of the funding period. Approaches should be rigorous, mechanistic, and innovative by (1) maximizing opportunities to conduct innovative in vivo human neuroscience research made available by direct access to the human brain from invasive surgical procedures, (2) employing approaches guided by specified theoretical constructs and/or quantitative, mechanistic models.
Funded investigators will join a consortium working group, coordinated by the NIH, to identify consensus standards of practice, including neuroethical considerations, to collect and provide data for ancillary studies, and to aggregate and standardize data for dissemination among the wider scientific community.

Eligibility

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Files

File Type Posted
PKG00294275.pdf PDF
RFA-NS-28-010-Full-Announcement.html HTML file

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