The BRAIN Initiative: Research on the Ethical Implications of Advancements in Neurotechnology and Brain Science (R21 Clinical Trial Optional) aims to fund exploratory/developmental research on core ethical issues arising from human brain research and emerging neurotechnologies supported by the BRAIN Initiative.
Target recipients include a broad range of organizations such as: higher education institutions, non-profits, for-profit organizations (including small businesses), local governments, and federal government entities.
This is a SECTOR-SPECIFIC grant, focused on neuroscience, neuroethics, and biomedical research.
Geographic scope is global, open to U.S. entities and non-U.S. (foreign) entities.
Key filtering criteria: Proposed research must address ethical implications of BRAIN Initiative advancements, be exploratory/developmental in nature (R21), and potentially higher-risk with high impact.
This grant is recurring, with annual funding opportunities expected for fiscal years 2025, 2026, and 2027.
Financial Structure
Budget Range: The combined budget for direct costs for the two-year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.
Eligible Costs: Pre-award costs are allowable as described in the NIH Grants Policy Statement.
Matching Fund Requirements: No matching funds are required.
Co-financing Requirements: No co-financing is required.
Payment Schedule and Mechanisms: Not explicitly detailed, but typically follows NIH grant disbursement processes upon award.
Financial Reporting Requirements: Recipients must submit financial statements as required by the NIH Grants Policy Statement and an expenditure data portion of the Federal Financial Report for closeout.
Audit Requirements: Not explicitly detailed, but subject to standard federal audit requirements for grants.
Indirect Cost Policies: NIH grants have specific indirect cost policies; applicants should refer to the NIH Grants Policy Statement.
Financial Guarantees Required: None specified.
Currency: USD
Eligibility Requirements
Organizational Types
Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Nonprofits with 501(c)(3) IRS Status
Nonprofits without 501(c)(3) IRS Status
For-Profit Organizations (including Small Businesses and Other For-Profits)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal (Federally Recognized and Other))
Eligible Agencies of the Federal Government (including NIH Intramural Program)
U.S. Territory or Possession entities
Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than Federally recognized tribal governments), Faith-based/Community-based Organizations, Regional Organizations.
Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are allowed.
Geographic Requirements
Open to organizations located in the U.S. and foreign countries.
Registration Requirements
Applicant organizations must complete and maintain active registrations in:
System for Award Management (SAM) - requires annual renewal.
Unique Entity Identifier (UEI) - issued via SAM.gov registration.
eRA Commons - identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI).
Follow instructions in the Research (R) Instructions in the How to Apply - Application Guide.
SF424(R&R) Cover
SF424(R&R) Project/Performance Site Locations
SF424(R&R) Other Project Information
SF424(R&R) Senior/Key Person Profile (with eRA Commons ID for all PD(s)/PI(s))
R&R or Modular Budget
R&R Subaward Budget
PHS 398 Cover Page Supplement
PHS 398 Research Plan (including Research Strategy, Current State-of-the-Art Statement, optional Preliminary Data, Project Timeline and Milestones)
Resource Sharing Plan
Data Management and Sharing Plan (effective for due dates on or after January 25, 2023)
Appendix (limited materials allowed)
PHS Human Subjects and Clinical Trials Information (if applicable)
PHS Assignment Request Form
Project Implementation and Reporting
Project Duration: Limited to 2 years.
Annual Milestones: Applications must include annual milestones; failure to do so will result in withdrawal.
Reporting Schedule:
Annual Research Performance Progress Report (RPPR).
Financial statements as required by NIH Grants Policy Statement.
Final RPPR, invention statement, and expenditure data for closeout.
Post-Award Requirements
Compliance with NIH Grants Policy Statement terms and conditions.
ClinicalTrials.gov registration and results reporting for applicable clinical trials.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval for protocols.
Data and Safety Monitoring Requirements for human biomedical and behavioral intervention studies.
Compliance with Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements if applicable.
Adherence to Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.
Reporting to the Federal Subaward Reporting System (FSRS) for subawards over $25,000.
Semiannual disclosures regarding civil, criminal, and administrative proceedings for entities with cumulative federal awards over $10,000,000.
Evaluation Criteria
Overall Impact
Reviewers will assess the likelihood of the project to exert a sustained, powerful influence on the research field(s).
Scored Review Criteria
Significance:
Addresses an important problem or critical barrier.
Rigor of prior research supporting the project.
Improvement of scientific knowledge, technical capability, or clinical practice.
How successful completion changes concepts, methods, technologies, treatments.
For this NOFO: Accuracy of state of the art description; benefits to brain research and public; strength of case for exploring specific ethical topic; potential for transformative advancements in ethical understanding; implications beyond BRAIN Initiative research; how results inform future phases and transform ethics standards.
Investigator(s):
PD(s)/PI(s), collaborators, and other researchers are well-suited.
Appropriate experience and training (for Early Stage Investigators).
Demonstrated record of accomplishments (for established investigators).
For collaborative/multi-PD/PI projects: complementary expertise, appropriate leadership/governance structure.
For this NOFO: Evidence of highly skilled investigators in interdisciplinary science; leverage of an embedded ethicist approach if appropriate.
Innovation:
Challenges and shifts current research paradigms via novel theoretical concepts, approaches, methodologies, instrumentation, or interventions.
Novelty within one field or broadly.
Proposes refinement, improvement, or new application of concepts/approaches.
Approach:
Overall strategy, methodology, and analyses are well-reasoned and appropriate.
Plans to address weaknesses in rigor of prior research.
Strategies to ensure a robust and unbiased approach.
Presentation of potential problems, alternative strategies, and benchmarks.
Feasibility for early-stage development, management of risky aspects.
Plans to address relevant biological variables (e.g., sex).
For human subjects: protection plans, inclusion/exclusion justifications.
For this NOFO: How research design advances state of the science/technology; clear assessment metrics for advancing beyond state-of-the-art; strength of rationale for high-risk projects; well-described operationally-defined milestones and progress indicators; potential for translational efforts to integrate ethical research into brain research; addressing proof-of-concept tests and alternative strategies; consideration of additional research stemming from the project; well-described methodological approach.
Environment:
Scientific environment contributes to success.
Adequate institutional support, equipment, and physical resources.
Benefit from unique features (scientific environment, subject populations, collaborative arrangements).
Study Timeline: Feasibility, efficiency, utilization of existing resources, discussion of potential challenges.
Protections for Human Subjects: Justification for involvement, protection against risks, potential benefits, knowledge to be gained, data and safety monitoring.
Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Justification for inclusion/exclusion based on scientific goals.
Vertebrate Animals: Description of procedures, justification for species, methods to limit discomfort.
Biohazards: Assessment of potential hazards, adequacy of protection.
Resubmissions: Evaluation of responses to prior comments and changes.
Applications from Foreign Organizations: Assessment of special opportunities for furthering research.
Select Agent Research: Information on agents, registration, monitoring, biosafety, biocontainment, security.
Resource Sharing Plans: Reasonableness of plan or rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity.
Compliance & Special Requirements
Regulatory Compliance
Adherence to NIH Grants Policy Statement.
Compliance with Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
Not subject to intergovernmental review (E.O. 12372).
Data Protection and Privacy
Required Data Management and Sharing Plan, adhering to the 2023 NIH Policy for Data Management and Sharing.
Data must be deposited to relevant data archives developed by the BRAIN Initiative (refer to NOT-MH-19-010).
Consideration of cybersecurity and privacy for human brain data and wireless transmissions to/from neural devices.
Ethical Standards
Strong emphasis on studying core ethical issues associated with human brain research.
Compliance with human subjects protection regulations (45 CFR Part 46) and consenting procedures.
Data and Safety Monitoring (DSM) for clinical trials and human biomedical/behavioral intervention studies.
Intellectual Property
Intellectual property will be managed in accord with established policy of the NIH, in compliance with Executive Order 10096, as amended, 45 CFR Part 7.
Unique Aspects and Strategic Opportunities
Interdisciplinary Research: Encourages multi-disciplinary teams, especially integrating ethicists into BRAIN Initiative-supported research projects.
High-Risk Projects: Welcome if they have the potential for exceptionally high impact, even with limited preliminary data.
Transformative Focus: Seeks novel, transformative approaches that integrate ethical considerations with evolving advancements in BRAIN Initiative research.
Data Sharing: Specific expectations for data sharing for BRAIN Initiative awards, with data deposited into relevant archives.
Clinical Trial Option: Accepts applications that either propose or do not propose clinical trial(s).
Potential Challenges or Limitations
Rigorous compliance with extensive NIH application instructions and policy guidelines is strictly enforced.
Requires detailed planning for human subjects protection and data management/sharing, if applicable.
Applications involving NIH Intramural Research Program have specific funding limitations (no salary/fringe for permanent federal employees, no F&A costs for them).
Grant Details
neurotechnology
neuroscience
brain research
ethics
biomedical research
data privacy
informed consent
neuroethics
r21 grant
exploratory research
developmental research
clinical trial optional
nih
nimh
innovation
research and development
healthcare
technology
social impact
BRAIN Initiative: Research on the Ethical Implications of Advancements in Neurotechnology and Brain Science (R21 Clinical Trial Optional)
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