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Grant Analysis

Purpose & Target

Core Objective: To support exploratory research and planning activities utilizing invasive neural recording and stimulating technologies in the human brain, aiming to establish feasibility, proof-of-principle, and early-stage development that lays the groundwork for potential subsequent, larger-scale research projects (U01 grants).
Target Recipient Type and Size: Eligible for a wide range of organizations including higher education institutions, nonprofits (with and without 501(c)(3) IRS status), for-profit organizations (including small businesses), and various government entities. No specific size restrictions beyond general organizational capability to conduct complex research.
SECTOR-SPECIFIC/SECTOR-AGNOSTIC: SECTOR-SPECIFIC
Geographic Scope: Organizations must be U.S.-based. Foreign components within U.S. organizations are allowed, but foreign institutions are not eligible to apply directly.
Key Filtering Criteria: Must involve basic experimental studies with humans, using invasive neural recording/stimulating technologies, with a clear plan to lead to a future U01 project. Not for clinical trials primarily focused on therapy development or regulatory approval.
Grant Frequency and Program Context: This is a recurring funding opportunity under the broader NIH BRAIN Initiative, with multiple application deadlines through September 2025. It's designed as an R61 (Exploratory/Developmental Grant) to precede a U01 (Cooperative Agreement).

Financial Structure

Budget Range: Application budgets may NOT exceed $700,000 (Direct Costs) in any single year.
Eligible Costs: Equipment, data sharing and management systems (if well justified and unique to the institution), animal research costs, and clinical research costs (if well justified).
Ineligible Costs: Inflationary increases in overall budget or any budget categories. For NIH intramural scientists, salary and related fringe benefits for Federal employees, and administrative/facilities support costs are excluded from the requested funds.
Matching Fund Requirements: This NOFO does NOT require cost sharing.
Co-financing Requirements: Not specified, but the R61 is intended to lead to a U01, implying a potential future funding step.
Payment Schedule and Mechanisms: Standard NIH grant payment mechanisms. Funds are released based on the Notice of Award (NoA) and ongoing reporting.
Financial Reporting Requirements: Recipients must submit an annual Research Performance Progress Report (RPPR) and financial statements as required by the NIH Grants Policy Statement. A final RPPR, invention statement, and expenditure data portion of the Federal Financial Report are required for closeout.
Audit Requirements: Not explicitly detailed, but implied by federal financial reporting and compliance with 45 CFR Part 75 and 2 CFR Part 200.
Financial Sustainability Expectations: The R61 grant itself is exploratory, aiming to establish feasibility for a subsequent, larger U01 project, implying potential for longer-term funding if successful.
Cost-sharing Structures: Not required.
Indirect Cost Policies: Direct Costs are exclusive of facilities and administrative costs for consortia, implying F&A costs are handled separately or additional to the $700,000 direct cost cap.
Budget Flexibility Parameters: Changes in budget should reflect changes in activities required by the science.
Financial Guarantees Required: Not specified.

Eligibility Requirements

Organizational Type

Must be one of the following:
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
Small Businesses
For-Profit Organizations (Other than Small Businesses)
Local Governments (State, County, City or Township, Special District)
Indian/Native American Tribal Governments (Federally Recognized or Other)
Eligible Agencies of the Federal Government (including NIH Intramural program)
U.S. Territory or Possession
Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations

Geographic Requirements

Must be a U.S. organization.
Non-domestic (non-U.S.) entities (Foreign Institutions) 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.

Registration Requirements

Applicant organizations must complete and maintain active registrations in:
System for Award Management (SAM) with annual renewal (includes Unique Entity Identifier - UEI).
NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations in lieu of CAGE code).
eRA Commons (organization must identify at least one Signing Official and one Program Director/Principal Investigator).
Grants.gov (requires active SAM registration).

Individual/Team Requirements

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must have an eRA Commons account.
PD(s)/PI(s) must commit at least 2.4 person months (20% effort on full-year appointment) throughout the duration of the award.
Multidisciplinary teams are strongly encouraged, typically including clinicians, scientists, device engineers, data/computational scientists, regulatory specialists, and/or ethics specialists.

Project Scope Requirements

Must propose basic science experimental studies involving human participants (defined as NIH clinical trials but also basic research).
Must involve invasive neural recording and stimulating technologies in the human brain.
Projects must be exploratory research and planning activities to establish feasibility, proof-of-principle, and early-stage development that would lay groundwork for a subsequent U01 grant (RFA-NS-22-041).

Exclusion Criteria

Clinical trials designed to answer specific questions about safety, tolerability, efficacy, and/or effectiveness of interventions (e.g., Phase I, II, III, or pivotal clinical trials).
Studies designed primarily to develop or improve disease/disorder therapeutics or devices.
Studies for which the primary goal is to achieve regulatory approval of neurotechnology.
Projects focused on the peripheral nervous system.
Imaging approaches not coupled with intracranial interventions, recording or stimulating.
Implementing rehabilitation therapies.
Definitive clinical trials of therapeutic devices.
Projects focused on augmentation of neural function in healthy individuals.
Applications lacking required Neuroethics considerations or Team management plan will not be reviewed.

Application Process

Application Deadlines and Timeline

Letter of Intent Due Dates: August 22, 2023; August 21, 2024; August 20, 2025 (encouraged, not binding).
Application Due Dates: September 22, 2023; September 20, 2024; September 19, 2025 (latest).
Submission Time: All applications are due by 5:00 PM local time of the applicant organization.
Scientific Merit Review: Approximately February 2024, February 2025, February 2026.
Advisory Council Review: Approximately May 2024, May 2025, May 2026.
Earliest Start Date: Approximately July 2024, July 2025, July 2026.
Expiration Date for Opportunity: September 20, 2025.

Application Procedure and Submission

Applications must be submitted electronically through one of the following:
NIH ASSIST system
Institutional system-to-system (S2S) solution
Grants.gov Workspace
Applicants are encouraged to apply early to allow time for corrections.
Organizations must complete all required registrations (SAM, UEI, eRA Commons, Grants.gov) PRIOR to submission, which can take 6+ weeks.

Required Documentation and Materials

SF424 (R&R) Application Guide: Follow all instructions unless otherwise specified in the NOFO.
Neuroethics Considerations: A separate attachment (PDF) of up to 3 pages describing informed consenting, risk considerations, device maintenance/removal, ethical issues specific to invasive human neuroscience research, and consent methodology to minimize coercion/undue influence/therapeutic misconception.
Team Management Plan: A separate attachment (PDF) of up to 1 page detailing the organizational structure, leadership, communication plans, decision-making processes, conflict resolution, publication policies, and plans for enhancing interdisciplinary collaboration.
PHS Human Subjects and Clinical Trials Information form: Required for studies involving human subjects/clinical research. Must answer 'Yes' to the four questions on 1.4 Clinical Trial Questionnaire and complete the form, as applications must propose basic experimental studies with humans that meet the NIH clinical trial definition.
Data Management and Sharing Plan: Required for all applications generating scientific data, regardless of direct costs, and effective for due dates on or after January 25, 2023. Must include data summary, standards, archive, and timelines for sharing.
Research Plan: Must include specific sections:
Description of how the R61 will enable research goals of a future U01 (RFA-NS-22-041).
Statement of neurobiological, neurological, or mental health questions, theoretical framework, and analytical methods.
Justification for human studies vs. non-human species and specific patient cohort.
Description of how studies in affected brain tissues address research questions, including animal study comparisons if applicable.
Justification of recording/manipulation methods, and how invasive interventions may confound results.
Timeline for research goals, strategic goals, key stages, and participant accrual.
Technical, procedural, and ethical aspects specific to invasive human patient studies.
Resource Sharing Plan: Required.
Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys). No publications or other material.

Project Implementation Timeline

Maximum Project Period: 3 years.
Progress Tracking Mechanisms: Annual Research Performance Progress Reports (RPPR).
Reporting Schedule: Annual RPPR and financial statements. Final RPPR, invention statement, and expenditure data upon closeout.

Support Offered

Type of Support: Primarily FUNDING (grant).
Application Assistance: Available from eRA Service Desk (technical issues), General Grants Information (application instructions), and Grants.gov Customer Support (registration/Workspace). Scientific/Research staff can advise on programmatic fit (prior consultation recommended).

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood of the project exerting a sustained, powerful influence on the research field, considering all review criteria.

Scored Review Criteria Significance

Does the project address an important problem or critical barrier in human neuroscience?
Is the prior research supporting the project rigorous?
How will successful completion improve scientific knowledge, technical capability, or clinical practice, and change concepts, methods, technologies, or interventions?
Is the scientific rationale well-supported by preliminary data, clinical/preclinical studies, literature, or knowledge of biological mechanisms?
Is the project essential to the planned future U01 (RFA-NS-22-041)?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well-suited with appropriate experience and training?
For collaborative/multi-PD/PI projects, do investigators have complementary and integrated expertise, and an appropriate leadership approach, governance, and organizational structure?
Does the project engage multidisciplinary teams (clinicians, scientists, device engineers, data/computational scientists, regulatory specialists, ethics specialists) as appropriate?

Innovation

Does the application challenge existing paradigms through novel theoretical concepts, approaches, methodologies, instrumentation, or interventions?
Is the innovation appropriate for the goals of the BRAIN Initiative?
Does the project maximize opportunities for innovative in vivo neuroscience research from invasive surgical procedures?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate for the aims?
Are plans in place to address weaknesses in prior research and ensure robust, unbiased approaches?
Are potential problems, alternative strategies, and benchmarks for success presented?
Will the strategy establish feasibility and manage risky aspects if in early stages?
Are plans for inclusion/exclusion of individuals based on sex, race, ethnicity, and age justified by scientific goals?
Does the project establish feasibility, validity, or other qualifying results that will support the subsequent U01?
Does the application describe recording/manipulation methods and address potential confounds from invasive interventions or implanted materials?
Does it address how studies in disease-affected brain tissues can answer research questions, including comparison to animal studies if feasible?

Environment

Will the scientific environment contribute to success (institutional support, equipment, physical resources)?
Does the project benefit from unique features, subject populations, or collaborative arrangements?
Are administrative, data coordinating, enrollment, and lab/testing centers appropriate?
If multi-site, is there evidence of capability for enrollment, protocol adherence, data collection/transmission, and operation within organizational structure?

Additional Review Criteria (Not scored, but considered)

Study Timeline: Is it detailed, feasible, and justified? Incorporates efficiencies and addresses challenges?
Protections for Human Subjects: Justification for involvement, adequacy of protection against risks, potential benefits, importance of knowledge, 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: Justification for use, interventions to minimize discomfort, euthanasia justification (if applicable).
Biohazards: Assessment of potential hazards and proposed protections.
Plans for Patient Recruitment/Retention: Documented availability of subject pool, outreach, follow-up, and retention plans.
Neuroethical Considerations: Adequately addressed details on informed consent, non-significant risk conditions, device maintenance/explantation, and other ethical issues specific to invasive human neuroscience research. Includes a plan for patient care post-study.
Resource Sharing Plans: Reasonableness of plans for sharing resources (e.g., model organisms) or rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity.
Budget and Period of Support: Justified and reasonable in relation to the proposed research.

Compliance & Special Requirements

Regulatory Compliance

Projects must adhere to 45 CFR Part 46 for the Protection of Human Subjects.
A single Institutional Review Board (sIRB) is required for multi-site research (NIH policy).
Compliance with FDA Investigational Device Exemption (IDE) conditions (or non-significant risk designation) is anticipated for devices used.
Compliance with federal civil rights laws prohibiting discrimination (race, color, national origin, age, sex, disability), and ensuring meaningful access for limited English proficiency and effective communication with persons with disabilities.
Compliance with federal conscience laws and religious nondiscrimination laws.

Data Management and Sharing

A Data Management and Sharing Plan is required (effective for applications due on or after January 25, 2023).
All BRAIN Initiative NOFOs require a Data Sharing Plan, specifying data to be shared, standards, archives, and timelines.
NIH Data Management and Sharing Policy must be adhered to.

Ethical Standards

Detailed Neuroethics considerations must be submitted, covering:
Informed consenting of research subjects with no direct benefit.
FDA-defined conditions of non-significant risk/significant risk.
Ethical and practical considerations of invasive device maintenance and ultimate removal.
Other ethical issues specific to invasive human neuroscience research (e.g., compensation, undue influence, therapeutic misconception, dual roles of clinician/investigator).
Plans for patient care at the end of the study and after the study period are required (e.g., explant, device maintenance).

Risk Management and Security

Applicants must address the technical, procedural, and ethical aspects specific to invasive studies involving human patients.
Data and safety monitoring is required for all NIH-supported human biomedical and behavioral intervention studies.

Intellectual Property Policies

Intellectual property will be managed in accordance with established NIH policy, in compliance with Executive Order 10096.
Patent rights for inventions developed in NIH facilities are NIH property unless rights are waived.

Special Considerations and Unique Aspects

This R61 grant is explicitly designed as an exploratory/developmental phase to lay the groundwork for a subsequent U01 Research Project (Cooperative Agreement) (RFA-NS-22-041).
Requires participation in a consortium working group, coordinated by NIH, to identify consensus standards of practice, including neuroethical considerations, data collection for ancillary studies, and data aggregation/standardization for dissemination.
High levels of innovation are invited and encouraged, which assumes some degree of risk.
Mentorship relationships facilitating special research expertise for investigators in intracranial human studies are allowed.
Projects should employ approaches guided by specified theoretical constructs and quantitative, mechanistic models where appropriate.
Collaboration with NIH intramural scientists is allowed; however, funds for intramural scientists cannot be requested in the application (they submit separate requests).
Encouragement to use Common Data Elements (CDEs) in NIH-funded research where applicable to facilitate data sharing and standardization.
The grant involves human subjects, requiring consideration of their protection and ethical aspects.

Grant Details