Grants8 | The most comprehensive grants search on the web

Grant Analysis

Purpose & Target

The core objective of this grant is to encourage research utilizing invasive neural recording and stimulation in humans to advance the understanding of neural circuitry related to mental health disorders. It aims to fill a gap in scientific knowledge regarding neural circuit function and has high translational potential for mental health.

Target recipient types: A wide range of organizations including higher education institutions, non-profits, for-profit organizations (including small businesses), and various government entities.
Target size: SECTOR-AGNOSTIC regarding organizational size, focusing more on research capacity and team expertise.
Geographic scope: Global; foreign organizations are explicitly eligible to apply.
Key filtering criteria: Research must involve invasive neural recording and/or stimulation in human subjects, focus on mental health questions with high translational potential, and include neuroethical considerations.
Grant frequency: This is a recurring opportunity with multiple application deadlines through October 2027, issued as a reissue of a previous funding opportunity (PAR-23-101).

Financial Structure

The combined budget for direct costs for the two-year project period may not exceed $275,000.
No more than $200,000 in direct costs may be requested in any single year.
This funding opportunity does not require cost sharing or matching funds.
Costs for collecting and submitting Common Data Elements (CDE) data to the National Data Archive (NDA) should be included in the requested budget.
Pre-award costs are allowable as described in the NIH Grants Policy Statement.
Financial reporting requires annual submission of the Research Performance Progress Report (RPPR) and financial statements.
A final RPPR and expenditure data are required for closeout of an award.

Eligibility Requirements

Eligible Organization Types

Higher Education Institutions: Public/State Controlled, Private.
Nonprofits: With 501(c)(3) IRS Status or without 501(c)(3) IRS Status (other than institutions of higher education).
For-Profit Organizations: Small Businesses, or other For-Profit Organizations.
Local Governments: State, County, City or Township, Special District, Federally Recognized Indian/Native American Tribal Governments, other Indian/Native American Tribal Governments.
Federal Governments: Eligible Agencies of the Federal Government, U.S. Territory or Possession.
Other: 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.
Foreign Organizations: Non-domestic (non-U.S.) Entities are eligible to apply, and foreign components of U.S. organizations are allowed.

Registration Requirements

System for Award Management (SAM): Applicants must complete and maintain an active registration, which requires annual renewal. This includes obtaining a Unique Entity Identifier (UEI).
NATO Commercial and Government Entity (NCAGE) Code: Required for foreign organizations in lieu of a CAGE code for SAM registration.
eRA Commons: Organizations must register and identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov: Applicants must have an active SAM registration to register with Grants.gov.
All registrations must be completed prior to application submission and can take 6 weeks or more.

Project-Specific Requirements

The proposed research must utilize invasive neural recording and/or stimulating opportunities in humans.
Projects involving animal studies, intervention-development clinical trials of therapeutic devices, stand-alone technology development not tied to a scientific question, applications lacking neuroethical considerations, or imaging not coupled with intra-cranial recording/stimulation are non-responsive and will not be reviewed.

Application Process

Application Process Steps

Registration: Complete all required registrations (SAM, UEI/NCAGE, eRA Commons, Grants.gov) well in advance (6+ weeks) of the application deadline.
Application Package Access: Access the specific application forms package through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Preparation: Follow instructions in the Research (R) Instructions in the 'How to Apply - Application Guide' and any program-specific instructions in this NOFO. Adhere to page limitations.
Submission: Submit electronically via Grants.gov by 5:00 PM local time of the applicant organization on the due date. Check application status in eRA Commons. Correct any errors and resubmit by the deadline.

Key Deadlines

Open Date (Earliest Submission Date): January 16, 2025
Application Due Dates (New):
February 16, 2025
June 16, 2025
October 16, 2025
February 16, 2026
June 16, 2026
October 16, 2026
February 16, 2027
June 16, 2027
October 16, 2027
Application Due Dates (Renewal / Resubmission / Revision):
March 16, 2025
July 16, 2025
November 16, 2025
March 16, 2026
July 16, 2026
November 16, 2026
March 16, 2027
July 16, 2027
November 16, 2027
Expiration Date: January 08, 2028 (no new applications accepted after the last due date before this date).

Required Documentation and Materials

SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, Budget/Modular Budget, Subaward Budget).
PHS 398 Cover Page Supplement.
PHS 398 Research Plan (including Research Strategy, Resource Sharing Plan, Other Plan(s) like the Data Management and Sharing Plan).
Appendix (limited materials allowed; no publications or other materials except blank questionnaires/surveys).
PHS Human Subjects and Clinical Trials Information form (Study Record, Delayed Onset Study, if applicable).
PHS Assignment Request Form.

Project Implementation and Reporting

Grant Duration: Maximum project period is 2 years.
Data Submission: Descriptive/raw data expected semi-annually (January 15 and July 15) to the National Data Archive (NDA). All other data submitted at publication or prior to grant end.
Progress Reporting: Research Performance Progress Report (RPPR) required annually.
Clinical Trial Reporting (if applicable): Registration and results reporting to ClinicalTrials.gov, submission of review determinations from data and safety monitoring entity (at least annually), timely submission of reportable events, establishment of recruitment milestones.

Application Assistance

eRA Service Desk for system issues.
General Grants Information for application instructions.
Grants.gov Customer Support for registration and Workspace help.
Specific Scientific/Research, Peer Review, and Financial/Grants Management contacts are provided in the NOFO.

Evaluation Criteria

Applications are evaluated for scientific and technical merit, with reviewers providing an overall impact score based on the likelihood of the project exerting a sustained, powerful influence on the research field. Scored Review Criteria

Importance of the Research (Significance and Innovation): Evaluates how the project advances understanding of neural circuits relevant to mental health disorders, its translational potential, and the novelty/innovation of the ideas, model systems, tools, or technologies. For R21s, emphasis is placed on conceptual framework, innovation, and potential for significant advancement. Extensive preliminary data is not required.
Rigor and Feasibility (Approach): Assesses the research design, methods, and analyses. For novel technological approaches, it considers how new approaches improve the field's ability to conduct mental health-relevant research. Includes feasibility of collecting neural recordings and synchronization with behavioral measures.
Expertise and Resources (Investigator(s) and Environment): Reviews the qualifications of the research team (encouraging varied scientific backgrounds like neurosurgery, electrophysiology, neuroscience, engineering, psychiatry, biostatistics, ethics, psychology) and the suitability of the research environment for invasive studies.

Additional Review Criteria (Considered, but not separately scored)

Protections for Human Subjects: Evaluation of justification for involvement, proposed protections, potential benefits, importance of knowledge gained, and data/safety monitoring for clinical trials (if applicable). Includes assessment of co-enrollment plans.
Vertebrate Animals: If applicable, evaluation of proposed procedures, justification for animal use, and interventions to minimize discomfort.
Biohazards: If applicable, assessment of hazardous materials/procedures and proposed protections.
Resubmissions/Renewals/Revisions: Evaluation of the updated application, progress made, or appropriateness of scope expansion, respectively.

Additional Review Considerations (Considered, but not scored)

Authentication of Key Biological and/or Chemical Resources: Evaluation of plans for identifying and ensuring validity of resources.
Budget and Period of Support: Assessment of whether the budget and requested period are justified and reasonable for the proposed research.

Compliance & Special Requirements

Regulatory and Ethical Compliance

Human Subjects Protection: Adherence to 45 CFR Part 46, including justification for human involvement, proposed protections against risks, potential benefits, importance of knowledge gained, and data/safety monitoring plans.
Neuroethical Considerations: Applications must include information on neuroethical considerations specific to invasive human neuroscience research (e.g., informed consent, undue influence, dual roles of clinician/investigator).
IRB/IEC Approval: Recipient institutions must ensure all protocols are reviewed and approved by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
FDA Regulations: Clinical research projects involving investigational therapeutics, vaccines, or medical interventions must comply with FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements.
Federal Regulations: Compliance with 42 CFR Part 52 and 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Non-Discrimination: Recipients must comply with applicable non-discrimination laws, including submission of an Assurance of Compliance (HHS-690).

Data Management and Security

Data Management and Sharing Plan (DMS Plan): Required for all applications generating scientific data, consistent with the 2023 NIH Policy. Data is expected to be shared via the National Data Archive (NDA).
Cybersecurity: If handling HHS systems/data, PII, or PHI, recipients must develop plans and procedures modeled after the NIST Cybersecurity framework.
Mandatory Disclosure: Recipients must disclose information related to violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.

Special Requirements and Considerations

Project Focus: Must be on invasive neural recording and stimulation in humans. Animal studies are non-responsive.
Innovation: The R21 mechanism encourages shorter, higher-risk applications with less preliminary data, emphasizing innovative ideas and approaches.
Team Composition: Encourages applications that incorporate multidisciplinary teams (e.g., neurosurgery, electrophysiology, neuroscience, engineering, psychiatry, biostatistics, ethics, psychology).
Exclusions: Intervention-development clinical trials of therapeutic devices, stand-alone novel technology development (not integrated into a scientific question), and imaging not coupled with intracranial recording/stimulating are not responsive.
Co-enrollment: For studies involving human participation, plans for co-enrollment in other studies must be described, including assessment of ethical implications, risks, burdens, benefits, and scientific validity.

Grant Details