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Grant Analysis

Purpose & Target

- Single, clear statement of grant's core objective: To support confirmatory efficacy testing of non-pharmacological and selected pharmacological interventions for mental disorders in adults and children, through an experimental therapeutics approach, to provide high scientific utility for 'go/no-go' decisions on further development or dissemination. - Explicit identification of target recipient type and size: Organizations capable of conducting rigorous clinical trials, including academic institutions, non-profits, for-profits (small and large), and various governmental and 'other' entities. No specific size by revenue or employee count is defined, but implies capacity for significant research. - MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': SECTOR-SPECIFIC (Mental Health, Clinical Research, Healthcare, Technology). - Geographic scope and any location requirements: Global; entities from the U.S. and non-U.S. (Foreign Organizations) are eligible. - Key filtering criteria for initial grant screening: Must be a confirmatory efficacy clinical trial (not initial development or pilot testing), must use an experimental therapeutics approach (testing mechanism of action), and must have prior evidence of target engagement and a preliminary efficacy signal. - Grant frequency and program context: Recurring opportunity with multiple application deadlines annually until October 2027; reissued from PAR-21-132, part of NIMH's broader clinical trial development pipeline.

Financial Structure

Total Funding Program Budget: $27,000,000.0 for FY 2026 (this amount funds PAR-25-179 and companion NOFOs).
Award Budget: Not limited, but budgets must reflect the actual needs of the proposed project.
Minimum grant amount per application: Not specified.
Maximum grant amount per application: Not specified.
Currency: USD.
Funding Rate: Not explicitly stated as a percentage of costs, but the grant mechanism is a financial assistance mechanism covering approved project costs.
Cost Sharing: Not required.
Indirect Cost Policies: Subject to NIH Grants Policy Statement.
Applicants are expected to budget for the costs of data submission to the National Institute of Mental Health Data Archive (NDA).

Eligibility Requirements

Organization Type

Eligible: Higher Education Institutions (Public/State Controlled, Private), Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education), Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education), For-Profit Organizations (Small Businesses), For-Profit Organizations (Other than Small Businesses), Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal (Federally Recognized, Other)), Federal Governments (Eligible Agencies of the Federal Government, 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, Non-domestic (non-U.S.) Entities (Foreign Organizations).

Geographic Location

U.S. and non-U.S. (Foreign Organizations) are eligible to apply.

Technical/Scientific Prerequisites

Proposed project must involve a clinical trial.
Intervention must be based on a compelling scientific rationale.
Must have previous demonstration that the intervention engages and alters the hypothesized mechanism of action (target).
Must have a preliminary efficacy signal.
Trial must be designed to provide high scientific utility for 'go/no-go' decisions about further development or dissemination.
For device-based studies, FDA guidance meetings prior to submission are expected.
For device-based studies, an open Investigational Device Exemption (IDE) or a documented FDA-submitted application/request for an IDE for a pivotal device study must be in place at the time of application submission. Documentation of discussions and meetings with FDA staff must be included.

Required Registrations

Applicant organizations must complete and maintain active registrations in:
- System for Award Management (SAM).
- NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations).
- Unique Entity Identifier (UEI).
- eRA Commons (including at least one Signing Official and one Program Director/Principal Investigator (PD/PI) account).
- Grants.gov.
All PD/PIs must have an eRA Commons account.

Application Process

Applications must be submitted electronically via NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
All required registrations (SAM, NCAGE, UEI, eRA Commons, Grants.gov) must be completed prior to application submission. Registration can take 6 weeks or more.

Key Dates

Open Date (Earliest Submission Date): January 14, 2025
Letter of Intent Due Date(s): 30 days prior to the application due date (encouraged, not required).
Application Due Dates (by 5:00 PM local time of applicant organization):
- February 14, 2025
- June 17, 2025
- October 15, 2025
- February 13, 2026
- June 15, 2026
- October 15, 2026
- February 17, 2027
- June 15, 2027
- October 15, 2027 (latest deadline)
Expiration Date: October 16, 2027

Required Documentation and Materials

SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile).
R&R or Modular Budget forms, including R&R Subaward Budget.
PHS 398 Cover Page Supplement.
PHS 398 Research Plan, including:
- Research Strategy: Must address transportability/scalability, potential impact, scientific advances, innovation, compelling scientific rationale, existing evidence of target engagement/validation/efficacy, intervention dosage/delivery parameters, feasibility, scientific rationale for measures, operationalization/monitoring of delivery, features for feasible/scalable implementation, clinical trial methodology, control condition selection, justified inclusion/exclusion criteria, approach feasibility, and statistical analysis plan/power analysis.
Letters of Support: For applications proposing FDA-regulated devices, letters from an industry partner and plans for a collaborative research agreement (CRA) must be included.
Resource Sharing Plan.
Data Management and Sharing Plan: Must describe how data will be shared via the National Institute of Mental Health Data Archive (NDA).
Appendix: Limited to blank questionnaires or surveys (no publications or other material).
PHS Human Subjects and Clinical Trials Information form: Required if human subjects are involved, including a Study Record or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information:
- Recruitment and Retention Plan: Clear description of sources, monitoring procedures, strategies for robust/representative sample, potential challenges, evidence of feasibility.
- Study Timeline: Timeline for benchmarks (e.g., finalizing procedures, enrollment, data collection, analysis, data sharing).
- Overall Structure of Study Team: Detailed description, including program management and oversight (program manager for device-based studies).
- For device-based studies: Documentation of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status, regulatory strategy, coverage/coding/reimbursement plan.
Other Clinical Trial-related Attachments: May include intervention delivery materials, training manuals, technological specifications, screenshots of mobile interventions (no videos).
PHS Assignment Request Form.

Project Implementation and Reporting

Project Period: Maximum 5 years; shorter durations are encouraged.
Annual Research Performance Progress Report (RPPR) and financial statements are required.
A final RPPR, invention statement, and expenditure data are required for closeout.
Data submission to NDA: Descriptive/raw data expected semi-annually (January 15 and July 15); all other data at the time of publication or prior to the end of the grant, whichever occurs first.
Registration and results reporting of all clinical trials on ClinicalTrials.gov is required.

Evaluation Criteria

Overall Impact

Reviewers assess the likelihood for the project to exert a sustained, powerful influence on the research field(s).

Scored Review Criteria

Factor 1: Importance of the Research (Significance and Innovation)
- Significance: Addresses unmet therapeutic need, potential to reduce burden of serious mental disorders, advances knowledge of pathophysiologic/psychopathologic mechanisms, rationale for anticipated clinically meaningful effect size (d=0.5).
- Innovation: Leverages technology or other innovative approaches to facilitate delivery, efficacy, and future scalability.
Factor 2: Rigor and Feasibility (Approach)
- Scientific rationale: Theory-driven, refutable hypotheses about mechanisms and intervention effects.
- Testable hypotheses for target(s)/mechanism(s) and detailed data analysis plan.
- Empirical foundation for intervention dosage and delivery parameters.
- Existing evidence of target engagement, preliminary target validation, and initial efficacy signal.
- Preliminary evidence of feasibility (e.g., intervention manuals, fidelity measures).
- Scientific rationale for measures used, including reliability and validity.
- Operationalization, monitoring, and quantification of intervention delivery.
- Features ensuring feasible and scalable implementation in practice (e.g., community collaborations, adaptable manuals, compatibility with resources, technology for fidelity, surrogate endpoints).
- Clinical trial methodology to inform 'go/no-go' decisions.
- Well-justified subject inclusion/exclusion criteria based on measurable disruption in mechanism.
- Feasibility of data acquisition and analysis timeline.
- Statistical analysis plan and corresponding power analysis for mediation.
Factor 3: Expertise and Resources (Investigator(s) and Environment)
- Expertise and track record of Senior/Key Personnel in clinical trials (e.g., subject recruitment/retention, ClinicalTrials.gov reporting, publications, methodological/statistical expertise).
- Utilization of relevant existing infrastructure (e.g., electronic medical records, administrative databases, patient registries) or other available resources.
- Description of collaborative arrangements for multiple performance sites.

Additional Review Criteria (Not scored individually, but considered for overall impact)

Protections for Human Subjects: Justification for involvement, adequacy of protection, potential benefits, importance of knowledge, data and safety monitoring.
Vertebrate Animals: Evaluation of involvement (note: projects with vertebrate animals are generally not responsive).
Biohazards: Assessment of hazardous materials/procedures and proposed protection.
Resubmissions, Renewals, Revisions: Evaluation of prior progress or proposed changes.

Additional Review Considerations (Not scored individually)

Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity.
Budget and Period of Support: Justification and reasonableness in relation to proposed research.

Compliance & Special Requirements

Regulatory Compliance

For applications testing the efficacy of devices, compliance with federal regulatory approval processes (e.g., FDA pathways like PMA, 510(k), de novo) is required.
Clinical research projects involving investigational therapeutics, vaccines, or other medical interventions must be performed under an FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE).
Registration and results reporting for all clinical trials on ClinicalTrials.gov is required by law for 'applicable clinical trials' and expected for all others.
All protocols involving human subjects must be reviewed and approved by the recipient institution's Institutional Review Board (IRB) or Independent Ethics Committee (IEC).

Data Protection and Privacy

Compliance with the 2023 NIH Policy for Data Management and Sharing is mandatory.
Data sharing via the National Institute of Mental Health Data Archive (NDA) is expected, utilizing Global Unique Identifier (GUID) and Data Dictionary technology.
Applications involving human subjects must include detailed human subject protections, consenting procedures, and planned enrollment tables for each participant group.
Data and Safety Monitoring Plan must adhere to NIMH and NIH policies, including timely submission of review determinations and reportable events.

Ethical Standards

Research must comply with ethical standards for human subjects protection. Studies involving vertebrate animals are explicitly stated as not responsive to this NOFO.

Risk Management and Security

Recipients and subrecipients with ongoing access to HHS-owned/operated information or operational technology systems must develop plans and procedures modeled after the NIST Cybersecurity framework to protect HHS systems and data.

Special Considerations & Scope Limitations

The grant strictly supports confirmatory efficacy clinical trials and requires an experimental therapeutics approach (testing mechanisms of action).
Applications not focused on a functional domain, symptoms, or mental health disorder are not responsive.
Applications lacking compelling evidence of target engagement and an initial efficacy signal are not responsive.
Applications involving adding a new level of analysis to assess or better understand mechanisms of an established intervention are not responsive if this is the primary focus.
Not intended for initial intervention development and pilot testing; these are supported by companion NOFOs.
Not intended solely for translation of existing treatments into technology-based applications (e.g., mHealth) unless it's part of testing a novel non-pharmacological component.
Encourages the use of NIMH Research Domain Criteria (RDoC) principles to inform subject eligibility, intervention targets, and outcome measures.
A deployment-focused approach is encouraged, considering stakeholder perspectives and real-world implementation feasibility.
Assessment of suicidal behavior in clinical trials is strongly encouraged, with justification required if excluded.
Leveraging existing resources and infrastructure, such as those provided by institutions with Clinical and Translational Science Awards (CTSAs) or Contract Research Organizations (CROs), is encouraged.
Use of common data collection instruments (CDEs) is expected.

Grant Details