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Grant Analysis

Purpose & Target

This grant supports definitive clinical trials evaluating the effectiveness of therapeutic and service interventions for the post-acute management of mental health conditions. The core objective is to understand the mechanisms of action, mediators, predictors, and moderators of these interventions to optimize longer-term outcomes for individuals across the lifespan. Eligible recipients include a broad spectrum of organizations: higher education institutions, nonprofits, for-profit organizations (including small businesses), local and federal governments, and various other entities. Organizational size is not defined by employee count, but applicants must demonstrate the capacity to conduct rigorous clinical trials. This grant is SECTOR-SPECIFIC, exclusively focusing on mental health and related healthcare services. Its geographic scope is international, accepting applications from both U.S. and non-U.S. (foreign) entities. Key filtering criteria for initial screening are: a clinical trial is required, the focus must be solely on post-acute mental health interventions, the study must include the examination of mechanisms of action, and it is not for pilot studies or early-stage efficacy testing. This is a recurring R01 Research Project Grant from NIMH, reissuing a previous opportunity, with multiple application windows through October 2027.

Financial Structure

Funding Amounts

Budget: Application budgets are not limited but must directly reflect the actual, justified needs of the proposed project. There is no specified total budget for the call or maximum award amount per application.
Project Period: The maximum project period allowed is 5 years, although most awards are anticipated to be for 3-4 years. The project's scope should determine the requested duration.

Co-financing and Matching Funds

This Notice of Funding Opportunity (NOFO) does not require cost sharing or any matching funds from the applicant.

Eligible and Ineligible Costs

Eligible Costs: Costs must align with the actual needs of the proposed project. Specifically, applicants are instructed to include costs for collecting and submitting Common Data Elements (CDEs) to the National Institute of Mental Health Data Archive (NDA) within their requested budget. Pre-award costs are allowable as described in the NIH Grants Policy Statement Section 7.9.1.
Ineligible Costs: Not explicitly detailed, but generally, costs not directly related to the proposed research or those disallowed by the NIH Grants Policy Statement would be considered ineligible.

Payment Schedule and Reporting

Payment Mechanisms: Specific payment schedules and disbursement mechanisms are not detailed in this document; standard NIH grant payment procedures apply.
Financial Reporting: Recipients are required to submit financial statements as per NIH guidelines. A Federal Financial Report (FFR) expenditure data portion is mandatory for the closeout of an award.

Other Financial Considerations

Indirect Cost Policies: For applications requesting $500,000 or more in direct costs in any given year, consortium Facilities and Administrative (F&A) costs are excluded when calculating this threshold. Standard NIH indirect cost policies generally apply.
Financial Guarantees: No specific financial guarantees or security requirements are mentioned in the grant materials.
Financial Sustainability Expectations: While not a direct financial requirement for the grant, the project design should consider the long-term scalability and sustained implementation of the intervention, implying a focus on resource-efficient and adaptable approaches.

Eligibility Requirements

Hard, Non-Negotiable Formal Criteria

Clinical Trial Required: Only applications that propose clinical trial(s) are accepted.
Focus on Post-Acute Phase: Projects must specifically evaluate interventions for the post-acute management of mental health conditions. Studies focused on acute phase interventions are considered nonresponsive and will not be reviewed.
Mechanism of Action Study: Applications must explicitly study whether the intervention engages its presumed target(s)/mechanism(s) and demonstrate how changes in these targets are associated with clinical benefit. Applications lacking this component will not be reviewed.
Research Setting: Studies must be conducted in community practice clinics/settings, not academic research laboratories that are not representative of typical clinical practice.
Application Type: Submissions must be New, Renewal, Resubmission, or Revision applications.
Required Registrations: All applicant organizations must complete and maintain active registrations in the following systems prior to application submission:
- System for Award Management (SAM) (requires annual renewal).
- Unique Entity Identifier (UEI) (obtained through SAM registration).
- eRA Commons (for the organization and for all Program Directors/Principal Investigators (PD/PIs)).
- Grants.gov.
- NATO Commercial and Government Entity (NCAGE) Code (required for foreign organizations in lieu of a CAGE code for SAM).
PD/PI Qualifications: The individual(s) designated as Program Director(s)/Principal Investigator(s) must possess the necessary skills, knowledge, and resources to conduct the proposed research.

Definitions of Terms

'Acute treatment': Defined as "management of an episode, crisis, or worsening of mental illness that requires intense treatment in order to contain symptoms, prevent harm, and stabilize functioning, in either outpatient or hospital settings."
'Post-acute phase': Refers to interventions that follow acute treatment, aiming to achieve symptom recovery, return to optimal functioning, prevent relapse/recurrence, facilitate care transitions, and promote adherence/continuity of services.

Organization Type, Size, and Legal Structure

Eligible Organization Types: A very broad range of organizations are eligible, including:
- Higher Education Institutions (Public/State Controlled, Private)
- Nonprofits (with or without 501(c)(3) IRS Status)
- For-Profit Organizations (including Small Businesses and Other than Small Businesses)
- Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal – both Federally Recognized and Other)
- Federal Governments (Eligible Agencies, U.S. Territory or Possession)
- Other types: 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, and Non-domestic (non-U.S.) Entities (Foreign Organizations).
Organizational Size: Not specified by employee count. Eligibility is based on having the capacity to effectively conduct the proposed clinical trial.

Geographic and Regulatory Requirements

Geographic: Open to applicants from the United States and foreign (non-U.S.) organizations. Foreign components within U.S. organizations are also permitted.
Regulatory: Applicants must adhere to the NIH Grants Policy Statement, all applicable federal regulations (e.g., 2 CFR Part 200), and specific NIH/NIMH policies concerning clinical trials, human subjects research, and data sharing.

Technical Expertise and Infrastructure

Applicants must demonstrate the required technical expertise to carry out the research. Proposals should ideally leverage existing research infrastructure such as practice-based research networks, electronic medical records, and Clinical and Translational Science Awards (CTSAs).

Exclusion Criteria and Disqualifying Factors Applications will be considered nonresponsive and not reviewed if they involve: * Studies solely focused on the effectiveness of acute phase interventions. * Studies that do not involve prospective data collection where patients are assigned to specific intervention conditions (unless a strong justification for quasi-experimental design is provided). * Research that examines intervention effectiveness but does not study whether the intervention engages its presumed target(s)/mechanism(s). * Adaptations of existing interventions without compelling justification and a clear experimental therapeutics approach. * The development and initial efficacy testing of novel intervention strategies or targets (these are supported under other NIH funding opportunities). * Studies conducted primarily in academic research laboratories as opposed to real-world community practice clinics/settings. * Trials using patented medications that lack superior efficacy or safety relative to currently available off-patent alternatives. * Studies of stigma or health literacy interventions that do not explicitly demonstrate impact on mental health service access, engagement, quality, or outcomes of care. * Research that addresses intervention impact using only archival or observational/naturalistically collected data.

Application Process

Application Timeline and Deadlines

Open Date (Earliest Submission): January 05, 2025
Letter of Intent Due Date: 30 days prior to the application due date (optional, but encouraged).
Application Due Dates (all by 5:00 PM local time of applicant organization):
- February 05, 2025
- June 05, 2025
- October 05, 2025
- February 05, 2026
- June 05, 2026
- October 05, 2026
- February 05, 2027
- June 05, 2027
- October 05, 2027 (Latest Final Deadline)
Expiration Date of Funding Opportunity: January 08, 2028
Review and Award Cycles: Applications undergo scientific merit review and advisory council review, leading to earliest possible start dates in December, April, and July of the following year cycles.

Required Documentation and Submission Materials Applicants must follow the instructions in the NIH 'How to Apply - Application Guide' with specific instructions from this NOFO: * Standard Forms: SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information (including Facilities and Other Resources). * Personnel Forms: Senior/Key Person Profile (including detailed biosketches describing experience collaborating with community practice partners, consumers, and policymakers). * Budget Forms: R&R or Modular Budget, and R&R Subaward Budget (if applicable). * PHS Forms: PHS 398 Cover Page Supplement, PHS 398 Research Plan. * Research Plan: Must include distinct sections on Significance, Innovation, and Rigor and Feasibility (Approach). This section must detail the rationale, target population, stage of illness, intervention goals, intensity, and critically, explicit plans to assess target engagement/mechanism of action. * Resource Sharing Plan. * Other Plan(s): A mandatory Data Management and Sharing Plan must be provided, outlining how data will be submitted to the National Institute of Mental Health Data Archive (NDA). * Appendix: Strictly limited to blank questionnaires or blank surveys only. No other materials (e.g., publications) are allowed. * PHS Human Subjects and Clinical Trials Information: Required for all human subjects research. This includes detailed plans for: * Recruitment and Retention: Describing sources, monitoring, strategies for broad representation, potential challenges, and feasibility evidence. * Study Timeline: Benchmarks for training, enrollment, data collection, analysis, and data sharing preparation. * Outcome Measures: Use of validated, generally accepted, and stakeholder-relevant measures. * Statistical Design and Power. * Other Clinical Trial-related Attachments: Such as an Intervention Manual/Materials, which may include screenshots of mobile interventions, technological specifications, training manuals, or treatment algorithms. * PHS Assignment Request Form. Support Types and Post-Award Obligations

Support Type: The primary support offered is monetary funding in the form of a grant.
Project Implementation Timeline: Applicants must provide a detailed timeline outlining key project benchmarks, from finalizing procedures and training to completing data collection, analysis, and preparing data for sharing.
Reporting Obligations: Awardees are required to submit annual Research Performance Progress Reports (RPPRs) and financial statements. Semi-annual submission of descriptive/raw data to the NDA (January 15 and July 15) is mandatory, with all other data due at the time of publication or grant end, whichever comes first.
Post-Award Compliance: Recipients must adhere to all terms of the Notice of Award and NIH Grants Policy Statement. This includes timely registration and results reporting to ClinicalTrials.gov, obtaining IRB or Independent Ethics Committee (IEC) approval, ensuring data and safety monitoring per NIH policy, and complying with any necessary FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements. Additionally, mandatory disclosures of federal criminal law violations are required.

Evaluation Criteria

Scoring Factors and Overall Impact Applications are evaluated for their scientific and technical merit to determine an Overall Impact Score. This score reflects the project's potential to significantly influence the research field(s) involved. Scored Review Criteria Reviewers assign separate scores to the following factors, which directly contribute to the Overall Impact Score: * Factor 1. Importance of the Research (Significance and Innovation): Assesses the practical effect, estimated effect size, and clinical meaningfulness of the intervention. It also evaluates the potential for the intervention's scalability and dissemination into practice, considering typical resources and workflows. Innovation is judged on the integration of novel research strategies, design/analytic elements (e.g., adaptive sequential randomization), and leveraging information technology to enhance reach, efficiency, or effectiveness. * Factor 2. Rigor and Feasibility (Approach): Examines the scientific soundness, experimental design, and methods. This includes the rationale for the intervention's target population, stage of illness, goals, intensity, and duration. A critical component is the detailed plan to explicitly address whether the intervention engages its presumed target(s)/mechanism(s), using valid and objective measures. Statistical power, sample size justification, and plans for assessing intervention fidelity are also evaluated. The involvement of end-users and the assessment of implementation factors are important considerations. * Factor 3. Expertise and Resources (Investigator(s) and Environment): Evaluates the qualifications and experience of the Program Director(s)/Principal Investigator(s) and other key personnel. It also assesses the appropriateness of the research environment and resources, including how existing infrastructure (e.g., practice-based research networks, electronic medical records, CTSAs) will be utilized. Additional Review Criteria (Considered for Overall Impact, Not Separately Scored)

Protections for Human Subjects: Evaluation of safeguards for human participants, including risk assessment, protection adequacy, potential benefits, knowledge importance, and data and safety monitoring plans.
Vertebrate Animals: If applicable, evaluation of animal involvement, justification, minimization of discomfort, and euthanasia methods.
Biohazards: If applicable, assessment of specific hazardous materials/procedures and proposed protections.
Resubmissions: The full application is evaluated, considering prior reviews.
Renewals: Progress made in the previous funding period is evaluated.
Revisions: The appropriateness of the proposed expansion of the project's scope is evaluated.

Additional Review Considerations (Not Scored, but Inform Funding Decisions)

Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring resource validity.
Budget and Period of Support: Assessment of whether the requested budget and project duration are justified and reasonable for the proposed research.

Social Impact and Cross-Cutting Themes

Social Impact: A key expectation is to reduce disparities in mental health outcomes for underserved groups (e.g., racial/ethnic minorities, those with language/cultural barriers, rural populations). The grant also aims to advance understanding of how effective mental health interventions can impact suicide-related outcomes, encouraging their assessment where feasible. This aligns with promoting Good Health and Well-being (SDG3) and Reduced Inequalities (SDG10).
Competitive Advantage: Strong applications will clearly articulate practical and clinical benefits, rigorously demonstrate the experimental therapeutics approach (linking interventions to mechanisms), show how the intervention is scalable and disseminable, include collaborations with community partners, and leverage existing infrastructure.
Quality Thresholds: Projects are expected to be statistically powered to provide definitive answers. Emphasis is placed on using empirically validated, direct, and objective measures for assessing change mechanisms.
Cross-Cutting Themes' Impact on Scoring: Projects demonstrating a commitment to inclusion (by addressing health disparities) and sustainability (by designing scalable interventions robust against implementation drift) are viewed favorably.

Compliance & Special Requirements

Regulatory and Ethical Compliance

Regulatory Compliance: Adherence to the NIH Grants Policy Statement is mandatory, along with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards). All applicable nondiscrimination laws must be followed, typically requiring an HHS-690 Assurance of Compliance. Federal statutes and regulations relevant to federal financial assistance are also in effect.
Industry-Specific Compliance: If the project involves health IT, compliance with 45 CFR part 170, Subpart B standards and the ONC Health IT Certification Program is required where applicable.
Ethical Standards: Strict adherence to human subjects protections (including 45 CFR Part 46 and specific NIH/NIMH policies like NOT-MH-19-027). IRB or Independent Ethics Committee (IEC) approval is required for all human subjects research. Plans for clinical management of suicidal behavior are expected when assessed.

Data Protection and Technology Specifications

Data Protection: A comprehensive Data Management and Sharing Plan is required. Data generated from the grant must be submitted to the National Institute of Mental Health Data Archive (NDA), utilizing Global Unique Identifiers (GUIDs) and the Data Dictionary. Applicants are responsible for certifying data quality before submission and reviewing for accuracy afterward. If accessing HHS-owned or operated information systems, compliance with the NIST Cybersecurity framework is required.
Technology Specifications: Technology-assisted approaches are encouraged for intervention delivery and monitoring. Applicants may be required to provide screenshots of mobile interventions and technological specifications in their application.

Risk Management and Security

Human Subjects Safety: A detailed Data and Safety Monitoring Plan is mandatory for all clinical trials, ensuring participant safety and data integrity. Timely reporting of any adverse events is expected.
Data Security: Compliance with the NIH Data Management and Sharing Policy and the NIST Cybersecurity framework helps ensure the security and integrity of sensitive research data.

Unique Aspects and Strategic Opportunities

Unique Aspects: This grant's distinct focus is on post-acute mental health interventions, specifically requiring definitive effectiveness trials that rigorously examine mechanisms of action (an 'experimental therapeutics approach'). It also uniquely encourages hybrid effectiveness-implementation trials.
Potential Challenges: Applicants may face challenges in meeting the high methodological rigor required for definitive clinical trials, demonstrating mechanism engagement, and navigating the stringent data management and sharing requirements for NDA. Justifying the scalability and real-world applicability of the intervention is also critical.
Strategic Opportunities: This opportunity provides a significant avenue to contribute to improving long-term mental health outcomes, reducing health disparities, and deepening the understanding of how interventions achieve their effects in real-world settings. Collaboration with clinical and community practice partners is a key strategic advantage, demonstrating real-world applicability and facilitating dissemination.

Cross-Cutting Considerations

Stakeholder Engagement: Projects are encouraged to involve end-users (e.g., service users, providers, administrators, payers) in the design and testing phases. This ensures the interventions are relevant, feasible, and that research results are useful for those who will implement and benefit from them.
Suicide Prevention: Where appropriate and feasible, interventions are encouraged to include the assessment of suicidal behavior outcomes to understand the intervention's impact on this critical area of public health.

Grant Details