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Grant Analysis

Purpose & Target

This grant, the R34 Planning Grant from the National Institute of Mental Health (NIMH), aims to pilot test patient navigation Emergency Department (ED) diversion models for youth up to 18 years of age experiencing non-urgent mental health problems. The core objective is to research and develop methods to effectively triage mental health acuity, provide emotional support, build mental health knowledge among caregivers, and link families to appropriate community mental health services, thereby reducing unnecessary ED visits. This is a SECTOR-SPECIFIC grant, focusing primarily on the Healthcare and Mental Health sectors, with a strong emphasis on clinical research. It targets a wide range of U.S.-based organizations, including higher education institutions, non-profits, for-profit organizations, and various governmental and community entities. The grant supports pilot work to detect signals of effectiveness, not large-scale, fully-powered studies. The geographic scope is limited to the United States, as foreign organizations and foreign components of U.S. organizations are not eligible. Key filtering criteria for initial screening include being a U.S.-based entity, possessing the capacity to conduct clinical trials, focusing on patient navigation and ED diversion for non-urgent youth mental health, proposing a pilot study, and committing to data sharing through the NIMH Data Archive (NDA). This is a recurring grant, with multiple application due dates extending through October 2027, indicating an ongoing program context aimed at fostering foundational research for future, larger-scale interventions.

Financial Structure

Funding Amounts and Limitations This R34 Planning Grant has specific limitations on the direct costs allowed:

Maximum Direct Costs Per Year: $225,000
Maximum Total Direct Costs: $450,000 over the entire 3-year project period.

Cost Sharing and Co-financing

Matching Fund Requirements: This grant does not require cost sharing or matching funds.

Eligible and Ineligible Costs

Eligible Costs: The budget should cover direct costs associated with conducting the pilot clinical trial research. Specifically, applicants are required to include funds for collecting and submitting Common Data Elements (CDEs) from all human research participants to the NIMH Data Archive (NDA). A cost estimator is provided by NDA to assist with budgeting for data submission.
Pre-award Costs: Allowable as described in the NIH Grants Policy Statement.
Ineligible Costs: The document does not explicitly list ineligible costs, but applicants should adhere to standard NIH grant policies regarding allowable expenses. The grant is not intended to support descriptive studies or evaluations of local practices, implying that costs solely related to these would be ineligible.

Financial Reporting and Audit Requirements

Reporting: Recipients are required to submit an annual Research Performance Progress Report (RPPR) and financial statements as per NIH policies. A final RPPR, invention statement, and expenditure data (Federal Financial Report) are required for grant closeout.
Audit: All NIH awards are subject to the terms and conditions, cost principles, and audit requirements outlined in 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.

Eligibility Requirements

Organizational Eligibility This grant is open to a broad range of U.S.-based organizations:

Higher Education Institutions: Public/State Controlled and Private Institutions.
Nonprofits: Both those with and without 501(c)(3) IRS status (excluding Institutions of Higher Education).
For-Profit Organizations: Including Small Businesses and other For-Profit entities.
Local Governments: State, County, City or Township, Special District, and Indian/Native American Tribal Governments (Federally Recognized and Other).
Federal Governments: Eligible Agencies of the Federal Government and 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, and Regional Organizations.

Geographic and Structural Requirements

Geographic Location: Only U.S.-based organizations are eligible. Non-domestic (non-U.S.) entities and foreign components of U.S. organizations are not eligible to apply.
Organizational Registrations: All applicant organizations must complete and maintain active registrations with:
- System for Award Management (SAM): Requires annual renewal.
- Unique Entity Identifier (UEI): Issued through SAM.gov, must be consistent across all registrations and the application.
- eRA Commons: Organizations must register and identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI).
- Grants.gov: Requires active SAM registration.

Project-Specific Eligibility

This funding opportunity requires that the proposed research include a clinical trial.
Applicants must propose pilot testing of patient navigation models. Applications that propose to test the effectiveness of traditional therapeutic or preventive interventions, are descriptive studies or evaluations of local practices, or do not focus on the mechanism(s) of action of navigator models will be considered non-responsive and will not be reviewed.
While not an explicit eligibility criterion, the grant prioritizes scalable approaches that are not heavily dependent on external research resources or extensive consultation.

Individual Eligibility (Program Director/Principal Investigator)

Any individual with the necessary skills, knowledge, and resources to carry out the proposed research as a PD/PI is invited to apply through an eligible organization. All PD/PIs must have an eRA Commons account.

Application Process

Application Deadlines and Submission Windows This grant has multiple application due dates throughout the year. The latest deadlines provided are:

New Applications: October 16, 2027 by 5:00 PM local time of the applicant organization.
Renewal / Resubmission / Revision Applications: November 16, 2027 by 5:00 PM local time of the applicant organization.

Applicants are strongly encouraged to submit their applications early to allow time for correcting any errors before the deadline. If a submission date falls on a weekend or federal holiday, the deadline is automatically extended to the next business day. Required Documentation and Materials Applicants must follow the instructions in the Research (R) Instructions in the 'How to Apply - Application Guide' and any program-specific instructions in this Funding Opportunity Announcement. Key documents include:

SF424(R&R) Forms: Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R or Modular Budget, R&R Subaward Budget.
PHS 398 Research Plan: Must include:
- Research Strategy: Detailing the importance (significance), rigor and feasibility (approach), and expertise and resources (investigator(s) and environment).
- Resource Sharing Plan.
- Data Management and Sharing Plan: Mandatory for all applications, regardless of direct costs. Must align with NIMH Data Archive (NDA) requirements.
PHS Human Subjects and Clinical Trials Information: Required for all human subjects research and clinical trials, including details on study population characteristics, eligibility criteria, recruitment and retention plans, protection and monitoring plans, protocol synopsis, and statistical design/power.
PHS Assignment Request Form.
Appendix: Only blank questionnaires or blank surveys are allowed. No publications or other material may be included.

Application Procedure and Platform Applications must be submitted electronically through one of the following platforms:

NIH ASSIST system (online preparation, submission, tracking).
Institutional system-to-system (S2S) solution.
Grants.gov Workspace.

Applicants must ensure all required organizational and individual registrations (SAM, UEI, eRA Commons, Grants.gov) are complete before submitting, as this process can take 6 weeks or more. Types of Support Offered This is primarily a funding opportunity, providing a grant to support the proposed pilot clinical trial research. Project Implementation Timeline and Reporting Obligations

Project Period: The maximum project period allowed is 3 years.
Reporting:
- Annual Research Performance Progress Report (RPPR).
- Semi-annual descriptive/raw data submission to the NIMH Data Archive (NDA) (due January 15 and July 15).
- Other data submission to NDA at the time of publication or prior to the end of the grant, whichever comes first.
- ClinicalTrials.gov Registration and Results Reporting: Required for all applicable clinical trials.
- Final RPPR, invention statement, and Federal Financial Report required for closeout.

Application Assistance Assistance is available from: * eRA Service Desk: For system questions (ASSIST, eRA Commons, errors). * General Grants Information: For application instructions and processes. * Grants.gov Customer Support: For Grants.gov registration and Workspace issues. * Scientific/Research Contact (Mary Acri, Ph.D.): For inquiries specific to the scientific scope of the funding opportunity. * Financial/Grants Management Contact (Tamara Kees): For budget and financial questions.

Evaluation Criteria

The evaluation of applications for this grant is based on their scientific and technical merit, assessed through the NIH peer review system. Reviewers provide an overall impact score based on the likelihood for the project to exert a sustained, powerful influence on the research field. Scored Review Criteria Reviewers will specifically score applications based on three main factors, each contributing significantly to the overall impact score:

Importance of the Research (Significance and Innovation):
- Significance: How the study contributes new knowledge and its potential for improved outcomes. This includes the potential public health impact in terms of reach to the target population and the meaningfulness of anticipated outcomes compared to existing approaches.
- Innovation: While not explicitly detailed as a separate score, the integration of novel technological approaches (e.g., mobile assessment, digital tools, real-time analytics, EHR data mining) and the use of optimization research designs (like SMART or MOST) are encouraged and will likely enhance this aspect.
Rigor and Feasibility (Approach):
- Methodology: The appropriateness of proposed methods to address research questions and the scientific rigor of the study design. This includes the adequacy of the proposed sample size for detecting a signal of effectiveness (for pilot work).
- Evidence Base: Evidence for the navigator components (e.g., psychoeducation, parenting strategies, addressing treatment barriers).
- Outcome Measures: Use of valid and reliable outcome measures that are meaningful to end-users.
- Experimental Therapeutics Approach: For clinical trials, a detailed plan addressing how the intervention engages its hypothesized mechanism(s) of action. This requires a conceptual framework linking targets/mechanisms to outcomes, measurement plans for engagement, and an analytic plan.
- Ethical Considerations: Adequate plans for the protection of human subjects, including recruitment and retention, informed consent, and management of risks (e.g., suicidal behavior/ideation).
Expertise and Resources (Investigator(s) and Environment):
- Investigator(s): The qualifications, experience, and suitability of the PD/PI(s) and key personnel for the proposed project.
- Environment: The scientific environment, institutional support, equipment, and physical resources available to ensure project success.
- Collaboration: Plans for involving collaborations and input from community practice partners/providers, consumers, and policymakers to ensure the intervention's acceptability, feasibility, scalability, and utility of results.

Additional Review Criteria (Not Scored, but Considered for Overall Impact)

Protections for Human Subjects: Comprehensive evaluation of ethical considerations.
Vertebrate Animals / Biohazards: If applicable, evaluation of adequate protection measures.
Resubmissions/Renewals/Revisions: Evaluation of prior progress or appropriateness of proposed changes.

Cross-Cutting Themes and Social Impact

The grant strongly encourages research studies that examine approaches to reduce disparities for underserved groups, such as racial and ethnic minority groups, individuals limited by language or cultural barriers, and individuals living in rural areas. While not a distinct scoring criterion, the incorporation of culturally relevant approaches and community engagement (e.g., through a Community Advisory Board) is encouraged and would likely be viewed favorably as contributing to broader impact and relevance.
Scalability: NIMH prioritizes applications proposing scalable approaches not overly reliant on research-specific resources, which is an important factor for potential broad uptake.

Compliance & Special Requirements

Regulatory Compliance Applicants and awardees must comply with a range of federal regulations and NIH policies, including:

NIH Grants Policy Statement: Governs all NIH awards.
2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
Public Health Service Act: Awards are made under Sections 301 and 405.
Non-discrimination Laws: Recipients agree to comply with applicable non-discrimination laws upon SAM.gov registration and must submit an Assurance of Compliance (HHS-690).

Data Protection and Privacy Regulations

Data Management and Sharing Plan (DMSP): A comprehensive DMSP is mandatory and must detail how scientific data will be managed and shared. This includes adherence to the 2023 NIH Policy for Data Management and Sharing.
NIMH Data Archive (NDA): Investigators funded under this NOFO are expected to share data via NDA. This requires using NDA's Global Unique Identifier (GUID) and Data Dictionary technology, and budgeting for data submission costs.
Cybersecurity: If the award involves consistent access to HHS information systems or handling Personal Identifiable Information (PII) or Personal Health Information (PHI), recipients must develop plans and procedures modeled after the NIST Cybersecurity Framework.

Ethical Standards and Human Subjects Requirements

Human Subjects Protection: Strict adherence to policies for human research protection, data and safety monitoring (including for suicidal behavior/ideation), Independent Safety Monitors, and Data and Safety Monitoring Boards (DSMBs).
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval: Required for all protocols involving human subjects.
Investigational New Drug (IND) or Investigational Device Exemption (IDE): Required if the project involves the use of investigational therapeutics, vaccines, or medical interventions.

Intellectual Property Policies

The grant document does not specify detailed intellectual property policies, but it mandates extensive data sharing through the NIMH Data Archive (NDA), which implies certain data usage and dissemination expectations.

Unique Aspects and Strategic Opportunities

R34 Planning Grant Focus: This is specifically a planning grant (R34) intended to support pilot work and develop scalable models for future, larger-scale (R01) studies. It is not designed for fully powered efficacy trials.
Clinical Trial Required: A clinical trial is a mandatory component of the proposed research, focusing on the pilot testing of patient navigation models.
Experimental Therapeutics Approach: Applicants must adopt NIMH's experimental therapeutics approach, which means the scope of work must include specifying and assessing intervention-induced changes in presumed targets/mechanisms. This ensures the research advances knowledge about therapeutic change mechanisms regardless of the clinical outcome.
Emphasis on Scalability: NIMH prioritizes models that can be broadly implemented and are not reliant on intensive research resources, indicating a focus on practical application and public health impact.
Addressing Disparities: Strong encouragement for research that develops culturally relevant approaches and reduces health disparities among underserved populations (e.g., racial/ethnic minorities, those with language/cultural barriers, rural residents).
Community Engagement: Encouragement for Community Advisory Boards (CABs) and collaborations with EDs, clinical, and community practice partners to inform study design and ensure real-world applicability.

Grant Details