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Grant Analysis

Purpose & Target

Core Objective: To solicit exploratory/developmental research applications that use a learning health care framework to support the adoption, implementation, sustainability, and continuous improvement of evidence-based practices in outpatient mental health and substance use treatment systems.
Target Recipient Type and Size: Eligible organizations include a wide range from higher education institutions, nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses), and various levels of government entities (state, county, city, tribal, federal agencies, U.S. territories/possessions), as well as independent school districts, public/Indian housing authorities, Native American tribal organizations, faith-based/community-based organizations, and regional organizations. No specific size limits (employee count) are defined, making it applicable to various organizational capacities.
MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': SECTOR-SPECIFIC.
Geographic scope and any location requirements: Limited to organizations located within the United States and its territories. Non-domestic (non-U.S.) entities or components of U.S. organizations are not eligible.
Key filtering criteria for initial grant screening: Focus on mental health and substance use treatment systems, research within a learning health care framework, mandatory active collaboration between behavioral health researchers and community behavioral health partners, and U.S.-based entities.
Grant frequency and program context: This is a reissued funding opportunity (PAR-25-278, reissues PAR-24-118), with multiple recurring application due dates annually, indicating it's a recurring program. It's part of the NIH's broader effort to advance mental health and substance use research.

Financial Structure

Award Instrument: Grant.
Maximum Funding: Direct costs are limited to $450,000 over the R34 project period.
Annual Funding Limit: No more than $225,000 in direct costs allowed in any one year.
Currency: USD (implied by U.S. Federal Government agency, NIH).
Cost Sharing: Not required.
Project Period: Total project period may not exceed three years.
Data Management and Sharing Plan Budget: Applicants are expected to formulate a budget strategy to cover the costs of data submission to the National Institute of Mental Health Data Archive (NDA).

Eligibility Requirements

Organization Type

Higher Education Institutions: Public/State Controlled, Private
Nonprofits: With 501(c)(3) IRS Status (Other than Institutions of Higher Education), Without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations: Small Businesses, Other than Small Businesses
Local Governments: State Governments, County Governments, City or Township Governments, Special District Governments, Indian/Native American Tribal Governments (Federally Recognized), Indian/Native American Tribal Governments (Other than Federally Recognized)
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

Geographic Location

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 not allowed.

Partnership Requirements

Requires active collaboration between behavioral health researchers and community behavioral health partners across all phases of the research process.
Applicants must involve clinical practice partners in the scientific development of the project.
Applicants must have institutional support for applying study findings to influence clinical practice within the outpatient mental health treatment setting.
Applicants must have an advisory board whose membership includes clinical practice partners and/or clinical practice partners as key personnel on the project.
Clinical practice partners can include community behavioral health practitioners, clinic leaders, service user advocates, and/or policymakers.

Registration Requirements

Applicant organizations must complete and maintain active registration with the System for Award Management (SAM).
Applicant organizations must obtain a Unique Entity Identifier (UEI) as part of SAM.gov registration.
Applicant organizations must register with eRA Commons.
Applicant organizations must register with Grants.gov.
Program Directors/Principal Investigators (PD/PIs) must have an eRA Commons account.

Application Process

Application Deadlines and Submission

New Applications Due Dates: February 16, 2025, June 16, 2025, October 16, 2025.
Renewal/Resubmission/Revision Due Dates: March 16, 2025, July 16, 2025, November 16, 2025.
All applications are due by 5:00 PM local time of the applicant organization.
If a due date falls on a weekend or Federal holiday, the deadline is extended to the next business day.
Letter of Intent: Optional, due 30 days prior to the application due date.
Submission Platform: Electronically via NIH ASSIST, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.

Required Documentation and Materials

Applications must follow instructions in the Research (R) Instructions in the 'How to Apply - Application Guide' and program-specific instructions in this NOFO.
Required forms include: SF424(R&R) Cover, SF424(R&R) Project/Performance Site Locations, SF424(R&R) Other Project Information, SF424(R&R) Senior/Key Person Profile, R&R or Modular Budget, R&R Subaward Budget, PHS 398 Cover Page Supplement, PHS 398 Research Plan.
Research Plan must include a Research Strategy section detailing Significance, Innovation, and Approach.
Resource Sharing Plan and Data Management and Sharing Plan are required.
PHS Human Subjects and Clinical Trials Information form required if human subjects research is involved.
Appendix: Only limited materials allowed; no publications or other material except blank questionnaires or surveys.
PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form.

Review and Selection Process

Applications will be evaluated for scientific and technical merit by Scientific Review Group(s) convened by NIMH.
All applications will receive a written critique.
Selection may involve a process where only the top half of applications are discussed and assigned an overall impact score.
Funding decisions consider: scientific and technical merit, availability of funds, and relevance to program priorities.

Timeline

Earliest Start Dates: December 2025 (for Feb/March submissions), April 2026 (for June/July submissions), July 2026 (for Oct/Nov submissions).

Post-Award Requirements

Reporting: Annual Research Performance Progress Report (RPPR) and financial statements required.
Closeout: A final RPPR, invention statement, and expenditure data are required for closeout.
Clinical Trial Reporting (if applicable): Requires registration and submission of results information to ClinicalTrials.gov, and compliance with data and safety monitoring requirements.
Data Sharing: Investigators are expected to submit descriptive/raw data semi-annually (January 15 and July 15) to the NIMH Data Archive (NDA); all other data expected at publication or end of grant, whichever is first.

Evaluation Criteria

Overall Impact

Reviewers will provide an overall impact score reflecting the likelihood of the project to exert a sustained, powerful influence on the research field(s) involved.

Scored Review Criteria

Factors 1, 2, and 3 contribute to the overall impact score, with Factors 1 and 2 also receiving separate factor scores.

Factor 1. Importance of the Research (Significance and Innovation)

Significance: Assessment of the overall significance and potential impact on data-driven learning health care in community-based mental health treatment settings.
Knowledge Generation: Likelihood that the project will generate knowledge and practices advancing the implementation, sustainability, continuous improvement, and effectiveness of evidence-based practices.
Future Research Potential: How the proposed research will generate data informing the feasibility and scope of future R01-level studies.
Novelty: Projects should propose novel solutions to challenges in implementing and sustaining data-driven learning health care.

Factor 2. Rigor and Feasibility (Approach)

Community Partner Input: How input from community behavioral health partners (e.g., service users, practitioners, CCBHC administrators, policymakers) contributed to the project design.
Collaborative Methods: Description of methods for collaboration between community and research partners (e.g., Team Science, Lean business methodology, Plan-Do-Study-Act (PDSA) cycles).
Methodological Rigor: Use of state-of-the-art methods in health services research, comparative effectiveness trials, implementation science, hybrid effectiveness-implementation designs, and/or learning health care research.
Research Design Justification: Justification for the chosen research design considering practical constraints, ethical issues, and trade-offs between internal and external validity.
Preliminary Data/Prior Research: How prior research and any preliminary data support feasibility, tolerability, acceptability, safety, and preliminary effectiveness.
Implementation of Findings: Plans for rapid implementation of research findings to improve clinical practices.
Clinical Trials (if applicable): For treatment/prevention trials, specification of intervention targets/mechanisms and assessment of changes. For services/policy/implementation trials, methods to understand 'how, why, for whom, and/or in what circumstances' the intervention is effective.
Adaptation Justification: For adaptations of established evidence-based practices, an empirical rationale, clear hypothesis, and plan to enhance outcomes.

Factor 3. Expertise and Resources (Investigator(s) and Environment)

Investigator Expertise: Evidence in biosketches of the investigative team's expertise in conducting comparative effectiveness, implementation science, or learning health care research in community-based mental health treatment settings.
Prior Collaborations: Description of past collaborations between behavioral health scientists and community behavioral health partners.
Community Partner Involvement: Identification of community behavioral health partners (service users, practitioners, CCBHC administrators, policymakers) as key personnel, with documentation of their roles, qualifications, and experience.

Additional Review Criteria (Not Scored, but considered in Overall Impact)

Protections for Human Subjects.
Vertebrate Animals (if applicable): Evaluation of procedures, justifications, and minimization of discomfort.
Biohazards (if applicable): Assessment of significant hazards and proposed protections.
Resubmissions: Evaluation of the full application as presented.
Renewals: Evaluation of progress made in the last funding period.
Revisions: Evaluation of the appropriateness of the proposed scope expansion.

Compliance & Special Requirements

Mandatory Collaboration

Active collaboration between behavioral health researchers and community behavioral health partners is required across all phases of the research process.
Clinical practice partners must be involved in the scientific development and have institutional support for applying study findings to influence clinical practice.
An advisory board including clinical practice partners and/or clinical practice partners as key personnel is mandatory.

Research Scope and Methodological Requirements

The R34 NOFO supports pilot research aimed at: examining feasibility of learning health research approaches, refining/pilot testing experimental protocols, and yielding pilot data for future R01-level studies.
If clinical trials are proposed, they must follow NIMH's experimental therapeutics approach, including specification of targets/mechanisms.
Applications proposing adaptations of existing interventions must provide empirical rationale and clear hypotheses for the adaptation.

Data Management and Sharing

All research generating scientific data must comply with the NIH Policy for Data Management and Sharing.
Data must be shared via the National Institute of Mental Health Data Archive (NDA).
Applicants must budget for data submission costs.
Submission of descriptive/raw data to NDA is expected semi-annually (January 15 and July 15).
All other data expected at the time of publication, or prior to the end of the grant.

Human Subjects and Animal Research

Compliance with NIH policies and federal regulations for human subjects protection and clinical research data and safety monitoring (e.g., NOT-MH-19-027) is required.
If applicable, research involving vertebrate animals must justify their use, appropriateness of species, and interventions to minimize discomfort.

IT and Cybersecurity Standards

Where funding involves health IT, recipients must use health IT meeting 45 CFR part 170, Subpart B standards.
For eligible clinicians/hospitals, use health IT certified under the ONC Health IT Certification Program.
Recipients handling HHS information/systems or personal identifiable information (PII)/personal health information (PHI) must develop cybersecurity plans modeled after the NIST Cybersecurity framework.

Legal and Administrative Compliance

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Recipients must comply with applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Mandatory disclosure of violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.
Pre-award costs are allowable as described in the NIH Grants Policy Statement Section 7.9.1.

Grant Details