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Grant Analysis

Purpose & Target

This grant, PAR-25-206, aims to fund pilot effectiveness trials for interventions and services designed for the post-acute management of mental health conditions. The goal is to evaluate the feasibility, tolerability, acceptability, safety, and preliminary indications of effectiveness of these approaches. This includes assessing whether the interventions engage their intended mechanisms and generating preliminary data for larger-scale effectiveness trials. This funding opportunity is SECTOR-SPECIFIC, focusing primarily on the mental health and healthcare sectors. It targets a broad range of organizational types, including academic institutions, nonprofits, for-profit businesses, and various government entities, allowing for varied organizational sizes. The grant has a global geographic scope, as non-U.S. entities are eligible to apply. It is a recurring grant with multiple application deadlines until its expiration date.

Financial Structure

The financial structure for this grant outlines specific limitations and reporting requirements: Funding Amount

The grant provides a maximum of $750,000 in direct costs over the entire project period.
There is an annual limit of no more than $250,000 in direct costs in any single year.
The total project period cannot exceed three years.

Eligible and Ineligible Costs

Specific eligible and ineligible costs are not detailed in the provided documents but are governed by the overarching NIH Grants Policy Statement.
Applicants are explicitly required to include costs for collecting and submitting Common Data Elements (CDE) data from all research participants to the NIMH Data Archive (NDA) in their proposed budget.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Matching Fund and Co-financing Requirements

This funding opportunity does not require cost sharing or matching funds from the applicant. This indicates that the grant is intended to cover 100% of the eligible direct costs up to the stated limits.

Financial Reporting and Audit Requirements

Recipients must submit a Research Performance Progress Report (RPPR) annually.
Financial statements are required as outlined in the NIH Grants Policy Statement.
A final RPPR, invention statement, and expenditure data are required for closeout of the award.
All awards are subject to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR Part 200).

Eligibility Requirements

To be eligible for this grant, your organization must meet specific criteria and complete several registrations. Eligible Organization Types This grant welcomes applications from a very broad range of entities, including: * Higher Education Institutions: Both public/state-controlled and private universities and colleges. * Nonprofit Organizations: Those with or without 501(c)(3) IRS status. * For-Profit Organizations: This includes both small businesses and larger for-profit entities. * Local Governments: State, county, city/township, special district governments, and both federally recognized and other Indian/Native American Tribal Governments. * Federal Governments: Eligible agencies of the U.S. Federal Government and entities in U.S. Territories or Possessions. * Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than federally recognized), Faith-based or Community-based Organizations, and Regional Organizations. * Foreign Organizations: Non-domestic (non-U.S.) entities and non-domestic components of U.S. Organizations are specifically eligible to apply. Required Qualifications and Registrations All applicants, regardless of type, must complete and maintain the following registrations prior to submitting an application (registration can take 6+ weeks): * System for Award Management (SAM): Requires active registration and annual renewal. Foreign organizations need an NCAGE code to register in SAM. * Unique Entity Identifier (UEI): Issued through the SAM.gov registration process, and must be used for all registrations and the grant application. * eRA Commons: Organizations must register and identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI). * Grants.gov: Active SAM registration is required to complete Grants.gov registration. Individual Eligibility (Program Director/Principal Investigator) Any individual with the necessary skills, knowledge, and resources to carry out the proposed research can serve as a PD/PI. For multiple PDs/PIs, specific NIH policies apply. Clinical Trial Requirement This funding opportunity only accepts applications that propose clinical trial(s). Projects not involving prospective data collection where patients are assigned to specific intervention conditions will be considered non-responsive. Scope and Focus Exclusions (Non-Responsive Applications) Applications will NOT be reviewed if they fall into these categories: * Studies examining the effectiveness of acute phase interventions (focus is exclusively on post-acute). * Studies that do not involve clinical trials with prospective data collection and patient assignment to intervention conditions. * Applications whose scope is on intervention effectiveness without studying target engagement/mechanisms and their association with clinical benefit. * Adaptations of existing interventions without compelling justification and an experimental therapeutics approach. * Applications focused on the development and initial efficacy testing of novel interventions/targets for the post-acute phase, or any interventions for the acute phase. * Studies conducted primarily in academic research laboratories instead of effectiveness studies in community practice clinics/settings that are representative of typical practice settings. * Trials using patented medications that lack superior efficacy or safety relative to currently available off-patent medications. * Studies of stigma or health literacy interventions that do not explicitly study the impact on mental health service access, engagement, quality, and/or outcomes of care. * Studies that address questions using only archival or observational/naturalistically collected data. Other Considerations

Cost Sharing: This NOFO does not require cost sharing.
Number of Applications: Applicant organizations may submit more than one application, provided each is scientifically distinct and does not overlap with other pending or submitted applications.

Application Process

Applying for this grant involves a structured electronic submission process with specific deadlines and required documentation. Application Deadlines and Submission Windows Applications are accepted multiple times a year until the grant's expiration date of January 8, 2028. The latest submission deadlines are: * New Applications: October 5, 2027 * Renewal/Resubmission/Revision Applications: November 5, 2027 All applications are due by 5:00 PM local time of the applicant organization. Applicants are strongly encouraged to submit early to allow time for correcting any errors. If a deadline falls on a weekend or federal holiday, the deadline is automatically extended to the next business day. Application Procedure and Steps

Registrations: Ensure your organization and all PD(s)/PI(s) are registered with SAM, UEI, eRA Commons, and Grants.gov. These registrations can take significant time (6+ weeks) and must be complete before submission.
Access Application Package: Use one of the following electronic platforms to prepare and submit your application:
- NIH ASSIST system (online preparation, submission, tracking)
- Institutional system-to-system (S2S) solution (check with your institution)
- Grants.gov Workspace (online preparation, submission)
Letter of Intent (LOI): While not required or binding, applicants are encouraged to submit an LOI 30 days prior to the application due date. This helps NIMH estimate review workload. The LOI should include a descriptive title, PD(s)/PI(s) contact information, key personnel, participating institutions, and the funding opportunity number.
Application Preparation: Follow the detailed instructions in the Research (R) Instructions within the How to Apply - Application Guide, along with any program-specific instructions in this NOFO.
Submission: Submit your application electronically through Grants.gov. Track the status in eRA Commons to ensure successful submission.

Required Documentation and Materials Applications must include, but are not limited to, the following components: * SF424(R&R) Forms: Cover, Project/Performance Site Locations, Other Project Information (including Facilities and Other Resources description), Senior/Key Person Profile (including Biosketch detailing relevant experience). * Budget Forms: R&R or Modular Budget, and R&R Subaward Budget (if applicable). * PHS 398 Cover Page Supplement. * PHS 398 Research Plan: This is a critical section and must include: * Research Strategy: Address the significance, innovation, rigor, and feasibility of your proposed approach. This includes detailed rationale for the intervention, plans for assessing target engagement/mechanisms, justification for the experimental design, and how the study takes into account RDoC constructs (if applicable). It must also describe provisions for assessing intervention fidelity, involving end users, and ensuring scalability. * Resource Sharing Plan: As per NIH guidelines. * Other Plan(s): Crucially, a Data Management and Sharing Plan that adheres to the 2023 NIH Policy. This plan must detail how data will be shared via the National Institute of Mental Health Data Archive (NDA), including use of Global Unique Identifiers (GUIDs) and Data Dictionary technology. Costs for data submission to NDA should be budgeted. * Appendix: Limited materials are allowed (e.g., blank questionnaires/surveys). Publications are not permitted. * PHS Human Subjects and Clinical Trials Information Form: Required if human subjects are involved. Includes detailed plans for study population characteristics (recruitment/retention, timeline), protocol synopsis (outcome measures, statistical design), and clinical trial-related attachments (e.g., intervention manuals, technical specifications, training materials). * PHS Assignment Request Form. Types of Support Offered This grant provides funding (financial assistance) for approved projects. It supports research and development activities in the form of an R01 Research Project Grant. Project Implementation and Reporting Obligations

Grant Duration: Maximum of three years.
Timeline: Applicants must provide a clear timeline for key study benchmarks, including finalizing procedures, staff training, enrollment, assessments, data collection, analysis, interpretation, and data sharing.
Reporting: Annual Research Performance Progress Reports (RPPR) and financial statements are required. Descriptive/raw data must be submitted to NDA semi-annually (January 15 and July 15). All other data is due at publication or prior to grant end. Clinical trials also require timely registration and results reporting to ClinicalTrials.gov, submission of review determinations, and reporting of events.

Post-Award Requirements

Adherence to all provisions of the Notice of Award (NoA).
Compliance with NIH Grants Policy Statement terms and conditions.
IRB/IEC approval and submission of documents for major protocol changes.
Compliance with NIH data and safety monitoring policies for human studies.
Adherence to Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements if applicable.
Mandatory disclosure of violations of federal criminal law involving fraud, bribery, or gratuity.
Final RPPR, invention statement, and expenditure data for closeout.

Evaluation Criteria

Applications for this grant will be evaluated based on their scientific and technical merit through a rigorous peer review process. Reviewers will provide an overall impact score based on the likelihood of the project to exert a sustained, powerful influence on the research field. Scored Review Criteria Three main factors receive individual scores and contribute to the overall impact score:

Factor 1. Importance of the Research (Significance and Innovation):
- Significance: Justify the practical effect of the proposed intervention/service, comparing its hypothesized effect size and clinical meaningfulness to existing approaches. Address its scalability and potential for dissemination given typical resources and structures. Clearly detail how the research will generate data for a firm conclusion about the feasibility of a future larger-scale trial.
- Innovation: Highlight the incorporation of innovative research strategies, design/analytic elements (e.g., adaptive sequential randomization, equipoise stratification), and how information technology is leveraged to increase reach, efficiency, or effectiveness, if applicable.
Factor 2. Rigor and Feasibility (Approach):
- Rationale: Detail the empirical basis for the intervention based on the target population, illness stage, intervention goals, timeframe, and intensity. This includes justifying the chosen experimental design (e.g., control group decision) and methods, explaining how results will inform future research stages.
- Experimental Therapeutics Approach: Describe plans to explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie its effects. This involves:
  - A clear conceptual framework linking the target(s)/mechanism(s) to clinical outcomes or behaviors.
  - Plans for assessing target engagement using valid and objective measures.
  - Analytic strategies to examine target engagement and its association with clinical benefit.
- RDoC Alignment: For preventive/therapeutic interventions, detail how the study considers RDoC (Research Domain Criteria) or RDoC-like constructs in subject eligibility, intervention targets/mechanisms, and outcomes, where feasible.
- Fidelity and Implementation: Describe provisions for assessing and monitoring intervention delivery fidelity. Detail plans for involving end users (community partners, consumers, policymakers) to ensure interventions are acceptable, feasible, and scalable. Address how consumer-, provider-, and setting-level factors associated with uptake and implementation will be assessed.
- Scalability and Sustainability: Describe design features to ensure the approach is feasible, scalable, and robust against implementation drift (e.g., using technology as scaffolding, expert consultation).
- Personalization and Moderators: As relevant, address how the trial contributes to personalized mental health care and plans for collecting data on potential moderators (clinical/biological variables) for future prescriptive approaches.
- Outcome Measures: Incorporate validated and generally accepted outcome measures, including stakeholder-relevant outcomes (e.g., functioning, health services use). Include assessment of suicidal behavior and related outcomes where feasible and appropriate, or provide strong justification for exclusion.
Factor 3. Expertise and Resources (Investigator(s) and Environment):
- Investigator(s): Assess the qualifications, experience, and leadership of the PD(s)/PI(s) and other key personnel, particularly their experience collaborating with community practice partners, consumers, and relevant policymakers.
- Environment: Evaluate the adequacy of the proposed project's scientific environment, institutional support, and availability of facilities and resources. This includes how existing infrastructure (e.g., practice-based research networks, EHRs) will be utilized.

Additional Review Criteria (Not Scored) Reviewers will consider these factors, which influence the overall impact score but do not receive separate scores: * Protections for Human Subjects: Evaluate the adequacy of plans for human subject protection. * Vertebrate Animals: If applicable, evaluate plans for animal involvement, justification, and minimizing discomfort. * Biohazards: If applicable, evaluate the safety measures for hazardous materials/procedures. * Resubmissions/Renewals/Revisions: Evaluate progress (for renewals) or appropriateness of scope expansion (for revisions). Additional Review Considerations (Not Scored) These items are considered but do not impact the overall impact score: * Authentication of Key Biological and/or Chemical Resources: Evaluate plans for ensuring the validity of these resources. * Budget and Period of Support: Evaluate whether the requested budget and project duration are justified and reasonable.

Compliance & Special Requirements

This grant has extensive compliance and special requirements due to its nature as a federal award involving human subjects and clinical trials. Regulatory Compliance

Federal Regulations: All awards are subject to the NIH Grants Policy Statement, 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards), and 42 CFR Part 52.
Non-discrimination: Recipients must comply with all applicable non-discrimination laws and submit an Assurance of Compliance (HHS-690).
Health IT Compliance: If award funding involves implementing, acquiring, or upgrading health IT, recipients must use technology that meets standards in 45 CFR part 170, Subpart B, and, for eligible clinicians/hospitals, technology certified under the ONC Health IT Certification Program if applicable.

Data Protection and Privacy

Data Management and Sharing Plan: A comprehensive plan is required, detailing how generated scientific data will be managed and shared in accordance with the 2023 NIH Policy. This includes submission of data to the National Institute of Mental Health Data Archive (NDA), utilizing Global Unique Identifiers (GUIDs) and Data Dictionary technology.
Cybersecurity: Recipients handling personally identifiable information (PII) or personal health information (PHI) obtained from HHS must develop plans and procedures modeled after the NIST Cybersecurity framework.

Ethical Standards and Human Subjects Protection

IRB/IEC Approval: All research protocols must be reviewed and approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Data and Safety Monitoring: Strict oversight and monitoring of all human biomedical and behavioral intervention studies (clinical trials) are required to ensure participant safety and data integrity.
Suicide Risk Assessment: Where feasible and appropriate, intervention research should include assessment of suicidal behavior. The application must address provisions for clinical management if suicidal behavior is reported.

International Collaboration

Foreign (non-U.S.) organizations are eligible but must adhere to specific NIH policies and procedures for foreign entities.

Technical and Project-Specific Requirements

Clinical Trial Required: Only applications proposing clinical trials will be considered.
Experimental Therapeutics Approach: Projects must not only test intervention effects but also explicitly inform understanding of whether the intervention engages associated change mechanisms.
Common Data Elements (CDEs): Investigators are expected to collect CDEs for mental health human subjects research and include costs for this in their budget. Data must be submitted to NDA.
Infrastructure Utilization: Applicants should capitalize on existing infrastructure (e.g., practice-based research networks, EHRs) to enhance recruitment and data collection efficiency.
Scalability and Sustainability: Interventions and service delivery strategies should be designed with an eye towards being feasible, scalable, and sustainable for real-world implementation.

Special Considerations and Strategic Opportunities

Focus on Post-Acute Phase: This is a unique and critical focus area, addressing the long-term, chronic management of mental health conditions after an acute episode.
Addressing Disparities: The grant strongly encourages pilot research that addresses disparities in post-acute care outcomes for underserved groups (e.g., racial/ethnic minorities, those with language/cultural barriers, rural populations).
Technology Integration: Technology-assisted approaches for monitoring, intervention delivery, and promoting treatment engagement are highly encouraged.
Partnerships: Collaborations between academic researchers and clinical/community practice partners are encouraged to ensure practice-relevant questions are addressed and findings are scalable.
Innovation: Projects that incorporate innovative research strategies, design/analytic elements, and leverage information technology are preferred.

Grant Details