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Grant Analysis

Purpose & Target

This grant, the 'Social disconnection and Suicide Risk in Late Life (R01 Clinical Trial Optional),' from the National Institute of Mental Health (NIMH), aims to fund research that explores the connection between social disconnection (like isolation and loneliness) and suicidal thoughts and behaviors in older adults. The main goal is to identify the underlying neurobiological, behavioral, and environmental mechanisms that contribute to this risk or offer protection against it. This information is intended to help develop better prevention and intervention strategies. This is a SECTOR-SPECIFIC grant, focusing primarily on Mental Health and Public Health Research related to aging. It targets research organizations capable of conducting rigorous scientific studies. The geographic scope includes organizations within the United States and international (non-U.S.) entities. This is a recurring funding opportunity, building upon previous announcements.

Financial Structure

This grant operates under a 'Grant' funding instrument, providing financial assistance for approved projects.

Budget Range: Application budgets are not limited but must accurately reflect the actual needs of your proposed project. There are no specified minimum or maximum grant amounts per application.
Direct Costs Over $500,000: If your project requests $500,000 or more in direct costs in any single year (excluding consortium F&A costs), you must contact a Scientific/Research Contact at least 6 weeks before submitting your application. This is a critical pre-submission requirement.
Matching Fund Requirements: This funding opportunity does not require cost sharing or matching funds.
Eligible Costs: All costs must align with the NIH Grants Policy Statement. Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1.
Currency: All financial figures are implicitly in U.S. Dollars (USD).
Funding Rate: The specific funding rate (percentage of eligible costs covered) is not specified in the grant materials.

Eligibility Requirements

To be eligible for this grant, your organization must fall into one of the following categories:

Higher Education Institutions: Public/State Controlled and Private.
Nonprofits: With or without 501(c)(3) IRS status.
For-Profit Organizations: Including small businesses and other for-profit entities.
Government Entities: Local (County, City, Township, Special District), State, Federally Recognized Indian/Native American Tribal Governments, Other Indian/Native American Tribal 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, Faith-based or Community-based Organizations, and Regional Organizations.
Foreign Organizations: Non-U.S. entities are explicitly eligible to apply, and non-U.S. components of U.S. organizations are also eligible.

Required Registrations: All applicant organizations must complete and maintain active registrations with the following systems before submitting their application: * System for Award Management (SAM): This includes obtaining a Unique Entity Identifier (UEI). * NATO Commercial and Government Entity (NCAGE) Code: Required for foreign organizations in lieu of a CAGE code to register in SAM. * eRA Commons: Organizations need at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account. * Grants.gov: Requires an active SAM registration. Individual Eligibility: Any individual with the necessary skills, knowledge, and resources can serve as a Program Director/Principal Investigator (PD/PI), provided their organization develops the application. All PD/PIs must have an eRA Commons account. Exclusion Criteria (Non-Responsive Applications): Your application will not be reviewed if it falls into these categories: * Studies solely focused on evaluating the safety, clinical efficacy, effectiveness, or implementation of new interventions (clinical trials must be mechanistic). * Studies that are purely descriptive and do not investigate underlying mechanisms. * Studies that assess mechanisms at only a single level of observation and analysis (e.g., only genetic, or only behavioral, without combining multiple levels). * Studies that address only social disconnection in late life without also measuring suicide risk/behaviors, or only late-life suicide without assessing social factors. * Nonhuman animal studies.

Application Process

Applying for this grant involves several steps and adherence to strict timelines: Key Dates and Deadlines There are multiple application due dates. The latest submission deadline for new applications is June 05, 2026, by 5:00 PM local time of the applicant organization. Other deadlines for new, renewal, resubmission, and revision applications are:

New Applications:
- February 05, 2025
- June 05, 2025
- October 05, 2025
- February 05, 2026
- June 05, 2026 (latest)
Renewal / Resubmission / Revision Applications (as allowed):
- March 05, 2025
- July 05, 2025
- November 05, 2025
- March 05, 2026
- July 05, 2026 (latest)

Applicants are encouraged to submit early to allow time for corrections. If a due date falls on a weekend or federal holiday, the deadline is extended to the next business day. Application Procedure and Submission Applications must be submitted electronically through one of the following methods:

NIH ASSIST system: To prepare, submit, and track online.
Institutional system-to-system (S2S) solution: Check with your institution for availability.
Grants.gov Workspace: To prepare and submit.

Required Documentation and Materials: You must follow instructions in the NIH 'How to Apply - Application Guide' and any program-specific instructions. Key components include:

SF424(R&R) forms: Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile.
Budget Forms: R&R or Modular Budget, R&R Subaward Budget.
PHS 398 Forms: Cover Page Supplement, Research Plan.
Research Plan (PHS 398): Must include sections addressing Significance, Rigor and Feasibility (Approach), and Expertise and Resources (Investigators and Environment).
Resource Sharing Plan: Required.
Other Plan(s): Specifically, a Data Management and Sharing Plan for all generated scientific data.
PHS Human Subjects and Clinical Trials Information: Required if human subjects are involved.
Biosketches: For all investigators, demonstrating expertise.
Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys). No publications or other external materials.

Project Implementation and Reporting

Grant Duration: The maximum project period allowed is 5 years.
Reporting Obligations:
- Annual Research Performance Progress Report (RPPR): Required annually.
- Semi-annual Data Submission to NDA: Expected every January 15 and July 15 for descriptive/raw data. All other data (e.g., published results) are expected at the time of publication or before the grant ends.
- Final RPPR, invention statement, and Federal Financial Report (expenditure data): Required for closeout of the award.

Evaluation Criteria

Applications are judged based on their scientific and technical merit, with a focus on their potential to significantly impact the field. Here's what reviewers will consider:

Overall Impact: This is the primary score, reflecting the likelihood that your project will have a sustained and powerful influence on research.

Scored Review Criteria These three factors will receive individual scores and contribute to the overall impact:

Factor 1. Importance of the Research (Significance and Innovation): Reviewers will assess how likely your project is to improve understanding of the link between social connectedness/disconnection and suicidality. Innovation in identifying novel targets for future prevention and intervention efforts is encouraged.
Factor 2. Rigor and Feasibility (Approach): This evaluates the soundness of your research design. If you're using a Research Domain Criteria (RDoC) approach, you must describe assessment methods that combine at least two levels of analysis (e.g., genes, behavior, brain circuits). Your hypotheses must be clear and testable. For mechanistic clinical trials, you'll need to explain how the study design addresses whether the intervention engages the presumed underlying mechanisms.
Factor 3. Expertise and Resources (Investigator(s) and Environment):
- Investigator(s): Reviewers look for adequate background, training, and expertise in both social connectedness/disconnection and suicidality. For human subjects research, demonstrate preparedness to handle clinical, ethical, and safety aspects, especially with participants at elevated suicide risk.
- Environment: Assess if institutional resources are appropriate for the proposed work.

Additional Review Criteria These are considered but do not receive separate scores:

Protections for Human Subjects: Justification for involvement, protection against risks, potential benefits, importance of knowledge gained, and data/safety monitoring plans.
Vertebrate Animals: If applicable, justification for animal use, appropriateness of species, and measures to minimize discomfort.
Biohazards: Assessment of proposed procedures and adequate protection.
Resubmissions: The full application as presented will be evaluated.

Additional Review Considerations These points inform the overall impact score but are not scored separately:

Authentication of Key Biological and/or Chemical Resources: Brief plans for ensuring validity.
Budget and Period of Support: Justification and reasonableness of the requested budget and project duration in relation to the proposed research.

Compliance & Special Requirements

This grant comes with several compliance and special requirements due to its nature as a federal award and focus on research, especially involving human subjects: Regulatory Compliance

Federal Regulations: All awards are subject to the terms and conditions outlined in 2 CFR Part 200 ('Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards'), the Public Health Service Act, and 42 CFR Part 52.
Mandatory Disclosure: Recipients or subrecipients must disclose any violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award (per 2 CFR 200.113).
Nondiscrimination: Recipients must comply with all applicable nondiscrimination laws and submit an 'Assurance of Compliance' (HHS-690).

Data Management and Sharing

NIH Data Management and Sharing Policy: Required for all projects generating scientific data, regardless of direct costs. A detailed Data Management and Sharing Plan must be submitted and adhered to.
NIMH Data Archive (NDA): Investigators funded under this NOFO are expected to share all generated data (raw or minimally processed) via the NDA, a secure informatics platform. This includes using the NDA's Global Unique Identifier (GUID) and Data Dictionary technology. You should budget for the costs of preparing and transferring data to the NDA.

Ethical Standards and Human Subjects Protection

Human Subjects Research: Research involving human subjects must adhere to 45 CFR Part 46 protections. This includes justifying human subject involvement, ensuring adequate protection against risks, and planning for data and safety monitoring.
IRB/IEC Approval: Recipient institutions must ensure all protocols are reviewed and approved by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Data and Safety Monitoring: Required for all NIH-supported human biomedical and behavioral intervention studies (clinical trials) to ensure participant safety and data integrity.
ClinicalTrials.gov: If the award includes clinical trials, the responsible party must register and submit results information on ClinicalTrials.gov.

Unique Aspects and Strategic Considerations

Mechanistic Clinical Trials Only: A crucial limitation is that proposed clinical trials must be mechanistic (aimed at understanding biological or behavioral processes), not for evaluating safety, clinical efficacy, effectiveness, or the development/implementation of new interventions. This means you need to show how an intervention affects underlying mechanisms, not just whether it works.
Interdisciplinary and Multi-level Research: The grant strongly encourages research that integrates multiple levels of analysis (e.g., neurobiological, behavioral, environmental) and employs cutting-edge methodologies. If using the RDoC framework, projects should use assessment methods that converge on the construct from at least two levels of analysis.
Health Disparities and Intersectionality: Research addressing health disparities in late-life social connection and suicide, particularly work that adopts an intersectionality framework (addressing multiple dimensions of identity and social systems), is highly encouraged.
Rigor and Transparency: Applicants are expected to incorporate appropriate features for enhancing reproducibility of NIH-supported research.
Risk Tolerance: The related R21 grant (PAR-25-066) is for higher-risk, high-payoff projects with little preliminary data, implying this R01 expects more established research proposals.
Knowledge Sharing: A significant emphasis is placed on broad data sharing through the NDA to maximize usability for meta-analyses and systems biology research.

Grant Details