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Grant Analysis

Purpose & Target

Grant Purpose and Target

Core Objective: To advance mechanistic and translational research on the onset and worsening of mood and psychotic disorders during the menopausal transition (perimenopause) and to identify novel targets for future mental health interventions or prevention efforts.
Target Recipient Type and Size: Open to a broad range of entities, including higher education institutions, nonprofit organizations, for-profit organizations (including small businesses), and various government entities. No explicit organizational size limitations are specified.
Designation: SECTOR-SPECIFIC
Geographic Scope: Eligible applicants include entities within the U.S. and non-U.S. (Foreign Organizations) entities.
Key Filtering Criteria: Research must focus on the menopausal transition, address mood/psychotic symptoms mechanistically, and involve human subjects.
Grant Frequency and Program Context: This is a recurring R01 Research Project Grant, a re-issue of PAR-23-097, and has a companion R21 grant mechanism (PAR-25-282) for higher-risk projects or those with less preliminary data.

Financial Structure

Funding Instrument: Grant.
Budget Range: Application budgets are not limited; however, they must reflect the actual needs of the proposed project. No specific minimum or maximum grant amount per application is defined.
Eligible Costs: Not explicitly itemized, but generally covers costs associated with approved research activities, including personnel, equipment, travel, and supplies, and must be in alignment with NIH Grants Policy Statement.
Ineligible Costs: Not explicitly itemized, but projects deemed non-responsive (e.g., stand-alone technology development, non-mechanistic studies) would have associated costs deemed ineligible.
Matching Fund Requirements: None. Cost sharing is not required.
Co-financing: Not explicitly required.
Indirect Cost Policies: Subject to standard NIH indirect cost policies and negotiated rates with applicant institutions.
Payment Schedule and Mechanisms: Standard NIH grant disbursement mechanisms apply.
Financial Reporting Requirements: Annual Research Performance Progress Reports (RPPR) and financial statements are required. A final RPPR and expenditure data are required at closeout.
Financial Guarantees: No specific financial guarantees are required beyond adherence to standard federal grant financial regulations.

Eligibility Requirements

Organizational Requirements

Eligible Organization Types:
- Higher Education Institutions (Public/State Controlled, Private)
- Nonprofits (with or without 501(c)(3) IRS Status)
- For-Profit Organizations (Small Businesses, Other)
- Local Governments (State, County, City/Township, Special District)
- Indian/Native American Tribal Governments (Federally Recognized, Other)
- Federal Governments (Eligible Agencies, 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, Regional Organizations, Non-domestic (non-U.S.) Entities (Foreign Organizations).
Required Registrations:
- System for Award Management (SAM) with active registration (requires annual renewal).
- NATO Commercial and Government Entity (NCAGE) Code for foreign organizations.
- Unique Entity Identifier (UEI) obtained through SAM.gov.
- eRA Commons account for the organization, with at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
- Grants.gov registration (requires active SAM registration).

Individual/Principal Investigator Requirements

Any individual with the skills, knowledge, and resources to conduct the proposed research is eligible.
All PD(s)/PI(s) must have an eRA Commons account.

Project Scope Eligibility

Focus: Research must explicitly target populations transitioning through menopause.
Research Type: Must be mechanistic and translational (designed to understand a biological/behavioral process or mechanism of action of an intervention). Studies that are purely descriptive or primarily evaluate safety, clinical efficacy, effectiveness, management, and/or implementation of new interventions are non-responsive.
Levels of Analysis: Studies must assess mechanisms across multiple levels of observation and analysis (e.g., genetic, cellular, brain circuit, physiological, behavioral, self-report). Studies focused on only a single level are non-responsive.
Validation: Projects must validate that participants are undergoing some phase of the menopausal transition; assumptions based solely on age are non-responsive.
Technology Development: Stand-alone development of novel technology is not supported; new methods should be integrated into an underlying scientific question.
Animal Studies: Nonhuman animal studies are non-responsive.

Application Process

Application Submission Platforms: Applications must be submitted through NIH ASSIST, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Application Content: Applicants must follow instructions in the Research (R) Instructions in the How to Apply - Application Guide, prioritizing any program-specific instructions outlined in this NOFO.
Page Limitations: Strict adherence to all page limitations as described in the How to Apply - Application Guide and the Table of Page Limits.
Documentation Requirements: Standard NIH application forms (SF424(R&R) series, PHS 398 series) with specific requirements for:
- Biographical Sketch: Must detail investigator expertise in menopausal transition, mood, and/or psychosis research.
- Research Strategy: Must include clear mechanistic hypotheses, methods for assessing menopause transition phase, details if an RDoC approach is used, and plans for managing comorbid conditions/comparison populations.
- Resource Sharing Plan: Required.
- Data Management and Sharing Plan: Required for all applications, regardless of requested direct costs. Data submission to the National Institute of Mental Health Data Archive (NDA) is expected, with budgeting for submission costs and semi-annual raw/descriptive data submission.
- Appendix: Limited to blank questionnaires or blank surveys only; no publications or other materials.
- PHS Human Subjects and Clinical Trials Information: Required for relevant research.
Pre-application Requirement: For projects requesting $500,000 or more in direct costs (excluding consortium F&A) in any single year, applicants must contact a Scientific/Research Contact at least 6 weeks before submitting the application.
Submission Deadline: Applications are due by 5:00 PM local time of the applicant organization. Early submission is encouraged.

Timeline

Open Date (Earliest Submission Date): January 05, 2025.
Latest Application Due Date: November 05, 2027 (for Renewal/Resubmission/Revision applications).
Grant Duration: Maximum 5 years project period.
Expiration Date: January 08, 2028 (after which new applications will not be accepted).

Reporting Obligations

Annual Reporting: Recipients must submit the Research Performance Progress Report (RPPR) and financial statements annually.
Closeout Reporting: A final RPPR, invention statement, and expenditure data are required for award closeout.
Data Sharing: Semi-annual submission of descriptive/raw data to NDA, and other data at the time of publication or prior to grant end.

Evaluation Criteria

Overall Impact

Reviewers will assess the project's likelihood to exert a sustained, powerful influence on the relevant research field(s).

Scored Review Criteria

Factor 1. Importance of the Research (Significance and Innovation):
- Potential for significant scientific advance.
- Novelty and originality of the research approach or hypothesis.
Factor 2. Rigor and Feasibility (Approach):
- Clarity of mechanistic hypotheses, and adequate capacity to test and potentially refute them.
- Defined methods to assess the phase of menopausal transition.
- If using an RDoC approach, assessment methods must converge on the construct from at least two levels of analysis (e.g., genes, molecules, cells, circuits, physiology, behavior, self-report).
- If using a dimensional construct, the study design must include an adequate number of individuals within the more severely impaired ranges of that dimension.
- Plans for assessing comorbid medical conditions and controlling for confounding influences.
- Justification for any comparison populations used.
- Incorporation of rigor and transparency features in experimental design.
Factor 3. Expertise and Resources (Investigator(s) and Environment):
- Investigator(s)' expertise in studying menopausal transition at the proposed levels of analysis.
- Investigator(s)' prior experience in conducting research on mood and/or psychosis.
- Encouragement for teams with varied scientific backgrounds (e.g., neuroscience, engineering, endocrinology, psychology, etc.).
- Strong encouragement for teams led by or including those with lived experience with perimenopausal depression or psychosis.

Additional Review Considerations (not scored, but impact overall assessment)

Protections for Human Subjects: Adequacy of plans for human subject protection.
Vertebrate Animals (if applicable): Ethical and scientific justification for use.
Biohazards (if applicable): Management and mitigation plans.
Resubmissions/Renewals/Revisions: Evaluation of progress made and appropriateness of proposed changes/expansion.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring the validity of resources.
Budget and Period of Support: Justification and reasonableness of requested budget and project duration in relation to the proposed research.

Compliance & Special Requirements

Regulatory Compliance

General Compliance: Adherence to all instructions in the How to Apply - Application Guide and this Notice of Funding Opportunity (NOFO).
Federal Regulations: Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) and all federal statutes and regulations relevant to federal financial assistance, including public policy requirements outlined in the NIH Grants Policy Statement Section 4.
Mandatory Disclosure: Recipients must disclose any information related to violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award.

Data Protection and Privacy

Data Management and Sharing: Required to comply with the 2023 NIH Policy for Data Management and Sharing. Specifically, data generated under this grant is expected to be shared via the National Institute of Mental Health Data Archive (NDA), utilizing their Global Unique Identifier (GUID) and Data Dictionary technology.
Human Subjects Protection: Strict adherence to NIH policies and federal regulations concerning human research protection and data and safety monitoring (per NOT-MH-19-027). Plans for protection of research participants and data and safety monitoring will be reviewed by NIMH.

Ethical Standards

Research Rigor: Applicants are strongly encouraged to review and incorporate features to enhance the reproducibility, rigor, and transparency of NIH-supported research (NOT-OD-15-103, NOT-MH-14-004).
Ethical Review: Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for all human subjects protocols.

Technical Specifications and Exclusions

Project Focus: Research must be mechanistic and translational, not merely descriptive, and integrate across multiple levels of analysis.
Technology Use: Encouraged to use cutting-edge methodologies (e.g., high-field MR neuroimaging, novel neural/behavioral recording). However, stand-alone development of novel technology is not supported.

Strategic Opportunities

Team Composition: Encourages interdisciplinary teams with varied scientific backgrounds. Notably, teams led by or including individuals with lived experience with perimenopausal depression or psychosis are highly encouraged.
Research Framework: Encourages adoption of an intersectionality framework to address multiple dimensions of identity and social systems.

Risk Management

Large Budget Proposals: Projects requesting $500,000 or more in direct costs in any given year require a mandatory pre-submission contact with a Scientific/Research Contact at least 6 weeks before the application deadline.

Grant Details