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Grant Analysis

Purpose & Target

Core objective: To advance translational research that enhances understanding of schizophrenia and related psychotic disorders in individuals aged 35 and above, aiming to identify targets for future prevention and treatment interventions.
Target recipient type: Research institutions, non-profits, for-profit organizations, and various government entities.
Target size: Not specified by employee count; focus is on research capacity and expertise.
SECTOR-SPECIFIC (Mental Health Research, Translational Medicine)
Geographic scope: United States and eligible non-U.S. entities (global eligibility).
Key filtering criteria: Research must focus on schizophrenia/psychotic disorders in mid- to late-life (age 35+); projects should be exploratory/developmental, potentially lacking preliminary data.
Grant frequency: Recurring (reissue of PAR-24-026).
Program context: Utilizes the R21 Exploratory/Developmental Research Grant mechanism, suitable for high-risk/high-reward projects, distinct from the R01 mechanism (PAR-25-039) which is for longer-term research with preliminary data.

Financial Structure

Maximum direct costs for the two-year project period: $275,000.
Maximum direct costs allowable in any single year: $200,000.
Currency: USD (implied, as it is a U.S. National Institutes of Health grant).
Cost sharing: Not required.
Eligible costs: Funds for collecting and submitting 'Common Data Elements (CDEs)' to the 'NIMH Data Archive (NDA)' should be included in the proposed budget. Pre-award costs are allowable as described in the NIH Grants Policy Statement.
Financial reporting: Annual 'Research Performance Progress Reports (RPPR)' and financial statements are required. A final RPPR and expenditure data are necessary for grant closeout.
Audit requirements: Awards are subject to the 'Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards' (2 CFR Part 200).

Eligibility Requirements

Eligible Organizations

Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (501(c)(3) IRS Status, without 510(c)(3))
For-Profit Organizations (Small Businesses, Other For-Profits)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal (Federally Recognized/Other))
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), Faith-based or Community-based Organizations, Regional Organizations, Non-domestic (non-U.S.) Entities (Foreign Organizations).

Geographic Location

Organizations located in the U.S. are eligible.
Non-domestic (non-U.S.) entities (Foreign Organizations) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Organizational Maturity/Capacity

The R21 grant mechanism supports 'exploratory/developmental research' and 'high risk/high reward projects that lack preliminary data'.
Applicants must be able to complete and maintain required registrations (SAM, NCAGE (if foreign), UEI, eRA Commons, Grants.gov).
Compliance with NIH Grants Policy Statement, federal regulations (2 CFR Part 200), and specific instructions within this funding opportunity is mandatory.

Exclusions

Studies primarily evaluating safety, clinical efficacy, and effectiveness will not be reviewed.
Mechanistic and translational research on psychosis during menopausal transition (as per PAR-23-102) is not supported under this NOFO.
Studies assessing mechanisms at only a single level of observation and analysis (without combining multiple levels/methods such as genetic, cellular, brain circuit, physiological, behavioral, self-report) will not be reviewed.
Studies focusing on psychosis in neurodegenerative diseases (e.g., Parkinson’s or Alzheimer’s disease, as per PAR-23-208) are excluded.
Studies targeting populations less than 35 years of age are generally excluded, unless scientifically justified as a relevant comparison population.
Brain-wide association studies (BWAS) that are solely data discovery without clear hypotheses or data reduction strategies will not be reviewed.
Applications that do not include human subjects will not be reviewed.
The grant does not support the stand-alone development of novel technology.

Application Process

Key Dates and Deadlines

Open Date (Earliest Submission Date): January 16, 2025.
Application Due Dates (by 5:00 PM local time of applicant organization):
- New applications: Latest due date is June 16, 2026.
- Renewal / Resubmission / Revision applications: Latest due date is July 16, 2026.
Expiration Date (of funding opportunity): September 08, 2026.
Project Period: Maximum of 2 years.
Earliest Start Date: Depends on the specific application due date and review cycle, with the latest being April 2027 for applications submitted on the final due date.

Application Submission Process

Applications must be submitted electronically through ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
Applicants are strongly encouraged to submit early to allow sufficient time for any necessary corrections before the deadline.
If a submission date falls on a weekend or U.S. federal holiday, the deadline is automatically extended to the next business day.
Applicants must monitor their application status in the eRA Commons.

Required Documentation and Materials

All applicants must follow the instructions provided in the 'Research (R) Instructions' within the 'How to Apply - Application Guide', unless specific deviations are noted in this funding opportunity.
Program-specific instructions within this NOFO take precedence over the general Application Guide instructions.
Adherence to all stated page limitations is strictly enforced.
Required forms include: SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R or Modular Budget, R&R Subaward Budget, PHS 398 Cover Page Supplement, PHS 398 Research Plan, PHS Human Subjects and Clinical Trials Information, and PHS Assignment Request Form.
For projects involving human subjects: At least one human subjects study record using the 'Study Record: PHS Human Subjects and Clinical Trials Information form' or a 'Delayed Onset Study' record is required.
Appendix materials are limited to blank questionnaires or surveys; no other materials, such as publications, are permitted.

Post-Award Requirements and Reporting

Recipients are required to submit a 'Research Performance Progress Report (RPPR)' annually and financial statements as specified.
A final RPPR, invention statement, and expenditure data are required for award closeout.
A 'Data Management and Sharing Plan' is required, detailing how research data will be managed and shared.
Data submission to the 'NIMH Data Archive (NDA)' is expected: descriptive/raw data semi-annually (January 15 and July 15), and all other data at the time of publication or grant end, whichever comes first.
For clinical trials, specific compliance requirements include timely registration and results reporting to ClinicalTrials.gov, submission of data and safety monitoring reviews, and establishment of recruitment milestones.
Recipient institutions must ensure that all research protocols undergo review and approval by their 'Institutional Review Board (IRB)' or 'Independent Ethics Committee (IEC)'.

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood of the project to significantly and sustainably influence the relevant research field(s). Projects do not need to be strong in all categories to achieve a high impact score.

Scored Review Criteria

Factor 1. Importance of the Research (Significance and Innovation):
- Addresses critical scientific questions in the field.
- Introduces novel scientific ideas, model systems, tools, or technologies with potential for high impact.
Factor 2. Rigor and Feasibility (Approach):
- Demonstrates a clear conceptual framework with testable and potentially refutable mechanistic hypotheses.
- If using a dimensional construct, the study design and sampling plan must ensure adequate inclusion of individuals across the full range of impairment.
- For RDoC approaches, assessment methods should integrate data from at least two levels of analysis (e.g., genes, cells, circuits, behavior).
- Includes plans for assessing and controlling for comorbid medical conditions.
- Provides scientific justification for including comparison populations younger than 35 years, if applicable.
- Incorporates principles of rigor and transparency in experimental design, as outlined in NIH and NIMH guidelines (NOT-OD-15-103, NOT-MH-14-004).
Factor 3. Expertise and Resources (Investigator(s) and Environment):
- Assesses the qualifications, experience, and complementary expertise of the research team.
- Evaluates the adequacy of the proposed research environment and available resources to successfully conduct the project.

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

Protections for Human Subjects: Adequacy of plans to protect human research participants.
Vertebrate Animals: Appropriate consideration and plans for the use of vertebrate animals, if applicable.
Biohazards: Identification and mitigation of biohazards.
Resubmissions/Revisions: Evaluation of progress from previous versions or appropriateness of expanded scope.
Authentication of Key Biological and/or Chemical Resources: Plans to ensure the validity and reliability of critical research materials.
Budget and Period of Support: Justification and reasonableness of the proposed budget and duration relative to the research scope.
Funding Decisions: Beyond scientific merit, funding decisions also consider the availability of funds and the project's relevance to NIMH program priorities.

Compliance & Special Requirements

Regulatory Compliance

Adherence to all provisions outlined in the NIH Grants Policy Statement is mandatory.
Compliance with '2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards' is required.
Awards are made under the authority of Sections 301 and 405 of the Public Health Service Act and Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
Recipients must comply with all applicable nondiscrimination laws and submit an 'Assurance of Compliance' (HHS-690).

Data Protection and Sharing

A 'Data Management and Sharing Plan' is required and must align with the 2023 NIH Policy for Data Management and Sharing.
Research data generated under this grant must be shared via the 'National Institute of Mental Health Data Archive (NDA)'.
Investigators are expected to utilize NDA's 'Global Unique Identifier (GUID)' and 'Data Dictionary' technologies for data submission.
Informed consent processes for study participants should include provisions for data sharing.
Investigators are responsible for certifying data quality and reviewing data for accuracy before and after submission to NDA.
Descriptive/raw data are to be submitted semi-annually (January 15 and July 15); other data types at publication or grant conclusion, whichever occurs first.

Ethical and Human Subject Standards

Applications must include 'PHS Human Subjects and Clinical Trials Information' that reflects NIH/NIMH policies on human research protection, data, and safety monitoring (NOT-MH-19-027).
'Institutional Review Board (IRB)' or 'Independent Ethics Committee (IEC)' approval is required for all human subject research protocols.
All human biomedical and behavioral intervention studies (clinical trials) are subject to NIH policies on data and safety monitoring.
Compliance with 'Investigational New Drug (IND)' or 'Investigational Device Exemption (IDE)' requirements is necessary for clinical research involving investigational products.

Risk Management and Security

The NIH reviews an applicant's federal award history in SAM.gov to assess business practices, integrity, and performance.
Mandatory disclosure of any information related to violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award is required.

Special Considerations & Unique Aspects

Exploratory/Developmental Focus: This R21 grant is specifically designed for 'exploratory/developmental research' and 'high risk/high reward projects' that may not have extensive preliminary data. The emphasis is on conceptual framework, innovation, and potential for significant impact.
Interdisciplinary Collaboration: The NOFO actively encourages applications from interdisciplinary research teams, including fields such as neuroscience, engineering, gerontology, social work, pharmacology, psychiatry, and psychology.
Lived Experience Inclusion: Teams that include or are led by individuals with lived experience of psychosis are highly encouraged to apply.
Emphasis on Mechanisms: A core objective is to identify neurobiological, behavioral, psychosocial, and environmental mechanisms underlying the emergence, trajectory, and outcomes of schizophrenia and related psychotic disorders.
Dimensional Approach: The grant encourages a 'Research Domain Criteria (RDoC)' approach, promoting a dimensional perspective on psychopathology rather than solely relying on traditional diagnostic categories.
Inclusivity and Health Equity: Research focusing on minority health and NIH-designated populations experiencing health disparities is encouraged, particularly adopting an 'intersectionality framework' to address multiple dimensions of identity and social systems.
Advanced Methodology Integration: Encourages the use of cutting-edge methodologies (e.g., very high field MR neuroimaging, novel recording devices), but explicitly states it 'does not support the stand-alone development of novel technology'. New methods should serve an underlying scientific question.
Budgeting for Data Sharing: Applicants should specifically budget for the costs associated with data submission to the NDA, utilizing tools like the 'NDA Data Submission Cost Model'.

Grant Details