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Grant Analysis

Purpose & Target

SECTOR-SPECIFIC: This grant is specifically for research in the genetics or epigenetics of substance use disorders.
The core objective is to support highly innovative studies by early stage investigators (ESIs) who are opening new research areas in the genetics or epigenetics of addiction.
Target recipient type: Research institutions (universities, nonprofits, government entities, and for-profit research organizations).
Target recipient size: Not explicitly defined by employee count for the institution, but the grant is aimed at individual early stage investigators.
Geographic scope: Applicants must be from a domestic (U.S.) institution; foreign components are allowed within a U.S.-led project.
Key filtering criteria: Applicant must be an Early Stage Investigator (ESI), the project must be highly innovative, and focus on genetics/epigenetics of substance use disorders.
Grant frequency: Recurring funding opportunity, reissued from PAR-20-225.

Financial Structure

Budget Range and Limitations: Application budgets are limited to $300,000 in Direct Costs each year for up to five years.
Maximum Grant Amount: The maximum project period is 5 years, making the total direct costs $1,500,000 (5 years x $300,000).
Minimum Grant Amount: Not explicitly stated, but the yearly limit implies a minimum for a full project, or potentially less if awarded for fewer years or partial amounts.
Currency: All amounts are in USD.
Eligible Costs: Funds may be requested for personnel (including collaborators), supplies, equipment, sub-contracts, and other allowable costs.
Ineligible Costs: Facilities and Administrative (F&A) costs should not be included in the initial budget request as they will be determined at the time of award.
Matching Fund Requirements: This FOA does not require cost sharing.
Co-financing Requirements: Not applicable; no co-financing is required.
Financial Reporting Requirements: Recipients are required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required by the NIH Grants Policy Statement.
Indirect Cost Policies: Applicable Facilities and Administrative (F&A) costs will be determined at the time of award.

Eligibility Requirements

Organizational Eligibility

Eligible Organization Types:
Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 501(c)(3) IRS Status, other than Institutions of Higher Education)
For-Profit Organizations (Small Businesses, For-Profit Organizations other than Small Businesses)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal Governments - Federally Recognized and others)
Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations
Geographic Location Requirements:
Applicant organizations must be domestic (U.S.) institutions.
Non-domestic (non-U.S.) Entities are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components (parts of the project conducted outside the U.S. by collaborators) are allowed.
Registration Requirements:
Must complete and maintain active registrations in: System for Award Management (SAM), Unique Entity Identifier (UEI), eRA Commons, and Grants.gov.
Registration can take 6 weeks or more; must be completed prior to application submission.

Individual Eligibility (Program Director/Principal Investigator - PD/PI)

Early Stage Investigator (ESI) Status:
Must meet the definition of an ESI at the time of submission.
An ESI is a new investigator who has not completed successfully for a significant NIH independent research award and is within 10 years of completing their terminal research degree or medical residency.
Extensions to the 10-year period may be granted under special circumstances (e.g., childbirth, family care responsibilities).
Applicants are responsible for reviewing/updating degree information in their eRA Commons account.
Independent Research Position:
Must hold an independent research position at a domestic (U.S.) institution as of September 1 of the fiscal year of the competition.
Independent research position means a position that automatically confers eligibility, by the applicant’s institutional policy, for an investigator to apply for R01 grants, with appropriate commitment of facilities.
Investigators still in training or mentored status (postdoctoral fellows) may apply if they have a written commitment of an independent faculty position by the receipt date.
Commitment:
Awardees are required to commit at least 3 person months (25%) out of a 12-month calendar year to activities supported by the Avenir Award.
Limitations:
Multiple PD(s)/PI(s) are not allowed; only one PD/PI can be listed on the SF424 form.
Applicant organizations may submit more than one application, provided each is scientifically distinct.
NIH will not accept duplicate or highly overlapping applications under review at the same time.
If the applicant receives an R01 (or equivalent) grant before the Avenir Award is made, they are no longer eligible for the Avenir Award.

Application Process

Application Process Timeline and Deadlines

Application Due Dates:
September 25, 2025 (latest specified deadline).
Applications are due by 5:00 PM local time of the applicant organization.
Letter of Intent (LOI) Due Date: 30 days prior to the application due date (not binding, but encouraged).
Letter of Reference Submission Window: September 19 to October 19 (for 2023 cycle, assumed similar for 2025), by 5:00 PM local time of applicant organization.
Earliest Start Date: July 2026 (for applications submitted Sept 2025).
Expiration Date of FOA: September 26, 2025.

Required Documentation and Materials

Application Package: Must be accessed through ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
Standard Forms: Follow instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, unless program-specific instructions deviate.
Cover Letter: Provide names and affiliations of significant collaborators (for conflict exclusion).
Project Summary/Abstract: Text only, describing project goals.
Project Narrative: 2-3 sentences in plain language describing how the research applies to genetics or epigenetics of addiction.
Bibliography & References Cited: Not required as a separate section but may be included in the essay within page limits (using PubMed IDs for brevity is suggested).
Facilities & Other Resources: Brief statement (1-page maximum) of facilities.
Senior/Key Person Profile: Only for the PD/PI.
Biographical Sketch: Attach PD/PI's biographical sketch (omitting Personal Statement and Research Support sections).
Current and Pending Support: List of current and pending support from all sources.
Research Plan (Essay): Upload an essay in place of a traditional research strategy.
The essay should address: (1) significance and potential impact to open new areas in genetics/epigenetics of addiction, leading to understanding and new treatments/prevention avenues; (2) what makes approaches innovative and how risks will be addressed; and (3) applicant's qualifications.
Preliminary data is allowed but not required.
Should include sections: Project Description, Innovativeness, Investigator Qualifications.
Letters of Support: Provide letters from significant collaborators.
Letters of Reference: Three (and no more than three) confidential letters of reference are required and must be submitted directly by referees.
Applications missing letters of reference will be considered incomplete and not reviewed.
Data Management and Sharing (DMS) Plan: Required for all applications generating scientific data, regardless of direct costs requested.

Submission Format and Platform

Electronic Submission: Applications must be submitted electronically via Grants.gov.
Tracking: Applicants must track submission status in eRA Commons.
Corrections: Applicants are encouraged to submit early to allow time for corrections; errors must be corrected and a changed/corrected application submitted by the due date and time.

Project Implementation Timeline and Reporting Obligations

Grant Duration: Maximum project period of 5 years.
Annual Reporting: Recipients are required to submit the Research Performance Progress Report (RPPR) annually.
Final Reporting: A final RPPR, invention statement, and expenditure data are required for closeout.

Post-Award Requirements

Award Notices: Formal notification is a Notice of Award (NoA).
Terms and Conditions: Awards are subject to NIH Grants Policy Statement and specific terms in the NoA.
ClinicalTrials.gov (if applicable): Responsible party must register and submit results for certain clinical trials.
IRB/IEC Approval: Recipient institutions must ensure all protocols are reviewed by their Institutional Review Board or Independent Ethics Committee.
Data and Safety Monitoring: Required for all NIH-supported human biomedical and behavioral intervention studies.
IND/IDE Requirements (if applicable): Clinical research involving investigational therapeutics/devices must follow FDA IND/IDE requirements.
Data Management and Sharing: Recipients must adhere to the approved DMS Plan.
Federal Funding Accountability and Transparency Act (FFATA): Reporting on first-tier subawards over $25,000 to FSRS.gov.
FAPIIS: Compliance with Federal Awardee Performance and Integrity Information System requirements.

Evaluation Criteria

Overall Impact

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

Scored Review Criteria

Significance:
Does the project address an important problem or critical barrier in the field?
Is the prior research supporting the project rigorous?
How will scientific knowledge, technical capability, or clinical practice improve if aims are achieved?
How will successful completion change concepts, methods, technologies, treatments, services, or preventative interventions?
For clinical trials: Is the scientific rationale well supported by preliminary data/literature? Is the trial necessary for testing safety/efficacy or advancing scientific understanding?
Investigator(s):
Are the PD/PI and collaborators well-suited to the project?
Do Early Stage Investigators have appropriate experience and training?
For clinical trials: Do the PD/PI(s) and key personnel have the expertise to organize, manage, and implement the trial and meet timelines? Do they have expertise in study coordination, data management, and statistics?
Innovation:
Does the application challenge existing paradigms using novel theoretical concepts, approaches, methodologies, instrumentation, or interventions?
Is the proposed refinement, improvement, or new application novel to one field or broadly novel?
For clinical trials: Does the design include innovative elements that enhance sensitivity, information potential, or potential to advance scientific knowledge/practice?
Approach:
Are the overall strategy, methodology, and analyses well-reasoned and appropriate for achieving aims?
Are plans included to address weaknesses in prior research rigor?
Are strategies presented to ensure a robust and unbiased approach?
Are potential problems, alternative strategies, and benchmarks for success outlined?
If early stage, will the strategy establish feasibility and manage risky aspects?
Are plans adequate to address relevant biological variables (e.g., sex) in animal/human studies?
For human subjects/clinical research: Are plans for human subject protection, and inclusion/exclusion based on sex, race, ethnicity, and age justified by scientific goals?
For clinical trials: Are study design, rationale, power, population, intervention arms, and duration appropriate? Are ethical issues, recruitment, retention, standardization, data management, and statistical analyses adequate?
Environment:
Will the scientific environment contribute to success?
Are institutional support, equipment, and physical resources adequate?
Will the project benefit from unique features (e.g., subject populations, collaborations)?
For clinical trials: Are administrative, data coordinating, enrollment, and testing centers appropriate? Is there evidence of site capability for multi-site trials?

Additional Review Criteria (Not Separately Scored)

Study Timeline (for clinical trials): Detailed, feasible, justified, incorporates efficiencies, discusses challenges and solutions.
Protections for Human Subjects: Justification for involvement, protection against risks, potential benefits, importance of knowledge, data/safety monitoring.
Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Evaluation of proposed plans for inclusion/exclusion based on scientific justification.
Vertebrate Animals: Description of procedures, justification for use, interventions to minimize discomfort, justification for euthanasia method.
Biohazards: Assessment of potential hazards and adequacy of protection.
Resource Sharing Plans: Reasonableness of Data Sharing Plan, Sharing Model Organisms, and Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity.
Budget and Period of Support: Whether the budget and requested period are justified and reasonable in relation to the proposed research.

Compliance & Special Requirements

Regulatory Compliance Requirements

Standard NIH Regulations: Awards are made under Sections 301 and 405 of the Public Health Service Act and Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
Data Protection and Privacy: NIDA strongly encourages data sharing; applicants are expected to submit data to NIH data archives.
Human Subjects/Animal Research: Compliance with specific regulations and guidelines for human subjects (45 CFR Part 46) and vertebrate animals.
Cannabis Research: Applications proposing research on cannabis or delta-9-THC are required to measure and report results using a standard delta-9-THC unit (5 milligrams of delta-9-THC). Justification needed if standard unit is not used.
Civil Rights and Nondiscrimination: Recipients of federal financial assistance from HHS must administer programs in compliance with federal civil rights laws (e.g., race, color, national origin, disability, age, religion, sex). This includes ensuring accessibility for individuals with limited English proficiency and disabilities.
Sexual Harassment: HHS funded programs must be administered in an environment free of sexual harassment.

Risk Management and Security Requirements

Select Agent Research: If applicable, reviewers will assess plans for select agent use, registration, monitoring, biosafety, biocontainment, and security.

Intellectual Property Policies

Resource Sharing: Investigators are expected to deposit selectively bred strains in appropriate repositories and register these strains and any research resources in the Neuroscience Information Framework.
Research Resource Identifiers (RRIDs) and DOIs are expected to be used in any publication.

Unique Aspects and Strategic Opportunities

Avenir Award Concept: The term 'Avenir' means 'future', signifying support for early stage investigators proposing highly innovative, potentially transformative studies that may lack preliminary data typically required for other grants.
Focus on Innovation: Emphasis is on high-impact, pioneering approaches that open new research areas in the genetics or epigenetics of addiction, rather than incremental advances.
Interdisciplinary Encouragement: Investigators outside the field of addiction interested in applying novel approaches are encouraged to apply.
No Specific Aims Required: The application format uses an 'Essay' instead of traditional specific aims, allowing for a broader presentation of innovative ideas and qualifications.
Clinical Trial Optional: The grant accepts applications that either propose or do not propose clinical trials.
Support for Early Career Researchers: Designed to help ESIs establish independent research programs in a high-impact area.
No Cost Sharing: Cost sharing is not required, reducing financial burden on applicant institutions.
Reference Letters: A mandatory component of the application, emphasizing the importance of external validation of the applicant's potential for creativity and innovation.

Grant Details