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Grant Analysis

Purpose & Target

Grant Purpose and Target

Core Objective: To support doctoral candidates for up to two years to complete their dissertation research projects related to Substance Use/Substance Use Disorder (SU/SUD).
Target Recipient: Doctoral candidates, affiliated with eligible US-based academic institutions, non-profits, for-profits, or government entities.
SECTOR-SPECIFIC: This grant is highly specific to the field of SU/SUD research.
Geographic Scope: United States-based organizations only. Foreign organizations are ineligible.
Key Filtering Criteria: Doctoral candidate status, US affiliation, research alignment with the National Institute on Drug Abuse (NIDA) Strategic Plan, and projects that do not involve leading independent clinical trials.
Grant Frequency: Recurring, with multiple application due dates until September 2026.

Financial Structure

Maximum direct costs allowed are $50,000 per year.
The maximum project period for support is two years, making the total potential funding per award $100,000.
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs. This excludes tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment.
This funding opportunity does not require cost sharing.
The grant funds are provided by NIH appropriations.
The currency for all financial amounts is USD.

Eligibility Requirements

Organizational Eligibility

Must be a US-based entity. Foreign organizations and foreign components of US organizations are not eligible to apply.
Eligible organization types include:
- 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 (Federally Recognized or Other))
- Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations
Must complete and maintain required federal registrations: System for Award Management (SAM), Unique Entity Identifier (UEI), eRA Commons, and Grants.gov. These registrations can take 6+ weeks and must be active prior to application submission.

Individual Eligibility (Doctoral Candidate/Principal Investigator - PI)

Must be a citizen or non-citizen national of the United States, or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status) by the time of award.
Must have completed all institutional requirements to enter the dissertation stage of their research program by the time of award.
Cannot have previously received F31 funding.
Cannot have concurrent F31 and R36 applications submitted.
Cannot propose research that involves leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.
Multiple Principal Investigator (PD/PI) applications are not allowed for this grant.

Application Process

Application Submission

Applications must be submitted electronically via the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
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 during the submission process.
If a submission date falls on a weekend or federal holiday, the deadline is automatically extended to the next business day.
The applicant organization must ensure that the Unique Entity Identifier (UEI) used on the application is consistent with the identifier used in their eRA Commons profile and the System for Award Management (SAM).
The Principal Investigator (PD/PI) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form.

Key Dates (Latest Deadline)

Application Due Date: June 16, 2026 (5:00 PM local time).
Scientific Merit Review: September 07, 2026.
Advisory Council Review: November 2026.
Earliest Start Date: April 2027.
Funding Opportunity (NOFO) Expiration Date: September 08, 2026.

Required Documentation and Materials

Standard application forms: SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile.
A one-page plan for 'Instruction in the Responsible Conduct of Research (RCR)', addressing format, subject matter, faculty participation, duration, and frequency of instruction.
A two-page 'Scientific Support Plan' outlining activities to ensure the PI's scientific understanding, professional skills development, and advisor's guidance.
Biographical Sketches for the PD/PI and dissertation project advisor, highlighting the PI's research promise and the advisor's mentoring experience.
R&R Budget and R&R Subaward Budget (if applicable).
PHS 398 Cover Page Supplement and Research Plan.
'Research Strategy' section explaining how the project advances career goals, how the innovation level is appropriate for the PI's career stage, and the relationship to any clinical trial experience.
Letters of Support (combined into a single PDF):
- A 'Letter of Certification' from the faculty advisor, dissertation committee chair, or university official, confirming the PD/PI meets eligibility criteria.
- 'Advisor and Reference Letters' (each no longer than 2 pages) from the faculty advisor and at least one other dissertation committee member. These should assess the candidate's progress, commitment to SU(D) research, potential as an independent investigator, and institutional support/resources.
Resource Sharing Plan.
PHS Human Subjects and Clinical Trials Information form (if applicable).
Only limited Appendix materials are allowed (e.g., blank questionnaires, blank surveys).

Post-Award Requirements and Compliance

Recipients are required to submit a Research Performance Progress Report (RPPR) annually and financial statements as required.
A final RPPR, invention statement, and expenditure data are required for closeout of the award.
If applicable, recipients must adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for protocols involving human subjects.

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood of the project to have a sustained and powerful influence on the relevant research field(s).

Factor 1: Importance of the Research

Significance: How important is the proposed research in addressing current scientific challenges? Does it fill a knowledge gap, solve a critical problem, or create a valuable advance? Is the scientific background and rationale rigorous and justified?
Innovation: Does the project apply novel concepts, methods, or technologies, or use existing ones in new ways, to enhance its impact? Note: A project doesn't need to be novel to be important.

Factor 2: Rigor and Feasibility

Rigor: Will the project produce unbiased, reproducible, and robust data? Is the experimental design rigorous with appropriate controls and justified sample sizes? Are plans for analysis, interpretation, and reporting robust? Are relevant biological variables (e.g., sex, age) adequately addressed? For human/vertebrate subjects, are interventions rigorous, outcomes justified, and results generalizable/relevant?
Feasibility: Is the proposed approach sound and achievable? Are there plans to address potential problems? For less certain projects, is the uncertainty balanced by potential major advances? For human subjects, is the plan to recruit and retain a diverse population adequate and feasible?

Factor 3: Expertise and Resources

Investigator(s): Does the doctoral candidate (and advisor/team) demonstrate appropriate background, training, and expertise for their career stage to conduct the work? For multi-PI applications (though not allowed for this grant type), the quality of the leadership plan is considered.
Environment: Are the institutional resources appropriate and sufficient to ensure the successful completion of the proposed dissertation research?

Additional Review Criteria (Considered but not scored)

Protections for Human Subjects: Justification for involvement, adequacy of protection against risks, potential benefits, importance of knowledge, and data/safety monitoring (if applicable).
Vertebrate Animals: Description of procedures, justification for use and species, interventions to minimize discomfort, and justification for euthanasia method (if applicable).
Biohazards: Assessment of specific hazardous materials/procedures and proposed protections.
Authentication of Key Biological and/or Chemical Resources: Brief plans for identifying and ensuring the validity of these resources.
Budget and Period of Support: Evaluation of whether the requested budget and duration are justified and reasonable for the proposed research.

Compliance & Special Requirements

Regulatory Compliance

Recipients must comply with 2 CFR Part 200, 'Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards'.
All NIH grant and cooperative agreement awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement.
Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Mandatory disclosure requirements apply for any violations of federal criminal law (fraud, bribery, gratuity) potentially affecting the federal award, as per 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Research-Specific Requirements

Research projects must align with the National Institute on Drug Abuse (NIDA) Strategic Plan (2022-2026) or NIDA HIV/AIDS research priorities.
Applications that involve leading an independent clinical trial are not responsive and will not be reviewed. Clinical trial experience is permitted if supervised by a more experienced Principal Investigator (PI) or mentor.
Applications that use alcohol alone as a misused substance are not responsive to this funding opportunity.
Projects involving human subjects or vertebrate animals must provide specific justifications and protection plans as part of the application.
Projects involving biohazards must evaluate specific hazards and propose adequate protection.

Technical and Data Requirements

For activities involving health IT implementation, acquisition, or upgrading, recipients must use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B (if applicable).
If the award involves consistent access to HHS information or operational technology systems and handling Personally Identifiable Information (PII) or Personal Health Information (PHI), recipients must develop plans and procedures modeled after the NIST Cybersecurity framework.
A Data Management and Sharing Plan is required to be implemented if applicable to the award.

Special Considerations

NIDA actively encourages research focused on females (both human and animal models) and sex differences across all areas of substance use research.
Applicants are strongly encouraged to discuss their proposed research plans with a NIDA program official prior to submission.
This program aims to facilitate the entry of promising new investigators into the field of substance use/disorder research.
Dissertation research can be conducted in conjunction with an ongoing research study or by using existing data.

Grant Details