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Grant Analysis

Purpose & Target

GRANT PURPOSE AND TARGET

The core objective of this grant is to support research education activities that enhance the knowledge of substance use and substance use disorder (SUD) research and provide opportunities for active participation in related research for clinicians, clinicians in training, and clinical researchers.
Target recipients are institutions and organizations that can host educational programs.
This grant is SECTOR-SPECIFIC, focusing on substance use and substance use disorder (SUD) research within the biomedical, behavioral, and clinical research fields.
Geographic scope: Organizations located in the US are eligible to apply. Foreign organizations and non-domestic components of US organizations are not eligible.
Key filtering criteria for initial screening: must be a US-based educational institution, non-profit, for-profit (including small businesses), or government entity proposing research education in SUD, and the proposal must not involve clinical trials.
Grant frequency: This is a reissuance of a previous program (PAR-21-320), indicating it is a recurring program.

Financial Structure

FINANCIAL STRUCTURE

Budget limitations: Application budgets are limited to $350,000 in direct costs annually.
Project period: Total project period may not exceed 5 years.
Indirect Costs: Reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, equipment, and consortium costs exceeding $25,000).
Personnel Costs:
Salary and fringe benefits appropriate for person-months devoted to the program.
Salaries may not exceed levels commensurate with institutional policy and congressionally mandated cap.
Salary support for PD/PI/co-Investigators is limited to up to 2.4 person months** (20% on a 12-month basis).
Program coordinators allowed if role is clearly defined and justified.
Unallowable: Costs for mentoring/activities if considered a regular part of academic duties.
Participant Costs:
Participants may be compensated if sufficiently justified and itemized.
Allowable costs depend on educational level/career status.
Per diem may be allowed with strong justification.
Funds may defray partial tuition and other education-related expenses.
Foreign travel must be exceptionally well justified.
Unallowable: Salary or stipend supplementation from this program for individuals supported by other NIH training/career development mechanisms (K, T, or F awards).
Unallowable: Costs to support full-time participants (40 hours/week for 12 continuous months).
Other Program-Related Expenses: Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included if justified and do not duplicate items generally available at the applicant institution.
Cost Sharing: Not required.

Eligibility Requirements

ORGANIZATIONAL ELIGIBILITY

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 For-Profit Organizations)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal (Federally Recognized or Other))
Federal Governments (U.S. Territory or Possession)
Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than Federally recognized tribal governments), Faith-based or Community-based Organizations, Regional Organizations
Geographic location requirements: Applicant organizations must be US-based entities. Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Institutional commitment: The sponsoring institution must assure support for the proposed program, including adequate staff, facilities, and educational resources.
Distinct from other federal funding: Proposed educational experiences must be distinct from those training and education programs currently receiving Federal support (e.g., cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs like T32).

INDIVIDUAL (PD/PI) ELIGIBILITY

Program Director/Principal Investigator (PD/PI): Any individual with the skills, knowledge, and resources to carry out the proposed research as the PD/PI is invited to apply.
PD/PI qualifications: The PD/PI should be an established investigator in the scientific area of the application, capable of providing administrative and scientific leadership, and is expected to monitor, assess, and report on the program.

PARTICIPANT ELIGIBILITY

This funding opportunity is intended for individuals in clinically focused careers, in training for clinical services, or in training to conduct clinical research, or quantitative backgrounds who are obtaining clinical research experiences.
Participants should primarily be U.S. citizens and permanent residents unless strongly justified for exceptional relevance to NIH.
Eligible participant career levels: graduate student, postdoctoral fellow, medical/nursing/dental/pharmacy students (and residents or equivalent), and/or independent scientist.
Exclusion criteria: This mechanism may not be used to support non-research-related clinical training.

REGISTRATION REQUIREMENTS

Applicant organizations must complete and maintain active registrations with:
System for Award Management (SAM) (requires annual renewal)
Unique Entity Identifier (UEI) (issued via SAM.gov registration)
eRA Commons (organization and PD/PI accounts)
Grants.gov
Registration can take 6 weeks or more and must be completed prior to application submission.

Application Process

APPLICATION PROCESS

Application Submission Options:
NIH ASSIST system (online preparation, submission, tracking).
Institutional system-to-system (S2S) solution.
Grants.gov Workspace (preparation and submission, track via eRA Commons).
Application Guide: Applicants must follow instructions in the 'Research (R) Instructions in the How to Apply - Application Guide', unless specified otherwise in this NOFO.

KEY DATES

Open Date (Earliest Submission Date): February 11, 2025.
Letter of Intent Due Date(s): 30 days before application due date. While not required or binding, it helps NIH estimate workload.
Application Due Dates: Multiple deadlines, including:
March 11, 2025
August 12, 2025
November 12, 2025
March 11, 2026
August 12, 2026
November 12, 2026
March 11, 2027
August 12, 2027
November 12, 2027 (Latest for this NOFO)
All applications are due by 5:00 PM local time of applicant organization.
If a due date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day.
Expiration Date: November 13, 2027.

REQUIRED DOCUMENTATION AND MATERIALS

Letter of Intent (Optional, but encouraged): Include descriptive title, PD/PI contact info, other key personnel, participating institutions, funding opportunity number and title.
Application Package: Accessed via ASSIST, Grants.gov Workspace, or institutional S2S.
SF424(R&R) forms: Follow instructions for Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile Expanded, R&R Budget.
PHS 398 Cover Page Supplement: Follow instructions.
PHS 398 Research Plan: Crucial for content:
Research Education Program Plan: Main component, must include:
- Proposed Research Education Program (rationale, learning objectives, activities, sequence/timetable, rigor/reproducibility integration, recruitment/selection procedures, participant levels, outcome measurement).
- Program Director/Principal Investigator (administration arrangements, leadership evidence).
- Program Faculty (research expertise, mentoring experience, SU/SUD clinician/research faculty).
- Program Participants (intended participants, eligibility criteria).
- Institutional Environment and Commitment (additional aspects beyond Facilities & Other Resources).
- Plan for Instruction in the Responsible Conduct of Research (RCR) (format, subject matter, faculty participation, duration, frequency).
- Evaluation Plan (baseline metrics, measures for short/long-term success, feedback mechanisms).
- Dissemination Plan (sharing findings/materials nationally).
Letters of Support: Must include a letter of institutional commitment.
Resource Sharing Plan: Required for software dissemination (if applicable); Data Management and Sharing Plan not applicable for this NOFO for due dates on or after January 25, 2023.
Appendix: Only limited materials allowed.
PHS Human Subjects and Clinical Trials Information form: Required if human subjects involved (Clinical Trial Not Allowed).
PHS Assignment Request Form.

POST-AWARD REPORTING AND COMPLIANCE

Research Performance Progress Report (RPPR): Annually.
Financial statements: As required.
Statement of Appointment (PHS Form 2271): For each participant appointed full-time for 8+ weeks.
Participant Termination Notice (PHS Form 416-7): Within 30 days of end of support for each participant (full-time, 8+ weeks).
Final RPPR and expenditure data for closeout.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval: Required for protocols involving human subjects.
Mandatory Disclosure: Recipients must report violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the award.

APPLICATION ASSISTANCE

eRA Service Desk for technical issues.
NIH General Grants Information for application instructions.
Grants.gov Customer Support for registration and Workspace issues.
Scientific/Research Contact(s) at NIDA are available for inquiries (email provided).

Evaluation Criteria

OVERALL IMPACT

Reviewers will assess the likelihood of the project to strongly advance research education by fulfilling the goal of this research education program, considering the following criteria:

SCORED REVIEW CRITERIA

Significance:
Does the program address a key audience and an important need in research education?
Is there convincing evidence that the program will significantly advance its stated goal?
Investigator(s):
Is the PD/PI capable of providing administrative and scientific leadership?
Is appropriate effort devoted by program leadership?
Do participating faculty have experience mentoring and teaching science?
Are faculty good role models through their scientific accomplishments?
For collaborative/multi-PD/PI projects: Are expertise complementary and integrated? Is the leadership approach, governance, and organizational structure appropriate?
Innovation:
Does the applicant make a strong case for effectively reaching the target audience?
Does the program develop or utilize innovative approaches and best practices to improve knowledge/skills?
Approach:
Are goals and objectives clearly stated, including audience level, content, and intended outcome?
Is the program based on sound rationale, educational concepts, and principles?
Is the evaluation plan sound and likely to provide information on effectiveness?
For participant recruitment: Are recruitment, retention, and follow-up activities adequate to ensure a highly qualified participant pool?
Is the plan for instruction in the Responsible Conduct of Research (RCR) adequate (format, subject matter, faculty participation, duration, frequency)? (Rated acceptable/unacceptable, not scored, but impacts overall assessment).
Environment:
Will the scientific and educational environment contribute to the program's goals?
Is there a plan to leverage the environment to enhance educational value?
Is there tangible evidence of institutional commitment?
Do faculty have sufficient institutional support to create a sound educational environment?
Is there evidence of collaboration and buy-in among participating programs/departments/institutions?

ADDITIONAL REVIEW CRITERIA (NO SEPARATE SCORES)

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: Justification for inclusion/exclusion based on sex, race, ethnicity, and age.
Vertebrate Animals: Description of procedures, justification for species, interventions to limit discomfort.
Biohazards: Assessment of potential hazards and proposed protection.
Training in Methods for Enhancing Reproducibility: Description of how trainees are instructed in rigor and reproducibility principles (scientific premise, experimental design, biological variables, resource authentication, data/material sharing, record keeping, transparency).

RENEWAL APPLICATIONS

The committee will consider the successful career outcomes of previous participants, including their transition to clinical researcher, clinician scientist, practicing clinician, or preceding career stages.

Compliance & Special Requirements

REGULATORY COMPLIANCE

Federal Regulations: All awards are subject to 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards), NIH Grants Policy Statement, and applicable nondiscrimination laws (e.g., Assurance of Compliance (HHS-690)).
Human Subjects Research: Must comply with 45 CFR Part 46 and specific NIH guidelines for human subjects protection, even if exempt.
Vertebrate Animals: If applicable, must comply with assessment criteria including justification of species and methods to limit discomfort.
Biohazards: If applicable, must propose adequate protection for personnel and environment.
Data Management and Sharing: A Data Management and Sharing Plan is not applicable for this NOFO for due dates on or after January 25, 2023. However, if support for software is requested, a software dissemination plan is required.
Responsible Conduct of Research (RCR): All applications must include a plan for RCR instruction, addressing format (face-to-face required, online only not acceptable), subject matter, faculty participation, duration, and frequency (at least once every four years, and at each career stage).

SPECIAL CONSIDERATIONS

Clinical Trial Not Allowed: This funding opportunity explicitly does not support clinical trials.
NIDA Special Considerations: Applicants are strongly encouraged to review and adhere to guidelines in 'Special Considerations for NIDA Funding Opportunities and Awards'.
Career Transition: A focus of the NOFO is to facilitate the transition of scholars to their next career stage; activities supporting this should be built into the application.
Interdisciplinary Research Education: Encouraged, including co-morbid conditions.
HIV/AIDS Research: NIDA encourages clinical research education in HIV/AIDS in substance users, specifically addressing HIV incidence, therapy tailoring, and associated comorbidities/coinfections/complications.
Educational Partnerships: Collaborations between multiple institutions are strongly encouraged.
Leveraging Existing Programs: Programs leveraging existing research programs and partnerships with primary and specialty care service organizations (including substance use treatment, prevention, and harm reduction) are strongly encouraged.
Intellectual Property: For software development, the software dissemination plan should ensure free availability of source code to non-profit biomedical researchers/educators, allow modification and sharing of modifications, permit commercialization of enhanced versions, and ensure transferability for continued development.
Monitoring and Evaluation: NIH and NIDA will periodically evaluate R25 programs using measures such as participant demographics, educational levels, new knowledge/skills acquired, and subsequent educational/career progress (e.g., STEM completion, research participation, publications, grant support).

Grant Details