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Grant Analysis

Purpose & Target

This grant aims to develop and/or enhance short-term research training opportunities for predoctoral students in biomedical, behavioral, or clinical research.
Target recipients are eligible, domestic institutions, primarily higher education institutions and non-profits, with a focus on supporting health professional students (medical, veterinary, other health-professional programs) and graduate students in physical or quantitative sciences.
This is a SECTOR-SPECIFIC grant, focused on biomedical, behavioral, and clinical research training within health sciences.
Geographic scope is limited to domestic (U.S.) institutions. Foreign organizations or non-U.S. components of U.S. organizations are not eligible.
Key filtering criteria: Applicant must be a U.S. institution with established research training programs capable of supporting predoctoral students for short-term, intensive research experiences (8-12 weeks).
This is a recurring grant opportunity, a reissue of PA-23-080, indicating a continuous program.

Financial Structure

Budget Range: Application budgets are not limited but must reflect the actual needs of the proposed project.
Eligible Costs: Funds may be used for expenses directly related to and necessary for research training.
Specific Allowable Costs:
- Stipends (subsistence allowance for trainees).
- Tuition and fees (NIH contributes to combined cost).
- Training related expenses: health insurance, staff salaries, consultant costs, mentor training activities, equipment, research supplies, and faculty/staff travel directly related to the training program.
- Trainee travel to scientific meetings and workshops deemed necessary for training.
Ineligible Costs:
- Costs for courses and study leading to an MD, DDS, DO, DVM, or other clinical/health professional degree, or residency training.
- Additional costs associated with awarding research elective credit for short-term training.
- Pre-award costs for stipends or tuition/fees are not allowable until a trainee is appointed.
Indirect Costs: Reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs over $25,000, and equipment expenditures).
Matching Fund Requirements: Cost sharing is not required.
Funding Rate: Not explicitly stated as a percentage, but implied to cover most direct training-related costs and an 8% indirect cost rate.
Payment Schedule/Mechanisms: Not detailed, but stipends and training related expenses are announced annually by NIH.
Financial Reporting: Recipients must comply with OMB Cost Principles and NIH Grants Policy Statement.

Eligibility Requirements

Organizational Eligibility

Eligible Organizations:
- Higher Education Institutions: Public/State Controlled Institutions of Higher Education, Private Institutions of Higher Education.
- Nonprofits: Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education), Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education).
- Local Governments: Indian/Native American Tribal Governments (Federally Recognized), Indian/Native American Tribal Governments (Other than Federally Recognized), U.S. Territory or Possession.
- Other: Native American Tribal Organizations (other than Federally recognized tribal governments), Faith-based or Community-based Organizations.
- Federal Governments: Eligible Agencies of the Federal Government, U.S. Territory or Possession.
Geographic Location: Must be domestic (U.S.) organizations. Non-domestic (non-U.S.) entities or non-U.S. components of U.S. organizations are not eligible.
Institutional Commitment: The sponsoring institution must assure support for the proposed program, including adequate staff, facilities, and educational resources.
Registrations: Must complete and maintain active registrations in:
- System for Award Management (SAM) - requires annual renewal.
- Unique Entity Identifier (UEI) - issued as part of SAM.gov registration.
- eRA Commons - requires at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
- Grants.gov - requires active SAM registration.
Duplicate Submissions: Organizations may submit more than one application if each is programmatically distinct. Duplicate or highly overlapping applications under review at the same time are not accepted.

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

Must be an established investigator in the scientific area of the proposed training program.
Must be capable of providing both administrative and scientific leadership.
Responsible for trainee selection, program direction, management, administration, and evaluation.
Must commit sufficient effort to ensure program success.
Demonstrated commitment to training future biomedical researchers.
Must have received training (or have a plan for training) on effective mentoring.

Application Process

Application Package and Submission

Required Application Instructions: Applicants must follow the Training (T) Instructions in the 'How to Apply Application Guide' and any program-specific instructions in this NOFO.
Submission Options: Applications must be submitted electronically via:
- NIH ASSIST system.
- Institutional system-to-system (S2S) solution.
- Grants.gov Workspace.
Page Limitations: All page limits specified in the 'How to Apply Application Guide' and 'Table of Page Limits' must be followed.

Key Dates and Deadlines

Open Date (Earliest Submission Date): December 25, 2024
Application Due Dates (multiple rounds, latest shown):
- New/Renewal/Resubmission/Revision:
  - September 25, 2027 (for May 2028 Earliest Start Date)
  - January 25, 2028 (for December 2028 Earliest Start Date)
Submission Time: All applications are due by 5:00 PM local time of the applicant organization.
Expiration Date: May 08, 2028.
Letter of Intent: Not Applicable.
Late Submissions: Applications that miss the due date and time are subject to NIH Policy on Late Application Submission.

Required Documentation and Materials

SF424(R&R) Cover: Follow instructions in the 'How to Apply Application Guide'.
SF424(R&R) Project/Performance Site Locations: Follow instructions.
SF424(R&R) Other Project Information: Follow instructions.
- Project Summary/Abstract: Include objectives, rationale, design, key activities, planned duration of appointments, projected number of trainees/scholars, and intended outcomes.
- Other Attachments: If an Advisory Committee is planned, provide a plan for its appointment, composition, roles, responsibilities, frequency of meetings, and evaluation methods.
SF424(R&R) Senior/Key Person Profile Expanded: Follow instructions.
PHS 398 Cover Page Supplement: Follow instructions.
PHS 398 Training Subaward Budget Attachment(s): Follow instructions.
Training Budget: Include all personnel (other than PD/PIs) in 'Other Personnel' section.
PHS 398 Research Training Program Plan: Comprised of 'Training Program Faculty, Trainees, and Training Record' and 'Other Training Program Appendix'.
- Program Administration: Describe PD/PIs' expertise, time commitment, commitment to training, and mentoring training.
- Program Faculty: Describe recruitment efforts, mentor training activities, and oversight mechanisms.
- Proposed Training: Describe evidence-informed approaches, data science principles, and career development activities.
- Training Program Evaluation: Describe how effectiveness will be assessed and procedures for responding to findings.
- Trainee Candidates and Retention Plans: Justification for positions, multifactorial candidate review process, and efforts to sustain scientific interests and monitor academic progress.
- Institutional Environment and Commitment to Training: Describe institutional/departmental commitment to success, safe/supportive environment, and procedures for accountability.
- Training Outcomes: Provide outcomes for program graduates (or similar programs), including research rigor, completion rates, time-to-degree, and career transitions.
- Progress Report (for Renewal Applications): Demonstrate successful training, program evolution, and describe successes/challenges.
Faculty, Trainees, and Training Record: Include Participating Faculty Biosketches with personal statements on mentoring and training rigor.
Letters of Support:
- Institutional Support Letter: Signed letter from a key institutional leader (President, Provost, Dean) describing resources, culture of rigor, support for faculty/trainees, core facilities, faculty recognition, safe environments, anti-discrimination policies, and support for program evaluation (not to exceed 10 pages).
PHS Assignment Request Form: Follow instructions.

Post-Award Requirements and Compliance

Reporting: Annual Research Performance Progress Report (RPPR) is required. Must submit Statement of Appointment (PHS Form 2271) for each trainee appointed.
Data Management and Sharing: Adhere to 2023 NIH Policy for Data Management and Sharing (if applicable).
Federal Financial Report: Expenditure data required for closeout.
Termination Notices: Required for all trainees for closeout.
Subaward Reporting: Report on all first-tier subawards over $25,000 to the Federal Subaward Reporting System (FSRS).
Integrity and Performance Reporting: Report civil, criminal, and administrative proceedings for active federal grants exceeding $10,000,000 cumulative value.

Evaluation Criteria

Overall Impact Score

Reviewers will assess the likelihood that the proposed training program will equip trainees with the necessary skills, knowledge, and experiences for successful careers in the biomedical research workforce.

Scored Review Criteria (Specific areas for scoring)

Training Program and Environment: Evaluation of the overall design and setting of the training.
Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)): Assessment of their leadership, administrative and scientific expertise, time commitment, and commitment to training.
Preceptors/Mentors: Evaluation of program faculty's active research status, commitment to training, mentoring philosophy, and capacity to provide a safe and supportive environment.
Trainees: Review of the proposed multifactorial candidate review process, justification for requested positions, and retention plans.
Training Record: For renewal applications, assessment of past program accomplishments, achievement of training objectives, and evidence of program evolution and evaluation.

Additional Review Criteria (Considered but not separately scored)

Protections for Human Subjects: Generally not applicable, but concerns will be noted.
Inclusion of Women, Minorities, and Individuals Across the Lifespan: Generally not applicable, but concerns will be noted.
Vertebrate Animals: Generally not applicable, but concerns will be noted.
Biohazards: Generally not applicable, but concerns will be noted.
Training in the Responsible Conduct of Research (RCR): Adequacy of the proposed RCR training plan based on:
- Format: Must include face-to-face interaction (online-only is not acceptable).
- Subject Matter: Must cover a broad selection of topics (e.g., conflict of interest, authorship, data management, research ethics).
- Faculty Participation: How faculty will be involved in instruction.
- Duration of Instruction: Minimum eight contact hours.
- Frequency of Instruction: At least once during each career stage (predoctoral) and no less than once every four years.
Training in Methods for Enhancing Reproducibility: Description of how the program provides training in scientific reasoning, rigorous research design, relevant experimental methods, consideration of biological variables (e.g., sex), resource authentication, quantitative approaches, data analysis, and interpretation.

Resubmissions, Renewals, and Revisions

Resubmissions: Committee will evaluate the application as presented, considering responses to previous comments and changes made.
Renewals: Committee will assess progress from the last funding period, achievement of objectives, and how the program has evolved. Success rates for graduation and career transitions are important.
Revisions: Committee will consider the appropriateness of expanding the project's scope and the adequacy of responses to prior review comments.

Compliance & Special Requirements

Regulatory Compliance

Applicable Regulations: Awards are subject to Sections 301 and 405 of the Public Health Service Act, Federal Regulations 42 CFR 63A and 2 CFR Part 200 ('Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards').
NIH Grants Policy Statement: All awards incorporate the NIH Grants Policy Statement as part of the terms and conditions.
NRSA Policies: National Research Service Award (NRSA) policies specifically apply to this program.
Nondiscrimination: Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Mandatory Disclosure: Recipients must disclose violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.

Data Protection and Security

Health IT Standards: If funding involves implementing, acquiring, or upgrading health IT, recipients must use technology meeting standards adopted in 45 CFR part 170, Subpart B, or certified under the ONC Health IT Certification Program for specific settings.
Cybersecurity: Recipients with ongoing access to HHS systems or handling PII/PHI must develop plans and procedures modeled after the NIST Cybersecurity framework.

Ethical Standards and Research Integrity

Responsible Conduct of Research (RCR): Programs must include a plan for RCR instruction, including specific format, subject matter, faculty participation, duration, and frequency requirements.
Research Reproducibility: Programs must provide training in methods for enhancing reproducibility, covering scientific reasoning, rigorous design, experimental methods, biological variables, resource authentication, quantitative approaches, and data analysis.
Clinical Trials: Appointed trainees are not allowed to lead independent clinical trials, but are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.
Discrimination/Harassment Policies: Institutional support letters must confirm policies, procedures, and oversight to prevent discrimination/harassment and appropriately respond to allegations.

Intellectual Property (IP)

Invention Reporting: Not required, as awards are primarily for educational purposes and exempt from PHS invention requirements.

Special Considerations

Consortium Requirements: Recipient organizations may provide training to students enrolled at other institutions through a partnership or consortium structure, which must be well justified to enhance program goals.
Trainee Eligibility: Trainees must be U.S. citizens, noncitizen nationals, or lawfully admitted for permanent residence. They must pursue full-time research training (normally 40 hours/week) for 2-3 months. Eligible trainees are medical, dental, other health-professional students, or graduate students in physical/quantitative sciences. They must be enrolled and in good standing, having completed at least one quarter/semester in their program. Individuals already matriculated in a formal research degree program in health sciences, or holding a research doctorate/master's degree, are generally not eligible for short-term positions.
Evaluation of Program Outcomes: NIH will assess overall program outcomes within ten years based on metrics like successful completion of degrees, subsequent participation in research/employment, and scientific publications, to determine future program continuation.
IC-Specific Requirements: Prospective applicants must consult the 'Table of IC-Specific Information, Requirements and Staff Contacts' as individual NIH Institutes and Centers (ICs) have specific program requirements and research interests within this NOFO.

Grant Details