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Grant Analysis

Purpose & Target

This grant's core objective is to identify and support research projects by exceptionally promising Early Stage Investigators (ESIs) who have a long-term interest in innovative genomics research, helping them establish independent research programs.
Target recipients are primarily research institutions, higher education institutions, nonprofits, and government entities, particularly those employing or supporting Early Stage Investigators (ESIs) in genomics.
This is a SECTOR-SPECIFIC grant, focused on genomics research.
The geographic scope is primarily United States (US) based organizations, though foreign components of U.S. organizations are allowed.
Key filtering criteria: Applicant organization must be US-based, and the lead Principal Investigator (PI) must be an NIH-defined Early Stage Investigator focused on genomics.
This grant is a recurring opportunity, being a reissue of a previous RFA, with multiple application cycles available through February 2027.

Financial Structure

Award Instrument: Grant.
Total Funds Available: NHGRI intends to commit a minimum of $2 million in FY 2022, 2023, and 2024 to fund 3-5 awards. This is a program-level commitment, not a specific amount for this RFA's full duration.
Maximum Award Budget (Direct Costs): Cannot exceed $400,000 in direct costs per year.
Project Period: Maximum project period is 5 years.
Cost Sharing/Matching Funds: Not required.
Eligible Costs: Standard research costs. Specific eligible costs include:
- Up to $1,500 per project year for the PD/PI to attend the NHGRI Research Training and Career Development Annual Meeting (must be clearly identified in budget justification).
- Funds to support face-to-face meetings of the Advisory Committee.
Ineligible Costs: Not explicitly detailed, but direct costs exclude indirect costs which are typically covered by institutional rates.
Financial Guarantees: No specific financial guarantees mentioned beyond standard NIH policies.
Reporting: Annual financial statements are required.

Eligibility Requirements

Organizational Eligibility

Higher Education Institutions: Public/State Controlled, Private
Nonprofits: With 501(c)(3) IRS Status, or without 501(c)(3) IRS Status
For-Profit Organizations: Small Businesses, or other For-Profit Organizations
Local Governments: State, County, City/Township, Special District, Indian/Native American Tribal (Federally Recognized or 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
Foreign Organizations: Not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are also not eligible to apply. Foreign components (as defined by NIH) are allowed.

Principal Investigator (PD/PI) Eligibility

Must be an NIH-defined Early Stage Investigator (ESI) at the time of application submission. ESI status must be recorded in the PD/PI's eRA Commons account.
Must be an independent researcher with a faculty appointment that is tenure track or equivalent (generally at the level of Assistant Professor or Research Assistant Professor).
Must have dedicated, independent laboratory space or access to research resources allowing independent research.
Researchers in mentored status (e.g., postdoctoral fellows) are not eligible.
Only a single PD/PI is allowed; multiple PD/PI applications will not be accepted.
Must commit at least three person-months (25%) of research effort each year to activities supported by this award.
Scientific overlap with other pending or active NIH grants (especially R01s) is not allowed; if a pending grant that does not maintain ESI status becomes active, the applicant PD/PI becomes ineligible.

Registration Requirements (for Organizations and Individuals)

Applicant Organizations must complete and maintain active registrations with:
- System for Award Management (SAM) - requires annual renewal.
- NATO Commercial and Government Entity (NCAGE) Code - required for foreign organizations (if foreign components are included).
- Unique Entity Identifier (UEI) - issued via SAM.gov registration.
- eRA Commons - organization must be registered with at least one Signing Official (SO) and one PD/PI account.
- Grants.gov
Program Directors/Principal Investigators (PD/PIs) must have an eRA Commons account and affiliate it with the applicant organization.

Application Process

Application Submission and Deadlines

Application Due Dates: All applications are due by 5:00 PM local time of the applicant organization.
- New/Renewal/Resubmission: February 28, 2025
- New/Renewal/Resubmission: February 27, 2026
- New/Renewal/Resubmission: February 26, 2027
Letter of Intent (LOI) Due Dates: (Optional, not binding)
- January 29, 2025
- January 28, 2026
- January 27, 2027
Submission Format: Electronic submission is mandatory via NIH ASSIST system, institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Late Applications: No late applications will be accepted.

Required Documentation and Materials

Standard Forms: SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R or Modular Budget, R&R Subaward Budget (if applicable), PHS 398 Cover Page Supplement, PHS 398 Research Plan.
Professional and Scientific Development Plan: Required 2-page document describing professional/scientific development activities, including the formation of an Advisory Committee. Applications without this plan will be considered non-responsive.
Advisory Committee: The plan should describe the expected contribution of members and selection considerations. Names of members are submitted just-in-time (after review meeting) with a letter from each member.
Biographical Sketch: Personal Statement must explicitly address the PD/PI's career track vision and long-term research interests/objectives in genomics.
Letters of Support:
- From the Department Chair where the PD/PI holds their primary academic appointment, detailing institutional commitment and tangible research support (e.g., startup packages, salary, protected time, space, equipment, core facilities).
- If a previous postdoctoral or research mentor is at the same institution, a letter outlining their respective roles and how the proposed research is independent of their lab/group.
Resource Sharing Plan: Summarize how resources (e.g., educational materials, methods, models, physical products, data, software) will be made available, including format, responsible parties, maintenance plans, and timelines.
Data Management and Sharing Plan: Required for all research generating scientific data, regardless of direct costs. Must align with NIH Data Management and Sharing Policy and NIH Genomic Data Sharing Policy.
PHS Human Subjects and Clinical Trials Information: Required if human subjects or NIH-defined clinical trials are involved.

Support Offered

Financial grant funding.
Potential for guidance from the Advisory Committee.

Project Implementation Timeline and Reporting

Maximum Project Period: 5 years.
Reporting Obligations: Annual Research Performance Progress Report (RPPR) and financial statements. A final RPPR, invention statement, and expenditure data are required for closeout.

Post-Award Requirements

Compliance with all NIH Grants Policy Statement terms and conditions.
If clinical trials are involved, registration and results reporting on ClinicalTrials.gov is expected.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for all protocols involving human subjects.
Compliance with NIH data and safety monitoring requirements for human biomedical and behavioral intervention studies.
Compliance with Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements if applicable.
Adherence to data management and sharing plans as approved.
Mandatory disclosure of violations of federal criminal law involving fraud, bribery, or gratuity.

Evaluation Criteria

Overall Impact Reviewers will assess the likelihood of the proposed project to exert a sustained, powerful influence on the research field(s). Scored Review Criteria These factors contribute to the scientific merit and overall impact score: - Factor 1: Importance of the Research (Significance and Innovation) - Assesses the project's potential to advance scientific knowledge and/or improve health, and the innovativeness of the concepts, approaches, or methods proposed. - Factor 2: Rigor and Feasibility (Approach) - Evaluates the design, methods, and analyses for their scientific rigor, and the feasibility of the proposed work. - Factor 3: Expertise and Resources (Investigator(s) and Environment) - Considers the qualifications and experience of the PD/PI and research team, and the adequacy of the institutional environment and resources. Additional Review Criteria (Considered, but not scored individually)

Protections for Human Subjects: Adequacy of protections for research participants.
Vertebrate Animals: Justification for use, appropriateness of species, interventions to minimize discomfort, and justification for euthanasia methods (if applicable).
Biohazards: Assessment of specific hazardous materials or procedures and proposed protections.
Resubmissions: Evaluation of the revised application based on previous reviews.

Additional Review Considerations (Considered, but not scored individually)

Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity of resources.
Budget and Period of Support: Justification and reasonableness of the budget and requested project period in relation to the proposed research.
Institutional Commitment: The strength of the institution's commitment to supporting the PD/PI's research (e.g., startup packages, salary, protected time, space, equipment, core facilities, specialized training) will be a factor in the review.

Compliance & Special Requirements

Regulatory Compliance Requirements

Adherence to the NIH Grants Policy Statement.
Compliance with 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
Compliance with Public Health Service Act (Sections 301 and 405) and 42 CFR Part 52.
Recipients must follow all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Compliance with federal statutes and regulations highlighted in NIH Grants Policy Statement Section 4 (Public Policy Requirements).

Data Protection and Privacy

Compliance with NIH Data Management and Sharing Policy (NOT-OD-21-013).
Compliance with NIH Genomic Data Sharing Policy (NOT-OD-14-124). NHGRI expects broad appropriate data sharing with timely release through accessible repositories.
Strong encouragement for participant consent for general research use (controlled access) or unrestricted access for genomic data. Consent language should avoid restrictions on user types or additional access requirements.
For projects with ongoing access to HHS information/operational technology systems or handling Personal Identifiable Information (PII) or Personal Health Information (PHI) from HHS, recipients must develop plans and procedures modeled after the NIST Cybersecurity framework.

Ethical and Research Standards

Human Subjects Protection: Required for studies involving human subjects, including IRB/IEC approval and data/safety monitoring. Compliance with IND/IDE requirements if applicable.
Vertebrate Animals: Strict evaluation of procedures, justifications, and welfare measures if involved.
Biohazards: Adequate protection measures required for significant biohazards.

Technical Requirements (Health IT)

If award funding involves implementing, acquiring, or upgrading health IT, it must meet standards in 45 CFR part 170, Subpart B, and be certified under the ONC Health IT Certification Program if applicable.

Special Considerations

Career Development Focus: A key goal is the career development of Early Stage Investigators, requiring a robust professional and scientific development plan and an Advisory Committee.
Independence: The program strongly encourages the PD/PI's independent research. Listing previous mentors as co-investigators is discouraged, especially if salary is requested; strong justification is needed if included.
Scope Exclusions: Research focused on understanding specific diseases or a limited set of diseases (e.g., tumor/somatic cancer genomes), understanding mechanisms underlying disease or other biological processes, or developing technologies targeting limited subsets of loci/genomic regions is generally considered non-responsive.
Clinical Trials: Clinical trials are optional.
Strategic Alignment: Proposed research must be responsive to the mission of NHGRI and align with the NHGRI 2020 Strategic Vision.

Grant Details