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Grant Details

Grant Analysis

Purpose & Target

This grant, 'Investigator Initiated Innovation in Computational Genomics and Data Science (R21 Clinical Trial Not Allowed)', aims to foster novel, investigator-initiated research in computational genomics, data science, statistics, bioinformatics, and data visualization/exploration. It supports the development of innovative analytical methodologies, approaches, and early-stage tools/software broadly applicable to human health and disease. - Target recipient type: Diverse organizational types including academic institutions, nonprofits, for-profit organizations (small and large businesses), and various government entities. - Target size: Not specifically defined by size, but supports a wide range of eligible organizations. - SECTOR-SPECIFIC: Genomics, Data Science, Bioinformatics. - Geographic scope: Organizations from the U.S. and non-U.S. (foreign) entities are eligible to apply. - Key filtering criteria: Projects must be highly innovative, focus on novel approaches, and explicitly exclude clinical trials, microbial genomics, maintenance of existing resources, non-generalizable research, and basic data science not tied to genomics. - Grant frequency and program context: This is a recurring funding opportunity, a reissue of a previous announcement (PAR-21-255), with multiple application due dates extending through 2027.

Financial Structure

  • The combined budget for direct costs for the two-year project period may not exceed $275,000.
  • No more than $200,000 may be requested in any single year.
  • Currency: USD.
  • Cost sharing is not required.
  • Co-financing is not required.
  • Up to 10% of the total budget may be used to support experimental work for the evaluation of computational approaches.
  • Financial reporting includes annual Research Performance Progress Reports (RPPR) and financial statements.
  • A final RPPR, invention statement, and expenditure data are required for award closeout.
  • Audit requirements are subject to 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.

Eligibility Requirements

Organizational Type & Registration
  • Eligible organization types include: Public/State/Private Institutions of Higher Education; Nonprofits (with/without 501(c)(3) IRS Status); Small Businesses; For-Profit Organizations (other than Small Businesses); State/County/City/Township/Special District Governments; Indian/Native American Tribal Governments (Federally Recognized & Other); Eligible Agencies of the Federal Government; U.S. Territory or Possession; 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; Non-domestic (non-U.S.) Entities (Foreign Organizations).
  • Required registrations: Applicant organizations must complete and maintain active registrations with the System for Award Management (SAM), obtain a Unique Entity Identifier (UEI), and register with eRA Commons and Grants.gov. Foreign organizations need an NCAGE code for SAM registration.
  • Individuals (Program Director/Principal Investigator) must have an eRA Commons account, affiliated with their organization.
Geographic & Project Scope
  • Geographic eligibility: Open to U.S. organizations and non-U.S. (foreign) entities.
  • Clinical Trial Status: Clinical trials are not allowed. Applications proposing clinical trials will not be accepted.
Exclusion Criteria
  • Projects considered non-responsive and will not be reviewed include:
    • Work focused on microbial genomics or the microbiome.
    • Development, maintenance, extension, or curation of existing genomic resources, repositories, knowledgebases, or platforms.
    • Research that is not broadly generalizable or is relevant to only one or a few diseases or biological systems (proof-of-concept studies with limited models are acceptable if methods are generalizable).
    • Development and application of ontologies or controlled vocabularies, or manual curation efforts.
    • Basic data science research that is not developed for genomics.
    • Research with most effort or resources devoted to experimental data generation (up to 10% of total budget for experimental evaluation is allowed).
    • Approaches not clearly pertaining to computational genomics and data science and/or lacking relevance to human health and diseases.
Capacity & Experience
  • Investigators are encouraged, but not required, to be new to genomic science or from underrepresented demographic groups/institutions. Applicants should possess the necessary skills, knowledge, and resources to conduct the proposed research.
  • Cost sharing is not required.

Application Process

Application Submission
  • Applications must be submitted electronically through ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
  • All applications are due by 5:00 PM local time of the applicant organization on the specified deadline date.
  • Applicants are encouraged to submit early to allow time for corrections.
Key Deadlines & Timelines
  • Latest Application Due Date: 2027-07-16 17:00:00-05:00 (for Renewal / Resubmission / Revision applications; local time, time zone approximated).
  • The Funding Opportunity expires on 2027-09-08.
  • Total project period may not exceed 2 years.
  • Review and Award Cycles:
    • Submissions by February 16 (2025, 2026, 2027) lead to Scientific Merit Review in July, Advisory Council Review in October, and Earliest Start Date in December.
    • Submissions by June 16 (2025, 2026, 2027) lead to Scientific Merit Review in November, Advisory Council Review in January (of next year), and Earliest Start Date in April (of next year).
Required Documentation
  • Standard application forms (SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, Budget).
  • PHS 398 Cover Page Supplement.
  • PHS 398 Research Plan, including:
    • Research Strategy: Explaining advancement of genomic science, broad applicability, generalizability, innovation (addressing gaps, distinctiveness, or outperforming existing approaches).
    • Plans for rigorous validation, benchmarking, comparisons.
    • Description of scalability, interoperability, robustness, documentation, and broad uptake plans.
    • Resource Sharing Plan: Summarizing availability of resources (educational materials, methods, physical products, protocols, findings, software) and plans for implementation, maintenance, community input, platform, and timeline. FAIR for Research Software (FAIR4RS) principles are recommended for software sharing.
  • Data Management and Sharing Plan (required for all applications generating scientific data, regardless of direct costs).
  • Appendix: Only limited materials allowed as per Application Guide.
  • PHS Human Subjects and Clinical Trials Information form (if human subjects involved).
  • PHS Assignment Request Form.
Post-Award Requirements
  • Recipients are required to submit a Research Performance Progress Report (RPPR) annually.
  • Financial statements are required as per NIH Grants Policy Statement.
  • A final RPPR, invention statement, and expenditure data portion of the Federal Financial Report are required for award closeout.

Evaluation Criteria

Applications are evaluated for scientific and technical merit based on the following criteria: Overall Impact
  • Reviewers provide an overall impact score reflecting the likelihood of the project to exert a sustained, powerful influence on the research field(s) involved.
Scored Review Criteria
  • Reviewers will score applications based on three main factors:
    • Factor 1. Importance of the Research (Significance and Innovation): Assesses how the proposed research advances genomic science and its broad applicability to human health and diseases. Emphasizes innovation, addressing critical gaps, distinctiveness from existing efforts, or significant outperformance of current approaches.
    • Factor 2. Rigor and Feasibility (Approach): Evaluates the plans for rigorous validation, benchmarking, comparisons with existing methodologies/tools, and overall feasibility. Assesses scalability, interoperability, robustness, documentation, and adoptability of methods/tools.
    • Factor 3. Expertise and Resources (Investigator(s) and Environment): Assesses the qualifications of the PD/PI(s) and the adequacy of the institutional environment and available resources to support the project.
Additional Review Criteria (Not Scored, but Impact Overall Score)
  • Protections for Human Subjects: Evaluation of justification for involvement, proposed protections, risks, benefits, and data safety monitoring, where applicable.
  • Vertebrate Animals: Evaluation of proposed procedures, justifications for animal use, and minimization of discomfort, where applicable.
  • Biohazards: Assessment of hazardous materials/procedures and proposed protection measures, where applicable.
  • Resubmissions/Renewals/Revisions: Evaluation of progress made or appropriateness of scope expansion for specific application types.
Additional Review Considerations (Not Scored, Do Not Impact Overall Score)
  • Authentication of Key Biological and/or Chemical Resources: Evaluation of plans for validating resources, where applicable.
  • Budget and Period of Support: Assessment of whether the budget and requested period are justified and reasonable relative to the proposed research.

Compliance & Special Requirements

Regulatory Compliance
  • All awards are subject to the NIH Grants Policy Statement, 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards), and applicable federal statutes and regulations.
  • Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
  • Human Subjects Research: Protocols must be reviewed by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
  • Health IT: If award funding involves implementing, acquiring, or upgrading health IT, recipients must use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, and if applicable, is certified under the ONC Health IT Certification Program.
  • Cybersecurity: Recipients having ongoing access to HHS systems/data must develop plans and procedures modeled after the NIST Cybersecurity framework.
  • Mandatory Disclosure: Recipients must disclose any violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.
Data Management & Sharing
  • A Data Management and Sharing Plan is mandatory for all projects generating scientific data and must be implemented as described in the approved plan.
  • Software sharing is recommended to follow FAIR for Research Software (FAIR4RS) principles.
Special Programmatic Requirements
  • Grantee Meeting: Grantees are required to participate actively and openly in one grantee meeting per year convened by NHGRI.
  • Clinical Trial Status: This funding opportunity explicitly states 'Clinical Trial Not Allowed'. Proposals including a clinical trial will be considered non-responsive.
  • Innovation Focus: The core of this grant is to support highly innovative research efforts in computational genomics, focusing on novel approaches and early-stage tools, rather than incremental advances or application of existing methods.

Grant Details

computational genomics data science bioinformatics genomic medicine genomics research statistics data visualization ai machine learning artificial intelligence privacy-preserving technologies federated learning novel methods early stage tools software development analytical approaches human health disease research r21 grant nih funding nhgri nlm scientific research research and development healthcare technology big data data analysis
Investigator Initiated Innovation in Computational Genomics and Data Science (R21 Clinical Trial Not Allowed)
PAR-25-229
National Institutes of Health (NIH)
UNIVERSITY NGO SME ENTERPRISE PUBLIC OTHER
US
HEALTHCARE TECHNOLOGY
DEVELOPMENT IDEA
OTHER
SDG3 SDG9
FUNDING RESEARCH_DEVELOPMENT CAPACITY_BUILDING NETWORKING
275000.00
None
275000.00
USD
None
July 16, 2027, 10 p.m.
November 2027 - January 2028