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Grant Analysis

Purpose & Target

Grant Purpose and Target This grant, the 'Ethical, Legal and Social Implications (ELSI) Small Research Grant (R03 Clinical Trial Optional)', aims to fund small-scale research projects that investigate the ethical, legal, and social implications arising from human genetics and genomics. It is designed for individual investigators or small teams. Core Objective To study the ethical, legal, and social implications (ELSI) of human genetics and genomics, including normative, conceptual, legal, economic, philosophical, anthropological, or historical analyses, as well as preliminary data collection or secondary analysis of existing data. Target Recipients This grant targets various organizational types, including: Higher Education Institutions, Nonprofits (both 501(c)(3) and others), For-Profit Organizations (including small businesses), Local Governments, Indian/Native American Tribal Governments, Federal Agencies, and other entities such as independent school districts, public housing authorities, faith-based/community-based organizations, and foreign organizations. It is suitable for projects led by single investigators or small teams. Sector Focus This grant is SECTOR-SPECIFIC, primarily focused on the fields of Genetics, Genomics, Health, and Social Sciences. It encourages applications from a wide range of academic disciplines, including bioethics, humanities, behavioral sciences, law, and data science. Geographic Scope This opportunity has a broad international geographic scope, as Non-domestic (non-U.S.) Entities (Foreign Organizations) are explicitly eligible to apply. Key Filtering Criteria

Your project must focus on the ethical, legal, or social implications of human genetics and genomics.
It should be a small, self-contained research project.
The budget limit is $50,000 in direct costs per year.
It can involve preliminary data collection or secondary analysis of existing data.

Grant Context and Frequency This funding opportunity (PAR-25-370) is a reissue of a previous program (PAR-23-295), indicating it is a recurring grant program. It is part of a larger series of ELSI funding opportunities offered by the NIH, which also includes R21 (Exploratory/Developmental) and R01 (Research Project) mechanisms for different project scopes and durations.

Financial Structure

Financial Structure This grant offers direct funding for research projects, with clear limits on the amount and specific guidelines regarding eligible costs and cost-sharing. Budget Range and Limitations

Maximum Grant Amount: Up to $50,000 in direct costs per year. There is no specified minimum award amount.
Total Project Period: The maximum project period is 2 years.

Eligible and Ineligible Costs

Eligible Costs:
- Costs required to implement the proposed Data Management and Sharing Plan.
- Costs required for the proposed Resource Sharing Plan.
- For projects generating genomic data from research participants, costs associated with complying with NIH and NHGRI Genomic Data Sharing Policy expectations (e.g., obtaining informed consent for future research use and broad data sharing, processes for new consent).
- Budgetary support to enable the successful involvement of community members or stakeholders as research team members or advisors (their research roles should be described in the budget justification).
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Matching Fund Requirements

No cost sharing is required for this funding opportunity. This means applicants are not obligated to contribute financially to the project from non-federal sources.

Payment Schedule and Mechanisms

The specific payment schedule and mechanisms are not detailed in the provided information, but will follow standard NIH grant payment procedures.

Financial Reporting Requirements

Recipients will be required to submit financial statements annually.
A final expenditure data portion of the Federal Financial Report is required for closeout of the award.

Audit Requirements

All NIH awards are subject to the terms and conditions described in the NIH Grants Policy Statement and Federal Regulations, including 2 CFR Part 200, which encompasses audit requirements for Federal awards.

Indirect Cost Policies

While not explicitly stated in terms of a percentage, standard NIH policies on indirect costs (also known as F&A costs) would apply. These are generally covered based on an institution's negotiated indirect cost rate, but the $50,000 limit applies to direct costs only, meaning indirect costs would be applied in addition to this limit.

Eligibility Requirements

Eligibility Requirements This grant has comprehensive eligibility criteria for organizations and individuals. Pay close attention to registration requirements, as these can take significant time. Eligible Organization Types

Higher Education Institutions:
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
Nonprofits (other than Institutions of Higher Education):
- Nonprofits with 501(c)(3) IRS Status
- Nonprofits without 501(c)(3) IRS Status
For-Profit Organizations:
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Local Governments:
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
Indian/Native American Tribal Governments:
- Federally Recognized Tribal Governments
- Other than Federally Recognized Tribal Governments
Federal Governments:
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other Eligible Entities (as per additional description):
- 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), including non-domestic components of U.S. Organizations.
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISISs)
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)

Specific Qualifications and Certifications All applicant organizations must complete and maintain the following active registrations prior to application submission. These processes can take 6 weeks or more: * System for Award Management (SAM): Requires annual renewal. Domestic organizations receive a Commercial and Government Entity (CAGE) Code. * NATO Commercial and Government Entity (NCAGE) Code: Required for foreign organizations to register in SAM. * Unique Entity Identifier (UEI): Issued as part of SAM.gov registration. Must be consistent across all registrations and on the grant application. * eRA Commons: Organizations must register and identify at least one 'Signing Official' (SO) and one 'Program Director/Principal Investigator' (PD/PI) account. Obtaining an eRA Commons account can take up to 2 weeks. * Grants.gov: Requires an active SAM registration. Team Composition and Qualification Requirements

The Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must have the skills, knowledge, and resources to carry out the proposed research.
For multiple PDs/PIs, a quality leadership plan to facilitate coordination and collaboration is required.
All PD(s)/PI(s) must have an eRA Commons account affiliated with the applicant organization.

Geographic Location Requirements

There are no specific country restrictions, as Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible.

Organizational Size and Capacity Requirements

The grant is specifically for small research projects, often those involving single investigators. While it doesn't specify employee counts, the project scope implies smaller, focused efforts.

Partnership or Consortium Requirements

No formal consortium is required. However, direct engagement with communities and other stakeholders is encouraged but not mandatory.

Exclusion Criteria

The NIH will not accept duplicate or highly overlapping applications that are under review at the same time. This means:
- A new (A0) application cannot be submitted before the summary statement from a review of an overlapping new (A0) or resubmission (A1) application is issued.
- A resubmission (A1) application cannot be submitted before the summary statement from the review of the previous new (A0) application is issued.
- Applications with substantial overlap with another application pending appeal of initial peer review are not accepted.
Applications that are incomplete or non-compliant with instructions will not be reviewed.

Application Process

Application Practical Information Applying for this grant requires careful attention to deadlines, documentation, and specific submission procedures. Application Procedure and Steps Applications must be submitted electronically through one of the following methods: 1. NIH ASSIST system: For preparing, submitting, and tracking applications online. 2. Institutional system-to-system (S2S) solution: Check with your institutional officials for availability. 3. Grants.gov Workspace: For preparing and submitting applications. After submission via Grants.gov, applicants must track the application status in eRA Commons. Application Deadlines and Submission Windows All applications are due by 5:00 PM local time of the applicant organization.

New Applications Due Dates:
- February 18, 2025
- June 17, 2025
- October 20, 2025
- February 17, 2026
- June 18, 2026
- October 16, 2026
Renewal / Resubmission / Revision Applications Due Dates:
- March 16, 2025
- July 16, 2025
- November 16, 2025
- March 16, 2026
- July 16, 2026
- November 16, 2026 (Latest Deadline)

Applicants are strongly encouraged to submit early to allow time for corrections. If a submission date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day. Required Documentation and Materials Applicants must follow the instructions in the 'Research (R) Instructions' within the 'How to Apply - Application Guide', along with any program-specific instructions. Key components include: * SF424(R&R) Forms: Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile. * R&R or Modular Budget: Including costs for Data Management and Sharing Plan and Resource Sharing Plan. * R&R Subaward Budget (if applicable). * PHS 398 Cover Page Supplement. * PHS 398 Research Plan: Must include a 'Resource Sharing Plan' and a 'Data Management and Sharing Plan'. * PHS Human Subjects and Clinical Trials Information form: Required if human subjects research, clinical research, and/or NIH-defined clinical trials are involved. * Appendix: Limited to blank questionnaires or surveys. No publications or other materials. * PD(s)/PI(s) eRA Commons ID: Must be included in the 'Credential field' of the 'Senior/Key Person Profile' form. Types of Support Offered

The support offered is a Grant, providing financial assistance.

Project Implementation Timeline

The maximum project period for this grant is 2 years.

Reporting Obligations

Annual: Research Performance Progress Report (RPPR).
Final: RPPR, invention statement, and expenditure data portion of the Federal Financial Report.

Post-Award Requirements Successful recipients must comply with: * All provisions in effect during the award period, other Department regulations, and applicable statutory provisions. * ClinicalTrials.gov Registration and Reporting: If the award involves clinical trials (NIH expects registration and results reporting for all trials, whether legally required or not). * Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval: For all human protocols. * Data and Safety Monitoring Requirements: For human biomedical and behavioral intervention studies. * Investigational New Drug (IND) or Investigational Device Exemption (IDE) Requirements: If applicable, for clinical research involving investigational therapeutics, vaccines, or medical interventions.

Evaluation Criteria

Evaluation Criteria Applications are evaluated for scientific and technical merit through the NIH peer review system. The R03 small grant supports discrete, well-defined projects that can be completed in two years with limited funding. Overall Impact Reviewers will assess the likelihood of the project to exert a sustained, powerful influence on the research field(s) involved, considering all scored and additional review criteria. A project does not need to be strong in all categories to be considered high impact. Scored Review Criteria These factors determine the scientific merit and contribute to the overall impact score. Factors 1 and 2 also receive separate scores.

Importance of the Research (Significance and Innovation):
- Evaluates the potential for the project to advance scientific knowledge and/or technical understanding related to ELSI in human genetics and genomics.
- Considers how the proposed research addresses critical problems and whether it improves current concepts, methods, technologies, treatments, services, or preventative interventions.
- Innovation: A proposed clinical trial might not be innovative itself but can address important questions or unmet needs. Preliminary data are not required, especially for pilot or feasibility studies.
Rigor and Feasibility (Approach):
- Assesses the soundness of the research design, methods, and analyses for accomplishing the specific aims.
- Considers the adequacy of the plans to ensure scientific rigor and reproducibility.
- For R03 grants, extensive detail is not always required, but the conceptual framework and general approach should be sound. Justification can come from literature, other data sources, or investigator-generated data.
Expertise and Resources (Investigator(s) and Environment):
- Investigator(s): Evaluates the background, training, and expertise of the investigator(s) relevant to the proposed work and their career stage. For multi-Principal Investigator (MPI) applications, the quality of the leadership plan and collaboration effectiveness are assessed.
- Environment: Considers whether the institutional resources and research environment are appropriate and conducive to the successful execution of the project.

Additional Review Criteria (Considered, but Not Scored) These items are considered when determining scientific and technical merit and for the overall impact score, but they do not receive separate criterion scores: * Protections for Human Subjects: Evaluates the justification for involving human subjects and proposed protections (e.g., risk, protection adequacy, potential benefits, knowledge to be gained, data/safety monitoring). For exempt research, assesses justification for exemption, characteristics of involvement, and material sources. * Vertebrate Animals: If applicable, evaluates procedures involving animals, justifications for use/species, interventions to minimize discomfort, and justification for euthanasia methods. * Biohazards: If applicable, evaluates whether hazardous materials/procedures are adequately protected against. * Resubmissions: Evaluates the full application as presented. * Renewals: Evaluates progress made in the last funding period. * Revisions: Evaluates the appropriateness of the proposed scope expansion. Additional Review Considerations (Not Scored, Not for Overall Impact) These items are considered but do not affect scoring: * Authentication of Key Biological and/or Chemical Resources: Evaluates plans for identifying and ensuring the validity of resources. * Budget and Period of Support: Evaluates whether the requested budget and project duration are fully justified and reasonable for the proposed research.

Compliance & Special Requirements

Compliance and Special Requirements This grant has rigorous compliance requirements, especially concerning data, ethics, and federal regulations. Applicants must be prepared to adhere to extensive policies. Regulatory Compliance Requirements

All NIH awards are subject to the NIH Grants Policy Statement and Federal Regulations 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Compliance with all relevant federal statutes and regulations pertaining to federal financial assistance.

Data Protection and Privacy Regulations

NIH Data Management and Sharing Policy (NOT-OD-21-013) and NIH Genomic Data Sharing Policy (NOT-OD-14-124) are mandatory.
Compliance with guidance on writing a Data Management and Sharing (DMS) Plan is required for all applications, regardless of direct costs requested.
NHGRI specific data sharing expectations: For applications directed to NHGRI, the DMS Plan must align with NHGRI's expectations for sharing comprehensive metadata, phenotypic, clinical, and environmental exposure data; using standardized data collection protocols/survey instruments; and employing standardized notation (e.g., controlled vocabularies, ontologies) for metadata.
Informed Consent: Human biological samples are expected to have been obtained with documented informed consent allowing for future research use and broad data sharing (NOT-HG-20-011). If new biospecimens are collected, the consent process needs high-level description in the Research Plan and detailed information in the Human Subjects Section.
Community Feedback: Applicants are encouraged to get feedback from communities regarding plans for sharing individual-level data and integrate recommendations on data access, privacy, and confidentiality into the DMS Plan.
Certificate of Confidentiality (CoC): Any project receiving NIH funding that collects or uses identifiable, sensitive information will automatically be issued a CoC.
Tribal Sovereignty: NIH recognizes Tribal sovereignty regarding data collection, management, and sharing for AI/AN populations (NOT-OD-22-214).

Technology Specifications

If the award involves implementing, acquiring, or upgrading health IT, the technology must meet standards and implementation specifications adopted in 45 CFR part 170, Subpart B.
For activities by eligible clinicians in ambulatory settings or hospitals, health IT must be certified under the ONC Health IT Certification Program if certified technology can support the activity.

Risk Management and Security Requirements

Recipients with ongoing access to HHS information/operational technology systems, or who receive/process PII/PHI from HHS, must develop plans and procedures modeled after the NIST Cybersecurity framework.

Unique Aspects or Requirements

This R03 Small Research Grant is designed for discrete, well-defined projects that can be completed within two years and require limited funding.
Of particular interest are projects proposing normative or conceptual analyses (legal, economic, philosophical, anthropological, historical) of new or emerging issues.
The mechanism can be used for preliminary data collection or secondary analysis of existing data.
Clinical Trial Optional: Applications can propose, or not propose, clinical trial(s).
Community and stakeholder involvement is encouraged, but not required.

Potential Challenges or Limitations

The strict budget limit of $50,000 direct costs per year means projects must be highly focused and self-contained.
Extensive data management and sharing requirements demand robust planning and infrastructure.
The detailed registration process (SAM, eRA Commons, Grants.gov) can be time-consuming and must be completed well in advance of application deadlines.

Strategic Alignment Opportunities

This grant aligns with the 2020 NHGRI Strategic Vision to continue focusing on ELSI research as genomics integrates into biomedicine and society.
It provides an avenue to address novel ELSI questions arising from innovations in gene editing, gene therapy, polygenic risk scores, and genomic testing.
Opportunity to study challenges related to genomic data generation, sharing, commercialization, and responsible data stewardship.
Addresses issues of genomic data disparities and the quality of genomic information for all populations.
Supports research on how genomic information impacts individual and group understanding, guarding against oversimplified genetic attributions.

Cross-Cutting Considerations

The grant implicitly addresses diversity and inclusion by encouraging applications from a broad range of disciplines and perspectives, and by focusing on disparities in genomic data from understudied populations.
Emphasis on data sharing and ethical sourcing of data underscores responsible conduct of research.
The focus on ELSI inherently covers ethical standards in human genetics and genomics research.

Grant Details