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Grant Analysis

Purpose & Target

Core Objective: This grant aims to support time-sensitive ancillary studies that leverage existing clinical projects (parent projects) to enhance scientific understanding related to the NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) mission.
Target Recipient: A broad range of organizations capable of conducting research, including higher education institutions, non-profits, for-profit entities, and various governmental bodies.
SECTOR-SPECIFIC: This grant is highly sector-specific, focusing on biomedical and biobehavioral research within clinical studies, aligned with the NIAMS mission.
Geographic Scope: Only organizations located within the United States or its territories/possessions are eligible.
Key Filtering Criteria: Applicants must propose an ancillary study that is truly 'time-sensitive' and can efficiently leverage an ongoing, independently funded clinical parent project. The project must not involve a new clinical trial. Non-time-sensitive projects or those that do not align with the NIAMS mission are excluded.
Grant Frequency and Program Context: This is a recurring funding opportunity (reissue of a previous PAR) within the NIH's R21 Exploratory/Developmental Research Grant program.

Financial Structure

Award instrument: Grant.
Direct costs are limited to $400,000 over the maximum two-year project period.
A maximum of $250,000 in direct costs is allowed in any single year.
No cost sharing is required by this funding opportunity.
Co-financing requirements are not specified; however, parent projects must be independently funded and will not receive additional financial support from this NOFO.
Payment schedules and mechanisms will follow standard NIH procedures as outlined in the Notice of Award.
Financial reporting requirements include annual financial statements and a final Federal Financial Report for closeout.
Audit requirements apply as per 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
Budget flexibility parameters are not explicitly detailed beyond the annual and total direct cost limits.
No specific financial guarantees are required beyond adherence to NIH financial policies and proper budget justification.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Eligibility Requirements

Organizational Eligibility

Eligible Types:
Higher Education Institutions: Public/State Controlled, Private
Nonprofits: 501(c)(3) IRS Status (Other than Institutions of Higher Education), Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations: Small Businesses, Other For-Profit Organizations
Local Governments: State, County, City or Township, Special District, Indian/Native American Tribal Governments (Federally Recognized), Indian/Native American Tribal Governments (Other than Federally Recognized)
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 tribal governments), Faith-based or Community-based Organizations, Regional Organizations
Ineligible Types: Non-domestic (non-U.S.) Entities (Foreign Organizations) and non-domestic (non-U.S.) components of U.S. Organizations.

Geographic Eligibility

Applicant organization must be located within the United States (including U.S. territories or possessions).

Technical & Project Specifics

The proposed study must be an ancillary study to a privately or publicly funded, active, ongoing clinical project (referred to as the 'parent project').
The parent project must provide a cohort of well-characterized patients, infrastructure, data, and biological samples that the ancillary study will leverage.
The ancillary study must focus on new research questions not studied in the parent project and must be related to the NIAMS mission.
The project must not involve a clinical trial. This R21 grant mechanism is specifically for 'Clinical Trial Not Allowed' applications.
The project must be time-sensitive, requiring an accelerated review and award process. Examples of time-sensitivity include the need to collect samples/data before the parent project ends, analyze fresh specimens, or collect post-intervention data from a trial that is concluding.
The ancillary study must not interfere with the parent project or unduly burden its participants.
Recruitment of patients not already enrolled in the parent study is generally not supported, with a small exception for healthy controls if costs are minimal (e.g., no more than one budget module).
Projects considered non-responsive and will not be reviewed include: those that do not demonstrate time-sensitivity, utilization of already collected data or preserved samples for later analysis, secondary analysis of existing datasets, or sample/data collection already part of the parent study.
The R21 mechanism is for innovative projects that may involve considerable risk but have potential for significant impact or breakthroughs; it is not for developing preliminary data for longer-term projects in well-established research areas or for less innovative pilot projects.

Principal Investigator (PD/PI) Eligibility

Any individual(s) with the necessary skills, knowledge, and resources may serve as PD(s)/PI(s).
Junior investigators are encouraged to take a leading role in clinical research with support and collaboration from senior investigators.

Registration Requirements

Applicant organizations must complete and maintain active registrations with:
System for Award Management (SAM) (requires annual renewal).
Unique Entity Identifier (UEI) (obtained through SAM.gov registration).
eRA Commons (organization needs at least one Signing Official and one Program Director/Principal Investigator account).
Grants.gov (requires active SAM registration).
All PD(s)/PI(s) must have an eRA Commons account affiliated with the applicant organization.

Application Process

Application Submission

Application forms must be accessed and submitted electronically through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
Applicants are strongly encouraged to submit applications early to allow time for correcting any errors prior to the deadline.
Incomplete, non-compliant, and/or non-responsive applications will not be reviewed.

Key Dates (Latest)

Open Date (Earliest Submission Date): March 09, 2025
Letter of Intent Due Date(s): 30 days prior to the application due date (e.g., November 05, 2025 for the December 05, 2025 due date).
Application Due Date(s): December 05, 2025, by 5:00 PM local time of the applicant organization.
Expiration Date: December 06, 2025.

Required Documentation and Materials

Letter of Intent (optional, but encouraged): Include descriptive title, PD(s)/PI(s) names, address, phone, names of other key personnel, participating institutions, and the funding opportunity number/title.
Standard NIH Application Forms (SF424(R&R) series, PHS 398 supplements).
Research Strategy: Must include a clearly identifiable 'Timeline' paragraph and 'Time-Sensitivity Justification' paragraph within the Approach section, explaining why expedited review/award is essential.
Letters of Support: Mandatory inclusion of a letter or statement from a parent study leadership committee (e.g., Steering Committee, Scientific Advisory Board) documenting approval of the proposed ancillary study. This letter must explicitly state the committee's decisional power, confirm accessibility of patient cohorts, samples, data, and biological materials, detail any agreements on data access/distribution, and assure adequate time remaining in the parent study.
Resource Sharing Plan: Required.
Data Management and Sharing Plan: Required for all applications planning research that generates scientific data.
Appendix: Limited materials allowed. Must include:
A one-page statement with parent clinical study PD/PI name, funding source, and funding period.
A three-page or less synopsis of the parent clinical project(s), providing sufficient information for reviewers to assess its ability to provide necessary resources.
Human Subjects and Clinical Trials Information: If human subjects are involved, include a human subjects study record. Must clearly describe procedures to protect subjects' privacy rights and document the burden to patients.

Project Period

The maximum project period allowed is two years.

Reporting Obligations

Annual Research Performance Progress Report (RPPR).
Annual financial statements.
Final RPPR, invention statement, and expenditure data for award closeout.
Recipients are required to implement their approved Data Management and Sharing Plan.

Review Process

Applications undergo scientific and technical merit review by a Scientific Review Group convened by NIAMS.
All applications receive a written critique.
A selection process identifies applications with the highest scientific and technical merit (generally the top half) for discussion and assignment of an overall impact score.
Recommended applications undergo a second level of review by the appropriate national Advisory Council or Board.
Funding decisions consider scientific and technical merit, availability of funds, and relevance to program priorities.
'Just-in-time' information may be requested if an application is under consideration for funding.

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood of the project to exert a sustained, powerful influence on the relevant research field(s).

Scored Review Criteria Importance of the Research (Significance and Innovation)

Scientific rationale and premise of the proposed ancillary study.
The insight to be gained from the study.
Justification for recruiting cohorts from the identified parent project, as opposed to other subjects.
Level of innovation and potential for significant impact on biomedical or biobehavioral research, leading to a breakthrough.
Potential to develop novel technology or tools that significantly accelerate research fields.
Application of methods, technologies, or approaches from outside the research field in a novel way.
Preference will be given to projects within NIAMS mission areas that are especially innovative, groundbreaking, and have a high potential impact.

Rigor and Feasibility (Approach)

Soundness of methods for data analysis and power calculations.
Justification for the required sample size (not merely a restatement from the parent clinical project).
Description of statistical procedures for data analysis; strong recommendation for a statistician to be part of the research team.
Demonstrated efficient leveraging of the parent project(s) resources.
Clear justification of the time-sensitive nature of the ancillary study and why an expedited review and award process is essential to its feasibility (must be presented in dedicated 'Timeline' and 'Time-Sensitivity Justification' paragraphs in the application).
A timeline demonstrating that the parent project has adequate time remaining for the proposed ancillary study.

Expertise and Resources (Investigator(s) and Environment)

Assessment of the skills, knowledge, and resources of the Program Director(s)/Principal Investigator(s).
Suitability of the research environment and resources available for the proposed work.

Additional Review Criteria (considered, but not scored)

Protections for Human Subjects: Evaluation of procedures to protect subjects' privacy rights and documentation of burden to participants.
Vertebrate Animals: Assessment of proposed procedures, justifications for use, interventions to minimize discomfort, and justification for euthanasia methods (if applicable).
Biohazards: Evaluation of potential hazards to personnel/environment and adequacy of proposed protection.
Resubmissions: Evaluation of the full application as presented.
Renewals: Assessment of progress made in the previous funding period.
Revisions: Evaluation of the appropriateness of any proposed expansion of the project's scope.

Additional Review Considerations (considered, but not scored)

Authentication of Key Biological and/or Chemical Resources: Review of plans for identifying and ensuring the validity of these resources.
Budget and Period of Support: Evaluation of whether the budget and requested project period are fully justified and reasonable relative to the proposed research.

Compliance & Special Requirements

Regulatory Compliance

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) is required.
Applicants must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Compliance with all federal statutes and regulations relevant to federal financial assistance, including NIH Grants Policy Statement Section 4 Public Policy Requirements, is mandatory.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for all human subjects protocols, with major changes needing to be provided to NIH.

Data Management & Sharing

Compliance with the 2023 NIH Policy for Data Management and Sharing is required when applicable, and the approved plan must be implemented.

Intellectual Property

An invention statement is required for award closeout, implying adherence to NIH's standard intellectual property policies.

Risk Management & Reporting

Recipients and subrecipients are subject to mandatory disclosure requirements for violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award (2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35).
NIH conducts reviews of an applicant's federal award history in SAM.gov to assess sound business practices, integrity, business ethics, and performance.

Special Considerations

This grant mechanism (R21) is specifically designed for exploratory/developmental research supporting novel scientific ideas or new model systems, tools, or technologies that carry considerable risk but have the potential for significant impact or lead to a breakthrough.
Preliminary data are not required for R21 applications, though they may be included if available.
Prospective applicants are strongly encouraged to contact the appropriate NIAMS Program Director prior to submitting an application to confirm suitability.
The NOFO encourages collaboration between basic and clinical investigators and partnership with private entities.
It also encourages junior investigators to take a leading role in clinical research with support from senior investigators.
Applications that do not sufficiently demonstrate the time-sensitive nature of the proposed ancillary study (e.g., secondary analysis of existing data, or sample collection already part of the parent study) will be considered non-responsive and will not be reviewed.

Grant Details