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Grant Analysis

Purpose & Target

Core Objective: To fund time-sensitive ancillary studies that leverage active, ongoing clinical projects (parent projects) to advance the mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and identify novel targets for disease diagnosis, treatment, and prevention.
Target Recipient Type/Size: Various organizations including Higher Education Institutions, Nonprofits, For-Profit organizations (including small businesses), and Government entities in the US. No specific size limits, but implies organizations capable of conducting research.
SECTOR-SPECIFIC: Biomedical research focused on diseases within the NIAMS portfolio (arthritis, musculoskeletal, and skin diseases).
Geographic Scope: U.S. organizations are eligible to apply. Foreign components (e.g., specific research activities) are allowed within a U.S. lead application.
Key Filtering Criteria: Must be an ancillary study building upon an active, ongoing clinical project. The proposed ancillary study itself must not be a clinical trial. It must demonstrate a clear time-sensitive need for accelerated review and award.
Grant Frequency: Recurring (this is a reissue of a previous funding opportunity, PAR-23-025).
Program Context: Part of the NIH's R01 Research Project Grant series, designed with an accelerated review and award process to capitalize on existing clinical resources.

Financial Structure

Budget for direct costs is limited up to $300,000 per year.
The maximum project period is four years.
No cost sharing is required.
Parent projects (the ongoing clinical studies) will not receive additional financial support from this funding opportunity.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Recruitment of a small number of healthy controls for the ancillary study is acceptable provided the cost is minimal (e.g., no more than one budget module).
Annual Research Performance Progress Reports (RPPR) and financial statements are required.
A final RPPR, invention statement, and expenditure data are required for award closeout.
All awards are subject to the terms and conditions, cost principles, and audit requirements described in the NIH Grants Policy Statement and 2 CFR Part 200.

Eligibility Requirements

Organizational Type & Location

Eligible: Higher Education Institutions (Public/State Controlled, Private), Nonprofits (with/without 501(c)(3) IRS Status), For-Profit Organizations (Small Businesses, Other), Local Governments (State, County, City or Township, Special District, Federally Recognized Indian/Native American Tribal Governments, Other Indian/Native American Tribal Governments), Federal Governments (Eligible Agencies, U.S. Territory or Possession), and 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).
Only U.S.-based organizations are eligible to apply.
Foreign organizations (non-U.S. entities) are not eligible to be the applicant organization.
Non-U.S. components of U.S. Organizations are not eligible to be the applicant organization.
Foreign components (research activities conducted outside the U.S. by a foreign collaborator) are allowed, as defined by the NIH Grants Policy Statement.

Project Type & Scope

Must propose ancillary studies to privately or publicly funded, active, ongoing clinical projects (parent projects).
Parent projects can be interventional clinical trials, observational clinical studies, or disease-specific repositories actively collecting patient samples and/or clinical data.
The parent project must provide a cohort of well-characterized patients, infrastructure, data, and biological samples for the ancillary study.
The proposed ancillary study itself must not be a clinical trial.
Must demonstrate a time-sensitive need for accelerated review and award (e.g., need to collect samples/data before parent project ends, analyze fresh specimens, or collect post-intervention data from an ending trial).
The ancillary study must not interfere with the parent project or unduly burden participants.
The ancillary study will not support the recruitment of patients who are not already enrolled in the parent study; however, recruitment of a small number of healthy controls is acceptable if the cost is minimal.
Applications that are not time-sensitive (e.g., utilizing already collected data/samples from finished projects, secondary analysis of existing datasets, sample/data collection already part of the parent study) are non-responsive and will be returned without review.

Technical & Administrative

Applicant organization must complete and maintain active registrations with the System for Award Management (SAM), a Unique Entity Identifier (UEI), and eRA Commons.
Foreign organizations (if allowed to apply for other NIH grants) must obtain a NATO Commercial and Government Entity (NCAGE) code in lieu of a CAGE code to register in SAM.
All Program Director(s)/Principal Investigator(s) (PD/PI(s)) must have an eRA Commons account.
Individuals serving as PD/PI must possess the necessary skills, knowledge, and resources for the proposed research.
Cost-sharing is not required.
Applicant organizations may submit more than one application, provided each is scientifically distinct.
Duplicate or highly overlapping applications under review at the same time are not accepted.
Required to comply with instructions for a Data Management and Sharing Plan.
All ancillary study applications MUST include a letter of approval from one of the parent study leadership committees (e.g., Steering Committee, Scientific Advisory Board, Data Safety Monitoring Board). This letter must explicitly state: 1) the decisional power of the letter-submitting party for approving the ancillary study, 2) that required patient cohorts, samples, data, and biological materials from the parent project are accessible to the ancillary study, and 3) assurance that there is adequate time left in the parent study for the ancillary study to be carried out. Applications missing this letter will be considered incomplete and will not be reviewed.

Application Process

Application Deadlines

April 09, 2025 (for New, Renewal, Resubmission, and Revision applications).
August 06, 2025 (for New, Renewal, Resubmission, and Revision applications).
December 05, 2025 (for New, Renewal, Resubmission, and Revision applications).
All applications are due by 5:00 PM local time of the applicant organization.
A Letter of Intent (optional, but encouraged) is due 30 days prior to the application due date.

Submission Process

Applications must be submitted electronically through ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Applicants are responsible for tracking the status of their application in eRA Commons to ensure successful submission.
Any errors found during the submission process must be corrected, and a changed/corrected application must be submitted by the due date and time.

Required Documentation & Materials

Standard forms: SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile.
Budget forms: R&R or Modular Budget, R&R Subaward Budget.
PHS 398 Cover Page Supplement.
PHS 398 Research Plan, which includes:
Research Strategy: Must clearly describe the ancillary study's scientific rationale and insight to be gained. Must include separate, clearly identifiable paragraphs titled 'Timeline' and 'Time-Sensitivity Justification' in the Approach section.
Resource Sharing Plan.
Data Management and Sharing Plan (required for all applications, regardless of direct costs).
Appendix: Limited to specific items:
A one-page statement indicating the parent clinical study PD/PI name, funding source, and funding period.
A three-page or less synopsis of the parent clinical project(s). Applications missing these items will be considered incomplete.
PHS Human Subjects and Clinical Trials Information form (if human subjects research is involved).
PHS Assignment Request Form.
A letter of approval from one of the parent study leadership committees (e.g., Steering Committee, Scientific Advisory Board, Data Safety Monitoring Board). This letter is mandatory and must explicitly state approval of the ancillary study, confirm access to required patient cohorts, samples, data, and biological materials, and assure adequate time remains in the parent study. Applications missing this letter will be considered incomplete.

Types of Support Offered

Direct financial funding (grant).
Application assistance is available through various contacts, including the eRA Service Desk, General Grants Information, Grants.gov Customer Support, and specific scientific, peer review, and financial contacts at NIAMS/NIH.

Project Implementation & Reporting

The maximum project duration is four years.
Applicants must propose a timeline demonstrating adequate time left in the parent project to carry out the proposed ancillary study.
Annual Research Performance Progress Reports (RPPR) and financial statements are required.
A final RPPR, invention statement, and expenditure data are required for award closeout.
Recipient institutions must ensure that research protocols involving human subjects are reviewed and approved by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Recipients must provide NIH with copies of documents related to all major changes in the status of ongoing protocols.

Evaluation Criteria

Overall Impact

Reviewers will provide an overall impact score reflecting the likelihood of the project exerting a sustained, powerful influence on the research field(s) involved.
An application does not need to be strong in all categories to be judged as likely to have a major scientific impact.

Scored Review Criteria

Importance of the Research (Significance and Innovation): Evaluation of the scientific rationale and premise of the proposed ancillary study, and the insight it is expected to gain. Applicants must explain why the parent project's cohorts are essential.
Rigor and Feasibility (Approach): Assessment of the proposed methods for data analysis, power calculations, and justification for the required sample size. Also evaluates the feasibility of the proposed work and the justification for the time-sensitive nature of the ancillary study, including the proposed timeline.
Expertise and Resources (Investigator(s) and Environment): Review of the skills, knowledge, and resources of the Program Director(s)/Principal Investigator(s) and the suitability of the research environment for conducting the proposed work.

Additional Review Criteria (considered, but not scored separately)

Protections for Human Subjects: Evaluation of the procedures to protect subjects' privacy rights and documentation of the burden to participants.
Vertebrate Animals: If applicable to the proposed project.
Biohazards: If applicable to the proposed project.
Resubmissions: Evaluation of the revised application.
Renewals: Evaluation of progress made in the previous funding period.
Revisions: Evaluation of the appropriateness of the proposed expansion of the scope of the project.

Additional Review Considerations (considered, but not scored)

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

Selection Criteria

Scientific and technical merit of the proposed project, as determined by the scientific peer review.
Availability of funds.
Relevance of the proposed project to NIAMS program priorities.

Compliance & Special Requirements

Regulatory & Policy Compliance

Adherence to the comprehensive NIH Grants Policy Statement and specific instructions outlined in the How to Apply - Application Guide.
Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Compliance with all applicable nondiscrimination laws, which is affirmed during SAM.gov registration and by submitting an Assurance of Compliance (HHS-690).
Compliance with all federal statutes and regulations relevant to federal financial assistance.
Mandatory disclosure of any information related to violations of federal criminal law involving fraud, bribery, or gratuity that could potentially affect the federal award.

Human Subjects & Data

For projects involving human subjects, all procedures to protect subjects' privacy rights must be clearly described.
Documentation detailing the burden to patients enrolled in the ancillary application must be provided.
Compliance with the 2023 NIH Policy for Data Management and Sharing is required, meaning all applications must include a Data Management and Sharing Plan.

Project-Specific Requirements & Exclusions

The proposed ancillary study itself cannot be a clinical trial. Applications proposing a clinical trial will not be accepted.
The ancillary study must be time-sensitive, justified by a need to collect samples or data that is concurrent with the ongoing parent clinical project (e.g., before the end of recruitment, for immediate analysis of fresh specimens, or for collecting post-intervention data from a trial that is concluding).
Applications that do not demonstrate this time-sensitivity will be considered non-responsive and returned without review.
Securing an explicit letter of approval from the parent study's leadership committee is a hard requirement. This letter must confirm both their approval and the ancillary study's access to the necessary patient cohorts, samples, data, and biological materials, as well as confirming sufficient time remains in the parent study.

Strategic Opportunities

The funding opportunity encourages collaboration between basic and clinical investigators.
Partnership with private entities is also encouraged.
Junior investigators are specifically encouraged to take a leading role in clinical research, with the support and collaboration of senior investigators.

Grant Details