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Grant Analysis

Purpose & Target

The core objective of this grant is to fund the implementation of investigator-initiated, single or multi-site, interventional clinical trials (all phases). The trials must focus on the prevention or treatment of rheumatic, musculoskeletal, or skin diseases or disorders, aligning with the research mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). - Target recipient type and size: The grant targets a wide range of U.S.-based organizations including higher education institutions, nonprofits, for-profit organizations (including small businesses), and various government entities. - SECTOR-SPECIFIC: This grant is highly sector-specific, focusing exclusively on clinical trials related to arthritis, musculoskeletal, and skin diseases. - Geographic scope and any location requirements: Applicant organizations must be based in the U.S. However, foreign components (e.g., international clinical sites) are allowed within the trial design, meaning the research itself can have an international reach. - Key filtering criteria for initial grant screening: Applicants must propose an NIH-defined clinical trial, not observational studies or basic experimental studies involving humans (BESH). The trial design and preparatory work must be largely complete before application. The proposed work must be within the NIAMS mission areas. - Grant frequency and program context: This is a recurring funding opportunity with multiple application due dates annually until its expiration date of March 05, 2027. It utilizes a two-phase (UG3/UH3) cooperative agreement mechanism, where the UG3 phase is for start-up activities and the UH3 phase is for full trial execution, contingent on meeting UG3 milestones.

Financial Structure

Award budget is limited to $250,000 direct costs for the UG3 phase (up to one year).
There are no stated budget limits for the UH3 phase (up to five years); however, budgets should reflect the actual needs of the proposed project.
This funding opportunity does not require cost sharing or matching funds.
If parts of the costs are to be provided by sources other than NIAMS, these contributions must be presented in detail in the budget justification.
Pre-award costs are allowable as described in the NIH Grants Policy Statement.
Financial reporting requirements include annual Research Performance Progress Reports (RPPR) and financial statements.

Eligibility Requirements

Organization Types

'Higher Education Institutions' (Public/State Controlled, Private)
'Nonprofits' (with/without 501(c)(3) IRS Status, other than Institutions of Higher Education)
'For-Profit Organizations' (Small Businesses, Other than Small Businesses)
'Local Governments' (State, County, City or Township, Special District)
'Indian/Native American Tribal Governments' (Federally Recognized, 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.

Geographic Location

'Applicant organizations must be based in the U.S.'
'Non-domestic (non-U.S.) Entities are not eligible to apply.'
'Foreign components (e.g., international clinical sites) are allowed within the trial design, as defined in the NIH Grants Policy Statement.'

Specific Qualifications and Certifications

'Applicant organizations must complete and maintain active registrations with the System for Award Management (SAM), obtain a Unique Entity Identifier (UEI), register with eRA Commons, and register with Grants.gov prior to application submission. Registration can take 6 weeks or more.'
'All Program Directors/Principal Investigators (PD/PIs) must have an eRA Commons account.'

Scope of Research

'Applications must propose an NIH-defined clinical trial; only applications proposing clinical trial(s) are accepted.'
'Trials must be investigator-initiated, single or multi-site, interventional (all phases).'
'Investigators must have completed all necessary trial preparation (e.g., trial design, protocol synopsis, data analysis plan) through other means prior to applying.'
'Studies involving animals are not responsive.'
'Studies involving only Basic Experimental Studies Involving Humans (BESH) are not responsive.'
'Applications that include intervention data collection in the UG3 phase are not responsive.'

Application Limitations

'Applicant organizations may submit more than one application, provided each application is scientifically distinct.'
'Duplicate or highly overlapping applications will not be accepted if under review simultaneously.'

Application Process

Application Deadlines

Applications are due by 5:00 PM local time of applicant organization.
Latest application due date: 2026-11-02 17:00.
Other recurring due dates: March 04, 2025; July 02, 2025; November 04, 2025; March 04, 2026; July 02, 2026.
The Notice of Funding Opportunity (NOFO) expires on March 05, 2027.

Submission Process

Applications must be submitted electronically through ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Applicants are encouraged to submit early to allow time for error correction.
Strict conformance to application instructions in the 'How to Apply - Application Guide' and this NOFO is required; non-compliant applications may be delayed or not accepted.
Consultation with NIAMS staff prior to submission is highly recommended.

Required Documentation and Materials

Standard application forms: SF424(R&R) (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, Budget, Subaward Budget) and PHS 398 forms (Cover Page Supplement, Research Plan, Human Subjects and Clinical Trials Information).
Research Plan sections must include: 'Specific Aims' (concise trial goals and endpoints), 'Research Strategy' (supporting data, team's experience, experimental approach, milestone plan, scientific rationale, potential biases, organizational structure, ethical issues, and for Phase III trials, plans for valid analysis of sex/racial/ethnic differences).
Required Plans: 'Resource Sharing Plan' and 'Data Management and Sharing Plan'.
Appendix: Limited to blank questionnaires or surveys; no publications or other material allowed.
Mandatory Attachments (PDF files):
- 'Clinical Monitoring Plan' (must use filename 'Clinical Monitoring Plan.pdf').
- 'Study Timeline' (detailed project performance objectives and corresponding timeline, including UG3 and UH3 milestones).
- 'Plan to Include Lived Experience' (1-page summary of strategies to advance scientific merit through expanded consideration for lived experience).

Project Implementation Timeline and Milestones

Grant duration: Limited to six years (up to one year for UG3 start-up phase, up to five years for UH3 implementation phase).
UG3 milestones (examples): Development of data management system/CRFs, recruitment/retention plans, finalization of protocol/manual of procedures/consent forms, statistical analysis plan, IRB/DSMB approval, initiation of contracts and training of clinical site personnel.
UH3 milestones (examples): Enrollment and follow-up of subjects, trial registration (ClinicalTrials.gov), results reporting (ClinicalTrials.gov), primary publication within one year of follow-up completion, submission of complete/cleaned/de-identified dataset.
Milestones are objective and performance-based; meeting them is conditional for transition from UG3 to UH3 and continuation of the award.

Post-Award Requirements and Compliance

Recipients are required to submit annual Research Performance Progress Reports (RPPR) and financial statements.
A final RPPR, invention statement, and expenditure data are required for award closeout.
Clinical trials must be registered and results submitted on ClinicalTrials.gov.
Protocols must be reviewed and approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Adherence to NIH Data and Safety Monitoring requirements for all human biomedical/behavioral intervention studies.
Compliance with FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements if applicable.

Evaluation Criteria

Overall Impact

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

Scored Review Criteria

'Factor 1: Importance of the Research (Significance and Innovation)': Evaluates the potential for high clinical impact within the NIAMS research mission, addressing critical questions about a disease or process, and the potential to improve health and impact clinical care.
'Factor 2: Rigor and Feasibility (Approach)': Assesses the overall strategy, methodology, statistical analysis plan, experimental approach, and how potential biases or challenges will be addressed. This also includes the adequacy of the clinical monitoring plan and project management plan for trial launch, conduct, and completion.
'Factor 3: Expertise and Resources (Investigator(s) and Environment)': Considers the study team's clinical trial experience, the organizational structure and administration, and the adequacy of the scientific environment.

Additional Review Criteria (Considered, but not separately scored)

'Protections for Human Subjects': Adequacy of plans for human subjects protection.
'Study Milestones': Assessment of the proposed objective and performance-based milestones for both UG3 (start-up) and UH3 (implementation) phases, including contingency plans for potential delays. Meeting milestones is critical for transition from UG3 to UH3.
'Lived Experience Engagement Plan': Evaluation of strategies for meaningful engagement of people with lived experience (patients, advocates, caregivers, community leaders) and other collaborators in the research process, and how this engagement will improve scientific and technical merit and research impact.
Other criteria considered include 'Vertebrate Animals' (if applicable), 'Biohazards', and specifics related to 'Resubmissions', 'Renewals', and 'Revisions'.

Additional Review Considerations (Considered, not scored, not impacting overall score)

'Clinical Monitoring Plan': Evaluation of the adequacy of procedures to ensure adherence to protocol, documentation, and intervention quality.
'Authentication of Key Biological and/or Chemical Resources'.
'Budget and Period of Support': Assessment that the budget reflects the actual needs of the proposed project.

Compliance & Special Requirements

Regulatory Compliance

Awards are subject to 2 CFR Part 200, 'Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards'.
Recipients must comply with all applicable non-discrimination laws, as agreed upon during SAM.gov registration, and submit an 'Assurance of Compliance (HHS-690)'.
All federal statutes and regulations relevant to federal financial assistance, as outlined in the NIH Grants Policy Statement, must be followed.

Data Protection and Sharing

A 'Data Management and Sharing Plan' is required for all applications generating scientific data, consistent with the 2023 NIH Policy for Data Management and Sharing. The plan must be implemented upon approval.
Recipients retain primary rights to data and software, subject to Government rights of access.

Ethical Standards

Applications must include comprehensive 'Protections for Human Subjects'.
Ethical issues surrounding the trial and the disease/condition under study must be explicitly discussed in the application.
The grant strongly encourages 'meaningful engagement of people with lived experience' (e.g., patients, advocates, caregivers, community leaders) and other collaborators to improve outcomes and health equity. This plan will be considered in peer review.

Risk Management and Security

A 'Clinical Monitoring Plan' is a mandatory attachment, detailing how trial conduct, documentation, and data quality will be monitored according to protocol, SOPs, GCP, and regulatory requirements.
Plans for handling deficiencies, appropriate reporting to relevant authorities, and ensuring confidentiality and subject privacy are required components of the Clinical Monitoring Plan.
NIAMS closely monitors progress, milestones, subject accrual, and safety throughout the project period.

Special Considerations

This is a 'Cooperative Agreement', meaning there will be substantial Federal scientific or programmatic involvement from NIH staff in assisting, guiding, coordinating, or participating in project activities.
The UG3 phase is specifically designed for final preparatory activities before the clinical trial begins, not for preliminary data collection or efficacy studies.
The use of innovative and efficient study designs, such as 'adaptive dose-finding designs', 'designs incorporating plans for sample size recalculation', or 'futility designs', is encouraged.
While foreign organizations cannot apply directly, 'foreign components' (e.g., international clinical sites) are allowed within the trial, provided the applicant organization is U.S.-based.

Grant Details