Core Objective: To fund clinical observational studies that generate data essential for designing future clinical studies in musculoskeletal, rheumatic, and skin diseases or conditions.
Target Recipient Type and Size: Eligible organizations include a broad range from Higher Education Institutions and Nonprofits to For-Profit Organizations (including Small Businesses) and various levels of Government entities.
Designation: This is a SECTOR-SPECIFIC grant.
Geographic Scope: Applicants must be based in the United States or U.S. Territories. Foreign organizations are not eligible to apply, although foreign components of a U.S. organization's project are allowed.
Key Filtering Criteria: Focuses exclusively on clinical observational studies (not clinical trials), and on specific disease areas: musculoskeletal, rheumatic, and skin diseases.
Grant Frequency and Program Context: This is a reissued funding opportunity (reissue of PAR-24-036) as part of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Clinical Research program, with multiple application due dates extending through November 2026.
Financial Structure
Funding Instrument: Grant.
Direct Cost Limitation: $475,000.0 over a four-year period, exclusive of consortium/subcontractual Facilities and Administrative (F&A) costs.
Annual Direct Cost Limit: No more than $250,000.0 in any single year.
Maximum Award Project Period: 4 years.
Cost Sharing: Not required.
Eligible Costs: Pre-award costs are allowable as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
Financial Reporting: Recipients must submit Research Performance Progress Reports (RPPR) annually and financial statements as required by NIH Grants Policy Statement Section 8.4.1 Reporting.
Closeout Requirements: A final RPPR, invention statement, and expenditure data portion of the Federal Financial Report are required for closeout.
Eligible: Nonprofits (with or without 501(c)(3) IRS Status, other than Institutions of Higher Education).
Eligible: For-Profit Organizations (including Small Businesses).
Eligible: Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal Governments).
Eligible: Federal Governments (Eligible Agencies of the Federal Government, U.S. Territory or Possession).
Eligible: 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: Foreign Organizations (Non-domestic (non-U.S.) Entities) are not eligible to apply as the primary applicant.
Ineligible: Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply as the primary applicant, though foreign components of a U.S.-led project are allowed.
Geographic Requirements
Applicant organization must be based in the United States or a U.S. Territory or Possession.
Registration Requirements
All applicant organizations must complete and maintain active registrations with:
System for Award Management (SAM) (requires annual renewal).
Unique Entity Identifier (UEI) (issued via SAM.gov registration).
eRA Commons (requires identification of a Signing Official and at least one Program Director/Principal Investigator account).
All Program Directors/Principal Investigators (PD(s)/PI(s)) must have an eRA Commons account affiliated with the applicant organization.
Registrations must be completed prior to application submission; process can take 6+ weeks.
Project-Specific Eligibility
Clinical Trial Not Allowed: Applications proposing NIH-defined clinical trials will not be supported.
Observational Studies Only: Only Clinical Observational (CO) studies will be supported. Studies that involve investigator intervention to alter care/treatment are not eligible.
Research Scope: Must focus on obtaining data for designing future clinical studies for musculoskeletal, rheumatic, or skin diseases/conditions.
Exclusions (Non-responsive applications):
Basic laboratory research or studies of laboratory animals.
Disease mechanisms or pathophysiology, or therapeutic target identification.
Studies on blood or tissue samples collected independently of the proposed project.
Any NIH-defined clinical trials.
Early stage biomarker discovery or development.
Duplicate Applications
NIH will not accept duplicate or highly overlapping applications under review at the same time. Each application must be scientifically distinct.
Application Process
Application Access and Submission
Applications must be submitted electronically through Grants.gov.
Follow instructions in the Research (R) Instructions in the How to Apply - Application Guide and specific NOFO instructions.
Page limitations described in the Application Guide and Table of Page Limits must be followed.
Specific sections requiring additional instructions:
SF424(R&R) Cover
SF424(R&R) Project/Performance Site Locations
SF424(R&R) Other Project Information
Facilities and Other Resources: Briefly describe infrastructure for clinical researchers.
SF424(R&R) Senior/Key Person Profile
R&R or Modular Budget
R&R Subaward Budget
PHS 398 Cover Page Supplement
PHS 398 Research Plan:
Research Strategy: Include a subsection 'Necessity for Future Clinical Research Study' describing how the CO study addresses obstacles for future clinical study design.
Letters of Support: From academic or industry groups may be included.
Resource Sharing Plan (if applicable).
Other Plan(s):
Data Management and Sharing Plan: Required for research generating scientific data, regardless of direct costs requested.
Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys; no publications).
PHS Human Subjects and Clinical Trials Information:
Required if Human Subjects are involved; must include at least one human subjects study record or delayed onset study record.
PHS Assignment Request Form
Post-Submission Materials
Applicants are required to follow NIH policy for post-submission materials.
Monitoring and Reporting Obligations
Annual Research Performance Progress Reports (RPPR) and financial statements.
Final RPPR, invention statement, and expenditure data are required for award closeout.
Performance will be reviewed based on details and outcomes shared within RPPRs.
Evaluation Criteria
Overall Impact
Reviewers provide an overall impact score based on the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.
A strong application does not need to be strong in all categories to be judged likely to have a major scientific impact.
Scored Review Criteria
Factor 1. Importance of the Research (Significance and Innovation):
How the proposed CO study will address a significant obstacle for the design of a future clinical study (trial or observational).
The knowledge gap addressed by the CO study and how filling it will enhance future clinical research design.
Likelihood that information obtained will facilitate design or conduct of high-quality clinical research.
Current state of clinical research, therapeutic development progress, and available therapies in the pipeline in the relevant disease area.
Potential for high impact: integration of all necessary components of a significant clinical study (preclinical therapy, regulatory approvals, clinical research network, patient access) and how the CO study provides the missing piece for future study design.
Factor 2. Rigor and Feasibility (Approach):
Quality of design, assessment methods, and analysis in observational studies.
Scientific rationale/premise of the study.
Justification for proposed work through rigorous literature citations, data from other sources, or investigator-generated data.
Factor 3. Expertise and Resources (Investigator(s) and Environment):
Investigator(s) background, training, and expertise appropriate for the proposed work and career stage.
Quality of the leadership plan for Multiple Principal Investigator (MPI) applications.
Appropriateness of institutional resources to ensure successful execution.
Additional Review Criteria (Considered but Not Scored)
Protections for Human Subjects:
Justification for involvement and proposed protections against research risk.
Adequacy of protection, potential benefits, importance of knowledge, and data/safety monitoring.
Justification for exemption categories under 45 CFR Part 46, if applicable.
Vertebrate Animals:
Description of procedures, justifications for use and species appropriateness, interventions to minimize discomfort, and justification for euthanasia method (if applicable).
Biohazards:
Evaluation of hazardous materials/procedures and adequacy of proposed protection.
Resubmissions/Renewals/Revisions:
Evaluation of the full application as presented (Resubmissions).
Progress made in the last funding period (Renewals).
Appropriateness of proposed scope expansion (Revisions).
Additional Review Considerations (Considered but Not Scored)
Authentication of Key Biological and/or Chemical Resources:
Plans for identifying and ensuring validity of key resources.
Budget and Period of Support:
Justification and reasonableness of the budget and requested project period in relation to the proposed research.
Compliance & Special Requirements
Regulatory Compliance
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under Sections 301 and 405 of the Public Health Service Act and Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
Recipients must comply with all applicable nondiscrimination laws (agree to this when registering in SAM.gov) and submit an Assurance of Compliance (HHS-690).
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
Data Management and Sharing
Required for research generating scientific data, consistent with the 2023 NIH Policy for Data Management and Sharing.
Upon approval, the Data Management and Sharing Plan must be implemented as described.
Human Subjects and Ethical Standards
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval: Recipient institutions must ensure protocols are reviewed by their IRB or IEC.
NIH requires copies of documents for major changes in the status of ongoing protocols involving human subjects.
Mandated Disclosures
Recipients or subrecipients must submit information related to violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award (as per 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35).
Project Specific Requirements
Clinical Observational (CO) Studies Only: No NIH-defined clinical trials are permitted. Only non-interventional studies where the investigator observes and collects data are supported.
Diversity of Study Cohort: Enrollment for the proposed study cohort should match the diversity of the population affected by the disease. Failure to do so may result in the application being considered low priority.
Strategic Alignment Opportunities
Applications leveraging telehealth methods, digital outcomes, or wearable devices are encouraged.
Studies addressing significant obstacles or questions in clinical study design, such as determining appropriate outcome measures or identifying disease stages for intervention response, are particularly encouraged.
While informing future clinical research, the resulting data may also have a direct impact on clinical care.
Grant Details
musculoskeletal diseases
rheumatic diseases
skin diseases
clinical observational studies
r01
research project grant
nih
niams
clinical research
health research
medical research
biomarkers
outcome measures
disease progression
comorbid conditions
patient outcomes
epidemiology
cohort studies
observational research
data collection
research design
health sciences
public health
us government funding
non-interventional studies
biomedical research
telehealth
digital outcomes
wearable devices
Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed)
PAR-24-280
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Clinical Research program
UNIVERSITY
NGO
STARTUP
SME
ENTERPRISE
PUBLIC
OTHER
US
HEALTHCARE
DEVELOPMENT
0-10
11-50
51-250
251-500
500+
SDG3
FUNDING
RESEARCH_DEVELOPMENT
475000.00
None
475000.00
USD
None
Nov. 2, 2026, 5 p.m.
March 2026 - May 2027 (across multiple review cycles)
Grants8