HEAL Initiative: Whole Joint Health Program (R61/R33 Clinical Trial Required)

Open Posted

Opportunity number
PAR-27-045
Agency
Applications due
Award size
Not on record

Opportunity facts

Funding instrument
Grant
Category
  • Health
Eligible applicants
  • Tribal Governments (Federally Recognized)
  • Other
  • City/Township Governments
  • Small Businesses
  • County Governments
  • Special District Governments
  • Higher Education Inst. (Public)
  • For Profit Organizations
  • Tribal Organizations (Not Federally Recognized)
  • Public or Indian Housing Auth.
  • 501(c)(3) Nonprofits
  • State Governments
  • Higher Education Inst. (Private)
  • Independent School Districts
  • Non-501(c)(3) Nonprofits
Points of contact

Opportunity details come from Grants.gov. Updated .

About this opportunity

The National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health, is soliciting applications for the HEAL Initiative: Whole Joint Health Program, a phased R61/R33 clinical trial research grant with an application due date of October 30, 2026. The program supports mechanistic clinical research on understudied biological mechanisms driving joint pain and requires a two-phase structure within a total project period not exceeding five years.

Eligible applicants include higher education institutions (public and private), 501(c)(3) and non-501(c)(3) nonprofits, for-profit organizations, small businesses, tribal governments (federally recognized and other), state and local governments, public or Indian housing authorities, independent school districts, and faith-based or community-based organizations. Non-U.S. entities and foreign components are not eligible to apply.

The R61 phase (2 to 3 years) requires hypothesis-driven mechanistic studies that measure whole joint mechanisms by integrating signals from at least one periarticular tissue (muscle, adipose, ligaments, tendons, or fascia) and their interactions with articular tissues (bone, synovium, cartilage) or the peripheral nervous system in clinical pain populations versus healthy controls. The R33 phase (2 to 3 years) tests non-pharmacologic or multimodal interventions directly targeting the identified mechanisms through rigorous clinical trials. Applications must specify quantitatively defined Go/No-Go transition criteria (such as Cohen's d > 0.5 or AUC/ROC > 0.7) to determine readiness for R33 advancement.

Budgets exceeding $500,000 annually for the R61 phase or $700,000 to $800,000 annually for the R33 phase require justification; no set funding cap applies. Applicants must register with SAM, obtain a Unique Entity Identifier, establish eRA Commons accounts, and register with Grants.gov prior to submission. A Data Management and Sharing Plan complying with HEAL public access and data sharing requirements is mandatory. Applications undergo two-stage peer review by scientific peer review groups and advisory councils, scored on significance and innovation (Factor 1), rigor and feasibility (Factor 2), and investigator expertise and resources (Factor 3). The program operates under Assistance Listing numbers 93.473, 93.213, 93.853, 93.273, 93.866, 93.846, 93.121, and 93.286, administered in partnership with the National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Biomedical Imaging and Bioengineering, National Institute of Neurological Disorders and Stroke, National Institute of Dental and Craniofacial Research, and the National Center for Complementary and Integrative Health.

Synopsis

The NIH Helping to End Addiction Long-term® (HEAL) Initiative is releasing this Notice of Funding Opportunity (NOFO) to support a phased mechanistic clinical research program focusing on understudied biological mechanisms that drive joint pain. The phased projects supported by this program (of up to five years total in duration) will first identify and validate multi-tissue mechanisms underlying joint pain, then test non-pharmacologic or multimodal interventions that directly target these mechanisms. The initiative responds to priorities identified in the 2023 HEAL Whole Joint Pain Workshop and supports the broader goals of the NIH HEAL Initiative and the Make America Healthy Again vision by advancing safe, non-addictive, and prevention-oriented approaches to chronic pain.

Eligibility

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Files

File Type Posted
PKG00294254.pdf PDF
PAR-27-045-Full-Announcement.html HTML file

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