HEAL Initiative: Understanding Individual Differences in Human Pain Conditions (R01 - Clinical Trial Optional)

The National Institutes of Health (NIH) has issued a Notice of Funding Opportunity (NOFO) under the HEAL Initiative titled "Understanding Individual Differences in Human Pain Conditions" (R01 - Clinical Trial Optional). This opportunity, spearheaded by multiple NIH components, aims to support research that explores the variations among individuals experiencing pain, with the ultimate goal of advancing personalized, evidence-based pain management strategies. Specifically, the program seeks to develop a "Whole Person Health" approach to pain treatment, taking into account biological, psychosocial, and environmental factors that contribute to pain sensitivity and response to treatments. Key research areas include understanding how factors like comorbid conditions, mental health, and substance use impact pain experiences and treatment outcomes. This NOFO encourages a multidisciplinary approach, supporting projects that combine clinical and/or preclinical data with innovative modeling techniques. Applicants are expected to gather data on inter-individual differences in pain as it relates to the use of pain management therapies, second pain conditions, comorbidities, and substance use or misuse. The research should aim to stratify pain experiences based on biological and biopsychosocial factors, which will aid in creating personalized pain management strategies. A critical component of this NOFO is the collection of comprehensive data to model and characterize these individual differences, providing a foundation for better-targeted treatments that reduce reliance on opioids and other high-risk pain management drugs. Eligible applicants include U.S.- and foreign-based higher education institutions, nonprofits, for-profit organizations, and government bodies. Awards are expected to be granted up to four projects, each receiving an annual budget up to $650,000 for a maximum project period of five years. Total funding availability is contingent on annual NIH appropriations, and each award is expected to contribute significantly to the HEAL Initiative’s overarching goal of mitigating the opioid crisis by developing safer and more effective pain management therapies. Applications must be submitted by February 6, 2025, via Grants.gov, and include a detailed project narrative, budget, and a Plan for Enhancing Diverse Perspectives (PEDP). The PEDP, a required attachment, should describe strategies for inclusivity in the project’s research team and subject recruitment. Applicants must use updated NIH application forms (FORMS-I) once they are available, and they must be registered with SAM.gov and eRA Commons well before the submission deadline to avoid delays. The NIH strongly encourages applicants to consult with HEAL Initiative staff at least six weeks prior to submission to ensure the proposed project aligns with the initiative's objectives. Applications will be reviewed based on scientific and technical merit, focusing on innovation, rigor, feasibility, and alignment with the NOFO’s goals. Emphasis will be placed on whether the project advances understanding of pain mechanisms across diverse populations and integrates rigorous modeling approaches to capture individual variability. NIH encourages the inclusion of data-sharing plans compliant with the HEAL Initiative’s Public Access and Data Sharing Policy, which mandates rapid sharing of data to maximize the impact of funded research. For additional support, applicants may attend the pre-submission webinars and submit queries to NIH program contacts. Following review, selected applicants will be notified, and awardees are expected to participate in an annual NIH HEAL Investigators Meeting to facilitate knowledge exchange and collaboration across the HEAL research community. Detailed guidance for submission, eligibility, and compliance is outlined in the full NOFO and associated NIH guidelines.