Notice of Intent to Publish HEAL KIDS (Knowledge, Innovation and Discovery Studies): Chronic Pain Program (UC2 Clinical Trial Optional)

Key Dates

None

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

The National Institutes of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) with other NIH Institutes and Centers (ICs), intends to publish a new Notice of Funding Opportunity (NOFO) to solicit applications for multi-PI team-based, challenging, high impact projects to improve understanding of mechanisms of chronic pain in children and adolescents and to accelerate the development of age appropriate, patient/family centered prevention and therapeutic approaches. This research will seek to advance an integrated understanding of the biological, psychological, and social factors that contribute to pediatric chronic pain. NIH is interested in pain research in infants, children, and adolescents that includes those with intellectual and physical disabilities and/or those who experience health disparities (e.g., diverse race/ethnicity, sexual and gender minorities, socioeconomically disadvantaged, medically underserved communities, people with limited English proficiency). NIH encourages applicants to consider community-engaged research and interdisciplinary, collaborative applications to be developed in partnership with patient communities and/or community organizations where possible.  The long-term goal is to develop improved knowledge of specific pediatric pain conditions as well as pain associated with diverse diseases/disorders, to improve understanding of pain in the context of child development and to facilitate the stratification of patients with specific pain conditions and co-morbidities to accelerate chronic pain prevention and therapeutic clinical trials.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 

The NOFO is expected to be published in May 2024 with an expected application due date in Fall 2024.

This NOFO will utilize the UC2 Research Project Cooperative Agreements activity code. Details of the planned NOFO are provided below. 
 

This effort is part of the NIH HEAL (Helping to End Addiction Long-term ®) Initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment and prevention of opioid misuse and opioid use disorder and (2) enhance pain management. More information and periodic updates about the Initiative are available at: https://heal.nih.gov/.
Pain in infants, children, and adolescents is common, often under-recognized, inconsistently assessed or measured, and inadequately treated. Moreover, the relationship between pain and human development and any potential effects of repeated pain experiences on future pain and physical dependency remain largely understudied. The NIH HEAL Initiative recognizes the need to support emerging research opportunities of broad scope and complexity in pain that require innovative team science approaches. This concept, as part of a suite of NIH HEAL Initiative programs, represents a major new effort to enhance pain management in pediatric populations. The goal of HEAL KIDS (Knowledge, Innovation and Discovery Studies) Pain initiative is to advance the understanding, assessment, measurement, treatment, and prevention of pain in infants, children, and adolescents, including those with disabilities and/or experiencing health disparities. The infrastructure, resources and knowledge created through this initial effort will inform ongoing and future HEAL Pain projects and facilitate the inclusion of pediatric populations across the spectrum of HEAL funded research. 

Structure
The current HEAL KIDS Pain organizational structure includes two interrelated programs, each addressing a critical area of pediatric pain research.  The Acute Pain Clinical Trials (APT) Program will focus on supporting research to improve the assessment, management, and treatment of acute pain in pediatric patients through innovative clinical trials (RFA-HD-24-011). The Chronic Pain Collaborating Teams (CPT) Program will support team science research projects to advance understanding of mechanisms of chronic pain in children and adolescents. Both programs will use a common Resource and Data Center to provide clinical trial coordinating activities and to facilitate standardization, harmonization, and collaborative data analysis (RFA-HD-24-012).  The APT and the CPT studies will integrate relevant behavioral and social influences and contexts of pain experiences. These may include but are not limited to: inclusion of social, environmental and other influences on the incidence of pain, the perception and experience of pain, and the pain reporting. The impact on families and caregivers and how that relates to pain experiences and reporting should also be considered. Integration of behavioral and social sciences in pain research is critical to fully understanding pain experiences, addressing disparities, and developing effective interventions. The overall goal of this initiative is to advance pediatric pain research by providing a framework for synergies across acute pain clinical trials and chronic pain studies and facilitate understanding of acute to chronic pain transition.

The HEAL KIDS CPT program is intended to support team-based, cross-cutting research approaches that combine clinical research, novel/cutting edge technologies, and measurement science into one platform, which will enhance our understanding of primary and secondary chronic pain processing in children and adolescents. Furthermore, it will expand our capacity to pursue challenging problems in basic biological understanding, therapeutics development and effective management of pediatric pain conditions.

Effective and safe treatments and multidisciplinary strategies are needed for moderate to severe primary chronic pain as well as refractory chronic pain in children with chronic diseases. Improving pain management, mental health, and functioning, while eliminating risk of opioid dependence, would be a major advance for pediatric patients. Importantly, successful treatment and prevention of chronic pain in children would diminish the potential for persistence of these pain conditions into adulthood. The reduced need for opioids in children and adolescents would also reduce the potential for addiction or misuse later in life. 
This Notice encourages teams of investigators in multiple disciplines to pursue coordinated research that integrates diverse areas of expertise under one umbrella, including but not limited to:

• Pediatric clinical pain management
• Clinical pain research
• Preclinical/basic pain biology and modeling
• Human psychology
• Specific disease and/or pathological conditions 
• Artificial Intelligence
• Data science 
   

The research teams are expected to address a significant scientific challenge that requires collaboration, synergy, knowledge integration and team interactions. Teams are encouraged to consider transformative objectives and design projects that would lead to new, innovative, and improved strategies to enhance understanding of chronic pain mechanisms at the individual level, resolve heterogeneity in patient populations in relation to the pain experience in the context of chronic diseases and conditions, and generate and validate evidence for chronic pain patient stratification.  The work should aim to test powerful tools, models and approaches to accelerate the development and translation of pain condition-specific efficacious therapeutics, and next-generation clinical management of pain. 
Projects should be focused on a specific pain condition, including but not limited to primary chronic pain, painful neuropathy, musculoskeletal pain, headache, chemotherapy-induced neuropathy, eye pain, sickle-cell pain, post-surgical pain, cancer pain, visceral pain and gynecologic pain. Painful disorders of the orofacial region, pain co-occurring with substance-use disorders, and other conditions will also be considered. 

Examples of pediatric pain research in the context of the CPT program include, but are not limited to: 

• Exploring mechanisms of pain in children and adolescents, including studies to define the neurobiology of pain mechanisms in children and how they change with age, investigate the sex differences in pain mechanisms, and determine the effects of pain on the developing brain. 
• Identifying risk factors and underlying mechanisms that may predispose to chronic pediatric pain, including identification of early childhood factors that increase pain vulnerability and affect pain management. 
• Developing evidence for new approaches to preventing the acute to chronic pain transition in children and adolescents.
• Examining large-scale data resources and big data approaches to discover an array of multi-level factors (biologic, clinical, psychosocial, behavioral, cultural, social, structural) related to pediatric chronic pain, and new patterns and trends that may translate to novel, targeted interventions for pediatric chronic pain.
• Evaluating and clinically validating age-appropriate measures, tools, and technologies for the assessment of chronic pain across the continuum of care.
   

 Applicants are strongly encouraged to consult with NIH program staff as plans for an application are being developed.

Funding Information

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Rebecca Lenzi, Ph.D
National Institute of Arthritis and Musculoskeletal Diseases and Skin Diseases
301-480-7447

Yan Wang, M.D. Ph.D.
National Institute of Arthritis and Musculoskeletal Diseases and Skin Diseases
301-594-4957