Notice of Intent to Publish a Notice of Funding Opportunity for the HEAL Initiative: HEAL KIDS (Knowledge, Innovation and Discovery Studies) Pain Program Resource and Data Center (U24 Clinical Trial Not Allowed)

Key Dates

• May 25, 2023 - Notice of Intent to Publish a Notice of Funding Opportunity for the HEAL Initiative: KIDS Acute Pain Clinical Trials (APCT) Program (U01 Clinical Trial Required). See Notice NOT-HD-23-015.

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

As part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and participating NIH Institutes and Centers (ICs) intend to publish a Notice of Funding Opportunity (NOFO) to support research that aligns with one of the research goals of the NIH HEAL Initiative to support new clinical trial programs and the expansion of existing programs to evaluate innovative therapies for pain management. The HEAL KIDS (Knowledge, Innovation and Discovery Studies) Pain program will include interrelated programs addressing critical needs in pediatric pain research. This Notice of Intent to Publish announces plans to support the HEAL KIDS Pain Resource and Data Center (RDC) which will provide the following: leadership in data curation and data harmonization; leveraging relevant data standards; administrative and logistical support including oversight of NIH HEAL-related requirements; and coordination of shared research-related resources for the HEAL KIDS Pain research activities and HEAL-compliant data registries. 

 
NICHD intends to utilize a cooperative agreement activity code (U24) for this NOFO. The HEAL KIDS Pain RDC NOFO is anticipated to publish in Summer 2023 with an expected application due date in Fall 2023. Anticipated details of the planned HEAL KIDS Pain RDC NOFO are provided below.

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 and opioid pain management on future pain physical dependency remain largely understudied. Few guidelines related to the assessment, management, and effective treatment of acute pain in specific pediatric populations exist, mainly due to a lack of rigorous generalizable data to inform evidence-based practice guidelines. Integration of behavioral and social sciences in pain research is also critical to fully understanding pain experiences, addressing disparities, and developing effective interventions. The overall goal of the HEAL KIDS Pain program is to move the field of pediatric pain research forward, including fostering a team science approach to addressing knowledge gaps in pediatric pain research.  This Notice encourages investigators with the experience, knowledge, and skills needed to provide leadership in data collection and management, data curation, data harmonization, and development of data standards; administrative and logistical support including oversight of NIH HEAL-related requirements; and coordination of all shared research-related resources for the broader HEAL KIDS Pain research program to begin to consider applying for the NOFO.
 

The HEAL KIDS Pain RDC will be expected to work collaboratively with clinical trial sites and DCCs awarded through the Acute Pain Clinical Trials (APCT) program to leverage relevant data standards and achieve the data curation and harmonization goals of the program. Each clinical trial DCC will provide all data management and coordinating activities directly related to the clinical trial proposed. The proposed APCT trials may include the entire age spectrum of pediatric patients that experience acute pain and may include, but are not limited to, randomized controlled trials, comparative effectiveness, or pragmatic designs. 

Planned responsibilities of the RDC include but are not limited to: 

• Manage, curate, and harmonize clinical trial data collected via the awarded APCT U01 clinical trials and potential future programs for the ultimate purpose of data sharing in the NIH HEAL Data Ecosystem. Develop and/or recommend common data elements (CDEs); the development and/or recommendation of tools that facilitate the curation of data using relevant data standards; and the development of data formats. Provide administrative, logistical, coordination support, and communication for meetings, working groups, and other committees related to the HEAL KIDS Pain program and HEAL Initiative throughout the funding period of award(s).
• Liaise and coordinate the development, preparation, review, and implementation of an overall set of Standard Operating Procedures (SOPs) for the interaction of the HEAL KIDS Pain programs incorporating the relevant policies, procedures, and requirements of the Office for Human Research Protections (OHRP), the NIH, and HEAL.
• NIH requires that all projects funded under this NOFO to actively coordinate, collaborate, and share data with the other HEAL KIDS Pain program grantees, as allowed and appropriate.

This Notice is being provided for informational purposes to allow potential applicants additional time to develop responsive applications. NIH reserves the right to modify the scope and objectives as described in this Notice. Final scope, objectives, and requirements will be set forth in the published NOFO. 

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)
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Perdita Taylor-Zapata, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9584
Email: taylorpe@mail.nih.gov

Tammara L. Jenkins, MSN, RN, PCNS-BC, FCCM
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6837
Email: tjenkins@mail.nih.gov