RFA-HD-24-012: HEAL Initiative: HEAL KIDS (Knowledge, Innovation and Discovery Studies) Pain Program Resource and Data Center (U24 Clinical Trial Not Allowed)
The National Institutes of Health (NIH) seeks applications for a single Resource and Data Center (RDC) to complement a broader HEAL program that is being developed to support the HEAL KIDS (Knowledge, Innovation, and Discovery Studies) Pain Program.
The HEAL KIDS Pain program will consist of interrelated programs addressing critical areas of pediatric pain research. The Acute Pain Clinical Trials program (APCT) is the first of these programs and will focus on supporting clinical trials that improve the knowledge of diagnosis, assessment, and treatment of acute pain in pediatric patients.
Key responsibilities of the HEAL KIDS Pain RDC include: (1) Providing logistical support and coordination for this broader research program; (2) Providing data collection, curation, and harmonization support for this broader research program leveraging relevant data standards; and (3) facilitating submission of data to HEAL-compliant data repositories and registering study level metadata with the HEAL Data Platform, in alignment with the HEAL Data Sharing Policy.
Acute Pain Clinical Trials Program
Applicants to this RDC NOFO are strongly encouraged to closely review the companion NOFO (RFA-HD-24-011) for the APCT Program to appreciate the collaborative nature of the full HEAL KIDS Pain program. As mentioned, the overall goal of the APCT program is to support innovative, groundbreaking, large-scale, multi-site clinical trials that seek to establish or implement systematic and/or multimodal approaches for the diagnosis, assessment, and adequate treatment of acute pain for pediatric patients across the continuum of care (including, but not limited to, pre-hospital settings, dental care facilities, outpatient clinic or urgent care, emergency departments, neonatal and pediatric intensive care units, and acute care/hospital facilities). The research conducted in the APCT program may include a broad range of research areas, research settings, and patient populations (from neonates to adolescents). Applications submitted in response to RFA-HD-24-011 are required to develop their proposed clinical trial that addresses an APCT priority area and include an organization in their application that will function as their Data Coordinating Center (DCC). Each clinical trial DCC will provide all data management and coordinating activities directly related to the clinical trial proposed. The DCCs and clinical trial sites will be expected to work collaboratively with the awarded HEAL KIDS Pain RDC to develop data standards and achieve the data integration and harmonization goals of the program. A detailed description of the DCC functions for the awarded clinical trials is described in the above referenced NOFO. NIH anticipates awarding up to 3-5 clinical trials to address gaps in pediatric acute pain research.
The responsibilities of the RDC include but are not limited to:
Products generated by awardees will become part of a shared resource intended to support infrastructure and maximize endeavors in the HEAL KIDS Pain program.
Specific functions of the awarded RDC are described below:
Data Curation Support
Administrative and Communications Hub
The RDC will serve as an administrative and communications hub for the HEAL KIDS Pain program. Specific functions related to the planned communications system are described below:
The NIH HEAL Initiative:
This NOFO is part of the NIH’s Helping to End Addiction Long-Term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at https://heal.nih.gov/.
In addition to scientific diversity, applicants should strive to incorporate diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences. Please refer to the Notice of NIH’s Interest in Diversity NOT-OD-20-031 for more details.
PI Meeting Attendance
The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative award recipients will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual NIH HEAL Investigators meeting, as well as other activities.
NIH requires that all projects funded under this NOFO will actively coordinate, collaborate, and share data with the other HEAL KIDS Pain program grantees, as allowed and appropriate.
Awardees will be expected to interact with other awardees of the HEAL KIDS Pain Initiative via NIH-sponsored workshops and meetings. Awardee project teams are expected to work interactively, sharing data, protocols, and tools within the HEAL KIDS Pain initiative and NIH HEAL Data Ecosystem (see details below) and, as rapidly as possible, with the broader scientific community.
See Section VIII. Other Information for award authorities and regulations.
HEAL funded researchers must make their HEAL data Findable, Accessible, Interoperable, and Reusable (FAIR) in line with the HEAL Data Sharing Policy and the broader efforts across NIH, as outlined in the NIH Strategic Plan for Data Science. The RDC will support investigators in meeting the following HEAL Data Sharing Policy requirements:
Coordination of Research Activities:
The various clinical trials proposed under the U01 mechanism will have the Resource and Data Center (U24) as the centralized home for coordinating data related activities across the HEAL kids Pain research program. The RDC will be primarily responsible for coordinating and/or facilitating scientific workgroups, convening subject matter expert panels and providing general infrastructure to facilitate scientific collaboration between all HEAL KIDS Pain program awardees. In order to do this, the RDC will be responsible for the establishment and management of an Executive Committee of all participating clinical trial and DCC PDs/PIs to facilitate communication and decision-making for the HEAL KIDS Pain program. It is also anticipated that the RDC will support programs to encourage continued scientific discussion to address the current needs/gaps in pediatric pain research. Anticipate at least (one) 1 facilitated meeting of all interested parties in the first year of award, in addition to one (1) other smaller NIH requested meetings per year as needed, and at least quarterly executive meetings.
Executive Committee:
The Executive Committee (EC) will create a document of guidance in overall project planning and project management, including: prioritization of activities; determining and reviewing study feasibility.
A representative from Each awardee in the HEAL Kids Pain Initiative will participate in an executive committee that will be established at the time of award. The representation for the EC include:
Institutions with Clinical and Translational Science Awards (CTSAs):
Applications from institutions that have a NIH Clinical and Translational Science Award (CTSA) must provide a letter of agreement from the CTSA PD/PI that identifies the level and type of support that will be provided for this grant, should it be awarded.
Pre-Application Technical Assistance Information:
An informational pre-application technical assistance webinar, addressing the scientific and administrative issues associated with this initiative, is anticipated. The purpose of this webinar will be to (1) familiarize potential applicants with established NIH guidelines and criteria for review, (2) discuss the areas of programmatic emphasis, and (3) facilitate the submission of a well-organized application.
Applicants interested in the pre-application technical assistance webinar should contact Perdita Taylor-Zapata ([email protected]) to request further details. Participation in the webinar is not required to submit an application in response to this NOFO. Individual consultation, separate from the pre-application webinar, is also available upon request and encouraged for all interested applicants.