Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

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.

Objectives

The 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 for the ultimate purpose of data sharing in the NIH HEAL Data Ecosystem. Examples of deliverables for the RDC include the development and/or recommendation of 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, such as Study Data Tabulation Models (SDTM) file data formats, for the submission of clinical trial data to relevant HEAL data ecosystems for future use and analysis.
• Oversee HEAL Data sharing through established NIH data repositories, study registration with the HEAL Data Platform, and other HEAL-related requirements for funded programs within the HEAL KIDS Pain program.
• 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).

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

• Administer and manage a data collection, retrieval, and storage system that will provide long-term sustained support for the HEAL KIDS Pain program. The collection, retrieval, and storage system will serve as a data curation tool that should be easily used by awardees for submission of data and should meet the necessary specifications for the overall HEAL Initiative and the HEAL KIDS Pain program.
• Day to day clinical data management for the APCT program will be the responsibility of each clinical trial's DCC. Each APCT U01 DCC, in conjunction with their partner clinical trial sites, will define and implement the best electronic data capture system for their proposed clinical trial. Each DCC will also be responsible for submitting all scientific data to the RDC for the purpose of data curation, harmonization, and meeting HEAL requirements. The RDC will work with the clinical trial staff and/or DCC staff, as appropriate, to promote data standardization, ensure data curation and harmonization with uniform collection of demographic, clinical, imaging, and biological data, as well as associated metadata, to the extent feasible. These harmonized datasets will enable future complex analyses of pediatric pain research as well as longer term follow/up of participants.
• Provide specifications for the use of all relevant data standards, including CDEs, across all HEAL KIDS Pain program studies. A CDE is applicable to multiple data sets across different sites and trials to improve data quality from multiple sources. If relevant CDEs have not been developed, the RDC and APCT PDs/PIs may collaborate with NIH staff to develop them and facilitate coordination with HEAL CDE Program Managers as needed (http://www.heal.nih.gov/data/common-data-elements). To maximize the usability of data, the RDC Awardee will be expected to work with the clinical trials program at the beginning of protocol development to utilize appropriate data standards in the definition and coding of data elements.
• Employ informatics and electronic data technologies and expertise to design and produce an electronic system that can be used by all sites conducting clinical trials that may be part of the HEAL KIDS Pain program. Such systems may need to be modified and re-designed as appropriate for new study protocols.
• Oversee HEAL data sharing requirements through facilitating submission of all HEAL KIDS Pain program data to HEAL-compliant data repositories and registering study level metadata, code, and associated documentation with the HEAL Data Platform, in alignment with the HEAL Data Sharing Policy, the NIH Data Management and Sharing (DMS) Policy, and the DMS Plans associated with each clinical trial. See the following website for more information on the NIH HEAL data ecosystem: https://heal.nih.gov/data/heal-data-ecosystem.
  • All clinical trial data should be submitted to the NICHD Data and Specimen Hub (DASH), unless otherwise specified by NIH. The NICHD DASH is a HEAL-approved data repository. See https://dash.nichd.nih.gov/resource/submission for information about DASH data submission processes.
  • Large-scale human genetic data should be shared through the National Center for Biotechnology Information (NCBI's) database of Genotypes and Phenotypes (dbGaP) and Sequence Read Archive (SRA), as appropriate.
• Work with the DCCs to ensure that the appropriate Institutional Certifications and/or other documentation is obtained specifying data may be shared through these data repositories.

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:

• Website Development - The RDC is expected to create and maintain a HEAL KIDS Pain program website that includes public-facing pages about the program and supported trials, as well as private/investigator-only pages to facilitate program communications and collaborations.
• Establish a communications system to support electronic communication linkages across the HEAL KIDS Pain program. This system should allow for teleconferences, meetings, webinars, working group collaborations, and other forms of electronic communication both within and across the HEAL KIDS Pain programs. The communication linkages must be reliable, secure, and support sending correspondence and sharing data files securely.
• Provide online resources for communication and support for generating password-protected current reports accessible to the HEAL KIDS Pain program staff.
• Provide logistical and hosting support for annual meetings between awardees, as well as other NIH-requested in-person, virtual, or hybrid meetings, including technical support, meeting facilitation, and meeting minutes/summaries for distribution. These meetings will provide a forum to discuss (1) research updates; (2) shared research resources; and (3) opportunities for synergy and collaboration (e.g., data standards, harmonization, and protocol modifications) with HEAL KIDS Pain program awardees and the RDC. Anticipate at least 1 (one) annual investigators' meeting per year, in addition to one (1) other smaller NIH requested meeting.
• Coordinate and/or facilitate scientific workgroups, convene subject-matter expert panels and provide other general infrastructure to facilitate scientific collaboration between all HEAL KIDS Pain program awardees, including 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 in the first year of award, in addition to one (1) other smaller NIH requested meetings per year as needed, and routine executive meetings (anticipating at least three) per year.
• In conjunction with Data Curation Support efforts, facilitate harmonization of CDEs and any data collection and standardization procedures across HEAL KIDS Pain program awardees by serving as lead and interface with the HEAL CDE Program Director in service of this goal. It is anticipated that this data harmonization process would occur during a kick-off meeting and conclude within the first year of the grant award. Awardees funded under the APCT U01 are expected to harmonize data collection on acute pain data elements (inclusive of HEAL CDEs) and outcomes whenever possible. Whenever appropriate, HEAL KIDS Pain program awardees are also expected to harmonize data with other relevant data standards. In addition, the RDC will work collaboratively with the HEAL KIDS Pain program to harmonize pain assessment and measurement tools in protocols and set data standards to maximize and facilitate future combined data analysis and use by the research community.
• Serve as a liaison to coordinate the development, preparation, review, and implementation of an overall set of Standard Operating Procedures (SOPs) for incorporating the relevant policies, procedures, and requirements of the HHS Office for Human Research Protections (OHRP), the NIH, and the HEAL Initiative. The SOPs must detail relationships, tasks, and responsibilities and the flow of data between the clinical site DCCs and the RDC.
• Provide other research support activities, as needed, such as assisting in the design of data collection modules, operational procedure manuals, and review of quality control systems.

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/.

Diversity

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:

• Selecting a HEAL compliant repository for long-term data storage.
• Registering your HEAL study in the HEAL Data Platform.
• Submitting metadata to the HEAL Data Platform.
• Using HEAL core Common Data Elements (CDEs) for pain studies.
• To the extent possible, HEAL awardees should be using broad consent language.

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:

• PI and/or Co-PI from each of the clinical trials awarded as U01 awards
• PI and/or Co-PI from the related DCCs for the clinical trials
• PI and/or Co-PI for the U24 Resource and Data Center award
• Project Manager from the U24 RDC award
• NICHD Project Scientists for the U01 and U24 awards

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 (taylorpe@mail.nih.gov) 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.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD(s)/PI(s) (or Multi-PDs/PIs) should be an experienced investigator and capable of providing both administrative and scientific leadership to the development and implementation of the proposed activities. The PD(s)/PI(s) should have a strong track record coordinating and administrating large and collaborative projects and datasets, and demonstrated experience in effectively communicating, messaging, and disseminating various resources and information to stakeholders. Experience and/or expertise in large scale, multisite pediatric clinical trials and the unique aspects of conducting research in the pediatric population is preferred.

Applicants should document the PD/PI's (and as relevant, additional senior/key personnel's) experience in 1) coordinating and administrating large and collaborative projects and datasets, and 2) effectively communicating, messaging, and disseminating various resources and information to stakeholders.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Tammara Jenkins, MSN, RN, PCNS-BC
Telephone: 301-435-6837
Email: tjenkins@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Facilities and Other Resources:?Describe the facilities and resources available for the coordination of a multi-site clinical trial as a Resource and Data Center, including any project management tools that will be used. Describe how the infrastructure at the Resource and Data Center will facilitate the efficient operation of the proposed multi-site clinical trials awarded under RFA-HD-24-011. If applicable, discuss any community participatory agreements and/or stakeholder agreements to support the protocol.

Other Attachments: The application must include the following documents, uploaded as separate pdf files.

Attachment 1. Resource and Data Center Experience

The filename "Resource and Data Center Experience.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers.

Applicants must provide information in a feasible format with characteristics of trials/studies that clearly demonstrate experience of proposed key personnel in the design, conduct, data analysis, and management of clinical research projects within the past five years.

The information should include:

A: clinical study?title
B: applicant's role in the study
C: a brief description of the study?
D: number of sites
E: whether the study?was completed on schedule or not
F: publication reference(s)

Attachment 2. Special Strengths
The filename "Special Strenghts.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers.

Provide a summary of the RDC’s special strengths as a pdf attachment. Applicants are encouraged to describe special or unique strengths that may be relevant to the HEAL initiative and the HEAL KIDS Pain program. This may include, but is not limited to, state-of-the art scientific capabilities that may be available for the HEAL KIDS Pain program, additional clinical research expertise (e.g., genomic, proteomic, pharmacokinetic, or pharmacodynamic statistical analysis) that could be drawn upon on an as-needed basis, as well as any research resources they have established at their institution.

Special administrative and logistical support strengths or experience related to clinical trial research (e.g., single institutional review boards, data and safety monitoring boards, advisory boards for clinical research, clinical research committees, community engagement groups, etc.) may also be highlighted, including level and support of clinical research.

Attachment 3. HEAL Public Access and Data Sharing Policy

NIH Intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing and immediate access to publications (https://heal.nih.gov/about/public-access-data). Guidelines for complying with the HEAL Public Access and Data Sharing Policy can be found at https://heal.nih.gov/data/complying-heal-data-sharing-policy. Resources and tools to assist with data related activities can be found at https://www.healdatafair.org/. For more detail and specific data sharing requirements, see Section 4. Other plans.

Publications resulting from NIH HEAL Initiative funded studies must be immediately publicly available upon publication.

• For manuscripts published in journals that are not immediately open access, authors should arrange with journals in advance to pay for immediate open access
• Costs to ensure manuscripts are immediately publicly available upon publication should be included in budget requests

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

The PD/PI of the RDC must be experienced in the coordination and management of data management of multi-center clinical trials, including success in meeting and supporting milestones and timelines. The unique strengths, accomplishments, experience, and capabilities to contribute to shared activities across multiple funded projects, with some background in data curation and harmonization efforts and programming assessments must be provided for each PD/PI and all Key Personnel. Applicants should also describe experience in seeking input from multiple stakeholders, including experience with approaches to seek expert opinions. Roles and responsibilities must be well-defined. The RDC will require a multidisciplinary team, including but not limited to, PD/PI (or Multi-PDs/PIs), Statisticians, Programmers, Project Managers, Project Assistants, Logistics, and Support staff. Previous experience and/or scientific expertise in informatics and managing the unique aspects of conducting pediatric research is preferred for Senior/Key Persons on the RDC team. Previous experience with managing HEAL data ecosystems requirements is also preferred but not required.

The application should reflect the team's hands-on involvement in RDC functions, including project management of complex protocols in various stages of development and implementation, coordination, tracking, logistics and administration, communications, data management (including quality control), data security and IT infrastructure (including development of public and secure study websites), input on data collection and data curation of APCT clinical trials, and possible analytical support for report generation through the study website. A Data Curation Manager must also be part of the RDC team. This individual will be designated to oversee data curation and harmonization across all data types expected from the project. Additionally, a Project Manager should be designated to liaison/coordinate with the U01 clinical trial DCC Program Managers to facilitate harmonization activities as well as team communication. All Key Personnel must provide an NIH Biosketch whether or not they are budgeted.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Application budgets must plan for the following:

• The RDC base budget must not exceed $600,000 in direct costs for any given year.

The following items must be included in the project budget:

• Electronic Data Curation System software site training, certifications, and/or licensing, as needed.
• Arrangement of logistical services for HEAL and HEAL KIDS Pain program-specific meetings
• Project Manager to serve as liaison to the APCT clinical trials teams.
• Travel to two APCT program meetings and/or HEAL meetings per year; travel to two additional meetings or workshops within the six -year award period.
• Support for the activities of the HEAL KIDS Pain program committees, (e.g., DSMBs or Steering or Executive) as requested, through provision of materials/documentation support, meeting planning and logistics and conference call/webinar coordination
• Other costs (itemized and justified)

The awarded RDC's facilities and administrative (F&A) rates on the initial competitive award will not be increased in future years due to changes in their negotiated rate agreements.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Concisely describe how the Resource and Data Center will coordinate and manage the activities of the HEAL KIDS Pain programs, coordinate interaction among the different programs and investigators, and contribute to standardization and harmonization of the HEAL KIDS Pain program datasets to further the scientific interests of the programs.

Research Strategy: The responsibilities of the RDC are varied. Each of the responsibilities described in "Section I. Funding Opportunity Description: 1. Research Objectives is relevant to the overall performance of the HEAL KIDS Pain program RDC, NIH HEAL-related data requirements, and HEAL KIDS Pain program activities.

Demonstrate expertise in the following responsibilities and describe in detail how the RDC will meet these responsibilities:

• Administer and manage a system (i.e., data collection, storage, and curation system) that will support the standardization and harmonization of clinical trials data in the HEAL KIDS Pain programs.
• Provide leadership, overall management, communication, collaboration, and primary oversight of data curation and harmonization.
• Assist HEAL KIDS Pain program awardees with the preparation of all data in accordance with NICHD DASH and other relevant data repository requirements, the HEAL Data Sharing Policy, and the NIH Data Management and Sharing (DMS) Policy, and the DMS Plans associated with each clinical trial and/or other relevant HEAL KIDS Pain program
• Submit curated clinical trials and other relevant program data and associated documentation to NICHD's DASH and other relevant HEAL compliant data repositories, register studies with the HEAL Data Platform, and support the broader program with data collection and management resources, as needed.
• Facilitate data harmonization using relevant data standards including common data elements (CDEs) and any data collection procedures across APCT awardees, including harmonizing data collection on acute pain data elements (inclusive of HEAL CDEs) and outcomes whenever possible.
• Other relevant data standards include Clinical Data Interchange Standards Consortium (CDISC), data classes, data elements, and associated vocabulary standards specified in the United States Core Data for Interoperability (USCDI) standards, as they are applicable (NOT-OD-20-146), common data models such as OMOP, and HL7 FHIR (Fast Healthcare Interoperability Resources) standard (NOT-OD-19-122) for exchange of EHR-based datasets.
• Collaborate with the HEAL KIDS Pain program investigators to harmonize pain assessment and measurement tools in protocols and set data standards to maximize and facilitate combined data analysis and use by the research community.
• Facilitate the extraction and transformation of data as collected by the clinical sites awarded under RFA-HD-24-011 and other HEAL KIDS Pain program activities into an data sets suitable for data processing, curation, harmonization, and submission to established data repositories for sharing with the public.
• Support system training and implementation for all HEAL KIDS Pain program investigators and research staff, as appropriate, to ensure data harmonization with uniform collection of demographic, clinical, imaging, and biological data, as well as associated metadata, to the extent feasible.
• Provide research support activities as needed, such as designing data collection modules, operational procedure manuals, quality control systems, and an internet-based communications system for HEAL KIDS Pain program investigators and staff.
• Create and maintain a HEAL KIDS Pain program website that includes both public-facing pages about the program and supported trials as well as private/investigator-only pages to facilitate program communications.
• Establish a reliable, secure communications system to support electronic communication linkages both across and within the HEAL KIDS Pain program.
• Coordinate the development, preparation, review, and implementation of an overall set of SOPs for the interaction of the HEAL KIDS Pain program, incorporating the relevant policies, procedures, and requirements of the Office for Human Research Protections (OHRP), the NIH, and the HEAL Initiative. The SOPs must detail relationships, tasks, and responsibilities and the flow of data between the APCT clinical site DCCs and the RDC.
• Serve as a liaison between HEAL KIDS Pain program awardees to harmonize data collection when appropriate.
• Provide logistical support for annual meetings, workshops, executive committee meetings, and outreach activities to the external community regarding HEAL KIDS Pain studies, as needed.
• Coordinate workgroups, committees, and expert panels and provide other general infrastructure to support collaboration between HEAL KIDS Pain program awardees.
• Propose and implement an Executive Committee that will work collaboratively with clinical sites awarded under RFA-HD-24-011 and subsequent DCC investigators to promote collaboration and communication that is effective in advancing the research goals of the HEAL KIDS clinical trials program.
• Oversee HEAL data sharing through established data repositories, study registration with the HEAL Data Platform, and other HEAL-related requirements for funded programs within the HEAL KIDS Pain program.

Letters of Support: Because this program requires a high degree of collaboration to be successful, departmental and institutional commitments to participate in the HEAL KIDS Pain program of research should be clearly documented. Provide letters of support from appropriate individuals at the applicant site detailing:

• Institutional support in areas of grants management, personnel provision, space allocation, procurement, IT infrastructure, as well as general logistical support of the research program. Evidence of previous experience in the unique needs of conducting pediatric research, as well as evidence of past support can be cited.
• Clearly expressed intent to:
  • Participate in a cooperative and collaborative manner with the HEAL KIDS Pain program investigators and research staff, DCC staff, and NIH staff, as needed, in all aspects of research as outlined in this NOFO.
  • Prioritize HEAL KIDS Pain program research, including committing to safeguard staff time for the satisfactory conduct of the related work.
  • Comply with HEAL and HEAL KIDS Pain program Data Management and Sharing Plans, policies and requirements as outlined in this NOFO and as determined by the program investigators
  • Keep confidential and do not disclose any confidential or proprietary information when working with program investigators and/or industry partners, other than outlined by HEAL KIDS Pain program developed policies and HEAL requirements.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

The HEAL Initiative has additional requirements that must be addressed in the Data Management and Sharing Plan (DMSP). All HEAL-generated data must be shared through the HEAL Initiative Data Ecosystem following HEAL’s compliance guidance (https://heal.nih.gov/data/complying-heal-data-sharing-policy). Specifically, HEAL applicants must include:

• Plans to submit data and metadata (and code, if applicable) to a HEAL-Compliant data repository (https://www.healdatafair.org/resources/guidance/selection) and follow requirements of the selected repository
• Plans to register your study with the HEAL platform within one year of award (https://heal.github.io/platform-documentation/study-registration/)
• Plans to submit HEAL-defined study-level metadata within one year of award (https://github.com/HEAL/heal-metadata-schemas/blob/main/for-investigators-how-to/study-level-metadata-fields/study-metadata-schema-for-humans.pdf) and https://heal.github.io/platform-documentation/slmd_submission/).
• HEAL pain clinical studies must include plan to use HEAL core Common Data Elements (https://heal.nih.gov/data/common-data-elements). HEAL Initiative clinical studies that are using copyrighted questionaries are required to obtain licenses for use prior to initiating data collection. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials.
• To the extent possible, all other (non-pain) HEAL studies conducting clinical trials or research involving human subjects are expected to use questionnaires by the HEAL Clinical Data Elements (CDE) Program (https://heal.nih.gov/data/common-data-elements) if applicable and relevant to their research.
• Studies using CDEs, regardless of whether they are part of the HEAL repository, will be required to report which questionnaires are being used.
• To the extent possible, HEAL awardees are expected to integrate broad data sharing consent language into their informed consent forms.

HEAL has developed additional details and resources to fulfill these requirement (https://www.healdatafair.org/resources/road-map).

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned to the appropriate NIH Institute (IC) or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Compliance with data management and sharing policies.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

Recipients of this initiative will be expected to interact with recipients of the HEAL KIDS Pain initiatives within HEAL via NIH-sponsored workshops and meetings.

The PD(s)/PI(s) will have the primary responsibility for:

• Design and execution of the Data curation system and plan for the U01 Acute Clinical Trials Program, supervision of personnel, interaction with subcontracted Data Coordinating Center and clinical site PIs, grants management officials, DCC, RDC, and the NIH.
• Assuming responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research supported under this NOFO in accordance with the terms and conditions of award, as well as all pertinent laws, regulations, and policies.
• Assuring their staff will maintain confidentiality of the information as developed by the clinical trials project team, including, but not limited to, study protocols, data analysis, conclusions, etc.
• Curating and/or publicly releasing and disseminating results, data and other products of the study in a timely manner, concordant with the approved plan for making quality-assured data and materials available to the scientific community and the NIH, consistent with NIH policies and achieving the goals of the NOFO.
• Collection and transmission of data to and from the DCC, and ensuring required data is submitted to the HEAL KIDS Pain RDC.
• Participating in a cooperative and interactive manner with members of the clinical trial project team, the HEAL KIDS Pain program team, the NIH HEAL Initiative, and the designated NIH staff (e.g., Program Officer(s) and Project Scientist(s)).
• Sharing data, materials, models, methods, information, and unique research resources that are generated by the project in concordance with NIH HEAL policies in order to facilitate progress.
• Complying with the processes and goals as delineated with the NOFO.
• Upon completion or termination of the research project, the recipients are expected to make all study materials and procedures broadly available (e.g., in the public domain) or making them accessible to the research community according to the NIH-approved plan submitted for each project, for making data and materials available to the scientific community and the NIH for the conduct of research.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

A Clinical Trial Protocol Steering Committee (SC) may be formed (in consultation with the NIH Program Officer (PO) under the U01 Acute Clinical Trials Program, depending on the number of clinical sites involved). The purpose of the SC will be to achieve the goals of the team, to establish publication and dispute resolution policies, and common protocols.

Similarly, a HEAL KIDS Pain Executive Committee (EC) may be formed by the RDC (in consultation with the NIH Program Officer). The purpose of the EC will be to achieve the goals of the data harmonization, to establish SOPs for decision making and communication amongst the U01 recipients and the RDC.

• The EC composition will be created in consultation with the NIH PO but generally will be composed of the PD(s)/PI(s) of the U01 and U24 awarded applications, a core of clinical site study coordinators, the RDC Project Manager or PI, as well as designated NIH staff. It is expected that most decisions on the activities of the EC will be reached by consensus, however, if a vote is required, the voting procedures will be outlined in consultation with the NIH PO.
• The U01 recipient will be responsible for accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the EC and any related subcommittees.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NIH Project Scientist(s) will provide technical assistance to the clinical trial protocol team. Specifically, the NIH Project Scientist will:

• Liaise with the NIH Project Officer and communication of progress and difficulties
• The NIH will name additional scientific consultants as necessary from within the NIH whose function will be to assist the Project Scientist(s) and protocol team in carrying out the goals and aims of the approved study. The NIH will have one vote (if voting body) regardless of the number of NIH personnel involved
• Have substantial scientific programmatic involvement in quality control, preparation of publications, research coordination and performance monitoring. The Project Scientist(s) will have the same access and privileges to any data generated by the grantee. The dominant role and primary responsibility for these activities resides with the recipients for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the recipients and the Project Scientist(s).
• Serve as a resource with respect to other ongoing NIH activities that may be relevant to the protocol to facilitate compatibility and avoid unnecessary duplication of effort.
• Serve as a voting member of the HEAL KIDS PAIN Executive Committee. The U01 Project Scientist will serve as a non-voting member of the committee, as only one NIH vote is allowed, regardless of the number of NIH personnel involved.
• Review procedures for assessing data quality and monitor study performance
• Serve as a co-author on study publications. In general, to warrant co-authorship, the NIH staff must have contributed to one or more of the following areas: (a) design of the interventions being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results; and (d) preparation and authorship of pertinent manuscripts.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• All parties will agree to work collaboratively in all activities of the HEAL KIDS Pain program, throughout the course of the award period.
• Participating in protocol-related meetings, and all HEAL KIDS Pain program, and NIH HEAL Initiative investigator meetings and other required meetings.
• The Steering Committee, if required, will be the governing body of the study. The Steering Committee chair will be selected by the steering committee via vote.
• The NIH Project Scientist will be a voting member of the Steering Committee. The Program Officer(s) and other members of the project team will be non-voting participants.
• The NIH Project Scientist may serve on the Executive Committee, as will the Project Scientist for the U24; however, only one will be the NIH voting member on the Executive Committee.
• The SC may, as it deems necessary, invite additional, non-voting scientific consultants to meetings at which research priorities and opportunities are discussed. The NIH reserves the right to augment the expertise of the SC when necessary.
• All responsibilities are divided between recipients and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

HEAL Data Sharing Requirements

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing.? All HEAL Initiative award recipients, regardless of the amount of direct costs requested for any one year, are required to comply with the HEAL Public Access and Data Sharing Policy. HEAL award recipients must follow all requirements and timelines developed through the HEAL Initiative Data Ecosystem (https://heal.nih.gov/about/heal-data-ecosystem), as described in HEAL’s compliance guidance:

1. Select a HEAL Compliant data repository (https://www.healdatafair.org/resources/guidance/selection)

• Data generated by HEAL Initiative-funded projects must be submitted to study-appropriate, HEAL-compliant data repositories to ensure the data is accessible via the HEAL Initiative Data Ecosystem.
• Some repositories require use of specific data dictionaries or structured data elements, so knowing your repository’s requirements up front can help reduce the burden of preparing data for submission.
• HEAL-funded recipients must follow requirements for selected repository.

2. Within one year of award, register your study with the HEAL platform

• This process will connect the Platform to information about your study and data, including metadata, and identify the selected repository. HEAL requests initial submission within one year of award, with annual updates, and to be updated in accordance with any release of study data.

3. Within one year of award, submit HEAL-specific study-level metadata.

• Some of the required study-level metadata (https://github.com/HEAL/heal-metadata-schemas/blob/main/for-investigators-how-to/study-level-metadata-fields/study-metadata-schema-for-humans.pdf) will be auto-populated as part of the registration process.

4. Submit data and metadata (and code, if applicable) to HEAL-Compliant repository

• At the completion of the study and/or when prepared to make the final data deposits in the repositor(ies) of choice, ensure your study registration (https://heal.github.io/platform-documentation/study-registration/) is complete.
• The NIH HEAL Initiative expects data used in publications to be submitted to repositories at the time of or prior to publication, and no later than the end of the project period.

5. Additional Requirements for HEAL Initiative studies conducting clinical research or research involving human subjects.

These studies must meet the following additional requirements:

• HEAL Initiative trials that are required to register in clinicaltrials.gov should reference support from and inclusion in the HEAL Initiative by including the standardized terms the HEAL Initiative (https://heal.nih.gov/) in the Study Description Section.
• All new HEAL clinical pain studies are required to use core questionnaires required by the HEAL Clinical Data Elements (CDE) Program (https://heal.nih.gov/data/common-data-elements). Outside of the core questionnaires, studies should select questionnaires from among the repository of supplemental questionnaires that are already being used by other HEAL clinical pain studies. The program has created the CDE files containing standardized variable names, responses, coding, and other information for all of these questionnaires The program has also formatted the case-report forms in a standardized way that is compliant with accessibility standards under Section 508 of the Rehabilitation Act of 1973 (29 U.S.C 794 (d); https://www.govinfo.gov/content/pkg/USCODE-2011-title29/html/USCODE-2011-title29-chap16-subchapV-sec794d.html ) which require[s] Federal agencies to make their electronic and information technology accessible to people with disabilities.
  • Studies that wish to use questionnaires not already included in the HEAL CDE repository should consult with their program official and the HEAL CDE team. New questionnaires will be considered for inclusion in the repository on a case-by-case basis and only when appropriate justification is provided.
  • HEAL Initiative clinical studies that are using copyrighted questionnaires are required to obtain licenses for use prior to initiating data collection. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials. For additional information, visit the HEAL CDE Program website listed above. To the extent possible, all other (non-pain) HEAL studies conducting clinical trials or research involving human subject are expected to use questionnaires by the HEAL Clinical Data Elements (CDE) Program (https://heal.nih.gov/data/common-data-elements) if applicable and relevant to their research.
  • To the extent possible, HEAL recipients are expected to integrate broad data sharing consent language into their informed consent forms.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Report and ensure immediate public access to HEAL-funded publications

Publications resulting from NIH HEAL Initiative funded studies must be immediately publicly available upon publication. ?

• For manuscripts published in journals that are not immediately open access,?authors should arrange with journals in advance to pay for immediate open access
• Costs to ensure manuscripts are immediately publicly available upon publication should be included in budget requests?

Prior to publication, HEAL expects investigators to alert their program officers of upcoming manuscripts to ensure coordination of communication and outreach efforts.

Award recipients and their collaborators are required to acknowledge HEAL Initiative support by referencing in the acknowledgement sections of any relevant publication:

This research was supported by the National Institutes of Health through the NIH HEAL Initiative (https://heal.nih.gov/) under award number [include specific grant/contract/award number; with NIH grant number(s) in this format: R01GM987654]. ?

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

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 Jenkins, MSN, RN, PCNS-BC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 240-461-7952
Email: tjenkins@mail.nih.gov

Wendy Weber, N.D., Ph.D., M.P.H.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-402-1272
Email: weberwj@mail.nih.gov

Mark Egli, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-594-6382
E-mail: megli@mail.nih.gov

William P Tonkins, Dr. PH, J.D.
NHLBI - NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Phone: 301-594-4979
E-mail: william.tonkins@nih.gov

Rebecca Hommer, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-827-2257
Email:rebecca.hommer@nih.gov

Dena Fischer, DDS, MSD, MS
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: (301) 594-4876
E-mail: dena.fischer@nih.gov

Karen A. Kehl, PhD, RN
National Institute of Nursing Research
Telephone: 301-594-8010
Email: karen.kehl@nih.gov

Rebecca Lenzi, PhD
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: (301) 402-2446
E-mail: rebecca.lenzi@nih.gov

Devon Oskvig, Ph.D.
National Institute on Aging (NIA)
Phone: (301) 496-9350
E-mail: devon.oskvig@nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Barbara Hodgkins
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-5306
Email: barb.hodgkins@nih.gov

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: judy.fox@nih.gov

Nina Hall
NHLBI - NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Phone: 301-435-0710
E-mail: hallnn@mail.nih.gov

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email:ChiefGrantsManagementOfficer@ninds.nih.gov

Diana Rutberg, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: (301) 594-4798
E-mail: dr258t@nih.gov

Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: osterk@mail.nih.gov

Sarisa Kowl
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-1921
E-mail: kowls@mail.nih.gov

Kathleen Moy
National Institute on Aging (NIA)
Phone: 301.827.2856
E-mail: kathleen.moy@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.