Part 1. Overview Information

Key Dates

The dates in bold and italics reflect changes per NOT-OD-24-094

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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose/Research Objectives

The purpose of this Notice of Funding Opportunity (NOFO), issued by the Office of the Director (OD), National Institutes of Health (NIH), is to invite applications from entities/institutions in Institutional Development Award (IDeA)?eligible states to participate in Environmental influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network (ISPCTN) as the Data Coordinating and Operations Center (DCOC). This NOFO runs in parallel with companion NOFO (RFA-OD-24-008) that will solicit applications for clinical sites within IDeA states. The DCOC and the Clinical Sites together will form the ECHO ISPCTN, a research network that will conduct pediatric multicenter clinical trials as part of the ECHO Program and engage in team science to implement solution-oriented research.

The ECHO ISPCTN is the intervention component of the ECHO Program and supports its overall mission to enhance the health of children for generations to come. Through the rigorous use of appropriate scientific methodology, and by and by recruiting and retaining sufficient participants for studies that require a multicenter pediatric clinical trial design, the ECHO ISPCTN aims to provide answers to relevant research questions more robustly and rapidly than any one site could do alone. The ECHO ISPCTN itself will be primarily responsible for initiating and conducting pediatric clinical trials, although it may also collaborate with other NIH research networks or non-network subject matter experts. The award will support approximately five pediatric clinical trials related to prevention or treatment of at least two of the 5 outcome areas of the ECHO Program: pre-, peri-, and postnatal outcomes; obesity; upper and lower airways; neurodevelopment; and positive health.

The ECHO ISPCTN Data Coordinating and Operations Center is the central site that provides biostatistical expertise for study design, data coordination and technical support, conducts quality control of clinical trials, and offers operational coordination for the ECHO ISPCTN. The Data Coordinating and Operations Center will support the ECHO ISPCTN Clinical Sites to

• Develop and conduct pediatric multicenter clinical trials, assuring the participation of children living in rural or underserved communities located in Institutional Development Award (IDeA) states
• Build pediatric clinical trial network capacity in IDeA states funded by the ECHO ISPCTN.
• Engage interested parties such as community members, nonprofit organizations, and professional societies to enhance ECHO ISPCTN clinical trial impact, transferability, rigor, and feasibility

Background 

Congress authorized the IDeA Program in 1993 to broaden the geographic distribution of NIH funding for biomedical and behavioral research. The program aims to enhance the competitiveness for research funding of institutions located in 23 states and the Commonwealth of Puerto Rico in which the aggregate success rate for grant applications to NIH has historically been low. Hence, the NIH designed this program to serve the health research needs of the rural or underserved populations in these states and to expand and strengthen research teams to compete successfully for NIH funding.

In 2016, the NIH established the Environmental influences on Child Health Outcomes IDeA States Pediatric Clinical Trials Network (ECHO ISPCTN) to provide access to state-of-the-art clinical trials for rural or underserved children living in IDeA states. Through the IDeA Program, the NIH aimed to leverage the resources that it had developed in these states in clinical and translational research and bridge a gap by providing these children and families access to clinical trials to enhance their health.

The ECHO ISPCTN is the only NIH pediatric clinical trials network with a specific focus on rural or underserved populations, populations of great prevalence in IDeA states. Children living in rural or underserved communities experience worse outcomes on many health indicators than their counterparts. Health inequities in rural or underserved areas may result from suboptimal socioeconomic and ecological conditions, including limited access to health care and other community and familial resources.

Children in IDeA states are under-represented in clinical trials. Improved access to state-of-the-art clinical trials helps answer important questions that result in health benefits for this population. The ECHO ISPCTN is uniquely positioned to identify targeted solutions to address the health issues of rural or underserved children by conducting clinical trials and disseminating the findings that can enhance the health of children. Through this approach, the ECHO ISPCTN bridges an important gap in pediatric health research.

This NOFO builds on the success of the first two cycles of the ECHO ISPCTN (RFA-OD-16-001, RFA-OD-16-002, RFA-OD-19-025, and RFA-OD-19-026) which developed research infrastructure and pediatric clinical trials expertise in IDeA states and conducted clinical trials, assuring the participation of rural or underserved children in ECHO ISPCTN clinical trials.

Network Structure

The overall framework of the ISPCTN will consist of dedicated pediatric clinical trial teams at participating ECHO ISPCTN Clinical Sites and a central Data Coordinating and Operations Center (DCOC) to provide comprehensive support of the network.

Clinical Sites
Each ISPCTN Clinical Site will support a team of one to two Principal Investigators, one to two early-stage investigators, and a full-time equivalent research coordinator. ECHO ISPCTN Clinical Sites will propose, develop, and conduct ECHO ISPCTN multicenter pediatric clinical trials; build capacity in their early-stage investigators and research staff to engage in high quality, rigorous multicenter trials; and engage interested parties such as community members, nonprofit organizations, and professional societies to ensure that network trials are informed by their priorities, needs, and capacities. The multicenter trials proposed by clinical sites should be related to the prevention or treatment of conditions in the 5 ECHO outcome areas: pre-, peri-, and postnatal outcomes; obesity; upper and lower airways; neurodevelopment; and positive health.  Applicants are encouraged to leverage resources and facilities supported by other NIH programs, such as the IDeA Program-Infrastructure for Clinical and Translational Research (IDeA-CTR) and the Clinical and Translational Science Award (CTSA) Program.

Partner Institutions
To enhance research expertise and potential to build capacity to include needed expertise on multicenter clinical trial proposals, ECHO ISPCTN Clinical Site and DCOC applicants may propose collaborations. Applicants may consider collaborating with other components or investigators within their own state or in other IDeA or non-IDeA states. The NIH will support a minimum of 75% of total costs to institutions within IDeA states.

Data Coordinating and Operations Center (for information only)
The ECHO ISPCTN Data Coordinating and Operations Center (DCOC) will provide support for research projects initiated by the ECHO ISPCTN Clinical Sites. Some examples of the services the DCOC will provide include but are not limited to the following. 

A. Support for Clinical Trials Development, Implementation and Dissemination

The DCOC will assist writing teams in developing protocols for multicenter clinical trials that relate to the five ECHO child health focus areas among children from rural or underserved backgrounds. While the DCOC will advise investigators, all major study design and budgetary decisions will be determined by the protocol chair(s), the leadership committee, and the program office, facilitated by the DCOC. Responsibilities include, but are not limited to

• Protocol Development
  
  • Establishing processes for clinical site protocol development with Steering Committee review
  • Assisting investigators with performing study feasibility assessments
  • Developing sampling strategies and advising on study design
  • Performing biostatistical analyses including sample size estimates and trial data analysis
  • Developing statistical analysis plans
• Regulatory
  • Providing regulatory sponsorship of clinical trials conducted under an investigational new drug (IND) or investigational device exemption (IDE)
  • Establishing processes for tracking studies and changes/approvals by the ECHO ISPCTN Protocol Review Committee, Data and Safety Monitoring Board (DSMB) and single institutional review board (IRB)
  • Developing a well-defined reporting process for adverse events (AEs) and unanticipated problems (as defined by OHRP) in compliance with local IRB requirements, 21 CFR 312.32 for Investigational New Drugs (IND), and 21 CRF 812.150 for Investigational Device Exemptions (IDE)
  • Documenting and following procedures for handling protocol deviations/violations
  • Implementing a plan to report safety analyses and AEs to the Data and Safety Monitoring Board (DSMB) in a format that highlights trends or signals
• Budgetary
  • Assisting investigators to develop study budgets
  • Overseeing and coordinating multicenter clinical trials including establishing subcontracts with participating clinical sites and disbursing trial-specific funds to sites
  • Monitoring and reporting study fund distributions and outstanding invoices to the program office
• Data Management
  • Establishing systems for data management and quality assurance
  • Monitoring and reporting study progress, participant safety, and adverse events to the program office and regulatory bodies
  • Monitoring and reporting participant study accrual, retention, and diversity to the program office and Steering Committee
  • Ensuring data completeness and fidelity to each study protocol
  • Performing clinical site visits as needed upon pre-approval of the program office
• Supporting investigators’ dissemination of study results

B. Clinical Trial Capacity Building 

The DCOC is responsible for providing systematic, core curricula for ECHO ISPCTN investigators of all levels and for research coordinators. The curricula will be focused on pediatric, multicenter clinical trial design, implementation, and publication, as well as the principles of Good Clinical Practice consistent with Food and Drug Administration ICH GCP E6 standards, and not more broadly on general research skills or academic advancement. The DCOC may use a variety of formats to ensure broad access to the curriculum including didactic lectures, workshops, enduring materials, or other interactive approaches to suit diverse learning styles. The DCOC will partner with existing, experienced clinical trial education providers to leverage expertise and resources whenever possible to reduce production costs and ensure network researchers are exposed to high quality content. The DCOC will monitor uptake of the curricula and adjust the dissemination strategy as necessary to ensure widespread participation among network investigators and research coordinators.

C. Engagement of Communities of Potential Participants and Other Interested Parties 

The DCOC will support clinical sites in engaging interested parties such as community members, nonprofit organizations, and professional societies to strengthen and enhance ECHO ISPCTN clinical trials research at the development, implementation, and dissemination phases. For instance, to assist investigators in identifying areas of research need, the DCOC may recommend foremost, external scientists to provide keynote addresses at ECHO ISPCTN investigator meetings. To help investigators identify participant-centered recruitment and retention plans, and preferences for return of individual study results, the DCOC may organize virtual or face-to-face engagement of individuals from the community of potential participants.

The DCOC will also support the dissemination of aggregate research products to lay, scientific, and medical communities by developing a communication plan for interested parties to learn of and access selected clinical trial-related information such as protocols, scientific publications, and lay study summaries. The communication plan will include press releases, newsletters, social media posts, and an ISPCTN-specific website linked to the existing ECHO Program website (echochildren.org). In support of scientific publications, the DCOC will establish, document, and follow processes for manuscripts and presentations tracking, preparation, review, communication, and submission that will apply to all network-funded studies. The DCOC will create reports and summaries for the ECHO ISPCTN Data and Safety Monitoring Board (DSMB), Protocol Review Committee (PRC) Steering Committee, Leadership Committee, and NIH.

As per NIH policy on public access (NIH Public Access Policy Details | Public Access), the DCOC will Report clinical trial results, data analysis plans, and an English-language informed consent document to the ClinicalTrials.gov database for every ECHO ISPCTN-funded study. Also, to satisfy NIH policies on data sharing (NOT-OD-21-013: Final NIH Policy for Data Management and Sharing), the DCOC will prepare and provide de-identified research data sets and biological specimens, if appropriate, to data repositories for public and controlled access on behalf of the network.

D. Administrative and Operational Support for Governance and Oversight Bodies

ECHO ISPCTN clinical trial conduct and overall functioning relies on the work of committees, work groups and task forces comprising network investigators and research coordinators, as well as external oversight bodies. (See Section VI. Award Administration Information, 2. Administrative and National Policy Requirements, Cooperative Agreement Terms and Conditions of Award for more details on network governance and oversight). The DCOC will provide logistical support to these groups to carry out their vital functions. Examples of logistical support that the DCOC will provide include scheduling and hosting virtual and in-person meetings, setting and distributing meeting agendas and minutes, preparing and submitting documents for review by regulatory and oversight bodies, and handling travel arrangements for oversight bodies to attend in-person meetings as needed.

The ECHO ISPCTN develops goals, objectives, indicators, and targets (GOIT) for the network in accordance with the overarching aims of the program. These GOIT are created, reviewed, and revised by the Steering Committee with input from the program office on an annual basis. The program office will establish consortium-level operational objectives related to 1) clinical trial concept development, 2) study implementation (including project timelines to start of enrollment and study participant accrual and retention), 3) data collection, completeness, and usability, and 4) publication and dissemination of ECHO ISPCTN study results. The DCOC will provide a dashboard to report progress of the network overall and for each clinical site toward attainment of GOIT milestones so that the network can adjust as needed.

Governance and Oversight
The ECHO ISPCTN governance will include a Leadership Committee consisting of a DCOC representative, NIH representative, and approximately five clinical site representatives to bi-directionally engage with clinical sites via “pods.” It will also include a Steering Committee with a representative from each award and NIH, and its work groups, subgroups, and task forces, as needed. This governance structure will share accountability for establishing, monitoring, and evaluating the achievement of ECHO ISPCTN goals, which include 

• Developing, conducting, and disseminating results from multicenter clinical trials research for children living in rural or underserved communities in IDeA states
• Building pediatric clinical trial capacity in IDeA States 
• Engaging interested parties such as community members, nonprofit organizations, and professional societies to enhance ECHO ISPCTN clinical trial impact, transferability, rigor, and feasibility.

For clinical trial oversight, the ECHO Program Office will convene an independent protocol review committee and an independent Data and Safety Monitoring Board for the network. For all study protocols, the ECHO ISPCTN will designate a single institutional review board (sIRB) for all study sites to streamline IRB protocol approval while maintaining participant safety and protection of human subjects oversight. (See Section VI. Award Administration Information, 2. Administrative and National Policy Requirements, Cooperative Agreement Terms and Conditions of Award for more details on network governance and oversight.)

ECHO ISPCTN Clinical Trials

The ECHO ISPCTN will develop, complete, and disseminate findings from approximately five multicenter clinical trials during this funding period. Each multicenter clinical trial must be focused on one or more of the five ECHO outcome areas, and over all five multicenter trials, at least two of the five outcome areas should be represented. The five ECHO outcome areas are pre-, peri-, and postnatal outcomes; obesity; upper and lower airways; neurodevelopment; and positive health.

Ongoing or completed trials that the ECHO ISPCTN initiated in the prior funding cycle include

• Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool (MoVeUP) (NCT05386355)
• Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters (BREATHE) (NCT05615870)

The following are examples of other research topics that demonstrate the breadth of possible study questions that could be suitable for the ECHO ISPCTN to investigate in future multicenter trials

• To what extent can use of telehealth for subspecialist follow-up appointments improve neurodevelopmental outcomes among premature infants in rural areas?
• To what extent can participation in culturally tailored behavior-change programs for families reduce childhood obesity?
• To what extent can participation in social media literacy programs enhance children’s mental health and well-being?
• To what extent can melatonin improve toddlers’ sleep hygiene and self-regulation?
• To what extent can use of devices to monitor airway obstruction in primary care offices improve the diagnosis of pediatric asthma?

The ECHO ISPCTN is particularly interested in studies conducted in the primary care setting.

Plan for Enhancing Diverse Perspectives

 The NIH  recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse 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 populations participate in and benefit from research, and enhancing public trust.

To support the best science, the NIH encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to the following

• Transdisciplinary research projects and collaborations among researchers, including those from fields such as computational biology, physics, engineering, mathematics, computer and data sciences, as well as bioethics.
• Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Individual applications and partnerships that enhance geographic and regional heterogeneity.
• Investigators and teams composed of researchers at different career stages
• Participation of individuals from diverse backgrounds, including groups historically underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women
• Opportunities to enhance the research environment to benefit early- and mid-career investigators. 

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310, submitted as Other Project Information as an attachment (see Section IV).

Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Only institutions or organizations in the following IDeA-eligible states/commonwealth are eligible to respond to this NOFO

• Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, and Wyoming.

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• 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 How to Apply Application Guide.

To be eligible for an award through this announcement, NIH invites any Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) from an IDeA-eligible state with the skills, knowledge, and resources necessary to carry out the proposed research to work with their organization to develop and submit an application for support. 

The primary institution must be in an IDeA state. PD(s)/PI(s) for the DCOC must have appropriate expertise and capability in biostatistics, data management, informatics, data analysis, project management, along with strong skills and experience in the design, execution, and analysis of pediatric clinical trials research.  Applicants are encouraged to include expertise in pediatric multicenter clinical trial research.

At a minimum, the DCOC PD(s)/PI(s) and staff must be prepared to cooperate effectively in all network functions with the NIH and the clinical sites. The PD(s)/PI(s) must have prior experience operating a data coordinating center in multicenter studies in the previous five years. Together, the DCOC PD(s)/PI(s) and staff should have the following minimum qualifications in terms of experience and expertise

• Planning, developing, and implementing pediatric studies, adhering to the special requirements which provide additional protections for children involved in human subjects research.
• Using a broad range of clinical trial study designs and statistical methods including pragmatic clinical trial methods.
• Designing data collection systems for distributed data entry and designing and implementing data quality control systems.
• Providing project management with knowledge of workflow and research team practices in implementation of clinical trials, including use of clinical trial management systems.
• Carrying out the management, oversight, and analysis of several concurrent studies.
• Working with a variety of interested parties including research participants and families, clinical practitioners, researchers, research informatics and technical personnel, and research organizations on workflows.
• Providing regulatory sponsorship of clinical trials conducted under an investigational new drug (IND) or investigational device exemption (IDE).
• Formal training in survey design and psychometrics is desirable.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

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).

An organization may participate as a lead organization in only one application submitted to this NOFO for the same due date.

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:

Lisa Steele, PhD
Chief, Epidemiology and Population Health Branch
Division of Aids, Behavioral and Population Sciences (DABP)
Center for Scientific Review, NIH
Phone: 301-257-2638
Email: lisa.steele@nih.gov

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed, with the following exception.

 For this specific NOFO, the Research Strategy section of the application is limited to 30 pages.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply Application Guide must be followed, with the exception of the following additional instructions (see Other Attachments).

Facilities and Other Resources
Applicants should describe facilities and other resources that may be relevant to research by the ECHO ISPCTN. Applicants can consider describing core support for trial research activities such as investigational new drug and device (IND/IDE) applications, research compliance, survey design and data management, single institutional review board (IRB) review for multicenter studies, and community engagement. Applicants can also consider describing access to relevant software programs such as for clinical trial management, data management, and remote collaboration and work management.

Plan for Enhancing Diverse Perspectives
In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The Plan for Enhancing Diverse Perspectives should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with the required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The Plan for Enhancing Diverse Perspectives may be no more than 1 page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the Plan for Enhancing Diverse Perspectives can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based)
• Description of any planned partnerships that may enhance geographic and regional diversity
• Plan to enhance recruiting of women and individuals from groups historically  under-represented in the biomedical, behavioral, and clinical research workforce
• Proposed monitoring activities to identify and measure Plan for Enhancing Diverse Perspectives  progress benchmarks
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s)
• Publication plan that enumerates planned manuscripts and proposed lead authorship
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

SF424(R&R) Senior/Key Person Profile

All instructions in the Ho to Apply Application Guide must be followed.

A biographical sketch should be included for all key personnel. The biographical sketch of the PD(s)/PI(s) should reflect their strengths, leadership, administrative skills, and scientific expertise. The applicant must demonstrate expertise in biostatistics, data management, data analysis, data quality assurance and project management in multicenter research.

PD(s)/PI(s) must describe prior experience in support of the design, conduct, analysis, result dissemination, and management of major collaborative multicenter clinical trials, preferably among children, and provide evidence of successful performance as a coordinating center for multicenter studies within the past five years. Further, applicants need to show evidence of experience monitoring trials, including the ability to generate monthly reports of participant enrollment and follow up in a multicenter setting, and safety reports for review by a data safety and monitoring board. The applicant should describe contributions in key areas of research development and design, data collection and analysis, monitoring of trial progress, and publication of trial results, and relate them to the proposed DCOC structure and function.

Previous experience in pediatric clinical research studies and studies conducted under Food and Drug Administration Investigational New Drug/Investigational Device Exemptions is strongly preferred. Applicants should provide evidence of knowledge of federal participant privacy and data confidentiality requirements and appropriate experience in ensuring that relevant mechanisms and procedures for human subjects protections are in place.

In addition, the applicant should highlight special administrative strengths or experience. This experience may include administrative service on clinical research regulatory, oversight, or advisory bodies (e.g., institutional review boards, data safety and monitoring boards, clinical research advisory boards, and clinical research committees) for the PD(s)/PI(s) and other senior/key persons.

If the PD(s)/PI(s) or other senior/key persons have substantial experience with recruitment and retention of diverse childhood populations, they should summarize them in their biosketch.

R&R Budget

All instructions in the How to Apply Application Guide must be followed.

The award provides allowances for the following types of costs:

Core Infrastructure Costs.

Applicants may budget up to $1,750,000 per year in direct costs for the following

• Salary and fringe benefits for the time and effort for PD(s)/PI(s)' commitment to the network—minimum of 6 person months overall for PD(s)/PI(s) for each of the five award years.
• Administration and coordination of general network operations.
• Project management, monitoring, and reporting to support clinical trial protocol development, implementation, and results dissemination.
• Biostatistical support of network trials.
• Clinical trials curriculum development and implementation among ECHO ISPCTN investigators and staff.
• Communications strategy to interested parties outside of the ECHO ISPCTN to learn of network activities.

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement under the Grants Policy Statement section 7).

Protocol-Specific Costs

Applicants should budget $3,500,000 per year in direct costs for protocol-specific capitation fees for distribution to the ECHO ISPCTN Clinical Sites to conduct clinical trials. These funds are reserved exclusively to reimburse clinical sites to conduct trials, and not for DCOC administrative, project management, or biostatistical costs to support specific trial protocols since these are considered by the NIH program office to be core infrastructure functions.

Items that may NOT be supported with award funds include

• Direct support of the laboratories and other facilities, salaries, fringe benefits, travel, and research projects that are not directly associated with or necessary for ECHO ISPCTN programmatic work.
• Patient care costs such as inpatient hospitalizations, outpatient visits, and laboratory or radiographic tests, unless exclusively for the purposes of implementing an NIH-approved ECHO ISPCTN protocol.
• Salary and support for central institutional administrative personnel (e.g., budget officers, grant assistants, and building maintenance personnel), which are usually paid from institutional overhead charges unless the conditions in Section 7.4 of the NIH Grants Policy Statement are met.
• Salary and support for administrative activities such as institutional public relations or health and educational services.

R&R Subaward Budget

All instructions in the How to Apply Application Guide must be followed.

NIH encourages partnerships with NIH-funded research programs (e.g., Center for Translational Research and Center for Translational Science Award) or other clinical trial support programs within the site's own state, another IDeA state, or a non-IDeA state to strengthen the following aspects of the DCOC’s performance: clinical trial project management, monitoring, and reporting, regulatory sponsorship of clinical trials conducted under investigational new drug or investigational device exemptions, biostatistics, and clinical trial curriculum development. If partnerships with institutions outside IDeA states are part of the proposed budget, a minimum of 75% of total costs must be awarded to institutions within IDeA states.

PHS 398 Cover Page Supplement

All instructions in the How to Apply Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply Application Guide must be followed, with the following additional instructions:

Applicants are not required to propose a clinical trial. Please follow the headings and subheadings outlined in this section, to ensure that all requested information is included and to streamline the study section review process.

If this is a renewal, a progress report is required within the research plan. In the progress report, describe participation and contribution to the ECHO ISPCTN in detail including in key areas of research development and design, participant recruitment and retention efforts, and data collection and analysis. List the total number of ECHO ISPCTN studies coordinated by the DCOC and number of participating sites for each study in the prior cycle. For each of these studies, list the time from: 1) single institutional review board (IRB) submission to approval, 2) single IRB approval to first participant enrolled, and 3) single IRB approval of English language materials to approval of Spanish versions. In addition, list the total number of training sessions developed and conducted by the DCOC that focused specifically on clinical trials, format for the sessions, and average number of attendees per session (median plus interquartile range).

Support Clinical Sites in Clinical Trials 
Describe plans for collaborating with ECHO ISPCTN Project Scientists to support clinical site investigators through the lifecycle of multiple simultaneous multicenter clinical trials. Specify how the applicant will support protocol chairs in key areas of study startup including development of trial concept proposals, protocols, feasibility assessments, and budgets, and preparing regulatory applications, study administrative documents, and databases. Also describe processes for fulfilling the trial coordination responsibilities of a DCOC including implementing and cataloguing standard operating procedures, activating clinical sites, meeting regulatory requirements, managing investigational products, creating data management plans, conducting study monitoring, and performing study closeout. Describe the types of clinical trial management and data collection systems and procedures that the applicant will use.

Explain a strategy to facilitate DCOC communications with protocol chairs, the NIH program office, the ECHO ISPCTN Leadership and Steering Committees, and the clinical sites participating in trials at all stages of a clinical trial’s lifecycle. The protocols-specific communications plan should describe how the applicant will maintain current and accurate email distribution lists by ECHO ISPCTN trial and by study role, arrange meetings and videoconferences, and leverage collaboration software tools.  

Describe plans for protocol-specific training and retraining of investigators and research staff at the clinical sites participating in any given ECHO ISPCTN clinical trial. As part of this plan, propose processes for communicating about and disseminating to sites initial and updated versions of study documents. Plans should involve use of the secure, network-only area the ECHO ISPCTN website that the DCOC will develop and maintain. Applicants must include plans for training sessions for scientific protocol implementation and for annual recertifications of study teams. Applicants must also propose a process for the DCOC to ensure clinical sites maintain up-to-date delegation of authority logs, that the DCOC and NIH are made aware of changes to the delegation of authority logs, and that study team members at clinical sites who join a trial after site activation are adequately trained on the protocol and receive additional DCOC support and monitoring during the transition period to ensure ongoing human subjects protections and maintenance of data quality.

Describe plans for acting in clinical trials as the sponsor or co-sponsor of Food and Drug Administration (FDA) Investigational New Drug or Investigational Device Exemption applications, collaborating with study principal investigators, and the NIH to provide data and documentation for FDA reporting.

Propose an approach to the financial management of clinical trials, including development of study- specific budgets that include subcontracts with clinical sites to enable transfer of capitation funds from the DCOC to the sites. Because contracting can delay study start up significantly, applicants must specify whether the applicant institution allows master agreements with clinical sites such that participation in each new ECHO ISPCTN trial by a clinical site requires only a budget modification to the master agreement or whether a study-specific subcontract must be executed for each trial. Also propose processes for efficiently processing invoices submitted by clinical sites for timely reimbursement of achievement of trial milestones. The approach must include plans for how the DCOC will provide a quarterly report of protocol fund distributions and outstanding invoices for review by the NIH and ECHO ISPCTN Steering Committee.

Quality Data Management
Propose a general process for data management of ECHO ISPCTN trials, from data collection, including how data will be entered, transferred, and stored securely, to analysis and de-identification for sharing in public-use datasets. Describe software and hardware systems that might be used and the quality control, validation, privacy/security, limited access, and backup features of these systems to protect study participant data and network resources. Describe systematic quality assurance strategies to prevent errors and continuous quality control practices that the applicant might use to identify and correct data errors in real-time.

Describe plans to organize and conduct both onsite and virtual monitoring of research studies in coordination with and preapproval of the NIH Program Official. Describe what actions the DCOC will take to improve processes if monitoring identifies deficiencies at a particular clinical site and how learnings will be shared with all ECHO ISPCTN clinical sites in the spirit of collaborative learning.

Explain general procedures that the DCOC will follow for conducting interim analyses for study safety and efficacy and reporting these to the data safety monitoring board at regular intervals, as well as for monitoring and time-sensitive reporting of serious adverse events to appropriate oversight and regulatory bodies.
 
Clinical Trial Capacity Building
Describe plans to provide professional development opportunities to ECHO ISPCTN DCOC and clinical site investigators and research coordinators for building a cadre of professionals within the network to perform multicenter pediatric clinical trials. Propose a structure and content for a Clinical Trial Skills Development Core to enhance knowledge and assure performance of clinical site investigators and staff on core, multicenter clinical trial skills. Appropriate training topics include but not limited to

• Principles of Good Clinical Practice
• Articulating a clinical trial research question based on a research gap analysis and potential health impact for children
• Justifying the need for a multicenter trial to meet study objectives based on supportive pilot data
• Identifying appropriate outcomes and endpoints, and how to measure them
• Assessing the feasibility of a proposed trial
• Designing an intervention and assessing fidelity to the intervention
• Additional clinical trial design elements including sample size determination, blinding, randomization, stopping rules and interim analyses
• Recruitment and retention techniques and contingency plans for potential delays
• Best practices for study conduct, including standard operating procedures and data quality management plans
• Creating capitated budgets including identifying appropriate performance-based milestones
• Data analysis approaches and trade offs
• Ethical considerations

Additional topics are possible, but all must be directly applicable to the design, conduct, analysis, or dissemination of pediatric, multicenter clinical trials within the ECHO ISPCTN, and not more broadly on developing general research skills, mentorship, or career advancement.

Propose a process for training clinical site investigators and personnel potentially including didactic and interactive sessions, as well as enduring videos, and practical tools. Applicants are strongly encouraged to partner with existing, experienced clinical trial education providers (e.g. Centers for Translational Research or Centers for Translational Science Awards) to leverage existing expertise and resources whenever possible to reduce production costs and ensure network researchers are exposed to high quality content. Describe how the applicant will conduct ongoing evaluation of the reach and effectiveness of the Clinical Trial Skills Development Core and adjust as needed.

Engagement of Interested Parties 
Describe a plan for developing general processes to facilitate clinical site investigators’ interaction with interested parties such as community members, nonprofit organizations, and professional societies to enhance ECHO ISPCTN clinical trial impact, transferability, rigor, and feasibility. Describe the process to develop comprehensive communications in English and Spanish. The plan could include

• Identifying and inviting researchers with promising pilot data to present their findings to clinical site investigators.
• Providing logistical and technical support for protocol chairs to convene community advisory boards of individuals from potential sample populations to enhance research accessibility and meaningfulness to participants, such as to understand preferences for the return of individual research results, or to enhance approaches to recruitment and retention.
• Developing and implementing a communication plan that includes maintaining an ECHO ISPCTN website with a restricted-access area for network researchers only and public area for anyone to access up-to-date information concerning ECHO ISPCTN clinical trials (e.g., trial protocols; trial progress, and recent publications). The DCOC-hosted ECHO ISPCTN website should link to the ECHO Program website (echochildren.org) and present content in a manner consistent with the ECHO Program style guide. 
• Providing the organizational structure for protocol chairs to create lay summaries of studies upon their publication in scientific journals, and disseminating lay summaries to relevant professional, advocacy, and community organizations.
• Collaborating with protocol chairs to develop materials for the return of individual participants’ research results as applicable.

Staffing Plan
Describe staffing plans for supporting day-to-day functioning of the network. The DCOC will provide input to protocol chairs throughout the lifecycle of all ECHO ISPCTN studies, understanding that major study design decisions will be determined by the protocol chairs and the ECHO ISPCTN Leadership Committee with input from the NIH project scientists. Describe plans for staffing DCOC functions from clinical trial design through dissemination. Describe how the applicant will build in flexibility in staffing to be able to respond to changing needs and variation in work effort based on the stage of ECHO ISPCTN trials at any given time. For instance, as some trials start and others close, the DCOC staffing needs will need to flex to meet network deadlines and to support multiple protocols at a time.

Administrative Responsibilities and Management 
Propose plans for managing and administering the DCOC. The DCOC must estimate appropriate and reasonable resources for individual studies before they begin and then manage those resources efficiently throughout a study’s lifecycle. Describe how the applicant will meet formal timelines for deliverables (e.g., site activation, publications and presentations, and study reports to the program office as well as oversight and regulatory bodies).

Propose an operational structure for providing and coordinating all DCOC functions for several ECHO ISPCTN protocols simultaneously (including lines of responsibility/authority for DCOC staff) and an administrative and management structure that supports and enhances the operational structure.

Logistical and Other Support Services
Describe plans to provide logistical and support services to the ECHO ISPCTN, including for planning and hosting in-person Network Face-to-Face Meetings (up to three per year) supplemented by additional virtual Steering Committee meetings, in-person Leadership Committee meetings (up to two per year) supplemented by additional virtual meetings, in-person and virtual Protocol Review Committee meetings, in-person and virtual Data Safety and Monitoring Board meetings, webinars, and other meetings as needed by the ECHO ISPCTN. This plan should include a description of management plans for soliciting input on and distributing meeting agendas, drafting and distributing meeting minutes, and following up on meeting action items. The plan should also describe how the applicant will handle travel arrangements for Protocol Review Committee members and the Data Safety and Monitoring Board members and invited lecturers.

Explain how the applicant will provide infrastructure and support for ongoing communication of ECHO ISPCTN activities via email and teleconference. Plans for logistical and support services should also include coordinating sample storage and managing investigational product.

Reporting
Describe plans for generating interval summary reports on participant enrollment, retention, and diversity both in aggregate and for each clinical site at meaningful, actionable intervals during protocol implementation. Explain how the applicant will provide these reports at least monthly for each ongoing trial for review by the program office and Steering and Leadership Committees. Explain how the applicant will provide additional progress reports to the program office and the Steering and Leadership Committees including at least monthly reports on study start-up timelines and milestones prior to protocol implementation and at least quarterly reports on protocol capitated fund distributions to clinical sites during protocol implementation.

Letters of Support
Applicants must provide letter(s) from the appropriate senior institutional officials (at or above the level of Dean, Vice President for Research, or equivalent) from the lead institution and partner institutions that

• Commit the institution to the ECHO ISPCTN goals, indicating that the program will be integral to their broad vision of clinical research.
• Define the position, authority, and reporting responsibility of the PD/PI(s) on the institution's organizational chart.
• Define the authority or influence that the PD/PI(s) will have overuse of facilities and space, as well as decision-making authority over hiring and approving of new faculty and support personnel.
• Guarantee the release time for faculty and salary support for research coordinators and ancillary personnel, as specified in the application budget.
• Define the financial and other resource support the applicant institution will provide. There are no dollar requirements, but specific commitment is required. Some examples include financial support and provision of research space and equipment. The letter writer can summarize specific commitments in a table. NIH encourages co-funding or matching funds from other sources (including industry) if these funds do not limit faculty research, communications, and implementation of ECHO ISPCTN studies, and if there are methods in place to ensure transparency, management of conflicts of interest, and prevent misuse of federal funds, and PD(s)/PI(s) can ensure that there will be no violation of NIH policies with respect to sharing of data and resources, academic freedom, and publication rights.

Include letters of support from partnering institutions or outside collaborators with statement of roles and responsibilities. If the PD(s)/PI(s) intend to leverage the research support of another NIH-funded center (e.g., Center for Translational Research and Center for Translational Science Award), include a letter of support from the center indicating the center's role in supporting the applicant's goals for clinical trial activities.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the  How to Apply 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 How to Apply 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.
• In addressing a Data Management and Sharing Plan, all applicants should state their agreement with the following centralized process. On behalf of the network, for each ECHO ISPCTN study, the Data Coordinating and Operations Center will upload the de-identified data to the NICHD Data and Specimen Hub (DASH), a controlled-access, public use database, in accordance with the NIH Data Management Sharing Policy.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply 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 How to Apply 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 How to Apply Application Guide must be followed.

See Section 2 - Study Population Characteristics

2.9: Inclusion Enrollment Report(s)

The ECHO ISPCTN Data Coordinating and Operations Center will provide Inclusion Enrollment Reports to the NIH and reports to ClinicalTrials.gov for network studies on behalf of all participating clinical sites.

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 How to Apply Application Guide must be followed.

Applicants should note a Justification for Delayed Onset Studies such as, "The ECHO ISPCTN has not yet determined which clinical trials it will conduct during the funding period that begins in June 2025. Therefore, human subjects study information is not available at this time."

PHS Assignment Request Form

All instructions in the How to Apply Application Guide must be followed.

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

See Part 2. 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. 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 How to Apply – 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply 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 How to Apply 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 the NIH ECHO Program Office. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications must include annual milestones. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

In order to expedite review, applicants are requested to notify the Center for Scientific Review by email at lisa.steele@nih.gov when the application has been submitted. Please include the FON and title, PD/PI name, and title of the application.

Pre-application Information Session
NIH anticipates hosting an informational pre-application session, addressing the scientific and administrative issues associated with this initiative, around one month prior to the Letter of Intent due date. The purpose of this information session is to (1) familiarize the potential applicant with established NIH guidelines and criteria for review, (2) discuss the areas of NIH programmatic emphasis, and (3) facilitate the submission of a well-organized application.
 

Post Submission Materials

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

Any instructions provided here are in addition to the instructions 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.

For this particular NOFO, note the following:

Applicants are NOT required or expected to include a research plan for a clinical trial.

The ECHO ISPCTN aims to build capacity of research teams located in IDeA states to develop, conduct, and disseminate results from pediatric, multicenter, clinical trials, thereby enhancing access to state-of-the-art clinical trials for children from rural or underserved areas living in IDeA states. By engaging in ECHO ISPCTN trials, research teams will gain experience to augment and strengthen the clinical research capacity of IDeA states overall. Investigators from IDeA states may or may not have extensive prior clinical trial experience or track records of publications and funding comparable to more experienced investigators.
 

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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, in accordance with NIH peer review policies and practices, 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 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 NIH Council of Councils. 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.

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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:

• Federalwide 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.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

HHS recognizes that NIH 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.

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 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 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.

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

• Supporting trial development and implementation: Establishing processes for clinical site protocol development with steering committee review, assisting with study feasibility assessments, advising on sampling strategies and statistical analysis plans, performing all biostatistical analyses; and maintaining a restricted-access researcher portal to house ECHO ISPCTN standard operating procedures and study-specific documents.
• Regulatory: Providing regulatory sponsorship of clinical trials conducted under an investigational new drug (IND) or investigational device exemption (IDE); establishing processes for tracking studies and recommendations of the Protocol Review Committee, Data and Safety Monitoring Board (DSMB) and single Institutional Review Board (IRB); developing a well-defined process for monitoring and reporting adverse event and unanticipated problems that is in compliance with local IRB requirements, 21 CFR 312.32 for INDs, and 21 CRF 812.150 for IDEs, as applicable; and documenting and following procedures for handling protocol deviations.
• Budgetary: Assisting investigators with the development of study budgets, establishing subcontracts with participating clinical sites to disburse trial-specific funds; and monitoring and reporting study fund distributions and outstanding invoices to the ECHO ISPCTN program office.
• Data management: Establishing systems for data management and quality assurance; monitoring and reporting participant accrual, retention, and diversity to the program office and steering committee; ensuring data completeness and fidelity to the study protocol; and performing clinical site visits as needed upon preapproval of the program office.
• Supporting results dissemination: Developing a communication plan for interested parties to learn of and access selected clinical trial-related information (such as protocols, scientific publications, and lay study summaries) including press releases, newsletters, social media posts, and an ISPCTN website linked to the existing ECHO website (echochildren.org); and establishing processes for scholarly output tracking, preparation, review, communication, and submission.
• Clinical trial capacity building: Providing systematic core curricula for ECHO ISPCTN investigators of all levels and for research coordinators focused on pediatric multicenter clinical trial design, implementation, and publication, as well as the Principles of Good Clinical Practice, and not more broadly on general research skills or academic advancement; and performing an early environmental scan so that the ECHO ISPCTN leverages existing, tested, clinical trial educational resources whenever possible.
• Engaging interested parties: Supporting clinical sites in engaging interested parties such as community members, nonprofit organizations, and professional societies to strengthen and enhance ECHO ISPCTN clinical trials research at the development, implementation, and dissemination phases.
• Complying with Data Sharing and Management plan as outlined in Section IV - Research Plan - Other Plans section of this RFA, including ensuring the appropriate language regarding sharing plans is included in study informed consent forms.
• Administrative and operational support: Supporting ECHO ISPCTN committees, work groups, and task forces in scheduling and hosting meetings, preparing and distributing meeting agendas and minutes, preparing and submitting documents for review by regulatory and oversight bodies, handling travel arrangements for oversight bodies to attend meetings as needed; tracking and posting a dashboard to report progress of the network overall and of individual clinical sites toward attainment of ECHO ISPCTN Goals, Objectives, Indicators and Targets (GOIT) milestones.
• 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 HHS, PHS, and NIH policies.

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

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. NIH assistance to the ECHO ISPCTN operations will be provided by the ECHO ISPCTN program official and project scientists. NIH staff will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination above and beyond the normal program stewardship role for grants. An ECHO ISPCTN program designate will serve as executive secretary to the Protocol Review Committee and Data Safety and Monitoring Board and provide minutes and findings to the ECHO Program Director for approval. In addition, in various matters related to study approval and oversight, the NIH staff will have final decision authority, as described below.

NIH Program Official
An ECHO ISPCTN Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. This program official's role is distinct from that of the project scientists, and will include the following

• Study and Budget Approval: Provide final approval of ECHO ISPCTN clinical trial protocols and their budgets, prior to initiation of any ECHO ISPCTN study, as well as assist in the development and review of study budgets including consideration of special institutional needs with regard to study-specific capitated payment schedules.
• Investigational New Drug (IND)/Investigational Device Exemption (IDE) Application Decisions: Determine on a case-by-case basis whether ECHO ISPCTN trials require Food and Drug Administration review, and if the regulatory sponsor for a clinical trial conducted under IND/IDE will be an ECHO ISPCTN clinical site or the Data Coordinating and Operations Center. The Data Coordinating and Operations Center will provide NIH staff with timely reports of serious adverse events (SAE) and protocol deviations. The NIH program official will work with the Data Coordinating and Operations Center and the ECHO ISPCTN Data Safety Monitoring Board to determine the final disposition of SAE Reports for all ECHO ISPCTN IND/IDE studies.
• NIH Public Access Policy Compliance Oversight: Ensure that all ECHO ISPCTN trials are registering and submitting trial information to the ClinicalTrials.gov registry and depositing de-identified study datasets to a central repository (e.g., NICHD Data and Specimen Hub (DASH)).
• Clinical Site Monitoring: Carry out continuous review activities, including regularly scheduled and ad hoc meetings with individual clinical sites to ensure that they are meeting objectives and handling all regulatory, fiscal, human subjects oversight, and administrative matters according to NIH policies and guidelines. In consultation with the ECHO ISPCTN project scientists, the NIH program official may initiate a decision to withhold funding support to a clinical site if the site does not meet technical performance requirements, such as by committing a critical protocol deviation or breach of participant safety, missing enrollment/retention targets by a wide margin, or submitting data of poor quality.
• Study Monitoring: With assistance from the ECHO ISPCTN Data Coordinating and Operations Center, monitor studies' human subjects' enrollment and safety, ensuring compliance with Office for Human Research Protections and NIH requirements for human subject research, as well as adherence to federal standards for data integrity. The ECHO ISPCTN program official may initiate a decision to modify, terminate, curtail, or suspend a study based on the advice of the Data Coordinating and Operations Center, Steering Committee, Leadership Committee, Protocol Review Committee, Data and Safety Monitoring Board, and/or Project Scientists.
• For-Cause Clinical Site Visits Oversight: Initiate a for-cause clinical site visit or preapprove and participate in one initiated by the Data Coordinating and Operations Center. Afterwards, the program official will review, approve, and submit the resultant corrective and preventive action plan developed by the Data Coordinating and Operations Center to the visited clinical site.
• Committee Work: Participate as a non-voting member of the ECHO ISPCTN Steering and Leadership Committees, and other relevant committees.

NIH Project Scientists
The NIH Project Scientists will have substantial scientific involvement as described below

• Trial Concept Development: Assist the steering committee with the identification of important areas of study and provide scientific support to investigators developing trial proposals to ensure they build upon existing literature and are feasible and appropriate to test in the ECHO ISPCTN.
• Protocol Drafting: Assist writing teams in the development of study protocols. The project scientists will also assist in the review and evaluation of clinical trial development at each stage of the process in conjunction with the Steering and Leadership Committees and make recommendations to enhance the scientific quality of the work. Specifically, the project scientists will identify scientific issues in implementation of the research and provide recommendations to improve rigor, applicability to the network, feasibility, or impact.
• Study Materials Development: Be integral members of the teams developing all study materials including manuals of procedures, scripted interactions with participants, informed consent and assent forms, recruitment advertisements, data capture forms, and data and safety monitoring plans. Project scientists will contribute to the development, review, and approval of all study materials.
• Dissemination of Study Results: Assist in the reporting of results to the community of investigators, study participants, and other interested parties. Project scientists will participate in proposing, coauthoring and reviewing manuscripts prior to their final approval from the ECHO Director for submission for publication.
• Scientific productivity reporting: Recommend administrative actions to enhance scientific productivity in protocol development, study start-up activities, trial conduct, and results dissemination.
• Committee Work: Participate as non-voting members of the ECHO ISPCTN Steering and Leadership Committees, and other relevant committees.

Areas of Joint Responsibility include:

Steering Committee 
The ECHO ISPCTN Steering Committee will be the main governing body of the ECHO ISPCTN and will have the primary responsibility for developing research policies by consensus, vetting studies for the network to consider for conduct, supervising the conduct of the studies, and reporting results.

The Steering Committee will consist of one PD/PI from each clinical site, the PD/PI(s) of the DCOC, and one NIH ECHO Project Scientist. The Steering Committee will determine all major scientific decisions by majority vote. Each clinical site will have one vote, as will the Data Coordinating and Operations Center and the NIH ECHO Project Scientist. The Steering Committee will establish subcommittees, work groups, and task forces as appropriate. The ISPCTN PD/PIs will elect a Steering Committee chair--either from a clinical site or external to ISPCTN--to create agendas for and facilitate Steering Committee meetings. The NIH ECHO Director can advise the ISPCTN PI/PDs on the expected qualifications or conflicts of interest of a potential internal or external chair. The NIH ECHO Program Office expects the Steering Committee chair to demonstrate outstanding skills in leadership, teamwork, and cooperation.  If the Steering Committee has an external chair, that person would serve as a non-voting member except in instances requiring a casting vote, when the votes on each side of a decision are equal.

The ECHO ISPCTN program office will appoint an executive secretary and external scientists to the ECHO ISPCTN Protocol Review Committee and Data and Safety Monitoring Board, both of which will report to the ECHO director. The Data Coordinating and Operations Center will provide logistical support to these groups.

The Steering Committee, with the assistance of the Data Coordinating and Operations Center, is responsible for coordinating protocol development, study design, protocol submission, study conduct, quality control and study monitoring, trial endpoint adjudication, drug ordering, data management, statistical analysis, protocol amendments/status changes, adherence to requirements regarding investigational drug, device, and other product management, compliance with federally mandated regulations, and protocol and performance reporting.

The ECHO ISPCTN will establish policies and procedures through the Data Coordinating and Operations Center, the Steering Committee, the Leadership Committee, and the NIH that govern its operations, including publications. These policies and procedures can be amended by the Steering Committee and the ECHO program office. ECHO ISPCTN members must accept and implement policies and procedures approved by the Steering Committee.

Leadership Committee 
The ECHO ISPCTN Leadership Committee will be a subgroup of the Steering Committee with added representation of one early stage investigator and one research nurse coordinator. The Leadership Committee will have representatives from the clinical sites, the Data Coordinating and Operations Center, and the NIH. The Steering Committee chair will also serve as Leadership Committee chair. One representative from each clinical site, the Data Coordinating and Operations Center, and the NIH will each have one Leadership Committee vote. In the case of ties, the ECHO ISPCTN program office reserves the right to allot the chairperson a tie-breaking vote.

The Leadership Committee will provide executive leadership for the ECHO ISPCTN by providing programmatic and budgetary oversight of strategic issues and resource use. It will prioritize research activities, develop governance policies for ratification by the Steering Committee, establish ad hoc committees, help to develop Steering Committee meeting agendas, and assist in the resolution of disputes within the network.

External Scientific Board
Five or more external experts will serve as the ECHO External Scientific Board and will be selected and appointed by the ECHO director. The external scientific board may review and offer input on ECHO ISPCTN structure, function, and studies during all phases of their lifecycle. External scientific board members will provide input, based on their individual areas of expertise, as needed over the course of the program. They will assist the program office regarding processes and substantive issues that arise during the funding cycle and will help ensure that the resources and research findings of the ECHO ISPCTN are as useful as possible to the public. The program office may invite external scientific board members to attend some ECHO ISPCTN Steering Committee or other network meetings.

Protocol Review Committee
The ECHO ISPCTN Protocol Review Committee will serve as a scientific oversight committee for the network. The Protocol Review Committee will review proposed protocols that the network is considering for implementation. The purpose of the protocol review committee is to assess the scientific merit of each proposed ECHO ISPCTN protocol. The committee will be appointed by and responsible to the ECHO ISPCTN program office to provide peer review of the protocols developed by network investigators.  All protocols will be reviewed and approved by the ECHO ISPCTN Steering Committee prior to submission to the Protocol Review Committee.

Membership of the ECHO ISPCTN Protocol Review Committee will include a chair, medical experts, scientists, statisticians, and other clinical research or trial experts. Membership will expand to include additional expertise as needed for any given protocol. The ECHO ISPCTN Protocol Review Committee Executive Secretary will be responsible for scheduling and attending committee meetings, taking minutes, and assisting the committee chair in drafting a report of recommendations for the ECHO director’s review.

Data and Safety Monitoring Board
The program office will establish an independent ECHO ISPCTN Data and Safety Monitoring Board to monitor and provide recommendations to the ECHO director regarding network studies' participant enrollment, retention, and safety, as well as data quality, and other issues as appropriate. The ECHO ISPCTN Protocol Review Committee and the Data and Safety Monitoring Board are separate bodies which may overlap in membership. The Data and Safety Monitoring Board will review Protocol Review Committee-approved protocols, informed consent forms, and data and safety monitoring plans prior to the start of participant recruitment. The program office will share the ECHO director-approved recommendations of the Data and Safety Monitoring Board with study teams and the Data Coordinating and Operations Center to add to their single institutional review board protocol submissions.

Single Institutional Review Board (IRB)
The ECHO ISPCTN will use a single institutional review board to streamline the protocol approval process and standardize the monitoring of human subjects' protections in network trials. The ECHO ISPCTN program office will respect the sovereignty of tribal nations to additionally include a tribal IRB.
 

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

Consistent with the 2023 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.

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.

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 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 2 CFR Part 200.113 and Appendix XII to 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 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

Tonse N.K. Raju, MD
Program Officer
Environmental influences on Child Health Outcomes (ECHO)
Office of the Director, National Institutes of Health
Three White Flint North, Room 03D17
11601 Landsdown Street
North Bethesda, MD 20852
Mobile: 202-302-3984 
ECHO Phone  301-435-5236
Tonse.raju@nih.gov
 

Michele McGuirl, Ph.D.
Email: michele.mcguirl@nih.gov

Janani Prabhakar
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-827-1321
E-mail: janani.prabhakar@nih.gov

The Office of Behavioral and Social Sciences (OBSSR) does not accept assignment of applications or manage awards that are funded. Please contact one of the ICs listed below for inquiries regarding the suitability of the proposed project for the NOFO and the IC's research portfolio.

Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov

Bonnie J. Jackson
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-5482
Email: bonnie.jackson@nih.gov
 

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@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 2 CFR Part 200.