EXPIRED
National Institutes of Health (NIH)
Office of The Director, National Institutes of Health (OD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of General Medical Sciences (NIGMS)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Dietary Supplements (ODS) March 28, 2024 Participation added (NOT-OD-24-092)
Office of Nutrition Research (ONR) March 28, 2024 Participation added (NOT-OD-24-092)
U24 Resource-Related Research Projects – Cooperative Agreements
See Part 2, Section III. 3. Additional Information on Eligibility.
This Notice of Funding Opportunity (NOFO), issued by the Office of the Director (OD), National Institutes of Health (NIH), invites applications from entities/institutions in Institutional Development Award (IDeA)-eligible states to participate as the Data Coordinating and Operations Center (DCOC) in the Environmental influences on Child Health Outcomes IDeA States Pediatric Clinical Trials Network (ECHO ISPCTN).
This RFA runs in parallel with companion RFA (Clinical Sites RFA-OD-24-008) that will solicit applications for ECHO ISPCTN Clinical Sites. The ECHO ISPCTN DCOC and Clinical Sites together will form the ECHO ISPCTN. 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.
The DCOC award budget will fund approximately five multicenter pediatric clinical trials with each trial related to prevention or treatment of one or more of ECHOs five outcome areas of interest: pre-, peri-, and postnatal outcomes; upper and lower airways; obesity; neurodevelopment; and positive health. Overall, the five trials should address at least two of the five areas.
The DCOC will support the ECHO ISPCTN Clinical Sites to
Through the rigorous use of appropriate scientific methodology and by recruiting and retaining the numbers of participants that justify multicenter trials, the ECHO ISPCTN aims to provide valid and generalizable answers to intervention research questions relevant to the health of children from rural or underserved backgrounds. The ECHO ISPCTN awardees will be primarily responsible for initiating and conducting clinical trials, although they may collaborate with other NIH research networks or subject matter experts outside the network.
This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.
Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.
April 01, 2024
The dates in bold and italics reflect changes per NOT-OD-24-094
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
June 14, 2024 | June 14, 2024 | Not Applicable | October 2024 | January 2025 | June 2025 |
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).
Not Applicable
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.
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
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.
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
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
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.)
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
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
The ECHO ISPCTN is particularly interested in studies conducted in the primary care setting.
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
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.
Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.
The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Required: Only accepting applications that propose clinical trial(s).
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
NIH intends to fund an estimate of 1 award, corresponding to a total of $8,000,000, for fiscal year 2025. Future year amounts will depend on annual appropriations.
Applicants may request a budget up to $1,750,000 per year in direct costs for Core Infrastructure Costs for the DCOCs roles in supporting general ECHO ISPCTN operations, and in facilitating network protocol concept development, manuscript preparation, completion of ongoing trials from the prior funding cycle, and development and implementation of 5 new clinical trials. Core Infrastructure Support will also support the DCOCs role in facilitating the work of ECHO ISPCTN committees and oversight bodies including its protocol review committee and data and safety monitoring board.
In addition, applicants should budget $3,500,000 per year in direct costs for Protocol-Specific Costs for distribution to the ECHO ISPCTN Clinical Sites as capitation fees to conduct clinical trials.
5 years
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
1. Eligible Applicants
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Only institutions or organizations in the following IDeA-eligible states/commonwealth are eligible to respond to this NOFO
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
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
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:
An organization may participate as a lead organization in only one application submitted to this NOFO for the same due date.
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.
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:
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
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.
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:
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
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
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 DCOCs 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 trials 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
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
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 studys 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
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:
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply Application Guide.
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, NIHs 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 organizations 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.
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.
Does the proposed Center address the needs of the research network that it will coordinate? Is the scope of activities proposed for the [Center] appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research network.?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the [Center]? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing clinical research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their [leadership approach, governance, plans for conflict resolution, and organizational structure] appropriate for the [Center]? Does the applicant have experience overseeing selection and management of subawards, if needed?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application propose novel organizational concepts or management strategies in coordinating the research network the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, or management strategies proposed?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Specific for this NOFO
Does the applicant demonstrate
Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Specific for this NOFO
Is there evidence of ability to
In the letters of support, does the institutional leadership demonstrate institutional commitment to support the proposed program?
To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?
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.
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not applicable
For Renewals, the committee will consider the progress made in the last funding period.
Not applicable
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.
Not applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
Not applicable
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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:
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.
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).
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:
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 investigators 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 applicants 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:
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
NIH Project Scientists
The NIH Project Scientists will have substantial scientific involvement as described below
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 directors 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.
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
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.