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Frequently Asked Questions
Relevant to All FOAs
How is this new NIH effort different from the NCS?
NIH has learned much from the NCS study. The FY16 program, ECHO, will differ from the NCS in several important ways — it is structured for increased efficiency by taking advantage of existing programs. At least initially, we propose to utilize extant cohorts – those that are already established. We also will support multiple existing cohorts to create a synthetic cohort and increase the reach of the program. Additionally, we have limited the focus of the potential studies to the four Focus Areas, and considered how best to integrate them (Core Elements). We will take maximal advantage of existing and developing advances in data science as well.
Further, we are proposing to launch an IDeA States Pediatric Clinical Trials Network to create a rural pediatric network to increase racial/ethnic/SES diversity by establishing a team of pediatric clinical researchers/trialists embedded at IDeA locations. It will allow NIH to leverage an existing infrastructure at IDeA locations, provide additional expertise, and address access gaps to research participation for rural and underserved children.
To summarize, the goal of ECHO is to more efficiently and effectively utilize and leverage our current resources to address a hugely important area of research — how early environmental exposures impact child health and development.
What are the components of ECHO?
- Coordinating Center [RFA-OD-16-006]: a central site responsible for organizing and managing activities and logistics for collaborative components of the consortium, including oversight and coordination of all ECHO programs, multi-cohort study design and protocol and informed consent development, a data management system, administrative management of multiple-site/-project studies, evaluation of progress, data quality and completeness, and sample storage.
- Data Analysis Center [RFA-OD-16-005]: responsible for developing and applying novel analytic methods for combining and analyzing existing and new longitudinal data from disparate extant cohorts, and for conducting multi-level analyses on pooled consortium data to address the impact of early life exposures on childhood health outcomes.
- Pediatric Cohort Sites [RFA-OD-16-004]: sites at which extant cohorts will be followed prospectively and where assessments of exposures and outcomes will be collected. Cohort sites will each conduct individual prospective longitudinal studies targeting at least one focus area and will participate with the other awardee clinical sites to conduct mutually agreed upon collaborative studies of a synthetic cohort of pooled sites.
- Patient/Person Reported Outcomes (PRO) Core [RFA-OD-16-003]: responsible for maintaining and providing PROs, assisting with the incorporation of PROs into study design, coordinating the mode of administration, and updating existing and validating emerging child PROs
- Children’s Health Exposure Analysis Resource (CHEAR) Core [PA-16-046]: serve as a resource for analyzing personal environmental exposures from existing and prospective collections; supplement to existing CHEAR resource.
- Genetics Core: responsible for coordinating the collection and measurement of genetic samples for SNP-chip analysis through standardized techniques [To be released in FY 2017].
- IDeA States Pediatric Clinical Research Network Data Coordination and Operating Center [RFA-OD-16-002]: a central site within the IDeA program that provides data coordination functions for pediatric clinical trials, technical instruction, adherence to state-of-the-art data standards, quality assurance, and an operational interface between the IDeA system and other entities, including the ECHO Coordinating Center and Steering Committee.
- IDeA States Pediatric Clinical Research Network Sites [RFA-OD-16-001]: sites at which teams of dedicated pediatric research staff will be established to augment geographic diversity of clinical trials.
What are the roles of the Coordinating Center vs. individual projects (e.g., data management, quality control, data distribution inside and outside ECHO)?
The Coordinating Center will serve as the hub for communication, collaboration, and interaction amongst the studies. ECHO will be overseen by NIH staff and a Steering Committee, which will be co-chaired by the NIH ECHO Program Director, the PI of the Coordinating Center, and the PI of the Data Analysis Center. The Steering Committee will also include the PIs of the Cores (i.e., the PRO Core, the CHEAR Core, and the Genetics Core), the PIs of the pediatric cohorts, and the PI of the IDeA States Pediatric Clinical Trials Network Data Coordinating and Operations Center. An Executive Committee of the Steering Committee also will be established, and will be composed of the three co-chairs and a representative from each of the funded elements — one each from the PRO Core, the Genetics Core, CHEAR Core, and the IDeA States Pediatric Clinical Trials Network DCOC, as well as one PI collectively representing the cohort sites.
The individual projects will investigate the key questions of import to their study, but also include measurements of the Core Elements. Further, all studies within each Focus Area will coordinate collection of standard disease-specific questions, as identified by the Focus Area cohort community, in addition to the study-specific questions and Core Elements.
Can international investigators and cohorts participate?
International cohorts and investigators can submit an application in response to the Pediatric Cohorts FOA only. However, the questions in the proposal have to be unique and compelling, and able to provide justification of the scientific impact of non-U.S. cohort data that currently is not possible using U.S. cohorts.
Are NIH intramural investigators/cohorts eligible?
NIH intramural investigators are not eligible to apply for ECHO funding and may not serve as PIs of the grant. However, they may be listed as collaborators for applications to the ECHO FOAs. Additionally, NIH intramural cohorts may be included in applications to the ECHO program, provided they meet the criteria for applying, as outlined in the ECHO Pediatric Cohorts FOA. ECHO funds cannot be used to support NIH intramural personnel salaries and other expenses associated with managing intramural cohorts.
Will data already collected need to be harmonized? How will future data be harmonized, and will NIH measurement tools, like PROMIS, be required?
Data collected in the past are not expected to conform to the data standards that will be developed for this program. When feasible, the ECHO Consortium may harmonize such existing data. In addition, advances in analytical tools can allow for comparison of data that were collected or measured differently. Prospective data will be collected through common protocols; the Coordinating Center will work with the Steering Committee to identify the standardized research measures, or Core Elements. Focus Area common measurements will be identified by the appropriate research communities through a subcommittee of the Steering Committee. The Data Analysis Center will work with the Coordinating Center to identify and implement any necessary measures for data harmonization, integration, and standardization. The PRO Core, CHEAR Core, and the Genetics Core also will provide insight into this process, particularly for their respective areas of expertise.
How does the IDeA state network fit with the overall program?
The IDeA States Pediatric Clinical Trials Network will be an additional related, but separate, opportunity. This network will consider the four ECHO Focus Areas a priority, and all prospective data collection will be encouraged to utilize the ECHO standardized research measures — the Core Elements. The PI of the Data Coordinating and Operations Center (DCOC) will be a member of the Steering Committee, and they will also participate, with the PIs from all the IDeA state sites, as a member of an ECHO Steering Committee subcommittee.
How does the ECHO program relate to the Precision Medicine Initiative?
The goal of the ECHO program is to determine the influence of environmental exposures on four specific pediatric health outcomes that have a high public health impact. It also is designed to take full advantage of existing resources, including the creation of a “synthetic cohort” from extant pre-, peri-, and postnatal clinical studies. We envision that between 10,000 – 50,000 participants will ultimately be recruited to ECHO.
In contrast, the PMI Cohort is designed to be a very large (1 million or more volunteers) national study investigating how genetic, lifestyle, and environmental factors affect health and the development of disease. Volunteers will represent the rich diversity of the US, including all ages and all health statuses, and may be enrolled as families.
The ECHO program is complementary to — but not duplicative of — the PMI Cohort Program. As each program develops, the NIH will explore leveraging opportunities for sharing data models, policies, and infrastructure resources to increase programmatic efficiencies and enhance their respective research resources.
Will pre-application workshops/webinars be held?
Yes, two pre-application webinars will be held. They are scheduled to be held on January 14 and February 1, 2016. Additional information will be posted to the ECHO website (www.nih.gov/echo) as it becomes available.
Can multiple applications be submitted using a single cohort?
While more than one scientifically appropriate application may be submitted using a single cohort, applicants should carefully consider the feasibility and the scientific questions that could be addressed. Additionally, the applications must address distinct specific aims/research questions. Applicants are encouraged to consider the best science (i.e., the questions with the highest impact) when developing the applications and determining how to apply.
What are the data sharing requirements for the ECHO program?
Your data in the ECHO multi-cohort study or in within-focus area multi-cohort protocols will be part of the ECHO consortium data and will be reasonably accessible to other ECHO investigators and the research community. The ECHO Steering Committee will help manage the publication and authorship roles through the Publications subcommittee, which will be responsible for developing publication policies and procedures, and reviewing abstract and manuscript proposals for cross-project papers and presentations.
Which application forms package should be submitted?
The budget form originally posted with four of the ECHO FOAs (RFA-OD-16-003, RFA-OD-16-004, RFA-OD-16-005, RFA-OD-16-006) did not accommodate the full 7 years of support allowed for the program. On December 15, a new application forms package with the appropriate budget form was posted in Grants.gov to address this issue. The FORMS-C-REVISED application forms package with the updated budget form must be used when applying for four of the ECHO FOAs.
The new application forms package notices are listed below:
- RFA-OD-16-003: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-038.html
- RFA-OD-16-004: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-037.html
- RFA-OD-16-005: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-036.html
- RFA-OD-16-006: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-035.html
For additional information, please refer to the Office of Extramural Research’s website.
This page last reviewed on March 24, 2016