Notice Number: NOT-OD-17-090
Release Date: August 10, 2017
Response Date: August 30, 2017
National Institutes of Health (NIH)
Through this Request for Information (RFI), the NIH seeks feedback on the development of the ECHO-wide Cohort data collection protocol.
Environmental influences on Child Health Outcomes (ECHO) is a nationwide NIH-funded research program whose mission is to enhance the health of children for generations to come. The program consists of observational and intervention components. This RFI pertains to the observational component, the ECHO Cohorts.
The overall scientific goal of the ECHO Cohorts is to investigate associations of a broad array of early environmental influences with child health and development. ECHO prioritizes addressing research questions that have impact on policies, practices, and programs.
ECHO defines “early” as conception to age 5 years. A “broad array of environmental influences” indicates multiple factors ranging, for example, from societal to physical, chemical, psychosocial, behavioral and biological.
ECHO focuses on the following five health outcomes throughout childhood and adolescence:
ECHO will establish the ECHO-wide Cohort, a collaborative research platform with data from 84 cohorts that reflect grant awards to 35 primary institutions. All of the cohorts existed at the time of ECHO’s inception in 2016. For most cohorts, recruitment began in the prenatal period; a few recruited before conception and most of the remainder at birth. In some cohorts, recruitment is ongoing. All cohorts are following children longitudinally, and all collect biospecimens. Some cohorts recruited their first participants in the 1980s, others as recently as 2016. All cohorts are following children longitudinally, and all collect biospecimens.
To create the ECHO-wide Cohort, every cohort will contribute existing data at the time of program inception and new data that they are collecting during the seven-year funding period. Across all cohorts, the participants reflect wide geographic, racial/ethnic, and socioeconomic diversity.
The ECHO-wide Cohort data platform will consist of data from at least 50,000 children, at two levels: first, essential data elements from all 84 cohorts, and second, recommended data from subsets of cohorts that are more comprehensive or are in emerging scientific areas. This data platform will serve as a national resource with which scientists can address a wide variety of research questions about the etiology or prediction of child health outcomes. ECHO’s Data Analysis Center, aided by other components of the program and guided by program policies, is responsible for acquiring, curation, managing, and analyzing ECHO-wide Cohort data.
To create the ECHO-wide Cohort, ECHO designated a working group whose charge is to develop a data collection protocol that requires or recommends that cohorts collect specified data elements, at certain stages of the life course, from preconception through adolescence. Starting with overarching research questions developed by ECHO outcome-oriented working groups, this data collection protocol working group has incorporated input from other working groups on exposures, from existing ECHO cohort protocols and experience of their investigators, from other studies’ protocols, and from theory and practice of designing data collection approaches.
To aid its work, the working group commissioned subcommittees for each of six life stages: preconception and prenatal, perinatal, infancy, early childhood, middle childhood, and adolescence. Each life stage subcommittee suggested salient data elements, from which the leadership of the working group drafted the overall protocol to balance, on the one hand, breadth and innovation, and on the other hand, feasibility in terms of burden to participants and staff.
The draft protocol (Protocol overview and data elements) consists of
In addition, for each data element, the draft protocol indicates whether cohorts should collect it
In its current format, the draft protocol purposely
Through this RFI, the NIH seeks input from stakeholders throughout the scientific community and general public on the ECHO-wide Cohort data collection protocol.
The NIH seeks comment on any or all of the following six bulleted topics:
If you suggest adding a data element,
Please specify a research question that requires it in addition to data elements already included.
Please specify the life stage(s) in which cohorts should collect it.
Types of biospecimens
If you suggest adding a biospecimen,
Please specify a research question that requires it in addition to biospecimens already included.
Please specify life stage(s) in which cohorts should collect it.
Please address the balance of its utility to answer relevant high-impact research questions with participant burden and likely success of collecting it
Innovative data collection methodology
May invoke data sources other than primary collection from participants or their caregivers
All respondents to this RFI must submit their comments online via the following website: firstname.lastname@example.org or email@example.com before 5 p.m. of your local time on August 30, 2017.
Response to this RFI is voluntary. Responders are free to address any or all of the items listed above; respondents should not feel compelled to address all items. Please note that the text box for each of the six bulleted topics limits your response to 250 words or fewer.
This RFI is for planning purposes only. No one should construe it as a solicitation for applications or as an obligation on the part of the Government to provide support for any ideas NIH identifies in response to it. Please note that the United States Government will not pay for the preparation of the information responders may submit or for its use of that information. NIH will compile responses and may or may not share them publicly.
We look forward to your input and hope that you will share this RFI with your colleagues. Please check before submission for any updates to this document.
Please direct all inquiries to:
Manjit Hanspal, PhD
National Institutes of Health
Christina Park, PhD, MHS
National Institutes of Health