Notice Number: NOT-OD-17-090
Key Dates
Release Date: August 10, 2017
Response Date: August 30, 2017
NOT-OD-17-103
NOT-OD-17-107
Issued by
National Institutes of Health (NIH)
Purpose
Through this Request for Information (RFI), the NIH seeks feedback on the development of the ECHO-wide Cohort data collection protocol.
Background
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:
- Pre-, peri- and postnatal outcomes;
- Obesity and its consequences;
- Upper and lower airway conditions;
- The many domains of neurodevelopment; and
- Positive health, which comprises positive attributes of healthy growth and development rather than absence of disease.
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.
Approach to Development of the ECHO-wide Cohort Data Collection Protocol
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
- Essential data elements that all cohorts collect, and
- Recommended elements, meaning that cohorts should collect these data if at all possible.
In addition, for each data element, the draft protocol indicates whether cohorts should collect it
- Once,
- During a particular life stage, or
- In multiple life stages.
In its current format, the draft protocol purposely
- Consists of concepts ( what ) rather than detailed measurement techniques ( how )
- Does not put a strict time limit on the length of, say, an in-person research visit.
- Does not designate the number or intervals of visits within a life course stage.
- Stipulates types of biospecimens cohorts should collect, process, and store based on relevant exposures, outcomes, and pathways (e.g. metals, hormones, epigenetics), rather than specific analytes.
Information Requested
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:
Data elements
- Data elements in the draft protocol that are unnecessary to address high-impact questions relevant to ECHO’s scientific goals, i.e., how a broad array of early environmental factors could influence the five primary ECHO child health outcomes.
- Additional data elements that are critical to address such questions.
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
- Biospecimens in the draft protocol that are unnecessary to address high-impact questions relevant to ECHO’s scientific goals.
- Additional biospecimens that are critical to address such questions.
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 - Alternative biospecimens to increase probability of success in collecting the specimen or lowering its participant burden, with pros and cons of that alternative
Innovative data collection methodology
- Innovative means to collect data or biospecimens from participants to increase accuracy or reduce burden or both
May invoke data sources other than primary collection from participants or their caregivers
Responses:
All respondents to this RFI must submit their comments online via the following website: [email protected] or [email protected] 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.
Inquiries
Please direct all inquiries to:
Manjit Hanspal, PhD
National Institutes of Health
Telephone: 301-435-5008
Email: [email protected]
Christina Park, PhD, MHS
National Institutes of Health
Telephone: 301-435-4013
Email: [email protected]
and Human Services (HHS)
