NOT-OD-15-117: Request for Information (RFI): Inviting Comments and Suggestions on the Environmental influences on Child Health Outcomes (ECHO) Program (the National Children's Study Alternative)

Request for Information (RFI): Inviting Comments and Suggestions on the Environmental influences on Child Health Outcomes (ECHO) Program (the National Children's Study Alternative)

Notice Number: NOT-OD-15-117

Key Dates
Release Date: July 13, 2015
Response Date: August 14, 2015

Related Announcements
None

Issued by
National Institutes of Health (NIH)

Purpose

This Notice is a time-sensitive Request for Information (RFI) inviting comments and suggestions on the proposed plan for the Environmental influences on Child Health Outcomes (ECHO) program.

NOTE: It is important to read this entire RFI notice to ensure an adequate response is prepared and to have a full understanding of how your response will be utilized.

Background

In 2000, Congress authorized a study of children's health and development - the National Children's Study (NCS) - as part of the Children's Health Act. Due to concerns of NIH leadership and stakeholders, in June 2014 the Institute of Medicine (IOM) was asked to review the NCS, a proposed national longitudinal study of environmental influences (including physical, chemical, biological, and psychosocial) on child health and development. The resulting IOM report expressed concerns about the study's design, management, oversight structure, and anticipated cost. As an outcome of the IOM report, the launch of the Main Study for the NCS was put on hold, and a working group of the Advisory Committee to the Director (ACD) of NIH, which included experts in the fields of pediatric and environmental health, was charged with reviewing the NCS to evaluate its feasibility. In December 2014, the ACD recommended that, while the overall goals of the NCS should remain a priority for future scientific support, the NCS was not feasible as currently outlined. After careful consideration and discussion with NIH senior leadership, Dr. Collins accepted the ACD's recommendation to discontinue the NCS.

To make best use of fiscal year (FY) 2015 appropriated funds, NIH leadership and staff worked diligently to identify opportunities to address challenges at the intersection of pediatric and environmental health through alternative approaches that are consistent with the original goals of the NCS, including establishing compelling new programs, integrating existing programs, and enhancing programs by incorporating more comprehensive environmental assessments. A major focus of the comprehensive effort is on the development of tools to enhance measurement of environmental exposures (e.g., physical, chemical, biological, psychosocial) and facilitate research across all of the initiatives and programs. Another key component of the plan is studying environmental influence on placental and in utero development, with the goal of identifying the "seeds" of future diseases and conditions. Finally, by leveraging extant programs, the plan aims to expand examination of environmental influences on later child development. In keeping with the spirit of the NCS, these initiatives aim to address the critical goal of understanding the impact of environmental influences on children's health and development to advance the field and our knowledge.

Going forward, the overarching goal of the FY 2016 plan is to leverage and expand extant cohorts to address new research questions to investigate the longitudinal impact of prenatal, perinatal, and postnatal environmental exposures on pediatric health outcomes with high public health impact. To do so, NIH proposes to support multiple synergistic, longitudinal studies using extant cohorts that represent variable environmental exposures (e.g., physical, chemical, biological, psychosocial, natural and built environments) that will share standardized research questions and focus on four key pediatric outcomes. All longitudinal studies will collect the same standardized, targeted data (Core Elements) as a component of the project, and will be managed through a Coordinating Center. The Coordinating Center, which will include an analytical or data science component, will be supported through a cooperative agreement with NIH. It will be overseen by a Steering Committee with NIH staff, the heads of the Coordinating Center, and the PIs of the studies.

The Core Elements to be addressed across all studies:

Demographics [e.g., race, gender, ethnicity, socioeconomic status, geographic location/diversity (e.g., IDeA States)]
Typical early development [e.g., growth, milestones, microbiome, sleep, nutrition, activity level]
Epigenetic influences on early childhood development [e.g., maternal "exposome"]
Environmental factors [e.g., physical, chemical, biological (in utero), psychosocial, natural and built environments]

Four focus areas will address research questions specific to critical pediatric conditions or health outcomes to assess range of functioning over time. These Focus Areas are:

Upper and lower airway (e.g., asthma, allergies, sleep disordered breathing)
Obesity (e.g., nutrition, diabetes, metabolic risk factors)
Pre-, peri-, and postnatal outcomes (e.g., birth defects, childhood outcomes)
Neurodevelopment [e.g., autism, ADHD, depression, social/behavioral development, cognition]

The FY 2016 plan aims to provide the flexibility and opportunity to investigate key questions of interest at the intersection of environmental health and pediatric research, while also leveraging additional features and capabilities of the studies. For example, the studies could: take maximal advantage of existing tissue banks collected across pregnancy (e.g., cervicovaginal secretions, maternal DNA, cord blood, placenta) and data sets by funding additional analyses; serve as a test bed for validating new technologies, tools, and approaches for efficient and effective environmental and pediatric monitoring; use systems approaches to develop multi-variable models to predict disease development; recruit future pregnancies and investigate outcomes of second children to serve as a comparison cohort to first pregnancy children.

As an additional research opportunity, the FY16 plan also proposes to create an IDeA States National Pediatric Clinical Research Network, which could:

Address access gaps for rural children through a national network for pediatric research embedded at IDeA locations
Link existing IDeA state centers with experts in clinical trials

Information Requested

This RFI seeks input from stakeholders throughout the extramural scientific community and the general public regarding the FY16 ECHO plan.

The NIH seeks comments on any or all of, but not limited to, the following topics:

The Core Elements:

Potential benefits, drawbacks, and areas of consideration for leveraging existing cohorts to collect standardized data elements
Additional core elements to be considered
Considerations for harmonizing data across cohorts
High impact areas of opportunity in addition to those listed
Anticipated advances and/or considerations for implementing state-of-the-art data collection and analytic methodologies throughout the duration of the study

The four Focus Areas:

Suggestions of existing research studies or resources that might address one or more of these areas, including a description of the study or resource (e.g., sample size, demographic information, major health or behavioral outcomes, environmental exposures, success with or potential for follow-up through childhood, available biologic or environmental specimens)
The additional IDeA States opportunity

How to Submit a Response

All comments must be submitted electronically on the submission website (https://grants.nih.gov/grants/rfi/rfi.cfm?ID=45).

Responses (no longer than 300 words in MS Word or pdf format) must be received by 11:59:59 pm (EST) on August 14, 2015. You will see an electronic confirmation acknowledging receipt of your response.

Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers. The Government will not pay for the preparation of any information submitted or for the Government's use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government's use of such information.

We look forward to your input and hope that you will share this RFI document with your colleagues.

Inquiries

Please direct all inquiries to:

Email: nihkidsandenvironment@nih.gov