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On December 7, National Institutes of Health (NIH) director Francis Collins announced the next funding phase of the agency’s Environmental Influences on Child Health Outcomes (ECHO) program, which includes seven new funding opportunity announcements (FOAs). ECHO is designed to comport with the goals of the National Children’s Study (NCS) (see Update, November 3, 2015) and is being implemented via a series of funding opportunity announcements (FOAs). It is expected that the ECHO program will be supported by and build on recent awards NIH made in September (see Update, September 4, 2015). A nationwide search is underway for an ECHO program manager. In the interim, NIH Deputy Director Lawrence Tabak will continue to lead the program.
ECHO program funding opportunities:
The National Institutes of Health (NIH) recently issued a notice, Announcement of NIH Plans for the Environmental Influences on Child Health Outcomes (ECHO) Program (NOT-OD-16-015), detailing the agency’s plans for program, also known as the National Children’s Study (NCS) alternative (see Update, July 17, 2015). The agency reports that it intends to “support multiple synergistic, longitudinal studies using extant maternal/pediatric cohorts that represent a broad range of environmental exposures,” including behavioral and social exposures. According to the notice, “all longitudinal studies will collect a standardized, targeted set of data (Core Elements), such as demographics, normative development, patient/person reported outcomes (PRO), environmental exposures, and genetic influences.” ECHO-supported studies will focus on four key pediatric outcomes or focus areas: (1) upper and lower airway; (2) obesity; (3) pre-, peri-, and postnatal outcomes; and (4) neurodevelopment. The program will also seek to “leverage the existing Institutional Development Award (IDeA) infrastructure” through its inclusion of a States Pediatric Clinical Trials Network.
National Institutes of Health (NIH) Principal Deputy Director Lawrence Tabak provided an update on the “redirection” of National Children’s Study (NCS) appropriated funding at the September 1 meeting of the NIH Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) Council of Councils.
Despite the NIH’s discontinuation of the NCS, in FY 2015, Congress provided $165 million for the study with direction to the agency to continue to support the mission and goals of the study, along with flexibility on how to carry this task out. Tabak announced that the awards associated with this funding will be made in September. As a consequence of not knowing whether Congress would continue to provide the funding associated with the discontinued study (see Update, July 17, 2015), however, NIH fully funded the FY 2015 awards via three initiatives:
Tabak reported that the remaining funds will be used to close out the former NCS program. (more…)
The National Institutes of Health (NIH) is inviting comments on its proposed plan for the Environmental influences on Child Health Outcomes (ECHO) program and has issued a time-sensitive Request for Information (RFI).
The ECHO program responds to the NIH’s decision to discontinue the National Children’s Study (NCS) in December 2014, per the recommendations of a working group of the Advisory Committee to the Director (ACD) of NIH (See Update, December 19, 2014). NIH emphasizes that in keeping with the spirit of the NCS, ECHO aims to address the critical goal of understanding the impact of environmental influences on children’s health and development.
The NCS was originally authorized by the Children’s Health Act of 2000. A program office within the Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD) led the implementation efforts of the study. The NCS was intended to be a “longitudinal observational birth cohort study to evaluate the effects of chronic and intermittent exposures on child health and human development in U.S. children.”
In December 2014, NIH director Francis Collins announced that per the recommendations of an Institute of Medicine report and the subsequent ACD recommendations the agency would discontinue the study. Congress, however, did not receive the decision as well as NIH would have hoped. At the March 2015 Labor-HHS hearings, Rep. Lucille Roybal-Allard articulated Congress’ concern with the decision: “Congress fully expected that the study would be carried through to its completion… In almost every fiscal appropriations report from the year 2000 to 2014 there have been specific instructions from both the House and the Senate directing the continuation of the Study.”
Accordingly, in its report accompanying the fiscal year (FY) 2016 appropriations bill for the Departments of Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS), the House expressed “disappointment” with the agency’s decision to discontinue the study. Similarly, the Senate Appropriations Committee found NIH’s decision to discontinue the National Children’s Study (NCS) after $1.3 billion in federal investment “deeply troubling” (See Update, June 30, 2015). Nevertheless, both houses continue to provide the resources to continue to fund research that would have been supported by NCS.
The House Appropriations Committee included report language that “directs and provides funding for continuation of the NCS in an alternative form called the National Children’s Study Alternative (NCS-A).” The House further directs NIH to work with pediatric groups to “develop a series of alternative research activities that build on NCS data and the overarching goals of the NCS to address the developmental origins of health and disease through a series of studies (including longitudinal) that incorporate expertise in biology and epidemiology, integrate basic science, and leverage maternal/infant cohorts, either de novo or from extant networks.” The agency is expected to focus on “at least prematurity, obesity, autism, asthma, and pediatric, rare diseases like cancer.” NIH is urged by the Senate “to recalibrate and realign the investment already made in the NCS to initiate new and focus existing longitudinal studies to address the objectives identified for the NCS. The NIH should rely upon a formal scientific advisory mechanism to coordinate efforts across studies. The research efforts should incorporate expertise in population health and environmental epidemiology, integrate basic science, and leverage maternal/infant cohorts.”
In the RFI notice, NIH explains that to make the best use of the FY 2015 appropriated funds, the agency has identified 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 this new 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.” The notice also notes that a second “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.”
The agency also explains that the overarching goal of ECHO is to investigate the longitudinal impact of prenatal, perinatal, and postnatal environmental exposures on pediatric health outcomes with high public health impact by leveraging and expanding extant cohorts. To this end, 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 – upper and lower airway; obesity; pre-, peri-, and postnatal outcomes; and neurodevelopment.”
According to the RFI, 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. An additional opportunity for creating an Institutional Development Award (IDeA) States National Pediatric Clinical Research Network is also being considered which would be expected to address access gaps for rural children through a national network for pediatric research embedded at IDeA locations and link existing IDeA state centers with experts in clinical trials.
In addition to comments on research questions specific critical pediatric conditions, NIH is also seeking comments on any or all of, but not limited to, the following topics: 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; and anticipated advances and/or considerations for implementing state-of-the-art data collection and analytic methodologies throughout the duration of the study.
The deadline for responding to the agency’s request is August 15, 2015. All comments must be submitted electronically on the NIH’s website.