The National Institutes of Health (NIH) has decided to discontinue the National Children’s Study (NCS). At the December 12 meeting of the NIH Advisory Committee to the Director (ACD), a working group charged by NIH director Francis Collins to evaluate whether the NCS “as currently outlined is feasible, especially in light of increasing and significant budget constraints,” concluded that the NCS as currently designed is not. The working group further recommended “that the NIH champion and support new study designs, informed by advances in technology and basic and applied research, that could make the original goals of the NCS more achievable, feasible, and affordable.”
The NCS was originally authorized by the Children’s Health Act of 2000. It is being implemented by a program office within the Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD). 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 the recently-passed fiscal year (FY) 2015 Consolidated and Further Continuing Appropriations Act (HR 83), also known as the “cromnibus,” Congress provided $165 million for the NCS “or research related to the Study’s goals and mission, and any funds in excess of the estimated need shall be transferred to and merged with the accounts for the various Institutes and Centers to support activity related to the goals and objectives of the NCS.” It further states that “NIH shall submit a spend[ing] plan on the NCS’s next phase to the Committees on Appropriations of the House of Representatives and the Senate not later than 90 days after the date of enactment of this Act.”
In the statement released announcing the NIH‘s decision, Collins said that he was “disappointed that this study failed to achieve its goals. Yet I am optimistic that other approaches will provide answers to these important research questions.” He concurred “with the report’s conclusions that research addressing the links between the environment and child health and development is much needed, and that the specific research in this area should be initiated within the scientific community, use mechanisms that can evolve with the science, employ the use of a growing number of clinical research networks, and capitalize on research and technology advances that have developed since the inception of the study.”
The NIH, Collins stated, will address the administrative and structural recommendations as necessary to effect this new direction and NIH will work with the Administration and Congress to discontinue the NCS. To that end, David Murray, NIH Associate Director for Prevention, has been appointed, effective immediately, to manage the orderly closure of the NCS.
Working Group’s Conclusion
Co-chaired by ACD members Russ Altman and Phillip Pizzo, both from Stanford University, the Working Group noted that despite its recommendations, the questions embodied in the Children’s Health Act of 2000 remain important and concluded that available funds should be used to pursue alternative approaches that engage the broader scientific community and that could lead to superior study designs—designs that optimize the use of new scientific knowledge and enabling technologies. These approaches may substantially enhance our knowledge about the impact of environmental, biological, behavioral, and social factors on child and adult development, health, and disease.
The Working Group’s conclusion is based on an evaluation of the aims, design, and management of the NCS. The report specially notes that:
1) The current aims, design, and scope of the NCS are unlikely to achieve the goals of providing meaningful insights into the mechanisms through which environmental factors influence health and development;
2) The study does not incorporate approaches informed by new biological insights about factors that impact child health and new enabling technologies;
3) Even with the potentially valuable goal of a national probability sample, the NCS sampling design is overly complex, and the study design remains incomplete even after years of effort; and
4) The NCS investigative team and management are not well suited to the tasks inherent to such a study, and the management oversight by multiple committees is cumbersome, further slowing progress.
Since passage of the Children’s Health Act of 2000, COSSA has followed and weighed in on various aspects of the study, most recently in an October 26 letter to the NCS Working Group outlining the social and behavioral science research community’s concerns regarding the NCS’ framework along with several other issues it felt the NCS Working Group should consider. The community believed that the study had “the potential to become an invaluable resource, yielding new insights into the complex linkages between social, genetic, and environmental factors and how these factors interact to influence health, growth and development across the life course.” But to ensure the study produces meaningful data, the NCS study design was paramount. COSSA stated its belief that the “benefits associated with drawing a representative sample in the NCS far outweigh its incremental costs.”
The working group’s report is available on the NIH’s website.