December 12, 2014

Statement on the National Children’s Study

In July of this year, I charged a working group of my Advisory Committee to the Director (ACD) with evaluating whether the National Children’s Study (NCS) as currently outlined is feasible, especially in light of increasing and significant budget constraints. The NCS was envisioned as a longitudinal, observational study examining the effects of a broad range of environmental and biological factors on children’s health and development by following 100,000 children from the womb to age 21. A pilot effort, known as the Vanguard Study, was initiated to test methods and approaches that might be used for the Main Study. Considerable experience was acquired as various enrollment approaches were tested, and many publications ensued – but most of the models were found unworkable. After several years of piloting, the Main Study has still not been launched. Furthermore, NIH leadership and stakeholders have had concerns about the study, and those concerns were echoed in a report by the National Academies (NAS), issued in June 2014. As a result, I placed the launch of the Main Study on hold until critical questions regarding next steps could be answered to ensure that this important area of research is pursued in the most rigorous manner.

Today, the ACD considered the final report of the NCS working group. The report concluded that the overall goals of examining how environmental factors influence child health and development are meritorious and should continue to be a priority for future scientific support, but that the NCS as currently designed is not feasible.

Further, the ACD made the following recommendations:

  • The NCS program office within the Eunice Kennedy Shriver National Institute of Child Health and Human Development should be dissolved.
  • Data from the Vanguard Study should be archived and available upon request by investigators for secondary analyses. However, the study should not collect any further data from study participants.
  • A list of alternative options to the NCS provided in the report should be considered by the NIH with additional input from the broader scientific community.

I and my leadership team have had time to consider this report over the last few weeks. Based on the working group’s findings and internal deliberation, I am accepting the ACD findings that the NCS is not feasible. I am disappointed that this study failed to achieve its goals. Yet I am optimistic that other approaches will provide answers to these important research questions. My leadership team 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. I concur 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. NIH will consider the alternative approaches defined in the report in consultation with the broader scientific community.

On behalf of NIH and the broader research community, we sincerely thank the participants in the Vanguard Study for their time and generosity. Their altruism has benefited, and will continue to benefit, research. We will work to establish a plan for making data and specimens from the Vanguard study available to advance much needed research.

I am appointing Dr. David Murray, NIH Associate Director for Prevention, effectively immediately, to manage the orderly transition of the NCS program office and closure of the study. I am grateful to the NCS Working Group for their careful and thoughtful feedback and advice on this challenging issue.

Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health