Statement on National Academy of Sciences Report on the National Children’s Study

A National Academy of Sciences (NAS) report released today raises significant concerns about the design, management, and oversight of the National Children’s Study (NCS).  I take these concerns very seriously. The NCS, which was requested by Congress through the Children’s Health Act of 2000, is envisioned to be a longitudinal, observational study that will follow 100,000 children from the womb to age 21 to examine the effects of a broad range of environmental and biological factors on children’s health, growth, and development.  The study has generated high expectations from many stakeholders.

Without question, the NCS has presented daunting challenges in design and implementation from the beginning. Much of the early work was focused on determining the optimal recruitment strategy and design for the study. Based on results of early pilot work, significant improvements were made to the research plan and management over the past several years. However, there have been continued concerns, both from outside experts and from NIH senior leadership, about whether the NCS is fully ready to scale up to the main study. Based on the NAS report and these persistent concerns, I am putting the main study on hold, effective immediately, in order to determine the best path forward. We are at an inflection point where critical questions need to be answered:

1. Is this study, as currently outlined, actually feasible in the face of significant budget constraints?
2. If yes, how do we move forward to implement necessary changes, including some of those outlined in the NAS report?
3. If no, are there new methods to answer key research questions that are most important to pediatric health today that capitalize on research and technology advances developed in the intervening years since the inception of the study?

I am assembling a team of experts in pediatrics, clinical study design, environmental science, genomics, computer bioinformatics, and other relevant areas within the next several weeks to advise me on the right thing to do with the study. These deliberations about the future of NCS will be transparent and embrace scientific and public input. I want to thank the NAS committee for their thoughtful and candid report.

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