National Children's Study (NCS) Working Group
The National Children's Study (NCS), which was requested by Congress through the Children's Health Act of 2000, is currently 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. Pilot efforts (known as the Vanguard study) have been mounted over the last five years, but the "Main Study" has not yet been initiated. Without question, the NCS has presented daunting challenges in design and implementation from the beginning. Based on results of early pilot work, significant changes were made to the research plan and management over the past several years. However, there have been continued concerns, both from outside experts, National Institutes of Health (NIH) senior leadership, and most recently the National Academy of Sciences (NAS) about whether the NCS is fully ready to scale up to the main study. A recent NAS report raises significant concerns about the design, management, and oversight of the main study, calling for a re-examination of the methodology and feasibility of this ambitious study.
The NCS Working Group of the ACD is charged with evaluating whether the NCS is feasible, as currently outlined, especially in light of increasing and significant budget constraints.
- If "yes", assessing how NIH can move forward to implement necessary changes, including some of those outlined in the NAS report.
- If "no", identifying whether there are 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.
Process, Deliverables, and Timeframe
The NCS Working Group of the ACD will present a final report for consideration by the ACD at its December 11–12, 2014 meeting.