The US National Institutes of Health has hit the brakes on the National Children's Study, the massive longitudinal project that would sequence the genomes of 100,000 US babies and collect loads of environmental, lifestyle, and medical data on them until the age of 21.
NIH said last week it would stop the study for a review after the National Academy of Sciences released a report saying the NCS needs some major changes to its design, management, and oversight.
NIH Director Francis Collins responded swiftly to the report by pausing the NSC program, saying the NCS "has presented daunting challenges in design and implementation from the beginning."
Collins says significant improvements have already been made to the program's research plan and management over the past several years, but he adds that the project now is at an "inflection point" and that there are concerns within NIH and from outside experts about whether the study is ready to scale up to full size.
Collins says he wants answers to three core questions. Is the study actually feasible, particularly in light of budget constraints? If so, what changes need to be made? If not, are there other methods for answering the key research questions the study was designed to address?
Science reports that the NAS recommendations include making some changes to the core hypotheses behind the study, beefing up scientific input and oversight, and enrolling the subjects during pregnancy, instead of at birth, as is the current plan.
"It's not like [NICHD needs] to start at square zero again," because much of the groundwork for NCS has already been laid, Greg Duncan, an economist at the University of California, Irvine, who worked on the panel that produced the NAS report, tells Science.
However, these changes would mean the study's initial recruitments, currently planned for 2015, will probably need to be delayed, Duncan notes.
Collins says he is assembling a team of experts in pediatrics, clinical study design, environmental science, genomics, bioinformatics, and other areas to advise him on what should be next for the NCS.