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Lawmakers seek to resurrect National Children’s Study

A huge study of U.S. children that the National Institutes of Health (NIH) terminated last year after spending more than $1 billion appears to have come back to life. House of Representatives and Senate spending committees this week called for a new version of the National Children’s Study (NCS) in 2016 that would be funded at the same level as the now-defunct NCS—$165 million a year.

According to sources, lawmakers agreed with pediatric groups that the study’s goals were too important to abandon. NIH is moving ahead with planning for the new study.

The history of the NCS goes back to 2000, when Congress called for NIH to follow a large group of children from before birth to age 21 and explore the influences of the environment, from toxic chemicals to social factors, on children’s health. Researchers set out to recruit 100,000 pregnant women at sites around the country. But the study became bogged down by a complex, expensive recruitment strategy. In December 2014, after an Institute of Medicine report found serious design and management flaws, NIH Director Francis Collins canceled the study.

This year, NIH has been archiving data from the NCS’s 40 Vanguard pilot centers, which had recruited 5700 women and their infants, and spending much of the $165 million that had been allocated for 2015 on related pediatric research, such as new tools for measuring exposures and studies of the placenta.

But now it seems the NCS is back. The House Appropriations Committee on 24 June approved a spending bill for the 2016 fiscal year that begins 1 October that tags $165 million for a “National Children’s Study Alternative.” An accompanying report (see p. 77) explains that lawmakers were “disappointed” by NIH’s decision to end the NCS and want NIH to work with pediatric groups to come up with a 10-year research plan that builds on NCS data and goals. NIH could leverage existing maternal and infant cohort studies, the document says. A House Republican staffer told ScienceInsider that, “after spending more than $1 billion [on the NCS], we believe instead of having all the research wasted that it needs to be reformed and refocused.”

The Senate’s version of the bill, approved by a committee on 25 June, also allots $165 million for the study. And its report, not yet officially released, has similar language—NIH should “recalibrate and realign the investment already made in the NCS to initiate new and focus existing longitudinal studies,” it says. Both bodies call for a scientific advisory committee to guide the effort.

Congress won’t decide on a final version of the spending bill that includes NIH until later this year. But the similarity of the House and Senate language on the children’s study increases the likelihood that it will be part of any final legislation.

NIH, which had requested $158 million in 2016 for pediatrics research related to the NCS’s goals, appears to be moving forward with the new NCS-like study. At an NIH advisory committee meeting earlier this month (2:16 here), NIH Principal Deputy Director Lawrence Tabak explained that the agency is looking at “creating a synthetic cohort from existing longitudinal studies.” Tabak expects to release a proposed plan in September.

The American Academy of Pediatrics (AAP), which has been urging lawmakers to fund a new version of the NCS similar to that described in the House and Senate reports, is “pleased with the proposed funding to develop an alternative to the NCS,” an AAP spokesperson said. “Congress made the right call for children’s research.”

Although he’s also happy with the House and Senate bills, former NCS investigator Dean Baker of the University of California, Irvine, says he’s concerned that NIH may stick to existing cohort studies instead of launching new birth cohorts needed to study early development. Baker and pediatrician Phil Landrigan of Mount Sinai Hospital in New York City recently co-authored a commentary in The New England Journal of Medicine urging NIH to fund a “confederation” of birth cohort studies at academic centers to replace the NCS.