Another expert counsellor to the US National Children’s Study (NCS) has resigned, marking the second resignation in less than two weeks from the government-appointed committee of advisers to the nascent study, which aims to track environmental influences on the health of 100,000 US children from before birth until age 21.
Jonas Ellenberg, a biostatistician who is also associate dean for research programme development at the University of Pennsylvania’s Perelman School of Medicine in Philadelphia, wrote this resignation e-mail on 16 March to Steven Hirschfeld, the study director. In it, he argues that the National Institute of Child Health and Human Development (NICHD) is taking the study in a direction that “does not reflect the parameters of study design reviewed and endorsed by the [Institute of Medicine of the US National Academies] in 2008”. Given this, Ellenberg “strongly” urged that the NCS be reviewed a second time by the Institute of Medicine (IOM).
This 2008 review of the NCS by the IOM found one of its key strengths to be its representative sampling of the US population. “The large, nationally representative, equal probability sample design, together with the inclusion of a large number of outcome and exposure measures over a long time span, are major strengths of the NCS,” the IOM committee wrote.
But last month, on pages 34 and 35 of this budget document submitted to Congress, the study leaders at the NICHD announced that they expect to abandon a national probability sample in favour of recruiting subjects from the offices of physicians and other health-care providers. That prompted the 5 March resignation of Ellen Silbergeld, an environmental scientist at Johns Hopkins University in Baltimore, Maryland, who asserted that the change means that the study “will no longer provide representative information of value to practitioners, researchers, and the public”.
Dissatisfied scientists involved with the multibillion-dollar study have been contacting their members of Congress to voice their concerns about its change in strategy. Francis Collins, director of the National Institutes of Health (NIH), who has ultimate authority over the study, may face hard questions on the issue as early as 20 March, when he will be testifying before the House subcommittee that funds the NIH.
Nature first reported about the change in study strategy last month. This report in Science further noted that the change may mean that the 105 counties initially recruited for the study will no longer be engaged in it.