20 JUNE 2014 • VOL 344 ISSUE 6190 1327 SCIENCE sciencemag.org
By Jocelyn Kaiser
After more than a decade of costly de- lays, a controversial plan to study the health of 100,000 U.S. babies to age 21 is in limbo again, in the wake of a critical outside review released on 16 June. At best, researchers will
need to rethink their plans yet again. At
worst, the National Institutes of Health
(NIH) may cancel the study.
The National Children’s Study (NCS)
“offers enormous potential, but it also presents a large number of … challenges,” says the
critique from a National Academies panel. To
overcome them, the academies recommend
that the study’s leader, the National Institute
of Child Health and Human Development
(NICHD), refine the study’s guiding hypotheses, bolster scientific input and oversight,
and modify how it recruits children.
“It’s not like [NICHD needs] to start at
square zero again,” because much of the
groundwork for NCS has already been laid,
says the panel’s chair, Greg Duncan, an economist at the University of California, Irvine.
But the needed changes would likely delay
initial recruitment, now planned for 2015.
And the price tag that the National Acad-
emies puts on the revamped study—upward
of $1.5 billion—could erode support for the
ambitious effort. In a statement, NIH Direc-
tor Francis Collins said that in response to
the “significant concerns” raised by the re-
port, he is putting NCS on hold.
NCS grew out of a request from Congress,
made 14 years ago, that NIH follow a large
group of children from birth to adulthood
in a bid to understand how environmental
factors, including social settings and chemical pollutants, influence health. Planners
decided to recruit 100,000 women and their
unborn babies by knocking on household
doors in a random sample of about 100 U.S.
counties. But this approach proved too ex-
pensive, so NICHD turned to other designs.
Members of Congress expressed concern in
2012, after NICHD, having spent $1 billion,
decided to pull the plug on 40 NCS sites run
by academic investigators and turn over
to large contractors the job of tracking the
4000 families it had already enrolled in a pilot study (Science, 11 January 2013, p. 133). In
March 2013, Congress called for the National
Academies’ National Research Council and
Institute of Medicine to review the study and
In general, the panel endorses the NCS
Europe and Japan, it notes, but the U.S. ver-
sion would be more comprehensive, in part
because researchers would collect exten-
sive data on environmental exposures. The
panel also agreed with NICHD’s decision to
design the study as a “data collection plat-
form” guided by just a few hypotheses—such
as that exposure to kitchen dust exacerbates
respiratory problems—and add more later.
But these “exemplar hypotheses” need to
be more scientifically robust, the National
The panel also found fault with how NCS
planned to recruit subjects: by enrolling
45,000 babies during the mother’s pregnancy and the same number at birth. Because this would miss prenatal exposures
during pregnancy, the panel urged NCS to
enroll 95,000 pregnant women—which it
could do for the same cost if it dropped plans
for separate studies of 10,000 women. Those
smaller studies were to focus on questions
such as preconception exposures and the effects of natural disasters. Enrolling siblings,
as is planned, could provide similar data on
preconception exposures, the panel noted.
Such changes would enable NICHD to en-
roll participants for about $1.5 billion over
7 years, the panel estimates, with annual
costs peaking at just over $300 million. (NIH
is now allocating $165 million per year for
the study.) Earlier NIH estimates predicted
the study could cost $3 billion. But the National Academies estimate does not include
costs such as archiving data and storing biological samples, the report notes.
Scientific leadership of NCS is a major
deficiency, the report finds. Although the
study has various advisory committees, “the
processes by which study decisions are made
and vetted are opaque,” it says. NCS needs
more expertise within its program office, the
panel concludes, as well as a new scientific
management group that has the authority to
approve the study’s design.
The report is seen as vindication by some
NCS critics, including academic scientists
who were pushed out of the study 2 years
ago. “Its conclusions are essentially the
same as mine. They’re just putting it more
nicely,” says epidemiologist Nigel Paneth of
Michigan State University in East Lansing,
who led a former NCS site in Detroit and has
been a vocal critic of study leadership.
Now that the National Academies has had
its say, the question is whether NIH will embrace its recommendations—and whether
Congress will keep funding the study. Collins
said he will assemble a team of experts to
advise him in the coming weeks on whether
the study is “actually feasible” given current
budget constraints and to help him decide
“the right thing to do with the study.” ■
NIH puts massive U.S.
children’s study on hold
National Academies report calls for overhaul
A plan to track the health of
100,000 U.S. babies is in jeopardy.