What will the US government owe the hundreds of thousands of Americans it will swab, prick, track and trace over the next 21 years, in the largest children's health study ever? So far, the answer from the National Children's Study is "not much".
The study, a joint effort led by the US Environmental Protection Agency and the National Institute of Health, also raises questions about a patient's right to privacy and to his own health records, according to a bioethicist who reviewed the NCS plan.
To understand the causes of asthma, obesity and other troubling childhood disease trends, the NCS will sample DNA and monitor the health and environmental exposures of 100,000 kids, throughout their youth, from the womb to the dorm room.
Such a huge sample will ensure that less common diseases, such as autism, are captured in the study.
To aid their hunt for lead and countless other toxins, NCS organizers in 2004 explored the use of RFID and GPS transponders, wireless motes and sensors implanted under the skin.
But the government balked at having to corral an overload of data from the devices, said Sarah Keim, NCS associate study director for operations and logistics. A 2004 report for the NCS, commissioned by the EPA, also envisions fashion-conscious teens rebelling against the sensor-laden clothes mom gave them.
The report concludes that implantable sensors, while promising, "are still too invasive and prompt numerous ethical concerns". There are similarly "no plans" to chip babies' diapers and men's underwear - another idea mentioned in the EPA report - according to Keim.
The NCS will still get its pound of flesh from volunteers, quite literally, through extensive biological sampling. At the top of the NCS doctors' wish list for samples: hair and nail clippings, baby teeth, saliva, urine, blood for genetic testing, breast milk, umbilical cord blood, placenta and meconium (a newborn's first poop).
All data collected for the NCS will be scrubbed of any personally identifiable information before researchers can see it, said Keim. The NCS is one of several colossal epidemiological studies coming online globally, made possible by ubiquitous sensors, faster computer processors and advances in genetic testing. Like the UK Biobank, which will examine the health of a half-million middle-aged Britons, the NCS is expected to generate a mountain of genetic test results.
And many study participants will want to see their results, the NCS has discovered in its surveys. The problem is that doctors will not know what most of the DNA test results mean. "Science has not advanced to the point where we know the clinical significance of many genetic markers," Keim said.
Test results can also be wrong, said Vanderbilt University bioethicist Ellen Wright Clayton, who reviewed the NCS research plan as part of a National Academy of Sciences panel. "Research labs do not have the same quality control measures as diagnostic labs," said Clayton.
Clayton declined to speak on behalf of the NAS panel, or specifically about the NCS. In a world already full of hypochondriacs self-diagnosing themselves via Google, doctors now fear raw research data and early findings might prompt patients to make bad choices. "Returning incidental findings (to patients) is one of the most vexed topics in research ethics," Clayton said. "We are in the middle of a huge debate."
In other words, scientists aren't sure whether or not they should return DNA test results to volunteer subjects, even those fearing they might have a genetic disposition to a particular form of cancer, for example.
The budget for the NCS - about $100 million per year - might not be enough to cover genetic counselling for individuals. Even as it searches for a full-time bioethicist, the NCS is moving forward. NCS workers in January 2009 will begin fanning out in a door-to-door search for test subjects. Recruiters in several US cities will be seeking a "vanguard" sample of pregnant women, and those not yet pregnant - asking them to commit themselves and their kids to 21 years of interviews, physical exams and lab tests. Getting poor Americans on board will not be easy, however.
Many Native Americans, for example, will not want to part with their hair, the NCS has found. Hair and the placenta are considered sacred by many tribes. Pregnant and parenting teens in one NCS focus group placed a high price on their umbilical cord blood and placentas, and their baby's blood. Volunteers can opt out of any part of the study that makes them feel uncomfortable, said Keim.
To ensure proper consent, women with cognitive impairments and some with mental illnesses will be excluded. NCS recruits, many living in dire poverty in housing projects and on Indian Reservations, might feel they are giving more than they are getting.
A promotional video for the NCS says participation is all about family and country. "People will look back on this and say, 'My kid was in the National Children's Study,' and that will be a point of pride for that family,'" said Dr Donald Dudley, an advisor to the NCS from the University of Texas, in the video.
NCS subjects, then, can expect little more than gestures of thanks for their prolonged assistance. "Volunteers," said Keim, can expect a "t-shirt, small toy, or gift certificate, and also modest monetary incentives for completing each visit." ®