The nation's biggest kids study is coming to Utah this month. But ethical questions remain, like what to tell parents about their children's health.
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Starting this month, thousands of newly pregnant Utahns and potential mothers-to-be will be asked to enroll in the largest study of children ever conducted in the country.
Parents who sign up for the National Children's Study will join an effort to solve a new mystery in children's health: How do kids' genes interact with the water they drink, the air they breathe, the soil they play in and the products they use -- to make them sick?
Scientists will be searching from womb to bedroom and beyond to understand why children increasingly suffer chronic diseases, such as asthma and learning disabilities, that have no other known cause.
Researchers will be figuratively -- and sometimes literally -- peering over mothers' shoulders, from gauging how close they are to their child to probing how much television or junk food they allow. They'll scan blood, urine, hair and nails to see what children or mothers are exposed to, from pesticides to drugs to stress.
"We recognize this is very, very intrusive," says Sean Firth, an epidemiologist and study project director in Utah. "We will become part of their lives."
Every scrap of information that will be collected is thought to be linked to a particular disease, he says, whether it's prenatal infection and autism, household dust and asthma, or family dynamics and child development.
"We are going to accomplish great things by pulling this off," says Firth.
But the massive study -- the goal is to enroll 100,000 children nationwide and follow them to age 21 -- also raises ethical questions: How can a parent commit their future child to tests and questions that not even researchers have dreamed up? And what do parents deserve to know about their children's health and environment -- and when?
'Change the world' » In Salt Lake County -- one of seven national pilot sites -- recruiters will start knocking on the doors of 7,000 households during the last week of April. It could take six months to reach every home in the study boundaries.
They will look for women ages 18 to 49 who are in their first trimester of pregnancy or women who are likely to become pregnant in the next five years. Teens who become pregnant during the study period will also be approached. Biological fathers will be invited, but don't have to participate for their children to be included.
The study will attempt to address the changing nature of childhood diseases. Although children used to die or suffer from infectious diseases, now their biggest threats are chronic diseases, which arise from the interaction of genes and environment, according to the study.
South Salt Lake mom Bronwen Calver hopes Utah women enroll to possibly help her son or his future children. Julian, 13, has asthma and allergies. While his asthma led to hospitalizations for bacterial pneumonia when he was a toddler -- he coughed so much he broke capillaries in his lungs -- it's under control now. Still, on bad-air days during the winter and summer, he uses an inhaler and stays indoors.
"I hear of more and more kids having asthma. You have to wonder if there's something environmental causing this," she says. "A lot of people don't understand how debilitating asthma can be. It makes your world very, very small when you're sick."
To build support, the local research team has been meeting with elected officials and community leaders in churches, ethnic organizations and schools.
Julie Miller, principal of Wasatch Elementary in Salt Lake City, is ready to urge parents to participate. She sees more children at school with asthma, allergies and diabetes. "I care [about the study] because I've spent a lifetime working with kids. ... There are things we can do to change the world we live in that will have a better outcome for all of us."
Breast milk to bedsheets » But on the national level, researchers acknowledge recruitment will be a "significant challenge" due to the burden placed on families. Over two decades, participants are expected to meet with researchers about a dozen times for four hours each, in their homes or at a clinic; keep records of doctor visits and fill out dozens of questionnaires. In the first two years alone, participants will devote 38 hours.
Researchers will take environmental samples from children's homes, and possibly day care centers and mothers' workplaces. They will chart graffiti, traffic and recreation spots in the neighborhoods.
They will vacuum household dust from tabletops, floors and bedsheets; take samples of placentas and umbilical-cord blood; collect vaginal swabs during pregnancy and breast milk afterward. They will gauge children's development, from language to motor skills, even videotaping mothers and infants playing.
Families will be paid $25 an hour for in-home and clinic visits and will receive gift certificates and other incidentals.
Because researchers don't know what information they will want to gather in the future, parents and children will be told at each visit what to expect. They can bow out at any time, or decide not to participate in certain portions. Children will be asked their opinions around age 7, 14 and 18. If they say "no," their parents cannot overrule them.
Asking consent before every visit makes the study "ethically stronger than much of what we do otherwise in research," says Jeffrey Botkin, associate vice president for research integrity at the University of Utah. He raised such ethical issues at the national level as co-chair of the study's ethics working group.
The commitment "sounds like a lot," says Andrea Riddle, who is trying to become pregnant with her second child. Nevertheless, the 31-year-old from West Jordan hopes to join, believing research of this magnitude requires the intrusiveness. "It's always better to know more about what's affecting children, how children are getting sick, how the environment affects them."
Gift to the future » If Riddle joins the study, she would want feedback as scientists discover environmental factors that affect children's health. "If they found your home is not safe -- something in the air, pesticides close by that could cause problems with the child -- I would hope they would [give] you the information right away."
But beyond immediately sharing information like blood pressure, height and weight, researchers are still working through how they will report other information, prompting criticism from the National Academy of Sciences (NAS). It reviewed the study last year at the federal government's request.
"Parents are often eager to get research results, regardless of their clinical utility or the availability of effective intervention," the NAS report said. The review also noted that researchers could be sued if they learn that certain exposures are dangerous and don't alert families to them.
"They need to have a plan on what they're going to do," says Ellen Wright Clayton, co-director of the Center for Biomedical Ethics and Society at Vanderbilt University, who was on the NAS review panel.
She says her personal opinion is that parents should be told, for example, if an ultrasound detects fetal deformities or a blood test reveals anemia. That's because those are known health effects or risks.
The study's researchers agree, and also will share information about signs of illnesses or developmental delays. But it's more complicated with other information. Most biological and environmental samples won't be analyzed until years later -- when and if funding becomes available -- delaying when researchers learn of risks.
Another problem: There are no national reporting standards for some samples, such as organophosphates, a chemical used in pesticides, says Edward Clark, chairman of the U.'s pediatrics department and principal investigator of the Utah portion of the study.
So researchers will have to determine what levels are dangerous before reporting to participants -- and potentially, neighborhoods.
Somewhere in the country, "We will have another Love Canal," Clark predicts, referring to a New York neighborhood built on top of toxic waste. "Our pledge is to bring this [information] back in a responsible way so individuals and communities will be aware of it and can develop an appropriate response."
Scientists will immediately analyze specimens that cannot be stored for long periods of time, including volatile organic compounds, according to Rod Larson, who is in charge of the study's environmental monitoring in Utah.
Such gasses are emitted from products such as paint, cleaning supplies, furniture and carpet, and are known to cause cancer and organ damage, according to the Environmental Protection Agency. Participants will be told if levels are too high as soon as the information is available, Larson says.
Firth, the Utah study project director, says it wouldn't make sense to share other information too soon, when researchers don't know what level is dangerous. "People [would] look at that and see a big chemical name and think, 'Holy cow. I'm in trouble.'"
Clayton, who recently joined an advisory committee for the study, agrees and says parents should understand what they are signing up for.
"A lot of people participate in research because they think they're going to learn something about their own health. ... They need to realize that participating in this is a gift to American children and the future."
Want to join in? You have to be invited
When will it be done?
Researchers will be tracking children from before birth to age 21, but they won't wait until 2025 to share results. Instead, they will analyze the data as funding becomes available. Preliminary results on birth disorders should be revealed in two years.
What is Utah's role?
Salt Lake County is one of seven sites piloting the study. A total of 105 sites across the country will be included.
Led by the University of Utah Department of Pediatrics, recruiters also will enroll Cache County women starting in 2011, as well as women in Lincoln and Uinta counties in Wyoming and Bear River County in Idaho. Utah's portion is being funded by a $50 million, five-year contract with the federal government, which will pay for 90 employees. Federal funding to continue the study is not guaranteed.
The Primary Children's Medical Center Foundation is funding separate research on related topics, including how infertility treatments affect infants and how domestic violence affects children's health.
How do parents participate?
Recruiters are targeting 15 Salt Lake County neighborhoods that were randomly chosen in 11 cities: Bluffdale, Cottonwood Heights, Draper, Magna, Midvale, Salt Lake City, Sandy, South Jordan, Taylorsville, West Jordan and West Valley City.
If you don't receive a letter or a knock on the door over the next six months inviting you to participate, you can't.
Who's in charge?
Authorized by Congress in 2000, the study is being led by agencies in the U.S. Department of Health and Human Services and the U.S. Environmental Protection Agency.
Where will data be stored?
After collection and packaging in Utah, samples of blood, urine, water and dirt will be shipped to Westat, a Maryland-based corporation contracted to be the coordinating center for the study.
How will privacy be protected?
Biological specimens -- blood, urine, hair, nails -- will be given unique identification numbers unrelated to the participants' personal information. Data that would tie the samples to a child or a parent, or other information about them, will be kept "separately, securely, and confidentially," according to the national research plan. The National Children's Study also has pledged to protect the data from forced release through a court subpoena.
Researchers must report to authorities if they believe children are in imminent danger or are being abused. Adults at risk of domestic violence will be offered help. And families in need of services such as food or clothing will be referred to help.
Here's what researchers are expected to do during a home visit when the child is 1 year old:
Sample » Indoor air, house dust, drinking water, noise levels, soil.
House » Observe integrity of painted surfaces, presence of appliances, structural integrity.
Neighborhood » Observe type and condition of houses, type of businesses, recreational areas, graffiti, traffic.
Sample » Breast milk.
Wellness » Ask about excessive alcohol use, substance abuse, mental health, use of pesticides, exposure to pets.
Parenting practices » Ask about attachment to child, activities with baby, attitudes about being a parent.
Sample » Blood, urine, hair and saliva.
Health » Ask about child's vaccines, teething, diet, injuries, child care, medicines, supplements, and use of car seat, TV and pacifiers.
Test » Language development, social interaction, motor development and cognitive abilities.
Source: National Children's Study Research Plan