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Study raises thorny questions about research on pregnant teens
Recruiting, who should give consent, can be tricky
Because of the unusual scope of the National Children's Study (NCS), it raises a significant range of ethical issues for its designers and for the IRBs that have been reviewing it at 105 study centers across the United States.
Although many of these issues have come up before in pediatric research, the multisite nature of the study meant that there were a number of areas where different IRBs might see things differently, says John Santelli, MPH, MD, an adolescent medicine specialist at Columbia University, New York City, who served on the NCS's ethics working group.
While the ethics working group's members obviously focused closely on federal regulations, many had IRB experience and also were trying to view the study in terms of dealing with IRBs, Santelli says.
"You know IRBs, they all see different sides of an issue," he says. "How do you coordinate all of that?"
The process, while lengthy has led to approaches that Santelli says may hold lessons for IRBs in reviewing other pediatric studies.
A case in point: Whether and how to recruit pregnant teens and teens who may become pregnant to the study in order to follow the progress of their children. Santelli says it's important to include pregnant teens in the National Children's Study, because they are more likely to have environmental exposures that may affect their children. But there were questions as to whether they could give consent on behalf of themselves and their fetuses to participate.
Santelli says the group looked closely at 45 CFR 46, subparts B and D, as well as state law, to try to arrive at some solutions.
One group Santelli was concerned about was teenagers who were not pregnant but were sexually active and could become pregnant. Plans were to recruit women over age 18 in that situation, but Santelli says dealing with teenagers raises some thorny issues.
Would it be ethical to recruit a teenager at risk of becoming pregnant without advising her about pregnancy prevention? Would requiring parental consent cause disclosure problems, since the teen might not want her parents to know she was sexually active?
In the end, it was decided not to attempt to recruit "pre-pregnant" adolescents.
"The IRB would have said, you can't just recruit 16-year-olds and 15 year-olds and expect them to get pregnant, you probably have to do some prevention," he says.
Who gives consent?
With pregnant teenagers come consenting issues – at what point is a teenage girl allowed to make her own decision to enroll in the study on behalf of herself and her fetus?
Santelli says different states have different laws governing medical treatment, age of majority and emancipation of minors. Pregnant minors in 28 states may consent for their own health care, while a similar number of states allow them to make health decisions for their fetuses.
He says the working group "pleaded for flexibility" from IRBs in dealing with these issues, since one pregnant teenager may be very different from another. Taking a firm position that a teen always should be the one to give consent, or never should, isn't practical.
"In some cases, the teen mothers are very responsible, in other cases you're going to find a teenager who's actually turned over the raising of the child to a grandmother," Santelli says. "If Grandma is raising the child and bringing the newborn in for health care and research visits, you've got to somehow recognize that, and if the mother is doing that job, you want to recognize that."
Santelli says he believes IRBs can use that same flexibility in dealing with pregnant teens in other research.
"The regulations provide a lot of flexibility about what is the best thing to do," he says. "You ought to use your common sense," he says. "I think IRBs often want to have one informed consent process that's kind of uniform for everybody. For most situations, that makes good sense – you don't want to have some people get the consent form and others not get the consent form.
"But when you're dealing with his kind of situation, you ought to be ready to deal with these realities. I think if you just use common sense, an IRB will come up with good solutions."