Are parents willing to allow children to participate in clinical research?
Studies show support for research, even when child won't benefit
To achieve success in pediatric research, investigators need to reach and convince one vital group of people — parents, who must decide whether to expose their children to the inconveniences and even potential risk of research participation.
Two recent studies have provided some insight into attitudes of parents toward their children's participation in research. The findings have a common theme: While some parents are reluctant, there is a substantial group of parents who would give consent for their children — if only anyone would ask them.1,2
"We were surprised that 92% of parents said they'd never been asked about participating in research involving children," says Matthew M. Davis, MD, MAPP, associate professor of pediatrics and assistant professor of internal medicine and public policy at the University of Michigan in Ann Arbor and director of the C.S. Mott Children's Hospital National Poll on Children's Health.
"That number to us suggests many missed opportunities for the research community to reach out to parents and children with the potential to participate in meaningful research regarding children's health."
He and David Wendler, PhD, head of the unit on vulnerable populations in the department of clinical bioethics at the National Institutes of Health, Bethesda, MD, say there are steps IRBs can take that would help ensure families get the information they need to decide whether to allow their children to participate in clinical studies.
"I think the take-home message for IRBs is that parents and kids are willing to be in this sort of research — not all of them, but the data suggest that a lot of them are willing to be, particularly when it's an important study," Wendler says. "Even if it's not going to help them personally, they want to contribute to an important project. So it's important for IRBs and for investigators to inform parents of that, without exploiting that possibility."
Polling parents
In December, the C.S. Mott Children's Hospital called more than 2,100 randomly selected adults to ask them about research participation. They completed a survey asking them whether they or their children ever had participated in research, and whether they would allow their children to do so.1
Ten percent of parents reported having been enrolled in research themselves, while 4% said their children had been in a medical study.
Parents were asked whether they would allow their child to participate in a study involving a new medication that previously had been found to be safe in adults. Thirty percent said they would.
Asked about more specific research scenarios, 25% percent of parents would allow their children to participate in a study as a healthy volunteer, as long as the risks were small, and 36% would allow their children to be in a study if the child had the disease being studied.
Davis says he finds these to be promising statistics — particularly the number of parents willing to let their children test drugs previously shown to be safe in adults.
"That is a huge part of pediatric research," he says. "That means we have a very large number of families out there who might participate if only they were asked. The question is, what's stopping us from asking?"
He says part of the answer may lie in insufficient funding for pediatric research, which C.S. Mott and other children's hospitals are seeking to rectify by supporting the Pediatric Research Establishment Act, currently before Congress. The bill would increase funding for cutting-edge pediatric research.
"Another possibility is that we need to improve the systems through which we try to recruit families to research," he says.
Davis says IRBs can contribute to that system by helping researchers understand the factors that are more likely to encourage or discourage parents from participating. Some of those factors were identified in the C.S. Mott survey.
Reasons parents might choose to include their children in a study were:
- If the risk of harm were small (42%);
- If the disease being studied ran in their family (32%);
- If their doctor encouraged participation (30%);
- If the research would help other children (27%); and
- If the child received payment (17%).
Some reasons they might decline to allow their children to participate were:
- Too high a chance for harm (73%);
- Concern about their child being used as a "guinea pig" (60%);
- A belief it was "inappropriate" for their child to participate (41%);
- If their child's doctor wasn't directly involved (38%); and
- If the disease being studied didn't affect their child (36%).
Davis says IRBs can encourage investigators to address those parental concerns during the recruitment process.
"I think it can be favorable for IRBs to advise investigators about these common stumbling blocks for parents," he says.
Davis suggests that IRBs also can be involved in efforts to broaden the appeal to families to become involved in research, while ensuring that such efforts are done in an appropriate way.
"I don't mean to say that IRBs are going to start advertising for research, but I do mean that there is a way to encourage families to consider research who may not have considered it before," he says.
Research without benefits
Wendler's group looked in more detail at a very specific type of pediatric research — studies in which children did not stand to potentially benefit clinically.2
He says these types of studies can make IRBs and even investigators very squeamish.
"There are a lot of people reluctant to approve them," he says. "I know a lot of people who are very reluctant to conduct them. Even pediatric investigators I talk to are nervous about it. They're not sure if what they are doing is acceptable or ethical."
While many children are enrolled in non-beneficial research, he says studies show that people often don't understand the difference between clinical care and clinical research, and so may not realize a study has no potential for benefit to their child.
Wendler's goal was to see if parents and children were willing to be involved in non-beneficial studies in principle.
His team surveyed 81 pairs of parents and children already involved in clinical care or in treatment trials for asthma or cancer, asking whether they would be willing to participate in various hypothetical clinical studies:
- When asked about a study with no benefit to the patient and posing a risk of headache, 71% of children and 72% of parents would agree to the child's participation.
- For a non-beneficial study that posed a small chance of a broken leg, 43% of children and 24% of parents would agree.
- When asked about a trial that posed a one-in-a-million chance of dying, 42% of children and 18% of parents were willing to let the child participate.
Wendler's group also asked children and parents whether they would be more willing to participate in non-beneficial research or in a charitable activity. More than a third of the children and more than half of the parents were equally willing to allow either activity.
He says federal regulations base their definitions of risks to children on activities they engage in as part of their daily lives. He thinks charitable activities are a more natural comparison and wanted to see how people perceived the two in a side-by-side comparison.
"Surprisingly, the children who were in research were more willing to help others by being in research, rather than by participating in a charitable activity," Wendler says. "When we asked them why, some would say, 'It won't help me but you can help more people by being in research. You can help kids with diseases and that's what I care about because I have a disease and I appreciate that.' You got the kind of responses that suggested that they really understand."
Assessing risks
The study also revealed the difficulty many people have in accurately comparing potential risks, Wendler says.
While only 18% of parents would allow their child to enroll in a non-beneficial study that posed a one-in-a-million chance of dying, 93% would allow their child to participate in a similar study described as having "the same risks as riding in a car."
Wendler notes that the risk of death in many car trips is more than one in a million.
"At least for these parents, wording that question that way leads them to prefer the more risky to the less risky activity just because of the way it's worded," he says. "I think it really does raise an interesting question about what's the right way to present this information to get people to make decisions that are reasonable for them."
He says IRBs need to be aware of how changes in the way data are presented may change people's perception of risk involved.
"Just being sensitive to the way the risks get described can have an enormous impact on the decisions parents and kids are going to make," he says. "That's not to say that I know right now what the right way to do it is. But at least it's good for them to be sensitive to that possibility and think about it."
Wendler says studies such as his own and the C.S. Mott poll, which deal in hypothetical situations and not the particulars of a real research decision, are necessarily limited.
"Those questions are very different than the decision that a parent faces when they decide whether or not to enroll their kids in an actual study," he says. "In that case, you've got a nurse or a doctor who's sitting down with you and asking you to do it and I think that changes it."
But he says he likes the idea of such polls, which can help achieve more of a national consensus on research.
"Right now, on the one hand, we want to protect the individual kid, and are very reluctant to do this sort of research," he says. "On the other hand, we want to improve clinical care for kids, which means we have to do this kind of research. I think we need more discussion and agreement on how to balance those two vital considerations in the right way."
References
- C.S. Mott Children's Hospital National Poll. Children in research: Many parents willing if risk of harm is small. May 12, 2008; Vol. 3, Issue 5. Available at: www.med.umich.edu.
- Wendler D, Jenkins T. Children's and their parents' views on facing research risks for the benefit of others. Arch Pediatr Adolesc Med 2008;162:9-14.
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