Explain research, give kids greater role

Children may not be aware they're in research

Despite efforts by IRBs and investigators to improve pediatric assent, a survey of children with cancer who have been enrolled in clinical trials showed they often don't understand that what they're involved in is research and that they wanted more of a say in making the decision to participate.

The survey of children ages 7 to 19 who had participated in oncology research through the Children's Oncology Group/Pediatric Brain Tumor Consortium was published in a recent issue of the journal Pediatrics.1

Investigator Yoram Unguru, MD, MS, MA, a pediatric oncologist at Herman and Walter Samuelson Children's Hospital at Sinai in Baltimore, MD, says it is the first study to examine younger and older children's understanding of the oncology research in which they were enrolled, as well as their decision-making preferences.

Unguru's group interviewed 37 children who had previously been enrolled in trials — some very recently, some months earlier — using a Quality of Assent (QuAs) instrument created by Unguru and modeled on an adult quality-of-consent tool.

Children were asked about their familiarity with research (whether they remembered hearing a research term such as "study," "research," "protocol," etc.), their knowledge of what research was, whether they understood its goals and about their own role in the decision to participate in a trial.

Unguru says he wasn't greatly surprised by results in the understanding portion of the study:

  • Nineteen respondents (51%) didn't know or remember that their treatment was considered to be research;
  • Asked whether they were able to understand the information given to them about the trial at enrollment, 26 (70%) indicated that it was "a little hard" or "very hard" to understand.
  • Most of the children understood that the purpose of research was to increase generalizable knowledge and the most common reason they gave for participating (27 children or 73%) was to "help other children." But the same number of children incorrectly thought that the research intervention was not more risky than other interventions and that the medicines they were given were proven to be the best treatment for their illness.

Kids want greater role

Unguru says this level of understanding actually compares pretty well to groups of adult research participants surveyed in other studies.

"Adult responses aren't all that different — you'd be shocked," he says. "While the majority of the kids didn't understand things like randomization or risk/benefit or that the intervention of the experimental arm may not be as effective as the standard arm, they did get certain aspects of it. The vast majority knew that the reason they were enrolled in the trial was to help kids who have cancer in the future."

He says he was intrigued by the results of the decision-making portion of the study.

While all of the children wanted to have a role in the research decision, nearly half reported that they had little or no role in their enrollment decision and 14 of the children (38%) said they didn't feel free to dissent to enrolling in the trial. Older children tended to want greater levels of involvement and all but one said they wanted to make the decision jointly with their parents.

Unguru says those results should cause investigators and IRBs to think about how children can participate better in those decisions.

"A fair number of the kids told me that while they felt they may have had a little role in deciding to participate in their clinical trials, the main reason they enrolled was because they were told to, either by their parents or their doctor," he says.

It's a tricky issue — Unguru says there are times when it's appropriate for a parent to overrule a child's wishes and enroll him or her in a trial.

"But I do think that at an individual level, we need to, as much as possible, try to figure out what these kids are able to do," he says. "This is where it gets difficult — to what extent do we need to listen to kids and allow their decisions to carry the day? We always need to listen and we always need to offer them the ability to participate, but there are different levels of participation."

Talk about research

To improve the understanding of pediatric participants, Unguru says the kids themselves had some good recommendations.

He says the overwhelming majority of the children (32, or 87%) said they would have wanted someone to explain research to them better before they were asked to enroll in a study. Often, he says, children come in with a cancer diagnosis and in the urgency to act quickly, consent and assent are rushed so that the intervention can start.

"The kids told me they really would have liked it if someone would have told them what this whole research thing is and why it's done, as part of the (assent) conversation," Unguru says. He says that preference held even when he pointed out that time can be of the essence in starting a treatment.

"Still, half of that 87% wanted that explanation, even if it meant delaying the start of treatment — and they were aware of the consequences of that. I found that very interesting."

He says children also suggested that they would have liked to talk to other kids involved in research, to get a better understanding of what it means to be a research participant. He says some of these conversations likely are going on informally now.

"If you go into a waiting room of any pediatric oncology unit, kids talk all the time," Unguru says. "They talk, they share, they learn from one another.

"I would argue as a parent that I would like to make sure the information kids are getting is appropriate information," especially given results on the knowledge portion of this survey, he says.

Unguru says that IRBs handling pediatric studies should make sure that investigators are taking steps to ensure that kids understand what their participation means. He's currently refining his QuAs tool to shorten the time it takes to administer it and he plans to use it in larger-scale trials to gather more data.

"A pediatric oncologist or research nurse can use an instrument similar to the one that I came up with to ascertain that kids understand what they're agreeing to when they assent to research," he says. "And the kids will be able to clarify what topics they don't understand as well.

"I'm trying to shorten this tool so that it will only take 15 minutes. Because time is a problem. We're all busy, we don't have a lot of time, but 15 minutes I think we can squeeze in."


  1. Unguru Y, Sill AM, Kamani N. The experiences of children enrolled in pediatric oncology research: Implications for Assent. Pediatrics 2010 Apr;125(4):e876-83.