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Childhood cancer patients enrolled in clinical trials need clearer communication about their role
Date:3/28/2010

A small study of children with cancer enrolled in therapeutic clinical research trials shows that they don't fully understand what physicians and parents tell them about their participation, nor do they feel they are genuinely involved in the choice to take part.

The study, led by Yoram Unguru, M.D., an associate faculty member at the Johns Hopkins Berman Institute of Bioethics, will be published online March 29 in the journal Pediatrics.

While an estimated 70 percent of young cancer patients participate in clinical trials during their treatment, more than half of the 37 children who were interviewed for the study did not know or recall that their treatment was considered experimental or part of research, the investigators report.

And out of a subset of 22 children, 19 of them did not understand their doctors' explanation at the time they agreed to take part in the clinical trial.

In addition, irrespective of age, every child interviewed with a 69-part questionnaire said they wanted to be involved in decision-making about their care and participation in research. Permission to participate in Unguru's study was sought first from the parents and adult caretakers, and then from the children.

"It was very enlightening to listen to the kids themselves talk," said Unguru, a pediatric hematologist and oncologist in Baltimore at the Herman and Walter Samuelson Children's Hospital at Sinai. "For the vast majority, their parents were the ones who made decisions and decided what was going to happen."

Longstanding doctrines are in place to ensure that human research subjects understand and consent to participate in advance. Furthermore, federal law explicitly requires that children must "provide their affirmative agreement" to participate in research "whenever possible."

Meanwhile, the American Academy of Pediatrics Committee on Bioethics states that doctors should ascertain that children comprehend i
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Contact: Michael Pena
mpena@jhsph.edu
410-625-7872
Johns Hopkins Medical Institutions
Source:Eurekalert

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