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

nformation they are given about their treatments. In conjunction with the Belmont Report a core historical document that lays out ethical principles and guidelines Unguru says the onus is on physician-investigators to verify that childhood patients understand.

However, it turns out that little rigorous research has been done to determine just how much minors with cancer actually understand about the treatment trials, Unguru says. He explained that, when doctors diagnose a child with cancer, they often also know about clinical research projects that hold promise for treatment and ask their patients and parents if they would like to participate.

Typically, physician-investigators first ask the adult decision-maker, then turn to the child. Unguru said some doctors are very thorough throughout this process, while others aren't.

"Rather than going through the assent process as it was meant to be done, often times the child signs a piece of paper, and all it represents is an empty signature," Unguru said. "The child may not know what he or she is signing because the parents often just say, Sign here."

The study is the result of face-to-face interviews with cancer patients from age 7 to 18 years and is believed to be the first examination of children's understanding of and preference for involvement in research. Unguru says past studies on children's comprehension of research participation have largely relied on hypothetical cases based on surveys of healthy, older adolescents.

Unguru acknowledged that age or perhaps even the young patients' health, or state of shock and confusion in the face of a cancer diagnosis might have made it impossible for some of them to fully grasp the concepts of clinical research. But, he insists, that doesn't mean doctors shouldn't at least try to do better.

"I argue that we have to do better, because if we do agree that assent is an important process and an important ideal, then we h
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Contact: Michael Pena
mpena@jhsph.edu
410-625-7872
Johns Hopkins Medical Institutions
Source:Eurekalert

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