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. 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."
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, said lead researcher Yoram Unguru. 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," Unguru said. "It may not know what he or she is signing because the parents often just say, Sign here."
Unguru acknowledged that age — 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.
MEDICA.de; Source: Johns Hopkins Medical Institutions