Improving informed consent for children in cancer treatme...( Does understanding improve if physician...),Health

"When faced with a cancer diagnosis for their child, parents are always going to feel anger and frustration," says Holly Rupnow, who serves on the Parent Advisory Group for the study. Mrs. Rupnow's daughter Skye, 7 years old, is in remission from acute leukemia, diagnosed in 1999 and treated at Rainbow Babies & Children's Hospital in a clinical trial. "Everything is happening so fast. The mind just shuts down when doctors are presenting you with so much information. If there is anything we can do to minimize the shock and enhance parental understanding, we should do it. That's why a study like this is so important, and why I am involved."

Dr. Kodish and his colleagues caution that the study results should not be interpreted as being critical of clinical trials. "The fact that optimal informed consent was not obtained does not make these studies unethical," they write. "Certainly, the medical professionals who participated in this study did their best to explain what parents needed to know," adds Dr. Kodish. "But the communications were inconsistent, with inconsistent results. This study helps us to design better communication tools to improve the overall process and quality of informed consent."

"This important work adds to the growing body of evidence that questions the effectiveness of the informed consent process," said Ralph I. Horwitz, MD, Dean and Vice President of Medical Affairs, Case Western Reserve University School of Medicine. "The findings are especially notable since they apply to children and their parents who are often omitted from such research. The ongoing studies by Dr. Kodish and his colleagues are urgently needed to provide children and their parents the understanding and protections they need."

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Contact: Eileen Korey
Eileen.Korey@UHHS.com
216-844-3825
University Hospitals of Cleveland
27-Jan-2004