Contact: Joy Carter(205) 934-1676[email protected]
A child's understanding of and their willingness to participate in a research trial vary depending on the child's age, illness and previous research experience, according to a recent study by researchers at the University of Alabama at Birmingham (UAB), the University of Wisconsin in Milwaukee and the Medical College of Wisconsin. "It's important that researchers understand and consider these differences when enrolling children in studies," says Marion Broome, Ph.D., professor of nursing at UAB.
The study, funded by the National Institute of Child Health and Human Development, is the first to focus on chronically-ill children and their participation in research since the National Institutes of Health (NIH) issued a mandate in 1998 that researchers offer children an opportunity to participate in studies. The study is pending publication in a national journal.
Researchers found that a child's understanding of a research study depends a great deal on the child's age and illness. "Younger children with cancer did not clearly understand the concept of research or that they were participating in a research study, however, all of the children with diabetes, regardless of their age, knew they were enrolled in a study," says Broome.
Researchers also found children with diabetes discussed monetary incentives as a motivating factor for participating, while children with cancer were not offered monetary incentives and were most often motivated by a desire to get well. "Many factors influence children's understanding and participation in research," says Broome. "Researchers should be cognizant of these factors and strive to develop processes that involve children in meaningful ways."
"Until recently, children were not allowed to participate in many trials, especially non-therapeutic research, because it was thought that they did not have the capacity to understand, therefore could not consent to participate in a study," says Broome. "We asked children about their understanding and their decisions to participate in research."
The study enrolled 34 children and adolescents, ages 8 to 22, with either diabetes or cancer who had recently enrolled in a research study. "The consent process was the same for children in all trials; however, the structure of the trials differed in several ways, including duration of involvement, incentives and the participant's understanding about the distinctions between standard treatment and experimental protocols," says Broome.
Broome and colleagues are continuing to analyze data gathered from the study. "The next step is to look at differences in understanding among family members, for instance, between the child and a parent, between the parents and even among siblings," says Broome.
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