A recommendation, which will be presented later in this chapter, calls on the FDA to bring its parental authorization waiver guidelines into line with those who regulate research conducted or supported by DHHS. It also asks the FDA, the National Institutes of Health (NIH) and the Office for Human Research Protections (OHRP) to cooperate to more explicitly define the factors to be considered in waiver decisions and protective measures appropriate to different situations where parental permission is removed. In their above-cited study, Geller et colleagues (2003) suggested that the older and more mature the child, the more likely it is that decisions will be made jointly and not by the lone parents. The children and adolescents who interviewed them generally believed that the child`s choice to participate should be the child`s choice, “unless they are like babies” (p. 264). But everyone wanted to know what their parents thought. A minority (all girls) said they would submit to their parents. Based on a study on students` understanding of research and research rights (4th, 7th and 10th and students) Bruzzese and Fisher (2003) indicated that a majority of students at all levels answered the questions correctly. However, a considerable minority of CM1 students seemed disoriented by the purpose of the research (which was to compare the ability of children of different ages to understand the importance of research).
Overall, the study reported a steady increase in students` understanding of the purpose and nature of the study, as well as the potential risks and benefits of the study based on age. In the study by Broome and colleagues previously cited (2001), researchers found that half of the 24 children with cancer showed that they were in research, while the 10 children with diabetes knew they were involved in research and more clearly between the clinical care of their condition and the treatment-related aspects of clinical trials, They were able to distinguish between themselves. The authors associate differences in understanding and differences in experience. Children with diabetes had lived longer with their condition, were in stable treatment, and have participated in several studies since their condition was diagnosed. As an incentive to participate in the research, these children also received a gift certificate or payment at the end of their studies. In contrast, children with cancer were diagnosed more recently, had little or no research experience, had the opportunity to participate in research shortly after being diagnosed in very stressful circumstances, and never received financial incentives to participate in research. These children often participated in several studies and the studies were usually linked simultaneously and between themselves and their clinical care. Some of the children with cancer were in data collection studies that did not include an experimental intervention, and some of them may not have understood that this data collection was research. . . .