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Ethical Conduct of Clinical Research Involving Children
Comprehension of Rights in Research
Several studies suggest that younger children have less understanding than adolescents of their rights in research, including rights related to confidentiality and their choice to participate in a study (or withdraw from a study once it has started). For example, Bruzzese and Fisher (2003) asked children in the 4th, 7th and 10th grades to identify violations of research rights in several hypothetical vignettes. The youngest children were least able to identify such situations. In a study of 9-, 15-, and 21-year-old males, Belter and Grisso (1984) concluded that the 9-year-olds were less able to recognize violations of patient rights and less able to protect against such violations than the 15- and 21-year-olds.
With respect to confidentiality specifically, Hurley and Underwood (2002) found that sizeable minorities of second graders in their study did not understand the “fine points of confidentiality,” despite repeated explanations in different contexts that information from their study would not be shared with family or school personnel (p. 140). Fourth and sixth graders did better. In their study of children ages 5 to 12 years, Abramovitch and colleagues (1991) likewise found younger children to be more uncertain about confidentiality.
In contrast, Bruzzese and Fisher (2003) reported that a large majority of the students at each grade level (4th, 7th, and 10th grades) in their study understood confidentiality. In discussing the difference between their findings and those of Abramovitch and colleagues (1991), Bruzzese and Fisher (2003) suggested that their repeated explanations of rights—before students took the permission form home to parents and again before the testing began—may have contributed to their better results among the younger children. Hurley and Underwood (2002) also provided repeated explanations, without the expected effects, but the youngest children in the study by Bruzzese and Fisher were older than the youngest children in the two other studies.
On the question of what would happen if they wanted to stop participating in the study, the children in the different age groups studied by Hurley and Underwood (2002) had similar, high levels of accurate responses. In contrast, the study by Ondrusek and colleagues (1998) cited earlier found that children under age 10 years had a low level of understanding that they could withdraw from the study. Even the older children believed that their parents would not like them to withdraw. Abramovitch and colleagues (1991) also found that few children ages 5 to 12 years believed that they had the right to withdraw from the study. In the study by Brusseze and Fisher (2003), fourth and seventh graders were less likely than older adolescents to understand that they had the right to withdraw from the study, although the majority in both groups did indicate accu-