Differences between families with different experiences of illness were also reported by Geller and colleagues (2003). They interviewed 37 pairs of parents and children or adolescents about participation in genetic susceptibility research. During interviews that asked questions about research that might offer benefit, the parents from families with a history of breast cancer indicated that they would not allow their daughters to refuse participation in potentially beneficial research. In contrast, the parents with a family history of heart disease were more likely to talk about “overriding” the wishes of a child who wanted to participate in a study (p. 266). Parents in both groups strongly agreed that children should not be enrolled against their will in research intended only to gain knowledge.

In the study by Zupancic and colleagues (1997) cited earlier, the investigators reported no differences in perceptions of severity of illness between parents who agreed and those who did not agree to their neonate’s participation in clinical trials in the intensive care unit. As described above, parents who agreed were more likely than parents who did not agree to believe that the trials would probably benefit their child and were less likely to believe that the trials were risky.

Overall, these studies point to the need for particular care in the design and review of processes for seeking parental permission for research that will involve seriously ill children and high-stress situations. Concerns about the inadequacy of current procedures have led to suggestions that the consent process be designed (and tested) as a “continuous” one that involves giving and then repeating information and explanations as research proceeds (see, e.g., Allmark et al., 2003). When a study involves a discrete, one-time intervention and an urgent situation, this approach likely will not be relevant.

Involvement of Children in Discussions and Decisions

The committee found limited information on parent’s views about the involvement of their child in discussions and decisions about the child’s participation in clinical research. It likewise located little research on the dynamics of family relationships in decisions about research participation or on the consequences for family relationships of different strategies for conducting the permission and assent process.

Based on a questionnaire study of 100 pairs of parents and adolescents at children’s hospitals, Sikand and colleagues (1997) reported that 57 percent of the adolescent-parent pairs agreed that parents’ permission for an adolescent’s participation in research was unnecessary for anonymous surveys. In other situations, the parents were consistently more likely to favor permission requirements. For example, 78 percent of the parents but only 59 percent of the adolescents favored parents’ permission for blood testing



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