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Ethical Conduct of Clinical Research Involving Children
of limited sociodemographic diversity. Some studies involved validated survey or interview instruments; others apparently did not. Publications did not always report quantitative information on parents’ responses, and some relied on quotes from parents that conveyed views vividly without providing a clear sense of how representative those views were.
A few studies included both parents who permitted their child’s enrollment in research and parents who did not, but most included only parents who had agreed to participation. A number of studies included at least some parents of children with serious illnesses or at risk of such illnesses. Several studies were conducted in other countries, mainly in Canada, Australia, and Western European nations. Differences in cultures, research practices, and health care norms could limit the relevance of these studies to the United States.
Reasons for Permitting or Not Permitting a Child’s Participation in Research
Some studies suggest that many parents (like many adults making decisions in their own right) view research as an opportunity to gain additional access to care and information about their child’s condition and treatment. In a Washington State study, 44 parents who had agreed to their child’s participation in an asthma study completed a questionnaire about their motives (Rothmier et al., 2003). The authors concluded that “[a]lthough altruistic motives are present in pediatric asthma research, most parents/ guardians gave consent for their child to learn more about their child’s asthma” (p. 1037). Access to the newest drugs and relationships with staff were also positive factors. Parents with lower family incomes were more likely to respond that access to free medications was a factor in their decision.
Of 181 Dutch parents who agreed to their child’s participation in a study of ibuprofen for the prevention of seizures, approximately one-third reported an expected benefit to their child as the reason for agreeing (van Stuijvenberg et al., 1998). Slightly more than half cited a desire to contribute to science as a motivation for agreeing to their child’s participation. Two-thirds of the parents reported that they saw no disadvantages to their child’s participation in the research.
Hayman and colleagues (2001) surveyed 94 New Zealand parents who agreed (69 percent response rate) and 103 who declined (47 percent response rate) to enroll their child in a physiological study (without a prospect of direct benefit) related to sudden infant death syndrome. All those who participated reported doing so for altruistic reasons. Just over a quarter of these parents were initially concerned about safety issues but no longer expressed concern after the study. Of the parents who de-