clined to participate, about half cited inconvenience and a quarter cited safety concerns.

In a study that included both parents who agreed (n = 221) and parents who did not agree (n = 208) to enter their infant in a randomized clinical trial of pertussis vaccine, Canadian researchers concluded that altruistic motivations (a desire to contribute to medical knowledge and to help others) were major factors contributing to parents’ willingness to enter their infants into the trial (Langley et al., 1998). The involvement of the family physician was also important to a majority of those who agreed. Concerns about painful procedures and blood drawing were important to parents who did not agree to their child’s participation.

Another group of Canadian investigators questioned parents who had agreed (n = 103) or declined (n = 37) to have their newborn infant included in one of three randomized, controlled clinical trials in a neonatal intensive care unit (Zupancic et al., 1997). (The response rates were between 80 and 85 percent for the two groups.) The researchers reported that parents giving permission for the infant’s enrollment were more likely to see the research as probably benefiting their child and less likely to perceive it as risky than were parents not giving permission. Parents who allowed their infants to enter the study were also less likely to view the consent process as too complex, although only a minority in each group gave this response—10 percent of those who gave permission versus 22 percent of those who did not. Nearly all parents who gave permission believed that it was important for children to take part in research because it would help other children. A large majority (84 percent) of the parents who did not give permission also responded positively about the importance of research participation. The two groups did not differ significantly in socioeconomic characteristics.

In a study that included parents permitting and parents not permitting a child’s participation in anesthesia research (168 and 78 parents, respectively), Tait and colleagues (1998) reported that parents who did not give permission cited fear for the child’s safety and the potential risk to the child as the most important factors in their decision. Very few reported that a lack of understanding of the research was a factor, but 15 percent were concerned about having insufficient time to decide. None reported feeling pressured to agree. Parents who gave permission cited the importance of the research and the low risk to the child as key factors in their decision. The parents who allowed their children to enter the study were more likely to have a child who had participated in a previous study and to have read the consent form completely.

In a statement presented to the committee, a group representing parents of children with asthma noted that parents may simultaneously understand the importance of allowing children to participate in research and be reluctant to allow their own children to serve, in their words, as “guinea pigs”



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement