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PEDIATRICS Vol. 111 No. 5 May 2003, pp. 1037-1041

Factors Influencing Parental Consent in Pediatric Clinical Research

Justin D. Rothmier, MD*, Mary V. Lasley, MD{ddagger},§ and Gail G. Shapiro, MD{ddagger},§

* Department of Family and Community Medicine, University of California, Davis, Sacramento, California
{ddagger} Department of Pediatrics, University of Washington, Seattle, Washington
§ Asthma, Inc Research Center, Seattle, Washington

--> Background. Although previous studies have looked at the motivation behind enrollment in clinical trials of adults and healthy subjects, little is known about the factors influencing parental consent in pediatric clinical studies where the subjects themselves do not provide consent.

Objective. This study was conducted to define a group of factors that impact parental consent in the pediatric clinical trial. This may allow investigators to identify a subset of specific appealing aspects of clinical trials that will promote participation while also bringing ethical issues to light that may require further consideration.

Methods. Forty-four parents or guardians of children currently participating in clinical asthma research completed questionnaires from July 1999 to September 1999 pertaining to motives for allowing their child to participate in clinical trials. The responses were then rated on a Likert numerical scale.

Results. The most important motive for parents is learning more about their child’s illness. Next important was the motive of helping medical knowledge. Availability of free medication was negatively correlated with family income.

Conclusions. Although altruistic motives are present in pediatric asthma research, most parents/guardians gave consent for their child to learn more about their child’s asthma. Access to free medication was more important in families with lower incomes than in families with higher incomes.

Key Words: motives • parents • guardians • participation • children • clinical trials

Received for publication Mar 28, 2002; Accepted Oct 3, 2002.


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