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Factors influencing parental consent in pediatric clinical research
Justin D Rothmier1, Mary V Lasley, Gail G Shapiro
1Department of Family and Community Medicine, University of California, Davis, Sacramento, California, USA.
Insights
Parental consent for pediatric clinical trials is driven by a desire to understand a child's illness and advance medical knowledge. Lower-income families particularly value access to free medication.
Area of Science:
- Pediatric Clinical Research
- Medical Ethics
- Informed Consent
Background:
- Limited understanding of factors influencing parental consent in pediatric clinical trials.
- Distinction from adult and healthy subject enrollment motivations.
Purpose of the Study:
- Identify key factors impacting parental consent in pediatric clinical trials.
- Promote participation by highlighting appealing aspects.
- Address ethical considerations in pediatric research.
Main Methods:
- Survey of 44 parents/guardians of children in asthma clinical trials.
- Data collected July-September 1999.
- Responses rated on a Likert scale.
Main Results:
- Primary parental motive: gaining knowledge about the child's illness.
- Secondary motive: contributing to medical knowledge.
- Free medication access inversely correlated with family income.
Conclusions:
- Parental consent in pediatric asthma trials driven by child's health understanding, not solely altruism.
- Free medication access is a significant factor for lower-income families.
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.