Rothmier Justin D, Lasley Mary V, Shapiro Gail G
Department of Family and Community Medicine, University of California, Davis, Sacramento, California, USA.
Pediatrics. 2003 May;111(5 Pt 1):1037-41. doi: 10.1542/peds.111.5.1037.
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.
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.
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.
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.
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.
尽管先前的研究探讨了成年人和健康受试者参与临床试验的动机，但对于在儿科临床研究中影响父母同意（受试者自身不提供同意）的因素却知之甚少。
开展本研究以确定一组影响儿科临床试验中父母同意的因素。这可能使研究人员能够识别出临床试验中特定的有吸引力的方面，这些方面既能促进参与，又能揭示可能需要进一步考虑的伦理问题。
1999年7月至1999年9月，44名目前参与哮喘临床研究的儿童的父母或监护人完成了有关允许其孩子参与临床试验动机的问卷。然后根据李克特数字量表对回答进行评分。
父母最重要的动机是更多地了解孩子的病情。其次重要的是帮助医学知识发展的动机。免费药物的提供与家庭收入呈负相关。
尽管在儿科哮喘研究中存在利他动机，但大多数父母/监护人同意孩子参与是为了更多地了解孩子的哮喘病情。获得免费药物对低收入家庭比对高收入家庭更重要。
