期刊
BMC MEDICAL ETHICS
卷 23, 期 1, 页码 -出版社
BMC
DOI: 10.1186/s12910-022-00856-y
关键词
Informed consent; Parental consent; Assent; Consent forms; Ethics; Clinical trials
资金
- Faculty of Medicine, Chiang Mai University [092-2564]
This study aimed to determine the elements and extent of information that child participants and their parents desire to read in an informed assent form/informed consent form of a pediatric drug trial. The results showed that risk-benefit aspects were perceived as the most concerning items. The findings can help stakeholders arrange essential information in order of importance and customize informed assent/consent forms for pediatric drug trials involving children with hematology or oncology diseases.
Background: This study aimed to determine the elements and the extent of information that child participants and their parents would like to read in an informed assent form (IAF)/informed consent form (ICF) of a pediatric drug trial. Methods: A descriptive survey was conducted to determine the perceived importance of each element of the ICF content from child participants and their parents who underwent informed assent/consent of a multi-center pediatric drug trial. The respondents were asked to indicate the level of importance of each item in a questionnaire, by giving a rating scale from 1 (not important) to 5 (very important). Results: A total of 22 families, 17 child participants with the diagnosis of hematology or oncology diseases and 27 parents, were enrolled. Among 30 items, risk-benefit aspects (i.e., direct health benefit [mean: 4.71 for child respondents, 4.89 for parent respondents], indirect/societal benefit [mean: 4.65, 4.85], major foreseeable risk [mean: 4.47, 4.78], post-trial benefit/provision [mean: 4.59, 4.74], and all adverse effects of the drug including uncommon adverse effects [mean: 4.53, 4.74]) were perceived to be of most concerning items from both child participants' and parents'view-point. None of the items were considered 'slightly important'or lower by more than 20% of the respondents. Conclusions: For pediatric drug trials, risk-benefit information (including direct health benefit, indirect/societal benefit, and post-trial benefit/provision, as well as major foreseeable risk and adverse effects of the drug) should be made a salient feature of an IAF/ICF. This empirical data could help related stakeholders arrange essential information in order of importance and tailor an IAF/ICF to better suit child participants' and parents' needs, particularly for pediatric drug trials involving children with the diagnosis of hematology or oncology diseases.
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