Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.
Clinical Research Center for Food and Herbal Product Trials and Development (CR-FAH), Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
BMC Med Ethics. 2022 Nov 16;23(1):113. doi: 10.1186/s12910-022-00856-y.
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.
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).
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' viewpoint. None of the items were considered 'slightly important' or lower by more than 20% of the respondents.
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.
本研究旨在确定儿童参与者及其父母希望在儿科药物试验的知情同意书（ICF）中阅读的信息内容和程度。
通过对接受多中心儿科药物试验知情同意的儿童参与者及其父母进行描述性调查，确定 ICF 内容的各个要素的重要性。受访者被要求在问卷中对每个项目的重要性水平进行评分，从 1（不重要）到 5（非常重要）。
共有 22 个家庭，17 名患有血液或肿瘤疾病的儿童参与者和 27 名家长参与了研究。在 30 个项目中，风险-获益方面（即直接健康获益[儿童参与者的平均得分：4.71，家长的平均得分：4.89]、间接/社会效益[平均得分：4.65，4.85]、主要可预见风险[平均得分：4.47，4.78]、试验后获益/提供[平均得分：4.59，4.74]和药物的所有不良反应，包括罕见不良反应[平均得分：4.53，4.74]）被认为是儿童参与者及其父母最关注的项目。没有一个项目被超过 20%的受访者认为是“稍微重要”或更低的。
对于儿科药物试验，风险-获益信息（包括直接健康获益、间接/社会效益和试验后获益/提供，以及主要可预见风险和药物的不良反应）应成为 IAF/ICF 的显著特征。这些经验数据可以帮助相关利益相关者按重要性顺序安排必要信息，并根据儿童参与者及其父母的需求定制 IAF/ICF，特别是对于涉及血液或肿瘤疾病的儿童的儿科药物试验。
