Vega Vega Paula, Miranda Castillo Claudia, Vargas Celis Ivonne
Escuela de Enfermería, Pontificia Universidad Católica de Chile, Santiago, Chile.
Facultad de Enfermería, Universidad Andres Bello, Santiago, Chile.
Andes Pediatr. 2024 Feb;95(1):91-106. doi: 10.32641/andespediatr.v95i1.4968.
The participation of children and adolescents in research requires bioethical measures to safeguard their autonomy and well-being through the application of the informed consent process.
To critically analyze the factors involved in the process of assent/consent in children and adolescents in research.
Integrative review of scientific evidence carried out between April and June 2023, from manuscripts published between 2014 and 2023 in Web of Science, PubMed, CUIDEN, and CINAHL databases, using the descriptors Process Assessment OR Assent AND Informed Consent AND Bioethics AND Minors OR Child OR Children AND adolescent OR teenage AND Pediatrics AND Research. Twenty primary articles were found, and the results were subjected to content analysis.
Three categories were identified: shared consent/assent; child-specific factors for giving assent (age of the child to give assent and autonomy of the child to give assent), and key aspects of the assent process (assent form format; assent form content, and context for applying the assent process).
The assent process is a key tool for legal and ethical compliance with the rights of children and adolescents in clinical trial participation. In addition to favoring participation in informed decision-making together with the parents, it is also an instance where the participant's competencies, capacity for understanding, and autonomy are valued.
儿童和青少年参与研究需要采取生物伦理措施，通过应用知情同意程序来保障他们的自主权和福祉。
批判性分析儿童和青少年参与研究时同意/赞成过程中涉及的因素。
于2023年4月至6月对科学证据进行综合回顾，检索2014年至2023年期间发表在科学网、PubMed、CUIDEN和CINAHL数据库中的手稿，使用描述词“过程评估”或“赞成”以及“知情同意”、“生物伦理学”、“未成年人”或“儿童”、“儿童”、“青少年”或“青少年时期”以及“儿科学”和“研究”。共找到20篇主要文章，并对结果进行了内容分析。
确定了三类：共同同意/赞成；儿童赞成的特定因素（儿童赞成的年龄和儿童赞成的自主权），以及赞成过程的关键方面（赞成表格格式；赞成表格内容，以及应用赞成过程的背景）。
赞成过程是在临床试验参与中在法律和伦理上遵守儿童和青少年权利的关键工具。除了有利于与父母一起参与知情决策外，它也是重视参与者能力、理解能力和自主权的一个契机。
