Leibson Tom, Koren Gideon
Division of Clinical Pharmacology and Toxicology at the Hospital for Sick Children, and University of Toronto, 555 University Ave., Toronto, ON, M5G 1X8, Canada,
Paediatr Drugs. 2015 Feb;17(1):5-11. doi: 10.1007/s40272-014-0108-y.
Pediatric drug research is gradually becoming more and more accepted as the norm for assessing whether a drug is safe and efficacious for infants and children. The process of informed consent and assent for these trials presents a major challenge. The aim of this review is to map historical, ethical and legal aspects relevant to the challenges of informed consent in the setting of pediatric drug research. The impact of age, level of maturity and life circumstances on the process of obtaining informed consent as well as the relations between consent and assent are discussed. There appears to be a lack of regulatory clarity in the area of pediatric clinical trials; while numerous statements have been made regarding children's rights to autonomy and their ability to care for themselves and for younger ones, the ever changing status of adolescence is still difficult to translate to informed consent. This may delay scientific and clinical advancement for children who are at the very junction of being independent and not needing parental permission. Obtaining consent and assent for pediatric clinical trials is a delicate matter, as both parent and child need to agree to participate. The appropriate transfer of information to guardians and the children, especially concerning potential risks and benefits, is at the heart of informed consent, as it serves to protect both patient and physician. As many adults lack health literacy, one must ensure that guardians receive relevant information at a level and in forms they can understand regarding the trials their children are asked to participate in.
儿科药物研究正逐渐越来越被视为评估药物对婴幼儿和儿童是否安全有效的规范。这些试验中的知情同意和赞同过程带来了重大挑战。本综述的目的是梳理与儿科药物研究中知情同意挑战相关的历史、伦理和法律方面。讨论了年龄、成熟程度和生活环境对获取知情同意过程的影响以及同意和赞同之间的关系。儿科临床试验领域似乎缺乏监管清晰度；虽然已经有许多关于儿童自主权利以及他们照顾自己和年幼者能力的声明，但青春期不断变化的状况仍难以转化为知情同意。这可能会延误处于独立边缘且无需父母许可的儿童的科学和临床进展。获取儿科临床试验的同意和赞同是一件微妙的事情，因为父母和孩子都需要同意参与。向监护人及儿童恰当传递信息，尤其是关于潜在风险和益处的信息，是知情同意的核心，因为这有助于保护患者和医生双方。由于许多成年人缺乏健康素养，必须确保监护人以他们能够理解的水平和形式收到关于其子女被要求参与的试验的相关信息。
