Shamoo Adil E, Moreno Jonathan D
University of Maryland, USA.
Am J Bioeth. 2004 Winter;4(1):25-31. doi: 10.1162/152651604773067316.
There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic Testing Using Random Notification), each school in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research.
人们普遍认为儿童的决策能力存在疑问，因此，一般来说，必须由父母或监护人允许儿童参加研究。此外，免受胁迫和强制这一涉及成年人研究的首要规则，对儿童来说更为重要。这一原则在《纽伦堡法典》（1947年）中得到了突出体现，并体现在各种联邦人类研究保护法规中。在一个名为“土星”（使用随机通知进行学生体育测试）的项目中，俄勒冈州公立学校系统中的每所学校都可以对高中学生运动员实施强制性药物检测项目。作为一项旨在识别学生运动员中药物使用情况的前瞻性研究，“土星”项目旨在评估随机药物检测的影响，并通过识别未报告药物使用情况的个体来验证调查数据。参加药物检测研究是学生参加学校体育运动的一项要求。除了这项研究设计具有强制性之外，在招募、知情同意和保密方面还存在道德上有问题的做法。本文关注的问题是，在遵守关于人类受试者研究、特别是儿童参与研究的现行道德标准的同时，是否可以结合强制性药物检测项目对高中生进行研究。
