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Research Involving Children: Recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

机译:涉及儿童的研究:国家保护人类生物医学和行为研究委员会的建议

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Throughout history, children have been subjects of research. A legendary Persian prince is said to have isolated newborn babies from all human speech in hopes of discovering whether language was natural and spontaneous. Queen Caroline of England recruited children from a foundling hospital in order to test Jenner's vaccination on them before it was applied to her own royal progeny. The modern controversy over research with children and the retarded can be traced to events at Willowbrook State Hospital for the Mentally Retarded where, during the 1950s and 1960s, healthy mentally retarded children were infected with mild hepatitis in order to study the natural history of the disease. That research aroused great public controversy and its merits and faults are debated even today. It initiated a discussion within and without the medical profession over whether any invasion or manipulation of the body or person of a nonconsenting subject could ever be ethically justified, apart from expectation of benefit to that subjct.1The prevailing codes of ethics governing the use of human subjects for experimentation are curiously ambivalent about children. The progenitor of these codes, The Code of Nuremberg, if taken literally, would exclude children as subjects, for it requires the voluntary consent of the subject "as absolutely essential," without any provision for proxy consent.1 The World Medical Association's Declaration of Helsinki, on the other hand, states that for nontherapeutic research involving legally incompetent subjects, "the consent of the legal guardian should be procured."3(p277) This position has been adopted by the American Medical Association:
机译:纵观历史,儿童一直是研究的对象。传说中一位波斯王子曾将新生婴儿与人类的所有言语隔离,希望发现语言是自然的还是自发的。英格兰女王卡罗琳女王从一家育婴医院招募了孩子,以测试詹纳的疫苗,然后再将其应用于自己的皇家后代。关于儿童和智障儿童的现代争论可以追溯到威洛布鲁克州立弱智儿童医院的事件,在该医院,1950年代和1960年代,健康的智障儿童感染了轻度肝炎,以研究这种疾病的自然史。 。这项研究引起了广泛的公众争议,其优缺点在今天仍然受到争议。它引发了在医学界内部和没有医学界的讨论,即除了对这一主体的利益期望之外,对未经同意的受试者的身体或个人的任何入侵或操纵是否有道理上可以合理化。1规范人类使用的现行道德规范实验对象对孩子充满异议。如果从字面上看,这些法规的前身《纽伦堡法规》将把儿童作为对象,因为它需要对象“绝对必要”的自愿同意,而无需任何代理同意书。1世界医学协会的《宣言》另一方面,赫尔辛基指出,对​​于涉及法律上不称职的受试者的非治疗性研究,“应征得法定监护人的同意。” 3(p277)美国医学会已采用以下立场:

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