Guidance on clinical research involving infants, children and young people: an update for researchers and research ethics committees
Guidance on clinical research involving infants, children and young people: an update for researchers and research ethics committees
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DOI：
10.1136/archdischild-2014-306444
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发表时间：
2014-10-01
影响因子：
5.2
通讯作者：
Greenough, Anne
中科院分区：
文献类型：
--
作者：
Modi, Neena;Vohra, Jyotsna;Greenough, Anne
背景英国儿科协会是皇家儿科和儿童健康学院(RCPCH)的前身，于1980年首次发布了与儿童研究有关的指南。1在此之前，涉及儿童的临床研究很少。1980年的指南发起了一场翻天覆地的变化，指出“涉及儿童的研究很重要”，“应该支持和鼓励”，以及“涉及儿童且对儿童没有好处的研究(非治疗性研究)不一定是不道德或非法的”。英国皇家儿科学会于2000年发布了最新的指导意见。2这两篇文献都被广泛引用。
BackgroundThe British Paediatric Association, the forerunner of the Royal College of Paediatrics and Child Health (RCPCH), first published guidance in relation to research involving children in 1980. 1 Prior to this time, little clinical research involved children. The 1980 guidance initiated a sea change, stating ‘research involving children is important’,‘should be supported and encouraged’and ‘research which involves a child and is of no benefit to that child (non-therapeutic research) is not necessarily either unethical or illegal’. Updated guidance was issued by the RCPCH in 2000. 2 Both documents have been cited extensively.