儿科临床研究安全采血限量及相关问题

发布时间：2018-03-31 15:15

  本文选题：审查指南　切入点：伦理委员会　出处：《临床儿科杂志》2017年09期

【摘要】：正儿科临床研究方案设计应严格遵循风险、不适和痛苦最小化原则。血样采集数量、次数以及可能的痛苦和伤害是儿科研究者、家长/监护人、儿童以及伦理委员会最为关心的问题之一。目前关于儿童采血限量的直接证据很少,国内尚未见相关指南报道。作者经查询世界卫生组织(WHO)简报、美国著名儿童医院的伦理审查指南以及美国北岸医疗集团(North ShoreLIJ Health System)人体受试者保护指南等资料[1-10],
[Abstract]:The risk, discomfort and pain minimization principles should be strictly followed in the design of clinical studies in pediatrics. The number, frequency, and potential pain and injury of blood samples are pediatricians, parents / guardians, Children and one of the issues of greatest concern to the Ethics Committee. At present, there is very little direct evidence on children's blood intake limits, and no relevant guidelines have been reported in the country. The author has consulted the World Health Organization (WHO) briefing. Guidelines for Ethical Review of famous Children's Hospitals in the United States and guidelines for the Protection of Human subjects of North ShoreLIJ Health system [1-10],
【作者单位】： 浙江大学医学院附属儿童医院;温州医科大学;
【基金】：国家自然科学基金(No.81573516,81273607) 国家科技重大专项(No.2013ZX09303003)
【分类号】：R72
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本文编号：1691290