2019年新药与临床试验规则：伦理委员会职责的变化
New drugs and clinical trials rules 2019: Changes in responsibilities of the ethics committee.
作者信息
Singh Neelu, Madkaikar Nivedita J, Gokhale Partha M, Parmar Deven V
机构信息
Department of Clinical Research, Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India.
Department of Clinical Development, Abbott Healthcare Private Limited, Mumbai, Maharashtra, India.
出版信息
Perspect Clin Res. 2020 Jan-Mar;11(1):37-43. doi: 10.4103/picr.PICR_208_19. Epub 2020 Jan 31.
The New drugs and Clinical trials rules 2019 (New rules) was introduced on 19 March 2019 by Government of India. New rules have set specific requirements for ethics committee (EC). The EC is required to follow requirements set as per New rules and to forward their report to Central Licensing Authority (CLA). This document is divided into different sections like definitions and applicable chapter & schedules for EC; changes related to registration of clinical studies and biomedical and health research; changes related to constitution, functions, proceedings, responsibility of EC for clinical trial; maintenance of records by EC; suspension and cancellation of registration of EC, post-trial access of drugs, changes and clarity related to academic clinical trials and role of ECs in compensation and medical management process.
印度政府于2019年3月19日出台了《2019年新药与临床试验规则》（新规则）。新规则对伦理委员会（EC）设定了具体要求。伦理委员会必须遵循新规则规定的要求，并将其报告提交给中央许可机构（CLA）。本文档分为不同章节，如伦理委员会的定义、适用章节及附表；临床研究以及生物医学与健康研究注册相关的变化；伦理委员会在临床试验中的组成、职能、程序、责任相关的变化；伦理委员会的记录保存；伦理委员会注册的暂停与取消；试验后药物获取；学术临床试验相关的变化与澄清；以及伦理委员会在赔偿和医疗管理过程中的作用。
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