Risk management in ethics review of the drug and medical device innovation

VernacularTitle:药品医疗器械创新中伦理审查风险控制探讨
Author: Zhen FAN ¹ ; Zhong-Yuan XU
Author Information

1. 北京市百瑞律师事务所
Keywords: multi-center clinical trials; joint liability; leading unit; risk management measure
From: The Chinese Journal of Clinical Pharmacology 2018;34(8):990-992
CountryChina
Language:Chinese
Abstract: This document of Opinions on Deeping the Review and Approval System Reform and Encouraging the Drug and Medical Device Innovation was proposed that to improve the efficiency of ethic review,we shall recognize the result of ethic review given by the leading unit of multi-center clinical trials.The leading unit of multi-center clinical trials,undertaking joint liability with the other unit,should have risk management measures on compensation for the injuries arising from research,such as drug-induced injury identification,enough trial liability insurance,the de-puty of sponsor being in China,etc.The leading unit of multi-center clinical trials being responsible for ethics of trial should write in informed consent.The ethics committee shall safeguard the rights and interests and welfare of the subjects in reviewing the test scheme and safeguard the ethical principles being more important than scientific research purposes.