The Thought about Establishment of Standardized Ethical Review Mechanism for Clinical Trials
10.12026/j.issn.1001-8565.2018.06.10
- VernacularTitle:建立规范的临床试验伦理审查机制的思考
- Author:
Lianghua LEI
1
;
Qiulian ZHOU
Author Information
1. 江西省人民医院
- Keywords:
Clinical Trials;
Ethical Review;
Continuing Review
- From:
Chinese Medical Ethics
2018;31(6):726-728,735
- CountryChina
- Language:Chinese
-
Abstract:
The establishment of standardized ethical review mechanism for clinical trials is an objective requirement for improving the ethical review of clinical trials and ensuring the safety and smoothness of various clinical trials. According to the practice of years engaged in the ethical review of clinical trials, this paper proposed to start from six aspects, that is, to establish a scientific and reasonable ethics committee; establish a special ethics office;establish a scientific and reasonable ethical review standard;grasp the emphasis of the ethical review;attach importance to the continuing review;strictly observe the principles of ethical review, and then establish a standardized ethical review mechanism for clinical trials.
