The Thought about Establishment of Standardized Ethical Review Mechanism for Clinical Trials / 中国医学伦理学

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.