药物临床试验知情同意书常见的伦理问题与对策

Common Ethical Issues in Informed Consent of Clinical Drug Practice and Relevant Countermeasures

从伦理角度探讨目前药物临床研究知情同意书存在的常见问题,依据知情同意书的四个基本要素,重点阐述应从研究的主要内容、知情同意的过程、知情同意的签署等方面设计知情同意书,以确保药物临床试验知情同意书的规范性和科学性。

This paper discusses common issues in informed consent of clinical drug practice from an ethical perspective. Based on the four basic elements of informed consent paper, it mainly includes the target research content and the procedure and the subscription of informed consent, aiming to ensure the standardized implementation and scientific features of informed consent of clinical drug practice.