论临床试验中的治疗性误解及对策

Therapentic Misconception and Countermeasures in Clinical Research

研究和临床治疗在根本目的、基本方法、风险的正当性,以及应遵循的伦理原则等多方面都存在着根本性的区别。在临床试验的理论与实践中,混淆治疗与研究两者的区别,就会造成治疗性误解,从而违背科研伦理的知情同意原则,损害受试者的利益。以研究和治疗的区分为出发点,对治疗性误解的原因、引起的主要伦理问题及对策加以讨论。

There are many essential differences between clinical research and medical care on the aspects of primary aim, basic methodology, the justification of risks and the ethical principals they should follow. In the theories and practices of clinical research, the confusion between the clinical research and medical care causes therapeutic misconception, which is in breach of ethical principles of informed consent and compromises human subjects＇ interests. This article will explore the major reasons of therapeutic misconception, the main ethical issues it caused and the corresponding resolutions.