从贝尔蒙报告审视医疗器械临床试验的伦理问题

摘要

医疗器械临床试验是最直接最有效地检测医疗器械性能的方式,贝尔蒙报告是对基本的道德原则及方针的陈述,用来帮助在解决涉及人体实验对象的科研中所产生的道德问题.本文从贝尔蒙报告角度来审视医疗器械临床试验的伦理问题,介绍了贝尔蒙报告产生的背景概念和医疗器械临床试验的概念及基本流程；贝尔蒙报告中的三项原则尊重个人、善行和平等公正原则在医疗器械临床试验中的体现以及针对贝尔蒙报告来解决医疗器械临床试验中产生的伦理问题的重大意义.通过知情同意的具体体现、对风险和好处的评估及受试者的选择和研究成果的分配三方面来解决临床试验中产生的伦理问题.%Clinical trial is the most direct and the most effective way to test the performance of medical equipments.The Belmont Report is the statement of the basic moral principles and guidelines,used to help solve the moral problems produced in scientific researches involving human subjects.This apaper examines the ethical issues in clinical trials for medical equipments from the perspective of the Belmont report.It first introduces the background and basic concepts of Belmont report,background concept and the concept and the basic process of medical equipment clinical trials.Then the three principles of the Belmont Report is presented and how to apply the Report to solve ethical problems arising in medical equipment trials.Application of informed consent risk and benefits assessment,and selection of subjects participants and the distribution of research results to address the ethical issues arising in clinical trials.