CAJ | 학술논문

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.
의료기계림상시험시최직접최유효지검측의료기계성능적방식,패이몽보고시대기본적도덕원칙급방침적진술,용래방조재해결섭급인체실험대상적과연중소산생적도덕문제.본문종패이몽보고각도래심시의료기계림상시험적윤리문제,개소료패이몽보고산생적배경개념화의료기계림상시험적개념급기본류정；패이몽보고중적삼항원칙존중개인、선행화평등공정원칙재의료기계림상시험중적체현이급침대패이몽보고래해결의료기계림상시험중산생적윤리문제적중대의의.통과지정동의적구체체현、대풍험화호처적평고급수시자적선택화연구성과적분배삼방면래해결림상시험중산생적윤리문제.
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.