刍议基于医院管理的临床试验受试者的知情同意权保护

ON THE PROTECTION OF INFORMED CONSENT RIGHTS OF SUBJECTS INVOLVED IN CLINICAL TRIAL FROM THE PERSPECTIVE OF HOSPITAL MANAGEMENT

随着临床试验在国内日渐频繁,知情同意权作为受试者的一项权利已经得到普遍认同,现在医患双方都比较注重诊疗实践中一般的知情同意,而对临床试验中受试者这一特殊群体的"知情同意"没有引起足够的重视,导致在实践中这项权利常被侵犯,为医疗纠纷埋下了隐患。医院作为临床试验的必经场所,理应肩负起保护受试者权益的重任,文章从医院管理着手通过分析目前受试者知情同意权的保护现状进而探讨保护措施。

With the increasingly frequent use of clinical trials in the country,informed consent right has widely been recognized as a common right of the subjects. Both doctors and patients are now paying more attention to this aspect in the practice of diagnosis and treatment,however,this right of the subjects of clinical trials caused very little attention,resulting in the frequent violence of this right and hidden possibility for medical disputes in practice.As the indispensable part of clinical trials,hospital should take the responsibility to protect the subjects＇ right. From the perspective of hospital management,this article makes an analysis on the current situation of the protection of the subjects＇ informed consent right and then discusses the protecting measures.