从一试验纠纷反思我国临床试验中研究者、受试者、申办者权益的保护  

Thinking about interests' protection for investigator, subject and sponsor in a clinical trial dispute in China

作　　者：张虹[1] 吴文源[1] 王乐民[1] 张红民[1] 

机构地区：[1]同济大学医学院附属同济医院临床药理室,上海200065

出　　处：《中国新药与临床杂志》2015年第9期697-699,共3页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：通过对一起临床试验出现的纠纷分析,提出临床试验的合同应加以规范,合同中除需明确规定申办者不仅应对参加临床试验的受试者提供相应保险,同时也需将保险的范围扩展至参加临床试验的研究者及其所在的医疗机构。另外,对临床试验中非预期的提前终止的项目,试验方案中必须有对受试者进行合理必要的后续治疗的预案,并将此可能的情形明确写入知情同意书中加以告知,以此尽可能地规避并减少临床试验中的纠纷。This article suggested that there should be standardization to the contract of clinical trials through the detailed discussion around a medical dispute in a clinical trial. The volunteers should be provided the insurance, which would also be provided to the investigators and their hospitals. It also suggests that in order to avoid and even eliminate the potential medical dispute as more as possible, there should be a preparedness in the clinical trial protocol to focus upon the follow- up therapy to the volunteers in case that the trial is ceased unexpectedly, which should also be well informed the volunteers.

关 键 词：临床试验 研究人员 研究对象 申办者 纠纷 权益 

分 类 号：R954.73[医药卫生—药学]