谈谈中国临床试验研究中受试者权益保障问题

Clinical Trials in China:the Protection of Trial Subjects' Rights and Benefits

随着国家《药品临床试验管理规范》的颁布与实施 ,我国新药临床试验研究水平有相当的提高 ,但也存在着一些问题 ,其中包括保护受试者权益问题。国家GCP有关章节中明确指出要保护受试者权益 ,并有具体规定 ,但在执行中尚有出入。如试验方案未经伦理委员会批准、未向受试者告知试验内容 ,或告知的不够充分、甚至在未签署知情同意书时就开始试验等。为此 ,我国采取了相应的措施 ,如设立药品临床研究培训中心 ;定期对临床试验基地的研究者以及相关人员如与试验有关的医师、药师及申办者进行GCP培训、基地审核制度 ,以法律手段来保证受试者权益等。

With the issue and practice of Good Clinical Practice (GCP) in China,great progress has been made.However,we should also notice that the overall clinical trial levels still lag behind the requirements of GCP.For instance,there are still many gaps and problems in the protection of human subjects' rights and benefits.In GCP there are some articles concerning the protection of human subjects,but there are also problems in present clinical trials.For example,some trial designs are not approved by Ethics Committee,the trial subjects have no access or inadequate access to the information related to the clinical trial and some subjects are even involved in the trial without giving informed content.In order to protect the benefits and rights of trial subjects,China has adopted the many measures.For instance,to establish the GCP training centers so as to provide regular training for the clinical trial investigatiors,doctors,pharmacists and sponsors,to set up the system for the checkup the trial bases,to protect trial subjects' benefits and rights by legal means.