关注伦理细节管理落实受试者权益保护

Pay attention to ethical detail management for the better protection of subjects＇ rights and interests

目的在临床研究项目的伦理审查中关注细节管理，将受试者权益保护落在实处，促进伦理委员会的自身建设与发展。方法参照国内外伦理管理和科研项目管理法规和制度制定实地访查要素，访查小组对我院2012年至2015年期间获批立项并通过伦理委员会审查的临床研究项目共37项进行实地访查。结果注册临床试验项目、上市后临床试验项目和研究者发起科学研究项目均符合访查要素：具备开展临床研究所需的硬件设施以及药品保存资质；受试者得到了方案规定的补偿；进行了知情同意。比较而言，注册临床试验项目符合要素标准的条目数和比例最高。对于知情同意执行实施过程的规范性，三类项目均符合访查要素：筛选受试者均签署知情同意书；知情同意书保存完整；医生和受试者／监护人进行知情同意并签字。而对访查中的其它要素仍有不同程度的忽视，其中符合记录知情同意过程并记录签署时间的项目数最少。结论研究者要重视研究过程采取的行为和措施；研究人员和管理人员要落实细节操作和管理，将受试者权益保护落在实处。

Objective To promote the Institutional Review Board（IRB） construction and development via paying more attention to the detail management and providing better protection of subjects rights and interests in ethical review of clinical trials and scientific research projects. Methods Assess- ment criteria were established according to the domestic and international laws and regulations on the management of ethical and scientific research project. Ethical site visit was performed on the 37 clinical trials/scientific research projects approved by IRB during the year 2012-2015. Results Clinical trials/ scientific research projects were divided into tree types= the registered clinical trials, the post-marketing clinical trials and the researcher initiated scientific research project. All the types met with the fol- lowing assessment criteria： satisfy the requirement of equipment, facilities and qualifications of drug preservation required for conducting clinical research; subjects were given compensation according to the protocol; informed consent were obtained. Among them, the registered clinical trials meet more criteria than other research types. Regarding to the standard of informed consent implementation, all types met with the following assessment criteria= all the subjects enrolled signed informed consent forms, informed consent forms are well documented; investigators and subjects/ the guardian signed the forms, However, during the site visit, some other criteria were also neglected more or less. Par- ticularly, only few project recorded the consent process and time spots singed the forms. Conclusions Investigators should pay more attention to the activities and behaviors taken place during the re- search implementation process, Researchers and management staffs should pay attention to ethical de tail management to guarantee better protection of subjects＇ rights and interests.