IIT研究中研究者的责任探究

On the Responsibility of Researchers in IIT Research

研究者发起的科研类临床研究日益增多。临床医生同时作为研究者,在很多方面都有所欠缺,如缺乏临床研究的基本素养、对研究团队的管理不足、对伦理审查流程的了解不足、对临床试验的质量把控不足等。为了更好地保护受试者,结合工作实践,提出研究团队需要加强临床研究过程的全链条质量把控,积极参加各类临床研究培训并加强研究者团队的自我约束,严格遵守伦理规范,接受监督,管理部门需要重视临床研究,创造有利于研究者发起的研究开展的条件,促进研究者发起的临床研究高质量、高水平有序开展。

There are more and more clinical researches initiated by researchers.As principal investigator,clinicians are deficient in many aspects,such as lack of basic literacy of clinical research,lack of management of research team,lack of understanding of ethical review process,lack of control of process quality of clinical trials,etc.In order to better protect the subjects,combined with the work practice,this paper put forward suggestions:the research team should strengthen the whole chain quality control of clinical research process,actively participate in various clinical research training and strengthen the self-discipline of the researcher team,strictly abide by the ethical norms,accept the supervision,management departments need to attach importance to clinical research and create conditions for investigator initiated trial,promote the orderly development of high-quality and high-level clinical research initiated by researchers.