临床试验研究者伦理意识提升的重要性及策略分析＊

研究者作为临床试验的实施者,是保证临床试验质量及受试者安全和权益的关键。因此,在临床研究开展的过程中,提高研究者的伦理意识,可以减少受试者在参加研究过程中可能遇到的风险,达到保护受试者的利益的目的。临床研究机构通过对主要研究者、低年资临床医师、临床医学生等不同群体进行有针对性的科研方法学培训及医学伦理培训,提高临床研究伦理培训的广度及深度,可以逐步加强本机构研究者的伦理意识。通过伦理委员会及其办公室、第三方伦理评估及认证等内部外部方式,促进研究者伦理意识的提升。同时,医疗机构通过构建受试者保护体系,可以对机构内的研究者制定有针对性的年度教育培训计划,定期对其教育培训的结果和质量做出评估,进行持续质量改进,以全面提升机构内研究者的伦理意识,落实伦理审查,加强跟踪审查,保证参加临床研究受试者的安全。

Importance and Strategic Analysis of Enhancing Ethical Awareness of Researchers

As implementers of clinical researches, researchers are the key to ensure the quality of clinical researches as well as the safety and interests of research subjects. Therefore, improving the researcher"s ethical awareness can reduce the risk that research subjects may encounter during their participation in the study, and achieve the goal of protecting the interests of research subjects. Through targeted training on scientific methodologies and medical ethics among primary investigators, junior doctors and medical students, clinical research institutions improve their coverage and depth on medical ethics training of clinical research and gradually strengthen the ethical awareness among researchers. Through both internal and external assessments, such as the ethics committee and its offices, as well as evaluation from the third-party, the ethical awareness of researchers will be promoted. At the same time, through the construction of human research protection program (HRPP), the medical institution can formulate targeted annual education and training plans for researchers within the institution, and regularly evaluate the results and qualities of their education and training, as well as to conduct continuous quality improvements in order to comprehensively enhance the ethical awareness of researchers in the institution, implement the ethical review and strengthen follow-up review, in order to ensure the safety of research subjects in clinical researches.