临床试验中电子知情和电子支付伦理审查经验与趋势探讨

Discussion on the Experience and Trend of Ethical Review of Electronic Consent and Electronic Payment in Clinical Trials

随着信息化社会的高速发展,越来越多的临床试验开始应用电子知情和电子支付等信息化手段,优化临床试验流程。电子知情和电子支付在临床试验中的应用给伦理审查带来了全新的挑战,伦理审查的要点和关注点有别于传统纸质流程,并且目前对电子知情和电子支付的伦理审查指南仍是空白。通过总结首都医科大学附属北京友谊医院开展临床试验电子知情和电子支付伦理审查经验,分析针对电子知情和电子支付的伦理审查要点,总结出其与传统流程的伦理关注点异同。探讨伦理视角下电子知情和电子支付在提高临床试验质量和效率方面的作用,未来伦理审查趋势及实际运行过程中可能存在的伦理问题及伦理监管。临床试验中应用各种信息化手段是必然趋势,这需要伦理委员会不断提高伦理审查能力,总结经验最终形成审查共识或指南。

With the rapid development of information society,more and more clinical trials are beginning to apply information means such as electronic consent and electronic payment,to optimize the clinical trial process.The application of electronic consent and electronic payment in clinical trials has brought new challenges to ethical review.The points and concerns of ethical review are different from the traditional paper process,and the guidelines for ethical review of electronic information and electronic payment are still blank at present.By summarizing the experience of the ethical review of electronic consent and electronic payment for clinical trials in Beijing Friendship Hospital,Capital Medical University,this paper analyzed the key points of ethical review of electronic consent and electronic payment,and summarized the similarities and differences between their ethical and traditional processes.This paper discussed the role of electronic consent and electronic payment in improving the quality and efficiency of clinical trials from the perspective of ethics,the trend of ethical review in the future,and the possible ethical problems and ethical supervision in the actual operation.It is an inevitable trend to apply various information methods in clinical trials,which requires the ethics committee to continuously improve the ethical review ability,summarize experience and finally form review consensus or guidelines.