案例讨论:智能手机应用相关研究的伦理评审考量

Concern of IRB Review for the Research with Smartphone Application:A Case Study

以一项智能手机应用临床研究方案评审的案例来探讨伦理委员会应该如何应对"智能时代"的各种新技术、新方法在临床研究中的应用。近年来智慧健康、移动医疗和大数据的发展使跨学科合作的新型临床研究方案越来越多地呈现在医学伦理委员会成员面前。这对医学伦理委员会的评审工作带来了新的挑战。伦理委员会如何在科学技术快速发展的今天既能一如既往地保护受试者的权益,也能指导研究者不断创新,是对伦理委员会能力的考验。因此,伦理委员会的能力建设更应与时俱进,更新知识,真正成为一个有能力、高效率、高水平、好沟通、国际化的伦理委员会。

This paper discussed the issue that how should an institutional review board（IRB）deal with the clinical research project that applying new technologies and methods, based on a case of a research project which examining the feasibility of applying smartphone application for disease early diagnosis. In recent years, artificial intelligence technology has been widely used in the field of medical sciences, particularly disease monitoring, early diagnosis and chronic disease control and prevention. Such application has provided an accurate, faster and effective means for researchers and patients. The rapid development of new technology has led to an increase in interdisciplinary collaboration in clinical research; such research proposal for IRB review, therefore not only Challenges IRB and its members, but also would affect the communication between researchers and IRB. How can an IRB continue to protect the rights and interests of study participants, meanwhile to support and promote development of science and technology in clinical research, is the reality that IRB has to face. Therefore, the capacity building of IRB should keep pace with the development of sciences and technology. An IRB, who is able to keep their knowledge updated, become more capable and highly efficient, well communicated, and with international vision, is the one we all expect.