摘要
通过整理2017年1月至2021年11月北京市某三甲医院医学伦理委员会审查的新一代人工智能独立软件研究,对其方案设计的完整性、受试者权益保护、数据利用与存储等多个维度涉及的共性问题进行分析归纳,提出伦理委员会在审查此类研究时应特别关注其在方案设计、数据安全性、风险评估、跟踪审查等不同于常规临床研究的方面,从而为新一代人工智能独立软件研究的伦理审查提供思路。
By sorting out the research of new generation of artificial intelligence(AI) independent software reviewed by medical ethic committee of a grade A tertiary hospital in Beijing from January 2017 to November 2021, this paper analyzed and summarized the common problems involved in multiple dimensions, such as the integrity of the protocol design, protection of the rights and interests of the subjects, the data using and storing, and proposed that ethic committee should pay special attention to the protocol integrity, data security, risk assessment, track review, and other aspects different from conventional clinical research, thus providing a idea for ethical review of new generation AI independent software research.
作者
杨千粟
白楠
曹江
王瑾
YANG Qiansu;BAI Nan;CAO Jiang;WANG Jin(Department of Pharmacy,Medical Supplies Center for People'sLiberation Army General Hospital,Beijing 100853,China)
出处
《中国医学伦理学》
2023年第2期186-192,共7页
Chinese Medical Ethics
关键词
深度学习
人工智能
医疗器械
独立软件
伦理审查
Deep Learning
Artificial Intelligence
Medical Device
Independent Software
Ethical Review
