Evaluations on Pending Regulation on Ethical Review Measures for Biomedical Research Involving Human Subjects and Artificial Intelligence

• Published in: IoT Technologies for Health Care Vol. 432; pp. 33 - 38
• Main Author: Sun, Xiaoyu
• Format: Book Chapter
• Language: English
• Published: Switzerland Springer International Publishing AG 2022; Springer International Publishing
• Series: Lecture Notes of the Institute for Computer Sciences, Social Informatics and Telecommunications Engineering
• Subjects: Biomedical research involving human beings; Data security; Ethical Review; Ethics Committees; Medical artificial intelligence
• ISBN: 9783030991968; 3030991962
• ISSN: 1867-8211; 1867-822X
• DOI: 10.1007/978-3-030-99197-5_3

The rapid development of Artificial Intelligence (AI) has extensively promoted medicine, pharmaceutical, and other related fields in recent years. The ethics review is one of the critical procedures of registration to get the medical artificial intelligence products approved and commercialized. The National Health Commission of the People's Republic of China published a consultation paper on the Ethical Review Measures for Biomedical Research Involving Human Beings (Second Version) (the Draft) on March 16th, 2021. Although the Draft indicated that the Ethics Review Committees need to be set up by the Regional and Institutional level, the review authorities of different levels were not clarified. The suggestion is that three tiers of Ethics Review Committees should be set up in China. The precise scope of review authorities for each level should be identified. Such as the complicated leading technology, gene editing, should be reviewed by National Ethics Review Committees. It will be the job of individual institute Ethics Review Committees to approve the clinical research with less risk such as a new ointment to treat acne. Furthermore, to standardize the research and development of artificial intelligence in healthcare in the age of AI, more clear guidance should be given to data security in the layers of data, algorithm, and application in the ethics review process. In addition, transparency and responsibility, as two of six principles in the Rome Call for AI Ethics promoted by the Pontifical Academy for Life and presented on February 28th, 2020, could be further strengthened in the Draft.