LEGAL ANALYSIS ON ETHICAL REVIEW SYSTEM OF HUMAN SUBJECTS IN TAIWAN

Shun-Liang Hsu

《南臺財經法學》 2期 (2016/06) Pp. 123-230

摘要

In 1991, the US Federal government adopted the amended law on 'Protection of Human Subjects', coded 45 CFR 46 and laid down a solid foundation and Common Rules for protecting human subjects during medical research trials by means of ethical reviews. In 1999 the system was later introduced to Taiwan by the National Institute of Health. During this period, the Health Authority in Taiwan also published several legal instruments to reinforce the protection of human subjects during trials. However those instruments were either controversial in legality; or the regulations on the ethics committee, in terms of organizational structure, memberships, examination/exemption standards, information management and supervision mechanism were not clear. Consequently, clinical clerks often find guidance missing when they need to make administrative decisions, as well as when substantial review of research protocol is necessary. This situation demonstrates that the current ethical review system in Taiwan is full of flaws. A thorough legal analysis of the current ethical review system is needed. The Health Authority should also play a leading role in calling the relevant departments in the government to work together to create a new and comprehensive law to safeguard patient's interests, so that a highly effective ethical gate keeping mechanism is in place so that medical advances will not put patient's health at unnecessary risk.

關鍵字

ethical review ； human trial ； Institutional Review Board(IRB) ； Human Subject Research Ethics Committee ； human subject protection