Human Subjects Research Act Article 3

The “competent authority” as referred to herein means the Ministry of Health and Welfare.Supervision, audit, administration and penalization of human subject research, as well as human subject protection, shall lie with the central competent authority with responsibility over the organization (institution), school, legal entity or group (hereinafter “ the research entity”) that principal investigator of the human subject research (hereinafter “the principal investigator”) serves.