Chapter 1 General Provisions
This Act is specially stipulated to regulate the right protection of human research subjects.
Implementation of research involving human subjects shall be governed by this Act. Where another law provides special provisions in relation whereof, such regulations shall instead govern.
Human subject research should respect the autonomy of the human subjects, and ensure balance of the risks and benefits from conduct of the research, minimizing invasiveness to the human subjects, and securing equitable distribution of research burdens and results, while protecting human subject’s rights.
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.
1. Human subject research (hereinafter “research”): refers to research involving obtaining, investigating, analyzing, or using human specimens or an individual person’s biological behavior, physiological, psychological, genetic or medical information.
2. Human specimens: refer to human (including a fetus and corpse) organs, tissues, cells, body fluids, or any derivative biomaterial arising from experimentation therewith.
3. Delinkage: refers to the operation of permanently disabling encoded biological specimens, data, and information from being linked to or matching them with the subjects personal data or information.