人體研究之受試者保護之倫理與法律的推進與反思--人體研究法施行的第一個十年

Reflections on the Ethical and Legal Aspects of Human Subject Protection: The First Decade of the Human Subjects Research Act

人體研究受試者保護於1986年醫療法制定時納入臺灣法規體系，不過僅適用於人體試驗，並未擴及所有以人為受試者之人體研究。隨著醫學研究的發展，社會要求於法律上應有更完整的受試者保護，2011年於立法委員黃淑英及學者、專家、民間團體推動下，完成人體研究法的制定。本法施行十年，於法規與倫理上對受試者保護均有所提升，然而仍有許多值得再思考或精進之處，包含：研究機構監督職責的落實，以及如何賦權或培力民眾受試者意識，以落實受試者保護。此外，2017年臺灣公布身心障礙者權利公約(Convention on the Rights of Persons with Disabilities)，身心障礙者參與醫學研究以自願同意為必要，與現行法規的代理同意顯然不同，而易受傷害群體與個人參與研究的特別保護措施如何兼顧尊重自主權，有必要重新思考、與時俱進，以符合人權發展的潮流。

 

Protections for human research subjects was incorporated into Taiwanese law when the Medical Care Act was enacted in 1986; however, the law only applies to human trials and has not been extended to all research involving human subjects. Societies now require more complete legal protection of medical research subjects. In 2011, the Legislative Yuan passed the Human Subjects Research Act, which was promoted by Legislator Huang Sue-Ying and civil society organizations. Over the ten years since the law’s implementation, subject protection has improved in terms of regulations and ethics. However, numerous areas can be improved or refined, such as implementing oversight by research institutions and increasing public awareness of human subject protection. Furthermore, Taiwan promulgated Convention on the Rights of Persons with Disabilities in 2017, which requires voluntary consent from persons with disabilities participating in medical research as opposed to the "proxy consent" allowed under current regulations. Moreover, rethinking current special protection measures for vulnerable groups or individuals participating in research in terms of balancing respect for autonomy and special protections as well as contemporary human rights standards is necessary.