Guidelines for Human Experimentation Revision
In a bid to uphold research ethics and safeguard human rights, Taiwan's regulations for protecting human subjects in research have been reinforced, as demonstrated by recent enforcement actions.
The Human Subjects Research Act, which imposes strict ethical standards and oversight responsibilities on research institutions and investigators, serves as the primary legislation for these regulations. The Act was put to the test in July 2025, when National Taiwan Normal University (NTNU) was ordered to halt a research project due to ethical violations. The university was fined NT$1.1 million, and the responsible professors were fined NT$500,000 each and barred from applying for government research grants for one year [1].
To ensure compliance with ethical standards and regulations, Taiwan employs several mechanisms. Institutional Review Boards (IRBs) are mandatory for approving and monitoring research involving human subjects. Research institutions are required to conduct ethics reviews and take corrective actions when ethical issues arise. The government also mandates training for clinical trial experts, with all professionals involved in clinical trials required to complete over 30 hours of training every six years [3].
In addition, the Ministry of Education and other authorities actively investigate allegations of misconduct and can impose fines, suspend projects, and restrict grant applications as penalties for violations of human subject protections [1]. The government is also urged to establish a clear division of labor, with medical ethics matters handled by the Department of Medical Affairs, while reports concerning drug trials and adverse effects handled by the Food and Drug Administration [2].
Furthermore, there should be more detailed regulations regarding who can become board members and the degree of proportional representation to ensure diversity and balance. The Ministry of Health and Welfare, tasked with overseeing the act, is urged to review these aspects of human subject research [2].
Recent improvements in Taiwan's regulations regarding research and human rights have been significant since the passage of the Human Subjects Research Act. The government should swiftly and thoroughly review the Act and the Regulations for the Organization and Operation of Institutional Review Board to ensure they are in line with the progress that has been made [2].
To further assure whistle-blowers, the ministry should establish an independent reporting mechanism for human research. This reporting mechanism, as stated in the Public Interest Whistleblower Protection Act passed in January, is to assure whistle-blowers that their identity would not be exposed [4].
As the regulatory environment remains active, the government's commitment to upholding research ethics and safeguarding human rights in research contexts is clear. The authorities should promptly conduct a comprehensive investigation into how many academic institutions and medical organizations are currently conducting human research and whether they comply with the law [1].
References: [1] Chen, Y. (2025, July 15). NTNU halted human subject research project due to ethical violations. Taiwan News. Retrieved from https://www.taiwannews.com.tw/en/news/4723850 [2] Chiu, T.-y. (2025, July 20). Urgent review of human subject research regulations needed. Taiwan News. Retrieved from https://www.taiwannews.com.tw/en/news/4723945 [3] Huang, J.-s. (2025, July 25). Mandatory training for clinical trial experts emphasized. Taiwan News. Retrieved from https://www.taiwannews.com.tw/en/news/4724059 [4] Lee, C.-y. (2025, January 1). Public Interest Whistleblower Protection Act takes effect. Taiwan News. Retrieved from https://www.taiwannews.com.tw/en/news/4717447
Science plays a crucial role in the implementation and enforcement of Taiwan's regulations for protecting human subjects in research, as evidenced by the ongoing education and training of clinical trial experts. To promote health and wellness, the Ministry of Education and other authorities pursue educational and self-development opportunities, such as the establishment of an independent reporting mechanism for human research in accordance with the Public Interest Whistleblower Protection Act.
