(June 7, 2010) On June 3, 2010, Taiwan's Executive Yuan (Cabinet) approved a draft bill that would require those who conduct research on humans to obtain the informed written consent of their subjects. The impetus for accelerated formulation of the draft document was reportedly a recent case in which a Taiwan research team “applied for patents in the United States for gout research findings allegedly obtained by using blood samples from aboriginal citizens without gaining their prior consent.” (Unauthorized Human Experiments to Be Banned,TAIWAN TODAY, June 4, 2010, available at http://taiwantoday.tw/ct.asp?xItem=105803&ctNode=452&mp=9.) The subsequent decision of Taiwan's National Health Research Institute to cancel the patent applications was deemed a significant step forward for human rights in general and for aboriginal rights in particular by local and international human rights advocates. (Id.; see also Patent Application Withdrawn in Biopiracy Dispute, TAIWAN TODAY, Mar. 24, 2010, available at http://taiwantoday.tw/ct.asp?xItem=96692&CtNode=436.)
The draft bill is in 17 articles, divided among six chapters (on general provisions, examination of research plans, guarantee of research subjects' rights and interests, management of research, penalties, and supplementary provisions). Among other provisions, the bill stipulates:
- In seeking subjects' consent, researchers must first explain to them the purpose of the research, the risks involved, and the subjects' rights and interests. The research organization concerned must also obtain the approval of an ethics committee for the planned study. Violators would face fines of between NT$100,000 (about US$3,125) and NT$1 million.
- Coercion, enticement of subjects through promises of material gain, or “other irregular methods” are not to be used in conducting research on human subjects.
- Researchers must first obtain the consent of the subject's closest relatives before conducting research on fetuses or cadavers. Violators will be subject to fines of between NT$50,000 and NT$500,000.
- The use of prisoners as research subjects is prohibited, unless they cannot be replaced with other subjects.
Aside from seeking to promote the development of scientific study of humans, the bill's adoption also would “give legal status to policy guidelines on research on human subjects announced in July 2007” and conforms to provisions of the Indigenous Peoples Basic Act. (Unauthorized Human Experiments to Be Banned, supra; Executive Yuan Approves Draft 'Law on Research of Human Subjects' [in Chinese], June 3, 2010, available at Government Information Office, Republic of China (Taiwan) website, http://info.gio.gov.tw/ct.asp?xItem=65653&ctNode=3764; Guidelines on Ethical Policies for Research on Human Subjects [in Chinese], July 17, 2007, available at Kaohsiung Veterans General Hospital website, http://www.vghks.gov.tw/erli/irb/table/%E4%BA%BA%E9%AB%94%E7%A0%94%E7%A9
%B6%E5%80%AB%E7%90%86%E6%94%BF%E7%AD%96%E6%8C%87%E5%BC%95.pdf; The Indigenous People's Basic Law [in English] (Feb. 5, 2005), Laws and Regulations Database of the Republic of China, available at http://law.moj.gov.tw/Eng/news/news_detail.aspx?id=1669&k1=indigenou