A law designed to better regulate the use of human subjects in research cleared the legislature yesterday, with informed consent by Aborigines made a precondition for research involving Aborigines and for the release of research results.
The legislature passed the Act on Human Subjects Research (人體研究法), the first step in establishing a statutory system to regulate research involving humans, which was previously governed by the non-binding Ethical Guidelines for Human Research set up by the Department of Health in 2007.
A main focus of the bill lies in Article 15, which stipulates that when Aborigines are used as research subjects, they must be consulted and give consent before research begins, as well as before the results are released.
Arrangements on the way consultations and consent shall be conducted, as well as on the use of commercial revenue generated from research projects, shall be made by the department, in collaboration with the Council of Indigenous Peoples, the article said.
The article, which was not included in the draft bill presented by the Executive Yuan, was introduced by Democratic Progressive Party Legislator Chen Ying (陳瑩) and Chinese Nationalist Party (KMT) Legislator Hsu Shao-ping (徐少萍) during the deliberation phase.
They said the article was necessary after several cases involving the misuse of genetic material came to light, citing the case of blood samples from Aborigines that were collected for health research, but were then used for genetic studies or sold to a genetic database overseas.
A notable case occurred last year, when then-National Health Research Institution leader Ko Ying-chin (葛應欽) withdrew a US patent application. The application was withdrawn following allegations by Canada-based international advocacy group ETC that the team had violated ethical codes by not informing Atayal Aborigines from villages in Hsinchu County of the patent application, which involved findings based on their blood samples.
The new act also stipulates that human research programs involving Aborigines shall be subject to other articles protecting the rights of human participants in research.
Before research involving human subjects is undertaken, it must be reviewed and approved by an ethical review board comprising at least five people, including legal experts and disinterested members of society, and at least two-fifths of members must not have an affiliation with research institutions, the act says.
Men and women must be represented on the review board, it says, with one gender limited to two-thirds of the board.
The law stipulates that informed consent must be obtained for all types of research involving human subjects, with such studies defined as a collection of human specimens, investigation into and the analysis of the data or research on behavioral ecology, physiology, psychology, genetics and medicine.
Exceptions to the consent requirement could be made when the research is considered obviously beneficial to a specific population, when the subject is an irreplaceable resource for research, or when fetuses or corpses are the subjects of research.
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