Politics

Taiwan Legislature greenlights new human subject research law

• Publication Date：12/12/2011
• Source： Taiwan Today

Taiwan’s Legislative Yuan passed a new act governing the use of human subjects in research Dec. 9, offering better protection of the rights of subjects while promoting scientific research and academic freedom.

The law makes ethical principles for conducting research involving human participants legally binding. Past practice was governed by a 2002 directive on the sampling of human subjects and the Guidelines for Human Research promulgated by the Department of Health in 2007, both of them nonbinding.

“Passage of the law will go a long way for the promotion of academic freedom and the protection of subjects in research,” said Democratic Progressive Party Legislator Huang Sue-ying, who pushed for the law in collaboration with legislators across party lines.

According to the act’s preamble, legislation was needed because “the rights of research subjects tend to be neglected and thus impinged upon, due to such factors as differential access to information and conflicts of interest between subjects and researchers.”

Under the new act, a research project involving human beings can proceed only after the research plan has been approved by an ethical review committee set up by the research institute.

The ethical review panel must comprise at least five disinterested persons, with at least two-fifths from outside the institution, and neither gender exceeding two-thirds of the members.

Annual reviews of approved research are required, and the committee may suspend a project in which irregularities affecting the rights or safety of participants are discovered until improvements are made, or cancel it outright.

Members of the review committee will face a fine from NT$60,000 (US$1,982) to NT$600,000 if they contravene legal procedure during review or are found to be involved in the research project.

The law stipulates that informed consent must be obtained from targeted adult subjects. Parental consent is required for child participants, and for research on corpses pre-death permission or the consent of relatives is needed.

Failure to obtain informed consent, as well as data obtained through force or inducement, will result in a penalty of up to NT$500,000.

Research involving human subjects is defined by the act as obtaining, investigating, analyzing or applying human samples or data from individuals in studies of behavioral ecology, physiology, psychology, genetics and medicine. (PCT-THN)