- Examining the Protection of Group's Interest under Taiwan's Human Biobank Management Act*
A Brief Review of the Disputed Cases
The Collection of Aboriginal People's Salvia
In 2007, Dr. Marie Lin, together with the Mackay Memorial Hospital, was accused of violation of research ethics for collecting saliva samples from the Kebalan tribe. According to the Association of Kebalan Development, Dr. Lin collected saliva samples from 29 Kebalan people without completely informing the underlying purpose of research use. Despite Dr. Lin's and Mackay Memorial Hospital's response that consent was sought from the group leader and individual through tribal group meetings, they were still subject to ethical discipline for not duly disclosing their research purpose to the tribal meeting when collecting samples from the aboriginal people.1
The Uninformed Commercial Use of Research Outcome 2
In 2010, Prof. Ying-Chin Ko was accused of violating research ethics for patenting his research outcome without prior consent from the Tayal tribe. By collecting blood samples from 1,500 aboriginal people, Prof. Ko was able to identify and locate the gene sequence that causes gout disposition. The [End Page 29] alleged misconduct was that when seeking consent, Prof. Ko did not clearly advise the tribal group of the purpose to commercialise the result of the research in the future. After further investigation, Prof. Ko admitted that the filing of application for U.S. patent proceeded without prior knowledge and consent from the tribal group, and promised that if there would be any commercial profit derived from the research, it would belong to the aboriginal people. Also, Prof. Ko promised he would withdraw the patent application.
EGC's Resolution to Destroy the Collected Samples
Considering the importance of group interest and the compliance with the relevant laws, the Ethical Governance Committee (the "EGC") of the Pilot Study of Taiwan Biobank recently resolved that the research team must abide by the Aboriginal People's Fundamental Law (the "Fundamental Law") before beginning to collect samples in the area of tribal group. Pursuant to the requirement in the Fundamental Law, to collect samples from the aboriginal people, the research team must first call a tribe meeting with the targeted group members. Furthermore, as to the samples that have been collected to date, if there is any sample collected from aboriginals without full compliance with the requirement of the Fundamental Law, such samples must be destroyed under the supervision of EGC members.
Issues and Questions
Not only do the aforesaid cases heighten the tension between the research subject and researcher, the underlying disputes also trigger a wave of reflections on the topics of behavioural norm with respect to biomedical research. Despite the fact that all the preceding cases involved some degree of the informed consent process, sadly, none of them seemed to be satisfying. Furthermore, as held by the resolution of EGC, under some circumstances, consent may not only need to be sought at the individual level, but at the group level as well. So the question is: why is individual consent not enough? Especially, when a researcher targets aboriginal people, why must the consent be sought from the tribal group? Moreover, apart from research involving aboriginal people, is there any other occasion which requires a same or similar protection of group interest?
The above questions became more interesting after Taiwan's legislators passed the "Human Biobank Management Act" (the "Act"), which aims to regulate the establishment of a biobank, and ensure the protection of participants' interests.3 According to the Act, the biobank is defined as for the purpose of biomedical research, the biobank contains participants' biological specimens, [End Page 30] natural persons' information and other related data and information based on human population or specific groups.4 In a similar vein, one may further ask: in the context of biobank research, is it sufficient to seek consent at the individual level only? What is the Act's view?
This article intends to examine the abovementioned cases through the light of the newly enacted Act. Taking the disputed facts as background material, this article intends to clarify some ambiguities and disputes in the Act, and...