From 24 to 26 May 2017, the Asian Bioethics Review (ABR) hosted an International Research Conference on the Governance of Biobanking in Biomedical Research. The Conference took place at the National University of Singapore’s (NUS) Centre for Biomedical Ethics.
A total of 28 academic speakers shared their views on current and emerging issues in the area of biobanking governance. Notable was the diversity of speakers: a mix of junior scholars and distinguished academics represented perspectives from various parts of Asia, North America, Africa, Europe and Australia. It is safe to say that the conference was yet another in a recent series of events [1, 2, 3, 4] that puts NUS and ABR firmly on the global map of bioethics scholarship.
Speakers addressed a variety of issues surrounding the governance of biobanking. Among the most notable ones were the issues of “‘ownership’ of tissue and data” and “appropriate consent”.
‘Ownership’ of Tissue and Data
A recurring theme of the conference was that of ‘ownership’ of biological material and data. Prof. Graeme Laurie, whose talk on ‘Biobanking in the United Kingdom’ kicked off the conference, reminded the audience that we should remain cognizant of the very language that we use to conceptualize our discourse. For instance, if we frame the discourse in terms of ‘ownership’, we might focus narrowly on trying to figure out who is the ultimate owner of the materials or data – and we might think that (only) the ultimate owner may decide on the use of the stored materials or data. However, a different terminology would bring other concerns to the forefront and, indeed, shape our very attitudes towards the way a biobank should operate. Two alternatives that Prof. Laurie discussed were ‘stewardship’ and ‘custodianship’. A biobank that operates under the paradigm of good stewardship might be under a duty to put the biological materials and data that it has stored to good (or best) use. In concrete terms, such a biobank might have to proactively share the biological materials and data that is has stored. In contrast, a biobank that operates under the alternative paradigm of ‘custodianship’ might adopt a more a cautious attitude. Instead of proactively seeking opportunities to put the materials and data to good use, its primary concern might be to remain a careful guardian of the materials and data that it has been entrusted with.
Appropriate Consent in Biobanking
Regardless of whether we use the paradigms of ownership, stewardship or custodianship, all speakers agreed that biobanks should seek appropriate consent for the storage and use of human biological materials and data. A key question that speakers addressed was then about the object of individual consent: should we ask individuals for their broad consent to use of their human biological material or data for research, in general? Or should meaningful consent, in the context of biobanking, always be consent to governance?
Another key question that various speakers discussed was about what biobanks should do in situations in which human biological materials or data have been stored, without appropriate consent having been obtained. Indeed, Prof. Michael Selgelid’s talk forcefully illustrated this conundrum in the context of the 2014-16 Ebola outbreak. During the outbreak, international organizations amassed large quantities of valuable tissue samples that could be key to future research on the Ebola virus. However, partly owing to the chaos that accompanied the epidemic, many samples were obtained without the taking of appropriate consent. Consent was, at most, obtained for the diagnostic use of blood samples but not for their storage and use for future research. The importance of appropriate consent is further amplified by the social context: many people in the areas where the Ebola outbreak took place hold strong views about what may be done with their blood and would object to its storage after therapeutic tests have conducted.
This point about the cultural beliefs about blood and other tissue was then also a key element in Prof. Keymanthri Moodley’s talk on ‘Legitimacy, Trust & Community Engagement in Biobanking in South Africa’. Prof. Moodley stressed the importance of community outreach and engagement in building trust between the public and biobankers and biomedical researchers. If such trust were present during the Ebola outbreak, one might surmise, that would make keeping the tissue more justifiable even if actual individual consent is absent.
Two speakers, Prof. Tan Soo Yong and Dr. Chan Tuck Wai, addressed the question of what to do in the absence of appropriate consent in the local, Singaporean context. Both speakers focused on provisions under Singapore’s new law on biomedical research and tissue banking (The Human Biomedical Research Act) that would allow for research to be carried out on human biological material without the appropriate consent of individuals. While the law generally requires appropriate consent to be taken for participation in research and obtainment of human tissue, it does allow for a waiver of consent various if requirements are met. Among these requirements are that it would be impracticable for researchers to obtain appropriate consent of individuals and that the research exposes individuals to more than minimal risk. The key requirement, however, that Prof. Tan and Dr. Chan focused on is that the proposed “research would reasonably be considered to contribute to the greater public good” (the ‘Greater Public Good Requirement’). Both speakers welcomed the fact that Singapore’s law allows for a waiver of consent, but they cautioned that the Greater Public Good Requirement is likely going to pose a high barrier. The precise nature of this barrier, both pointed out, will become clearer once the Ministry of Health issues guidance on the interpretation of the law, including the Greater Public Good Requirement.
This blog post could not do justice to the full variety of issues that speakers discussed at the conference. It should thus be welcome news that several of the presentations are expected to make their way into a special ABR December 2017 on Biobanking Governance!
This blog article was contributed by:
Markus Labude joined the Centre for Biomedical Ethics (CBmE) in 2015 as a Research Associate under the ‘Funding Initiative for Capacity Development in Biomedical Ethics in Singapore’. Markus is a graduate of Yale University’s doctoral program in philosophy, where he specialized in ethics and political philosophy. At Yale, Markus co-founded the Working Group in Moral Philosophy. He was also a fellow at Yale’s Graduate Writing Center, a member of Yale’s Center of Law & Philosophy, and a member of the Global Justice Program. Prior to joining the CBmE, Markus was a visiting researcher at the University of Frankfurt’s research cluster on “The Formation of Normative Orders”. Markus’ key research interests include philosophy & public policy, research regulation, legal philosophy and the methodology of ethics and political philosophy.