Calvin Wai-Loon Ho

Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era

Biobanks have been heralded as essential tools for translating biomedical research into practice, driving precision medicine to improve pathways for global healthcare treatment and services. Many nations have established specific governance systems to facilitate research and to address the complex ethical, legal and social challenges that they present, but this has not lead to uniformity across the world. Despite significant progress in responding to the ethical, legal and social implications of biobanking, operational, sustainability and funding challenges continue to emerge. No coherent strategy has yet been identified for addressing them. This has brought into question the overall viability and usefulness of biobanks in light of the significant resources required to keep them running. This review sets out the challenges that the biobanking community has had to overcome since their inception in the early 2000s. The first section provides a brief outline of the diversity in biobank and regulatory architecture in seven countries: Australia, Germany, Japan, Singapore, Taiwan, the UK, and the USA. The article then discusses four waves of responses to biobanking challenges. This article had its genesis in a discussion on biobanks during the Centre for Health, Law and Emerging Technologies (HeLEX) conference in Oxford UK, co-sponsored by the Centre for Law and Genetics (University of Tasmania). This article aims to provide a review of the issues associated with biobank practices and governance, with a view to informing the future course of both large-scale and smaller scale biobanks.

ELSI practices in genomic research in East Asia: implications for research collaboration and public participation

Common infrastructures and platforms are required for international collaborations in large-scale human genomic research and policy development, such as the Global Alliance for Genomics and Health and the ‘ELSI 2.0’ initiative. Such initiatives may require international harmonization of ethical and regulatory requirements. To enable this, however, a greater understanding of issues and practices that relate to the ethical, legal and social implications (ELSI) of genomic research will be needed for the different countries and global regions involved in such research. Here, we review the ELSI practices and regulations for genomic research in six East Asian countries (China, Indonesia, Japan, Singapore, South Korea and Taiwan), highlighting the main similarities and differences between these countries, and more generally, in relation to Western countries. While there are significant differences in ELSI practices among these East Asian countries, there is a consistent emphasis on advancing genomic science and technology. In addition, considerable emphasis is placed on informed consent for participation in research, whether through the contribution of tissue samples or personal information. However, a higher level of engagement with interested stakeholders and the public will be needed in some countries.

Therapeutic Misconception in Psychiatry Research: A Systematic Review.

Therapeutic misconception (TM) denotes the phenomenon in which research subjects conflate research purpose, protocols and procedures with clinical treatment. We examined the prevalence, contributory factors, clinical associations, impact, and collated solutions on TM within psychiatric research, and made suggestions going ahead. Literature search for relevant empirical research papers was conducted until February 2015. Eighty-eight reports were extracted, of which 31 were selected, summarised into different headings for discussion of implications and collated solutions of TM. We found variable and high rates of TM (ranging from 12.5% to 86%) in some psychiatry research populations. Contributory factors to TM included perceived medical roles of researchers, media, research setting and subject factors. Greater TM in affective, neurodevelopmental and psychotic spectrum conditions were associated with demographic variables (such as lower education, increased age), clinical factors (such as poor insight, cognitive deficits, increased symptoms, poorer self-rated quality of health), and social functioning (such as decreased independence). Inattention to TM may lead to frustration, negative impression and abandonment of participation in psychiatry research. Strategies such as the employment of a neutral educator during the informed consent process and education modules may be effective in addressing TM. Further research is warranted to examine the different TM facets, specific clinical correlates and more effective management strategies.

Vulnerability in International Policy Discussion on Research involving Children

This paper provides an evaluation of the discussion on the concept of vulnerability in research involving children, which took place at the 10th Global Summit of National Bioethics Committees—the primary international forum for members of national bioethics (or ethics) bodies to share their experiences and discuss emerging bioethical issues. Children are generally considered to be a vulnerable population in international guidelines, hence special considerations are entailed. Ideally, children should play a role in the development of research projects, as well as in decision-making about their involvement. In research activities involving children, the level of risk that they are exposed to must be justified. Given the roles that national bioethics bodies hold in their respective societies, they are strategically positioned to identify and address vulnerabilities that occur in the context of research involving children, and to consider means by which research may be better aligned with ethical and regulatory norms. It is clear from the Global Summit that while vulnerability remains a critical concept, national bioethics bodies have an important role to play in contributing to its refinement in international policy, and in ensuring the adequate adaptation and implementation of international guidance.§

Caring About Meatballs, Autonomy, and Human Dignity: Neuroethics and the Boundaries of Decision Making Among Persons With Dementia

Lavazza and Reichlin (2018) provide an instructive ethical analysis of a real-life case, involving Oscar, a vegan activist living with dementia in a nursing home in Sweden, who was, by accident, se...

Vulnerability in Healthcare and Research involving Children

Vulnerability is a fundamental area of interest and debate in bioethics, and where children and young persons are concerned, it is typically invoked as justification for specific measures of protection. There is a degree of consensus that vulnerability is a complex that encapsulates overlapping moral interests and concerns arising from our needs as human beings, commonly manifested in different types and levels of dependencies. Not surprisingly, several taxonomies of vulnerability have been proposed. For instance, the taxonomy of Mackenzie, Rogers and Dodds comprises three different sources (which are inherent, situational and pathogenic) and two different states of vulnerability (these being dispositional and occurrent). A commonality that this taxonomy shares with other taxonomies is the acknowledgement that vulnerability is intrinsic to being human, which is broadly referred to as inherent or ontological vulnerability. There is also a general commonality of goal in enabling the identification of specific (and especially extraordinary) forms of vulnerability that necessitate overt interventions in mitigating potentially greater harms. Clearly, children and young persons have greater inherent vulnerability owing to their physical and cognitive limitations, as well as their proportionately lower capacity of meeting particular needs.

Governance of biomedical research in Singapore and the challenge of conflicts of interest.

This article discusses the establishment of a governance framework for biomedical research in Singapore. It focuses on the work of the Bioethics Advisory Committee (BAC), which has been instrumental in institutionalizing a governance framework, through the provision of recommendations to the government, and through the coordination of efforts among government agencies. However, developing capabilities in biomedical sciences presents challenges that are qualitatively different from those of past technologies. The state has a greater role to play in balancing conflicting and potentially irreconcilable economic, social, and political goals. This article analyzes the various ways by which the BAC has facilitated this.

Intellectual Property and Access to Essential Medicines: A Tenuous Link?

According to the World Health Organization, essential medicines are medicines that satisfy priority health care needs of a population, and they are selected with regard to disease prevalence, safety, efficacy, and comparative cost-effectiveness. In addition, they are intended to be available in functioning health systems at all times in adequate amounts, in appropriate dosage forms, with assured quality, and at affordable prices. Affordability is commonly regarded as central to the accessibility of essential medicines. However, keeping the price of medicines low has been argued by some to be inimical to pharmaceutical innovation and investment. This has in turn led to a criticism of the pharmaceutical industry, which performs a critical socio-economic function of drug development, but allegedly at an unjustifiably high profit margin that precludes access by many of those who need the medicines. From about the middle of the last century onwards, the politics of drug development assumed a more complex character for a number of reasons that are related to the globalisation of research and development, drug production, and intellectual property rights. With more than two billion people in lowand middle-income countries (LMIC) lacking adequate access to essential medicines, there is growing demand on the pharmaceutical industry to contribute to improving access to medicines for the poor in these countries. The sustainable way forward is one that balances the interest in drug innovation and development with alleviating the health-related sufferings and burdens of the world’s poor in the long run. These are not irreconcilable goals, but it is important not to essentialise (or unduly simplify) the relationship between price of essential medicines and their accessibility. In addition,