Embracing complexity and uncertainty: An analysis of three orders of ELSA research on biobanks (original) (raw)
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Bioethics and large-scale biobanking: individualistic ethics and collective projects*
Genomics, society and policy, 2005
Like most bioethical discussion, examination of human biobanks has been largely framed in terms of research subjects' rights, principally informed consent, with some gestures toward public benefits. However, informed consent is for the competent, rights-bearing individual: focussing on the individual, it thus neglects social, economic and even political matters; focussing on the competent rights-bearer, it does not serve situations where consent is plainly inappropriate (eg, the young child) or where coercion can obviously be justified (the criminal). Using the British experience of large-scale biobanking, I argue that the focus on consenting individuals distorts our ways of thinking about biobanks and has serious practical ramifications. This becomes clear if we contrast the case of adult biobanks intended for medical research with two other forms of biobanking. Thus child cohort studies-vital for sound scientific investigation of the interplay of genetics and environment in health-have been very badly funded next to adult studies. On the other hand, forensic databases have attracted massive investment, but little debatepartly owing to a sense that here, at least, is a case where consent is not relevant. Contrasting these central types of biobanking, I will suggest that there are powerful factors at work in limiting 'ethics' to individual rights. Projects of this size should direct our attention to more overtly political questions concerning priority setting and organisation of medical research.
The Emergence of Biobanks in the Legal Landscape: Towards a New Model of Governance
Journal of Law and Society, 2012
Biobanks are increasingly seen as new tools for medical research. Their main purpose is to collect, store, and distribute human body materials. These activities are regulated by legal instruments which are heterogeneous in source (national and international), and in form (binding and non-binding). We analyse these to underline the need for a new model of governance for modern biobanks. The protection initially ensured by respect for fundamental rights will need to focus on more interactions with society in order to ensure biobanks' sustainability. International regulation is more oriented on ethical principles and traces the limits of the uses of genetics, while European regulation is more concerned with the protection of fundamental rights and the elaboration of standards for biobanks' quality assurance. But is this protection adequate and sufficient? Do we need to move from the biomedical research analogy to new forms of legal protection, and governance systems which involve citizens?
Biobanking and public health: is a human rights approach the tie that binds?
Human Genetics, 2011
Ethical principles guiding public health and genomic medicine are often at odds: whereas public health practice adopts collectivist principles that emphasize population-based benefits, recent advances in genomic and personalized medicine are grounded in an individualist ethic that privileges informed consent, and the balancing of individual risk and benefit. Indeed, the attraction of personalized medicine is the promise it holds out to help individuals get the ''right medicine for the right problem at the right time.'' Research biobanks are an effective tool in the genomic medicine toolbox. Biobanking in public health presents a unique case study to unpack some of these issues in more detail. For example, there is a long history of using banked tissue obtained under clinical diagnostic conditions for later public health uses. But despite the collectivist approach of public health, the principles applied to the ethical challenges of biobanking (e.g. informed consent, autonomy, privacy) remain individualist. We demonstrate the value of using human rights as a public health ethics framework to address this tension in biobanking by applying it to two illustrative cases.
There seems to be no settled definition of biobanks. One commonly used describes them as organised collections of biological samples and associated data. Biobanks offer a site of interaction between the public, patients, researchers, physicians, bioinformaticians, regulators, policy makers and companies. The relationships between these actors are not always smooth. Debates over biobanking design and practices are rather frequent. The governance of biobanks is a complex process "since the domains of science and technology, healthcare, economy, law as much as the public administration each operate according to different logics and emphasize different values or motives to different degrees", according to Gottweis & Lauss. Challenges in the governance of biobanks: The multitude of options regarding the institutional forms of biobanks, and their mode of governance. The same applies for the diversity in regulatory frameworks, especially in relation to the interplay of national and transnational practices that have emerged. Following that, the emergence of a need for harmonization and common standards regarding the quality of data (and samples) with reference to an envisaged potential to share them, for the benefit of research. Different ways to engage citizens-depending on local setting and existing practices. At a broader level, the institutional setting comes in relation to the national view on biobanking projects (biologic material as national resource, a national DNA repository) and their positioning in the bioeconomy, meaning their relation to economic development.
Public participation is increasingly an aspect of policy development in many areas, and the governance of biomedical research is no exception. There are good reasons for this: biomedical research relies on public funding; it relies on biological samples and information from large numbers of patients and healthy individuals; and the outcomes of biomedical research are dramatically and irrevocably changing our society. There is thus arguably a democratic imperative for including public values in strategic decisions about the governance of biomedical research. However, it is not immediately clear how this might best be achieved. While different approaches have been proposed and trialled, we focus here on the use of public deliberation as a mechanism to develop input for policy on biomedical research. We begin by explaining the rationale for conducting public deliberation in biomedical research. We focus, in particular, on the ELS (ethical, legal, social) aspects of human tissue biobanking. The last few years have seen the development of methods for conducting public deliberation on these issues in several jurisdictions, for the purpose of incorporating lay public voices in biobanking policy. We explain the theoretical foundation underlying the notion of deliberation, and outline the main lessons and capacities that have been developed in the area of conducting public deliberation on biobanks. We next provide an analysis of the theoretical and practical challenges that we feel still need to be addressed for the use of public deliberation to guide ethical norms and governance of biomedical research. We examine the issues of: (i) linking
The social dimension of biobanking: objectives and challenges
Life Sciences, Society and Policy, 2017
The present article allows to explore, analyze and reflect on the consequences and problems posed by biobanks and attempts to prove the need of social and humanitarian support in establishing and functioning of biobanks as a new type of scientific institutions. The basis of the article is the latest publications devoted to social and humanitarian aspects of biobanking and Russian experience of the initial formation of this subject domain (before the first professional biobanks were established in Russia in the 2010-s, the only highly specialized collections of bio-samples had been registered). The article marks and classifies different aspects of biobanking that objectively demands the participation of specialists in ethics and social sciences. The cases of biobanking development and risks are estimated; the objective need of applied ethics and social sciences specialists' participation in biobanking is proved.