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Biobanking: Social, Political and Ethical Aspects

  1. Richard Tutton

Published Online: 15 JAN 2010

DOI: 10.1002/9780470015902.a0022083

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Tutton, R. 2010. Biobanking: Social, Political and Ethical Aspects. eLS.

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  1. Lancaster University, ESRC Centre for Economic and Social Aspects of Genomics (Cesagen), Lancaster, UK

Publication History

  1. Published Online: 15 JAN 2010

Introduction: Biobanking Today

  1. Top of page
  2. Introduction: Biobanking Today
  3. Governance and Legitimation of Biobanks
  4. Consent in the Era of Biobanking
  5. Ownership, Control and the Economies of Biobanks
  6. Summary
  7. References

In the past 10 years, a sizeable literature has been produced on the social, ethical, legal and commercial dimensions of biobanking. Several edited anthologies have been published (Arnason et al., 2004; Dabrock et al., 2010; Eriksson and Hansson, 2001; Faulkner-Sleebom, 2008; Gottweis and Petersen, 2008; Häyry et al., 2007; Tutton and Corrigan, 2004), and at least one major review of the literature has already appeared (Hoeyer, 2008). The term biobanking itself describes a diverse range of research and clinical activity, ranging from research in the epidemiology of common complex diseases, pharmacogenetics, rare genetic diseases, oncology and stem cells, to therapeutic applications such as blood transfusion or organ transplantation. Biobanks are situated in a range of institutions such as hospitals, universities, pharmaceutical companies and charities and vary in provenance, size, composition, methodology, economy and governance. There is disagreement among academic commentators, scientists and policymakers about what defines a biobank and whether this is the best term to use, with some preferring expressions such as ‘genetic database’ instead (Corrigan and Tutton, 2009; Gibbons et al., 2007). Despite such ambiguities, there are strong expectations among scientists, policymakers and others that biobanks will play an important part in improving future human health and in bringing substantial economic benefits to those who use and invest in them.

This article cannot give adequate coverage to all of the research and therapeutic forms of biobanking that are ongoing today. Given that prospective, population-based biobanks designed for research into genetic, environmental and lifestyle factors associated with common, complex diseases or the genetic basis of drug response have garnered the most interest from commentators, this article will concentrate on this type of biobanking. It will acknowledge, however, the discussions led by those who have looked at cancer (Dixon-Woods et al., 2008) and stem-cell biobanking (Brown and Kraft, 2006) where appropriate. Prospective, population-based biobanking has become a global activity, with initiatives appearing in Québec, Scotland, Japan, the United States, Newfoundland, Taiwan, Singapore, China, Germany, the United Kingdom, Iceland, Estonia, Sweden, India and Western Australia to list but a few places. Although most of these are ongoing concerns, some have met with local opposition or encountered difficulties related to their financing or commercialization models and have either shut down or continued in different forms (Rose, 2006).

This article gives an overview of the principal social, ethical and legal issues that commentators have debated in relation to biobanking. Different groups of researchers have contributed to these debates, including bioethicists, lawyers, sociologists of science and anthropologists, as well as geneticists, biologists and others. This article focuses on the following clusters of issues: debates about the appropriate form of consent for biobanks; questions of ownership, property and the broader economic context to biobanking; the way biobanks draw on and reflect ideas of national identity, citizenship, and the extent to which they succeed in being inclusive of racial/ethnic minorities; and, to begin with, the particular challenges to governance that biobanks present and how they have sought their social and political legitimation.

Governance and Legitimation of Biobanks

  1. Top of page
  2. Introduction: Biobanking Today
  3. Governance and Legitimation of Biobanks
  4. Consent in the Era of Biobanking
  5. Ownership, Control and the Economies of Biobanks
  6. Summary
  7. References

Sociologists of science and political scientists have drawn attention to the governance frameworks of science and technology within which biobanks have appeared and the problems faced by their institutional funders and supporters to establish their social and political legitimacy. Biobanks emerged at a time when policymakers and commentators were concerned with public controversies surrounding technological and scientific issues such as cloning, gene therapy, genetic testing and genetically modified (GM) food, and were recognizing the need ‘to build and maintain high levels of public trust through the effective governance of … emerging biotechnologies’ (Martin, 2001, p. 171). Throughout the 1980s and 1990s, networks of research and governance changed with greater ties between academic and commercial organizations and in some countries there was a move to facilitate the commercial exploitation of publicly constituted resources, effectively blurring the lines between the private and the public. Many biobanks are situated on these contested ‘blurred’ lines between the public and the private in ways that have sometimes been controversial. In the 1990s, we also saw the emergence of an institutionalized ELSI (ethical, legal, social implications) research agenda in human, animal and plant genomics in North America and Europe, as well as the introduction of new advisory bodies focusing on matters related to genetics, such as the Human Genetics Commission (HGC) in the United Kingdom, which involved greater lay involvement. Civil society groups also became active during this time, addressing issues related to animal, plant and human genetics research.

Against this background, and faced with concerns about trust, data security, confidentiality, consent, discrimination and commercial interests expressed by academic commentators and policy actors, the organizers of many biobanks have had to build legitimation for their initiatives (Petersen, 2006; Salter and Jones, 2005). This has been particularly important for population-based prospective biobanks because many receive public funding and depend on successfully enrolling a great number of volunteers. Given this, a number of them have undertaken various forms of community and public engagement (Godard et al., 2004). Sociologists as well as policymakers have found many of these consultative activities to be problematic, pointing to the way they are narrowly defined and controlled to the exclusion of addressing more substantial issues (Petersen, 2007; McNamara and Petersen, 2008; Walmsley, 2009). However, biobanks in other countries such as Japan appear to have been developed with little consultation with the public or the academic community (Triendl and Gottweis, 2008).

In addition to public engagement, it is also argued that as part of their strategy to achieve legitimacy organizers of biobanks have sought to enrol bioethicists to negotiate the way through the political, ethical and legal uncertainties that they face (Salter and Jones, 2005). As a group, bioethicists have recognized expertise and competence in the area of biomedical governance and have an authoritative claim to policy-relevant knowledge. It is also fair to say, however, that other professionals with similar credentials such as social scientists and lawyers have also been recruited to work alongside scientists, clinicians and others, including consumer or patient representatives, on the issues that biobanks face. A number of biobanks have created their own in-house oversight committees. The UK Biobank, for instance, established a semi-independent Ethics and Governance Council (EGC), which was perceived to be crucial in securing public confidence in the project. With a bioethicist as its first chair, the EGC was created long before UK Biobank began its recruitment of volunteers in 2006. It has been argued that bodies such as the EGC represent a ‘regulation plus’ model (Haddow et al., 2007) whereby biobanks provide an additional layer of scrutiny to the existing structures of governance, with the aim of securing public confidence in them.

Two particular issues in the governance of biobanks – which have impinged directly on questions about their legitimacy – have attracted particular attention: the first concerns the process by which individuals consent to deposit tissue samples and personal information with biobanks; and the second relates to the rights of ownership, control and financial benefit that comes from the use of these samples and data by third parties that include commercial organizations. These will be addressed in turn in the sections that follow.

Consent in the Era of Biobanking

  1. Top of page
  2. Introduction: Biobanking Today
  3. Governance and Legitimation of Biobanks
  4. Consent in the Era of Biobanking
  5. Ownership, Control and the Economies of Biobanks
  6. Summary
  7. References

The issue of consent has been a dominant concern of much writing about prospective genomic or epidemiological databases (see Beskow et al., 2001; Clayton, 2005; Shickle, 2006; for a review of this extensive literature see Hoeyer, 2008). The prominence given to the consent question comes in part from what was happening in Iceland in the late 1990s. The plan developed by deCODE Genetics with the support of the Icelandic Government and Parliament was to create the Health Sector Database – essentially an electronic patient record system – that would be combined with a genealogical database (which was already in the public domain) and a deoxyribonucleic acid (DNA) database. The Health Sector Database was to operate on a presumed consent basis, with a concession that individuals could opt-out within a certain period to prevent their medical records from being automatically included in the database. This was seen as going against international norms and faced a significant legal challenge in the Supreme Court of Iceland that ruled against this approach (Palsson, 2008). However, further to this, it has been suggested that many observers were confused about what was happening in Iceland and believed that presumed consent also extended to the genetic database, which was not the case (see Hoeyer, 2008). This misunderstanding informed much of the critical commentary on Iceland and contributed to consent becoming a highly controversial issue in relation to genomic and epidemiological databases. See also deCODE and Iceland: A Critique

Moreover, as debates about the status, ownership and control of human tissue and genetic information came to the fore in the 1990s in light of its newly commercialized value, whether we were talking about things or persons, or perhaps something in between became a significant point of contestation (Knoppers and Laberge, 1995). This was especially the case because, with molecular DNA analysis, tissue samples became a source of genetic information about individuals that was perceived to be revealing something essential about them (Hoeyer, 2008). These observations about the link between tissues, DNA and human personhood seem to be borne out by some of the debate about the type of consent with which biobanks should operate. Given that prospective biobanks are configured as resources for multiple researchers to access and use over a potentially long period of time, it is not possible to tell individuals how their samples and genetic or other kind of information might be used in the future with any degree of specificity at the time when they are enrolled. Some argue that seeking re-consent from individuals over time as new studies apply to use the biobank is likely to be expensive; refusals or nonresponses could undermine the integrity of both the intended research and the resource itself and it would be burdensome to the individuals being recontacted on potentially several occasions. The fear is that they might even develop negative attitudes towards biomedical research (Berg, 2001). This has led some to speak about a crisis involving consent in the context of biobanking (Lipworth et al., 2006).

In the United States and Europe, there have been different institutional responses to this situation: in the former, the issue of informed consent has become bound up with the identifiability or anonymity of samples. US policymakers have broadened the category of ‘nonidentifiable’ samples to include those where the investigator accessing the biobank is unable to link that sample to a named individual (Elger and Caplan, 2006). When samples are rendered as ‘nonidentifiable’, informed consent is not deemed to be necessary for their continued and future use. Therefore, in the US context, informed consent is linked to questions of individual identifiability and concerns about privacy and confidentiality. When the personal identity of individuals is protected, informed consent is not required for subsequent use of the samples. However, this expansion of nonidentifiability is not without its problems, since the link between the sample and the individual still remains, albeit in an encrypted form held by the biobank, and could be used in circumstances such as criminal investigation or for other purposes. For instance, after the tsunami in 2005, the Swedish Parliament temporarily amended legislation related to medical biobanks to permit access to identify bodily remains (Holmlund et al., 2006).

An alternative approach followed by a number of biobanks in Europe and Asia has been to move from informed consent to broad consent, supplemented by two compensatory measures: first that ethics committees approve of all future research using the biobank in question and second, that individuals have a right to withdraw at any time (although what this means in practice is not always clear) (Elger and Caplan, 2006). Those who advocate broad consent cite evidence on the views of public groups to support their case, referring to studies that indicate that people do not attach a similar priority to informed consent as ethicists (Chen et al., 2005). This point is largely supported by empirical research on individuals’ experience of being participants in biobanks by anthropologists and sociologists (see Hoeyer, 2008). Lunshof et al. 2008 go further in their argument that the promise of privacy and confidentiality is untenable in the era of genomic research that is predicated on the networking and sharing of vast quantities of data. Researchers should adopt an ‘open consent’ model that recognizes and documents the fact that individuals will have their personal information disclosed to third parties both now and in the future.

There are also discussions about alternative ethical frameworks to informed consent such as those based on solidarity and equity in relation to biobanking. Chadwick and Berg 2001 observe that the rules on informed consent were developed in the middle of the twentieth century and argue ‘now might be the time for a fresh ethical perspective’ (p. 321). They suggest that individuals have a duty to participate in biobanks where the subsequent research using these resources could benefit wider society and future generations, an act of solidarity similar to providing blood for transfusion or organs for transplantation. These ideas about solidarity and equity are not unproblematic, however, in a time when there are significant commercial interests in banking human tissue.

Ownership, Control and the Economies of Biobanks

  1. Top of page
  2. Introduction: Biobanking Today
  3. Governance and Legitimation of Biobanks
  4. Consent in the Era of Biobanking
  5. Ownership, Control and the Economies of Biobanks
  6. Summary
  7. References

Recent work on the political economy of the life sciences in the twenty-first century by sociologists of science and technology points to the broader economic context in which biobanks must be situated. Biobanks, whether for epidemiological, pharmacogenetic, cancer or stem-cell research, are positioned as having a pivotal role in the ‘bioknowledge economy’ (Tupasela, 2006). With their promise to utilize the genetic or biological characteristics of populations as resources for the production of intellectual property, biobanks are seen as key elements in the production of ‘biovalue’, by which life itself is seen as productive of surplus value (Cooper, 2008). In addition to their potential to be resources that will improve human health, biobanks could also provide the means for boosting national or regional biotechnology and the pharmaceutical sectors. In countries such as Iceland, Estonia and Latvia, biobank initiatives were represented as ways of establishing an economic resource out of the ‘raw materials’ of DNA samples, producing profit for private companies and bringing inward investment in capital and jobs to these economies (Abbott, 2001; Merz et al., 2004; Mieszkowski, 2003). Such expectations about the economic benefits of biobanks in the context of international competitiveness in the new ‘bioeconomy’ are important elements in the story of contemporary biobanking (Fortun, 2008).

As already suggested, the debate on consent is entangled with questions of ownership, commercial access and benefit-sharing. With the exception of private cord blood banking, where individuals pay to have tissue stored for potential future use (see Brown and Kraft, 2006), most types of biobanks operate on the principle that individuals would voluntarily and freely provide biological samples and personal information. The transaction between the biobank and the volunteer or patient is, therefore, a noncommercial one and has sometimes been conceptualized as a ‘gift relationship’ – a deliberate echo of Richard Titmuss’ use of that expression in relation to blood donation (Tutton and Corrigan, 2004; Waldby and Mitchell, 2006) – to emphasize that people should be acting altruistically. Access to and use of biobanks, however, might very well be on commercial terms, with biotechnology and pharmaceutical companies as well as universities as likely future users of these resources. This has led to a debate about whether and on what terms such organizations should financially benefit from research conducted using samples freely provided by individuals. The dominant view in bioethics literature and in guidelines produced by bodies such as the Nuffield Council on Bioethics 1995 is that to secure the promised benefits to health in the form of new diagnostics or drugs, commercial actors must be entitled to intellectual property on products developed as a result of research using biobank resources. However, research on public views on access to prospective, population-based epidemiological biobanks points to a strong preference for only health services and academic research organizations to have use of these resources (Shickle et al., 2002). Other research reports a more variable picture of public opposition and ambivalence to commercial companies accessing biobanks to which individuals have freely contributed samples (Haddow et al., 2007). See also Commercialization of Human Genetic Research

The debate about ownership, commercial access and benefit-sharing in relation to biobanking stems in part from broader concerns with the commodification of the human body (Andrews and Nelkin, 2002), the patenting and selling of genetic information (Knoppers and Laberge, 1995) and long-standing debates in legal theory about property in the human body (Grubb, 1998). These debates are informed by case law such as the much-discussed judgement of the Supreme Court of California on John Moore v. Regents of the University of California (Boyle, 1992). The plaintiff, John Moore, claimed that he held property rights in the tissue excised by doctors who performed his splenectomy and who then used this tissue to develop a cell line, which had potential commercial value. The court's decision to deny his action was based on the reasoning that tissue in itself could not be considered property. Only when it was turned into a cell line and had been invested with and altered by human labour, could it become property. Since Moore did not own the tissue removed from his body, he had no claim over the cell line and no entitlement to a share of profits made from its commercial development. The Moore case has become a touchstone for commentaries on the ethical and legal issues involved in the use of human tissue and is a frequent point of reference for regulatory, advisory and ethics bodies. For some legal commentators, the case exemplifies that ‘while property rights are routinely granted in respect of human material, this is usually done to the exclusion of the one person who is central to the entire enterprise, namely, the individual from whom the material has been taken’ (Laurie, 2002, p. 304). This is not only unjust but, as the argument goes, granting property rights could be a way of relegitimizing research and overcoming the ‘crisis in confidence’ in its governance by giving people more control over what happens to their tissue (Laurie, 2002). Biobanks would therefore not solely rely on consent but incorporate a system of property rights.

Such arguments have not gone unchallenged, however, from a number of quarters. Some social scientists have questioned whether there really is a ‘crisis in confidence’ and suggest that there is a range of public views on the use of different types of tissue. In the context of cancer biobanking, the interest in controlling what is done with the tissue might be less important than the potential ‘pay-off’ from therapeutic research conducted using that tissue (Sebire and Dixon-Woods, 2007). Moreover, the focus on property and property rights detracts from the point that much research using human tissue is conducted in charitable, academic and clinical settings and is not driven by commercial interests.

Beyond the focus on property rights, others have discussed models of benefit-sharing and ways of negotiating public and private interests in biobanks, such as the idea that biobanks should be organized as ‘charitable trusts’ to safeguard public interests by controlling the use made of these resources by third parties (Winickoff and Winickoff, 2003). Partnership rather than property is the dominant theme of such commentaries. Others have examined the question of introducing systems of benefit-sharing (Berg, 2001; Simm, 2005; Wilson, 2004), including community-based ‘benefit-sharing’ that could involve both ‘in kind’ and monetary benefits (Haddow et al., 2007). The thrust of some of these contributions is that those running biobanks should recognize the need for some form of reciprocation for the free, voluntary contributions of individuals and families to biobanks and benefit-sharing could be one way in which this is achieved (Busby, 2006; Haddow et al., 2007; Winickoff, 2007).

Biobanking, national identity and in/exclusion of racial/ethnic minorities

Besides raising the kinds of ethical, legal and economic issues discussed in the preceding sections, across the world, the formation of biobanks often invoke or are entangled with discourses of collective identity, community, nationhood or ideas about racial/ethnic groups and differences. The concern expressed by some anthropologists and sociologists is that new genetic knowledge produced from population-based genetic research could essentialize ideas of national identity and citizenship (Arnason and Simpson, 2003). Some researchers have considered how those promoting these initiatives actively construct the ‘population’ of the biobank in various ways that draw on or are congruent with legal, social and political ideas of the nation. In some cases, this is articulated in terms of claims about the homogeneity of the national population, such as in Iceland where deCODE Genetics and many of its supporters emphasized the genetically isolated and homogeneous nature of the Icelandic population (Palsson, 2008), which was reinforced by scientific and popular media reports. Although such claims did not go unchallenged (Arnason, 2003), they helped to make the case for the Icelandic population being a ‘good population’ for genetics research at a time when inward investment was needed (Fortun, 2008; Rose, 2001). In other national contexts too, such as Israel and Japan, similar discourses of population homogeneity have been evident, drawing on the dominant discourses of national identity (see Prainsack, 2008; Triendl and Gottweis, 2008).

By contrast, in countries such as the United States and the United Kingdom, notions of diversity seem to loom larger in discourses around prospective, population-based biobanks. The much-discussed plans to create a national, prospective biobank in the United States takes place in a context in which there is specific legislation to redress under-representation or exclusion of women and minorities in biomedical research, emphasizing potential differences among such groups (see Epstein, 2007). In the United Kingdom, it has been argued that UK Biobank has invoked an ‘imagined national community’ united around certain touchstones of British national identity, such as the National Health Service, as well as drawing on more contemporary discourses of innovation, global competitiveness and multiculturalism (Busby and Martin, 2006).

The inclusion of different racial/ethnic groups in the creation, design and rationale of biobanks raises a number of problems. Empirical studies of the scientific and social issues of including minority racial/ethnic groups in biobanks highlight the potential conflict that can arise between the objectives of ‘social inclusivity’ and ‘analytical acuity’ (see Smart et al., 2008). Although researchers might wish to include minority groups in the studies, there are concerns that doing so could adversely affect the quality of their science. This is related to concerns that it will not be possible to include minority population groups in sufficient numbers in order for studies to be suitably ‘powered’ to draw reliable conclusions. This issue has been hotly debated in the scientific literature, with different approaches being advocated for dealing with it (see Collins, 2004). One response is for biobanks to be designed to specifically research and address the health needs of defined populations, such as the Translational Genomic Research in the African Diaspora Biobank that was set up at the National Human Genome Center at Howard University in 2003 (Royal and Dunston, 2004). The UK Biobank, by contrast, has set minimum targets for the recruitment of individuals from a number of specified minority racial/ethnic groups (Tutton, 2008). Although it is hoped that the inclusion of minorities in biobanks will help identity and redress health inequalities, it is also recognized that research on disease susceptibility could highlight different risk profiles for such groups and reinforce stereotypes, leading to stigmatization or further discrimination (Chadwick, 2003).

Summary

  1. Top of page
  2. Introduction: Biobanking Today
  3. Governance and Legitimation of Biobanks
  4. Consent in the Era of Biobanking
  5. Ownership, Control and the Economies of Biobanks
  6. Summary
  7. References

For ethicists, lawyers, social scientists and others, biobanking is a significant sociotechnical activity in the field of biomedical research that raises a wide range of issues relating to the formal conditions and procedures by which individuals are recruited to these initiatives; how biobanks establish their social and political legitimacy through novel governance structures; how public and private interests are negotiated by biobanks in a context of great commercial interest in human tissue and personal clinical data and how biobanks reflect cultural and political discourses of national identity and might serve to address the health needs of different groups in society.

In the past five years, there have been a number of new initiatives to set standards for biobanking at an international level and to foster greater coordination and cooperation among different biobanks. Organizations such as the P3G (Public Population Project in Genomics) Consortium in Quebec, Canada has been a notable actor, and the European Commission under the aegis of its Framework Programme Seven has supported initiatives at the European level to coordinate the work of biobanks in member and associate member states. There is an emergent global biobanking community of scientists, technicians, ethicists, lawyers and others engaged in a project of harmonizing scientific, technical and ethical practices and encouraging greater data-sharing across national borders. As these initiatives progress, they will raise further social, ethical and legal issues (Knoppers, 2005). Moreover, as many existing biobanks move from the banking to the research phase, opening their resources for researchers to access and use, it is clear that many of the issues outlined in this article will remain pertinent for the foreseeable future.

References

  1. Top of page
  2. Introduction: Biobanking Today
  3. Governance and Legitimation of Biobanks
  4. Consent in the Era of Biobanking
  5. Ownership, Control and the Economies of Biobanks
  6. Summary
  7. References
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