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lthough scientific and commercial excitement Partnership in about genomic biobanks has subsided since A the biotech bust in 2000, they continue to fas- cinate life scientists, bioethicists, and politicians alike. U.K. Biobank: Indeed, these assemblages of personal health infor- mation, human DNA, and heterogeneous capital have become and remain important events in the ethics and A Third Way politics of the life sciences.1 For starters, they continue to reveal and produce the central scientific, technolog- For Genomic ical, and economic paradigms so ascendant in biology today: genome, infotech, and market. Biobanks also illustrate what might be called the new distributive Property? politics of biomedical research. Within those politics, the commodification of persons – or at the very least, David E. Winickoff of their informational representations – has chal- lenged the ontological, ethical, and political under- pinnings of the social contract between researchers and their human research subjects.2 In brief, biobanks are unsettling relations between genes, tissue, medical records, and persons (both individual and collective). But it is also clear that these relations are increasingly being restructured by new rights of control, access, exclusion, and use known as “property,” both material and intellectual. Bioethics scholarship on biobank governance has comparatively ignored property in favor of focusing on consent, Institutional Review Boards (IRBs), and privacy.3 This is both expected and strange. Expected because bioethics as a field has tended to focus on the claims of individuals rather than collectivities, and it has insufficiently theorized the role of capital in research. And strange for two reasons: first, because in a research domain permeated by markets, property entitlement is so obviously constitutive of the ethical order;4 second, because recent disputes around the ownership of medical records, genetic data, and tis- sue samples demonstrate that the now-famous Moore v. Regents case was just the tip of a large iceberg of normative unsettlement in this area.5 Yet, perhaps in spite of bioethics, biobanks are reanimating old ethi- cal dilemmas about the marketization of persons. One problem in this area has emerged with particular force: how can societies negotiate the desire to incen- tivize private capital to construct the mega-experi- mental apparatus of genomic biobanks in order to help drive knowledge and economy forward, even as they remain deeply concerned about the penetration of markets into the personal domains of genome and body, health, and personhood?
David E. Winickoff, J.D., M.A., is an Assistant Professor of Bioethics and Society and the Associate Director of the Science, Technology and Society Center at the University of California, Berkeley.
440 journal of law, medicine & ethics David E. Winickoff
Practical solutions to this ethical dilemma remain the design of the project, which has a central node in elusive, despite some preliminary models both real Manchester. and imagined. In my own work comparing property Over the last ten years, biobank controversies in Ice- relations and governance in multiple biobanking con- land and elsewhere have illustrated that project sus- texts, I have proposed a new legal-institutional vision tainability will demand innovative thinking in ethical, for negotiating a middle path for genomic resources legal, and social areas that move beyond simply adapt- between commodification and inalienability: the ing privacy and consent to new contexts.14 Respond- “Charitable Trust Model.”6 But I am far from alone in ing to the obvious need for new institutional forms to trying to articulate a potential “third way” for treating govern such large assemblages, the United Kingdom the ownership of personal information, tissue, DNA, has enacted many thoughtful design innovations in its and intellectual property in genomic biobanking. national biobanking project. U.K. Biobank’s institu- Many of these ideas call for some form of profit sharing and benefit sharing with research donors – whether by U.K. Biobank will be a national database and contract, regulation, taxation, of ethi- biobank linking the DNA of 500,000 individuals cal standards – to remedy problems of distributive justice.7 Nevertheless, to medical records and lifestyle details and will these ideas remain only suggestive spend £64 million (approximately $122 million) until real attempts at negotiating in public and private money. such a “third way” occur. A promising new attempt to find a “third way” has recently emerged in the United tional structure is significant, for it enacts a thought- Kingdom in the form of the U.K. Biobank project. ful form of shared governance for this newly imagined Although the scientific and social protocols of U.K. kind of common pool resource: both in rhetoric and Biobank have been questioned by scientists and civil legal entitlement, British politicians and biomedical society groups alike,8 an international team of peer elites have constituted a form of “partnership” between reviewers recently called governance at U.K. Biobank funders, biobank donors, and future users – a system “exemplary” and predicted it “would be held up as a of shared property entitlements. gold standard across the world.”9 Governance in U.K. Biobank deserves attention and scrutiny, as it is stak- 1. The U.K. Learns from Iceland ing out a new imagination of the genomic biobank as The governance approach implemented in the United a common-pool resource. To bastardize a famous Brit- Kingdom for its biobank project has its roots in the ish quotation, U.K. Biobank embodies the worst form ethical and political critiques emerging out of an ear- of governance, except all those other forms that have lier project in Iceland. In December 1998, the Icelan- been tried from time to time.10 From a pragmatic per- dic Parliament passed the Health Sector Database spective, the U.K. Biobank’s governance model reveals Act, which set out a new regime for the control of both strengths and weaknesses that may be instructive citizen health information in a modern democracy.15 to genome project planners around the world. Such information was at once declared a “national resource”16 to be controlled by the state and exclusively Property and Control in U.K. Biobank licensed to private industry for inclusion into a com- U.K. Biobank will be a national database and biobank mercial genomic database of national scope. The Act linking the DNA of 500,000 individuals to medi- immediately took on international significance and cal records and lifestyle details and will spend £64 has been written about widely in the law, bioethics, million (approximately $122 million) in public and and social scientific literatures.17 private money. The U.K. Medical Research Council At the core of the Health Sector Database Act (HSD (MRC)11 and the Wellcome Trust12 will reportedly each Act) was the authorization of the database’s creation contribute £28 million (approximately $55 million), and operation in Iceland by a private sector licensee.18 with the remainder falling to various governmental The Health Sector Database could be granted for a health agencies in the U.K.13 Other important con- renewable term of no more than 12 years and had to tributors to the project include the group of 500,000 meet the requirements of Iceland’s Data Protection volunteers aged between 40 and 69 from the British Commission, which had been created by a previously public, who will be recruited as donors of personal enacted privacy law. DeCODE Genetics, an Ameri- health information and DNA. Further, a multitude can corporation with an Icelandic subsidiary, secured of facilities, contractors, and staff will be involved in the license to create and operate the HSD in 2000, genetics and group rights • fall 2007 441 SYMPOSIUM though its exclusive right was explicitly contemplated Martin, a sociologist of science and technology at the from the beginning.19 DeCODE’s plans to link the University of Nottingham, later submitted a written health data with genetic and genealogical informa- memorandum outlining the particular challenges of tion were widely known, although the Act itself said the new commercial involvement in genetics world- nothing about biological samples or DNA, and did wide, stating: not mention genealogical records. The Act authorized the licensee to use the data for profit, but it provided The recent experience of events in Iceland con- for the protection of privacy through new encryption cerning the activities of deCODE genetics and the technologies. The HSD Act’s most controversial provi- proposed creation of the Icelandic Health Sector sion authorized the transfer of all medical record data Database highlight the need for transparency in to the licensee for commercial development without decision making, widespread consultation and the express consent of individuals, thereby invoking a public debate, and strong oversight mechanisms. rule of “presumed consent.” Such an approach to policy in the U.K. could help The Health Sector Database controversy reanimated ensure that genetic databases are well supported, classic ethical debates about human bodies and mar- function in an ethical manner and provide genuine kets, but in the new context of the broad commercial- benefits.24 ization of biomedical research. An early salvo in the Iceland controversy came in a New York Times op-ed In addition to adducing the Iceland project, Martin by the eminent Harvard population geneticist Rich- also noted the emergence of for-profit genomics proj- ard Lewontin, who provocatively declared that Ice- ects in Framingham, Massachusetts, and elsewhere in land had just transformed “its entire population into a the United States as evidence that “public sample col- captive biomedical commodity.”20 For its critics within lections” were beginning to be “commercially exploited Iceland, the Health Sector Database Act embraced a to create human genetics databases.”25 Martin noted naïve genetic hype and the corporate appropriation of the many conflict of interest problems associated with common cultural and scientific resources. Such posi- commercializing public resources, and in this sense tions were met by strong counter-arguments concern- he was prescient: many of these projects, including ing the opportunity to leverage private foreign capi- Framingham Genomics Medicine, subsequently col- tal for biomedical knowledge-making and economic lapsed due to problems of control and access to bio- growth within Iceland, and the Act passed. However, logical samples.26 the transfer of national health records to deCODE Genetics never took place, and the database was never 2. The Ideal of Partnership built, due to the legal and ethical controversy over Out of these hearings, British politicians began to informed consent and the commodification of health articulate a vision for genomic property in the United information.21 Kingdom that explicitly rejected “ownership,” i.e., allo- The formulation of biobank governance in the cating alienable title in a traditional sense. In 2001, United Kingdom needs to be seen as an explicit the House of Lords Science and Technology Commit- response to Iceland. As the Iceland project limped tee issued a report entitled Human Genetic Databases: along, the United Kingdom began to discuss its own Challenges and Opportunities. After summarizing genomic initiative in earnest. A House of Lords Sci- testimonies regarding the property aspects of the pro- ence and Technology Committee Report from 2001 spective U.K. Biobank project, the report states that “in demonstrates the extent to which the British approach common with most of our witnesses, we do not regard to property in genomics was a response to the Icelan- ownership of biological samples as a particularly use- dic controversy. The Committee solicited expert advice ful concept with respect to human genetic databases.” on the design of provisions for the control of tissue Furthermore, it states that “we prefer the notion of samples and information, and these experts registered partnership between participants and researchers, for their disapproval of the consent and withdrawal provi- medical advance and the benefit of others, including sions in Iceland.22 Further, an influential report writ- future generations.”27 ten for the Wellcome Trust by Paul Martin and Jane Parliament’s rejection of “ownership” for “partner- Kaye noted that “the heavy involvement of industry ship” stems from deep public and bioethical concerns in human genetics research…can constrict academic about rendering personal health information and freedom and open access to important research human tissue into an alienable commodity. The notion resources such as DNA banks,” and that “[t]his has of “ownership” suggests the full and undivided bundle been a major worry for those sections of the Icelandic of entitlements associated with property, including research community not associated with deCODE.”23 rights of possession, use, access, exclusion, and alien-
442 journal of law, medicine & ethics David E. Winickoff ation. As property scholar Joseph Singer has usefully ing divide between leaders and experts empowered to stated it, “The core conception is the notion of abso- make decisions in the biomedical domain and the citi- lute control; ownership is the ability to do what you zens and patients affected by those decisions. In this like with your own, without having to account to any- context, finding a rhetorical replacement for owner- one else for your actions.”28 In other words, ownership ship of tissue, genes, and medical information was an tends to convey a notion of exclusivity and full mas- attempt to manage the alienation of these personal tery. It also conveys the idea of complete alienability effects and parts without further alienating Britain’s and even commodity. wary health consumers. For politicians and planners In contrast, the notion of “partnership” works against in the U.K., claims however unfounded of commercial the notion of exclusive ownership and connotes a form exploitation by national health institutions would fur- of cooperative human relations with respect to shared ther jeopardize the trust of patients and research sub- conditions and aims. Indeed, from its very begin- jects. The principal of “partnership” was a way to man- ning as an English word, partner denoted a shared or age these concerns without giving up the potential of joint property relation.29 In modern vernacular usage, collaboration with industry, a key aim of the national a partner is “a person with a joint share in or use of program. something; a person who is party to something.”30 We speak of spouses and intimate relations as “partners,” 3. Property Entitlements in U.K. Biobank and in the business context, partners are “individuals U.K. Biobank never became a legal partnership with interests and investments in a business or enter- between donors, funders, and the nation. Moreover, prise, among whom expenses, profits, and losses are no one is even talking about partnership these days. shared.”31 A partnership, then, in English is really a Instead, public officials in the United Kingdom and form of joint venture. In business, the Oxford English elsewhere are increasingly speaking of the genomic Dictionary tells us, it is “an association of two or more biobank as a collective resource,39 and the language of people as partners for the running of a business, with partnership has shifted to other notions such as stew- shared expenses, profit, and loss; the members of such ardship. In 2004, John Newton, the first CEO of U.K. an association collectively; a joint business.”32 Biobank, said the project would constitute “the world’s In Anglo-American law, partnership has a specific biggest resource for the study of nature and nurture legal meaning: the “relation which subsists between in health and disease.”40 In a recent Biobank press persons carrying on a business in common with a view release, Colin Blakemore, Chief Executive of the Med- of profit”33 or “an association of two or more persons to ical Research Council, predicted that “over the coming carry on as co-owners a business for profit.”34 In both years the data from this study will grow into a unique the American and British legal systems, partnership resource for future generations.”41 involves joint control of assets and an equity inter- The system of entitlements for this newly imagined est in risks and benefits.35 A legal partnership entails resource institutes an unprecedented set of relations mutual duties of loyalty. In his famous 1928 opinion as between donors, managers, funders, and the public. a New York appellate judge in Meinhard v. Salmon,36 Drawing on Elinor Ostrom’s theory of common pool Benjamin Cardozo held that Salmon, as a managing resources,42 we can analyze forms of property and gov- partner in a joint venture, owed his investing part- ernance manifested by U.K. Biobank in order to inves- ner Meinhard a fiduciary duty that required inform- tigate these relations. Indeed, U.K. Biobank itself, like ing him of a new business opportunity. He declared other genomic biobanks, can be usefully described that partners owe each other the highest duty of loy- as a new kind of common pool resource.43 Ostrom’s alty – or in his famous phrase, “Not honesty alone, but well-known book demonstrated that common pool the punctilio of an honor the most sensitive.”37 Now, resources in the environmental goods context evinced the case remains a landmark in the common law of a broad array of formal and informal governance partnership because the latter is a relationship of trust structures that can and do prevent overuse, thus cast- concerning joint assets, risks, and opportunities. ing doubt on the conclusion that joint ownership The aspiration of politicians to construct U.K. necessarily leads to resource depletion. Her schema Biobank as a “partnership” among donors and the of common pool resource systems and taxonomy of research community, lay people and experts, and clinic governance arrangements can help us assess (in the and country, did not come out of nowhere. For some subsequent section) U.K. Biobank as a partnership time in the U.K., leaders within the health system and among donors, managers, and resources. bioethics community have been noting the erosion of Extending Ostrom’s work,44 we can make a distinc- citizen trust towards the health care establishment.38 tion between the “resource system” and the “resource This “trust problem,” it has been noted, reflects a grow- units” of a biobank.45 In the case of biobanks, the genetics and group rights • fall 2007 443 SYMPOSIUM resource system consists of the col- By understanding the actual entitlement lection of genetic information from human samples; health information structure of U.K. Biobank property, one is in a drawn directly from participants and better position to evaluate whether the notion their National Health Service medi- of partnership has been meaningfully realized. cal records; the database’s software and hardware architecture; and per- haps even the participants themselves, or certainly the relation between owner and asset then is not one their willingness to participate. The resource units of a homeowner to an estate, but rather of fiduciaries consist of data or knowledge derived from the bio- over a jointly held resource to be managed for public bank, which may also be the subject of intellectual beneficiaries. property that can be licensed or transferred. This restraint is reinforced by U.K. Biobank Ltd’s Entitlements over these pieces of the common pool public pledge to play a role of “steward” over samples resource are determined in the project’s founding and personal health data. Although U.K. Biobank Ltd constitution, mission statement, and terms of dona- understands it possesses the full set of core property tion and use. In order to create U.K. Biobank, the entitlements in tissue and data, the document explains U.K. Medical Research Council and the Wellcome that Trust formed U.K. Biobank Limited (Ltd), a chari- table company, through a joint venture agreement U.K. Biobank does not intend to exercise all of in order to exercise “management oversight of U.K. these rights; for example, it will not sell samples. Biobank.”46 U.K. Biobank Ltd’s document called the Rather, U.K. Biobank will serve as the steward of Ethics and Governance Framework (EGF) was devel- the resource, maintaining and building it for the oped in 2003 by an Interim Advisory Group, a group public good in accordance with its purpose. This charged by U.K. Biobank’s major funders “to set stan- implies both the judicious protecting and sharing dards for the project and make sure that all necessary of the resource.51 safeguards are in place to ensure that the data and samples are only used for scientifically and ethically In addition to a policy of not selling samples, the EGF approved research.”47 Despite statements made in the pledges that “data and samples will only be used for Parliamentary discussions of biobank ownership, the ethically and scientifically approved research,” and EGF declares that “U.K. Biobank Limited will be the that only research uses approved by both U.K. Bio- legal owner of the database and the sample collection” bank and a relevant ethics committee will be allowed. and that “participants will not have property rights Further, the EGF explains that “safeguards will be in the samples.”48 Perhaps this is an attempt to deal maintained to ensure the confidentiality of the par- clearly with a vexed issue. But given the language in ticipants’ data and samples.”52 These will include put- the House of Lords report, it is somewhat surprising ting data and samples in reversibly anonymized form, that the EGF freely invokes and assigns “ownership” and storing and linking them at “very high standards in this way. of security.”53 Nevertheless, U.K. Biobank Ltd’s ownership in the Furthermore, the British taxpaying public enjoys a resource will be constrained in a number of impor- form of entitlement in the resource, as it is the legal tant ways. The first major restraint lies in its legal beneficiary of U.K. Biobank qua charity. The U.K. obligation as a non-profit entity to act in accordance public enjoys indirect representation on the Board of with its charitable purpose, namely “to build a major Directors, the seven-member body that includes two resource that can support a diverse range of medical members from the governmental health bureaucracy, research intended to improve the prevention, diag- one from the MRC, and the other form the Depart- nosis, and treatment of illness and the promotion of ment of Health. These two institutions, as arms of health throughout society.”49 U.K. Biobank Limited’s British government, are in theory accountable to the Board of Directors will have fiduciary duties under taxpaying electorate. In practice, however, this power U.K. charity law to manage the organization and its is quite attenuated: the average taxpayer is not likely property in accordance with its charitable purpose. to care much about U.K. Biobank, and there are few The EGF clarifies, in fact, that U.K. Biobank’s Direc- incentives to generate collective action for more direct tors legally act both as charitable trustees under U.K. involvement in governance. charity law and as company directors under U.K. cor- In the U.K. Biobank project, duties to produce porate law.50 Assuming that U.K. Biobank Ltd’s prop- public benefit are supplemented by a commitment erty rights in data and tissue samples are enforceable, to accountability. U.K. Biobank Ltd takes a pledge
444 journal of law, medicine & ethics David E. Winickoff of transparency, stating that it will “inform partici- Assessing Governance and Property in pants about uses of the resource…[and] will strive U.K. Biobank to build a relationship of trust with participants and By understanding the actual entitlement structure of the wider public, in order to foster acceptance of the U.K. Biobank property, one is in a better position to ways the resource is developed and used.”54 Further, “a evaluate whether the notion of partnership has been detailed Access Policy for use of the resource will be meaningfully realized.61 Has the U.K. found the elu- developed, with guidance from the Ethics and Gover- sive “third way” between full alienability and non- nance Council, which will evolve in response to users, commodification of genomic properties? Viewed from participants and the wider public.”55 Participants may a pragmatic perspective, U.K. Biobank indeed holds not have control over access choices, but at least they an intriguing set of property and governance arrange- will be made aware of guiding policies. U.K. Biobank ments. In short, the U.K. has likely found a third way. has also made a major effort to “engage the public” However, the project falls short of its own ideals con- on issues related to biobank governance;56 so far, the cerning “partnership,” and in so doing, loses a poten- project has held a number of “public consultations” tial source of strength. in the United Kingdom with various segments and stakeholders.57 1. Strengths Though declared to give up “ownership” of samples, Politicians and project planners in the U.K. have made biobank donors retain certain rights and powers. a number of choices that make it more likely to succeed Research participants must give their affirmative con- where others have failed. First, although U.K. Biobank sent according to a process specified in the Ethics and explicitly appropriates “ownership” of genomic prop- Governance Framework, and donors hold the power erty, its institutional structure achieves an interesting to withdraw from the project at any time. Both of mixture of public and private entitlement. Embrac- these rules confer more powers on donors than did the ing the need for a trusted intermediary to hold and Icelandic Health Sector Database Act and its notori- manage the national genomic resource, the U.K. has ous time-limited “opt-out” mechanism. Furthermore, adopted a public-private charitable model of institu- the EGF also states that a “participants’ panel” may be tional governance. It is a useful way of honoring the set up in the future in order to allow participants to charitable intent of donors, protecting against liqui- “express views” and submit complaints.58 dation in the event of insolvency, promoting research, Finally, the constitution of the Ethics and Gover- and enacting a form of stewardship that respects the nance Council (EGC) itself is a significant develop- dignitary interests of bodies and persons.62 For this ment in the world of biobank governance, though its reason alone, U.K. Biobank’s institutional structure relevance to entitlement is a bit unclear. The EGC holds important advantages over many other possible performs a number of oversight functions for the property arrangements.63 project.59 Its tripartite remit is to do the following: Second, the firm protection of withdrawal rights for (1) act as an independent guardian of the U.K. Bio- donors is a positive feature that is missing from many bank EGF and advise on its revision; (2) monitor and other tissue collection projects, and indicates a good report publicly on the conformity of the U.K. Biobank faith attempt to endow donors with limited but real project with the EGF; and (3) advise more generally rights of control over their tissues. This feature evinces on the interests of research participants and the gen- a moral sensibility concerning the relation of individu- eral public in relation to U.K. Biobank. However, it is als to their extracted tissues currently lacking in U.S. only within the remit of the EGC to “advise” the Board common law.64 of Directors, at most a “soft” legal status with little Third, U.K. Biobank’s stance towards public consul- official authority, a source of weakness that has been tation breaks important new ground, for it embraces criticized within public consultations and by biobank a soft form of public ownership over this collective commentators.60 The group has no veto power on any technoscientific endeavor. In an effort to learn from policy matter, and its real power lies in going public diverse stakeholders and shape the protocol into if it is unhappy with U.K. Biobank’s actions. Further- something with broad support, U.K. Biobank Ltd has more, it remains unclear whose interests will be pri- engaged various British publics and experts in critical oritized with respect to EGC constituencies, including ways. Although U.K. Biobank’s “public consultations” the British public, the participants, and U.K. Biobank have been rightly criticized as too politically tailored Ltd itself. by biobank planners,65 they nevertheless evince a new type of reflexive relation between science and society. In this new set of relations, publics have an impor- tant role in shaping both knowledge and technologi- genetics and group rights • fall 2007 445 SYMPOSIUM cal production, with more “socially robust” knowledge project sustainability. Viability of U.K. Biobank will and tools as potential consequences.66 Such a shift require the recruitment of the 500,000 donors, and will be increasingly important for democracies as they also the prevention of mass invocation of the right to grapple with crucial biotechnological choices. withdraw once samples and information are received. Finally, although this relates less directly to prop- Both attracting and retaining participants will require erty, U.K. Biobank planners have undertaken their that people trust that the project will be managed in work with proper pacing. They have taken ample time ways that are consistent with their core values and developing the Ethics and Governance Framework expectations. Mounting evidence suggests that there before barreling ahead and have learned from pitfalls may be a divide between public expectations and those experienced in similar projects abroad. Although there of biobank managers, thereby creating an agency gap will always be voices within the research community with potentially destabilizing effects. counseling speed, proper pacing can reap benefits not The core values and expectations of many biobank only in the ethical realm, but in the science as well. donors are finally coming to light through social scien- In the U.K., voices of reason prevailed, including the tific inquiry. Results suggest the possibility of problems voices of civil society critics.67 looming on the horizon. During one public consulta- Slowing down the pace has meant that U.K. Bio- tion on U.K. Biobank performed by People Science bank’s eventual scientific protocol – though still con- and Policy Limited in 2002, a number of respondents troversial – will now have the benefit of learning from commented positively on U.K. Biobank’s commitment developments in the field. For instance, in general, to engage actively with participants, and its relation- population genomics has taken a turn back to the ship to the public trust in U.K. Biobank. However, environment as a crucial factor in gene function and public participants also expressed a strong concern health outcomes. As the explanatory power ascribed that companies would focus on “profitable diseases” to genes in isolation of environment has dimin- rather than on major public health issues and whether ished,68 the scientific protocol of U.K. Biobank and any real benefits to the public from U.K. Biobank other genomic cohort initiatives have been reframed would emerge down the road.70 to include richer phenotypic and environmental data During a public comment period on the initial draft sets. The “gold standard” population genomics study of the Ethics and Governance Framework, there were has begun to look more like a traditional long-term major concerns regarding decision-making processes epidemiological study, with genotype included as one around commercial use. One respondent wondered of many significant variables used to explain health whether the consent process would outcomes. Within the genetics community, we are seeing a new desire to invest in these long-term and include information about new commercial uses or continuous relationships with groups of research par- contracts concerning their samples? Only by pro- ticipants; famous longitudinal studies like the Fram- viding such information will participants genuinely ingham Heart Study serve as such models.69 be allowed to exercise a right of conscience, on the same model as shareholders who have ethical objec- 2. A Weakness tions to particular…practices.71 (Emphasis added.) Amidst many strengths one weakness stands out: a critical distance remains between the rhetoric of part- Another response indicated that it would be important nership and actual structure of entitlements within to present to the public not only with the intention of U.K. Biobank with respect to the donors. Parliamen- “augmenting the value of the resource” and aiming for tary rhetoric aside, donors possess little control share, “the greatest benefit” in generalized terms, but also “to and no equity share, in the common pool resource (see show the form of checks and balances that will ensure Figure 1). The donors do enjoy the right to withdraw of these intentions – and thus specify who will have individual donors, and a vague sort of representation influence on defining what actually constitutes benefit by the Ethics and Governance Council. Thus, though – for whom.”72 (Emphasis added.) Concerns around donors may be “partners” in a limited sense, they have governance were explicitly cast in terms of who exactly no role in institutional governance. would be making resource allocations, and addressed By failing to provide for some governance role for the lack of channels for meaningful donor input. As the donors, project planners have lost an important the italicized portions indicate above, respondents potential strength: from the perspective of pragma- explicitly invoked shareholder models and the prin- tism, some mechanism of meaningful representation ciple of checks and balances, thus indicating a search of the donor collective could greatly enhance both for a different governance framework than that of a participation rate, participant trust, and by extension, rule of experts.
446 journal of law, medicine & ethics David E. Winickoff
Figure 1 Property Entitlements in U.K. Biobank
Entitlement Explanation of Entitlement Possession of Entitlement
access right to enter and enjoy non-subtractive U.K. Biobank Ltd/Board of Directors, subject to its charitable rights mission. May be licensed to third parties if protocols are approved by U.K. Biobank and an ethics committee.
contribution right to contribute to the content U.K. Biobank Ltd/Board of Directors, subject to its charitable mission. Extended to selected individuals within the U.K. health system.
extraction right to obtain resource units or prod- U.K. Biobank Ltd/Board of Directors, subject to its chari- ucts of a resource system table mission. May be transferred to third parties if proto- cols are approved by U.K. Biobank managers and an ethics committee.
removal the right to remove one’s contribution Donors as individuals, subject to practicalities. Processed from the resource data or material cannot be removed.
management rights to regulate internal use patterns U.K. Biobank Ltd/Board of Directors, subject to its charitable and to transform the resource by making mission, with advice from the Ethics and Governance Com- improvements mittee. Rules must be reflected in the Ethics and Gover- nance Framework.
exclusion the right to allocate access, contribution, U.K. Biobank Ltd/Board of Directors, subject to its charitable extraction, and removal rights and how mission. those rights may be transferred
alienation right to sell or lease management and U.K. Biobank Ltd/Board of Directors, subject to its charitable exclusion rights mission. Current policy expresses the intent never to sell.
Terms of ownership and control were also central expressed towards entities like the Scottish Execu- themes in a 2004 Scottish study of ten focus groups tive, the U.K. National Health Service, universities, exploring citizen attitudes about Scotland’s arm of and the medical profession. Finally, there was clear the U.K. Biobank.73 This work found that people were discomfort about a loss of control over what was one’s willing to contribute to “the common good” and “the “own.”77 The researchers concluded that the strong future of society” in this way,74 but that there were support for “public ownership” of genomic property important differences in attitudes across different grew out of a deep uneasiness with losing control of demographics concerning the role of the private sec- their samples and information. tor. For instance, patient groups seemed more com- These and other studies suggest that public con- fortable with the fact that commercial entities would sultation and the principles of openness will likely have access to the resource, believing this might be insufficient to establish trust in the governance of speed up the production of new therapies, and they genetic databases. After holding a number of focus described the role of industry as a “necessary evil.”75 groups of their own in the U.K., social scientists Mairi Nevertheless, the majority of respondents in the Levitt and Sue Weldon have expressed doubt that the focus groups thought DNA and information access “expert agenda of policy-makers and medical ethics” should be limited to medical personnel, academics, or addresses broader concerns expressed by potential “research scientists.”76 Most respondents thought the participants such as choice, consent, lack of control, database should be “publicly owned” and controlled and the difficulty of establishing trustworthy gover- in some way, though different levels of trust were nance arrangements.78 They conclude that people genetics and group rights • fall 2007 447 SYMPOSIUM perceive potential users to be motivated by success In the context of U.K. Biobank, the Board of Direc- and profit rather than by health care priorities. These tors will have broad discretion as they set the rules researchers suggest that people will need evidence of for access to the biobank’s “resource system” and a relationship with obligations and expectations on “resource units.” Actual constraints on U.K. Biobank’s both sides. Board of Directors in setting policies on intellectual Public concerns regarding access, public owner- property (IP) and access are currently vague.83 Yet, ship, and control in the U.K. resonate with recent these policies on access and IP will set the balance empirical work conducted in other countries. Swed- among the potentially competing goals of assuring ish anthropologist Klaus Hoeyer and colleagues scientific openness, incentivizing commercial invest- recently sampled public attitudes concerning pub- ment in the life sciences, and promoting public access lic biobanking initiatives there. In a survey sent to to future therapies. Value hierarchies have not been approximately 1,200 donors, respondents were asked made clear. The encouragement of broad access is one to rank the importance of different issues raised in of the stated aims of U.K. Biobank, but so is wealth creation. How specifically does promoting materials-sharing con- In the wake of the well-documented failures of the strain licensing decisions? The Human Genome Diversity Project, community more exclusive the terms of access are, the greater the market value participation in research governance of population of access ex ante will tend to be. In genetics projects emerged as a central concern. Iceland, the immediate exclusive license to a private company was at the core of ethical and political tissue-based research. Surprisingly, only four per- debate. How is attracting private investment traded cent marked “whether the donor is informed about off as a goal against non-proprietary knowledge cre- the purpose of research.”79 The highest-ranking con- ation, and should “wealth” effects play into the calcu- cerns were actually equality of access to and general lus? There will necessarily be winners and losers when applicability of research results, corporate skew of goals within the broad categories of “research,” “medi- the research agenda, and eugenics. Investigating the cal advance,” and “health” are given specificity, under- motivation to contribute in the face of these concerns, scoring classic political questions of who decides. the Swedish researchers found that people wanted to The broad discretion of biobank managers is less help the collective cause, but feared various misuses of a problem to the extent that we believe that their of science; they were suspicious of corporate inter- actions will align with the preferences of donors. But ests in general, but seemed to accept the proposed alignment is unlikely, and the likely gap in values mix of public and private in the Swedish biobanking increases the probability of problems with recruiting project.80 and retention. An analysis of the membership of U.K. Strong public opinions regarding the control of Biobank’s Board of Directors suggests there may be a samples raise important questions of donor represen- distributive agency gap between the directors and the tation in the distributional decisions of biobanks. In donor group, especially with regard to the potential the face of the changing political economy of research, involvement of the commercial sector. Board mem- the “distributive agency” of biobank managers has dra- bership evinces a clear logic of representing important matically increased.81 In democracies, distributional Biobank constituencies, i.e., funders and also poten- choices tend to be allocated to representational bod- tial users.84 The U.K. government, and especially the ies, not experts, because they implicate basic values Medical Research Council and the Department of and visions of a good society, not just technical con- Health, are well represented on the board. Likewise, cerns.82 For example, allocating resources and struc- the Wellcome Trust has one board member. The aca- turing the tax system are core functions of a democrat- demic research community is represented by two ically elected government because of concern for the members. Furthermore, as is usual with corporate shape of obligations among individuals and between boards, membership includes those with status and individuals and the collective. Whereas managing the special experience deemed relevant. The accounting biomedical research regime used to be more of a tech- partner with privatization experience signifies that the nical exercise in which experts steered human subjects funders were seeking expertise in financial relations research towards common mutual goals, the modern at the public-private interface. Alan Langlands, the conditions of research have presented biomedical Chairman of the Board, was the Chief Executive of the elites with new distributive choices. National Health Service from 1994-2000.85 His con-
448 journal of law, medicine & ethics David E. Winickoff current position as the Chair of the Scottish Institute ing representational forms for the donor collective in for Enterprise, a governmental organization seeking biobanking would have both social and scientific ben- to promote business development in Scotland, rein- efits for the research as a whole, and hold promise for forces that this was a major area of expertise sought negotiating a path between raw commodification and by the funders. market inalienability of human tissue collections.88 One thing is clear about board membership: donor In the U.K. context, this is also likely to be true from representation is conspicuously absent. The extent to a pragmatic perspective. Given current board mem- which this matters is debatable. It might be argued bership, there is a significant risk that if certain com- that donor representation on the board would be mere mercial deals are struck or if public access is some- tokenism to; no body could adequately represent the how limited, there may be a real or perceived sense in donor collective of U.K. Biobank, which will be a col- which managers have reneged on an implied promise lection of 500,000 heterogeneous donors, without a to advance the “public good.” The adoption of a con- clearly shared goal. At least a for-profit company and troversial policy might operate as a triggering event, its large number of shareholders share a common eliciting withdrawals of donations and a decrease in interest in making money. Will not the collective of the value of the resource. U.K. Biobank be likely to lack such goals? And in what The practical challenges, however, of adapting rep- way can the donor collective be meaningfully consid- resentational structures within this context, a national- ered a political collective? scale project of 500,000, are daunting. Nevertheless, Representing the donor collective in biobank gover- if donors had some form of real representative power, nance may be easier than it first seems. First, because then project goals would be better achieved. Although payment is not allowed in recruitment, research par- existing ideas related to “benefit sharing” and labor ticipants will be solely donating out of the desire to organizing are useful, project planners and potential contribute to the public good. Just as shareholders in research participants ought to consider new forms of a company are bound together by a common wish to “partnership governance” that draw upon the legal make money, all donors will likely share the desire to logic of corporate governance in order to solve the maximize health goods for the public. Collective repre- agency problems involved in the management of col- sentation could help promote this shared interest and lective genomic assets. Such structures could improve make management more accountable. In fact, such a U.K. Biobank’s ability to realize a true partnership group might establish an important source of checks between donors and researchers and find the elusive and balances in the system. “third way” for genomic property. Second, just because the group of donors will be The problem of how to align biobank resource dis- defined and created by the planners of U.K. Biobank tribution with the values of the donor collective has does not mean that it cannot constitute, ex post facto, not escaped attention in the U.K. Haddow and Lau- a new and meaningful community that is worthy of rie et al., the Scottish academics previously discussed, representing. To argue otherwise is simply a failure draw upon emerging norms and practices of “benefit of imagination. They would constitute a meaningful sharing”89 to achieve this realignment. Having dis- collective, just as the heterogeneous group of small cussed public concerns about public return, they high- investors in some private enterprise would constitute light the “Provincial Approval Model” of benefit shar- a collective. The size of the group’s membership, and ing proposed by Daryl Pullman and Andrew Latus for its likely heterogeneity, do not diminish the claims Newfoundland and Labrador as a viable framework of shareholders. They should not do so here simply for enforcing these expectations.90 This Canadian pro- because the shared interests are charitable. posal calls for the establishment of a Standing Commit- tee on Human Genetic Research (SCHGR) that would Realizing ‘Partnership Governance’ operate in concert with local ethical review, and would in Genomic Biobanks also aim to “ensure that research sponsors enter into In the wake of the well-documented failures of the appropriate benefit-sharing arrangements with the Human Genome Diversity Project, community partic- province.”91 The Scottish group signaled the potential ipation in research governance of population genetics utility of the principles articulated under this model – projects emerged as a central concern.86 Bioethicists distributive justice, the communal nature of genetic have argued that where researched populations share information, and the promotion of health as a public some genetic characteristics or privacy risks, some good92 – and they argue that ethical oversight bodies form of group consent or community consultation such as the Ethics and Governance Council (EGC) in should be required.87 Drawing from my own compara- U.K. Biobank would be “ideally placed to recommend tive study of genomics, I have concluded that develop- the adoption of benefit sharing arrangements.”93 genetics and group rights • fall 2007 449 SYMPOSIUM
A greater concern for benefit sharing, and more However, looking at the situation prior to donation attention to the issues of distributive justice within and the transfer of entitlement, the group of donors project oversight more generally, are important gov- as a collective possesses a crucial form of material and ernance issues for such an oversight body as the EGC. informational material that could be used to demand Benefit-sharing proposals such as this, however, do not a share of power. The ability to construe their contri- address the core agency problem underlying this dis- butions as capital, rather than labor, and to collectiv- cussion – i.e., the problem of representing donor inter- ize prior to research donation has allowed some rare ests. Although a greater emphasis on benefit sharing disease groups to use biobanking to achieve their own may produce more equitable and acceptable arrange- research goals.99 For example, Pseudoxanthoma Elas- ments in the eyes of the EGC, this would only help ticum (PXE) International,100 mentioned by Fortun, solve the agency gap to the extent that we believed the is a non-profit foundation devoted to driving research EGC actually represented adequately the preferences on the rare tissue disorder. PXE International has and views of the donors. It might be, for instance, become a well-known model for the way it has lever- that under certain circumstances the donor collective aged its control of the biobank qua biocapital in order might favor a completely private sector approach to to achieve collective goals. some scientific problems. But donors would still lack A bigger problem with trade unionism might be any institutionalized forum to bring these preferences that project planners, who hold most of the power forward to the EGC or Biobank Managers, and also as project initiators, will be unlikely to facilitate the any power to exert these preferences. organization of a donor group in the mode of labor, Using the analogy of labor for the organization of especially if enhancing an ethos of trust and goodwill donors is another creative possibility for addressing is the central goal. The labor analogy imagines an this collective action problem. In a 2003 essay, anthro- interest-based form of relations that may not promote pologist of science Mike Fortun invoked the notion of the very trust and goodwill that both sides, research- trade unionism, via Polish “Solidarity,”94 to suggest ers and donors, seek. Unionism also tends to move the ways in which the politics of biobanking could be re- discourse away from charity and towards an interest imagined from the ground up. There Fortun argues in politics that can undermine reciprocity and produc- that a bioethics arrangement to protect individual tive deliberation.101 autonomy and privacy in biobanking has the unfor- How then to move “partnership” from rhetoric to tunate additional effect of reproducing the “atomi- practice in this large of a project, involving such a het- zation that benefits the status quo alone.”95 He asks, erogeneous group? “[W]hat are the means by which the participants in An idea we have developed elsewhere involves con- these efforts – the people who provide the informative stituting a committee of direct representatives of the flesh, without which nothing would be possible – will research participant group that would play a formal be given a collective voice in the future of the enter- role within the governance of the charitable trust.102 prise?”96 Stressing the need for a more democratic The by-laws of the non-profit corporation or charitable biopolitical order, Fortun argues that organized labor trust would specify that use of the resource would be might be a useful model for producing collective edu- contingent on review and approval of two bodies, the cation, deliberation, and decision-making.97 typical ethics review board and also a “Donor Approval Trade unionism is a very interesting idea, but also Committee” (DAC). This body would approve research has its problems. Fortun’s call for “genomic solidarity” protocols, but would also serve as a conduit between the recognizes the collective importance of donors and donor group, the board of trustees, and the research- enjoins us to imagine alternative forms of collective ers in order to address controversial projects or issues action that could redistribute power in biobank gov- as they arise. In the United States, a similar body has ernance. Working from the normative intuition that actually emerged out of the Framingham Heart Study the existing power and ownership relations among in Massachusetts.103 And with the U.K. Biobank, the research institutions and donors may be unfair, For- DAC would provide an important democratic element tun equates the participants with the group of labor- to the governance of the trust, but is envisioned also as ers. But why should the analogy necessarily be labor a flexible mechanism through which communication instead of capital?98 After all, the donors are provid- and learning could take place among the biobank con- ing the physical and information capital necessary for stituents. But such a body would not come into being the collective resource to be built. It is true that the spontaneously. value of biobanks is enhanced if participants are will- ing to be recontacted and to update their information over time, which could be construed as a form of labor.
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Implementing Partnership through bution. This is a classic collective action problem, and “Charitable Shareholding” a familiar one in the realm of corporate governance Whether and how such an idea might be adapted pro- in the for-profit arena, where a single corporation ductively to a national project are difficult questions. might have thousands of capital contributors, i.e., the It is one thing to see how a group like PXE Interna- shareholders. An individual shareholder might not tional or an American Indian tribe with sovereign have sufficient time or interest to attend to matters of legal status might possess the necessary level of politi- corporate policy, but the idea that shareholders will cal organization and cohesion of purpose to produce be represented in corporate decision-making is one a biobanking collective that is able to develop mutu- of the pillars of the corporate concept. Why should ally acceptable terms of access and control to bodies, the same concept not apply in the realm of biobanks? DNA, and health information. It is quite another to Hopefully, I have argued successfully that neither a see how these examples are either relevant or useful in theoretical nor a pragmatic reason exists for not doing thinking through mechanisms to close the agency gap so; to the contrary, there is every reason to do so. in large-scale projects such as U.K. Biobank, where U.K. Biobank planners might begin to implement the volunteer group is likely to be large, heteroge- this idea by taking a lesson from the formation of trade neous, and disconnected prior to the research. Given unions. During the consent process, potential donors the ethical and pragmatic concerns discussed above, would be informed that a donor association would be how could such projects move beyond public consul- formed, and that they may sign on to the association tation to embrace a participatory model of resource as a voluntary matter if they chose to do so. Signing entitlement, given the special challenges of collective on would mean that they would be responsible for action in these situations? voting for donor association leadership, including a As discussed above, we began to suggest that certain president. In order to help institute real power sharing aspects of non-profit corporate law could supplement within the biobank governance structure, this presi- the elements of charitable trust law, e.g., that these dent could serve on the U.K. Biobank Board of Direc- donor representatives could be elected periodically tors, akin to how a major institutional investor would through proxy voting, in a process akin to the election sit on such a commercial corporate board. Further- of board members by corporate shareholders.104 Using more, the donor association could be responsible for the law corporations for rethinking agency in the bio- filling a number of seats on the Ethics and Governance bank context is less strange than it may seem at first, Council, or perhaps form a separate donor approval especially if one remembers that the corporate form committee. Once a certain threshold number of sig- is applicable to organizing collective action not only natures were obtained, say 10,000 for the projected for profit, but also for charitable goals. U.K. Biobank, 500,000 person biobank, U.K. Biobank Ltd could after all, is a legal corporation. contact this group and notify them that the associa- Any Anglo-American introductory course in the law tion had been formed and make a call for nominees for of corporations will quickly introduce students to one donor association leadership. central problem: when people come together to form Each signatory to the donor association moving an association, how will they ensure that the leaders forward would have a voting share in the association designated to make important and binding decisions elections. The votes could be operationalized by a for the collective will act in accordance with the inter- combination of email and regular mail, just as proxy ests of the collective? Most of the law of corporations voting occurs within corporate governance. U.K. Bio- is aimed at solving the agency problems that can arise bank would have to provide support in the form of a between managers of pooled assets and the sharehold- staff member who would engage exclusively as a par- ers. Rules about fiduciary duties of managers, laws ticipant liaison and relations officer. An interim lead- against self-dealing, and proxy voting are all aimed at ership group would be appointed in this preliminary closing the gap between managers and shareholders, a process, to be replaced or reconfirmed by annual elec- relationship that is fraught with the potential for mis- tions in the future. trust and misappropriation. It would be the task of the donor association leader- The charitable trust form can easily and legally ship to organize at least one public meeting per year, accommodate elements of the non-profit corporate so that attitudes and preferences could be assessed, form; indeed this hybrid form describes U.K. Bio- and policy choices regarding resource distribution be bank’s legal status. Each individual donor’s stake in deliberated. For instance, this group could develop the management of the resulting resource is too small guiding criteria for preferable research topics in the to warrant care, but the sum total is valuable and peo- biobank and could also feature presentations from ple might have preferences about its charitable distri- representatives from the other major funders to dis- genetics and group rights • fall 2007 451 SYMPOSIUM cuss joint goals and visions. Leadership would be then tions, and they will hold particular views, which could bound to represent these collective decisions on the equally be said of any system of political representa- Board of Directors and on the Ethics and Governance tion. The challenge for those structuring the process Council. As both representatives of the donor group, by which aggregated attitudes become embodied as well as officials of a charitable organization with a in a small set of representatives is to find some way particular mission, the donor association would repre- – through deliberation, debate, voting, etc. – to come sent the donors while U.K. Biobank would make dis- to an acceptable form of representation. The key tributive and ethical decisions with respect to the use insights here are merely that (1) solving the agency of the common pool resource, the biobank itself. gap between biobank donors and managers may work Some might worry that the shared governance towards solving the well-documented trust problem; arrangement envisioned here might, as in a trade (2) the donor group requires direct representation if union, take donors out of the altruistic mode and put the social project of biobanking is to move forward them into an interest group modality in which they fairly and sustainably; and (3) the tools of corporate merely advance their self-interests. Would not this governance may be useful here as they address prob- talk of “shareholders” and power sharing undermine lems of agency and collective action. the very altruism or sense of obligation that motivates Having such a donors association and process in people to participate in the first place? It is true that place could prove exceedingly useful as U.K. Biobank the representatives of the donor association could help faces policy choices that will inevitably require legiti- enact the collective preferences of the donor group mation. In addition to the terms of commercial access with respect to how resources are allocated. However, to the resource and its derivative intellectual property, the organization is compelled by law to act in accor- other controversial policy decisions are sure to arise dance with its charitable mission. Neither the donor around the terms of recontact of donors, the terms representatives nor the Board of Director as a whole of any benefit share and subsequent charitable use of could act in a way that would benefit themselves or revenue, and unforeseen types of research at the ethi- their groups in a direct financial way without seri- cal frontier. Such a system is likely to provide institu- ously jeopardizing the organization’s mission and tax- tional flexibility and political legitimacy at a fast evolv- exempt legal status. ing edge of science and commerce. Furthermore, this objection rests on the mistaken notion that the exertion of agency in how charitable Conclusion contributions are allocated somehow vitiates the In this paper, we have been mostly analyzing U.K. Bio- purity of altruism or is contrary to the spirit of public- bank, but there is great danger in trying to general- mindedness. The contrary hypothesis, namely that ize from the U.K. example to all other large-scale bio- increasing the agency of charitable donors might actu- banking projects, especially given divergent political ally encourage more investment in public-minded cultures. These cultures carry different conceptions of projects, actually seems more likely. Large charitable the obligations flowing between individuals and the donors, such as Bill and Melinda Gates among others, collective. And the existing social contract around are motivated to make large charitable contributions health care within societies, as well as the current sta- in part because they can direct donations to their most tus and distribution of public health, should have a pressing charitable priorities. In sum, donor group direct bearing on any analysis of the rights and duties representation within biobank management would flowing from public biobanking projects. Neverthe- not imply that they could or should advance narrow less, insights developed here may be usefully adapted self-interests; it only means that they have a share in in a variety of contexts in which tissue donors or other determining how a collective public resource is chari- groups of research subjects require increased recogni- tably allocated, a form of empowerment that might tion as collective entities. actually enhance the spirit of public giving. As a general rule, biobanking projects across the A second objection is that the donor association U.S.A., Japan, and elsewhere lack meaningful forms envisioned here, and its process of electing represen- of collective representation for donors. The U.K. tatives for terms on the Board of Directors and on the Biobank’s articulation of a partnership ideal, and its Ethics and Governance Council, will only reproduce thoughtful use of the charitable trust in its innovative the same problems of agency and representation. form of governance, provide the seeds of a genuinely Donors are unlikely to agree in their preferences, and new approach to the problems of genomic property. new forms of representation will always be just that, And by taking cues from the law of agency and corpo- representations. Somebody must speak for somebody rate accountability to shareholders, aspiration could else, and it will be specific donors who take these posi- become reality. True “partnership” would necessarily
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Tissue,” American Journal of Law and Medicine 28, no. 1 go beyond the idea of consultation to embrace forms (2002): 77-105; D. M. Gitter, “Ownership of Human Tissue: A of direct representation. This sort of joint venture for Proposal for Federal Recognition of Human Research Partici- science and society could help constitute a just bio- pants’ Property Rights in Their Biological Material,” Washington & Lee Law Review 61 (2004): 257-345. There is an extensive politics for our age. older literature on “profit sharing” with regard to tissue donation for research that emerged around the Moore v. Regents case. See, Acknowledgements e.g., M. T. Danforth, “Cells, Sales, and Royalties: The Patient’s This work was made possible by a 2006 U.K. ESRC Visiting Fellow- Right to a Portion of the Profits,” Yale Law & Policy Review 6 ship at the Genomics and Policy Forum, University of Edinburgh. (1988): 179-201. For a critique of the market-dominated nature I would like to thank the organizers of the “Group Genomics” con- of most benefit-sharing proposals, see C. Hayden, “Taking as ference at ASU in fall 2004 for the opportunity to present an early Giving: Bioscience, Exchange, and the Politics of Benefit-Shar- version of this work. I would also like to give special thanks to ing,” Social Studies of Science (forthcoming, 2007). Graeme Laurie, Gillian Haddow, Kathryn G. Hunter, Michael Ban- 8. See, e.g., V. Barbour, “U.K. Biobank: A Project in Search of Pro- ner, Nadja Kanellopoulou, Heather Butterfield, Aimee Kelley, and tocol?” Lancet 361, no 9370 (2003): 1734-38; J. Giles, “Huge Klaus Hoeyer for their generous engagement with this work. All Biobank Project Launches Despite Critics,” Nature 440, no. remaining errors…. 7082 (2006): 263; H. Wallace, “The Development of U.K. Bio- bank: Excluding Scientific Controversy from Ethical Debate,” Critical Public Health 15, no. 4 (2005): 323-333; but see also References F. S. Collins, “The Case For a U.S. Prospective Cohort Study of 1. See, e.g., A. Ong and S. J. Collier, eds., Global Assemblages: Tech- Genes and Environment,” Nature 429, no. 6990 (2004): 475-77 nology, Politics, and Ethics as Anthropological Problems (Mal- (invoking U.K. Biobank to help justify a similar projects in the den, MA: Blackwell, 2005). U.S.). 2. See D. E. Winickoff and L. Neumann, “Towards a Social Con- 9. U.K. Biobank, U.K. Biobank Gets Unanimous Backing from tract for Genomics: Property and the Public in the ‘Biotrust’ International Experts after Piloting Phase, Press Release, Model,” Genomics, Society and Policy 1, no. 3 (2005): 8-21. August 21, 2006, available at
17. See, e.g., G. Palsson and P. Rabinow, “Iceland: The Case of a 42. E. Ostrom, Governing the Commons: The Evolution of Institu- National Human Genome Project,” Anthropology Today 15, tions for Collective Action (Cambridge: Cambridge University no. 5 (1999): 14-18; H. T. Greely, “Iceland’s Plan for Genomics Press, 1990). Research: Facts and Implications,” Jurimetrics 40 (2000): 153- 43. A common-pool resource, often called a common property 191; G. J. Annas, “Rules for Research on Human Genetic Varia- resource, is a type of good consisting of a resource system, tion – Lessons from Iceland,” New England Journal of Medicine whose characteristics make it difficult, but not impossible to 342, no. 24 (2000): 1830-33, at 1830; M. Fortun, Promising prevent users from obtaining benefits from its use. Unlike pure Genomics (forthcoming, University of California Press); Dr. “public goods,” common pool resources are subject to overuse, Skúli Sigurdsson, an Icelandic historian of science and member the so-called “tragedy of the commons” because they are sub- of the Act’s opposition, has been a meticulous analyst and bib- tractable, but are capable of yielding benefits in a sustainable liographer of the database controversy. See his publications and flow. Id. highly useful bibliography of the database controversy, avail- 44. Common pool resource theory is currently being extended able at
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59. Ethics and Governance Council Web site, available at
health and biomedical research enterprise to argue against the 99. S. F. Terry, “Learning Genetics,” Health Affairs 22, no. 5 (2003): need for burdensome procedures of going back to individuals 166-71. everytime a new research protocol was proposed for studying 100. PXE International’s homepage can be found at
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