Get 20M+ Full-Text Papers For Less Than $1.50/day. Subscribe now for You or Your Team.

Learn More →

Between the individual and the community: the impact of genetics on ethical models

Between the individual and the community: the impact of genetics on ethical models New Genetics and Society Vol. 28, No. 2, June 2009, 173–188 Between the individual and the community: the impact of genetics on ethical models Heather Widdows Department of Philosophy, University of Birmingham, Birmingham, B15 2TT, UK This paper discusses how genetics is influencing ethical frameworks with particular focus on the effectiveness and appropriateness of individual and communal models. It suggests that genetics supports a relational understanding of the person and therefore that genetic ethics requires ethical models which respect both individuals and groups. First, the inadequacy of individualistic frameworks – at conceptual, ethical and practical levels – is outlined. Second, the “communal turn” in genetic ethics in both clinical and population ethics is considered. Third, it is claimed that this communal turn is applicable to genetic ethics in general and to illustrate this two further examples are explored: those of UK Biobank and personalized medicine. The paper concludes that ethical frameworks in genetic ethics must accommodate both group and individual concerns. Keywords: ethics; individualism; communal ethics; groups; trust model; personalized medicine Introduction This paper discusses how genetics is influencing ethical frameworks with particular focus on the effectiveness and appropriateness of individual and communal models. It suggests that genetics supports a relational understanding of the person and there- fore that genetic ethics requires ethical models which respect both individuals and groups. In order to make this case the paper first describes why individualistic frame- works are unsatisfactory in the genetic era. This is done in three ways. First, the picture of the moral agent as an isolated individual will be considered; second, the ethical frameworks deriving from this picture will be critiqued and third the practical impossibility of maintaining individual ethical norms will be described. Having outlined these critiques of the solely individual model the paper will describe the “communal turn” in genetic ethics which has occurred in part in response to these inadequacies in both clinical and population ethics. The paper will argue that communal models that can address the ethical issues of groups Email: h.widdows@bham.ac.uk ISSN 1463-6778 print/ISSN 1469-9915 online # 2009 Taylor & Francis DOI: 10.1080/14636770902901611 http://www.informaworld.com 174 H. Widdows are necessary to supplement individual models not only in these spheres but in all aspects of genetics if the ethical issues arising in this field are to be competently addressed. To illustrate the importance of models that can accommodate groups, two examples, that of UK Biobank and of personalized medicine, will be con- sidered. It will be concluded that in order to address the most pertinent issues of genetic ethics groups as well as individuals must be considered and thus ethical models must accommodate both group and individual concerns. Criticisms of the individual model The individualism of bioethics has been criticized for a number of reasons: on con- ceptual grounds, for relying on an over-individualist model of the self; on ethical grounds, for promoting a narrow ethical framework; and on practical grounds, as being impossible to maintain in the genetic era. The isolated individual First then, the conceptual criticism, that to present the individual as separable from community and a nexus of relationships is a misrepresentation of the person. This is a common critique of post-Enlightenment moral theory and emerges from many schools of thought, including communitarian, virtue and feminist. Communitarians critique the individual of liberal philosophy and ask who is the “‘person’ that exists independently of, and able to freely choose, the ends that give her life meaning and value?” (Mulhall and Swift 1996, p. 10). From this perspective to portray the individual as a separable moral agent “misunderstands the relation between the individual and her society or community, and more specifically, ignores the extent to which it is the societies in which people live that shape who they are and the values that they have” (Mulhall and Swift 1996, p. 13). Other positions, such as those of virtue ethics and feminist theory, make similar and parallel criticisms. Virtue ethics, like communitarian thought, rejects the notion of a separated and isolated individual and argues for an integrated and interconnected conception of the self. For example, Iris Murdoch is critical of over-simplistic and unrealistic ethical frameworks which present the individual as surveying the facts and then rationally making a choice (Murdoch 1992, p. 150). She contends that the picture of the autonomous separate individual is false and that such theories wrongly portray the moral agent “as an isolated will” (Murdoch 1970, p. 49). She sums up this picture describing “the fearful solitude of the individual marooned upon a tiny island in the middle of a sea of scientific facts” (Murdoch 1970, p. 27). For Murdoch, as for all virtue ethicists, an isolated separate non-relational picture of the individual is false and particularly flawed when used as a model for ethical decision-making. New Genetics and Society 175 In a similar vein feminist theorists critique the model of the unconnected individual and “it is by now commonplace to criticize traditional liberal democracy for its abstract individualism” (Gould 2004, p. 7). Like communitarians and virtue ethicists feminist thinkers argue for an alternative picture of the moral agent; of persons not as isolated autonomous individuals, but as relational, social and con- nected beings making choices in the context of their relationships. In this schema choices are made and characters develop in the “concrete interactions of particular caring and choosing individuals, who are often concerned for each other and make choices together with others with whom they are engaged in common projects and interdependent networks (economic, technological, social, cultural or personal)” (Gould 2004, p. 63). Accordingly feminist theorists have con- ceptualized alternative understandings of the individual as a relational individual, and have suggested alternative ethical frameworks derived from relational models of persons. Of particular importance in this field has been the debate about relational autonomy and the ethics of care (Gilligan 1982, Noddings 1984, Mackenzie and Stoljar 2000, Held 2006). Such feminist critiques have been influ- ential in the bioethics field and feminist bioethicists have emphasized the impor- tance of difference and championed the values of social justice over those of individual choice (Wolf 1996, Donchin and Purdy 1999, Tong 2001). These conceptual criticisms of the individualist picture are supported by genetic understandings of the human person. The genetic individual is not an “isolated indi- vidual” but one who is genetically related both to current groups and to past and future generations – manifested for example in the interest in genetic heritage (Nordgren and Juengst 2009). Thus the genetic individual is fundamentally a “con- nected individual”, connected to consanguineous relations and family groups, ethnic groups and wider communities and potentially in some of the language which surrounds the human genome to “humankind” as a meta-collective (Widdows 2007). Frameworks based on the isolated individual The contested and critiqued representation of the moral agent as an isolated individ- ual underlies many ethical frameworks. Thus, while it may be the case that the rec- ognition that human beings are social and relational has “become a truism in social philosophy” (Gould 2004, p. 63), the implications of this for ethical frameworks has yet to be fully realized. This is particularly true of bioethics which has focused on the individual as the primary unit of ethical concern to the extent that bioethics “has reified the individual and individual autonomy” (Koenig 2001, p. 33). The ethical focus of bioethics is (or has been) almost exclusively the indi- vidual. In both clinical and population research settings the main concern is to protect the individual from harm and preserve autonomy and privacy. The individual focus of bioethics is well documented and derives its develop- ment from a professional medical ethic of the doctor–patient relationship. 176 H. Widdows The framework of this professional relationship was quite properly individual, based on the duties of the doctor to their patient. This model, appropriate in the context of a professional one-to-one relationship, was applied across bioethics to situations where the individual doctor–patient relationship was less binding and thus the model less relevant, for example, in research ethics and population genetics. The focus on the individual was further enshrined with the acceptance of prin- ciplism as the primary methodology of bioethics. A principlist methodology need not necessarily be individualist; however, in this context it has become so in part because it is applied by practitioners in a case-by-case setting. In such instances it is the needs of the individual patient which are most pressing and there- fore dominate. Moreover, often the principle of autonomy has tended to be elevated over other principles again serving to locate ethics at the individual level (Goldworth 1996). In a similar manner to the conceptual criticisms of the individual model principlism has been criticized for being reductionist and for failing to “capture the moral life quite properly” (Evans 2000, p. 37). Such criticisms echo those of communitarian, virtue and feminist thinkers discussed above, namely that a solely individual-focused ethic is not a comprehensive ethic but based on a contested model which conceptualizes the moral agent as an isolated individual. As a result the ethical framework is one which privileges individual ethical concerns, such as individual choice, over other ethical concerns. Just as genetics challenges the “unconnected individual” it also challenges the individualism inherent in this bioethical framework. Genetics brings into question the place of the individual as the sole locus of ethical concern, for “the fact that genetic information about one person can be of value to others poses an important challenge to the primacy of respect for the principle of autonomy in medicine” (Parker 2001, p. 21). Thus the ethical priority of individual autonomy and the indi- vidual focus of bioethical frameworks become problematic in genetic ethics. Practical difficulties The criticisms regarding the isolated conception of the moral agent and the result- ing ethical framework are compounded by the practical difficulties of maintaining the key ethical practices of confidentiality and informed consent in the genetic era. These practices are overtly and expressly designed to protect and safeguard the rights and interests of the individual and to prevent the individual from being harmed: confidentiality to protect the individuals’ privacy and informed consent to protect the individual’s bodily integrity. Confidentiality is “one of the most important principles of medical ethics” (Harris 1985, p. 225) and it has been termed the “central ethical pillar of clinical practice” (Boyd et al. 1997, p. 51). Confidentiality developed in the context of the doctor–patient relationship, and the doctor is charged with protecting the indi- vidual’s confidentiality irrespective of whether other individuals, for example family members or reproductive partners, have legitimate interests. In the genetic New Genetics and Society 177 era this is problematic as genetic information does impact upon other individuals and indeed how to manage competing ethical claims is regarded as “among the most important challenges identified by a group of nurses, physicians, and genetic councilors who were asked what ethical and professional challenges they faced when they saw patients with genetic concerns” (Bartels 2001, p. 15). Informed consent, the second fundamental standard of medical ethics is proble- matic for similar reasons in the genetic era. Individual consent is intended to protect the individual and ensure the patient’s wishes are respected: “respect for the person requires a patient’s autonomous consent be obtained before any treatment or procedure involving the patient can be carried out, and ... no consent will be auton- omous unless it is fully informed” (Harris 1985, p. 205). However, questions about whether connected individuals’ rights and interests are adequately respected if only individual consent is required have been raised, in particular, with regard to whether family members should be consulted and broader models of consent adopted. Accordingly in the genetic era it is not clear that individual practices – such as confidentiality and informed consent – are sufficient to guarantee good ethical practice (Husted 1997, Knoppers 1997, 1999). These practices only protect the individual and therefore neglect the ethical interests of relevant others, for example family members and members of the genetically related group. In the genetic context health decisions no longer only concern the individual as “disclos- ure of genetic information by individual DNA donors also exposes information about others with similar genetic profiles” (Mitchell and Happe 2001, p. 376). Thus at the practical level, just as at the conceptual and ethical framework levels, the fact that the “key feature about genetic information is that it is typically information about a family, or even ... about a larger community not just about an individual patient” (Brock 2001, p. 34) makes purely individual practices proble- matic. Moreover, it is quite simply not feasible to guarantee total individual confi- dentiality into the future as genetic information is always indentifying, for example when compared to a database, hence making complete certainty with regard to confidentiality, particularly over time, impossible. Limitations of the individual model These three critiques suggest that there are real concerns about solely individual models of ethics, at conceptual, ethical and practical levels. In light of such criti- cisms it has been suggested that ethical models are sought which can recognize the rights and interests not only of the individual but also of other genetically related individuals and groups who have an interest in such information and who may potentially be harmed. This is true of both clinical and population genetics. In clinical genetics, as discussed, the inability of individual models to take into account the rights and interests of other family members has been regarded as an increasingly concerning ethical issue (Bartels 2001). The focus only on the individ- ual has led practitioners to be concerned about whether others with legitimate 178 H. Widdows interests are being harmed. In attempts to address such concerns family models such as those of the “joint account” (Parker and Lucassen 2004) and the “family cove- nant” (Doukas and Berg 2001) have been suggested. The joint account model regards genetic information as essentially family information and argues that only in exceptional cases should information be withheld by an individual. The family covenant model also considers the family the appropriate “unit of care” and aims to offer “the individual, family and physician a mechanism to help resolve compet- ing claims for confidentiality and disclosure” (Doukas and Berg 2001, p. 3). In this model the family agrees together how such familial information is to be shared. These models have been regarded as steps towards more communal models, for example, the family covenant has been praised as being “a significant step by recognizing that in genetics the family plays a significant role in genetic counseling and testing, and the family, not simply the individual is the patient” (McKellin 2001, p. 31). They are attempts to move beyond the purely individual model and to accommodate the rights and interests of all involved. These models still use the practices of individual consent and confidentiality, but attempt to widen their scope. However, they are not without difficulties, for example, how are competing interests within the family to be resolved and how are individuals to be protected? Moreover, what constitutes the family unit? Are only genetically related family members to be included and how far does the family unit extend? Resolving such complex issues is not easy, especially if one considers the diverging cultural and social norms regarding family membership and authority within such groups. However, despite such complexities, the need to supplement the individual model in order to do justice to the legitimate interests of family members is clear. The limits of the individual model are also evident in population genetics particularly when considering genomic research on indigenous populations with relatively homogeneous (and therefore potentially valuable) genotypes. In these cases again the shared nature of genetic information means that genetic research on one member of the group “has implications for all members of those groups, whether or not they decided – or even were asked – to take part in the research” (Greely 2001, p. 222). Accordingly, information derived from a sample taken from one member of the group is relevant to other members of the group and other members of the group have interests in the ownership and use of such information. Thus, even when properly applied, informed consent and confidentiality cannot protect the rights and interests of related individuals or of the group. To illustrate we can consider the case of the Hagahai tribe of Papua New Guinea from 1994. In this case samples were taken from a few individuals and a patent granted on a cell line containing unmodified Hagahai DNA and several methods for its use in detecting HTLV-1-related retroviruses. The patenting of unmodified DNA raised a number of ethical concerns which the individual model is not equipped to address as the site of ethical concern is not just the individual from whom the DNA is taken, but other connected parties have rights and interests and can be harmed. In addition there may also be collective concerns New Genetics and Society 179 about culture, heritage and ownership. (Dickenson 2002, Tedlock 2006) In this case there was an awareness that the individual model was not sufficient and a “benefit- sharing” agreement was discussed. However, as this agreement amounted to little more than an unofficial promise from the named researcher on the patent that she would give her share to the Hagahai any group provision was inadequate and clearly a more robust ethical framework was needed. The granting of this patent was met with opposition from indigenous rights groups who deemed it unethical for unmodified DNA owned in any circumstance – “no patents on life” – let alone owned by the US government (Shiva 1997, 2001, 2005, Winickoff 2003). In 1996, following protest, the patent was “disclaimed”; however, the Hagahai cell line remains in the public domain and is now available to the public at the American Type Culture Collection as ATCC Number: CRL-10528 Organism: Homo Sapiens (human) at a cost of $290. In other similar cases there is no evidence of any recognition of the communal interests involved, however feeble. For example, patent applications were filed by “US federal health agencies on genetic samples derived from indigenous peoples in the Solomon Islands and Panama” (Barker 2004, p. 595). The cell lines were taken from consenting individ- uals – one from a 40-year-old woman and one from a 50-year-old man (Barker 2004, p. 595) – and again under pressure the patent claim was withdrawn. However, as with the Hagahai, the cell lines remain on deposit at the American Type Culture Collection. In these cases only individual ethical frameworks were employed (in the seeking of informed consent from the individuals from whom samples were taken). No attempts were made to address the wider concerns of related individuals or the group. These individual measures were not adequately applied as only oral consent was attained from an unschooled and illiterate research subject with apparently little knowledge of the proposed research (Winickoff 2003). However, even if such practices had been used appropriately the ethical issues would not have been adequately addressed. Yet, although there is a clear need for models which include groups, just as there are problems with family models there are problems with models which take the group as the unit of ethical concern. As difficult as it might be to determine the bounds of the family and to find a mechanism for balancing interests within a family this is arguably even more problematic when it comes to groups. The most pressing ethical issue here is who speaks for the group and how can vulnerable individuals and minorities be protected and represented within the group? The danger is “that individuals and their claims of right will be crushed beneath the greater weight of groups and their claims of right” (Jones 1999, p. 92). In such instances it is important to ensure that ethical models include the insights of the individual model and protect individuals while also recognizing the interests of other individuals and of the group. However, despite these significant difficulties, these examples, of family genetics and of DNA patenting, show the limits of solely individual ethical frameworks. In these frameworks only the individual who is tested or from whom samples 180 H. Widdows are taken is protected; the rights and interests of other individuals with legitimate interests, such as the family or the wider ethnic group, are ignored. It is not only that other individuals have not been asked to consent, although that is an important issue, but also other group ethical issues are neglected, such as group vulnerability, discrimination and exploitation. These group ethical issues are of obvious impor- tance in the case of vulnerable indigenous groups, but they are also important for vulnerable families, for example those who are in danger of being discriminated against on genetic grounds (Lapham et al. 1996). In addition not only are not all individuals with legitimate interests protected if only individual models are used, but, as noted earlier, even those individuals at the centre of the practices who do give their informed consent cannot realistically have their confidentiality guaran- teed into the future given the identifying nature of the material. The communal turn It is the need to address these ethical issues which has led to the “communal turn” in bioethics and the seeking of ethical frameworks which can accommodate the rights and interests of groups as well as individuals. As we have noted this is true at the clinical level where the claims of families have been increasingly discussed, and at the level of population genetics where there have been considerable changes in practice. For example, in population genetics informed consent is increasingly being supplemented by group consent and “prior consultation and communication with these specific communities and populations are emerging as ethical prerequi- sites” (Knoppers and Chadwick 2005, p. 76). This increasingly strong requirement for group consent demonstrates the “communal turn” which Knoppers and Chadwick identify in five general trends away from individual models and towards reciprocity, mutuality, solidarity, citizenry and universality (Knoppers and Chadwick 2005). They argue that this turn is particularly evident in population genetics and in the simple fact that in “the implementation of processes that respect the need for public consultation and debate ... [have] .. . come to prominence, particularly in relation to population data- bases” (Knoppers and Chadwick 2005, p. 77) there is a recognition of the communal nature of such ethical decisions. They claim that the need to move beyond individual models is particularly pressing in population genetics as in these contexts seeking fully informed individual consent is not practical either because of the numbers involved or because of the uncertainty of the future research. To explore this communal turn and further support the claim that ethical models must be able to accommodate both individual and communal concerns, two further cases will be considered: that of UK Biobank and that of personalized medicine. UK Biobank UK Biobank and the ethical framework it has adopted can be placed within the communal turn identified by Chadwick and Knoppers for exactly the reasons New Genetics and Society 181 they have suggested. Quite simply, in population projects of the size of UK Biobank to insist on the “gold standard” of fully informed individual consent would be impracticable and unrealistic. Such a requirement would require return to the donors for every new study – and potentially for every subsequent study which drew on previous data. To do this would be not only administratively cumbersome but, more importantly, overly burdensome on the donors. Thus if stan- dard notions of informed consent were insisted upon then broad-based population studies such as that of UK Biobank, would be unworkable. Accordingly biobanks and other forms of population genomics have sought new models of consent (usually supplemented by other ethical safeguards). For example, a model of group and broad consent has been propagated which denies researchers “complete freedom to do whatever they want with biobank samples, yet increases the number of samples likely to be available for future research compared with an approach that requires researchers to recontact individuals to obtain consent for every new study” (Maschke 2006, p. 193). UK Biobank is no different in this regard from other population studies and has adopted a broad model of individual consent within the “trust model” rather than a traditional model of fully informed consent. In the trust model, “when a person agrees to donate tissue, the recipient has a responsibility to serve as a trustee, or steward, of the tissue in order to ensure protection of the contribution” (Winickoff and Winickoff 2003, p. 1182). Using the trust model open-ended “broad” consent is sought: “because it is impossible for the donor to make an informed choice about the risks and benefits of unspecified future research protocols, such per- mission should never be called informed consent” (Winickoff and Winickoff 2003). Therefore, instead of seeking consent for particular research or particular types of research UK Biobank participants are asked to consent at the time of recruitment in a single act of consent “for research in general that is consistent with UK Biobank’s stated purpose (rather than for specific research)” (UK Biobank 2007, p. 5). The open-ended nature of this “broad consent” is made clear to participants from the outset. It is overtly not “fully informed”, indeed this would be impossible given that the nature of the research is as yet unknown. (UK Biobank 2007, p. 6) Thus consent is given for research on “trust” in accordance with the “trust model”. In other words the participants trust UK Biobank to use their material and information only in ways that fit the stated purpose of UK Biobank; that is, to “build a major resource that can support a diverse range of research intended to improve the prevention, diagnosis, and treatment of illness and the promotion of health throughout society” (UK Biobank 2007, p. 3). When asked to consent participants are asked on the basis that participation is “an opportunity to contribute to a resource that may, in the long term, help enhance other people’s health” (UK Biobank 2007, p. 5). “Broad consent” is supported and ensured by the establishment of an Ethics and Governance Council (EGC) and the right to withdraw. The EGC is independent of UK Biobank and its remit includes: 182 H. Widdows acting as an independent guardian of the Ethics and Governance Framework and advising the Board on its revision; monitoring and reporting publicly on the confor- mity of the UK Biobank project within this Framework; and advising more generally on the interests of participants and the general public in relation to UK Biobank. (UK Biobank 2007, p. 15) Broad consent effectively functions as a gateway to the “donor group” whose rights and interests are then protected as a group. The donor group’s interests are then protected (or “stewarded”) according to the trust model. In the trust model the donor group’s trust can be safeguarded in a number of ways and there are a number of possible mechanisms for maintaining trust and for enhancing the invol- vement of the donor group. For example, possible forms of participation “might include membership on the trust’s IRB, membership on a donor committee that has veto power over particular projects, and election of a donor to serve on the board of trustees. Research applications could be evaluated by the trustees according to a set of criteria that would ensure public benefit” (Winickoff and Winickoff 2003, pp. 1182–1183). In the case of UK Biobank it is the EGC’s responsibility to fulfill this stewardship role and ensure that the rights and interests of the donor group are protected and safeguarded. Thus, UK Biobank, having adopted the trust model, employs an ethical framework which recognizes groups as well as individuals. This is not to say that UK Biobank adopts only a group model. Individuals give their broad consent at the beginning of the process and individuals have a right to withdraw – “at any time and without having to explain why and without penalty” (UK Biobank 2007, p. 6). Options are available as to how far they wish to with- draw. For example, they may simply wish to cease contact with UK Biobank, or they may wish to put their data beyond further use. However, for UK Biobank to succeed it must maintain participation levels and thus it must maintain the trust of the participants as mass withdrawal would destroy the UK Biobank project. The individual model functions at entry and exit, but for the duration of participation the participants are protected not because they gave informed consent, but because “the Ethics and Governance Council will keep use of the resource under review in order to advise on conformance with this Framework and the IP and Access Policy and to assure itself, and others, that the resource is being used in the public interest” (UK Biobank 2007, p. 13). Thus the ethical framework considers the rights of the donors not only as the rights and interests of individuals but as the rights and interests of the “donor group”. This is not to say that UK Biobank gives attention to groups per se, but rather that pivotal ethical interests it respects are those of the “donor group” and the “public as a whole” (the two groups the EGC has a remit to protect). Furthermore, the public good is influential in determining the remit of UK Biobank. Thus, public interest is central to this model and participants “trust” UK Biobank to serve the public interest. The ultimate concern is not for individual participants (although their rights and interests are protected) and they are made aware that they New Genetics and Society 183 themselves will not directly benefit, but for the public good conceived of in popu- lation terms. Moreover given the nature of the study it is not likely to be current participants that benefit but younger persons and future generations – in other words, the future population as a group and the individuals therein. UK Biobank’s adoption of broad consent in the context of the trust model provides an example of an ethical framework that combines the rights and interests of both groups and individuals: both in its protection of the “donor group” and in its overarching aim to benefit the public good. The need to move beyond the traditional practices of fully informed consent and confidentiality is necessitated, as Chadwick and Knoppers point out, by the nature of such population and future-orientated research and thus the ethical framework that UK Biobank has arrived at to protect the rights and interests of all parties includes both groups and individuals as sites of ethical concern. Personalized medicine Having argued that ethical frameworks need to recognize both individual and group concerns in both clinical and population research settings this final section will examine whether this is in the case in what one would imagine is the most indivi- dualized aspect of genetics, that of “personalized medicine”. Personalized medicine and the notion of an individual “genetic blueprint” have gripped popular imagin- ation suggesting an individual model (Nordgren and Juengst 2009). However, more detailed examination shows that in this arena, as much as in the others con- sidered, it is essential to have a ethical framework that can address group as well as individual issues. Interest in “personalized” medicine reached its zenith in the last four to five years with claims of “bespoke”, “tailored” and “individualized” medicine: “the right medicine for the right patient, at the right dose” (Lipton 2003, p. 14). Personalized medicine or pharmacogenetics concerns “the relationship between genetic make up and drug therapy” and is best “defined .. . as an area of research and a set of tech- nologies aimed at addressing problems of variation in drug effect, by linking drug response to individual genetic variation” (Corrigan 2004, p. 144). Accordingly, given its potential to tailor “new medicines to an individual’s genetic profile” (Corrigan 2004, pp. 144–145) pharmacogenetics promises much. It promises fewer adverse reactions and more effective treatments as it enables tailoring prescriptions “to an individual’s genotype and, in principle, reduce[s] drug safety problems and improve[s] the effectiveness of treatments” (Smart et al. 2004, p. 324). Given this emphasis on a medicine tailored to fit the individual it would seem that highly individualistic models are being invoked and promoted. However, a more detailed consideration suggests that even in this arena – the most individua- listic of the genetic era – this is not necessarily the case. For, despite the hype, the promise of personalized medicine is to groups rather than individuals as pharmaco- genetic testing tends to “suggest a particular drug for genetically defined groups” 184 H. Widdows (Corrigan 2004, p. 145) and consequently will “probably be used to stratify patient populations into groups determined by their genotype” (Webster et al. 2004, p. 663). Thus rather than personalized in the sense of tailored to fit an individual they are tailored to a type. Using the metaphor and language of tailored medicine Smart et al. describe it as “‘off-the-peg’ prescribing to genotype groups rather than individually ‘bespoke’ medicine” (Smart et al. 2004, p. 323). Thus to adequately protect individuals and to ensure ethical practice, ethical models are needed that recognize group harms as pharmacogenetics leads to the “creation of new, genetically stratified, forms of difference and new forms of injus- tice based on these divisions” (Smart et al. 2004, p. 324). This focus on groups – despite a prima facie assumption that personalized medicine is concerned with indi- viduals – suggests that in this area of personalized medicine, no less than any other area of genetics, group ethics is fundamental to any adequate ethical framework. Indeed the need for models that recognize groups and the harm to individuals arising by virtue of belonging to a group is arguably particularly important in this sphere as the “creation of novel genetically stratified groups ... lead[s] to new genetically based forms of inequality” (Smart et al. 2004, p. 325, emphasis in original). In particular Smart et al. cite six key issues that arise in this context: first, the creation of “orphan populations”; second, unequal distribution of risk between some genetically defined groups (in that drugs may not be adequately tested on sub-groups); third, inappropriate denial of therapy according to group pre- scribing decisions; fourth, stigma and social discrimination of sub-groups; five, whether or not the expense of tailored medicine will make it the preserve of the wealthy or educated; and six, whether or not it will be used to overcome or entrench inequalities of race or ethnic categories (Smart et al. 2004, p. 327). Most interesting for this discussion is that most of these new ethical issues that the authors cite as arising in the context of personalized medicine are concerned with injustice to the “group”; this is not to say that these concerns do not impact upon individuals or that they do so in the same way (some individuals are more vulnerable than others) but rather that group models are to the fore in these issues. Only the third ethical concern addresses potential injustices to the individual as opposed to the group. In this instance the concern is that associations between genotype and drug responses are essentially matters of probability, therefore “some patients cate- gorised as ‘at risk’ would in fact not suffer from an adverse event were they to be offered the treatment. Similarly, some patients categorised as ‘non-responders’ would actually get a benefit from the therapy” (Smart et al. 2004, p. 331). In this example the individual would suffer from being wrongly identified with a certain group, whereas in the other five ethical issues it is the shared characteristics – those of the group – that are the primary focus of ethical concern. In this instance, no less than in the earlier cases we considered of the family and vulnerable indigenous groups, ensuring confidentiality and informed consent alone will not protect an individual or guarantee them fair treatment if they are a member of an orphan population. Likewise all of these concerns, for example, concerns New Genetics and Society 185 about underrepresented groups (point two) and issues of stigma and discrimination (point four) as well as more traditional social justice concerns for unequal distri- butions of wealth and power (point five) and for racial and ethnic discrimination (point six) return us firmly to group ethical issues of discrimination and injustice. To address such issues of injustice, inequality and harm, forms of ethical analysis that are structurally able to accommodate groups as well as individuals are necess- ary. For instance, if we consider one example, that of race or ethnicity, it is clear that considering the individual without connection to the group is nonsensical as it is only membership of the group that constitutes the ethically relevant category. To recognize the communal nature of the issue does not of course mean that the group, or individuals within the group, will be more justly treated. For, as Smart et al. rightly point out, “pharmacogenetics information may alleviate, or it may entrench existing inequities in healthcare based on race or ethnicity” (Smart et al. 2004, p. 335). However, even if these dangers are there at least group ethical issues, such as those deriving from race and ethnicity, are visible on com- munal models (as are wealth and power) as points of possible injustice and relevant to ethical assessment. If only individual models are used these forms of injustice and harm are far less visible and thus can only be addressed indirectly. For example historical racial discriminations may be directly challenged using parma- cogentics as “ethnic or racial difference may become an object of study, and a potential source of targeted treatments for population groups that have been histori- cally excluded from the ostensibly universal drug discovery and development process” (Smart et al. 2004, pp. 334–335). However, racial difference may also be used unethically, not for scientific reasons “to develop medicine for some racial or ethnic group” but “on economic grounds because white Caucasians in developed countries are a wealthier patient group than individuals with the same condition living in developing countries” (Lipton 2003, p. 15). However, unless group models are used such points of ethical concern are invisible and consequently despite being ethically significant are ignored. Thus even in this apparently individualized arena of personalized medicine the concerns of the individual are fundamentally tied to the group and community to whom the individual belongs. Moreover individual models of ethics alone will not be sufficient to recognize and address the ethical concerns that arise in these contexts. Likewise the standard practices of informed consent and confidentiality will not ensure that groups and the individuals within them will be justly treated. Thus again more nuanced models are needed, which can recognize and assess the rights and interests of individuals considered alone, individuals recognized as parts of groups and of groups. Conclusion In sum then the claim is that genetics does indeed support the communal turn, and that in order to adequately recognize and address the issues of genetic ethics 186 H. Widdows frameworks are needed which can incorporate the rights and interests of both indi- viduals and groups. This is the case not just with regard to families or genetically homogeneous groups such as indigenous populations which could be regarded as already having exceptional relational ties, but in all genetic arenas, including those of population databases, pharmacogenetics and personalized medicine. In all of these instances ethical models are required that can recognize group concerns and address injustices that derive from group membership as well as harms to the individual alone. This said, the concern with groups and the move to communal models does not necessarily entail that the justice concerns of redressing inequities (racial, economic and social) will be met. Indeed the ethical danger in communal models is always that the biggest or most powerful group will impose its will and group models are rightly criticized on precisely this point. However, what com- munal models do is rectify the individualist concerns of traditional bioethics and perhaps, if ethical frameworks can be devised that make visible the significant ethical concerns of both individuals and groups, the rights and interests of all will be better protected. Notes 1. For example the ethics of care presents individuals not as isolated but as relational and interdependent, “enmeshed in relations with others” (Held 2006, p. 156). In the ethics of care frameworks the “moral life is populated by caring relations in which the interests of self and others are mingled and trust is crucial” (Held 2006, p. 157). 2. Principlism became popular in medical ethics in the 1960s and 1970s in the US, applying the four principles of autonomy, non-maleficence, beneficence and justice. A version of principlism was endorsed by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) and in the same year T.L. Beauchamp and J.F. Childress published Principles of biomedical ethics which became the seminal textbook of medical ethics (now in its fifth edition) and established principlism as the methodology of medical ethics. 3. Additional criticism along these lines can be found in Clouser and Gert (1990) and Gert et al. (1997). 4. The emphasis on informed consent is also related to the horrors of Nazi research practices and the wish to prevent such atrocities occurring again and it is this which led to “the post-war consensus – from Nuremberg to Helsinki to the Common Rule – .. . that, to the greatest extent possible, people should not be exposed to the risks of human subjects research without their informed consent” (Greely 2001, p. 223). 5. Susan Moller Okin has famously addressed this issue in the context of group rights and the oppression of women. She argues strongly that we should be wary of group rights as they threaten the rights of women within groups (Okin 2002). 6. UK Biobank will recruit 500,000 people aged 40–69. It will take physical samples, ask lifestyle questions, and link this information to health-relevant records. 7. For example, there is no suggestion that (or indeed rationale by which) UK Biobank would prioritize the interest of groups such as patient groups or lobbying groups. Rather, access will be prioritized in accordance with the aims of Biobank for the public good interpreted broadly. (The access policy is still under development and due to be completed this year but this assumption is uncontroversial and in accord with all Biobank material.) New Genetics and Society 187 8. This is true in the ways in which genetics is fictionalized - especially regarding science fiction - and also in popular assumptions about genetic tests. For example Fred Ledley, founder of genetic testing company mygenome.com, says about genetic testing that “It’s really putting you as an individual first” and he states that the future lies in “empowering individuals with access to genetic tests together with information and support required to make effective and ethical decisions about how such tests might impact their personal lives” [sic] (Randerson 2006). 9. Smart et al. cite one example of this, namely “a drug combination called BiDil in the USA, which is undergoing trials as a treatment specifically for African Americans who have suffered heart failure” (Smart et al. 2004, p. 336). References Barker, J., 2004. The Human Genome Diversity Project: “peoples”, “populations” and the cultural politics of identification. Cultural Studies, 18 (4), 571–606. Bartels, D.M., 2001. Family Covenants and Confidentiality within Families. American Journal of Bioethics, 1 (3), 15–16. Beauchamp, T.L. and Childress, J.F., 2001. Principles of Biomedical Ethics. 5th ed. Oxford: Oxford University Press. Boyd, K.M., Higgs, R. and Pinching, A.J., eds., 1997. The New Dictionary of Medical Ethics. London: BMJ Publishing Group. Brock, D., 2001. Genetics and confidentiality. American Journal of Bioethics, 1 (3), 34–35. Clouser, K.D. and Gert, B., 1990. A critique of principlism. Journal of Medicine and Philosophy, 15, 219–236. Corrigan, O.P., 2004. Pharmacogenetics, ethical issues: review of the Nuffield Council on Bioethics Report. Journal of Medical Ethics, 31, 144–148. Dickenson, D., 2002. Commodification of human tissue: implications for feminist and development ethics. Developing World Bioethics, 2, 55–63. Donchin, A. and Purdy, L., 1999. Embodying bioethics: recent feminist advances. Oxford: Rowman & Littlefield. Doukas, D.J. and Berg, J.W., 2001. The family covenant and genetic testing. American Journal of Bioethics, 1 (3), 2–16. Evans, J.H., 2000. A sociological account of the growth of principlism. Hastings Center Report,30 (5), 31–38. Gert, B., Cluver, C.M., and Clouser, K.D., 1997. Bioethics: a return to fundamentals. Oxford Univer- sity Press. Gilligan, C., 1982. In a different voice. Cambridge, MA: Harvard University Press. Goldworth, A., 1996. Informed consent revisited. Cambridge Quarterly of Health Care Ethics,5, 214–220. Gould, C., 2004. Globalising democracy and human rights. Cambridge University Press. Greely, H.T., 2001. Human genomics research: new challenges for research ethics. Perspectives in Biology and Medicine, 44 (2), 221–229. Harris, J., 1985. The value of life: an introduction to medical ethics. London: Routledge & Kegan Paul. Held, V., 2006. The ethics of care: personal, political and global. Oxford University Press. Husted, J., 1997. Autonomy and a right not to know. In: R. Chadwick, et al., eds. The right to know and the right not to know. Aldershot: Ashgate, 55–68. Jones, P., 1999. Human Rights, Group Rights and Peoples’ Rights. Human Rights Quarterly, 21 (1), 80–107. Knoppers, B.M., 1997. Human DNA: law and policy. The Hague: Kluwer Law International. 188 H. Widdows Knoppers, B.M., 1999. Who should have access to genetic information. In: J. Burley, ed. The genetic revolution and human rights. Oxford University Press, 39–53. Knoppers, B.M. and Chadwick, R., 2005. Human genetic research: emerging trends in ethics. Nature, 6, 75–79. Koenig, B.A., 2001. Why not grant primacy to the family? American Journal of Bioethics, 1 (3), 33–34. Lapham, E.V., Kozma, C., and Weiss, J.O., 1996. Genetic discrimination: perspectives of consumers. Science, 274 (5287), 621–624. Lipton, P., 2003. Pharmacogenetics: the ethical issues. Pharmacogenomics Journal, 3, 14–16. Mackenzie, C. and Stoljar, N., eds., 2000. Relational autonomy: feminist perspectives on autonomy, agency, and the social self. Oxford and New York: Oxford University Press. Maschke, K.J., 2006. Alternative consent approaches for biobank research. The Lancet Oncology,7, 193–194. McKellin, W.H., 2001. Clinical Ethics and Family Morality. American Journal of Bioethics, 1 (3), 31–32. Mitchell, G.R. and Happe, K., 2001. Informed consent after the human genome project. Rhetoric and Public Affairs, 4 (3), 375–406. Mulhall, S. and Swift, A., 1996. Liberals and communitarians. 2nd ed. Oxford: Blackwell. Murdoch, I., 1970. The sovereignty of good. London: Routledge & Kegan Paul. Murdoch, I., 1992. Metaphysics as a guide to morals. London: Chatto & Windus. Noddings, N., 1984. Caring: a feminine approach to ethics. Berkeley, CA and London: University of California Press. Nordgren, A. and Juengst, E., 2009. Can genomics tell me who I am? Essentialist rhetoric in direct-to- consumer DNA testing. New Genetics and Society, 28 (2), 157–172. Okin, S.M., 2002. “Mistresses of their own destiny”: group rights, gender and reaslistic rights of exit. Ethics, 112, 205–230. Parker, M., 2001. Confidentiality in genetic testing. American Journal of Bioethics, 1 (3), 21–22. Parker, M. and Lucassen, A.M., 2004. Genetic information: a joint account? British Medical Journal, 329, 165–167. Randerson, J., 2006. Genetic medics build up high hopes. The Guardian, 7 September [online]. Available from: http://www.guardian.co.uk/technology/2006/sep/07/guardianweekly technologysection [Accessed 14 April 2008]. Shiva, V., 1997. Biopiracy: the plunder of nature and knowledge. Cambridge: South End Press. Shiva, V., 2001. Protect or plunder? Understanding intellectual property. London: Zed Books Ltd. Shiva, V., 2005. Earth democracy: justice sustainability and peace. London: Zed Books Ltd. Smart, A., Martin, P., and Parker, M., 2004. Tailored medicine: whom will it fit? The ethics of patient and disease stratification. Bioethics, 18 (4), 322–343. Tedlock, B., 2006. Indigenous heritage and biopiracy in the age of intellectual property rights. Explore, 2 (3), 256–259. Tong, R., 2001. Towards a feminist global bioethics. Healthcare Analysis, 9, 229–246. UK Biobank, 2007. Ethics and governance framework [online]. Available from: http://www. ukbiobank.ac.uk/docs/20071011_EGF_Version_3_1_0October_2007withTOR.pdf [Accessed 8 April 2008]. Webster, A., et al., 2004. Integrating pharmacogenetics into society: in search of a model. Nature,5, 663–669. Widdows, H., 2007. Conceptualising the self in the genetic era. Health Care Analysis, 15, 5–12. Winickoff, D.E., 2003. Governing population genomics. Jurimetrics, 43, 187–228. Winickoff, D.E. and Winickoff, R.N., 2003. The charitable trust as a model for genomic biobanks. New England Journal of Medicine, 349, 1180–1184. Wolf, S., 1996. Feminism and bioethics: beyond reproduction. New York: Oxford University Press. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png New Genetics & Society Taylor & Francis

Between the individual and the community: the impact of genetics on ethical models

New Genetics & Society , Volume 28 (2): 16 – Jun 1, 2009

Loading next page...
 
/lp/taylor-francis/between-the-individual-and-the-community-the-impact-of-genetics-on-hL4LJ8W36T

References (53)

Publisher
Taylor & Francis
Copyright
Copyright Taylor & Francis
ISSN
1469-9915
eISSN
1463-6778
DOI
10.1080/14636770902901611
Publisher site
See Article on Publisher Site

Abstract

New Genetics and Society Vol. 28, No. 2, June 2009, 173–188 Between the individual and the community: the impact of genetics on ethical models Heather Widdows Department of Philosophy, University of Birmingham, Birmingham, B15 2TT, UK This paper discusses how genetics is influencing ethical frameworks with particular focus on the effectiveness and appropriateness of individual and communal models. It suggests that genetics supports a relational understanding of the person and therefore that genetic ethics requires ethical models which respect both individuals and groups. First, the inadequacy of individualistic frameworks – at conceptual, ethical and practical levels – is outlined. Second, the “communal turn” in genetic ethics in both clinical and population ethics is considered. Third, it is claimed that this communal turn is applicable to genetic ethics in general and to illustrate this two further examples are explored: those of UK Biobank and personalized medicine. The paper concludes that ethical frameworks in genetic ethics must accommodate both group and individual concerns. Keywords: ethics; individualism; communal ethics; groups; trust model; personalized medicine Introduction This paper discusses how genetics is influencing ethical frameworks with particular focus on the effectiveness and appropriateness of individual and communal models. It suggests that genetics supports a relational understanding of the person and there- fore that genetic ethics requires ethical models which respect both individuals and groups. In order to make this case the paper first describes why individualistic frame- works are unsatisfactory in the genetic era. This is done in three ways. First, the picture of the moral agent as an isolated individual will be considered; second, the ethical frameworks deriving from this picture will be critiqued and third the practical impossibility of maintaining individual ethical norms will be described. Having outlined these critiques of the solely individual model the paper will describe the “communal turn” in genetic ethics which has occurred in part in response to these inadequacies in both clinical and population ethics. The paper will argue that communal models that can address the ethical issues of groups Email: h.widdows@bham.ac.uk ISSN 1463-6778 print/ISSN 1469-9915 online # 2009 Taylor & Francis DOI: 10.1080/14636770902901611 http://www.informaworld.com 174 H. Widdows are necessary to supplement individual models not only in these spheres but in all aspects of genetics if the ethical issues arising in this field are to be competently addressed. To illustrate the importance of models that can accommodate groups, two examples, that of UK Biobank and of personalized medicine, will be con- sidered. It will be concluded that in order to address the most pertinent issues of genetic ethics groups as well as individuals must be considered and thus ethical models must accommodate both group and individual concerns. Criticisms of the individual model The individualism of bioethics has been criticized for a number of reasons: on con- ceptual grounds, for relying on an over-individualist model of the self; on ethical grounds, for promoting a narrow ethical framework; and on practical grounds, as being impossible to maintain in the genetic era. The isolated individual First then, the conceptual criticism, that to present the individual as separable from community and a nexus of relationships is a misrepresentation of the person. This is a common critique of post-Enlightenment moral theory and emerges from many schools of thought, including communitarian, virtue and feminist. Communitarians critique the individual of liberal philosophy and ask who is the “‘person’ that exists independently of, and able to freely choose, the ends that give her life meaning and value?” (Mulhall and Swift 1996, p. 10). From this perspective to portray the individual as a separable moral agent “misunderstands the relation between the individual and her society or community, and more specifically, ignores the extent to which it is the societies in which people live that shape who they are and the values that they have” (Mulhall and Swift 1996, p. 13). Other positions, such as those of virtue ethics and feminist theory, make similar and parallel criticisms. Virtue ethics, like communitarian thought, rejects the notion of a separated and isolated individual and argues for an integrated and interconnected conception of the self. For example, Iris Murdoch is critical of over-simplistic and unrealistic ethical frameworks which present the individual as surveying the facts and then rationally making a choice (Murdoch 1992, p. 150). She contends that the picture of the autonomous separate individual is false and that such theories wrongly portray the moral agent “as an isolated will” (Murdoch 1970, p. 49). She sums up this picture describing “the fearful solitude of the individual marooned upon a tiny island in the middle of a sea of scientific facts” (Murdoch 1970, p. 27). For Murdoch, as for all virtue ethicists, an isolated separate non-relational picture of the individual is false and particularly flawed when used as a model for ethical decision-making. New Genetics and Society 175 In a similar vein feminist theorists critique the model of the unconnected individual and “it is by now commonplace to criticize traditional liberal democracy for its abstract individualism” (Gould 2004, p. 7). Like communitarians and virtue ethicists feminist thinkers argue for an alternative picture of the moral agent; of persons not as isolated autonomous individuals, but as relational, social and con- nected beings making choices in the context of their relationships. In this schema choices are made and characters develop in the “concrete interactions of particular caring and choosing individuals, who are often concerned for each other and make choices together with others with whom they are engaged in common projects and interdependent networks (economic, technological, social, cultural or personal)” (Gould 2004, p. 63). Accordingly feminist theorists have con- ceptualized alternative understandings of the individual as a relational individual, and have suggested alternative ethical frameworks derived from relational models of persons. Of particular importance in this field has been the debate about relational autonomy and the ethics of care (Gilligan 1982, Noddings 1984, Mackenzie and Stoljar 2000, Held 2006). Such feminist critiques have been influ- ential in the bioethics field and feminist bioethicists have emphasized the impor- tance of difference and championed the values of social justice over those of individual choice (Wolf 1996, Donchin and Purdy 1999, Tong 2001). These conceptual criticisms of the individualist picture are supported by genetic understandings of the human person. The genetic individual is not an “isolated indi- vidual” but one who is genetically related both to current groups and to past and future generations – manifested for example in the interest in genetic heritage (Nordgren and Juengst 2009). Thus the genetic individual is fundamentally a “con- nected individual”, connected to consanguineous relations and family groups, ethnic groups and wider communities and potentially in some of the language which surrounds the human genome to “humankind” as a meta-collective (Widdows 2007). Frameworks based on the isolated individual The contested and critiqued representation of the moral agent as an isolated individ- ual underlies many ethical frameworks. Thus, while it may be the case that the rec- ognition that human beings are social and relational has “become a truism in social philosophy” (Gould 2004, p. 63), the implications of this for ethical frameworks has yet to be fully realized. This is particularly true of bioethics which has focused on the individual as the primary unit of ethical concern to the extent that bioethics “has reified the individual and individual autonomy” (Koenig 2001, p. 33). The ethical focus of bioethics is (or has been) almost exclusively the indi- vidual. In both clinical and population research settings the main concern is to protect the individual from harm and preserve autonomy and privacy. The individual focus of bioethics is well documented and derives its develop- ment from a professional medical ethic of the doctor–patient relationship. 176 H. Widdows The framework of this professional relationship was quite properly individual, based on the duties of the doctor to their patient. This model, appropriate in the context of a professional one-to-one relationship, was applied across bioethics to situations where the individual doctor–patient relationship was less binding and thus the model less relevant, for example, in research ethics and population genetics. The focus on the individual was further enshrined with the acceptance of prin- ciplism as the primary methodology of bioethics. A principlist methodology need not necessarily be individualist; however, in this context it has become so in part because it is applied by practitioners in a case-by-case setting. In such instances it is the needs of the individual patient which are most pressing and there- fore dominate. Moreover, often the principle of autonomy has tended to be elevated over other principles again serving to locate ethics at the individual level (Goldworth 1996). In a similar manner to the conceptual criticisms of the individual model principlism has been criticized for being reductionist and for failing to “capture the moral life quite properly” (Evans 2000, p. 37). Such criticisms echo those of communitarian, virtue and feminist thinkers discussed above, namely that a solely individual-focused ethic is not a comprehensive ethic but based on a contested model which conceptualizes the moral agent as an isolated individual. As a result the ethical framework is one which privileges individual ethical concerns, such as individual choice, over other ethical concerns. Just as genetics challenges the “unconnected individual” it also challenges the individualism inherent in this bioethical framework. Genetics brings into question the place of the individual as the sole locus of ethical concern, for “the fact that genetic information about one person can be of value to others poses an important challenge to the primacy of respect for the principle of autonomy in medicine” (Parker 2001, p. 21). Thus the ethical priority of individual autonomy and the indi- vidual focus of bioethical frameworks become problematic in genetic ethics. Practical difficulties The criticisms regarding the isolated conception of the moral agent and the result- ing ethical framework are compounded by the practical difficulties of maintaining the key ethical practices of confidentiality and informed consent in the genetic era. These practices are overtly and expressly designed to protect and safeguard the rights and interests of the individual and to prevent the individual from being harmed: confidentiality to protect the individuals’ privacy and informed consent to protect the individual’s bodily integrity. Confidentiality is “one of the most important principles of medical ethics” (Harris 1985, p. 225) and it has been termed the “central ethical pillar of clinical practice” (Boyd et al. 1997, p. 51). Confidentiality developed in the context of the doctor–patient relationship, and the doctor is charged with protecting the indi- vidual’s confidentiality irrespective of whether other individuals, for example family members or reproductive partners, have legitimate interests. In the genetic New Genetics and Society 177 era this is problematic as genetic information does impact upon other individuals and indeed how to manage competing ethical claims is regarded as “among the most important challenges identified by a group of nurses, physicians, and genetic councilors who were asked what ethical and professional challenges they faced when they saw patients with genetic concerns” (Bartels 2001, p. 15). Informed consent, the second fundamental standard of medical ethics is proble- matic for similar reasons in the genetic era. Individual consent is intended to protect the individual and ensure the patient’s wishes are respected: “respect for the person requires a patient’s autonomous consent be obtained before any treatment or procedure involving the patient can be carried out, and ... no consent will be auton- omous unless it is fully informed” (Harris 1985, p. 205). However, questions about whether connected individuals’ rights and interests are adequately respected if only individual consent is required have been raised, in particular, with regard to whether family members should be consulted and broader models of consent adopted. Accordingly in the genetic era it is not clear that individual practices – such as confidentiality and informed consent – are sufficient to guarantee good ethical practice (Husted 1997, Knoppers 1997, 1999). These practices only protect the individual and therefore neglect the ethical interests of relevant others, for example family members and members of the genetically related group. In the genetic context health decisions no longer only concern the individual as “disclos- ure of genetic information by individual DNA donors also exposes information about others with similar genetic profiles” (Mitchell and Happe 2001, p. 376). Thus at the practical level, just as at the conceptual and ethical framework levels, the fact that the “key feature about genetic information is that it is typically information about a family, or even ... about a larger community not just about an individual patient” (Brock 2001, p. 34) makes purely individual practices proble- matic. Moreover, it is quite simply not feasible to guarantee total individual confi- dentiality into the future as genetic information is always indentifying, for example when compared to a database, hence making complete certainty with regard to confidentiality, particularly over time, impossible. Limitations of the individual model These three critiques suggest that there are real concerns about solely individual models of ethics, at conceptual, ethical and practical levels. In light of such criti- cisms it has been suggested that ethical models are sought which can recognize the rights and interests not only of the individual but also of other genetically related individuals and groups who have an interest in such information and who may potentially be harmed. This is true of both clinical and population genetics. In clinical genetics, as discussed, the inability of individual models to take into account the rights and interests of other family members has been regarded as an increasingly concerning ethical issue (Bartels 2001). The focus only on the individ- ual has led practitioners to be concerned about whether others with legitimate 178 H. Widdows interests are being harmed. In attempts to address such concerns family models such as those of the “joint account” (Parker and Lucassen 2004) and the “family cove- nant” (Doukas and Berg 2001) have been suggested. The joint account model regards genetic information as essentially family information and argues that only in exceptional cases should information be withheld by an individual. The family covenant model also considers the family the appropriate “unit of care” and aims to offer “the individual, family and physician a mechanism to help resolve compet- ing claims for confidentiality and disclosure” (Doukas and Berg 2001, p. 3). In this model the family agrees together how such familial information is to be shared. These models have been regarded as steps towards more communal models, for example, the family covenant has been praised as being “a significant step by recognizing that in genetics the family plays a significant role in genetic counseling and testing, and the family, not simply the individual is the patient” (McKellin 2001, p. 31). They are attempts to move beyond the purely individual model and to accommodate the rights and interests of all involved. These models still use the practices of individual consent and confidentiality, but attempt to widen their scope. However, they are not without difficulties, for example, how are competing interests within the family to be resolved and how are individuals to be protected? Moreover, what constitutes the family unit? Are only genetically related family members to be included and how far does the family unit extend? Resolving such complex issues is not easy, especially if one considers the diverging cultural and social norms regarding family membership and authority within such groups. However, despite such complexities, the need to supplement the individual model in order to do justice to the legitimate interests of family members is clear. The limits of the individual model are also evident in population genetics particularly when considering genomic research on indigenous populations with relatively homogeneous (and therefore potentially valuable) genotypes. In these cases again the shared nature of genetic information means that genetic research on one member of the group “has implications for all members of those groups, whether or not they decided – or even were asked – to take part in the research” (Greely 2001, p. 222). Accordingly, information derived from a sample taken from one member of the group is relevant to other members of the group and other members of the group have interests in the ownership and use of such information. Thus, even when properly applied, informed consent and confidentiality cannot protect the rights and interests of related individuals or of the group. To illustrate we can consider the case of the Hagahai tribe of Papua New Guinea from 1994. In this case samples were taken from a few individuals and a patent granted on a cell line containing unmodified Hagahai DNA and several methods for its use in detecting HTLV-1-related retroviruses. The patenting of unmodified DNA raised a number of ethical concerns which the individual model is not equipped to address as the site of ethical concern is not just the individual from whom the DNA is taken, but other connected parties have rights and interests and can be harmed. In addition there may also be collective concerns New Genetics and Society 179 about culture, heritage and ownership. (Dickenson 2002, Tedlock 2006) In this case there was an awareness that the individual model was not sufficient and a “benefit- sharing” agreement was discussed. However, as this agreement amounted to little more than an unofficial promise from the named researcher on the patent that she would give her share to the Hagahai any group provision was inadequate and clearly a more robust ethical framework was needed. The granting of this patent was met with opposition from indigenous rights groups who deemed it unethical for unmodified DNA owned in any circumstance – “no patents on life” – let alone owned by the US government (Shiva 1997, 2001, 2005, Winickoff 2003). In 1996, following protest, the patent was “disclaimed”; however, the Hagahai cell line remains in the public domain and is now available to the public at the American Type Culture Collection as ATCC Number: CRL-10528 Organism: Homo Sapiens (human) at a cost of $290. In other similar cases there is no evidence of any recognition of the communal interests involved, however feeble. For example, patent applications were filed by “US federal health agencies on genetic samples derived from indigenous peoples in the Solomon Islands and Panama” (Barker 2004, p. 595). The cell lines were taken from consenting individ- uals – one from a 40-year-old woman and one from a 50-year-old man (Barker 2004, p. 595) – and again under pressure the patent claim was withdrawn. However, as with the Hagahai, the cell lines remain on deposit at the American Type Culture Collection. In these cases only individual ethical frameworks were employed (in the seeking of informed consent from the individuals from whom samples were taken). No attempts were made to address the wider concerns of related individuals or the group. These individual measures were not adequately applied as only oral consent was attained from an unschooled and illiterate research subject with apparently little knowledge of the proposed research (Winickoff 2003). However, even if such practices had been used appropriately the ethical issues would not have been adequately addressed. Yet, although there is a clear need for models which include groups, just as there are problems with family models there are problems with models which take the group as the unit of ethical concern. As difficult as it might be to determine the bounds of the family and to find a mechanism for balancing interests within a family this is arguably even more problematic when it comes to groups. The most pressing ethical issue here is who speaks for the group and how can vulnerable individuals and minorities be protected and represented within the group? The danger is “that individuals and their claims of right will be crushed beneath the greater weight of groups and their claims of right” (Jones 1999, p. 92). In such instances it is important to ensure that ethical models include the insights of the individual model and protect individuals while also recognizing the interests of other individuals and of the group. However, despite these significant difficulties, these examples, of family genetics and of DNA patenting, show the limits of solely individual ethical frameworks. In these frameworks only the individual who is tested or from whom samples 180 H. Widdows are taken is protected; the rights and interests of other individuals with legitimate interests, such as the family or the wider ethnic group, are ignored. It is not only that other individuals have not been asked to consent, although that is an important issue, but also other group ethical issues are neglected, such as group vulnerability, discrimination and exploitation. These group ethical issues are of obvious impor- tance in the case of vulnerable indigenous groups, but they are also important for vulnerable families, for example those who are in danger of being discriminated against on genetic grounds (Lapham et al. 1996). In addition not only are not all individuals with legitimate interests protected if only individual models are used, but, as noted earlier, even those individuals at the centre of the practices who do give their informed consent cannot realistically have their confidentiality guaran- teed into the future given the identifying nature of the material. The communal turn It is the need to address these ethical issues which has led to the “communal turn” in bioethics and the seeking of ethical frameworks which can accommodate the rights and interests of groups as well as individuals. As we have noted this is true at the clinical level where the claims of families have been increasingly discussed, and at the level of population genetics where there have been considerable changes in practice. For example, in population genetics informed consent is increasingly being supplemented by group consent and “prior consultation and communication with these specific communities and populations are emerging as ethical prerequi- sites” (Knoppers and Chadwick 2005, p. 76). This increasingly strong requirement for group consent demonstrates the “communal turn” which Knoppers and Chadwick identify in five general trends away from individual models and towards reciprocity, mutuality, solidarity, citizenry and universality (Knoppers and Chadwick 2005). They argue that this turn is particularly evident in population genetics and in the simple fact that in “the implementation of processes that respect the need for public consultation and debate ... [have] .. . come to prominence, particularly in relation to population data- bases” (Knoppers and Chadwick 2005, p. 77) there is a recognition of the communal nature of such ethical decisions. They claim that the need to move beyond individual models is particularly pressing in population genetics as in these contexts seeking fully informed individual consent is not practical either because of the numbers involved or because of the uncertainty of the future research. To explore this communal turn and further support the claim that ethical models must be able to accommodate both individual and communal concerns, two further cases will be considered: that of UK Biobank and that of personalized medicine. UK Biobank UK Biobank and the ethical framework it has adopted can be placed within the communal turn identified by Chadwick and Knoppers for exactly the reasons New Genetics and Society 181 they have suggested. Quite simply, in population projects of the size of UK Biobank to insist on the “gold standard” of fully informed individual consent would be impracticable and unrealistic. Such a requirement would require return to the donors for every new study – and potentially for every subsequent study which drew on previous data. To do this would be not only administratively cumbersome but, more importantly, overly burdensome on the donors. Thus if stan- dard notions of informed consent were insisted upon then broad-based population studies such as that of UK Biobank, would be unworkable. Accordingly biobanks and other forms of population genomics have sought new models of consent (usually supplemented by other ethical safeguards). For example, a model of group and broad consent has been propagated which denies researchers “complete freedom to do whatever they want with biobank samples, yet increases the number of samples likely to be available for future research compared with an approach that requires researchers to recontact individuals to obtain consent for every new study” (Maschke 2006, p. 193). UK Biobank is no different in this regard from other population studies and has adopted a broad model of individual consent within the “trust model” rather than a traditional model of fully informed consent. In the trust model, “when a person agrees to donate tissue, the recipient has a responsibility to serve as a trustee, or steward, of the tissue in order to ensure protection of the contribution” (Winickoff and Winickoff 2003, p. 1182). Using the trust model open-ended “broad” consent is sought: “because it is impossible for the donor to make an informed choice about the risks and benefits of unspecified future research protocols, such per- mission should never be called informed consent” (Winickoff and Winickoff 2003). Therefore, instead of seeking consent for particular research or particular types of research UK Biobank participants are asked to consent at the time of recruitment in a single act of consent “for research in general that is consistent with UK Biobank’s stated purpose (rather than for specific research)” (UK Biobank 2007, p. 5). The open-ended nature of this “broad consent” is made clear to participants from the outset. It is overtly not “fully informed”, indeed this would be impossible given that the nature of the research is as yet unknown. (UK Biobank 2007, p. 6) Thus consent is given for research on “trust” in accordance with the “trust model”. In other words the participants trust UK Biobank to use their material and information only in ways that fit the stated purpose of UK Biobank; that is, to “build a major resource that can support a diverse range of research intended to improve the prevention, diagnosis, and treatment of illness and the promotion of health throughout society” (UK Biobank 2007, p. 3). When asked to consent participants are asked on the basis that participation is “an opportunity to contribute to a resource that may, in the long term, help enhance other people’s health” (UK Biobank 2007, p. 5). “Broad consent” is supported and ensured by the establishment of an Ethics and Governance Council (EGC) and the right to withdraw. The EGC is independent of UK Biobank and its remit includes: 182 H. Widdows acting as an independent guardian of the Ethics and Governance Framework and advising the Board on its revision; monitoring and reporting publicly on the confor- mity of the UK Biobank project within this Framework; and advising more generally on the interests of participants and the general public in relation to UK Biobank. (UK Biobank 2007, p. 15) Broad consent effectively functions as a gateway to the “donor group” whose rights and interests are then protected as a group. The donor group’s interests are then protected (or “stewarded”) according to the trust model. In the trust model the donor group’s trust can be safeguarded in a number of ways and there are a number of possible mechanisms for maintaining trust and for enhancing the invol- vement of the donor group. For example, possible forms of participation “might include membership on the trust’s IRB, membership on a donor committee that has veto power over particular projects, and election of a donor to serve on the board of trustees. Research applications could be evaluated by the trustees according to a set of criteria that would ensure public benefit” (Winickoff and Winickoff 2003, pp. 1182–1183). In the case of UK Biobank it is the EGC’s responsibility to fulfill this stewardship role and ensure that the rights and interests of the donor group are protected and safeguarded. Thus, UK Biobank, having adopted the trust model, employs an ethical framework which recognizes groups as well as individuals. This is not to say that UK Biobank adopts only a group model. Individuals give their broad consent at the beginning of the process and individuals have a right to withdraw – “at any time and without having to explain why and without penalty” (UK Biobank 2007, p. 6). Options are available as to how far they wish to with- draw. For example, they may simply wish to cease contact with UK Biobank, or they may wish to put their data beyond further use. However, for UK Biobank to succeed it must maintain participation levels and thus it must maintain the trust of the participants as mass withdrawal would destroy the UK Biobank project. The individual model functions at entry and exit, but for the duration of participation the participants are protected not because they gave informed consent, but because “the Ethics and Governance Council will keep use of the resource under review in order to advise on conformance with this Framework and the IP and Access Policy and to assure itself, and others, that the resource is being used in the public interest” (UK Biobank 2007, p. 13). Thus the ethical framework considers the rights of the donors not only as the rights and interests of individuals but as the rights and interests of the “donor group”. This is not to say that UK Biobank gives attention to groups per se, but rather that pivotal ethical interests it respects are those of the “donor group” and the “public as a whole” (the two groups the EGC has a remit to protect). Furthermore, the public good is influential in determining the remit of UK Biobank. Thus, public interest is central to this model and participants “trust” UK Biobank to serve the public interest. The ultimate concern is not for individual participants (although their rights and interests are protected) and they are made aware that they New Genetics and Society 183 themselves will not directly benefit, but for the public good conceived of in popu- lation terms. Moreover given the nature of the study it is not likely to be current participants that benefit but younger persons and future generations – in other words, the future population as a group and the individuals therein. UK Biobank’s adoption of broad consent in the context of the trust model provides an example of an ethical framework that combines the rights and interests of both groups and individuals: both in its protection of the “donor group” and in its overarching aim to benefit the public good. The need to move beyond the traditional practices of fully informed consent and confidentiality is necessitated, as Chadwick and Knoppers point out, by the nature of such population and future-orientated research and thus the ethical framework that UK Biobank has arrived at to protect the rights and interests of all parties includes both groups and individuals as sites of ethical concern. Personalized medicine Having argued that ethical frameworks need to recognize both individual and group concerns in both clinical and population research settings this final section will examine whether this is in the case in what one would imagine is the most indivi- dualized aspect of genetics, that of “personalized medicine”. Personalized medicine and the notion of an individual “genetic blueprint” have gripped popular imagin- ation suggesting an individual model (Nordgren and Juengst 2009). However, more detailed examination shows that in this arena, as much as in the others con- sidered, it is essential to have a ethical framework that can address group as well as individual issues. Interest in “personalized” medicine reached its zenith in the last four to five years with claims of “bespoke”, “tailored” and “individualized” medicine: “the right medicine for the right patient, at the right dose” (Lipton 2003, p. 14). Personalized medicine or pharmacogenetics concerns “the relationship between genetic make up and drug therapy” and is best “defined .. . as an area of research and a set of tech- nologies aimed at addressing problems of variation in drug effect, by linking drug response to individual genetic variation” (Corrigan 2004, p. 144). Accordingly, given its potential to tailor “new medicines to an individual’s genetic profile” (Corrigan 2004, pp. 144–145) pharmacogenetics promises much. It promises fewer adverse reactions and more effective treatments as it enables tailoring prescriptions “to an individual’s genotype and, in principle, reduce[s] drug safety problems and improve[s] the effectiveness of treatments” (Smart et al. 2004, p. 324). Given this emphasis on a medicine tailored to fit the individual it would seem that highly individualistic models are being invoked and promoted. However, a more detailed consideration suggests that even in this arena – the most individua- listic of the genetic era – this is not necessarily the case. For, despite the hype, the promise of personalized medicine is to groups rather than individuals as pharmaco- genetic testing tends to “suggest a particular drug for genetically defined groups” 184 H. Widdows (Corrigan 2004, p. 145) and consequently will “probably be used to stratify patient populations into groups determined by their genotype” (Webster et al. 2004, p. 663). Thus rather than personalized in the sense of tailored to fit an individual they are tailored to a type. Using the metaphor and language of tailored medicine Smart et al. describe it as “‘off-the-peg’ prescribing to genotype groups rather than individually ‘bespoke’ medicine” (Smart et al. 2004, p. 323). Thus to adequately protect individuals and to ensure ethical practice, ethical models are needed that recognize group harms as pharmacogenetics leads to the “creation of new, genetically stratified, forms of difference and new forms of injus- tice based on these divisions” (Smart et al. 2004, p. 324). This focus on groups – despite a prima facie assumption that personalized medicine is concerned with indi- viduals – suggests that in this area of personalized medicine, no less than any other area of genetics, group ethics is fundamental to any adequate ethical framework. Indeed the need for models that recognize groups and the harm to individuals arising by virtue of belonging to a group is arguably particularly important in this sphere as the “creation of novel genetically stratified groups ... lead[s] to new genetically based forms of inequality” (Smart et al. 2004, p. 325, emphasis in original). In particular Smart et al. cite six key issues that arise in this context: first, the creation of “orphan populations”; second, unequal distribution of risk between some genetically defined groups (in that drugs may not be adequately tested on sub-groups); third, inappropriate denial of therapy according to group pre- scribing decisions; fourth, stigma and social discrimination of sub-groups; five, whether or not the expense of tailored medicine will make it the preserve of the wealthy or educated; and six, whether or not it will be used to overcome or entrench inequalities of race or ethnic categories (Smart et al. 2004, p. 327). Most interesting for this discussion is that most of these new ethical issues that the authors cite as arising in the context of personalized medicine are concerned with injustice to the “group”; this is not to say that these concerns do not impact upon individuals or that they do so in the same way (some individuals are more vulnerable than others) but rather that group models are to the fore in these issues. Only the third ethical concern addresses potential injustices to the individual as opposed to the group. In this instance the concern is that associations between genotype and drug responses are essentially matters of probability, therefore “some patients cate- gorised as ‘at risk’ would in fact not suffer from an adverse event were they to be offered the treatment. Similarly, some patients categorised as ‘non-responders’ would actually get a benefit from the therapy” (Smart et al. 2004, p. 331). In this example the individual would suffer from being wrongly identified with a certain group, whereas in the other five ethical issues it is the shared characteristics – those of the group – that are the primary focus of ethical concern. In this instance, no less than in the earlier cases we considered of the family and vulnerable indigenous groups, ensuring confidentiality and informed consent alone will not protect an individual or guarantee them fair treatment if they are a member of an orphan population. Likewise all of these concerns, for example, concerns New Genetics and Society 185 about underrepresented groups (point two) and issues of stigma and discrimination (point four) as well as more traditional social justice concerns for unequal distri- butions of wealth and power (point five) and for racial and ethnic discrimination (point six) return us firmly to group ethical issues of discrimination and injustice. To address such issues of injustice, inequality and harm, forms of ethical analysis that are structurally able to accommodate groups as well as individuals are necess- ary. For instance, if we consider one example, that of race or ethnicity, it is clear that considering the individual without connection to the group is nonsensical as it is only membership of the group that constitutes the ethically relevant category. To recognize the communal nature of the issue does not of course mean that the group, or individuals within the group, will be more justly treated. For, as Smart et al. rightly point out, “pharmacogenetics information may alleviate, or it may entrench existing inequities in healthcare based on race or ethnicity” (Smart et al. 2004, p. 335). However, even if these dangers are there at least group ethical issues, such as those deriving from race and ethnicity, are visible on com- munal models (as are wealth and power) as points of possible injustice and relevant to ethical assessment. If only individual models are used these forms of injustice and harm are far less visible and thus can only be addressed indirectly. For example historical racial discriminations may be directly challenged using parma- cogentics as “ethnic or racial difference may become an object of study, and a potential source of targeted treatments for population groups that have been histori- cally excluded from the ostensibly universal drug discovery and development process” (Smart et al. 2004, pp. 334–335). However, racial difference may also be used unethically, not for scientific reasons “to develop medicine for some racial or ethnic group” but “on economic grounds because white Caucasians in developed countries are a wealthier patient group than individuals with the same condition living in developing countries” (Lipton 2003, p. 15). However, unless group models are used such points of ethical concern are invisible and consequently despite being ethically significant are ignored. Thus even in this apparently individualized arena of personalized medicine the concerns of the individual are fundamentally tied to the group and community to whom the individual belongs. Moreover individual models of ethics alone will not be sufficient to recognize and address the ethical concerns that arise in these contexts. Likewise the standard practices of informed consent and confidentiality will not ensure that groups and the individuals within them will be justly treated. Thus again more nuanced models are needed, which can recognize and assess the rights and interests of individuals considered alone, individuals recognized as parts of groups and of groups. Conclusion In sum then the claim is that genetics does indeed support the communal turn, and that in order to adequately recognize and address the issues of genetic ethics 186 H. Widdows frameworks are needed which can incorporate the rights and interests of both indi- viduals and groups. This is the case not just with regard to families or genetically homogeneous groups such as indigenous populations which could be regarded as already having exceptional relational ties, but in all genetic arenas, including those of population databases, pharmacogenetics and personalized medicine. In all of these instances ethical models are required that can recognize group concerns and address injustices that derive from group membership as well as harms to the individual alone. This said, the concern with groups and the move to communal models does not necessarily entail that the justice concerns of redressing inequities (racial, economic and social) will be met. Indeed the ethical danger in communal models is always that the biggest or most powerful group will impose its will and group models are rightly criticized on precisely this point. However, what com- munal models do is rectify the individualist concerns of traditional bioethics and perhaps, if ethical frameworks can be devised that make visible the significant ethical concerns of both individuals and groups, the rights and interests of all will be better protected. Notes 1. For example the ethics of care presents individuals not as isolated but as relational and interdependent, “enmeshed in relations with others” (Held 2006, p. 156). In the ethics of care frameworks the “moral life is populated by caring relations in which the interests of self and others are mingled and trust is crucial” (Held 2006, p. 157). 2. Principlism became popular in medical ethics in the 1960s and 1970s in the US, applying the four principles of autonomy, non-maleficence, beneficence and justice. A version of principlism was endorsed by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) and in the same year T.L. Beauchamp and J.F. Childress published Principles of biomedical ethics which became the seminal textbook of medical ethics (now in its fifth edition) and established principlism as the methodology of medical ethics. 3. Additional criticism along these lines can be found in Clouser and Gert (1990) and Gert et al. (1997). 4. The emphasis on informed consent is also related to the horrors of Nazi research practices and the wish to prevent such atrocities occurring again and it is this which led to “the post-war consensus – from Nuremberg to Helsinki to the Common Rule – .. . that, to the greatest extent possible, people should not be exposed to the risks of human subjects research without their informed consent” (Greely 2001, p. 223). 5. Susan Moller Okin has famously addressed this issue in the context of group rights and the oppression of women. She argues strongly that we should be wary of group rights as they threaten the rights of women within groups (Okin 2002). 6. UK Biobank will recruit 500,000 people aged 40–69. It will take physical samples, ask lifestyle questions, and link this information to health-relevant records. 7. For example, there is no suggestion that (or indeed rationale by which) UK Biobank would prioritize the interest of groups such as patient groups or lobbying groups. Rather, access will be prioritized in accordance with the aims of Biobank for the public good interpreted broadly. (The access policy is still under development and due to be completed this year but this assumption is uncontroversial and in accord with all Biobank material.) New Genetics and Society 187 8. This is true in the ways in which genetics is fictionalized - especially regarding science fiction - and also in popular assumptions about genetic tests. For example Fred Ledley, founder of genetic testing company mygenome.com, says about genetic testing that “It’s really putting you as an individual first” and he states that the future lies in “empowering individuals with access to genetic tests together with information and support required to make effective and ethical decisions about how such tests might impact their personal lives” [sic] (Randerson 2006). 9. Smart et al. cite one example of this, namely “a drug combination called BiDil in the USA, which is undergoing trials as a treatment specifically for African Americans who have suffered heart failure” (Smart et al. 2004, p. 336). References Barker, J., 2004. The Human Genome Diversity Project: “peoples”, “populations” and the cultural politics of identification. Cultural Studies, 18 (4), 571–606. Bartels, D.M., 2001. Family Covenants and Confidentiality within Families. American Journal of Bioethics, 1 (3), 15–16. Beauchamp, T.L. and Childress, J.F., 2001. Principles of Biomedical Ethics. 5th ed. Oxford: Oxford University Press. Boyd, K.M., Higgs, R. and Pinching, A.J., eds., 1997. The New Dictionary of Medical Ethics. London: BMJ Publishing Group. Brock, D., 2001. Genetics and confidentiality. American Journal of Bioethics, 1 (3), 34–35. Clouser, K.D. and Gert, B., 1990. A critique of principlism. Journal of Medicine and Philosophy, 15, 219–236. Corrigan, O.P., 2004. Pharmacogenetics, ethical issues: review of the Nuffield Council on Bioethics Report. Journal of Medical Ethics, 31, 144–148. Dickenson, D., 2002. Commodification of human tissue: implications for feminist and development ethics. Developing World Bioethics, 2, 55–63. Donchin, A. and Purdy, L., 1999. Embodying bioethics: recent feminist advances. Oxford: Rowman & Littlefield. Doukas, D.J. and Berg, J.W., 2001. The family covenant and genetic testing. American Journal of Bioethics, 1 (3), 2–16. Evans, J.H., 2000. A sociological account of the growth of principlism. Hastings Center Report,30 (5), 31–38. Gert, B., Cluver, C.M., and Clouser, K.D., 1997. Bioethics: a return to fundamentals. Oxford Univer- sity Press. Gilligan, C., 1982. In a different voice. Cambridge, MA: Harvard University Press. Goldworth, A., 1996. Informed consent revisited. Cambridge Quarterly of Health Care Ethics,5, 214–220. Gould, C., 2004. Globalising democracy and human rights. Cambridge University Press. Greely, H.T., 2001. Human genomics research: new challenges for research ethics. Perspectives in Biology and Medicine, 44 (2), 221–229. Harris, J., 1985. The value of life: an introduction to medical ethics. London: Routledge & Kegan Paul. Held, V., 2006. The ethics of care: personal, political and global. Oxford University Press. Husted, J., 1997. Autonomy and a right not to know. In: R. Chadwick, et al., eds. The right to know and the right not to know. Aldershot: Ashgate, 55–68. Jones, P., 1999. Human Rights, Group Rights and Peoples’ Rights. Human Rights Quarterly, 21 (1), 80–107. Knoppers, B.M., 1997. Human DNA: law and policy. The Hague: Kluwer Law International. 188 H. Widdows Knoppers, B.M., 1999. Who should have access to genetic information. In: J. Burley, ed. The genetic revolution and human rights. Oxford University Press, 39–53. Knoppers, B.M. and Chadwick, R., 2005. Human genetic research: emerging trends in ethics. Nature, 6, 75–79. Koenig, B.A., 2001. Why not grant primacy to the family? American Journal of Bioethics, 1 (3), 33–34. Lapham, E.V., Kozma, C., and Weiss, J.O., 1996. Genetic discrimination: perspectives of consumers. Science, 274 (5287), 621–624. Lipton, P., 2003. Pharmacogenetics: the ethical issues. Pharmacogenomics Journal, 3, 14–16. Mackenzie, C. and Stoljar, N., eds., 2000. Relational autonomy: feminist perspectives on autonomy, agency, and the social self. Oxford and New York: Oxford University Press. Maschke, K.J., 2006. Alternative consent approaches for biobank research. The Lancet Oncology,7, 193–194. McKellin, W.H., 2001. Clinical Ethics and Family Morality. American Journal of Bioethics, 1 (3), 31–32. Mitchell, G.R. and Happe, K., 2001. Informed consent after the human genome project. Rhetoric and Public Affairs, 4 (3), 375–406. Mulhall, S. and Swift, A., 1996. Liberals and communitarians. 2nd ed. Oxford: Blackwell. Murdoch, I., 1970. The sovereignty of good. London: Routledge & Kegan Paul. Murdoch, I., 1992. Metaphysics as a guide to morals. London: Chatto & Windus. Noddings, N., 1984. Caring: a feminine approach to ethics. Berkeley, CA and London: University of California Press. Nordgren, A. and Juengst, E., 2009. Can genomics tell me who I am? Essentialist rhetoric in direct-to- consumer DNA testing. New Genetics and Society, 28 (2), 157–172. Okin, S.M., 2002. “Mistresses of their own destiny”: group rights, gender and reaslistic rights of exit. Ethics, 112, 205–230. Parker, M., 2001. Confidentiality in genetic testing. American Journal of Bioethics, 1 (3), 21–22. Parker, M. and Lucassen, A.M., 2004. Genetic information: a joint account? British Medical Journal, 329, 165–167. Randerson, J., 2006. Genetic medics build up high hopes. The Guardian, 7 September [online]. Available from: http://www.guardian.co.uk/technology/2006/sep/07/guardianweekly technologysection [Accessed 14 April 2008]. Shiva, V., 1997. Biopiracy: the plunder of nature and knowledge. Cambridge: South End Press. Shiva, V., 2001. Protect or plunder? Understanding intellectual property. London: Zed Books Ltd. Shiva, V., 2005. Earth democracy: justice sustainability and peace. London: Zed Books Ltd. Smart, A., Martin, P., and Parker, M., 2004. Tailored medicine: whom will it fit? The ethics of patient and disease stratification. Bioethics, 18 (4), 322–343. Tedlock, B., 2006. Indigenous heritage and biopiracy in the age of intellectual property rights. Explore, 2 (3), 256–259. Tong, R., 2001. Towards a feminist global bioethics. Healthcare Analysis, 9, 229–246. UK Biobank, 2007. Ethics and governance framework [online]. Available from: http://www. ukbiobank.ac.uk/docs/20071011_EGF_Version_3_1_0October_2007withTOR.pdf [Accessed 8 April 2008]. Webster, A., et al., 2004. Integrating pharmacogenetics into society: in search of a model. Nature,5, 663–669. Widdows, H., 2007. Conceptualising the self in the genetic era. Health Care Analysis, 15, 5–12. Winickoff, D.E., 2003. Governing population genomics. Jurimetrics, 43, 187–228. Winickoff, D.E. and Winickoff, R.N., 2003. The charitable trust as a model for genomic biobanks. New England Journal of Medicine, 349, 1180–1184. Wolf, S., 1996. Feminism and bioethics: beyond reproduction. New York: Oxford University Press.

Journal

New Genetics & SocietyTaylor & Francis

Published: Jun 1, 2009

Keywords: ethics; individualism; communal ethics; groups; trust model; personalized medicine

There are no references for this article.