Balancing ethical considerations

6.17 The Inquiry is therefore centrally engaged in ethical issues. The challenge is to articulate, in an inclusive way, the reasons and arguments that could be used to resolve dilemmas and to provide justifications for answers to the questions raised by the Inquiry. The challenge is also to identify values or principles that reflect our way of life. What makes this task problematic is the recognition that our way of life will evolve over time, and may be changed by the use of genetic information itself. Faced with this situation, IP 26 and DP 66 referred to some established sources of values and principles.

6.18 These values and principles are revisited in this chapter and are referred to, where relevant, throughout this Report. The Inquiry’s responsibility is to make recommendations that reflect an appropriate balance of ethical considerations. To justify regulatory reform, a balance needs to reached among the ethical considerations described in this chapter.

6.19 The Inquiry recognises that reaching a balance will often be difficult. Indeed, the concept of a balance suggests that considerations can be weighed against one another, or together, and that one consideration will always have the same weight relative to others. Even if this is so, contexts for decisions will attract different clusters of ethical considerations, so that different relative balancing will be required. Some participants may always give a greater weight to one consideration, for instance, respect for autonomy, than do other participants. Accordingly, when speaking of a balance of ethical considerations, the Inquiry recognises that it is a balance that needs to be considered for each regulatory issue.

6.20 In discussing the ethical contribution to the development of biotechnology policy in Canada, Susan Sherwin noted that a strategy such as that outlined in this chapter will not always offer a definitive solution:

Thus, when approaching complex policy matters, we should actively seek out moral perspectives that help to identify and explore as many moral dimensions of the problem as possible. This requires us to pursue deliberative strategies that will promote sensitivity to the multiple moral considerations that are relevant to the issues before us. Nevertheless, the identification of morally relevant factors does not always produce a unique moral solution. Hence, even if we were able to identify all the morally relevant aspects of a situation, we might still not know how to resolve the specific moral dilemma before us. Although these substantive moral tools (theories) will exclude certain options, they sometimes fail to select a single best solution. In such cases, we must rely on effective strategies that can produce an ethically acceptable decision. Only an ethically adequate procedure can resolve these various types of ambiguity.^[7]

Aristotle: prudence and uncertainty

6.21 Among the many philosophical and theological concepts and theories that have contributed to the contemporary understanding of ethics, the Ancient Greek concept of prudence stands out as a principle of particular relevance to the area of genetics. According to Aristotle, the prudent person is one who engages in well-conducted deliberation which is timely, measured and takes into account the particular problems and circumstances of the case in order to foresee ‘even the unforeseeable’. The fact that genetic information gives rise to unforeseen, and even unforeseeable, situations involving both benefit and risk, makes the concept of prudence and the standards of deliberation it entails particularly applicable in this area.

6.22 The ‘principle of caution’ has emerged as a modern version of this concept. Hans Jonas, devising an ‘ethic of responsibility’, argues that the capacity of modern technology to transform our lives has altered the primary task of ethics. ^[8] Traditional (Platonic) ethics is based on an understanding of the human condition as given once and for all, so that the good to be attained is readily determinable and eternally valid. Modern technological developments challenge this vision, shifting the focus of ethical inquiry from the perspective of eternity to that of temporality ‘in its ever-new, always unprecedented productions, which no knowledge of essence can predict’.^[9]

6.23 Given this, the epistemological confidence that underpins traditional systems of morality gives way to a potent sense of uncertainty about the future, as the rate of technological change increases. Jonas makes this uncertainty a central tool in his approach to ethics and argues that the question of responsibility for the changeable and perishable, rather than concern for fidelity to eternally fixed norms, ought to be the dominant concern of modern ethics.

6.24 Iain Robertson, in a submission to the Inquiry,^[10] echoed these concerns in advancing ‘uncertainty’ and ‘ambiguity’ as relevant ethical principles. He identified qualitative and quantitative uncertainty—the former illustrated by the uncertainty as to whether accounts of personal illness were true and the latter by the uncertainty as to the causal effects of illness. He also identified general and specific uncertainty–the former illustrated by the uncertainty of knowledge of health across a population and the latter by the uncertainty as to whether an individual’s ill health corresponds to what is known at a population level. He argued that the recognition of these uncertainties was important because certainty of behaviour, for instance by a health professional, can inspire confidence but may not be a reliable guide to the efficacy of treatment.

Principlist ethics

6.25 The school of principlist ethics has dominated the field of health research ethics since it first gained momentum in the late 1960s and was given formal articulation in the Belmont Report.^[11] It is characterised by an assumption that scientific progress is essential for the good of humanity, coupled with a concern to protect individual and group rights that may be endangered in the course of scientific research. It seeks to establish principles that must be respected in carrying out this work, building upon traditional principles of medical practice and ethics. These include the principles set out in the ‘Georgetown mantra’, which are respect for autonomy, beneficence, non-maleficence, and justice.^[12] These and related principles are already enforced in legal and regulatory frameworks dealing with human rights and research protocols. Their application to the field of genetics is seen as an extension of existing concepts to cover a field of research and medical practice in which, although the science is new, the ethical issues to which it gives rise are not. For instance, disclosing a genetic diagnosis requires attention to ethical considerations of beneficence and non-maleficence in the same way as disclosure of a non-genetic diagnosis. What is different is that the diagnosis will often have important meaning for the patient’s relatives, which the consideration of harm and benefit must include.

6.26 For example, informing family members of the diagnosis of illness in their father without his consent would, in traditional principlist ethics, be unethical because it would offend the principle of respect for (the father’s) autonomy. Principlist ethics might argue that the same principle should apply to the disclosure of a genetic diagnosis. However, what may be different is that a genetic diagnosis may mean that siblings and children are at risk of a familial cancer, perhaps one that is treatable if identified early and monitored. Reliance on the principle of respect for autonomy alone would ignore the ethical interest of siblings and children in having information to make decisions about their own health.

6.27 The use of genetic information in insurance and employment reflects an application of principlist ethics. In insurance, respecting individuals’ decisions not to undertake genetic testing (their autonomy) so as to obtain insurance on the most beneficial terms can compete with the injustice to other insureds who may over time have to bear a higher premium as a result. The perceived risk of being denied insurance may act as a disincentive to testing, possibly precluding early diagnosis of treatable conditions. This could be said to offend the principle of beneficence. Respecting the autonomy of employees, by allowing them to work where they want, can offend the principle of non-maleficence by exposing them, and sometimes other workers, to avoidable risks of harm. Requiring genetic tests in insurance or employment may pit individual autonomy against protection of, and justice to, others.

6.28 Principlist ethical guidance was endorsed in several early submissions to the Inquiry. The Australian Medical Association (AMA) emphasised the importance of the principles of the ‘Georgetown mantra’ in ensuring that patients’ interests are protected.^[13] The Australian Academy of Science also favoured reliance on established principles of health care and research ethics, arguing that genetic information should not be regarded as inherently different from any other form of biological or medical information. The Academy expressed concern that excessive restrictions on the use of clinical data and samples, because of their genetic information, might hinder the conduct of clinical pathology and epidemiology, to the detriment of the future of health care in our community and the international standing of Australian research in these areas.^[14] As these submissions recognise, the fact that principlist ethics already informs the regulation of health care and research means that it needs to be included among ethical considerations arising from the use of genetic information.

6.29 However, other submissions questioned the suitability or adequacy of this source of ethics. ACROD Limited doubted that these principles were sufficiently robust and claimed that they need to be supplemented by a more specifically focused code of ethics to address risks of genetic discrimination.^[15] Cormac Nagle of the Mercy Hospital for Women preferred a broader approach than one confined to these principles, recognising that, in the specific arena of research ethics, varied membership of review committees would have this effect.^[16] Iain Robertson argued

1) that health ethics are highly complex; 2) that the simple ‘algebraic’ approach suggested by the ‘Georgetown Mantra’ is inappropriate, because rational balancing of the different principles cannot possibly cope with the interactions and relative valuing of the principles that would be required; and 3) that an empirical approach to the values placed on each principle by the different real people and groups in our community is required.^[17]

Consequentialist ethics

6.30 Principlist ethics measures the goodness or badness of conduct by whether or not it accords with a principle. This kind of justification can be, and often is, contrasted with those that determine the goodness or badness of conduct by reference to its consequences. Commonly called consequentialist or utilitarian ethics, this approach to justification, and that of principlist ethics, are two commonly used moral arguments. They are frequently used to support opposing views on conduct. The example of using coded genetic information in research without individual consent can serve as a simple illustration. Principlist ethics might argue that such an act is unethical because it does not respect participants’ autonomy. Consequentialist ethics might argue that the conduct is ethically sound because it will maximise the benefit for society.

6.31 Consequentialist ethics is frequently used to justify political and social judgments because of the impact on communities and society. Principlist ethics has long been associated with decisions affecting individuals, as in professional relationships, because of the close and historical alignment of ethical principles and professional duties to clients or patients.

Professional ethics

6.32 The social identification of health professionals, and the grant to them by society of the right to treat individuals, is accompanied by their acceptance of professional responsibilities. The health professions have developed enduring ideas of good professional conduct that are usefully referred to as professional ethics.

6.33 The need for professional ethics to focus on the relationship between individual professionals and their patients or clients lies in the typical imbalance of knowledge, and therefore power, between the two. Professional ethical obligations recognise the risk that professionals may misuse their power. Typical of these obligations are those to maintain the confidentiality of information about patients, to give priority to patients’ interests over their own, and to avoid conflicts between personal interests and professional duties.

6.34 The development of health care ethics and bioethics in the past three decades has drawn heavily on professional ethics. The development of codes of professional practice has been through the formulation of simply stated principles. As a result, most health professionals are familiar with principlist ethics, and accept them. This history has another important feature—self-regulation. One submission argued that, in relation to genetic information, ethical obligations were too important to be left to professionals to formulate.^[18] On the other hand, the AMA argued that the knowledge and responsibility of health professionals gave them an essential role where citizens were asked to contribute genetic information.^[19]

Critical ethics

6.35 Critical ethics questions the assumption that scientific progress is necessarily for the good of humanity. It criticises principlist bioethics for remaining silent on fundamental issues raised by the progress of health science (including genetics), arguing that bioethics frequently does little more than legitimise the activities of laboratories and governments. Critical ethics exposes the strong identification between principlist ethics and professional ethics. In place of the traditionally concern with patients’ welfare, it seeks recognition of a wider set of responsibilities than those that professionals traditionally accept, and a wider set of interests than those of clients and patients.

6.36 In relation to human genetic information, critical ethics highlights two key areas of concern. The first relates to the fact that genetic research depends on the medical-industrial complex and involves significant commercial interests. Critical ethics points to the risk that such interests may compromise compliance with ethical principles and values that are significant for the retention of an Australian ethos and society. For example, existing socio-economic inequalities may be exacerbated, to the detriment of society, if access to new health interventions based on uses of genetic information are determined solely by market forces. These concerns were voiced in numerous submissions to the Inquiry.^[20]

6.37 The second concern of critical ethics relates to the potential for abuses flowing from the creation of a human standard based on genetic discoveries. Here, critical ethics recognises fears about eugenics and other forms of genetics-based discrimination. In submissions to the Inquiry, the concern that genetic testing may lead to eugenic practices of selection, particularly in relation to sex and sexual orientation, was articulated.^[21]Critical ethics questions the motivations and assumptions that can be concealed and used to contain and limit more traditional ethical voices. Critical ethics is important when considering the design of regulatory frameworks so as to ensure transparency and openness in regulatory processes.

Ethics of discussion

6.38 Procedural ethics or the ethics of discussion attempts to integrate principlist and critical concerns. It recognises the pluralism of moral positions and emphasises the consequent need to ensure that moral discussion and debate is effective. It takes the view that the role of ethicists is not to establish standards to control biomedical developments but to promote discussion of the meaning and implications of these developments for communal life, and to identify (rather than prescribe) the moral questions that emerge from this debate.

6.39 An ethics of discussion is advocated as most appropriate to the field of bioethics to avoid the reduction of ethics to mere application of rules, the replication of hierarchical structures, and the focusing on technical issues, which may exclude lay participants. A shift away from a focus on ethical ‘rules’ toward an emphasis on discussion and critical reflection is said to be required, not only in the field of bioethics, but more generally in the contemporary approach to ethics:

Increasingly, the ethics of research and the ethics by which we live our lives will depend on negotiation. Stripped of the certainties of the past, we have to take responsibility for reconstructing the world and finding perspectives we can live with. This is a communal and political activity, in the broadest sense.^[22]

6.40 Some submissions to the Inquiry expressed support for a broader and more facilitative approach to ethics.^[23] Nick Saunders and Paul Komesaroff identified the essential function of an ethics of discussion:

Ethical decision making involves communication and negotiation between individuals and groups in the community around issues of values. As is widely recognised, it is possible for individuals of integrity to hold widely different, even contradictory, views in relation to ethical questions. In a given situation, there is often no unique single, valid ethical decision or action. What makes a decision ethical is therefore not its substantive content but the process that generated it – namely the quality of the dialogues and reflection in which the protagonists engaged.^[24]

6.41 However, the important role for ethics in assisting society to reach decisions, and not merely ensure the quality of discussion, was also emphasised:

Discussion is most important, but if it does not come to a conclusion or a decision it remains an academic approach and unhelpful to both the individual case and society. Discussion ethics should inform members of ethics committees and lead them to make better decisions.^[25]

6.42 The Inquiry identified several areas where there are strong differences of opinion, not the least of which is those relating to parentage testing. In such contexts, attending to the ethics of discussion can assist in eliciting the underlying assumptions that contesting parties bring to the debate and identify agreements and differences more clearly.

6.43 An ethics of discussion sets standards for such a process. Those standards may not lead to a reconciliation of differing values or value based positions but, it is argued, will clarify in respectful, reasoned and effective ways, the differences that parties to the debate choose to maintain.

6.44 New discoveries are likely to emerge which will present new challenges to the regulatory regimes recommended in this Report. For this reason, among others, the Report recommends the establishment of the Human Genetics Commission of Australia (HGCA) (see Chapter 5). As these new issues emerge, recognition of and attention to an ethics of discussion will be important in identifying differing responses from existing ethical positions and articulating elements of an emerging community ethos that responds to new discoveries.

Civic ethics

6.45 While principlist and professional ethics focus on the ethics of decisions made by or about individuals, critical ethics and the ethics of discussion recognise the importance of considering community or civic perspectives in ethical matters. The use of genetic information has the potential to affect the interests of whole communities and so it is important to identify the fact that there will be community levels of ethical considerations. Accordingly, there is value in separately identifying a civic ethics.

6.46 In their submission, Saunders and Komesaroff pointed to the importance of diverse and extensive community input, channelled into responsive and democratic decision making processes.^[26] They also emphasised the need for informed public debate and consultation on genetic issues. Community interests were also highlighted by UnitingCare NSW & ACT, which emphasised the need to consult groups who are directly affected by genetic-related illness or disability to ensure that ethical principles are applied in a way that meets the needs of vulnerable individuals and families.^[27]

6.47 The challenge to civic ethics is not only to consider the needs and perspectives of these people, but to provide them with appropriate services, such as counselling, to enable them to exercise in an informed way the responsibility they have to use genetic information.^[28] A similar mutuality between community and individuals was recognised by Iain Robertson who argued that:

The ethical principle of mutuality recognises that the principle of individual autonomy is optimised when the strength of civil society is maximised, and that care should be taken when promoting the principle of autonomy to avoid limiting that autonomy by ill-considered constraints on public health action. At the same time, public health action is best advanced when individual autonomy is respected.^[29]

6.48 The difficult issues of consent for genetic research using human tissue illustrates an emerging tension between an ethical view that gives primacy to individual choice and an ethical view that gives equal or higher, priority to community value. One submission to the Inquiry identified the high value to the community, often difficult to specify in advance, of using tissue from existing collections for population- level genetic research.^[30] There was concern that the opportunity to realise the value of this research could be denied by a traditional ethical insistence on fully detailed individual consent by every tissue donor to every use.

Narrative ethics

6.49 The need to apply ethical principles in ways that meet the needs of vulnerable families and individuals may be described by reference to yet another style in bioethics. Narrative ethics—the dependence on first hand accounts of those facing health care decisions as a source of reasons and justifications for those decisions—has a well established place in contemporary bioethics,^[31] and was recognised in submissions to the Inquiry.^[32]

6.50 The dilemma surrounding the disclosure of a diagnosis to genetic relatives is one of the contexts in which narrative ethics is likely to shed more light than principlist or professional ethics. Accounts of how families have dealt with these situations—with resulting benefit or harm—will be a valuable source of ethical guidance for families that face similar challenges.