Evans’  sociological perspective on bioethics identifies four jurisdictional spaces that might be inhabited by bioethicists. These concern health care ethics consultations, research bioethics, public policy bioethics, and cultural bioethics. Evans’ account stresses the importance of understanding the ‘jurisdiction givers’ who provide access to these spaces. He suggests that the possibility of the professionalization of bioethics in the USA, and also the principlist form it took, were a consequence of the government officials becoming jurisdiction givers. Their expectations were for an abstract body of knowledge that could claim to provide a common morality in a pluralist society. As bioethics adopted this form it gained jurisdiction. Evans argues that the status of professional bioethics is waning in the USA because both government and the media (as gatekeepers to cultural bioethics) are turning directly to the spokespeople for partisan social movements rather than looking to bioethicists to mediate the opposing arguments.
This section of the paper considers four justificatory narratives that provide plausible explanations for governance activities, and therefore serve to legitimate it. These are the response to scandalous activity, the imperative to address public concerns about potentially irresponsible scientific advance, the need to resolve deep disagreements about bioethical matters in a pluralist society, and the desire to delineate public bioethics from other political issues. These narratives are not the only ones that might be considered, but they are sufficient to show that thinking about bioethics as a governance practice raises distinctive questions that merit further study.
Bioethics Governance as a Response to Scandal: The Case of Research Governance
One of the dominant narratives that serves to drive bioethics governance is that it is a necessary response scandals of professional immorality. This is perhaps most easily seen in relation to the governance of medical research. On this account, the abuse of human research subjects leads to regulatory interventions to control researchers and protect participants. While doubts have been raised about the historical accuracy of this explanation in respect of specific regulatory developments , there is little doubt that it is seen by many as the explanation for the need for governance.
Even if this account of the origins of research governance is more myth than history, it enables us to connect the rationale with an appropriate framework of critique. Given that scandal is generated by events that are considered to transgress norms (even if those norms were never explicit), a successful governance framework will address both the occurrence of such events and the management of expectations in order to sustain public trust and confidence. This need not be seen as an exercise in external control. The research community has an interest in good governance provided that it serves to maintain the social licence that it requires for its work .
So far as the tools of bioethics governance are concerned, three dimensions of the regulation of health research are worthy of mention. The first concerns the codification of principles. Here, the response to the abuses of Nazi medicine that were revealed in the War Trials is often regarded as pivotal. The ‘Nuremberg Principles’ stressed the primacy of individual rights over the advancement of science and the importance of informed consent [1, 23]. The World Medical Association took this approach forward in the Declaration of Helsinki, first adopted in 1964 and amended for the seventh time in 2013 . It is important not to claim too much for this component of bioethics governance. Germany was the first country to pass laws protecting research subjects, so Nazi medicine was not pursued in ignorance of the requirements [20:106, 23]. Nevertheless, standards are an important tool. They make it clear to researchers what is expected of them, hopefully providing a guide to their conduct but also enabling them to be called to account. They can also be protective, offering a means to explain to the public that they are acting ethically. Committees charged with scrutinizing research cannot be identified as ‘ethics’ committees without some set of principles to define ethical issues. In the absence of such standards, even if they are gatekeepers whose permission is required before research takes place, they not are not engaged with bioethics governance but with other types of question such as scientific review, prioritization of resources or reputation management.
Principles may be essential to the creation of an ethical governance system, but they are not sufficient. As the exposés of Beecher in the USA , and Pappworth in the UK [49, 50], showed significant numbers of medical research studies were (in various different ways) unethical long after the Nuremberg Principles had been promulgated. This was more a professional than public scandal, although Beecher’s criticisms were neglected until amplified by journalists. Both came from within the medical profession not outside it. So too did the most visible governance mechanism in medical research, the Institutional Review Board or Research Ethics Committee. This was promoted by the US Surgeon General in 1966 on prompting by the US National Institutes of Health (which had had some sort of ethical review since 1953) [26:333] and extended as a regulatory requirement by the Belmont Report in 1979 [57:ch5]. As Adam Hedgecoe has shown, the history of RECs in the UK is similarly bottom up . It began in hospitals seeking US funding. It was picked up pragmatically by the Royal College of Physicians in the form of a Committee on the Ethical Supervision on Clinical Investigations in Institutions, which reported in 1967. Committees were required administratively by the Department of Health in its Red Book of 1991 . They only became a legal requirement in 2004 following the implementation of the EU’s clinical trials directive . Prior review by gatekeeping committees is now an established part of the governance structure for medical experimentation to provide assurance that studies are designed in accordance with the ethical principles previously established.
In itself, this does nothing to ensure that studies are well conducted and following a research scandal in North Staffordshire , the UK National Health Service put in place a further dimension of the governance, known as the Research Governance Framework for Health and Social Care . This incorporated the features already described; a restatement of principles (the primacy of the rights of participants, informed consent, confidentiality and data protection) and the requirement of ethics review. However, it went further and specified the separate responsibilities for the conduct of the trial that lay with (a) principal investigators, (b) research sponsors, and (c) the organisations which employ the researchers. These clarifications have enabled accountability for breaches in the conduct of research, monitored by the Health Research Authority, although regulatory action in this area remains rare.
Thus, we have an archetype of a bioethics governance structure; codified ethical standards, licensing through ethical review and oversight/accountability through research governance. In origin, this emerged from within the professions and serves to protect its reputation. Its continuation is typically justified by reference to a series of historical scandals against whose recurrence the governance system is claimed to provide protection for participants.
Bioethics Governance as the Restraint of Irresponsible Science
A second explanatory narrative for the need for bioethics governance lies in fears about scientific advance. In this story, science is portrayed as being driven by a technological imperative, doing things because it can, without regard for whether it should. This was one of the planks of the argument put forward by Kennedy for the establishment of national a bioethics commission on the USA model in the 1980s . It is this aspect of bioethics governance that lay behind the creation of the Nuffield Council on Bioethics in 1991. Its terms of reference, as yet unchanged, require it:
To identify and define ethical questions raised by recent advances in biological and medical research in order to respond to, and to anticipate, public concern;
To make arrangements for examining and reporting on such questions with a view to promoting public understanding and discussion;
It is also charged with publishing reports on these matters and making representations to appropriate regulatory or other bodies. The working assumption is that scientific advances are a matter of public concern that needs to be allayed.
As with the evolution of research governance, it would be wrong to see the creation of commissions charged with considering the implications of scientific advance as external regulation driven by lay people or even as necessarily resisted by scientists. Warnock, another advocate of a national commission, suggested that it would be a counter-balance to
an almost medieval obscurantism… a hostility to science based on vague thoughts that there are some things that we should not know, but based more than anything on fear and ignorance…. After the last war there was there was a cliché to the effect that man’s scientific knowledge has outstripped his moral sense. At that time it was uttered in the context of the physical sciences. The bomb had, rightly, frightened us all. Now the same cliché is more and more to be heard in the context of the biological sciences. We must take it seriously. Only within an ethical framework widely seen to be secure and sensible can we continue, as we must, to push back the frontiers of science .
Although the source of public concern is different, bioethics governance is once again a mechanism for enabling public confidence to be maintained.
It is a moot point whether ‘science’ is a single thing about which concerns are raised, or whether the need for governance arises differently in relation to distinct issues. The Nuffield Council on Bioethics, as a non-government body, does not precisely reflect the expectations of the UNESCO Declaration. It is, however, the only British body with an overarching remit for keeping new bioethical issues under review. More characteristically, the tendency of the UK has been to address bioethical issues through specialist institutions rather than a generic one. Thus, issues in assisted human reproduction are on the agendas of many national bioethics commissions but in the UK they have been addressed by sector specific means. The Warnock Committee reported on the policy in 1984 , leading to the creation of the sector regulator the Human Fertilisation and Embryology Authority. Questions around organ donation were explored by the Redfern Committee into a scandal at Alder Hey, the Retained Organ Commission, a sector regulator (The Human Tissue Authority), a Parliamentary Select Committee and an Organ Donation Task Force. Non-Government investigations into organ donation have included reports from the King’s Fund, the Nuffield Council and from the BMA. The UK’s preparation for pandemics has included a Committee on the Ethics of Pandemic Influenza. Some of the issues around the biodata being gathered by Genomics England have been addressed by the ad hoc route of asking a trusted bioethicist to convene a group of people to help draft a letter of advice to the Chief Medical Officer. Parliamentary Select Committees have examined a number of other bioethical questions generated by scientific advances, including regenerative medicine, mitochondrial DNA donation, and the use of biodata.
It is also clear that there are important bioethical issues that are perceived to give rise to governance challenges that are not driven by scientific advance but by clashes of values. While interest in bioethics governance can be promoted by ‘morally disruptive’ technologies , it is not necessary to have new technologies for bioethical controversy to arise. This can be seen in relation to debates over abortion, where technological advances (such as the move to medical rather than surgical methods) provide the opportunity to revisit fundamental conflicts over the status of the human fetus rather than generate new ethical arguments. It can also be seen in deliberations over end of life care, where the arguments are well known but the solutions remain hotly contested. In the UK, the private member’s bill process has led to full Parliamentary debates on assisted dying in both Houses, but this has not resolved the matter.Footnote 6 We need therefore to consider further explanations of the role and function of bioethics governance processes.
Governance as a Response to Pluralism
A starting point would be the fact of deep disagreement; a problem of moral pluralism . This creates a challenge for bioethics governance mechanisms to achieve a sufficient degree of closure to enable health and research systems to function. This will clearly be a key feature of clinical ethics support, in which the patient’s position will often dictate a timescale for decisions to be taken. In the policy context, decisions may also need to be taken within specific time frames. There is no neutral position in the face of controversy about, or professional and public demand to be permitted to use, new (or indeed established) technologies. A decision to sustain the status quo needs justification just as much as one to reform the position. The decision cannot, therefore, be ducked. Amongst the functions of bioethics governance is to legitimate such decisions.
Sometimes, this might be a form of closure that claims to have resolved a substantive dispute and answered the concerns. In other circumstances, however, the position may be reached on a temporary or provisional basis, so that pressing policy decisions can be made but revisited at a later date. Here, it might be better to describe the governance process as one whereby jurisdictional distinctions are created that allocate the decisions to particular decision-making processes. Under such an approach, an issue is regarded as closed in certain fora, and the settling of controversy is deferred or diverted to a different forum. Thus, pluralism is acknowledged in a way that balances the desire for public debate with the need to facilitate research and clinical care.
An illustration can be found in the terms of the Abortion Act 1967, which sets out conditions when termination of pregnancy is permissible. For the purposes of individual clinical decisions this defines the ethical questions, balancing women’s rights with other values. The responsibility for assessing whether those conditions are met is allocated to two medical practitioners. Accountability is limited to the scrutiny of their good faith and does not extend to the substantive judgment itself. Controversy remains about the legitimacy of this settlement but it is deferred away from the clinic to Parliament, managerial oversight and political campaigning. In such fora, the issues are far from resolved.
A further aspect of jurisdictional deferral can be seen in the Human Fertilisation and Embryology Act’s tiers of authority to create norms . Some matters are determined by Parliament, some by the HFEA through its licensing conditions or Code of Practice, and some by clinics or individual clinicians. This distribution of authority is a key technique of bioethics governance. These decision-makers remain accountable through Parliament and in the courts. Without this, the jurisdictional settlement would become unstable but with sufficient accountability it can handle the challenges of balancing competing values in society and enable decisions on bioethical issues to be implemented. Separating out these tiers of norm-making powers enables the differentiation of who should be involved in which types of activities. It seems legitimate for the HFEA to exclude from the licensing committee those who are opposed on principle, in order to ensure that the legislation is applied and not undermined. However, a governance structure that completely prevented the possibility of dispute over such issues would soon lose its legitimacy.
If bioethics governance is to be an effective response to the challenge of moral pluralism an account is therefore required of the ways its processes for mediating between conflicting factions demonstrate sufficient respect for differences to justify acting on conclusions reached . This might involve some appeal to the representativeness of the membership of governance bodies. Thus, the constitution of some national ethics committees requires that membership includes a range of characteristics that reflect the diversity of the populations. The Belgian Advisory Committee on Bioethics has its origins in a co-operation agreement of 15 January 1993 signed by the federal Government, the French-speaking Community, the Dutch-speaking Community, the German-speaking Community and the Joint Commission for Community Matters. It has 35 voting members, representing various constituencies, each of which must evenly balance French and Dutch speaking members. Each of member has an alternate to ensure that their perspective is not lost if they are absent.Footnote 7
It seems clear that the fact of pluralism is one of the important contexts in which the institutions of bioethics governance function. However, it does not explain the creation of bodies specifically concerned with bioethics rather than more general approaches to public debate and democratic decision-making. The observation by Evans that in the USA, the gatekeepers have turned away from inviting professional bioethicists to dominate the jurisdictional spaces in favour of partisan social movements draws attention to the need to identify a justificatory narrative for bioethics governance that makes a substantive ethical contribution to the ways in which pluralism is acknowledged.
Governance as a Response to Relativism
A fourth sustaining narrative for bioethics governance concerns its claim to move beyond a relativist assumption that all ethical opinions are entitled to equal respect. It needs to be more than just counting votes if it can claim to be worthy of separate consideration beyond other democratic mechanisms. Issues might be resolved by plebiscite, counting votes, as in the decision of Oregon to permit physician assisted suicide . It has been argued that the governance of new health technologies in the European Union has been determined more by regulation of markets, based on managing risk and respecting human rights, than by ethics . Bioethics governance seems to be based on the idea that there is something sufficiently distinctive about the topics within its scope to render these mechanisms unsatisfactory. It aims for substantive ethical argument to drive decision-making. Market approaches make such arguments exceptional, reasons to restrict the normal economic freedoms. Plebiscites privilege the quantity of support rather than its basis. An opinion counts even if it is rationally indefensible or based on scientific error.
The response to challenge relativism takes one of two main forms. The first is substantive and takes the form of a search for common principles that can then be implemented through the governance institutions. In this model, the relationship between the committees and the ethical debates may be ambiguous and questions arise as to how far they should be concerned with substantive ethics and how far with ensuring compliance with standards of which they are stewards not creators [2, 36]. The response to relativism lies in the robustness of the principles rather than the enforcement processes.
We have already seen how the emergence of principlism in the USA to take this role can be linked to the Rawlsian idea of ‘public reason’. The essence of this approach is the use of concepts that can provide a common currency for debate, even though they will be supported by participants for different (and sometimes contradictory) reasons, and do not involve judging the morality of others: ‘it neither criticizes nor attacks any comprehensive doctrine, religious or nonreligious, except insofar as that doctrine is incompatible with the essentials of public reason and a democratic polity’ .
In the context of clinical ethics, there are manifestations of the public reason approach in the form of professional guidance, consensus statements and regulatory requirements for maintaining a licence to practise. The study of bioethics governance might take the form of reviewing such documentary manifestations as evidence of the content of bioethical public reason.
In relation to the wider functions of bioethics in support of public policy, international conventions can be seen as a similar response to the challenges of relativism through the establishment of a foundation of common principles. The UNESCO Declaration has already been noted. The Council of Europe’s Oviedo Convention provides another example. Developed within the human rights paradigm, it pronounces on issues that are firmly within the scope of academic bioethics and subsequent protocols have extended its reach further. Whether the process is seen as intellectually satisfactory or merely an exercise in politics will determine whether this turn to ‘public reason’ provides a satisfactory response to the problem of relativism  and requires consideration of the logic of public ethics [43, 68].
There is a second approach that seeks to address the challenge of moving from disagreement to some normative framework without simply accepting the validity of different views in our pluralist societies. Here the focus is not on the premises and conclusions of public reason, but upon the character of the processes that are thought in themselves to provide legitimacy for the positions reached. The Nuffield Council on Bioethics has adopted a position of this type. A stock take of its work, by Chan and Harris in 2006, suggested that it might have incrementally developed something a little like ‘Nuffield Council Ethical Framework for Bioethics’ . They identified a number of principles that seemed to be drawn upon, although not always consistently; avoidance of harm, the duty of beneficence, respect for persons and autonomy, justice and just resource allocation, informed consent, confidentiality and privacy, respect for dignity, and naturalness.
Since then, the Council has committed itself to a different legitimation narrative based on the procedural aspects of public reasoning rather than its conceptual content. In response to the fact of pluralism, it has committed to a principle of ‘inclusiveness: no single view or approach to bioethics should be favoured, and the expression of all views should be encouraged and welcomed .’ On this basis legitimacy can be drawn partly from the fact that no one has been excluded from the debate. In response to the problem of relativism, it has asserted the importance of applying to all arguments ‘tests of coherence and rationality’ in a rigorous way, ‘based on the best evidence available, and supported by careful and comprehensive analysis’ . Here the approach seeks to distinguish the resolution of disagreement through compromise and negotiation from bioethics by characterizing it as an evidence-based argumentative activity in which participants must justify and not merely assert their positions.