Whose ethics, whose accountability? A debate about university research ethics committees

Abstract

Research ethics approval procedures and research ethics committees (RECs) are now well-established in most Western Universities. RECs base their judgements on an ethics code that has been developed by the health and biomedical sciences research community and that is widely considered to be universally valid regardless of discipline. On the other hand, a sizeable body of literature has emerged criticising the work of RECs, as, among other things, overly bureaucratic and unresponsive to the needs of disciplines outside the biomedical sciences. This article adopts the format of a debate between a Chair of a university REC and a social science researcher as a vehicle for contrasting different perspectives on research ethics. The fictional debate allows for a productive discussion between the two sides, incorporating key insights from the recent literature and concludes with a synthesis that sketches out some ideas about how university RECs can be made more responsive and accountable.

Keywords:

• research ethics
• committees
• debate
• accountability

Notes

Notes

1. The media entertainment industry is an interesting exception: one could argue that TV programmes (e.g. Big Brother) showing public humiliation of candidates have pushed back the boundaries of the morally acceptable at the same rate as research ethics has limited the scope of academic and scientific research opportunities.

2. This article has been written from a UK perspective and closely reflects developments in the UK, but a considerable effort has been made to establish whether the arguments made and position taken for the article are also applicable to university RECs in other countries. For the UK, the Nuffield Foundation has commissioned a comprehensive evaluation of the organising structures as well as the role, remit and conduct of university RECs that has been published in 2004 (Tinker and Coomber 2004). There is some degree of variation in how university RECs operate both across and even within different countries, for example in how the membership is recruited, the extent to which both staff and student research is captured and the division of authority and responsibility between university RECs and other government and professional bodies involved in research ethics enforcement. However, the core ethical principles governing research ethics in most countries show very little variation as they are historically derived in response to the atrocities committed in the name of medical research by Nazi medical doctors (Macfarlane 2009). The Bellmont Report published in 1979 by the US Commission for the Protection of Human Subjects in Biomedical and Behavioural Research in response to these crimes but also to the US ‘Tuskegee’ medical research scandal has been a catalyst for research ethics legislation in many countries including the US, UK and many other European countries (see, for example, Macfarlane 2009). As a consequence, research ethics codes are fairly similar across different nations and are very similar across disciplines, but there are variations in terms of the autonomy that universities have in self-regulating the conduct of their researchers and how they organise their internal research ethics approval processes. These reflect different national traditions and regulatory choices as well as choices made by the universities themselves. For example, decisions about membership structure and representation of staff researchers, ways of communicating with researchers, transparency and permission of appeals are largely determined by the universities themselves, but whether the university or the health service has the ultimate authority to approve applications for research on working conditions of health service employees will depend on the national regulatory framework for research. This article has been influenced by my own professional experience as a social scientist working at a large business school at a UK university where I am the course director of a substantial doctoral research degree programme. In this role, as well as because of my own research, I have frequent interactions with university and other ethics committees.

3. Of course, there are middle positions between these two approaches to research ethics that can be taken with very good reason and some may argue that they represent a false dualism, but recent developments towards an ‘ethics creep’ (Haggerty 2004) make it worthwhile to explore this issue from these two diametrically opposed points of view.

4. According to Power (1997, 43), new public management ‘emphasizes cost control, financial transparency, the atomisation of organisational sub-units, the decentralisation of management autonomy, the creation of market and quasi-market mechanisms separating purchasing and providing functions of their linkages via contracts and enhancement of accountability to the customers for the quality of service via the creation of performance indicators’. The rise of new public management and managerialism in higher education is well-documented in the literature. See for instance, Henkel (2000) and Chandler, Barry, and Clark (2002).

5. A key requirement of Habermas’ concept of communicative rationality is not only that rationality is understood as a communicative process of argument – based on conversations or dialogue with action-oriented to develop shared understanding and consensus, but also that such dialogue should occur openly and should be free from domination and coercion ‘overt or covert that is often rooted in the trappings of power and authority that prevail in most organisation’ (Halloway 2004).

6. See the large number of publications that have voiced researchers’ exasperation with what they perceive as over-bureaucratic and encroaching and unaccountable RECs. Criticisms have range from imposing excessive bureaucratic requirements to incompetence (Dubois and James 2004), unreasonable requests for changes to research designs, concealing conflicts of interests and favouring selected colleagues (Keith-Spiegel, Koocher, and Tabachnik 2006; Edwards, Kirchin, and Huxtable 2004). See also, Haggerty (2004) on ‘the ethics creep’.

7. For the UK, the Nuffield Foundation has commissioned a stock-taking of ‘the role, remit and conduct’ of university RECs (Tinker and Coomber 2004). The main concern of this stock-taking exercise was to establish whether universities had established committees and formal policies, which types and whose research were scrutinised, whether the ethics committees provided training and whether lay members were represented. From this review, however, it is quite clear that Speaker A's ethical review arrangements represent an ideal rather than the normal UK university research ethics practice.

8. Merton (1973) advocates four norms that for him underpin the conduct of science for the ‘pursuit of truth’. These norms are universalism (knowledge claims to be evaluated on their impersonal merit), communalism (scientific knowledge as public good), disinterestedness (no financial or personal interests should influence the quest for truth) and organised scepticism (independent objective verification of all knowledge by the community of scientists). See, Montgomery and Oliver (2009) on the changes of the norms on research integrity since the second half of the twentieth century.

9. A useful pragmatic definition of trust is that ‘an agent exhibits trust when he/she exposes herself/himself to the risk of opportunistic behaviour by others and when he/she has no reason to believe that the trusted other will exploit this opportunity’ (Humphrey and Schmitz 1996, 4). A key point is that trust makes the trustor vulnerable to the behaviour of the trustee, but the trustor ignores this possibility and this chosen ignorance makes social interaction possible. The relationship between trust, social control and managerial control has been explored by a number of authors, for example by Hoecht (2004), who characterises trust as a form of social control that, unlike direct managerial control, is able to create self-motivated commitment and is therefore effective even where information asymmetries exist and direct supervision or bureaucratic forms of auditing and control will not work particularly well and have considerable opportunity costs. The trust literature does, however, generally accept that trust should be complemented by some form and degree of control in order to reduce the risk of ‘betrayal’.

10. See, for example, Montgomery and Oliver (2009), who distinguish three phases of normative and regulative control of science and research since the second half of the twentieth century.

11. The Korean scientist Hwang Woo-Suk of the Seoul National University, who was considered to be one of the leading experts in his field, was found by a Korean court to be guilty of violating bioethics laws, misusing state funds for personal gain and to have falsely claimed to have achieved a major breakthrough in stem cell research by fabricating his research data. See www.telegraph.co.uk/worldnews/asia/southkorea (accessed 19 November 2009).

12. For a critical discussion of quality management in HE, see, for example, Hoecht (2006).

13. See, for example, Macfarlane (2009) on the need for researchers to make constant judgements during the research process that should be inspired by virtue ethics.

14. See, for example, Yu (2008), questioning the assumption that research participants are always automatically vulnerable.

15. There are some differences in views of what exactly is meant by accountability in the accounting and management and the political science literature. According to Middlehurst and Woodhouse (1995, 260), a core feature of accountability is ‘that of “rendering to account” of what one is doing in relation to goals that have been set or legitimate expectations that others may have of one's products, services or processes, in terms that can be understood by those who have a need or right to understand the “account”’. Ball, Vincent, and Radnor (1997) distinguish between market accountability and political accountability. According to Ball, Vincent, and Radnor (1997, 148), ‘proponents of market accountability may choose to emphasize either accountability through service provision or accountability through effective financial management. The defining feature of the former, accountability through service provision, is the organisation's responsiveness to customer demands, and ability to adapt its services accordingly. The latter, accountability through effective management, stresses not so much the services themselves but the process by which they are provided’ (italics in original text). The key feature of political accountability is that those who act on behalf of the electorate, either as elected representatives or as paid civil servants, use particular processes through which they ‘hold themselves accountable for their stewardship’ (Simey 1985, 17) quoted in Ball, Vincent, and Radnor (1997, 148).

16. Consent had been sought from relatives retrospectively, but the response of the professional body, the UK's Nursing and Midwifery Council, after the screening of the story on the BBC's Panorama programme was to start proceedings against the nurse for ethical misconduct and to strike her off the professional register. This can be understood as the use of their ethics code to punish and silence a whistleblower. Fortunately, the decision was overturned with the help of the High Court (BBC News, http://news.bbc.co.uk/go/pr/fr/-/1/hi/england/8303304.stm (accessed 12 October 2009)).

17. Ethics has a very powerful legitimacy claim: it is about doing the right thing, doing what is good, proper and moral, following a moral course of action. Anyone arguing against its principles and objectives can easily be accused of being a (moral) egoist and of pursuing their narrow self-interest. While the right ethical judgements can be difficult to make, ethics as a discipline largely stands above criticism. As a consequence, individuals and committees that have been put in the position to make decision on ethical issues carry a significant amount of prestige as well as expert and moral power. A key factor for the high status of ethics committee members is that they are likely to be perceived as having been admitted to their position because they are experts in deciding what is right and proper, not, or at least not primarily, because of their ability to secure membership via other status claims. A non-representative snapshot survey accessing publicly available information of UK universities conducted by the author in summer 2009 indicates that ex-officio members and academics with a science discipline background are strongly represented at UK university RECs.

18. Utilitarianism advocates individuals pursuing the course of action that has the ‘best consequences’ for the majority whereby best consequences can be defined in different ways. The interests or even fundamental rights of individuals can be sacrificed for maximum utility overall. Deontological theories of ethics advocate that ethical decisions should be made by moral rules that should not be broken, regardless of whether this would yield the maximum utility for the overall majority affected. For Immanuel Kant, morality is founded on the rejection of all non-universalizable principles. This is the basis of his concept of the ‘categorical imperative’ that can be famously expressed as the maxim ‘act only on the maxim through which you can at the same time will that it be a universal law’ (Singer 1993, 177).

19. See O’Reilly et al. (2009), who argue, on the basis of a discourse analysis of 260 REC decision letters to researchers, that the communication of RECs with researchers employs a discourse that establishes the RECs’ authority claim over the applicants and implies that their decisions can be attributed to the (under) performance of the applicants. ‘These tactics ‘do’ accountability by showing that routines of ethical assessment have been enacted, by establishing the factuality of claims and by managing questions of fault and blame. They may, however, also risk undermining legitimacy by failing to acknowledge the inherent contestability of ethical decision-making or the limited nature of the cultural authority accorded to RECs, and thus may appear as an illegitimate exercise of power’ (O’Reilly et al. 2009, 246).