This response welcomes Sheehan et al’s discussion of the criticisms that have been made of mandatory, pre-emptive ethics regulation and their outline of a philosophical rationale for it. However, it is argued that they misrepresent some of the key criticisms and fail to provide any effective response to them.
- ethics committees/consultation
- research ethics
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Sheehan et al outline some of the criticisms that have been made of the current regime of mandatory, pre-emptive ethics regulation of social research and then go on to consider various arguments in support of it.1 However, their presentation and appraisal of the criticisms is inadequate in significant respects.
The authors present the central question with which they are concerned as follows: ‘What is the justification for a system or process of ethics governance?’. And they note that this refers to how regulatory systems ‘can be justified (rather than how they come to be taken as justified)’. They then add that: ‘this form of the question cannot be lightly dismissed despite attempts to do so, for example, by branding research ethics governance an indefensible form of ‘moralism’ (p. 2). And as an example of such ‘light dismissal’, they cite an article that I coauthored.2 However, that is the extent of their discussion: they do not address the argument that ethics regulation involves a kind of moralism. ‘Moralism’ is a term, drawn from the work of Bernard Williams,3 which makes the point that ethical arguments can take exaggerated forms and may be given excessive weight by comparison with other considerations. Our argument was that the process of mandatory, pre-emptive ethics regulation by its very nature tends to give too much weight to certain ethical considerations, for example the principle of informed consent, and we presented the grounds for our argument.4 Moreover, this is directly relevant to the question of what the justification for such ethics regulation could be, since the substantive justifications usually offered for it rely on such moralism. Sheehan et al do not engage with this criticism.
The authors employ a similarly evasive manoeuvre in dealing with the question of ethical expertise. They (pp. 1–2) write that one criticism:1
questions the authority of RECs, as suggested by Hammersley’s comment that REC authority is “presumably based on an appeal to expertise”. RECs have authority to approve research because of their expertise in ethical decision-making. But the objection questions both the fact of REC expertise and any robust and defensible concept of such expertise. Hammersley’s presumption here looks to be flawed when examining how RECs actually function. As Dixon-Woods et al suggest:
The authority of RECs’ decisions derives not from their appeal to the moral superiority of any ethical position, but through their place in the organisational structure and the social positioning of the parties to the process thus implied.5
Given that the authors wish to focus on how ethics regulation can be justified—as opposed to what justifications are in fact offered for it and why people accept it—this is a strange line of argument. After all, Dixon-Woods et al are using ‘authority’ in the sociological not the normative sense. It is true that most researchers comply with the regulatory regime because of ‘the organisational structure and the social positioning of the parties to the process’. But this does not serve as a rationale for the regulatory role, as the authors effectively recognise by their own efforts to provide such a rationale in their article. In effect, they employ a non-sequitur to bypass the criticism they mention. The implication is that there is no problem regarding the ethical expertise on which RECs must rely, but they do not establish this. They do not address my arguments about the severe limits to the knowledge likely to be available to members of RECs, as regards the situations in which the research is to be carried out and the various kinds of method that may be employed. Instead, they treat the issue of ethical expertise as irrelevant to the ‘normative legitimacy of RECs’. But, if RECs do not have the expertise required for carrying out their function, what legitimacy could they possibly have?
Towards the end of their article Sheehan et al claim that the fact that there can be reasonable disagreement about whether a study should go ahead justifies mandatory, pre-emptive assessment, in other words the form of ethics regulation that now exists. They write that: ‘Those who reject the idea that research ethics governance should be pre-emptive simply fail to see that there can be reasonable disagreement about whether the research should proceed’ (p. 5). This is a very surprising argument. The suggestion that critics have failed to see that there can be reasonable disagreement about whether particular studies should proceed is at odds with the fact that they have used precisely this point to question the expertise of RECs.6 The authors go on as follows: ‘Given the question and the possibility of reasonable disagreement about what research should proceed, we require a method for making decisions that takes account of the ethically relevant considerations in order to reach a judgement.’ This is true, and there are several methods, including: allowing researchers to make the best decision they can, subject to later review in the face of complaints; decision by some body deemed to have the authority but, arguably, without the necessary expertise. The authors do not tell us why the first of these is less desirable than the second.
Sheehan et al mention a third argument put forward by critics, regarding the autonomy of researchers. They write that one ‘ethical claim against research ethics governance appeals to a right to conduct research, and takes several forms. Taking regulation as censorship and research as analogous to speech and expression, the right to research involves freedom of speech and expression’ (p. 2). This is one of the grounds on which Dingwall challenges ethics regulation.7–9 The sole point the authors make in response to his argument is to suggest that ‘it is hard to see this right as absolute’ (p. 3). But the point is not whether ‘the right to research’ is absolute, there are limits to all rights, but rather that such a right is essential to a properly functioning democracy. Furthermore, Dingwall accepts the need for regulation in the context of biomedicine—in that context he takes the right to research to be outweighed by the need for protection of patients. By labelling his position ‘the libertarian account’, the authors misrepresent it, despite the fact that they themselves go on to recognise a right to research as part of human flourishing.
It is also worth pointing out that the argument regarding researcher autonomy can be framed in terms of academic freedom. While this has sometimes been conflated with free speech, there are grounds for drawing a clear distinction.10 The primary argument for academic freedom is that considerable autonomy in deciding what is to be researched, and how, is essential if the academic production of knowledge is to be carried out effectively. There are, of course, limits to academic autonomy, but, once again, that does not in itself justify its systematic infringement by ethics regulation.11
Sheehan et al also mention arguments about the level of harm likely to be involved in social research. However, here too there is significant distortion: they claim that the critics assert that there is an ‘overall lack of harm in social research’ (p. 2), whereas, in fact, the argument has been that most social research carries a relatively low likelihood of serious harm, compared for example with many medical trials. This is precisely the point that Dingwall (2008) makes in the quotation from his argument that they provide (p. 2) and in the rest of his article. This sort of distortion does not facilitate sensible discussion about what level of potential harm would warrant what kinds of regulation, an issue that the authors mention at one point but do not address. (Elsewhere, I have provided a detailed discussion of harm, and what is involved in judging degrees of likelihood and seriousness, though I certainly would not claim to have solved all the problems involved in doing this4)
While Sheehan et al’s engagement with criticisms of mandatory, pre-emptive ethics regulation of social research is welcome, they misrepresent them and fail to provide any effective response.
The author is grateful for the comments on an earlier draft from Robert Dingwall, Ron Iphofen and Will van den Hoonaard. They do not bear any responsibility for the final version.
Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.
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