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• Three wise men: a reply to a response to ‘Is triage incoherent?’
  Colin Parker
  Published on: 18 May 2017
• In response to “Developing commensurate review”
  David Hunter
  Published on: 18 May 2017
• In response to “Is Triage Incoherent?”
  David Hunter
  Published on: 18 May 2017
• Developing commensurate review
  Hugh T Davies
  Published on: 18 May 2017
• Is Triage Incoherent?
  colin parker
  Published on: 18 May 2017

• Published on: 18 May 2017

  Three wise men: a reply to a response to ‘Is triage incoherent?’

  • Colin Parker

  I thank David Hunter for his response to my ‘somewhat vitriolic attack on its central premises and conclusions’; and may I say that in the context of an informality of logic my overriding vitriolic or critical concern was with his arguments, and my conclusion is still that they are ineffective in serving his purpose.

  There are some minor points of misunderstanding on Hunter’s part which may be helpful to conside...

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  I thank David Hunter for his response to my ‘somewhat vitriolic attack on its central premises and conclusions’; and may I say that in the context of an informality of logic my overriding vitriolic or critical concern was with his arguments, and my conclusion is still that they are ineffective in serving his purpose.

  There are some minor points of misunderstanding on Hunter’s part which may be helpful to consider before assessing the value of his arguments based on an idea of mathematical proof. He thinks I am not correct to attribute to him the view that ‘the NRES system is the worst of this type of delegated authority’. The context for our discussion was a comparison between the REC and the NRES triage: to imagine an even worst system does not necessarily involve one with this type of delegated authority, eg to imagine an anti-research group evaluating research. For Hunter to offer an example of a form of pre-review which is not even of this type of delegated authority fails to address my comment. Regarding my analogy to the triage nurse he has not dealt well with it for the REC too acts in a ‘situation of need’, and of course, being human may make a mistake; but he is clearly mistaken in thinking this would be avoided had an entire care team done the job. We have too many counter examples of this; and the triage nurse often makes a correct ‘final decision’ in bandaging a patient’s finger.

  Hunter mistakenly thinks my comments about his second argument ‘rather uncharitable’ because he believes they suggest his evidence was merely personal to him, but my comments in this paragraph clearly referred to committees and their members. The more important point here, however, is that he does not attempt to deal with my counterargument to an idea of ‘blindness on some issues’: he has not shown that NRES Advisers will miss ethical issues. Regarding his current view that ‘50% of REC members have had this experience’ of ethical icebergs, or missing ethical issues, he says ‘many eyes make light work’. This is poor evidence, for 50% of REC members refers to members from many RECs; in the REC considering an application it may be 100% missing the ethical issue, eg Northwich Park.

  He attempts to clarify his third argument, saying RECs ‘are supposed to represent the general populace if some views aren’t represented then they are failing in their jobs’. This is either an argument that each REC ought to contain a Dr Shipman, or there is some unclarity in his interpretation of ‘represents’. Second, ignoring the opacity of colour, his view that people’s ethical views colour what issues they see as ethically important...’ is either necessarily true, or necessarily false: ie the view is the issue, or the view does not have a positive or negative attitude to the issue, eg one supports the innocent but can’t tell if A is innocent.

  His denial that ‘the ethicist is the paradigm person ...’ who will apply ethical theories to issues is weak, for he understands the debates in REC meetings as a clash of different ethical theories, ie the ethicist’s repertoire represents the views which others strive to attain. It seems that Hunter’s perspective is that in the way that clinicians’ knowledge represents the technical requirements of the REC, the ethicists’ knowledge would represent the ethical dimension. He believes the ideal REC has a mixed membership with different expertise: exactly, and given this view some may wonder whether the status of the lay ethicist should be raised to that of expert in the REC. But of rather more importance and in a setting with some semantic darkness, he seeks to deny the priority of moral concern relative to theories of ethics with ‘What I am claiming is that different people have different ethical views, some of which can be expressed in terms of different ethical theories’. As a response to clarify his position this statement cannot be distinguished from a tautology. Incidentally, he does say that ‘we do not currently know which ethical theory, if any, is the correct position to take...’. The question is, the correct position to take on what. Ethical theories may be part of an academic exercise but moral conduct is not. He concludes: ‘If there are many different ethical views, then a few people are unlikely to serve as appropriate representatives ...’. He cannot see the priority of the moral life which each of us is faced with: it is this which gives us our perspective, ie the qualification of the NRES Advisers on this particular point is that they are human.

  Hunter’s last argument which is finally to offer evidence for his view of the superior efficacy of the REC as opposed to the NRES triage, is an appeal to political theory; it compares a nation’s citizenry with a small group, ie the REC, to show that the smaller group, the NRES Advisers, are less reliable. Given the variability in intellect and attitude and a host of other variables it is not justifiable to bestow any relevant characteristics of the mass onto a smaller group to conclude that they are more reliable than an even smaller group. This is clearly an article of faith with Hunter: ‘it will in general be more reliable...’. But this is the very point at issue: he offers no evidence for it. No evidence except a ‘mathematical proof’ which to be expected is not a mathematical proof.

  His so-called mathematical proof is ‘based on the idea that the more times the event is iterated the more likely it is that the average outcome will occur’. Now, this is alright for tossing a coin, but it says nothing about any supposed superiority in a democratic system. Hunter continues: ‘If the average outcome is more likely to be right (ie greater than 50%) than wrong then the more iterations the more likely the right answer will be reached by the process’. This is a tautology, but can we make anything out of it?’ First, the system is unlike the idea it is supposed to be based on, ie the average (right) outcome is greater than 50% but in the coin example the average outcome of 50% occurs. Second, the proof is limited to ‘an expert-driven environment since each individual chooser must have a greater than 50% chance of arriving at the correct answer’. Disregarding the low expectations of our experts this proof says nothing about the numbers of experts required to meet this standard; it does not distinguish the REC from the NRES Advisers.

  It seems that Hunter has attempted to replace Condorcet’s calculus of probabilities with a calculus of certainty but also he relies on what he calls an allegation about Condorcet’s Jury Theorem as if he did not believe it: this untutored authoritarianism would leave the Frenchman turning in his grave. But Hunter’s final statement is his tour de force: it is that ‘the collective performance of a group in arriving at a correct judgement on the basis of majority rule will be superior to the average individual performance’. We must of course first amend this statement to ‘the average collective performance ...’ but the statement is built on his prior assumptions about ‘greater than 50%’ and the ‘51% expert’ and all it says is that the collective chooses, not how it chooses correctly. The statement does not describe how REC’s come to a decisions, eg how the real expert’s initially minority view brings a majority to her view. A minor conclusion here is that coin tossing is not a good analogy for intelligent decision making, and the mathematical content tells us no more than that a decision is made. A major conclusion is that Hunter’s theorem has nothing to say about the quality or effectiveness of any collective performance, ie it offers no comparison of the REC and the NRES triage.

  But as Hunter is keen to use a mathematical proof to show that the NRES triage as a class is likely to be less efficacious than a REC let us look again at his perspective. If we note the distinction between process and outcome in the work of committees and consider his ‘the collective performance ...’ statement as referring to process, we see on this basis that the committee is always right, for not all individuals will agree in some of the cases, ie the statement under this interpretation is a tautology. However, if we consider the outcome of a committee’s work and the occasions when the committee qua committee chooses wrongly, ie against the wishes of some individuals, then the statement is false. It is clear that Hunter’s statement, ‘the collective performance ...’ is necessarily true, or necessarily false; it cannot help him to justify his view about the superiority of the REC in this context. A continuous difficulty in the melange of mathematics and politics has been a lack of plausible argument. As I said in my original response to Hunter’s article the triage method has not been shown by him to be relatively ineffective.

  Author’s affiliations

  C Parker Leeds (East) Research Ethics Committee, Lay Member

  Clinical Sciences Building, Room 5.2, St James’s University Hospital, Beckett Street, Leeds LS9 7TF

  Competing interests: none

  REFERENCES

  1. Hunter D, Proportional ethical review and the identification of ethical issues. J Med Ethics 2007; 33: 241-245. Doi:10.1136/jme.2006. 016782

  2. Parker C, Is triage incoherent? J Med Ethics 2008; E-letter: http://jme.bmj.com/ cgi/eletters/33/4/241.

  3. Hunter D, In response to ‘Is triage incoherent?’ J Med Ethics 2008; E-letter: http:jme.bmj.com/cgi/eletters/33/4/241#1967,9Jan2008

  4. Department of Health. Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees. June 2005.

  5. Central Office for Research Committees. Summary of Comments on AHAG Report, January 2006:4.

  6. Association of Research Ethics Committees. AREC Council Response to “Implementing the recommendations of the Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees: a consultation”. COREC/NPSA publication, January 2006. April 2006.

  7. Hunter D, The roles of research ethics committees: implications for membership. Research Ethics Review 2007; 3-1, 24-26.

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  Conflict of Interest:
  None declared.

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• Published on: 18 May 2017

  In response to “Developing commensurate review”

  • David Hunter, Lecturer in Bioethics

  Dear Dr Davies Thank you for your helpful response to my paper, “Proportional ethical review and the identification of ethical issues”.[1][2] I recognize that regulation will inevitably reduce the amount of research, though I suspect strangling is perhaps a bridge too far, I would be curious to hear whether the Central Office for Research Ethics Committees' and now the National Research Ethics Service's (NRES) annual repor...

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  Dear Dr Davies Thank you for your helpful response to my paper, “Proportional ethical review and the identification of ethical issues”.[1][2] I recognize that regulation will inevitably reduce the amount of research, though I suspect strangling is perhaps a bridge too far, I would be curious to hear whether the Central Office for Research Ethics Committees' and now the National Research Ethics Service's (NRES) annual reports show a significant decline in the amount of research applications.[i] I'm unconvinced however that this is the right approach to reducing the burden of regulation on research. As I've argued elsewhere in this journal it appears to me that this measure is only likely on average to save between one and three days depending on the quantity of applications suitable for triaging and the length of time the triage takes.[3] I'm inclined to think simplifying the form is likely to be more efficacious, without involving the same risks in terms of research participant safety.[ii]

  I'm glad that a trial dry run is being undertaken though as I noted in that paper:

  “Remarkably, however, in these days of evidence-based practices, trials of this new system have to the best of my knowledge not yet been carried out, but instead will be carried out as part of the now-agreed- upon implementation process. In other words, we are implementing a system that is supposed to improve efficiency with little evidence that it will in fact do this.”[3]

  I'm curious as well about the statistical validity of the trial run, and how close a parallel it will be to the new system if it is put in place. Nonetheless I have been reassured by how NRES responded to the feedback from the Association of Research Ethics Committees and others in regards to the consultation plans and their willingness to engage with their critics.[4]

  I look forward to your report, and to hearing whether any icebergs are spotted, although it should be noted, icebergs mostly float below the surface so they tend to be hard to spot!

  Notes & References: i. Of course it would also need to be shown that changes to the figures actually reflected the amount of research being carried out, I imagine the amount of research reviewed by Local Research Ethics Committees declined dramatically once Multi-Centre Research Ethics Committees were established without the amount of research being carried out declining.

  ii. I recognise that efforts to do so are underway.

  1. Hunter, D. 'Proportional Ethical Review and the Identification of Ethical Issues' Journal of Medical Ethics. (2007);33:241-245.

  2. Davies, H. T. 'Developing commensurate review' Journal of Medical Ethics. (2008); Eletter: http://jme.bmj.com/cgi/eletters/33/4/241 (Accessed 9/01/08)

  3. Hunter, D. 'Efficiency and the Proposed Reforms to the NHS Research Ethics System' Journal of Medical Ethics. (2007);33:651-654.

  4. Association of Research Ethics Committees. AREC Council Response to "Implementing the recommendations of the Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees: a consultation". COREC/NPSA publication January 2006. April 2006. http://www.arec.org.uk/consultations/AREC%20implementation%20reponse%20(final).pdf (Accessed 9/01/08).

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  Conflict of Interest:
  None declared.

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• Published on: 18 May 2017

  In response to “Is Triage Incoherent?”

  • David Hunter, Lecturer in Bioethics

  I would like to thank Mr Parker for the opportunity of clarifying my paper presented by this somewhat vitriolic attack on its central premises and conclusions.[1][2] In the article I give four arguments for why systems of proportional review are unlikely to be as effective as full blown research ethics committee (REC) review. These are: expertise; ethical icebergs; ethical diversity and pluralism; and uncertainty. Unfor...

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  I would like to thank Mr Parker for the opportunity of clarifying my paper presented by this somewhat vitriolic attack on its central premises and conclusions.[1][2] In the article I give four arguments for why systems of proportional review are unlikely to be as effective as full blown research ethics committee (REC) review. These are: expertise; ethical icebergs; ethical diversity and pluralism; and uncertainty. Unfortunately Parker has misinterpreted my paper as defending a democratic ideal of research ethics review that it does not defend. I will address Parker's points in turn.

  First Parker states that I claim that: “the NRES triage system as the worst of this type of delegated authority and it is this which he concludes is ineffective.” This is not quite correct, I do not claim this. There are of course worse systems of proportional ethical review available than that proposed by the National Research Ethics Service (NRES), for example researchers themselves deciding whether their study raised significant ethical issues and needs ethics review.[i][3] And the original proposals of NRES where one individual would make the final decision on whether or not an application contained material ethical concerns was clearly more troublesome than the presently proposed system where a minimum of three individuals will be involved in the final decision. [3][4] Instead I am arguing that proportional review systems as a class are likely to be less efficacious than full blown research ethics committee review and that in particular the proposal presented by NRES is unlikely to do an adequate job of maintaining the current high standards of research participant protection.[1][3]

  The first argument I give is that a small group, in this proposal a minimum of three people, are unlikely to possess the wide range of expertise necessary to identify all the possible material ethical concerns, or be familiar with the wide range of possible research methodologies.[1] In regards to this argument, Parker gives the helpful analogy of an A & E triage nurse who “prioritises patients; one may note that she does not identify all the risks involved: she classifies cases as the adviser does”. [2] The point being one presumes that the triage nurse does what must be acknowledged as a fairly difficult job of classification reasonably efficiently. Unfortunately this seems to be beside the point, the triage nurse acts in a situation of need and will no doubt sometimes make mistakes in categorization that would have been avoided had an entire care team done the job. In essence this is exactly what I am arguing, rather than simply having the A & E triage nurse (the National Research Ethics Advisor) to make the final judgement about the care of a patient (the research proposal) it is more appropriate that this decision is made by the care team (a research ethics committee). As such the analogy fails, I'll concede happily that triage might be a useful way of efficiently making some initial decisions, but this doesn't mean that it is an appropriate process for making a final decision, nor that someone, however well trained, has the expertise to do this for the wide range of projects that are presented to research ethics committees.

  The second argument relies on existence of what I have dubbed “ethical icebergs” which are ethical issues which a committee member doesn't notice until the committee meeting. This is not an uncommonly reported experience for ethics committee members. I conclude from this that people may be blind to certain ethical issues depending on their background and interests. In regards to this second argument, Parker makes a fair point giving an alternative explanation of the ethical icebergs.[2] That said he rather uncharitably suggests that the only evidence given of the existence of these icebergs is my own experience of them, this is not the case in the paper I note that the Association of Research Ethics Committee's response to the consultation noted this as a common experience of it's membership. [1] Furthermore I have since been involved in a research project attempting to quantify this experience, which has reached the conclusion that 50% of Research Ethics Committee members have had this experience.[5] In that paper we discuss the possible explanations of ethical icebergs in more detail, and while I concede that Parker's explanation no doubt explains some of these incidents, it seems plausible to me that ethical blindness likewise explains some of these incidents. In any case whatever the explanation of ethical icebergs, to avoid these icebergs many eyes make light work.

  The third argument I give is that given the range of different ethical views it is difficult for a small group to adequately reflect these views. This has two detrimental effects. Firstly insofar as research ethics committees are supposed to represent the general populace if some views aren't represented then they are failing in their jobs. Secondly given that people's ethical views colour what issues they see as ethically important the existence of multiple ethical views will lead to very different conclusions about the same application from small groups. In regards to this third argument, unfortunately Parker has misread my argument. He claims that I have mistaken the term “research ethics committee” for a description and as such I hold “that the ethicist is the paradigm person who will apply what he takes it to describe”.[2] I must admit to being confused by this conclusion since nowhere in this article do I express the opinion that ethicists are the paradigm members of research ethics committees. I have I must admit argued elsewhere that they are one important element of a research ethics committee.[6] But I did not assert either here nor there that they are the paradigm members, in actuality I argued elsewhere that the ideal research ethics committee has a mixed membership with different expertise. Indeed it is precisely the inability of one member to encompass the necessary expertise which influences this conclusion and is the basis for my first argument. I'm afraid the confusion here is Parker's not mine.

  He then ventures into the area of meta-ethics further claiming “He believes that people in making moral judgments are guided by ethical theories”.[2] This is an unfortunate reading of my argument. I am not suggesting that people as a general rule consult ethical theories when making moral decisions. What I am claiming is that different people have different ethical views, some of which can be expressed in terms of different ethical theories. This should have been clear from this statement in the paper: “Although I do not intend to imply that RECs often overtly debate ethical theory, the subtext of several common debates that take place at REC meetings is a background clash of different ethical theories”.[1] What my argument relies on is that there are a variety of different ethical views held by people, and that these different views will lead them to see different things as important. It matters not whether these different views are formalised in terms of ethical theories or not that, for the sake of this argument, is beside the point. If there are many different ethical views, then a few people are unlikely to serve as appropriate representatives for these different viewpoints, whereas a full committee is more likely to serve as adequate representation. As such Parker's meta-ethical criticism is beside the point, as long as people do hold different ethical views, the argument still stands.

  Finally my last argument relies on the Condorcet's Jury Theorem which alleges to show that “the collective performance of a group in arriving at a correct judgement on the basis of majority rule will be superior to the average individual performance”. Given this a larger group (a research ethics committee) will in general be more reliable decision makers to a smaller group (the National Research Ethics Advisers). Parker criticises my last argument claiming that it is a “misunderstanding of part of political theory to demonstrate the superiority of the democratic process”.[2] He criticises the usage of Condorcet's Jury Theorem in this context by arguing that this theorem is about the superiority of democratic processes whereas in this case we are actually dealing with expertise driven decisions. In particular he misunderstands the purpose of the theorem. He appears to conflate Rousseau's idea of the 'general will' with the theorem. Rousseau felt that the general will could not be mistaken because whatever it wanted was, by definition, correct in the best interest of the populace.[7] As Parker notes this is indeed a tautology and so would be no proof at all. However this is not how the theorem functions. The theorem is a mathematical proof based on the idea that the more times the event is iterated the more likely it is that the average outcome will occur.[8] If the average outcome is more likely to be right (i.e. greater than 50%) than wrong then the more iterations the more likely the right answer will be reached by the process. The proof only functions in an expert driven environment since each individual chooser must have a greater than 50% chance of arriving at the correct answer, otherwise the theorem doesn't hold. As such Parker is mistaken in his interpretation, what the theorem shows us is not the trivial “the collective performance represents the collective” that he takes it to give us but instead as I argued in the article: “the collective performance of a group in arriving at a correct judgement on the basis of majority rule will be superior to the average individual performance”.[1][2] As such a larger group, all else being equal will make more reliable judgements.

  I've shown in the paper and in this follow up that larger groups will in general be more reliable ethical decision makers. This casts doubt on the adequacy of the proposed changes to the NHS research ethics system in terms of making accurate ethical decisions, and as such to providing an appropriate level of protection for research participants.

  Notes & References: i. Before one dismisses this as absurd, I've heard anecdotal reports of this form of pre-review being used in UK universities, often in conjunction with a quick check sheet for identifying common ethical issues.

  1. Hunter, D. 'Proportional Ethical Review and the Identification of Ethical Issues' Journal of Medical Ethics. (2007);33:241-245.

  2. Parker, C 'Is Triage Incoherent?' Journal of Medical Ethics. (2008); Eletter: http://jme.bmj.com/cgi/eletters/33/4/241 (Accessed 9/01/08)

  3. Central Office for Research Ethics Committees. Building on improvement: implementing the recommendations of the report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees. Aug 2006. http://www.nres.npsa.nhs.uk/docs/corporate/development/ImplementationPlan.pdf (Accessed 09/01/08).

  4. Central Office for Research Ethics Committees. Implementing the recommendations of the Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees: a consultation. Jan 2006. http://www.nres.npsa.nhs.uk/docs/corporate/development/ ImplementationPlanConsultation.pdf (Accessed 09/01/08).

  5 Elliott, L. Hunter, D. ‘The experiences of Ethics Committee Members: Contradictions between Individuals and Committees’ Journal of Medical Ethics. In press. Preprint available as a Current Controversy: http://jme.bmj.com/preprint/elliott.pdf

  6. Hunter, D. ‘The roles of research ethics committees: implications for membership.’ Research Ethics Review. (2007) Vol 3, No 1, 24-26.

  7. Wolker, R. Rousseau. (1995) Oxford: Oxford UP.

  8. Koch T, Ridgley M. ( 2000) The Condorcet’s Jury theorem in a bioethical context: the dynamics of group decision making. Group Decision Negotiation;9:379–92.

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  Conflict of Interest:
  None declared.

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• Published on: 18 May 2017

  Developing commensurate review

  • Hugh T Davies, Research Ethics Advisor

  Dear Sir,

  There is evidence that regulation is strangling research (1). The National Research Ethics Service, meeting its stated aim to "facilitate ethical research" is therefore undertaking a pilot study in which applications from 4 Research Ethics Committees are independently reviewed by 3 volunteers (members of RECs appointed after advertisement and interview)to see if it is felt studies present material e...

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  Dear Sir,

  There is evidence that regulation is strangling research (1). The National Research Ethics Service, meeting its stated aim to "facilitate ethical research" is therefore undertaking a pilot study in which applications from 4 Research Ethics Committees are independently reviewed by 3 volunteers (members of RECs appointed after advertisement and interview)to see if it is felt studies present material ethical issues. If they don't, we are asking these volunteers to undertake review and we will compare their analysis with that of the REC. This study is also being conducted in Scotland.

  We hope to have a report later in the year and will report the sighting of any ethical icebergs!

  REFERENCES 1. Sullivan R The good, the bad, and the ugly: effect of regulation on cancer research The Lancet Oncology, Jan 2008:9;2-3 http://www.thelancet.com/journals/lanonc/article/PIIS1470204507703881/fulltext

  For more similar references visit http://www.eric-on-line.co.uk and "Search eric" using the keywords "Research regulation,hindering research"

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  Conflict of Interest:
  None declared.

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• Published on: 18 May 2017

  Is Triage Incoherent?

  • colin parker, retired

  This response to Hunter’s article, ‘Proportional ethical review and the identification of ethical issues’, provides counter arguments to undermine his understanding of the issues. It is shown that his attempt to ground the effectiveness of the REC system in some similarity to democratic ideals fails, and that his criticism of the concept of triage is ineffective. The conclusion is that expert groups of whatever size d...

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  This response to Hunter’s article, ‘Proportional ethical review and the identification of ethical issues’, provides counter arguments to undermine his understanding of the issues. It is shown that his attempt to ground the effectiveness of the REC system in some similarity to democratic ideals fails, and that his criticism of the concept of triage is ineffective. The conclusion is that expert groups of whatever size decide on the basis of evidence and argument rather than on a democratic ideal of agreement.

  Hunter’s article [1] argues that the National Research Ethics Service proportional ethical review, or triage, is ineffective because only a ‘properly constituted research ethics committee ... (can effectively identify) ... the risks and ethical issues posed by an application ...’ (p 241). One will see immediately from this that the ‘properly constituted’ committee is a group of experts and not simply a reflection of democracy. He acknowledges the prevailing variety of proportional ethical review, eg as in a REC sub committee, but considers the NRES triage system [2] as the worst of this type of delegated authority and it is this which he concludes is ineffective. He believes that other instances of the variety would be more or less successful as they approach or depart from the real functioning of the REC. He lists four issues affecting the REC which he believes must be properly met for adequate functioning, these are: expertise; ethical icebergs; ethical diversity and pluralism; and uncertainty.

  The first two issues refer to empirical matters requiring factual judgements about efficiency or effectiveness. On the first issue he points out that the triage system would have a series of stages or evaluations of ethical risk, but thinks it would be doubtful that the advisers at each stage would have the necessary experience or expertise ‘to assess the risks posed by the wide variety of research ...’ (p 242). Though, a comparison here to provide an initial context is the A & E triage nurse who prioritises patients; one may note that she does not identify all the risks involved: she classifies cases as the adviser does. Hunter points out that there are three stages in the advisers’ triage system but feels it is doubtful in any of the stages ‘that any one person could’ (p 242) properly assess the risks [3]. Certainly, the extent of liaison between the advisers is relevant; and the use of collaborative investigation of risk would be material in reducing the weakness of solitary working. It is easy to accept that we all learn from one another in a group or committee setting, but it is not conclusively shown by Hunter that this is really a lack in the triage system [4]. Even if in the formation of difficult decisions about risk the three individuals do not regularly form a committee, he has not justified his doubt that well trained and experienced advisers could adequately fulfil the task.

  Regarding his second criticism of the triage system, the ‘ethical icebergs’, Hunter suggests that ‘our background, experience and ethical beliefs .... cause us to be blind to some issues and very sensitive to others’ (p 242). His evidence for this is that during preparation for a REC sometimes he misses serious ethical issues which arise in the committee. But it seems wrong to base this gap in preparedness on blindness to some issues, for if that were the case it would be normal to doubt that the issues raised in the committee were serious [5]. It seems to be at least as likely that this phenomenon is a matter of simply not picking out all the relevant elements, ie it is a matter of scanning research applications and noting or not noting relevant issues. It is more a matter in committee of being reminded of something rather than being taught it. This would include scientific matter for experts and moral matters for lay members. Hunters conclusion that the NRES adviser [6] is ‘more sensitive to certain issues and less sensitive to others’ (p243) is relative to background and training which can be amended or strengthened, and is not clarified by resorting to an explanation of ‘blindness’. He suggests too that the adviser may rely excessively on the coordinators’ decision about level of risk in an application, but in the REC one can similarly rely on others to properly prepare or raise issues; this would not be a fault restricted to the triage system: we all have to do what is required of us.

  Hunter’s third criticism of the triage system, ‘ethical diversity and pluralism’, leaves the relatively factual considerations of his first two concerns and plunges him into conceptual criticism. It is here that we see an element of iatrogenesis, ie his treatment produces rather odd side effects. In order to expose Hunter’s arguments it may be helpful initially to notice the distinction between a name and a description. Wittgenstein’s example [7] of this is ‘Mr Green is green’, and we can offer ‘Wonderful beer is dreadful’. We have to notice whether a title is a name or a description. Consider ‘research ethics committee’, is this a name or a description? Hunter takes it to be the latter, and believes that the ethicist is the paradigm person who will apply what he takes it to describe.

  There is nothing really misleading about this, one may remember that in the days before research ethics committees there were moralists who applied moral standards to human behaviour. If it were only the use of the word ‘ethics’ replacing ‘morals’ it would not be very confusing, and we could understand the ‘research ethics committee’ as referring to the ‘moral-research committee’. This descriptive title would save us from Hunter’s view that ‘people cannot be expected to pick up on all the risks and ethical issues .... because of the plurality of ethical positions available’ (p 243). He believes that people in making moral judgements are guided by ethical theories.

  We are faced by the rather odd consequence from understanding the research ethics committee as a name that our moral judgements are structured and sustained by ethical theories, eg ‘a utilitarian may be more sensitive to ... whereas a deontologist might be more concerned about ...’ (p 243) [8]. We may remember that when children are taught to catch a ball they are not introduced to the activity through a study of the theory of gravity. The theory of gravity is developed after human experience of objects in space; the theory offers a theoretical account of such phenomena. As with moral behaviour movement in space and time is rational before the generation of any theories. One can see that young children in school are not taught ethics or ethical theories; they are taught to be kind to their neighbour, to be fair, to be tolerant. We are all the same, more or less concerned with moral action, not with ethical theories about moral action. From these considerations one can see that Hunter’s conclusion about applications, ‘the decision on whether or not they are ethically controversial will be theory dependent’ (p 243) is a tautology. Similarly, his ‘As each of us has our own beliefs about morality, people will inevitably make different judgements about the same applications’ (p 243), ie his suggestion that our own beliefs imply different judgements, is a tautology. We see that we can share beliefs about morality and make different judgements, eg some think that telling the truth to our neighbour is what is required whilst others favour a more subtle hypocrisy.

  Hunter has stumbled over the distinction between a name and a description and fallen into the error of thinking that it is theories of morality which give sense to moral action, when the opposite is the case: moral action gives more or less sense to moral theories. It is worthwhile for ethicists of whatever type to consider that one theory of gravity produces clarity, whilst a number of theories of ethics produces unclarity. The variety of ethical theories is not a confirmation of our understanding of moral matters. He acknowledges that two RECs may come to different judgements about the same application, but he thinks this is minimized by the ‘people who represent the different ethical viewpoints present’ (p 243). What is happening here, of course, is that people who largely come from the same culture, share so many moral perspectives [9]. His conclusion that the three advisers in the triage system are unlikely to represent ‘all or even most ethical viewpoints’ (p 243), or ethical theories, completely misses the primacy of the moral view. Each of the advisers in the triage will be fully equipped with individual moral experience [10].

  The fourth criticism which Hunter applies against the NRES triage system is a misunderstanding of part of political theory to demonstrate the superiority of the democratic process. The essence of his case is that from that context the best decisions are made by the biggest group. He extrapolates from this to suggest that any triage system must be deficient and the full REC relatively admirable. However, one must consider that when one is faced with technical or intellectual matters it seems counter intuitive to leave decisions to the mass of people. There is, of course, a body of statistical evidence supporting the idea of the pre-eminence of democratic processes in making decisions about technical matters, as opposed to the individual expert’s specific input; but this evidence can be misleading. The democratic body which has created the better treatments, perhaps disseminated through computer systems, is made up of experts; thus, classifying decision systems within expert groups as democratic does not support the political idea of democratic decisions. Both the REC and the triage adviser are part of the relevant expert group; so we cannot discriminate between them as the source of good decisions. We may acknowledge that even when one is concerned with technical or moral matters it cannot be certain that a group of twenty will outperform a group of three. But let us look further at Hunter’s arguments.

  Referring to the Northwick Park Hospital clinical trial he says it is ‘inappropriate for any person or small group ... to make the decision .... because committees will be more reliable in making decisions in these situations of fundamental uncertainty’ (p 243). He reminds us that in this case animal testing did not indicate ‘severe adverse reactions’ (p 243) but nevertheless, retrospectively a number of individual experts in the field criticized the protocol, ie it was not a situation of fundamental uncertainty. Additionally, the REC approved it; but Hunter does not dwell on this: he believes committees are more reliable because ‘mathematically we can show this to be true’ (p 243). To achieve this, he then jumps from a bigger (expert) group relative to the triage advisers to the system of democracy: ‘the Condorcet jury theorem ... (shows) ... the superiority of democracy’ (p 243).

  This contribution from Condorcet is a theorem about the value of democracy, ie that the general will should be followed. The theorem is a way of justifying the general will: ‘the collective performance of a group in arriving at a correct judgement on the basis of majority rule will be superior to the average individual performance, provided that certain conditions hold’ (p 243). Simply put, this is the view that the majority judgement better represents the majority than any individual judgement would, ie it is a tautology: the collective performance represents the collective. The relevance of ‘The main relevant condition ... that each person has a greater than 50% chance of making the best decision’ (p 243) is that the ‘best’ decision is the collective decision. Hunter is associating the expertise of the REC with the value of democracy, and contrasting such valuable expertise to the triage system which allegedly does not possess the resources to arrive at correct judgement.

  Hunter needs to show that the decision of the larger group or democracy produces the best decision, but all he is doing is showing that the larger group produces what it most desires. Clearly the use of the word ‘best’ is ambiguous here: meaning something like ‘the decision representing the views of the majority’ or ‘the most effective decision’. His view is that ‘If people making the decision are competent in the area in which the decision is being made, then the probable answer is likely to be the best answer’ (p 244). This collapse into a tautology linking best answer with competence undermines him completely. We have to conclude that a tautology gives us no reason to say ‘This gives us some reason to believe in the safety of numbers in grey areas’ (p 244). We need the safety of experts who have been tested by other experts, not just ‘numbers’. Of course, the triage system may not in fact improve the effectiveness of the REC, but Hunter has not demonstrated his imagined deficits in the triage system; whilst his footnoted mathematical formula aimed at supporting his faith in numbers is a monument to obscurity. Mathematics will not lend intelligibility to a misconceived or misapplied theory. We have to conclude that the triage method of dealing with research applications on a basis of evidence and argument has not been shown by Hunter’s use of arguments to be ineffective.

  Author’s affiliations C Parker Leeds (East) Research Ethics Committee, Lay Member, Clinical Sciences Building, Room 5.2, St James’s University Hospital, Beckett Street, Leeds, LS9 7TF

  Competing interests: none

  REFERENCES 1. Hunter D, Proportional ethical review and the identification of ethical issues. J Med Ethics 2007; 33:241-245. Doi: 10.1136/ jme.2006.016782 2. Department of Health. Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees. June 2005. 3. Central Office for Research Committees. Summary of comments on AHAG Report, January 2006: 4. 4. Blunt J, Savulescu J, Watson AJM. Meeting the challenges facing research ethics committees: some practical suggestions. BMJ 1998;316:58- 61. 5. Association of Research Ethics Committees. AREC Council Response to “Implementing the recommendations of the Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees: a consultation”. COREC / NPSA publication January 2006. April 2006. 6. Central Office for Research Ethics Committees. Implementing the recommendations of the Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees: a consultation. January 2006. 7. Wittgenstein L, Philosophical investigations. Blackwell, Oxford, 1963. 8. Garrard E, Dawson A. What is the role of the research ethics committee? Paternalism, inducements, and harm in research ethics. J Med Ethics 2005; 31: 419-23. 9. Edwards SJL, Ashcroft R, Kirchin S. Research Ethics Committees: differences and moral judgement. Bioethics 2004; 18: 408-27. 10. World Medical Association. Ethical principles for medical research involving human subjects (Declaration of Helsinki), Tokyo, 2004.

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  Conflict of Interest:
  None declared.

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