In this paper I set out to examine aspects of the relationship between research and research ethics, and the role of research ethics committees (RECs), focusing on practice in the UK. I consider the formal relationship in the form of REC review and also the less formal ways in which research and ethics can and should relate to each other. The central thesis of this paper is that the role of the ethics committee is much broader than just ethical review. As apparent in recent articles on the topic, RECs act as regulatory authorities with concerns beyond those of ethical deliberation.1 2 I argue that RECs are regulatory rather than advisory. I show how they fit within the procedural account of law and provide some analysis of RECs as regulatory authorities, primarily suggesting that it is through fair procedures that they will be held accountable. I further examine how some of the recent changes to RECs affect their regulatory status.

At present, “ethics approval” is a necessity for most research being carried out in the NHS and also within universities (even though this review process is often by means of a self-assessment or “proportional” review process). The Medicines for Human Use (Clinical Trials) Regulations 2004 require that all clinical trials of investigational medical products have ethical approval before they can begin. Proceeding with such a trial without approval from an REC will be a criminal offence.3 This means that ethics committees have immense power over the research that is carried out. It also gives those ethics committees that fall within the remit of these regulations formal regulatory status. While not all RECs have this status formally, in practice they will act with the same authority. Brazier and Cave describe the position as follows:

NHS employees failing to seek approval from the relevant REC are likely to be disciplined by their employing trusts. Outside the NHS, researchers may face disciplinary action by professional regulatory authorities. Conducting research without ethical review may constitute impaired “fitness to practice”. In 2007, the General Medical Council instigated disciplinary action against Andrew Wakefield, the author of a 1998 Lancet paper linking autism and the MMR vaccine. Among ten counts of serious professional misconduct was the claim that no proper ethics committee approval was sought. Journal editors also play a monitoring role. One of the functions of the Committee on Publication Ethics is to ensure that its members do not publish studies unless guidelines on ethical review are followed.3

Yet the haphazard way in which ethics committees have evolved means that it is not always clear how this power is being exercised. In both the university and NHS settings, ethics committees have the power to refuse approval for potential research, and without ethics approval we see the end of potential research projects. As RECs regulate research, the question arises, where does their mandate come from? In some cases, the answer is the Department of Health, as all ethics committees that fall within the NHS sphere are coordinated by the Central Office for Research Ethics Committees (COREC).4 However, in the university setting, especially in non-medical research, the answer is less clear. Ethics committees were born of a concern for the protection of research participants. In this paper, I examine how RECs exercise their regulatory authority; I consider both those that are acting as statutory authorities and also those that act with informal, de facto authority. I suggest that when we consider these committees, we will see that their legitimacy arises through fair procedures of review even if these deliberations give rise to apparently inconsistent outcomes. Therefore, it is not an intrinsic problem that different committees may reach differing or inconsistent outcomes. The ethics review process can thus be seen as what Black describes as “proceduralizing regulation”:

Procedural law is a shift to more indirect and abstract guidance mechanisms, but ones which are, like material law, purposive in their orientation.5

In considering the ethical review process, we need also to be clear that not all reasons given by an ethics committee will be ethical reasons, and indeed it confuses the matter and allows for considerable vagaries in the decision-making process to push this agendai. In this paper I outline the evolution of ethics committees from advisory groups developed in an ad hoc fashion to address ethical concerns into the regulatory authorities they are today. As regulatory authorities, ethics committees could conceivably have many functions beyond even the ones they have now. It is clear that at present they promote patient safety and good technical standards and are also responsible for projects’ being adequately insured. However, there are further candidate roles they may take up—the protection of public health, for example. I also suggest that the role of ethics in this regulatory authority is quite specific and should not be overemphasised. I reiterate that I see RECs that do not have formal statutory authority as also falling into the category of regulatory authorities, even if they do not have a direct mandate from government. The distinction here is between de facto and de jure powers. It is clear that informal RECs function to regulate research and have powers of veto over proposed research similar to those with statutory backing. It should also be remembered that ethics committees can be subject to judicial review.7 It is arguable that any individual harmed during the course of an REC-approved research project could have a case against that committee. Brazier and Cave summarise the legal situation:

It has been held that ethics committees can be subject to judicial review. Arguably committees recognised by the UK Ethics Committee Authority have sufficient legal personality to be a defendant in a civil law suit. However, for those which lack statutory recognition, both the appointing strategic health authority and each individual ethics committee member of the committee have direct legal responsibilities to research participants.3

I will also examine the relationship between research ethics and research beyond that of research ethics committee deliberations. Does ethical review absolve researchers from any other ethical deliberation? Do we want ethically led research? If so, how do we achieve this aim? I suggest that while the role of ethics in the regulation of research is narrow, this is not to be seen as a contradiction of the claim that research can be highly informed or even led by ethics. When considering the application of the term ethical deliberation, we see how easily the term ethical can come to mean many things or indeed nothing. Perhaps, as Black suggests, ethics is an inclusive term:

Defining an issue as one appropriate for pragmatic, technical discourse is at the same time a decision that deliberation should only occur between those who are competent to deliberate in a technical manner—it’s a decision for “experts”. Defining it as one appropriate for ethical or moral discourse broadens the range of deliberants.8

However the terms ethics and ethical if used uncritically or without explanation can lead to confusion. Black’s use of the word provides an example of an umbrella usage of the term. Such usage should be distinguished from ethics in a technical sense. The umbrella usage seems to act as an inclusive term to describe deliberations that are not specific to any area of expertise—to lay deliberations. Ethics in a technical sense will involve expertise. The members of an ethics committee will come from a variety of backgrounds with different expertise; different voices will be heard in the deliberations. The role of ethics in a technical sense in these deliberations will, however, be limited. If the term ethics committee is used simply as a description of a non-expert group, this should be emphasised to avoid confusion.

WHAT RECS ARE AND ARE NOT

RECs were born out of past abuses and are primarily concerned with the protection of research subjects. This concern can be traced back to the Declaration of Helsinki:

In medical research on human subjects, considerations related to the wellbeing of the human subject should take precedence over the interests of science and society.9

Within the NHS, RECs are now coordinated by COREC, which is in turn part of the National Patient Safety Agency. This seems to be consistent with the origins of RECs in protecting the interests of research subjects. If there is a conflict of interest between research and subjects, a balancing of the interests should always, given this role, be weighted in favour of the protection of the subject. This reflects a tension between the of ethics committee’s role as an authority that regulates research and its role as an authority to protect patients. Peterson points out that

… the aim of science differs from that of medical risk appraisals. Scientists strive to acquire as many true beliefs as possible, while minimising the false ones. However, the aim of a medical risk appraisal is not to provide a correct representation of medical facts. The aim is rather to protect patients from medical hazards.10

(This quotation also reflects a tension that may extend to certain types of clinical trial in which the role of the doctor and the role of the researcher are one.)

This also shows how different interests may be given different weights by individuals on the committee. In an evaluation of research proposals, these weightings should be explained as part of the reasons for the decisions. One of the main roles of the ethics committee will be a risk assessment exercise. The reasoning that underlies the protection of the research subject is essentially precautionary. There is much literature on the role of the precautionary principle in risk regulation.11 12 The principle can be defined as follows:

The precautionary principle is a principle which states that in cases where there are threats to human health or the environment the fact that there is scientific uncertainty over those threats should not be used as the reason for not taking action to prevent harm.11

While it is not suggested here that RECs fit within the traditional boundaries of risk regulation, there is much that we gain from drawing on the literature of that field. It is especially worth consideration as I am here proposing that accountability and legitimacy can be achieved through fair procedures. Fisher points out that the precautionary principle is most useful as a guide in a procedural rather than a substantive sense.

While the distinction between process and substance is often a highly artificial one, conceptualising the principle as one of process reflects the fact that the principle does not dictate a particular outcome.11

The model of proceduralisation thus describes comfortably the underlying structures of RECs, and the focus on procedures rather than outcomes will be an appropriate standard for holding RECs accountable. Another aspect of this risk assessment is the difficulty of quantifying “novel” risks.12 The assessment before RECs may often be of this kind. Research by its very nature is an exploration of the unknown. This means that this assessment can be a particularly difficult one to make.

The model I propose here follows that of Daniels and Sabin, who attempt to solve the problem of accountability by focusing on reasons for decisions.13 They state that reasons must be justifiable. So although there may be inconsistency in outcome, there should be consistency in the reasoning used. It will not be enough for RECs to use precaution as a guiding principle: they must also have concrete procedures in place against which decisions can be assessed.12

This will also be important because of the “subjective” nature of that risk—that is, when we assess it we are often guided more by individual perceptions of harm than we are inclined to admit. In assessing risk, it will often be conceived of subjectively, different individuals having different perspectives. As Covello notes:

Risks are perceived to be higher if the activity is perceived to be involuntary, catastrophic, not personally controllable, inequitable in the distribution of its risks and benefits, unfamiliar, and highly complex. Other factors influencing risk perceptions are whether the adverse effects are immediate or delayed, whether exposure to the hazard is continuous or occasional, whether the technology is perceived to be necessary or luxury, whether the adverse effects are well-known or uncertain, and whether the activity is certain to be fatal.14

This illustrates how individual preferences and prejudices play a central (albeit not explicit) role in the REC decision-making process. Because different people are bound to have very different understandings of potential harm (the “subjectivities” of risk), it’s near impossible to determine the right or wrong outcome. In the case of RECs, this may be further complicated by the mixture of experts and non-experts on the committee, as it has been shown that these two groups will differ in their estimates of potential risks.14 The “subjectivity” of risk may be something that can be drawn out in the deliberative process and also by looking at the reasons given for particular decisions. This will make the policing of procedure even more important.ii

If we want to expand the role of RECs into a more broadly independent regulatory one, would this need to happen explicitly? At present we can see how a gradual shift has taken place due to the nature of the decisions that RECs are being asked to make. Once we are aware that this is the case, then it is at least important to acknowledge it explicitly, especially as this gradual shift has increased the powers of RECs. We may also wish to consider whether particular conditions of membership to these committees should be put in place to avoid biased conclusions. New conditions may need to be put on group membership to ensure that RECs have suitable individuals to inform different categories of decision—for example, economists, scientists, lawyers. It could also be suggested that all committees have an ethicist among their number.iii It may further be necessary to ensure that when the review takes place, individuals are being reviewed by their peers. This condition may become more important when proposed methodologies are questioned. This should all be considered in the light of the limits within which statutory RECs now operate. As Brazier and Cave pointed out,

Regulation 15(5) of the Clinical Trials Regulations limits the remit of research ethics committees, providing a list of relevant matters which the committee should consider. In summary these include a consideration of the relevance of the trial and its design; the balance of risks and benefits; the protocol; the suitability of the investigator and the facilities; the information sheet and procedure for obtaining informed consent; indemnity, insurance and compensation arrangements and payments to the participant and investigator.3

Limitations such as these may be problematic for members of the REC. Surely it will be problematic for a scientific expert to approve a project they believe to be seriously methodologically flawed or for a lawyer to approve a project from which questionable legal issues arise. I discuss this further below. Suffice to say at this point that while measures like this may seem to bring the review process back to basics, this may not be a welcome change.

Ethics committees have moved beyond the role of protecting the patient and now are seen as a way to promote best practice and safety and in general to create standards for research. However, it remains to be seen how best to incorporate these new aims into a process originally concerned with ethical deliberation. Take, for example, the aim of promoting best practice: in a regulatory sense, this takes on a dual meaning. Do we mean best practice ethically, or best practice technically? These should not be conflated into one idea. Ethics committees acting in their regulatory capacity have in the past been able to reject a project because it was based on “bad science” in the technical sense, although statutory RECs no longer have this power. To some, this power of rejection for technical reasons was problematic, as they believed that this was beyond the remit of RECs. However, these concerns have weight only if we see the role of the REC to be that of a committee that deals with ethical concerns. Clearly it is more than that. The recommendations of the Ad Hoc Advisory Group (AHAG) have led to a further widening of the division between ethics review and scientific review.15 However, this seems to miss the point: an ethics committee should be seen as an appropriate group to undertake both these types of consideration; its function as a regulatory authority may even require this. Not all decisions for rejecting research that are based on technically bad science will be ethical decisions, although some may; but they will be appropriate decisions for the review process. A refusal to acknowledge and accept the regulatory status of RECs and acknowledge the controls they have in this role means that there is a somehow mistaken view of the types of decision an ethics committee can make. Promoting the idea that the purpose of RECs is to consider only the “ethical” forces us to fall back onto a mistaken definition of what it is for something to be ethical—that is, it forces us to say that all decisions are “ethical” if they are decisions committees can make. This will obviously not be the case. It can also mean that research will have a perceived ethical legitimacy by virtue of the review process, which is not appropriate either. Some decisions that are based on technically bad science will be ethical decisions, while some will simply be prudent decisions on the part of the committee—both of these types of decision should be seen as legitimately falling within the scope of the decisions that an authority regulating research should make.1

PROCEDURAL AND SUBSTANTIVE ISSUES IN DELIBERATION

I now consider some procedural and substantive issues in the ethical review process. When I consider procedural issues of ethical review, I am addressing issues that are part not of the substance of the decision, but, rather, of the process that gives rise to it. My analysis draws heavily on the model proposed by Daniels and Sabin. Although they were speaking of procedures for resource rationing, I think that their model holds in this context also:

When we lack consensus on principles that tell us what is fair, or even when we have general principles but are burdened by reasonable disagreements about how they apply, we may nevertheless find a process or procedure that most can accept as fair to those who are affected by such decisions. That fair process then determines for us what counts as a fair outcome.13

This model also seems to work well because the principle guiding the decisions of an ethics committee is that of precaution—the primary consideration should be patient or subject safety. As mentioned earlier, this is a principle from which it is difficult to gain consistency in the outcomes of decisions; indeed. But, as Stokes points out in the context of decision-making under the precautionary principle,

… consistency in the outcome of precautionary decision making (i.e., in the measures adopted on that basis) is an impractical goal given the demand for regulatory responses that readily adapt to suit circumstances of uncertainty.12

It is argued here that inconsistency of outcome need not automatically be assumed to be unjustifiable. If this claim is true, the procedures in place become especially important. The haphazard way in which ethics committees have evolved could have implications for the procedures involved. Take, for example, ethics review forms in the university setting. The forms were largely led by issues that arose in medical research, and thus the sort of question being asked and issues raised were inappropriate for the fields of, for example, the social sciences. While these forms may encompass many ethical concerns that we may have in the questions they ask and the issues they raise, it is not always clear that these concerns are also addressed through their application. It could lead to unfairness when the forms are being applied across disciplines. Although there is now a move away from the use of uniform ethics review forms in many universities, it is representative of the complexity of considering ethics review in a procedural sense—that is, the complexity of the regulatory function of RECs. They now regulate many areas of research and therefore must have procedures in place that are of general applicability.

Stringent procedures should not be seen as compromising the independence of RECs. Consider the following criticism:

If COREC was to substitute its opinion for that of the ethics committees, we could be moving in a dangerous direction. As RECs are meant to provide an independent opinion on whether a research proposal is ethical, that opinion needs to be independent of both science and the state, otherwise participants may not have adequate protection from scientific excesses.16

This statement gives rise to many issues. It is unclear how fair procedures might infringe on the independence of RECs. It is one thing for an REC to be told what to think and quite another for it to be told how to think—that is, what procedures for review should be in place. There is quite a difference between an authority’s having independence and its having a free rein. It is also unclear why RECs should be independent of the state. COREC is an arm of the National Patient Safety Agency, which means that the state is a party in the process of ethical review. Indeed, it seems appropriate that RECs as a regulatory authority have this connection.

The next point to consider is the method of RECs. This has been alluded to in the discussion of their precautionary underpinnings. Should RECs have an explicitly stated method of adjudication? As a regulatory authority, do they already have a stated method—a paternalistic or precautionary one concerned with the protection of research subjects? The AHAG recommended that inconsistency in the decisions across ethics committees needs to be explained.15 However, explanation need not mean that inconsistencies in these decisions should be eliminated. The fairness of the procedure will be especially important in justifying any inconsistency. If we have situations in which it can be argued that like cases are not being treated alike, the substance of the reasons given for the dissimilarity in treatment will determine whether such inconsistencies are justifiable. It has been suggested in some quarters that the wish to remove excessive inconsistency in decisions made by RECs is unworkable, because “ethical” decision-making cannot be standardised in the same way as medical decision-making can.16 However, criticisms such as this to me seem to miss the point; while it may not be possible for decision outcomes to be standardised, the procedures for review can be. Standardisation of procedures would seem to fulfil the ideals of accountability and fairness underpinning the AHAG recommendation in this instance. This also coincides with the AHAG call for broader participation in the REC review process. Humber puts forward the following arguments:

… there is an important check present when a committee makes a decision that is not present when an individual makes a decision. Given a sufficiently large and diverse committee, there will almost always be people who represent different ethical viewpoints present and each perspective will, at least, get a chance to make its case—whether or not it is ultimately accepted by the committee.2

The importance of wider participation should not be overstated or accepted as a sufficient condition for legitimacy of outcome. I think the check that should be in place is that fair procedures are used by all ethics committees. It is not clear to me that more opinions mean that better decisions will be reached or that the use of more methods in ethics will increase the likelihood of better decision-making. A call for wider participation is part of the procedural process but it is not without problem. To quote Black again:

If we operate on the assumption that society is plural, differentiated, that there is no monopoly on knowledge, or even no single vantage point from which the whole can be observed then there is no “one” who can decide; decisions must therefore have to be made by a combination of “others”, however those are identified and defined. In fact the close association between proceduralization and participation and deliberation is illustrated by the frequent advocation of the latter as one of the techniques of proceduralization itself. But any discussion of regulation or policy that advocates greater participation, negotiation, and deliberation as the solution to the problems it identifies offers not a solution but a new set of questions. Yet calls for procedures that will facilitate participation or deliberation often do not go further, and do not consider the form that participation should take.8

It is not enough to simply presume that broader participation will lead to “better” decision-making. Some further work must be done. This brings us to the importance of the reasons given for the decisions that are made. When we define the role of ethics within the ethics review process, we can be clearer about whether decisions are made for ethical reasons or for other types of reason. At present, all reasons are in danger of being considered as falling into the category of ethics. Reasons that are ethical reasons will need to be carefully explained. Reasons for decisions will be important for the sake of accountability. They will show why certain conclusions may or may not be justifiable. This is especially important in ethical deliberation, where there is an opportunity for differing and contradictory conclusions to be reached. Decisions that may at first appear to be inconsistent can on further analysis be shown to be quite justifiable. As Daniels and Sabin argue:

The value of having rationales—not simply rules … is that they can be educative about the importance of conserving resources and they can reveal a pattern of thoughtful attempts to meet needs fairly under budget constraints.13

Daniels and Sabin describe what they call “accountability for reasonableness” in the decision-making process. This accountability is also important when we are acknowledging the role of ethics committees and their status as a regulatory authority. If we force or allow all reasons to be hidden behind the term ethics, then how can we hope to achieve accountability? Reasons must be made clear, and provided that they fall within the bounds of what we think is justifiable prohibition or admission, then inconsistency need not be eliminated. Rather, it should be explained. I quote Daniels and Sabin again:

Generally, when there is a violation of the formal principle of justice, we are challenged to evaluate the weight attributed to a reason or principle that was applied in one case but not in the other. We are asked to find a difference in the cases, that is, to show that they were not really similar in all relevant ways, or to affirm the uniform application of that reason or principle or some alternative principle. But in the condition of moral pluralism we face, we have no candidate principle that enjoys our endorsement independently of the fair procedure we are employing. A reason that may seem compelling or decisive in one process may not have that force in another. To be sure, we are not flipping coins in either case. We are deliberating carefully in a reason-driven and reason-giving way. But the weight given to reasons in each setting is a reasonable reflection of other moral disagreements and moral uncertainty—the very uncertainty about what counts as a just outcome that compels us to adopt a procedural approach to fair outcomes.13

The lack of agreed, objective ethical criteria or of a universally accepted ethic that we can use in decision-making means that procedures and reasons are even more important. This does not mean that all the decisions and deliberations of ethics committees will similarly lack objective criteria. Take the example of the technical evaluation of the science involved. There should be accepted standards that apply objectively to considerations of the technical side of the science. The reasons will still be important—but they will not be sufficient to justify decisions contrary to these objective standards. The reasons given for the decisions made should be explained in accordance with the category of deliberation that they fall into. For instance, proposed research could be rejected because the methods used are dated or it is financially not worthwhile. The reasons seem fine, but they should not be called ethical reasons. So I agree with Dawson and Yentis, who say:

We suggest that it should be, at the very least, permissible for RECs to question the researcher about methodological issues, and, if necessary, refuse to approve the project until satisfactory answers are obtained.1

The recommendations of the AHAG, stating that ethics committees should not make decisions about the science, seems to try to meet the concern that committees may have been making recommendations beyond their expertise. I think that it does so incorrectly; instead, we should ensure that RECs have suitable membership to make decisions such as these. Although this may seem to jar slightly with the “inclusive” nature of proceduralism as a method of regulation, it is not, I think, sufficiently problematic to justify removing these types of decision from the review process. In their recommendations, the AHAG suggest that the membership of RECs be changed so that it is more representative of the general population. I am unsure why this would be necessary or what sort of role this would fulfil. Although at present the concept of citizens’ juries as aiding democracy is quite a fashionable one, I am not sure that it would be appropriate in this instance.iv

CONCLUSIONS

If it is accepted that ethics committees are regulatory authorities, as opposed to consultation groups, we are left with some problems concerning their role. As regulatory authorities, should ethics committees be promoting moral minimums or should they aim at promoting best “ethical” practice? This question should be considered in the light of my proposal that the role of ethics within the regulatory committee be clearly delineated and in some cases reduced. It should also be considered in the light of the ethical standards that regulation expects in other domains. In coming to a conclusion, it will also be important to keep in mind the remit of ethics committees as authorities created to promote the interests of subjects and patients. Once this role is fulfilled, should further steps be taken in order to promote best ethical practice? If we want to promote best ethical practice, I believe that we are best served by moving outside the review process towards a more consultative or advisory approach. Researchers should be able to raise concerns without fear that their research will suffer as a result. Similarly, researchers should not feel that they can devolve responsibility for the ethics to some third party. Ultimately, researchers will be responsible for their own research and this means responsibility in all areas. This is why I suggest that ethics review should not be seen as the beginning and the end of ethical considerations for researchers. At present the view is taken that science and ethics exist in confrontation with each other. This confrontational view needs to be abolished. Arguably, an acknowledgement of the facts that, first, ethics committees now act as regulatory authorities and, second, not all reasons for research being restricted will be “ethical” reasons can help achieve this aim. To facilitate the growth of this type of relationship, two steps should be taken: one, the role of ethics within RECs must be clearly delineated, and, two, the relationship between ethics and research must be extended beyond the ethical review process.

Many will not believe that the relationship between ethics and research needs to be extended in this fashion. This may be true with regard to the constraints one exerts on the other. However, if we are thinking of the influence one has on the other in promoting better and more considered research, then I think that this growth in the relationship should be welcomed. I would show echo Hedgecoe and colleagues, who argue that:

As Europeans, we can no longer think of RECs as individual, discrete bodies in which ethical debates are played out in isolation. Nor can bioethics assume that training REC members in ethical decision making is as influential as may be assumed. We need to see RECs in their context, a part of an international regulatory system for pharmaceutical products, subject to the pressures of different interest groups at different levels (EU, national and local). If we are to understand RECs and the decisions they make, we must understand what they have become.19

However, it is still important to stress that external influences in the form of required standards should not be the end of the process. Dawson and Yentis rightly remind us that:

Ethics should be not only a part of good science, but its driver—for the primary justification for much medical research is the ethical obligation to provide the most effective treatments.1