Abstract
Ethical review of applications to conduct research projects continues to be a focus of scrutiny and controversy. We argue that attention to the actual practices of ethical review has the potential to inform debate. We explore how research ethics committees (RECs) establish their position and authority through the texts they use in their correspondence with applicants. Using a discursive analysis applied to 260 letters, we identify four positions of particular interest: RECs positioned as disinterested and responsible; as representing the interests of potential participants; as facilitating ethically sound, high-quality research; and as engaged in dialogue. These positions are used strategically to deflect criticism or complaint. This analysis has implications for reducing contestation between researchers and RECs, suggesting that more dialogic rather than hierarchical approaches to positioning might be helpful.
Introduction
The regulation of health research has burgeoned in recent years. 1 A prominent feature of all regulatory systems in research is some form of ethical assessment, usually institutionalized as a research ethics committee (REC). In the UK, the Research Governance Framework 2 requires research conducted in the National Health Service (NHS) to receive advice from an NHS REC. The REC system can be understood as creating an institutional location for ruling on the ethical standing of applications to conduct research. 3 This location privileges the REC's ruling as the authoritative one, but does not wholly deflect challenge and criticism by researchers. 4–7 Much of the contestation about REC expertise and authority may derive from an unwillingness of researchers to grant RECs what Paul Starr 8 terms ‘cultural authority’: the power to define reality and have those definitions prevail as valid and true.
REC opinions must be given in writing. In this paper, we argue that attention to the actual practices of ethical review has the potential to inform debates, by exploring how RECs establish their position and authority through the texts they produce in their correspondence with applicants. Adding to previous research on how RECs ‘do accountability’ 9 in their letters, we use an approach based on discourse analysis (DA) to focus specifically on the subject positions that RECs both take on and impose on others.
We start from Potter and Wetherell's 10 insight that discourses do not ‘just describe things, they do things’ and seek to show how RECs engage in practices of positioning. Positions provide authors with a way of accounting for and making sense of themselves in terms of their motives, experiences and reactions, and managing their identity. Burr 11 notes that by taking up a subject position, the speaker or writer takes on an associated set of rights and obligations. At the same time, subject positions have explicitly relational properties, and obtain their situational meaning in relation to other possible subject positions and discourses. 12 In identifying with particular subject positions, authors take a stand against competing positions, either by strengthening their own position or by weakening competing positions. 13 We were interested in how RECs managed their own identities, and how they may also seek to manage the identities of others, including the applicants. We were further interested in how the discourse of REC letters are organized to be persuasive; 14 how RECs assert speaking rights; how they construct obligations; and how they manage issues of stake and interest.
Methods
REC activities relating to research in the UK NHS are coordinated by the National Research Ethics Service (NRES). Applications are reviewed at REC meetings, where applications are discussed by the committee. Applicants are invited to attend, and if in attendance may be invited to answer specific questions. The committee may discuss privately any matters arising from the discussion, and a decision is made that must be communicated by letter. The data in our study comprised 260 decision letters written by NHS RECs. These letters had been uploaded to the NRES national Research Ethics Database (RED). To enable us to undertake our research, we were granted access by NRES to the RED. All of the letters in our sample were fully anonymised. The project was deemed ‘service evaluation’ by NRES and REC approval was thus not required.
Our project was concerned with letters written by RECs to applicants following the first meeting at which an application was considered. Three possible decisions can be made by RECs when they first consider applications: favourable, provisional and unfavourable. We were interested in applications that received an unfavourable or provisional decision at first review, as such decisions indicated that there was an issue in the application that troubled the REC. For applications in our study that received a provisional opinion at first review, the final decision (i.e. the decision eventually rendered after the applicants had responded) was recorded.
Decision letters about applications for three different types of study were included in our analysis: cancer trials, studies involving the use of human tissue and studies involving children under 16 (see Table 1, which also explains the tags used to label extracts). The differences between these topics are not the focus of this paper, but using these data-sets does illustrate the pervasiveness of the characteristics of REC practices.
Clarification of inclusion criteria
DA is an approach ideally suited to show how institutional research can benefit from a linguistic perspective, 15 and in particular how RECs position themselves through the texts of their letters. 13 With the turn to language-based approaches, DA is an especially valued approach to analysing textual data. 16 DA appeals to researchers as an analytic tool for its ability to reveal how institutions and individuals are formed, constructed and given meaning. 17 DA is a difficult form of analysis to define in precise terms, and different approaches lay claim to the term, but there is agreement that it represents a commitment to the study of talk and text in social practice with a focus on language and how it is rhetorically organized. 18 DA is perhaps better understood as an orientation towards analysis rather than as a set of executable techniques. For this study, we based our approach to DA on the account given by Potter and Wetherell, 10 which was developed in the fields of sociology, psychology and communications studies. Using this form of DA enables a systematic, empirically and analytically grounded observation of the ways in which RECs convey their concerns to research applicants, the ways in which they construct their authority and expertise, and their rights to speak.
Findings
Our analysis found that RECs take up a number of different identities and roles in their letters that we may understand as positions. At the same time, RECs assign positions to the readers of the letters (the applicants) and to those external to the correspondence, including potential research participants. RECs routinely position themselves as representing a range of interests directed at managing the position of being on all ‘sides’, including the side of ethical practice, the side of the participants, the side of the applicant and of quality research. These practices might be seen as involving the construction of a self and an identity that allows RECs to carry off certain accomplishments, including the assignment and claiming of responsibility and blame. 19
RECs as disinterested and responsible
Some of the work of the letters is concerned with the building up of category entitlements. RECs establish themselves as having a ‘right to speak’
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on ethical matters due to their institutional entitlements. The REC is able to impose a complementary identity on the applicants: one whose duty is to be attentive to the matters that the REC is concerned with, and to comply with the REC's requests.
‘[..] requested that all future applications demonstrate the applicants’ thought processes in relation to how ethical issues were addressed in the study’ (TIDB0055.txt – Provisional/favourable opinion); ‘A68 to include further information on ethical issues in relation to patient harm’ (ID100.txt – Provisional/favourable opinion).
These kinds of directions suggest that the power relationship between the applicants is one of hierarchical authority, where rules may be enforced unilaterally; 20 this is not a form of control by persuasion, but rather laying down of the terms on which applicants may secure a favourable opinion. The institutional authority is signalled by the ‘command’ style of the instructions, but also by the invoking of administrative process (e.g. ‘A68’). RECs are not, however, engaged generally in a despotic exercise of power, nor is brute force a characteristic of the letters. Rather, RECs typically reinforce or escalate their formal entitlements to rule by showing that they are qualified to speak on ethics, because they are free of the interests and stakes that might blind others, particularly researchers, to ethical faults. We use the term ‘interest’ here in the sense of having the potential for personal advantage, and the term ‘disinterest’ to describe having no potential to benefit.
By showing their immunity from having the same interest or stake in the research as the applicants, RECs position themselves as the authoritative sources of opinions on ethical issues and on risks. This involves the discursive practices of ‘stake innoculation’
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– protecting the credibility of any views expressed by discounting the influence of having a stake in what is said. RECs thus often position themselves as disinterested or impartial, lacking the kinds of stakes that cause applicants to fail to identify the ethical problems in their plans.
(3) ‘The Committee felt that to describe the side effects as “mild and temporary” is not a true indication of the situation…’ (TIDB0741.txt – Provisional/favourable opinion); (4) ‘Possible effect on health insurance should be included as risk’ (PID1283.txt – Provisional/favourable opinion).
RECs’ disavowal of a stake in any particular research project allows them to position themselves as making visible ethical issues that might be less evident to a party with an interest. In extract 3 there is a suggestion that the research team have softened the extent of harm, thus implying that the applicants as having vested interest in the research. The REC, by contrast, positions itself as having the ability to recognize the reality: ‘not a true indication of the situation’. The REC's authority is further marked in extract 4 through its recognition of the wider context. Using the modal verb ‘should’ imposes an obligation on the applications to consider the wider context of the research in terms of the impact that their research may have, and reinforces a hierarchical form of authority.
RECs as representing the interests of potential participants
Acquitting itself of interest enables the REC to establish a boundary between its work and concerns and those of the applicants. But the REC may also position itself as not wholly neutral, and rather as having a stake in the wellbeing and interests of possible research participants. An identity is, in consequence, imposed on research participants, positioning them as requiring the protection and intercession of the REC in order to avoid being exposed to the enthusiasms and motives of researchers. This might include, for example, a defence of research participants’ entitlements to voluntary participation and freedom from coercion.
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(5) ‘Concern was expressed that the study would involve children and families that had benefited from the charity and also may be known to <named applicant> and in particular whether potential participants would feel obliged to take part’ (PID1034.txt – Provisional/favourable opinion); (6) ‘The participant's right to withdraw from the study should be highlighted, plus what happens if they do not take part’ (ID072.txt – Provisional/favourable opinion).
By positioning themselves as aligned with the interests of the participants, the REC manages both its duty to potential participants and the duty that the applicants have to the participants. Particular emphasis is placed by the RECs on the duty to ensure that potential participants are given full information about projects in which they might participate. The use of complex language and technical jargon by applicants is very frequently represented as an impediment to the proper discharge of responsibilities to participants.
(7) ‘The PIS was considered to be too lengthy and the language too complicated which would discourage potential participants. Technical terms such as “baseline, vital signs”, etc must be translated into lay terms’ (TIDB 1478.txt – Provisional/favourable opinion); (8) ‘Lay language should be used for ease of understanding’ (PID 1088.txt – Unfavourable opinion).
These extracts show the participants and applicants are positioned very differently by the REC. The REC positions the applicant as having a responsibility to ensure that potential participants understand to what they are agreeing and constructs an asymmetry highlighting the differences between the applicant and the participants. It sets up the entitlements of the participant and the corresponding obligations of the applicant, and positions itself as the honest broker.
The REC positions itself as responsible for interpreting what is required in order to satisfy ethical requirements, such as that of informed consent. REC letters establish not only that RECs have a right to speak, but also to rule on such matters. They present their opinions as the outcomes of an evaluative process through which they have come to definite conclusions.
(9) ‘Members feel that it is not acceptable; to allow participants only one hour to decide whether or not to take part in the study…’ (TIDA0010.txt – Unfavourable opinion); (10) ‘The consent form should be amended seeking specific consent in to the video recording’ (PID 0041.txt – Provisional/favourable opinion); (11) ‘It must say specifically what is being consented to’ (ID072.txt – Provisional/favourable opinion).
In extracts 10 and 11 the RECs express authority through the use of modal verbs ‘should’ and ‘must’, and close any alternative interpretation of how informed consent should be viewed. Here, the hierarchical relationship is clearly evident, with the REC imposing its view. Although in extract 9 the REC's view is presented as a ‘feeling’, this is juxtaposed with the meaning constructed through the term ‘unacceptable’, which is a clear indicator of the REC's opinion on this aspect of consent and orients to the need for compliance by the applicants.
Groups regarded as vulnerable are established discursively in letters as a special concern for RECs. Dalton and McVilly
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argue a central focus for research ethics involving vulnerable groups is protection from harm and exploitation. The problems associated with securing consent from vulnerable groups including children,
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those with mental health problems,
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the terminally ill
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and older people
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are widely discussed in the academic literature. In their letters, RECs mark out the need to protect these groups, positioning themselves as a protector of the vulnerable. In contrast to some of the ‘command’-based modes of discourse seen earlier, this may be achieved rhetorically and through persuasion, by questioning the applicants’ justifications for their plans.
(12) ‘If under 6 year olds are to be selected, then a separate subject information sheet would need to be produced. Would it be possible to exclude this group? If not, then these subjects would need to be tested for Gillick
A
competency before consent is obtained’ (PID0010.txt – Provisional/favourable opinion); (13) ‘The Committee is concerned that very sick patients are being asked to make a huge commitment – 1 weekly visit of 4 hours for 12 weeks…’ (ID553.txt – Provisional/favourable opinion).
In these extracts, the REC is asserting that a problem exists. In extract 12, a definitional process is at work: the ‘under 6 year olds’ are marked out as warranting special consideration. In extract 13 the REC positions itself as concerned with participants’ welfare. The upgraded status of ‘very sick’ and the nature of commitment as ‘huge commitment’ serves to demonstrate the REC's dissatisfaction with the demands the applicants intend to make of a vulnerable group, and again serves to reinforce the boundary between the interests of applicants and potential participants, with the REC positioning itself firmly on the side of virtue. The extract implicitly criticizes applicants for seeking to allow their interests to dominate over those of participants. By establishing this as morally deviant, the applicants are now positioned as weakened in their efforts to do as they wish. Such a tactic is thus directed much more at encouraging reflexivity on the part of the applicants than the more ‘command’-based instructions seen earlier.
RECs as facilitating ethically sound, high-quality research
Though RECs are often accused of being a ‘hindrance’ to research, they may position themselves as facilitating research and construct an identity that offers some solidarity with the research process. Much of the content of the letters was not concerned with admonishing or reprimanding applicants, but with ensuring that the proposed research was enabled to meet the ethical standards that the REC felt were warranted.
Though rare, there are instances in the letters that actively praise elements of the application as a way of showing researchers what they are getting right. By pointing out what the applicants are doing well, and/or explicitly recognizing that their proposed research is of value, the REC shows that it is positioned to facilitate the process of research by balancing requests for changes with positive feedback, and establishes itself as reasonable and ‘on the side’ of good research.
(14) ‘The Research Ethics Committee would like to commend you on your clear and well written application…’ (PID1853.txt – Provisional/favourable opinion); (15) ‘The Committee considered the introduction to the patient information sheet to be excellent and suggested it could be used as an example of the form of wording required’ (ID393.txt – Provisional/favourable opinion); (16) ‘Thank you for asking us to review your interesting and important study.’ (TIDB0410.txt – Provisional/favourable opinion).
Much more common than praise, however, are efforts by RECs to get applicants to improve their plans to a standard that the REC considers satisfactory. A frequent tactic in the letters is the offering of advice, suggestions or recommendations that could potentially facilitate or improve the research.
(17) ‘A simple version of the flow chart could be useful to both therapists and parents to show how the research interacts with normal therapy’ (PID 0683.txt Provisional/favourable opinion); (18) ‘Although it is acknowledged that the patient information sheet is given to supplement a comprehensive verbal explanation of the study, members felt that the incorporation of a flow chart might make the study information clearer’ (ID 5471.txt – Provisional/favourable opinion); (19) ‘Committee member Mr <name> would be happy to give advice on the Information Sheet. He can be contacted on <telephone number> ’ (ID 170.txt – Provisional/favourable opinion).
Bremner 27 argues that requests may be mitigated through the use of certain suggestive phrases, but despite the mitigated phraseology there is often a strong directive in these extracts: there is an implication that the REC's advice need to be followed in order to secure a favourable opinion. In these examples, the REC makes an assessment about the proposed research and advocates possible improvements. An issue for assessment is preference organization, 28 where deviations from the norm are accountable and the preferred response to an assessment is agreement. 29 In these examples the position of the REC as holding the power is directed through their role of decision-making. Compliance by the applicants with the suggested changes is implicit in the recommendations. Again, the modality of power is a hierarchical one, but notably, and importantly, the REC sometimes constructs their guidance as helpful, rather than hindering (e.g. in the offer of a telephone number in extract 19).
The offering of advice does not stop at what might conventionally be understood as ‘ethical’ matters. RECs sometimes position themselves not only as having ethical expertise but also as capable of assessment of the scientific and technical aspects of research. Commenting on the scientific aspects of applications REC performs boundary work, serving to establish that there is no firm boundary between science and ethics,
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and asserting an entitlement on the part of the REC to comment on any matter that it sees as being relevant to the execution of high-quality research.
(20) ‘Dr <name> , <named REC> statistician, had sought clarification regarding sample size estimate and analysis from <name> , the study statistician’ (ID212.txt – Provisional/favourable opinion); (21) ‘The MREC Medical Statistician (<named REC member> ) pointed out that the statistics were adequate but that the power calculation was not as accurate as it could/should have been…….’ (PID 1035.txt – Provisional/favourable opinion).
Here, the work of defining the scientific matter as an ethical one is again achieved rhetorically partly through invoking the category entitlements associated not only with the REC, but also by enlisting the specific expertise of particular REC members. Tacit conventions about knowledge, attitudes and expertise are inferentially available when people are assigned to a category so they are then, by virtue of the category, entitled to certain knowledge claims. 13 When assigned to a particular category, those with that role and responsibility (e.g. the statistician) are presented as having the expertise to formulate a judgement and are entitled to have that judgement deemed accurate. 13
RECs as engaged in dialogue
REC letters sometimes use discursive strategies to open potential dialogue and demonstrate the role of the applicant in the process, in efforts directed at ensuring that the REC is seen to make an informed, fair and competent decision about an application, and potentially also deflecting possible accusations of uninformed decisions and failure to consult with the applicant. They may, for example, implicitly or explicitly invite applicants to help to resolve an ethical dilemma. Here, applicants are positioned as having relevant expertise and competence, and as capable of offering an opinion that the REC would find useful and acceptable.
(22) ‘What are the limits of confidentiality if a young person reveals they have done harm to someone else?’ (PID1624.txt – Provisional/favourable opinion); (23) ‘A question was raised whether the decision for caesarean could possibly be influenced by the fact there was such an ongoing study. On the face of it, it seems unlikely but we would be pleased to have your thoughts on the matter’ (TIDB0410.txt – Provisional/favourable opinion).
In extract 22 the REC directly questions applicants about their proposed potential actions should ‘harm to someone else’ be revealed. Applicants are obliged to safeguard privacy and confidentiality 31 and guarantee that the parameters of this protection are clearly explained. 32 Confidentiality, however, is not straightforward 33 and there are various facets of confidentiality that RECs view as problematic. Notably, this extract does not propose a solution to the issue raised by the REC; the applicant is instead asked to provide a suitable response. This kind of participatory (rather than command-based) form is significant. Extract 23 is more collaboratively phrased. There is the indication that the knowledge of the researcher could override the concerns of the REC. It raises the query as possibility rather than as fact and invites direct collaboration (‘pleased to have your thoughts’) in a way that works with the research team and values their contribution.
Subject positions as dynamic not static
We have demonstrated that the identity of the REC is fluid and flexible and that a variety of subject positions can be taken up as an interactional resource. We have provided a range of examples from three samples of REC letters to show that the REC can construct multiple identities, both for itself and other parties such as applicants and potential participants, and that these shift through the discourse. Because of the nature of our analysis and the need to provide a range of examples to illustrate our points, what is less clear thus far is that these positions are variable and dynamic within any particular letter. 34 In any single letter the REC may shift through different positions and take up a range of identities. In Box 1 we present a single case study to demonstrate the fluidity of identity not just across RECs but within them.
Case study example extracts
1. REC positions itself as disinterested and responsible
General – ‘The Committee raised concern that the proposed study might deter young women from accessing emergency family planning and queried whether <named researcher> felt that this was a realistic concern.’
2. REC positions itself as representing the interests of potential research participants
Consent – ‘Members queried whether the proposed Consent Process for those participants who were recruited via FP nurses a <named organisation> and a random sample of community FP clinics was reasonable…’
Risk/harm – ‘It was pointed out that the Patient Information Sheets must include details regarding the implications of a positive Chlamydia test result in terms of sexual contacts/partners etc.’
3. REC positions itself as facilitating ethically sound, high-quality research
Helper of research– ‘The MREC suggested that in terms of the study design, it would be more usual to undertake the qualitative work first….’
Positioned as knowledgeable – ‘The MREC Medical Statistician (<named REC member>) pointed out that the statistics were adequate but that the power calculation was not accurate.’
4. REC positions itself as engaged in dialogue
Seeking clarification – ‘Clarification/further information was requested regarding the three focus groups, i.e. how would they be convened etc?’
In this letter the REC takes up a number of different positions to construct their identity and present neutrality in the decision-making. It takes up a range of identities that could be viewed as promoting all sides. The flexibility of these positions is evident through the range of examples provided above, whereby the REC positions itself as having a duty of care to the participants, engages in discourse designed to facilitate research and promotes collaboration with the research team in the decision-making process. The REC fluently moves between having participants as their central concern (by raising issues of consent, and potential risk and harm) and being concerned with the quality of the research (by positioning knowledge as a relevant feature), while not disregarding the contribution of the applicant (by seeking clarification and further information). RECs do not create and occupy one single subject position and maintain this consistently and in a static way through their written interactions with applicants. Instead the subject positions they adopt have a fluid and flexible nature.
Discussion
By using DA on naturally occurring data (the actual letters produced by RECs), we are able to uncover some of the ways in which RECs communicate with applicants and how they manage their identity and social relationships. Our analysis demonstrates that RECs construct, occupy and maintain a range of subject positions, both for themselves and for research teams and possible participants, in their letters to applicants. We show that RECs have multiple flexible identities and these are created through text as a way of managing and maintaining their social relationships with the research community. RECs position themselves in ways that create and maintain functional boundaries. Disclaiming an interest or stake in research projects is an important tactic that allows RECs to assert a claim to impartiality, but one that is tempered by a favouring of the interests of possible participants. These discursive tactics structure the relationships between RECs and applicants, and organize the proper responses.
Positioning is not necessarily intentional, but may nonetheless involve the active claiming of identities. 35 Recognition of the potential implications of the positions adopted may mean that authors are less likely to position themselves in ways they did not intend, as well as informing strategies in struggles with identity. 11 Our findings have important implications for addressing the criticisms that have been made, in the UK and elsewhere, of the performance of RECs, 36 including obstructing research that would be of benefit to patients, 6 undermining researchers’ professional responsibilities and integrity, 37 and unwarranted paternalism, 38 among other problems. Our analysis offers some suggestions that perhaps deserve consideration and evaluation.
First, it might be argued that as long as RECs are seen to rule through administratively conferred privilege, rather than the exercise of professional expertise, they are prone to contestation. Making people do what they would not otherwise do, and moreover what they do not feel is the right thing to do, will always provoke resistance of various kinds. 39 Use of ‘command’-like directives, of the kind that we identified in some of our extracts, reinforces the kind of hierarchical relationship most likely to cause resentment, positioning as it does the applicant as an unruly subject with no option other than obedience. It could be argued that RECs might, as far as possible, reduce these to a minimum.
Second, RECs might wish to consider how they might more forcefully demonstrate their expertise, rather than simply their entitlement, in making judgements and rulings. People can achieve the position of expert through many discursive strategies. One of these is to display certain kinds of knowledge. 40 A notable feature of our findings is the extent to which it tends to be only in matters of scientific concern (such as the design of a study, or its statistics), that forms of expertise get specifically called upon to justify the REC's opinion. Yet, as has been shown elsewhere, 9 formal ethical reasoning tends to be absent from letters. If REC letters did more to demonstrate that specific forms of expertise relating to ethics, and thus a claim to special wisdom, lay at the basis of their power, they might be able to show an authority based more in competence than in office. As Giddens 41 points out, people are much more likely to acquiesce in the exercise of expert power when they place their trust in the body of knowledge and the competence of the practitioner. Such an analysis would argue for RECs offering far more elaborated and reasoned accounts of their views than are currently evident. Our intention here is not to be prescriptive about the specific formal ethical position that we feel RECs should adopt. Rather, our point is more about the need for RECs to demonstrate the rationale for their decisions and to be explicit about how they come to regard particular issues or proposed actions as unethical. Setting out the principles that guide their decision-making, and more explicitly recognizing that ethics is often difficult, contingent and negotiated, is likely to increase transparency and promote accountability, and provide a more sound basis for engagement.
A third suggestion is more optimistic about current REC practices. This concerns the ways in which RECs manage issues of stake and interest. We would argue that it is important both for RECs themselves and also for researchers that RECs continue to manage their identity as one that explicitly disavows a stake in particular research projects, and that is aligned with the interests of possible participants. This is not to suggest that RECs should not be supportive of research (and the potential benefits to be gained from it) in more general terms, but rather that they should continue to demonstrate that their decisions are not influenced in any way by their own ability to benefit. Indeed, one of the positions that RECs commonly adopt is as the facilitator of ethically sound, high-quality research; yet they manage to achieve this without compromising their primary concern with the interests of potential participants. To do otherwise would, we would suggest, risk the social licence for research. As described elsewhere, 42 the social licence refers to the nature of the bargain between the institution of research and society; RECs are an important element of the governance system that aims to enable participants to cooperate with researchers by assuring them that the risks of research are well managed. 43
Finally, we suggest that some practices that are already available in some REC letters should be further promoted. In some letters there is evidence of a more participatory model of governance, where RECs recognize the kinds of expertise and competence that researchers can bring to bear in resolving issues – whether they are tricky ethical dilemmas or more mundane questions of how best to handle a procedural problem. This approach would appear to engage many of the inclusive and participatory principles, including the active involvement of workers in the management of risk that are argued to be ideal in regulation. 44,45 It is also consistent with O'Neill's 46 call for more explicit effort to establish a relationship of trust among the parties in research, and Miller and Boulton's 1 argument for engagement of applicants, participants and ethics committees to develop a clear understanding and a commitment to the welfare of individuals in order to advance knowledge. Similar calls for a more dialogic approach to ethics have also been made by others. 47,48 A dialogic approach does not, of course, mean that RECs should relinquish their role in identifying, classifying and commenting on ethical problems. Earlier we called for more displays of formal ethical reasoning to appear in REC letters, and suggested this may encourage researchers to acquiesce on the basis of enhanced trust in the REC's knowledge and competence. This is not incompatible with our calls here for a more participatory approach, as detailed accounts of how a particular ethical decision has been arrived at can also open up possibilities for engagement. In our data, there were several examples of how RECs were able to use rhetorical strategies of persuasion to indicate ethical problems and direct their resolution. But creating more opportunities for applicants to help resolve these by engaging them as partners might encourage more ethical awareness and reflexivity on the part of applicants, rather than a passive dependence and submission to the will of the REC.
An ethics review process that encouraged this kind of dialogue would be more demanding for both applicants and RECs. Applicants might have to engage far more seriously and thoughtfully in ethics, and RECs in their turn would need to be prepared to cooperate accordingly. Respect, patience and a willingness to engage would be needed on both sides.
Footnotes
Gillick-competence is a legal rule that stipulates that a child is deemed competent when s/he demonstrates a sufficient understanding and intelligence that enables an understanding of what is being proposed for treatment or research. 48