Trust, confidence and the regulation of risk: examining the Research Governance Framework for Health and Social Care
Lead Research Organisation:
University of Leicester
Department Name: Health Sciences
Abstract
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Organisations
Publications
Angell E
(2018)
Style Matters: An Analysis of 100 Research Ethics Committee Decision Letters
in Research Ethics
Ashcroft R, Dixon-Woods M.
(2011)
Bioethics Around the Globe
Dixon-Woods M
(2009)
Why do people cooperate with medical research? Findings from three studies.
in Social science & medicine (1982)
Dixon-Woods M
(2010)
Regulating research, regulating professionals.
in Journal of the Royal Society of Medicine
Dixon-Woods M
(2008)
Regulation and the social licence for medical research.
in Medicine, health care, and philosophy
O'Reilly M
(2009)
Doing accountability: a discourse analysis of research ethics committee letters.
in Sociology of health & illness
| Description | STREAM 1: POLICY ANALYSIS Our literature review of the emergence of research governance in its current form in the UK drew on Everett Hughes' (1958) characterisation of the relationship between a profession and society in terms of two important concepts: licence and mandate. Licence is granted to certain occupational groups to carry out particular activities; a mandate is claimed by members of the group to define for itself proper conduct in relation to matters concerned with their work. Hughes emphasises that the social licence goes well beyond a legal permission to carry on certain kind of work, but involves claims to broad legal, moral and intellectual entitlements. Hughes was interested in how "bargains" were struck between professions and society, and how unrest on either side reveals otherwise hidden aspects of the bargain. We felt that these ideas had considerable explanatory purchase when researchers are considered as an occupational group seeking to exercise a mandate, and research as requiring a social licence. We propose that the model of governance and regulation now in place is one that emphatically displaces the responsibility for the proper conduct of research within the NHS from the medical profession, and instead institutes a system of external controls, thus significantly undermining researchers' mandate. One possible explanation for the emergence of governance in this form might emphasise the role of European Union legislation as the prompt for the RGF, and certainly this was an important factor. It continued a tradition of introducing governance procedures in response to administrative fiats (such as the requirement, dating to the 1960s, that US research funded through the National Institutes for Health be approved by a Research Ethics Committee). However, a broader historical and sociological perspective is needed. We argue that the growing distinction between medical research and medical practice, which, combined with the risks (moral and otherwise) that research appeared to generate, gave research the status of a discretionary activity, a sub-field requiring more specific oversight and control. Medical research could no longer be understood as an activity only carried out by doctors on a single register bound by a common ethical code; rather, it is now part of a more general enterprise that lacks a unitary professional structure. Researchers make many claims for the professional features of the work they undertake, but they do not display the characteristics of a single profession. There is no single professional association or register, and research thus lacks a single set of explicit standards of professionalism, code of conduct, or set of sanctions imposed from within. Alongside the apparent weaknesses of the professional structure of research, the role of "scandal", appearing to demonstrate that researchers could easily succumb to the profane, was also important in the emergence of the "new governance". Research has now been refigured as what Rothstein et al (2006) term an institutional risk, one that requires organisations to demonstrate that they have in place systems for controlling the risks of an activity to deflect criticisms of their accountability. The response to research scandals and the apparent weaknesses of self-regulation by researchers has been a move away from agent-based approaches, which rely on the professional credentials of researchers, toward formalised, external regulation in the form of research governance and associated regulatory practices. Our formal documentary analysis found that the need for research governance is created in policy documents through the invoking of several key issues including the risks posed by research and the need to protect participants from harm. The ability of researchers (individually or collectively) to manage their responsibilities effectively, and with the best interests of research participants in mind, is cast into doubt in the documents through the invoking of past research misconduct and claims that researchers have defective understanding and awareness of ethical issues (Department of Health, 2005). As Bacchi (2000) notes, the framing of problems in this way can serve to block certain possible solutions from consideration. The combined effect of these invocations works to destabilise an agent-based approach, and close down any possibility of a strengthening this as the way forward; an external system of research governance presented as the only satisfactory solution. This approach is further justified through a process of institutional isomorphism, through appeals to similar systems in clinical governance and social care. In its aim to "forestall poor performance, adverse incidents, research misconduct and fraud and promote good practice", the RGF can be read as re-defining research as a risky enterprise and instituting a risk regulation regime (Hood et al, 2001). The current system of research governance in health research has a central focus not only on the creation of rules and systems to channel things through, but also the ability to demonstrate that those rules, systems, and procedures are in place. A key function of this is the demonstration of accountability, and the assignment or location of accountability with particular agents and/or groups at specific points within the system. The policy documents consistently reiterate the need to have "systems in place" to guide and record research and reflects a move from a "tell me" to a "show me" worked (Rothstein, Huber and Gaskell, 2006) A prominent feature of the Research Governance Framework (as of virtually all forms of regulatory systems in research worldwide) is some form of ethical assessment, usually institutionalised as a Research Ethics Committee (REC). The NHS REC system can be understood as a means of creating an institutional location for ruling on the ethical standing of applications to conduct research. An analysis of the National Research Ethics Service (NRES) application form shows that it produces certain issues as key ethical concerns (such as the arrangements for gaining informed consent) whereas others remain invisible. Thus, although the RGF acknowledges that the rationale and legitimation for conducting research is to contribute to the public good, there is no requirement on the standard application form for the applicant to make a case for the benefits of the research and/or how it will benefit the public. The form itself, with boxes to tick, questions to answer correctly, and documentation to include, creates a new realm of procedural requirements that may be considerably removed from that of "ethics", understood as moral conduct. STREAM 2. CONFIDENCE AND TRUST IN RESEARCH Our analysis of 128 accounts of people who were asked to participate in three different studies (a clinical trial of antibiotics in pregnancy, a genetic epidemiological study of blood pressure regulation, and a childhood cancer tissue bank) suggested that the social organisation of research is fundamental to the judgements people make about cooperation with research. It further suggests that cooperation may be a much more useful way of thinking about how people come to engage in collaboratively oriented actions such as research participation, rather than currently dominant (and individualistic) models such as those concerned with the adequacy of consent. There were two essential characteristics of participants' account of cooperation with medical research. First, the account must be able to that show that individuals have contributed to the public good and demonstrated kinship and fellow-feeling. Second, it must also be able to demonstrate that they were not stupid, gullible, and foolhardy in so doing. Our data suggested that a "moral account" of participation based purely on altruism and notions of research as a public good was unlikely to be sufficient to engage cooperation on its own. Though it is conventional for people presented with invitations to resort to (sometimes highly elaborated) justifications and excuses if they wish to refuse (Kitzinger & Frith 1999), our analysis suggested that it was culturally plausible for individuals presented with a request to contribute to research to assess whether this is genuinely something good, to judge any benefits (such as "warm glow" or improved treatment) to themselves or those close to them, and to evaluate whether the costs and risks were in proportion to any benefits. Our data provided clear evidence that people's reasoning and engagement were actively structured by the institutional field in which research projects were located. An especially important finding was that, though an orientation towards research as an institution was important in generating a moral account of participation, it was an orientation towards medicine, healthcare and professionals that was important in informing an account of why it was reasonable and safe to participate; many of the cues about safety that participants were relying did not derive from any detailed knowledge of the regulatory code for research. Our findings challenge the influential literature which has advanced a theoretical distinction between trust and confidence. Critics point to the importance of trust and the risk that rule- and contract-based forms of regulation do violence to trust, with negative consequences. However, our data suggest that the distinction between trust and confidence may be difficult to discern empirically. People appeared to orient towards research based on positive expectations about what occurs within a community with commonly shared norms and a high degree of value congruence, as well as relying on fiduciary aspects of their relationships with health professionals, thus conforming to a trust-based model. But they also relied on assumptions about constraint and oversight that were much more consistent with a confidence-based model. In making judgements about the goodness and safety of particular studies, participants did engage in monitoring of visible signs of 'reasonable practice' (Power, 1999) of the kind that might be mandated by a regulatory regime. Participants therefore responded to aspects of the 'front stage' of research projects, including the credentials of professionals and the cues provided by 'branding' of projects as, for example, 'NHS' or 'University' rather than commercial. The role identities of particular professionals and institutionally located interpersonal relations helped to confer legitimacy and secure people's cooperation. Thinking about cooperation rather than trust or confidence helps to direct our attention to how judgements and actions that might at first glance appear individual (such as consent), are in fact institutionally and organisationally structured. STREAM 3. FUNCTIONING OF RECS AND RESEARCH GOVERNANCE Doing accountability in REC letters Research Ethics Committees (RECs) are an important institution of the regulation of research, but the intensity of contestation about their practices makes the question of REC accountability an important one. Our discourse analysis of 260 REC letters revealed a number of discursive strategies and rhetorical devices used by RECs to "do accountability". Descriptions in letters were put together to perform accountability work, manage questions of fault and blame attribution, and legitimate courses of action. REC letters used discursive tactics display how RECs have executed a rigorous and diligent process and take their decisions seriously and with proper authority. They also used such tactics to show that what is proposed by the applicants is not recognised by the REC as desirable, proper, or appropriate. They suggested that the issues raised in their letter are not their fault, but rather they have been obliged to raise them: the applicants are to blame for missing information and making mistakes and ethical blunders that require correction. The rhetorical organisation of the texts often disallowed alternative accounts of "ethical" practice (including those proposed by the applicants), instead asserting the REC's own account as the privileged one. This privilege is claimed through the category entitlements conferred by REC membership, but may also be bolstered through reference to external authorities. We argue that much of the contestation about REC expertise and authority derives from an unwillingness of researchers to grant RECs what Starr (1982) terms "cultural authority": the power to define reality and have those definitions prevail as valid and true. We suggest that, paradoxically, some of the tactics used by RECs in their letters, while on the one hand "doing" accountability, at the same time function to diminish legitimacy. This can be seen by looking at how RECs tend to present their views as ethical "facts", even though the issues at hand are opinions and judgements that are inherently contestable. Threats to legitimacy are reinforced by the lack of formal ethical reasoning in the letters; there are few examples of ethical arguments being rehearsed. When issues such as informed consent are raised, it is usually as a procedural norm. Subject positions in REC letters Our analysis of subject positions further suggests that some of problems of REC legitimacy may be associated with the ways in which RECs take up, in their letters, identities and roles that we may understand as positions. RECs construct, occupy and maintain a range of subject positions, both for themselves and for research teams and possible research participants, in their letters to applicants. 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. By displaying a duty of care to the participants, the REC positions itself as on the 'side' of the participants with each research project. 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 (Scott, 2008). Use of "command"-like directives, of the kind that we identified in some of our letters, 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. Our analysis also suggests that if REC letters did more to demonstrate that highly 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 (1989) 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. Interviews with researchers We interviewed 31 university-based researchers who had been involved in a range of different types of project (clinical trials, tissue-based research, qualitative studies, epidemiological research, and others). Participants attributed the rise in regulation of research both to the wrong-doing of a small number of researchers, but also saw it as part of a more global move towards increased regulation, and were thus consistent with our policy analysis. Many researchers were broadly sympathetic to the idea that self-regulation was not a wholly satisfactory model, in part because of the pressures on researchers to take "short cuts" and because researchers may not be fully aware of ethical issues; there was therefore broad agreement that some external control and scrutiny were needed. Researchers generally saw various aspects of the ethics review process as positive, but very few saw any positive impact of gaining research governance approval from NHS trusts. Ethics review was valued for its demonstration that a project's standing as ethically sound could be assured. There were, however, specific frustrations: some ethics committees were perceived to lack the relevant expertise (e.g. in qualitative research methods, some vulnerable groups) to assess certain applications, and the process was perceived as demanding and time-consuming. The research governance process was much resented because, without delivering any evident benefits.It was seen to impose deeply frustrating delays, to divert resources intended for research, to hinder valuable scientific progress that would help patients, to create barriers to the recruitment of research participants, to deter collaborators (especially those outside healthcare and academia) and to increase costs. Some participants also expressed concern that R&D offices sometimes acted outside their remit. Many problems were seen to arise from the duplication of procedures across many different sites, the inconsistency in processes and procedures between sites, and the lack of proportionality. Requirements for researchers to obtain honorary contracts with each trust, and to undergo multiple health and criminal checks before being allowed to engage in data collection, were a particular source of frustration. Researchers discussed various options for improving existing systems. They recognised that researchers in healthcare came from a wide variety of backgrounds and have different qualifications and experience, and that this posed problems for any approach that relied on licensing of researchers. |
| Exploitation Route | These findings have helped to inform policy and practice in relation to research regulation and governance. |
| Sectors | Healthcare |
| Description | Wellcome Trust Senior Investigator award |
| Amount | £890,000 (GBP) |
| Funding ID | WT097899 |
| Organisation | Wellcome Trust |
| Sector | Charity/Non Profit |
| Country | United Kingdom |
| Start | 09/2012 |
| End | 09/2017 |
| Description | Future thinking: the next 40 years of medical sociology. Plenary talk |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | Yes |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Sparked questions and discussions afterward Increase in number of requests for methodological and theoretical expertise. |
| Year(s) Of Engagement Activity | 2008 |
| Description | Is Biomedical Science Over-Regulated? |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Local |
| Primary Audience | Professional Practitioners |
| Results and Impact | Presentation sparked questions and discussion. N/A |
| Year(s) Of Engagement Activity | 2007,2008 |
| URL | http://news.ulster.ac.uk/releases/2007/3174.html |
| Description | Managing risk and uncertainty in participation in biomedical research: Trust, confidence, and regulation. TG04 'Sociology of Risk and Uncertainty' at the First ISA Forum on Sociology 'Sociology and Public Debate,' Barcelona, Spain, 5-9 September 2008. |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | Yes |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Sparked questions and discussion N/A |
| Year(s) Of Engagement Activity | 2008 |
| Description | Presentation on Trust and confidence in biomedical research: an empirical investigation. BSA Medical Sociology Group 40th Anniversary Conference 2008, University of Sussex, Brighton, UK, Sept 2008. |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | Yes |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Sparked questions and discussion N/A |
| Year(s) Of Engagement Activity | 2008 |
| Description | Presentation: Why do people take part in biobank research? Accounts from participants. Governing Biobanks - What are the challenges? St. Anne's College, Oxford, United Kingdom, June 2008. |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | Yes |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Sparked questions and discussion N/A |
| Year(s) Of Engagement Activity | 2008 |
| URL | http://www.dph.ox.ac.uk/helex/about/images-and-documents/GovBiobanks_PROGRAMME-1.pdf |
| Description | Regulating health research: a sociological narrative. Presentation at King's College London seminar series |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | Yes |
| Geographic Reach | Local |
| Primary Audience | Professional Practitioners |
| Results and Impact | Sparked questions and discussion Further interest in area of work |
| Year(s) Of Engagement Activity | 2008 |