Research ethics and ethics governance: where do we stand now?
The norm of good research practice in British universities is to obtain a favourable opinion (or approval) from a competent research ethics committee (REC) before commencing most kinds of research that involve human participants in some way. The research agenda at universities has evolved greatly in the last decade, with increased focus on interdisciplinary scholarship and cross-cutting research themes relating to the environment, health, technology, education, and cities and sustainable infrastructure (among other areas). Much of this research involves human participants and their data. As part of this, funders, especially in the humanities and the social sciences (e.g., ESRC; Wellcome; British Academy), have made ethics approval a pre-requisite of their funding for all kinds of research projects. Similarly, an increasing number of academic journals (including in non-medical disciplines) require that authors provide evidence of ethics approval during manuscript submission.
And yet, while ethical norms for conducting academic research itself are relatively clear, there is little understanding of how university RECs themselves actually operate. This raises questions not only about how ethical decisions are taken, but also about the kind of institutional mechanisms that RECs have in place for reviewing applications and offering appropriate support to researchers. Similarly, there is little understanding about how university RECs may achieve internal as well as external consistency, especially because they have developed in the absence of top-down coordinating role as we see elsewhere, for example with NHS RECs and the Health Research Authority (and devolved administration equivalents). In this blog, we offer insights from a recent project that sought to offer some answers to these important questions.
Ethics governance across Scottish universities: a qualitative approach
Over the past year, through the generous funding provided by the Carnegie Trust for the Universities of Scotland, a small team, led by Dr Edward Dove of Edinburgh Law School and assisted by University of Aberdeen PhD candidate Cristina Douglas, has explored the intricacies of research ethics governance across Scottish universities. The methodology involved a three-sided qualitative approach: (i) document analysis (looking at various guidelines and documents related to ethics); (ii) interviews with REC members, administrators, and managers; and (iii) direct observation of REC meetings (which were held virtually during the COVID-19 pandemic).
This approach, which is adapted from a previous study of NHS RECs (and termed anthropology of regulation) and focuses on the regulatory dimensions of these bodies, allowed for a deep understanding of how Scottish universities RECs work; their remit; their members’ perceptions of the role and REC system in terms of what works well, what works less well, and what can be done better. Useful insights were also gained about the challenges and difficulties that REC members face; the support offered by or needed from higher structures; and researchers’ attitudes toward ethics process and committees within a university setting.
Out of 15 Scottish universities, 13 participated in the project (University of Edinburgh was excluded for potential conflict of interest). From October 2021 to February 2022, the team interviewed 23 participants, whose role within RECs varied: REC chairs; experts/academic members; lay/external members; and administrative and managerial staff. Additionally, the team observed 6 REC meetings at 6 different universities.
Scottish universities RECs: varied, yet consistent
We found that RECs have a varied operation, which in part may be a reflection of the different profiles of Scottish universities: those that are teaching or research-orientated; geographically compact or spread across multiple sites; constituted as higher education institution in the more recent past or many centuries ago. There was also a fair amount of variety in terms of what members understood to be the remit of their REC and what should constitute the content of ethics review. However, we also found that RECs demonstrated a good amount of consistency in terms of how their members describe how they learned their role and their motivation for becoming a REC member; how they learn to review applications and take decisions; and their perceptions of the system and applicants’ attitudes more generally.
Overall, our interview participants described their role as REC members as rewarding for its intellectual challenge. RECs are regarded as imbued with a sense of collegiality and, quite often, friendship and appreciation of other members’ deep dedication. At times, however, REC membership has been perceived as frustrating. Interestingly, the frustrations have not been directly related to the role itself. Rather, these frustrations were born out of external aspects such as applicants’ dismissal of ethics (either in terms of superficial discussions of ethics in the applications or their attitudes toward REC’s decision/members); trying to fit REC commitments alongside busy academic schedules; and/or the lack of an appropriate online system to support the role. However, research applicants’ attitudes are seen as becoming increasingly enlightened and positive over time, with most of them being appreciative of the support and advice they receive during the application process. As such, REC members see themselves more as a kind of critical colleague of the ethical aspects of a research, engaging in a dialogue with the applicant rather than in an interrogation as a gatekeeper.
This view is also reflected in comments on potential checks of researchers’ compliance and/or audit, where in addition to the role of critical colleague, the REC may also act as a compliance-checking regulator to ensure its own processes are followed well, and researchers are undertaking their approved projects in an ethical manner and in accordance with the favourable opinion provided. When we asked our participants if RECs should be involved in the lifecycle of a research project not only by reviewing its ethics approach, but also by following-up with its compliance, most REC members commented on the potential harm to the trusting relationship between RECs and researchers. Moreover, compliance was regarded as an ethical principle for individual researcher’s overall integrity that would go beyond a REC’s remit – and, in a way, the researcher’s own responsibility in creating/maintaining their reputation. In this regard, non-compliance was considered as an exceptional occurrence that had to do with individual personalities rather than a structural matter of REC review and relations with researchers. This understanding of university RECs’ role (or, for that matter, lack of) in relation to researchers’ compliance with ethics approval is yet again a major difference from the HRA/NHS system, which can conduct a random audit on their approved projects. On the other hand, auditing of school or college RECs reviews and approvals was part of many university RECs and largely seen in favourable terms. This audit, conducted by way of mandatory annual reports or accessing randomly chosen reviews in the online system, was perceived as a constructive approach of addressing issues of consistency across a university’s various RECs and ensuring robust processes are in place.
As to the ethics review process itself – both in terms of what kind of research needs ethics approval and what should constitute the content of the review – we observed a fair amount of variation. At first glance, any research involving (living) human subjects would require ethics approval from a REC. In practice, however, a much wider range of proposals might still pose ethical challenges (and, for that matter, potential harms) even when they are not designed as ‘research’ (e.g., educational or improvement projects) or do not involve living humans (e.g., archival research). The deciding factor, it seems, is not so much the nature of a discipline (e.g., social sciences more inclined to involve human participants), but rather the nature of each individual project. With one notable exception in which all research projects, regardless of discipline and risk level, were submitted to a REC, most RECs within a university operate under a self-referral system, in which individual researchers decide whether their research might need approval or not, and in doing so, identify what they consider to be ethical issues and ways in which those issues can be adequately addressed. This in turn, would then be assessed by the REC members, who may agree (or not) with the identified issues and ways to address them, in addition to other ethical issues they may identify. While the system of self-referral situates trust in researchers – both in terms of recognising the importance of formal REC approval and of weighing the ethical implications of their research – at the very core of its culture, many participants commented on the potential of research projects that were not clear-cut to fall through the proverbial cracks. This issue became even more apparent during our end-of-project roundtable discussion of potential individual cases which didn’t fit the criteria of ethics review: research (e.g., improvement service); discipline (e.g., archival material); or participants (e.g., living subjects). In the absence of a more appropriate model of triaging projects for ethics review (e.g., ethics officers with this specific mission), the potential of oversight remains acutely present.
In terms of the reviewing process, ethics review has also been regarded differently by REC members: while some have commented that they review ethical issues only, other REC members considered their duty to also look at other issues such as data protection or information storage. This extension of RECs’ remit to what could be seen as non-ethical issues might be related to the lack of robust research governance structures and a sense of duty on REC members’ part to make sure that research conducted at their university respects all legal requirements. However, the counter-effect of this mission creep seems to generate a lot of anxiety among REC members and discussion of what should constitute an ethics review (as opposed to a review of other dimensions of a project). With stricter legislation in place regarding personal data protection since the General Data Protection Regulation came into effect in 2018 (and updates in the UK legal landscape since then), REC members reported that they felt that they lack the expertise in reviewing such issues and, in a sense, that these issues may shift ethics from a deeply engaging discussion to a ’tick box’ exercise. On the other hand, this extension of remit might be related to a REC being used as the physical place where research-related documentation is centralised in the absence of an alternative designated structure (i.e., robust institutional research governance). This seems at times to be the source of confusion for RECs in terms of what documents they are meant to review and approve. More than in any other aspects of our findings, what constitutes RECs’ remit and content of application review highlights the challenges that RECs face. It also suggests to us the importance of creating robust research governance structures at universities and sharing of best practices (the latter of which is rather limited across universities) to help RECs and researchers alike smoothly navigate the processes involved with bringing ethical (and legally compliant) research to fruition.
A big difference in how RECs operate across Scottish universities is related to the supporting review system they use: that is, a paper-based (and via email) or online system. Those RECs that use an online system seem to be more efficient in terms of allocating reviews; reviewing an application; and discussing and communicating the decision. Although there was no single online system identified as the “gold standard”, and arriving at a satisfactory online version often took various iterations, all participants recognised the importance of having some kind of an online system – and ideally one developed by a commercial provider with a strong track record of successful systems. However, making the case for investing and prioritising the acquisition of such system proved particularly challenging, even when higher institutional personnel showed support. Regardless of the type of system, though, it became clear to us that the REC’s administrator/manager plays a vital role in the smooth operation of a REC: receiving and triaging applications; sourcing reviewers who have the expertise and time; communicating with the applicant; and setting up meetings and keeping updated all parties involved.
Ethics governance – how can we do better? Areas for further improvements and future directions
Overall, most of our participants perceive university RECs as operating well. However, when we asked what they consider areas for further improvement, most of them commented on: implementation of an online system; more experience with how to evaluate various kinds of research projects; best practice exchange and training opportunities, both for applicants and for reviewers; more accurate reflection of the REC role into the university’s workload allocation model; and greater recognition of the importance of research ethics governance in the university’s research environment (which in turn has training implications for the wider research community), and for the member themselves, their career advancement. While some members commented on the inter-institutional experience exchange in which they participated, this seemed to be the exception rather than the norm. Everyone, however, welcomed such an approach not only as a way of improving their performance as REC members, but also as opportunities for professional growth.
During a roundtable organised at the University of Edinburgh as an end-of-project event in late May 2022, it became clear to us that there is consensus on these needs for improvement and desire for sharing of best practice, and a strong willingness in achieving this as part of a collaborative network. Such a network would be the first of its kind as it would operate in a professional supporting capacity and its agenda would be set up by its own members rather than dictated from above. A collaborative network would also create the space for discussing how practical issues (e.g., sourcing external members; building REC membership into the academic role) have been successfully addressed at other members’ host universities. Additionally, the network could meet for future roundtables for experience exchange – a need identified by most of our participants. Such initiatives could be sponsored by several funders. This would be not only a recognition of the importance of RECs within the university research landscape and a way of protecting them against actual or perceived mission creep, but also facilitate a heightened awareness of the importance of supporting their members in their own effort in assisting students and staff alike in undertaking as ethically robust research as possible.
Project Details can be found here.
Cristina Douglas, the research assistant for the project, is a medical anthropologist and a PhD candidate at the University of Aberdeen. Cristina’s main research interest is focused on human-animal relationships in later life, especially when accompanied by cognitive impairment.
Edward Dove is a Lecturer in Health Law and Regulation at Edinburgh Law School.