Universities and Ethics Review
How is ethics review organised in different institutions, subjects, and countries? How ethics review of research projects is organised in UK universities is subject to wide variation. In this section we present details of a survey which describes this variation. We also include accounts of additional tiers of review that might be required for health related research, research carried out among specific minority groups, research that might require multiple reviews from different institutions, and research in a foreign country.
University ethics review: A survey of Institutional variation
As part of our preparations for the Durham Colloquium, we asked James McMurray of the University of Sussex to undertake a survey of ethics review activity in UK institutions awarding degrees in the UK. Below is a summary of James’ data.
The survey covered one hundred and sixty three degree-awarding UK institutions. In 2016 and/or 2017, twenty-seven offered courses in anthropology, ninety-five offered sociology, and sixty-four offered geography. In all cases where information on ethics procedures was available, institutions had a central committee which, at the least, formulated a general research ethics policy and periodically reviewed ethical issues and reported their findings upwards. In institutions where ethics review procedures have been delegated to more specialised sub-committees or panels, the central committee also received periodic reports from them.
The role of centralised RECs.
In thirty of the one hundred and nine institutions for which information was available, central committees were responsible for ethics review in at least some circumstances. In twenty-one of these cases, a central committee or review panel was responsible for all non- or low-risk ethics reviews. Examples of central committees of this type include those at Goldsmiths and the London School of Economics. University College London is an example of a central committee which undertakes reviews of most proposed research, but delegates to subcommittees only in specific areas, such as Education and Social Care. In the remaining nine cases central committees deal only with the review of proposed research which meets specific criteria, such as proposals considered to be high risk, or proposals which are both high risk and propose to deal specifically with confidential or distressing information. Bath Spa university is an example of the former and Aston of the latter.
In thirty-two cases central committees review proposals referred upwards to them by subcommittees or panels in cases where there is disagreement, conflict of interest or particular concern over ethical issues. However, in some institutions – such as King’s College London – final responsibility for ethics review remains with devolved committees, and the central committee does not receive referrals.
Devolution to Subcommittees or Panels
In eighty-eight of the institutions for which information is available, responsibility for ethics review procedures has been delegated to some degree. In many cases, the degree to which this responsibility was devolved is dependent on the level of risk associated with a research proposal, with supervisors or ‘Level One’ panels being responsible for lower risk approval and ‘Level Two’ panels taking responsibility for higher-risk approval. Identifying the risk-level is in some cases the responsibility of the researchers themselves – often via a checklist. In other cases – such as the University of Gloucestershire - proposals are first submitted to a gatekeeper, who may be a specific officer or the chair of a ‘Level One’ ethics panel, who identifies the correct committee or panel to assess it. In other cases – such as Edinburgh Napier University – supervisors and ‘Level One’ panels must both approve proposals before referring them up the hierarchy, thus filtering out inappropriate proposals at the school level.
In nineteen cases responsibility for (staff and post-graduate) non-low risk ethics review has been devolved to ‘Level One’ – that is, to departments or schools dealing with specific subject areas – in at least some cases. In seven of these cases – for example, Oxford University and Durham University – all reviews are undertaken at this level, although complex or difficult cases may be referred upwards. Often the decision of whether to devolve responsibility to this level is up to a ‘Level Two’ committee, which may recognise the need for subject-specific concerns only in some cases – Southampton University is an example of this. In other institutions, such as the University of Kent and Liverpool Hope University – devolution depends at least in part on the volume of research proposals being received, with higher volumes prompting a delegation of responsibility.
In the remaining sixty-nine institutions where responsibility for ethics review has been devolved to some degree, reviews are carried out by ‘Level Two’ committees representing a group of research areas or faculties. In some cases – such as the Universities of Glasgow and Cardiff – these committees may be concerned specifically with those disciplines – such as the Social Sciences – likely to engage in ethnographic research. In others – such as the Universities of Southampton and Bradford – these ‘Level Two’ committees may represent broad swathes of disciplines, including such unlikely subjects a mathematics, business, and health.
Ethics review in Institutions which offer Anthropology
Of the twenty-five institutions offering anthropology included in this list and for which information is available, responsibility for the review of high-risk proposals lies with a central committee in seven cases. This number includes the London School of Economics, the University of Sussex and Goldsmiths.
Of the remaining eighteen institutions, responsibility for ethics review is devolved to ‘Level One’ – that is, specific subject areas – in four cases: the Universities of Cambridge, Durham, Edinburgh, and Oxford. In all other cases devolution is to ‘Level Two’, and anthropological research proposals are reviewed by faculty or school committees also concerned with other subjects, generally the social sciences and humanities.
As will be clear from the survey, the variation in just where a REC sits within the institutional structures of a university is considerable. Furthermore, just where a REC sits is likely to be correlated with its scope, function and manner of operation. Generally, the more centralised the procedures, the more they are likely to reflect institutional rather than disciplinary or researcher interests. For this reason it is important to ascertain just how the REC operates and what the expectations are of those putting their research through it.
Given that your research might be conceived in one place but carried out in another, the question of REC approval may increase in complexity with not one but two or more formal ethical approvals being needed. The three most likely scenarios of interest to anthropologists are 1) where issues of health and medicine are concerned; 2) where a particular ethnic minority group are to be studied; and, 4) where research is carried out across national boundaries. In each case, the need for secondary review arises in part because the authority of one ethics committee is not considered adequate or competent to authorise research that takes in a different jurisdiction.
In general, research into health and medicine both in the UK and abroad requires consideration by specialist RECs acting on behalf of health services and the people who they serve and represent. The responsibility for oversight might operate at national, regional or individual hospital level. In the UK for example, any research that involves service users and their families has to obtain clearance from and National Health Service Research Ethics Committee (NHS REC). The requirement also includes carers and past patients who have been identified through NHS records as well as all NHS staff. The REC oversight requirement is thus cast pretty widely. The machinery for ethics review in the NHS is extensive and complex and has in recent years become one of the major impediments to carrying out qualitative research into health-related topics. The UK NHS has responded to this criticism by establishing Health Research Authorities (HRAs) to centralise and harmonise the applications procedure across different local health authorities in the UK. It has also introduced a system of filtering designed to expedite projects deemed to be of lesser ethical risk (see for example the Health Research Authority’s Ethics ‘decision tool’.
Nonetheless, having obtained ethical clearance from one’s RO only to find that there is another procedure to negotiate can prove arduous and time-consuming. In planning research that will require a supplementary approval, adequate time to get through the necessary ethical procedures needs to be factored in if your research timetable is to remain in tact. It might also be worthwhile finding out whether the approval of a REC outside of one’s RO obviates the need to start with internal review (or indeed whether there are circumstances in which this arrangement can work the other way around).
The protection of human research subjects by means of ethics review has in recent years taken on some distinctive forms when it comes to minority groups and interests. The basic proposition at work here is that where minority groups are concerned, the people who are best positioned to know what needs protecting are representatives of the groups themselves. This response has developed beyond mere ‘citizen’ representation on RECs to more precisely targeted participation and on into the formation of RECs that deal specifically with issues relating to a single community. First nation or indigenous groups in Canada, Latin and Central America, New Zealand and Australia have come forward to engage with researchers from different disciplines to ensure that research carried out upon or among them by outsiders is not harmful or damaging, serves their interests and not just other people’s. As part of the evaluation there is generally an expectation that research will not just be participatory in design but ultimately emancipatory in its effects. Such bodies are there to ensure that abuse and exploitation that was the norm in the past is not continued in the present. They play an important role in mediating across differentials of power and resource in order to mitigate the likelihood of harm and to promote beneficial outcomes. However, their position as mediators also places them in positions of considerable power when it comes to vetoing certain kinds of research. Over and above any role of subject protection per se, this kind of ethics review machinery can operate as a powerful gatekeeper when it comes to legitimate access to certain communities.
An example of the role of RECs operating in the interest of indigenous communities is the Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS). This organisation was established to represent the social, political and cultural interests of Aboriginal and Torres Strait Islander communities. AIATSIS later established its own ethical guidelines for research and an ethics committee to review projects that involve these communities. The intention is to use ethics review as a means to ensure that people’s ‘rights, culture and heritage are respected, that they understand the aims and methods of the research, and that they will share in the results of this work’ (AIATSIS, 2018).
A major (and growing) problem for anthropologists carrying out ethnographic studies in countries other than their own is how to balance formal and informal aspects of approval and clearance. In many of the countries in which UK anthropologists worked in the past, the gradient was a clear reflection of the hegemony of the global north - field-sites could be identified and accessed more or less untrammelled by concerns about research governance. In other, formerly ‘closed’ countries, such as China and the USSR, the possibilities for conducting ethnographic fieldwork and collaborations have considerably improved. Nowadays, however, a range of institutional concerns about the legality and legitimacy of research are likely to be there not only at the outset of research but also in the country of destination. In addition to visas, research approvals, permits and security clearances, a researcher might now face ethical approval as a requirement.
There is now a growing expectation that, when research is to take place in a country different from that of the research sponsor, it is expected that there will be local ethics review or what is generally referred to as a ‘two-ended review’. In the biomedical sciences, this requirement in itself is seen as an ethical expectation (Emmanuel et al 2000 ). The Universal Declaration on Bioethics and Human Rights, for example, states the following:
‘Independent, multidisciplinary and pluralist ethics committees should be established, promoted and supported at the appropriate level in order to a) assess the relevant ethical, legal and scientific and social issues related to research projects involving human beings, b) provide advice on ethical problems in clinical settings, c) assess scientific and technological developments, formulate recommendations and contribute to the preparation of guidelines on issues within the scope of this Declaration and d) foster debate, education and public awareness of, and engagement in, bioethics’. (UNESCO 2005, Article 19)
Once planted, such initiatives have a habit of growing - rather like Delueze and Guattari’s rhizomes - into other fields (1987). There are signs that the guidelines for human subject protection in the biomedical sciences are providing templates beyond their original remit. For example, in India, the National Committee for Ethics in Social Science Research in Health (NCESSRH) produced its own Ethical Guidelines for Social Science Research in Health. in 2000. However, the machinery to review social science projects locally is still very limited in the contexts in which anthropologists might want to work. There is therefore a danger that projects will be routed through other, less appropriate routes (see Gaining Ethical Approval: A case study from Sri Lanka). There is also a danger that the request for ethics review might actually play a role in creating the systems that do the reviewing (see the case study of Margaret Sleeboom-Faulkner’s experience in China).
It is clear that the machinery of ethics review is proliferating in the contexts in which anthropologists would hope to work. Moreover, the proliferation is uneven - there may be no expectations at all, review may be perfunctory or it may prove to be a sine qua non of research going ahead at all. As in reviews carried out in one’s home institutions, local review might result in an ethnographic project being further modified.
If there is a clear expectation of ‘two-ended’ review it may well be worth carrying some preliminary investigations as to what the review options are. The likely way into this would be via the web and among the vast array of materials posted it is worthwhile bearing in mind that, whilst they have the appearance of authority, it might be one that is exaggerated in terms of its reach and power. Having identified possible routes, check out whether they are creditable and likely to give ethnographic research a sympathetic hearing, perhaps by contacting the committee’s chair.
Case study: Gaining Ethical Approval: A case study from Sri Lanka.
The following is an abridged extract from the forthcoming book by Sariola and Simpson: Research as Development: clinical trials, collaboration and bioethics in Sri Lanka (2019)
In 2007, the Forum of Ethics Committees Sri Lanka drafted a guideline: ‘Ethics Review Committee Guidelines: a guide for developing standard operating procedures for committees that review biomedical proposals’. This document was intended to unify the Island’s diverse procedures in the context of ethics review. Support for local capacity-building initiatives has come from organisations such as the Forum for Ethics review Committees in Asia and the Western Pacific (FERCAP), the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) and the Global Forum on Bioethics (GFB), all of which signal the bioethical collaborations which necessarily underpin scientific collaboration. Affiliation to these organisations and the establishment of local branches (for example, FERC-Sri Lanka) is an important route to harmonisation and the dissemination of good practice. It is also a way for local researchers to connect with regional networks and to participate in transnational research assemblages.
As with many of the Sri Lankan medical researchers with whom we went on to work, the idea of a review board in the UK giving approval for research that would go on in another country seemed inherently problematic. It was therefore no surprise that we were asked to submit an application for ethics review to a local ethics committee. Applying for this approval signals particular collaborative intent and shaped how our intentions were to be grafted onto local networks. At the time, the clearance had to come from a medical REC because our study was seen to be focusing on matters of health even if by proxy. Moreover, the local social science departments did not have any ethics committees. However, not having ethical clearance was not seen to be an option by our medical collaborators who were building up expectations that having ethical clearance was mandatory.
The form was lengthy. Most of it was geared to biomedical research and the collection of samples. Nonetheless, the form was important evidence detailing who and what we were about and one element of the transaction gave us the need to think about our local relations further. Section 184.108.40.206 of the Ethics Committee Guidelines for Sri Lanka specified that a) a local collaborator (co-investigator) from Sri Lanka with equal responsibility is essential and b) a written agreement regarding sample/data ownership publication strategy (including issues such as authorship and the right of the Sri Lankan collaborator to publish data pertaining to Sri Lanka) and intellectual property rights should be in place (FERCSL 2007). It was clear that without the REC’s approval, our research could not progress; a local imprimatur was essential. While we upheld the collaborative prospect and saw value in a shared process, some of these notions just did not fit with our ideas about ethnography as a way of working with others to understand their social and cultural practices. We discussed our concerns with our main contact-cum-gatekeeper-cum-collaborator and were reassured that the form was really to protect against ‘other kinds of researchers’, namely those who come from the global north to prospect and extract without due reward and recognition for local researchers and, at worst, act in ways that harm local populations. The spectre of the unethical researcher was one that loomed large in local discourses and particularly where foreign researchers were concerned. The history of exploitation by outsiders is simply too long and too flagrant for this not to be the case. It was made clear that we were not seen as falling into this category but we nonetheless had to fill in the forms – no doubt a precautionary measure, just in case we turned out to be different from what we appeared and, in fact, were just the same as all the others. Nevertheless, the form did indeed cause us much anxiety. Ultimately, however, the forms, once filled in and successfully reviewed, were never referred to again. In many respects, the documents and the process of review functioned more as a public legitimation of the relation we had with our collaborators rather than as an evaluation of the potential of our research to cause harm to our ‘subjects’. In short, ethics review in this particular research was as much about marking the relationships that the research would initiate as it was about the protection of those who would participate in it. From the outset, collaboration was folded into the research in ways that would shape and prescribe both what we researched and how we could go about it; this was not fieldwork as we have known it (Faubion and Marcus 2009).
Case study: Research Ethics as an Additional Dimension of Ethnographic Research Practice: Ethics Approval for Research in China
International research projects can benefit enormously from collaboration with local researchers. Their design, however, is affected by research ethics, which in itself creates a new research reality for projects. This process is exemplified by an ethnographic research project on the institutional dynamics of networks of so-called stem cell therapy providers in clinics in China and beyond.
First of all, it is important to realise that it can be painfully embarrassing to discuss the ethicality of research methods used by collaborators, which thus far have been taken for granted as obvious everyday behaviour. Some project funders, such as the European Research Council (ERC), insist upon the submission of reports signed by ethics officers as evidence of the implementation of ethics guidelines. This means that ‘foreign’ collaborators are subject to the same ethical requirements as researchers ‘at home’. The frequency with which we needed to discuss research ethics when conducting research in China in itself seemed to presume that researchers in China are in some sense ethically deficient. There were occasions when our research collaborators were stumped by the issues raised. For example, a discussion about the ethicality of a researcher visiting clinics to enquire about the prices for unauthorised therapies was met with disbelief. Asking for the price and availability of stem cell therapy for, say muscular dystrophy, for the benefit of a foreign friend, can be viewed as covert research in need of research ethics permission from an ethics review committee on a case-by-case basis. This arrangement would make the research impossible, as the identification of a clinic worthwhile visiting in this open-ended form of research requires investigation in itself and at its location. Furthermore, an ethics committee would not be able to judge the situation very well, and by the time a decision would be reached, the clinic might have moved elsewhere. So, how could the project even hope to yield new insight into the institutional dynamics of stem cell therapy providers and the ways in which these evolve in interaction with regulatory politics?
At first, there was some confusion among project members about the ethicality of stem cell therapy provision, as the degree of controversy in China and the UK clearly differed, especially before October 2009, when new regulation prohibited unauthorised clinical applications of stem cells. This difference derived, not just from the diversity in clinical research and therapy practices of informed consent taking, but also from the different institutional organisation of the therapies. As in other countries, there has for a long time been controversy in China about the ethicality of stem cell therapy provision and the conditions under which it should be allowed. It was, after all, the institutional organisation, discussions on research ethics and the implementation of regulation that our research aimed to examine. Without research at a particular location we would not have been able to understand the institutional circumstances in which stem cell research and therapy are organised, and this would mean that there was no way for us to find out why and what kind of stem cell intervention was taking place. Questions related to profit-making, research background, ethics review, certification, government support, clientele and institutional location would be crucial to get even a basic understanding of whether we were looking at plain snake-oil provision or more sophisticated and organised forms of stem cell experimentation.
Ethics review by committee that takes place abroad can go far beyond their expertise, especially when it comes to the research about ethical issues in society. These issues can only be understood in tandem with the practice of research ethics, as they are entangled with matters of governance and cultures of ethics, and are often of a political nature. In other words, ethics review in some cases might take on the role of policing research. This concern is even more acute when it comes to conducting research abroad. The notion of formal ethics review of research conducted in another country presumes that an ethics review committee in one country can determine the ethicality of research behaviour in another. This has led to both formal and informal calls for ‘national’ ethics review in the country where research is to be carried out. However, research ethics committees in the social sciences might have different functions abroad, or there may be none available. One of our researchers, when discussing her sub-project with a political regulator-cum-scientist, found that researcher enquiries prompted the establishment of a new ethics review committee. The nature of the legitimacy of this committee and its expertise were unclear. The committee had been concerned about the damage the research project could do to its reputation as well as other ethical and political concerns related to foreign examination of Chinese research practices. After examination, the committee gave permission for the research. However, had their competitors reviewed the research, the project could have been rejected as politically dubious or inadequate for many reason. The researcher’s position is vulnerable indeed.
Perhaps unexpectedly, ad hoc permissions received from committees whose expertise/legitimacy is unknown can have consequences that reach far beyond what is regarded as permissible by the research ethics committee at home or the principal investigator of the project. For instance, permissions signed by a person of great authority can open many doors, in this case for research in a range of hospitals, which would normally not have been accessible to the research. Furthermore, such permission could enable research into the conditions of patients and their families who should be left alone. The specificity of these issues can never be covered by an ethics review committee, as they form part of the research itself, and should be discussed in detail by members of the project, including the collaborating researchers.
In short, ethics review at home deals with issues as they are understood at home. As a mode of governance, however, it can also be used to re-review projects on the basis of their political sensitivity. This may be more likely to happen when a research project is reviewed an research ethics committee abroad. Alongside this formalised review of research ethics, it is important to realise that ethnographic researchers need to negotiate the ethicality of their research on site, simply because the ethicality of research is often entangled with what is regarded as ethical and permissible at the location of research. In short, a project does not just need to plan ’going through ethics review’; it also needs to take into account the effects of research ethics on the research practice with consequences for the research methods used in the research design. As the example from China shows, research ethics has in many respects become an additional dimension of ethnographic research practice and therefore needs to be considered as part of research epistemology.
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