Copyright Sociological Research Online, 2002


Julie Kent, Emma Williamson, Trudy Goodenough and Richard Ashcroft (2002) 'Social Science Gets the Ethics Treatment: Research governance and ethical review'
Sociological Research Online, vol. 7, no. 4, <>

To cite articles published in Sociological Research Online, please reference the above information and include paragraph numbers if necessary

Received: 20/5/2002      Accepted: 25/11/2002      Published: 30/11/2002


The paper examines the current provision for ethical review within the social sciences and considers how existent structures could be improved to protect human research subjects in accordance with international guidelines and regulation. This paper examines the current regulation of social science in the form of professional guidelines, peer review, funding application procedures and steering/advisory groups, and compares these processes with the independent ethical review currently required for health research. This paper also addresses the concepts of 'risk' and regulation by comparing the provision of review processes for health and non-health based research. The authors question the distinctions made between different types of medical research which represent epidemiological research, for example, as non-intrusive thus creating a hierarchy of research which results in social science researchers slipping through the ethical review net.

Ethics; Regulation.; Research; Review; Risk


In Britain and most of Europe, unlike in the US, social scientists are rarely required to obtain ethical review of their research unless it is to be conducted in conjunction with health practitioners, or within a health setting. Psychological research is commonly required to seek ethical approval from institutionally based review boards but social and health research are currently subject to divergent regulatory structures. This divergence can be related to the different institutional and professional perceptions of the risks attached to health and to social research, and to the differing traditions within these areas of knowledge production. This leads to a situation where less intrusive research about health may require independent ethical approval yet potentially intrusive social research outside of health does not. Current concerns about the regulation of health research in the UK and our own recent experience of obtaining ethical approval for a social science project which aims to explore issues around ethical protection in genetic epidemiology provide a starting point for our consideration of the issues at stake here.

We begin therefore by outlining the current policy debate in the UK around research governance and situating this within an international context. In the next section we describe the current regulation of health research and then go on to look at regulation of social research. This comparison leads us to consider whether there is a case for ethical review of social research in the UK in line with other countries such as the US. We discuss how risks are defined in relation to different types of research, the purpose of regulation, ethical review and the increased importance attached to accountability of researchers. Our aim is to stimulate debate about the value of ethical review and importance of ethical protection for research subjects in social research projects.

Research Governance - The Need for Ethical Protection

There is international recognition of the ethical principles for biomedical research enshrined in the World Medical Association's Declaration of Helsinki concerning informed consent, confidentiality, anonymity and protection from harm and exploitation for research subjects. These principles have underpinned the work of ethics committees and ethical review processes. Ethical review, usually conducted by an ethics committee, is intended to assess the merits of a proposal to conduct research and to set a standard for the ethical practice of researchers in carrying out this proposal. In so doing these committees are intended to afford research participants ethical protection. Frequently this means they discuss aspects of the research design, methodology potential consequences and unintended consequences of the research. It is, however, unusual for such an ethics committee to be concerned with the conduct of any particular researcher, or with issues of research integrity (for example, prevention of research fraud or mismanagement). Furthermore it is unusual for committees to have any audit or investigatory role to ensure that researchers comply with the terms of the approval they receive. In one sense this makes research ethics review a "light touch" regulatory regime. But in another sense it can mean that ethics committees apply more stringent standards than they might otherwise do since they have only one opportunity (normally) to set the terms for what will or will not count as ethical practice in research. Related to this, ethics committees tend to focus on two elements in determining what is acceptable: the risk (or benefit) posed to the participants; and the information and consent process. Much therefore depends on how these risks and benefits are assessed by the committee, and on the high status currently assigned to informed consent. Discussion of other ethical issues (for instance, the moral status of the research question) tends only to take a minor role, and is rarely, if ever, determinative of ethical approval or refusal to approve. Our current research seeks to critically examine the extent to which, in studies of genetic epidemiology, the research participants' own views of ethical issues might inform the deliberations of such committees in the UK context (the EPEG project). We will report elsewhere on the views research participants themselves have regarding ethical protection. However, given the purpose of our research we were faced with something of a double standard in relation to ethical review processes. As a social research project there was no formal requirement for us to obtain ethical approval for our research. This raised some important issues for consideration that we reflect on here.

The growth of information technologies, the development of new health technologies and increasing use of personal, including genetic, information for research shapes the context within which current social researchers practice. Parallel to this the need for new legislation for data protection has been identified and recently implemented in the UK (Data Protection Act, 1998). Wider debate about the need for secure methods for storing information and constraints on its use, especially for commercial ventures has been evident (Ashcroft, 2002). The role of governments in collecting or selling population information has come under critical review (Kaye & Martin 2000, Rose, 2001) at the same time as their role as regulators has been seen as increasingly important (Salter & Frewer, 2000). Sociologists have highlighted concerns about the risk of increased public surveillance as part of the new public health movement (Petersen & Bunton, 2002) and pointed to the breakdown in public trust of 'experts' and expert systems of knowledge. As part of a new emphasis on a democratic relationship between science and society (Home Office, 1999), citizens are increasingly encouraged, at least in some circles, to question the traditions of scientific practice and knowledge production. In the wake of controversies around food safety, environmental degradation, BSE, and organ retention there has been an increased recognition of scientific uncertainty (Office of Science and Technology, 2000). In EU regulatory policy the need for a precautionary approach to risk management has been implemented (European Commission, 2000) and in the UK the medical establishment has led a review of its practices relating to the use of biological samples for research through the retained organs commission, and the government is reviewing the law on human organs and tissue use (Department of Health, 2002). Against this background Irwin suggests that new mechanisms and institutions are needed to facilitate scrutiny of expert knowledge:

Emerging forms of peer review should all be seen as necessary - but necessarily partial - elements of a broader socio-technical response. The challenge is to achieve a flexible and responsive set of institutional structures for the development and scrutiny of expert knowledges of different kinds (Irwin, 1995 pp.173).

We were caused to address the issue of the ethical review of our own research by a number of different factors. In the first place, as a study on the ethics of research, which itself involved research with human participants, who were already research participants in a biomedical research project, we felt that it was important to adhere to the highest standards of ethical regulation of research. Second, since such participants were could already be aware that at least some research was reviewed by an ethics committee, we felt it important to meet these expectations on their part. Third, since we depended for access to at least some of our participants on the co-operation of the large epidemiological study most of our participants were participating in, and since this study had its own ethics committee (but whose interests did not cohere precisely with our own) we felt it important to obtain independent ethical review in order to have adjudication if necessary between our conception of ethical research and the conception of the "host" study's ethics committee. Fourthly, our funder has a strong presumption that the research it funds will be reviewed by an independent ethical committee. Our principal problem was that no ethics committee existed which had responsibility for non- health- related research.

Our own solution to the immediate problem of proceeding with our research was to approach a local NHS research ethics (LREC) committee for independent review of our protocol. This in itself highlighted key differences between the regulation of health research and social research projects in the UK and raised in our minds questions about the suitability of such a review process for social research. What became apparent was that there were different ideas about the potential risks of health research compared to social research. There is a much stronger tradition of ethical review for health research as we shall see. Yet does the absence of ethical review for social research projects in the UK assume that they are safe and do not have the potential to harm? The literature on social research ethics suggests otherwise (Punch 1986, Renzetti & Lee 1993, Lee- Treweek & Linkogle 2000, De Laine 2000) so how do we explain this difference especially in the context of practices elsewhere?

In a review of the literature on scientific deception Grayson (1995) describes the rather different regulatory climates of the US and European countries. In the US growing political concern about scientific fraud and deception in the 1970's and 80's led to public debate about scientific practices and institutional reform in the area of publicly funded (health) research in the face of resistance from the academic community and claims that is should be self-regulating. Interestingly Grayson observes that the US case

"makes clear that self-policing through the traditional method of 'scientific dialogue' is not a realistic option once scientific misconduct has become a major issue of public concern. Not only does it fail to satisfy public and political demands for accountability, it can be deeply unpopular among accused scientists themselves if there is a lack of due process" (Grayson 1995:59).

Reluctantly, according to Grayson, more formal procedures have been put in place in US universities since the 90's and elsewhere the emergence of institutional review boards is described (Sieber, 1992). In contrast to the high public profile of debate about scientific misconduct in the US, the situation in Europe and the UK is described as rather different. In the UK "much of the British scientific community can be described as still in a state of denial" about the presence of scientific misconduct (p82) and "Unlike their American counterparts, British universities are not required to establish misconduct policies or ethical training programmes as a condition of receiving public funding" (1995:86). While this appears to be the case at the time of Grayson's review we suggest that more recent events have had an impact on the regulatory climate in the UK.

Regulating Health Research

In the UK Local Research Ethics Committees (LRECs) are guided by a range of policy documents intended to protect human subjects (Council of Europe 1997, Biotechnology Industry Organization 1999, Medical Research Council, 1993, Medical Research Council 2000), especially vulnerable subjects, (Medical Research Council 1993), the transfer of information (HUGO 2000), and standards of research (World Medical Association 1964). These guidelines differ across national and international boundaries both in terms of their content and the way in which they are implemented. For UK purposes, the most important guidelines are now the Department of Health's Governance Arrangements for Research Ethics Committees (Department of Health, 2001c, 2000, 1997) and the European Clinical Trials Directive, which at the time of writing is still to be enacted into UK law (European Commission, 2000). Whilst such guidance focuses on research on human subjects the guidelines are predominately perceived as most relevant to medical or health research at least in part because these types of research are perceived as potentially intrusive and harmful. As a result of the potential impact of medical research on individual patients, all health research is required to submit for independent ethical review. The aim of this process is to protect participants/patients from unnecessary or unethical research. Such review also ensures that the choices which patients have about their treatment are not compromised by the research process[1].

Health research however is itself diverse and includes randomised control trials and epidemiological study. Epidemiological research, which is the focus of our current empirical work, offers a useful example of where discrepancies arise. The main argument for differentiating between epidemiological and other (medical) research is that medical research on human subjects is generally intrusive, therapeutic, and clinical. Epidemiological research on the other hand is considered non-intrusive, non-therapeutic, and non- clinical and therefore it is widely assumed that

Most epidemiological research carries no risk to participants (Olsen, Bolumar, et al. 1999:1025).

The ethical review process then aims to assess the potential risks to research participants and whether appropriate protection is afforded them by the researchers and assess the scientific validity of research proposals.

Ethical Review in the Health Sciences

In order to ensure that the guidelines for research ethics are followed in practice, it is essential to institute adequate procedures for protocols to be assessed by properly constituted committees (Campbell, 1997, pp.174)

LRECs usually comprise 12-18 members, of whom at least one third must be "lay". Lay members must not be directly or indirectly employed by an NHS body, although they may have worked as a clinician if this ended at least 5 years ago. Further, lay members' professional work should not be in medical research or a cognate activity. Where a project includes more than one centre it is required to submit an application for approval to a multi- centre research ethics committee (MREC) (similarly constituted). These bodies are governed by the Central Office Of Research Ethics Committees (COREC), which is part of the Department of Health, whose role is to make policy for research ethics committees, set standards of training, performance and review, and to act as a clearing house for advice and guidelines for RECs. Researchers are required to submit for ethical approval in the following circumstances:

You must apply to an NHS REC when your research involves:
  • NHS patients, i.e. those subjects recruited by virtue of their past or present treatment by the NHS including those treated under contract with the private sector.
  • People identified through their capacity as relatives of or carers for NHS patients
  • Foetal material and in vitro fertilisation involving NHS patients.
  • The recently dead in NHS premises.
  • Access to records of past and present NHS patients.
  • The use of, or potential access to, NHS premises or facilities (including NHS staff).
  • (COREC Webpage).

This list is quite specifically related to research which could have an impact on the NHS, either through a request to access information collected by the NHS, or via recruitment where the NHS are being asked to act as a go-between for researchers wanting to access patients and staff. There is guidance about the role and responsibilities of LRECs themselves ( There have however been criticisms of the efficacy of LRECs (Ashcroft et al, 2001, Nicholl, 2000, Alberti, 2000) and in particular their lack of powers to investigate malpractice or respond to complaints about research.

There are numerous reports in the literature describing the problems encountered by epidemiological investigators in obtaining approval for population-wide studies from multiple IECs (Independent Ethics Committees) existing within a single community. By contrast, the literature is almost silent about the attention that is given to ensuring that, once approved, individual studies are actually conducted in an ethical fashion (Jamrozik 2000 pp. 336).

The extent therefore that LREC's are equipped to monitor the research process or indeed the appropriateness of them doing so is a contentious issue (Neuberger 1993, Grayson 1995).

More recently within the community of health and medical researchers more stringent measures for investigating misconduct or unethical practice have been called for by for example the BMJ, the Lancet and the Wellcome Trust (Grayson 1995). In the past few years research governance in the health service has become a high profile political issue in the UK especially since practices relating to the use of children's organs removed at post mortem at Alder Hey for research purposes were the subject of public outrage and concern (Department of Health, 2001a, 2001b).

Regulating Social Research

Social science research, outside of the NHS, does not have to apply for ethical approval under the criteria above. As it currently stands very few alternatives exist. Some institutions may have their own research and ethics committees to oversee NHS research and may actively encourage other researchers to use it, but this is rare and standards vary.[2] There are however a number of mechanisms which can be seen as shaping and regulating research practice. These include professional guidelines, the approval of grant applications by funding bodies, peer review and project advisory groups. Essentially these amount to a process of self- regulation.

Professional Guidance

This section examines the current ethical guidance offered social scientists from a range of professional research bodies. The British Sociological Association (BSA) has an approved statement of ethical principle[3]. The BSA guidelines address: professional integrity; relations with and responsibility towards research participants; and relations with and responsibilities towards sponsors and/or funders. Whilst comprehensive in the issues they address (informed consent, on-going consent, anonymity, covert research, and privacy) this statement suggests that:

Although Sociologists, like other researchers are committed to the advancement of knowledge, that goal does not, of itself, provide an entitlement to override the rights of others. Members must satisfy themselves that a study is necessary for the furtherance of knowledge before embarking upon it (British Sociological Association, 2001)

International guidance (Declaration of Helsinki, 1964) suggests that benefits to society through knowledge can not override individual rights to privacy and informed choice. All research has to deal with this issue and balance the needs of society against the individual. To make this choice we need to establish risks and in health research it is an independent ethical review committee who assesses this risk and not the researcher.

The BSA statement, like that of the Social Research Association (SRA) is, on the whole, a positive statement of ethical intent. However without an ethical review process it need not carry any weight within individual projects, and relies on a process of self-regulation. The recent review of ethical guidelines conducted by the BSA and the SRA continues to highlight this (<>). Membership of these organisations is voluntary and members do not have to sign up to this statement but are referred to it for guidance . The BSA starts with the following:

This statement is meant, primarily, to inform members' ethical judgements rather than to impose on them an external set of standards. The purpose is to make members aware of the ethical issues that may arise in their work, and to encourage them to educate themselves and their colleagues to behave ethically (British Sociological Association 2001).

The above extract also raises an important issue in relation to regulation itself. What are the set of standards external to? Within medicine, ethical standards are seen to characterise the fiduciary relationship between doctors and patients and are expected to be transmitted via a process of professionalisation. Similarly, as the BSA statement implies, social scientists are expected to internalise a set of professional values that inform their actions as researchers. As it stands this guidance, whilst extremely useful, does not constitute ethical review. What is at issue then is whether such guidance is sufficient in ensuring that research participants receive appropriate ethical protection.

Funded Research

Funding institutions are responsible for distributing monies for social science research and as such require researchers to adhere to specific guidelines and standards within their work. UK funding bodies include for example: the Economic and Social Research council (ESRC); Joseph Rowntree Foundation (JRF); the Medical Research Council (MRC); and the Wellcome Trust.

In relation to ethical intent the ESRC requires that:

"Where ethical considerations arise", suggests that in some circumstances ethical issues will not arise. The three key principles referred to here also raises a number of questions about how the various concepts are being defined. How for example is the "independence and impartiality of researchers to the subject of the research" defined? The ESRC has an Ethics Advisory Panel to whom referrals of research proposals are made if there are ethical concerns pertaining to it though we have no confirmation that such a group is actively engaged in the review of proposals or what criteria would be used to refer a proposal or project to such a committee[4].

Obtaining funding is often a laborious task, particularly when applying for European monies, which requires a great deal of time and effort. Funding bodies will want to know a great deal about the proposed research, how it will be conducted, when it will take place, who will be involved, and how the research will be disseminated. All of these measures are important for ensuring a high standard of social research. However, the detail required within this process with regard to issues of informed consent, confidentiality, and information disseminated to potential research participants is absent. Often it is only when required to formulate questions, consent forms, information sheets, and recruitment methods that the significance of these issues become apparent. At the funding stage when monies are not yet guaranteed it is unrealistic to expect a researcher to invest the time and effort required to develop these materials alongside the task of completing lengthy application forms. Whilst guidelines for writing grant applications include some of the key ethical considerations of social research current proposal reviews at the funding stage do not constitute ethical review. Individual researchers are not required to submit research materials (information sheets, consent forms, detailed research questions) to funders to ensure that they adhere to these principles, and the principles themselves are based on 'good practice'. All of the guidelines and recommendations outlined above are aimed at improving research through ethical practice. Very little of this policy however is based on clearly articulated ethical principles. In contrast medical research funders require applicants to obtain ethical approval prior to the funding being given[5], although COREC has recently announced that it no longer permits MRECs to review research prior to the award of funding. There is perhaps some confusion here around the role of ethical review: is it to protect the interests of participants, or to reduce the legal risks faced by funders and hosts of research? In practice the distinction may not matter, but it clearly is important in the context of the ethical arguments for the value of review.

Peer Review

This type of review is perceived, within the social sciences as extremely important. It is widely held that peer review is a form of guidance and that this self-regulation of research is adequate in order to protect research participants and uphold high standards within the social sciences. We have a number of concerns with this approach. Firstly peer review in relation to publication occurs after the research has been completed. If an article is rejected because the research on which it is based is unsound, then research participants have already been subjected to unsound research. Secondly, following on from the first point, conducting research that is unsound is a waste of resources. In a climate where resource management is an important part of the academic research culture, this is very much an ethical issue. Thirdly, peer review itself is problematic. There is distrust about the types of networks which produce reviewers, and the type of shared cultural heritage such reviewers have. In other words, peer review can perpetuate the old boys network, in whatever form that takes[6].

In conjunction with the ESRC, Science City recently conducted an internet-based discussion about the role of peer review in the social sciences. This, 'Global cyberconference on peer review in the social sciences' (<>) addressed a number of issues. These include:

Much of the discussion focuses around issues of bias, and professional relationships between reviewers and reviewees[7]. This reinforces the primary aim of the review process and illustrates how this focus is not intended to ensure that standards are kept and participants not harmed but to see that conflicts of interest between professionals are dealt with to ensure fairness of representation within publication and through funding. Very little consensus was achieved within this cyberconference, yet it was useful because it outlined the various contradictions in power and status which influence researchers within an academic context. It also highlights very clearly how peer review is perceived by some to be an outdated concept, particularly in relation to the dissemination techniques available with new technologies. It is evident that peer review is not a substitute for ethical review a point also made by Grayson (1995) in her discussion of the US experience.

A number of funding bodies require that researchers engage within a continuous peer review process via a steering or advisory group. Such groups are intended to advise the research team throughout the research process from its inception to completion. An advisory group could expect to offer advice with regard to the wording of information sent to participants, the method of data collection, as well as theoretical concerns which may arise throughout the course of the project. If organised properly, with a constitution, quorate membership, and a clear understanding from all involved such groups are a very useful resource within the social sciences. But although these groups incorporate reporting mechanisms and contribute to a process of research governance, can they act as ethical reviewers? Whilst in principle steering or advisory groups are a very useful method of developing a research project, in practice they can prove difficult to implement. They have to be planned in advance if they are to be quorate and thus useful. Planning ahead requires that strict deadlines are made and kept by individual researchers and the team as a whole. These deadlines can be affected by a whole number of unforeseen delays. As such it is feasible that the group is considering issues relevant to the research, but not necessarily those issues which would constitute ethical review. The membership of advisory groups is usually at the discretion of the project team and may include representation from a range of interested parties such as academics, service providers, users, and lay representatives. If addressing issues of ethical protection, advisory or steering groups need to account for the experiences and views of a whole range of individuals if professional interests are to be open to question and challenge. What is unclear is what formal (or legal) responsibilities such groups have, whether members are accountable for their role or have a duty of care.

The reliance then of social researchers on professional guidance and self-regulation raises questions about their accountability to a wider public. It is also apparent that in the absence of independent ethical review questions about the risks to which research participants might be exposed or the adequacy of ethical protection afforded them remain.

A Lack of Ethical Principles - The Case for Ethical Review of Social Research?

A comparison of the regulation of health and social research in the UK raises some interesting questions about the ways in which 'risk' is defined in relation to different categories of research, the efficacy of the ethical review process as operated for health research and whether there is a case for similar or equivalent process of review for social research. It also raises questions about the acceptability of the existing process of self- regulation for social science in the context of increasing demands for public accountability of scientists.

Categorising 'Risk' of Research and Types of Research

One of the major problems with the submission of social research proposals to health based ethics committees is the format of the current application forms. This poses both a practical problem and an ideological one as the questions asked are based on a particular model of health research. Of specific concern are questions such as, "Is this study likely to cause discomfort or distress to subjects/patients?"

Within clinical research, whether therapeutic or non-therapeutic, evidence may exist which allows assessment of the possible risks or discomfort and distress, for example risks of adverse effects of a new drug. However, whilst it may be possible to quantify clinical risks, and such risks are considered relevant within a clinical/non-clinical differentiation, there are also claims that even clinical research carries much less risk than is commonly believed.

Empirical data have become available that indicate that, in general, it is not particularly hazardous to be a research subject. For example, Arnold has estimated the risks of physical or psychological harm to subjects in Phase I drug testing. According to his estimates, the occupational hazards of the role of subject in this type of research are slightly greater than those of being an office secretary, one-seventh those of window washers, and one-ninth those of miners (Levine, 1988, 39).

Within medical research there are also differences between types of study that can create problems within the ethical review process. In arguing for a complete overhaul of the ethical review system Jamrozik says:

It is clear that systems of ethical oversight designed primarily to regulate intervention studies involving individual patients associated with single institutions have been completely overtaken by developments in clinical, molecular and epidemiological research (Jamrozik, 2000, 338).

In his view ethics committees are frequently unable to take account of the needs of epidemiologists to conduct population studies or make appropriate distinctions between the ethical issues associated with observational and experimental studies.

In contrast, assessing the risks to participants of social science research[8] is more problematic. The risks to an individual of specific research are difficult to measure and predict. Risks might include adverse consequences of revealing information about illegal activities such as sex work, drug taking, domestic violence (Coomber, 2002). If anonymity and confidentiality is not assured the respondent may be exposed in a way that could lead to loss of status, or credibility - for example in the workplace in a study which explores aspects of their employment. While the potential for physical harm (as in the case of new medical treatments) is low, there is a potential of psychological, emotional distress or 'social risk' (Ringheim, 1995).

In many of its forms, social research intrudes into the lives of those studied. While some participants in sociological research may find the experience a positive and welcome one, for others, the experience may be disturbing. Even if not harmed, those studied may feel wronged by aspects of the research process. This can be particularly so if they perceive apparent intrusions into their private and personal worlds, or where research gives rise to false hopes, uncalled-for self-knowledge, or unnecessary anxiety (BSA, <http://www.>, 2002).

Often a distinction is made within social science research between 'sensitive' and 'non-sensitive' research areas. We challenge such a distinction on the premise that whilst it is not possible to adequately quantify 'risk' within social research, it cannot be assumed that any research interaction is free from negative ethical consequences either for the participant or more generally[9]. Lee & Renzetti suggest that

A sensitive topic is one that potentially poses for those involved a substantial threat, the emergence of which renders problematic for the researcher and/or researched the collection, holding, and/or dissemination of research data (Lee & Renzetti, 1993:5).

(They go on to suggest that research is more likely to be threatening):

  1. where research intrudes into the private sphere or delves into some deeply personal experience
  2. where the study is concerned with deviance and control
  3. where it impinges on the vested interests or powerful persons or the exercise of coercion or domination
  4. where it deals with things sacred to those being studied that they do not wish profaned. (Lee & Renzetti 1993:6)

At the same time they and Ringheim (1995) observe that the 'sensitivity' of research can not always be fully anticipated. Ethical review may assist in a wider assessment of potential sensitivities. Moreover, where research is to be conducted in different localities and communities one way of avoiding 'westerm ethical imperialism' is for a process of ethical review to be conducted within that locality (Ringheim 1995:1695). So if we are to be aware of culture and circumstance then it is difficult to differentiate research on account of sensitivity.

Already, within this paper, the concept of 'risk' has emerged in relation to research, health, and society more generally. Specifically within psychological and/or social research on 'patients' which comes under the jurisdiction of the LREC, there is an assumption that non- clinical trials with (physically) non-intrusive interactions are relatively safe and certainly less problematic than (physically) intrusive clinical trials.

In considering the burdens imposed upon the research subject, it is of value to distinguish risk of physical or psychological injury from various phenomena for which more fitting terms are "inconvenience", "embarrassment," and so on; "mere inconvenience" is a general term that may be used to discuss these phenomena (Levine.R.J. 1988, 40).

As there is very little research that has attempted to ascertain the impact of research on participants[10] such a view is not grounded within evidence but it is assumed by LREC members (usually with connections to the medical profession and who are only rarely social scientists) that social research methods are themselves safe.

Given the diversity in research design and methodologies within health research the location of social science research within a continuum of research and risk assessment is not such a novel idea but points to the need for an ethical review process which is designed to take account of different methodologies and diverse risks. Health researchers who use social science methodologies already face problems arising from the composition and operation of LRECs resulting in what many regard as inappropriate and unsympathetic responses. It could therefore be argued that the creation of a social science ethics review committee may alleviate many of the problems such researchers currently face by ensuring that committee members have a better understanding of social research methods, the frequency of types of ethical issue raised in social research and that there is more appropriate representation. However, the extent to which representation included those without a social science training would distinguish such a review process from an extended form of professional self- regulation or peer review.

It is our view that we cannot presume to understand the impact of research, whether conducted within the social sciences or health, without first talking to participants in order to ascertain their perceptions and experiences. Though this raises epistemiological issues about the way in which 'risk' is defined if we see risk as a form of social rationality and socially constituted then the subjective views of participants should carry some weight. The premise of our current research is that without such information we cannot make the leap from potential danger/risk and experience to ethical protection. Feminist researchers, in particular, have examined the impact of social research on participants. They have been critical of approaches which assume that a) individuals like talking to researchers (Oakley.A. 1981) and b) that it is 'safe' for them to do (Kelly et al; 1995). Taking part in research, whether social research or not, may impact on individuals not least within the research process itself.

Ethical Review, Risk and Power

Research addresses issues of knowledge/power and, in studies that intend to elicit individual perceptions and experiences, raises the question "whose 'voice' is heard within the research context and wider society?"

"when society has problems with science, it is often over the question of uncertainty and risk" (House of Lords 2000).

Relating the concept of 'risk' to regulation, 'risk' is perceived as only one element of a regulatory discourse that seeks to 'facilitate', rather than control, a range of opposing views and standpoints. Referring specifically to 'the genetic revolution', although just as relevant for wider health research, Julia Black claims:

It is seen variously to be an issue of risk (to health, the environment), a question of choice (of patients, consumers), a matter of property rights (to patents, an individual's DNA), of confidentiality (against employers, insurance companies, other family members), or a question of ethics. (Black, 1998; 621).

Here risk has been separated from questions of choice, fears relating to property rights, confidentiality, and questions of ethics[11]. Levine (1988) also makes this distinction when he differentiates between physical, psychological, social and economic risk both in relation to individuals and wider society. There are perspectives however which would assimilate these issues as risk associated with social capital more generally within a social context.

The 'risk society' is not about physical or ecological risks alone but rather the way in which citizens feel themselves 'at risk' from social and technological development. It is this awareness of threat which makes late modernity distinctive (Irwin, 1995, 47).

Within our research (the EPEG project) we are interested in how research participants consider risk as a factor determining their research participation and wider social citizenship. This may differ considerably to those with other interests, for example: LREC committee's with a governance agenda, pharmaceutical companies with a profit agenda and specific interest groups whose agenda is matched to their political aims and objectives. In relation to health research, that which is most frequently governed by ethics committees, risk again includes a number of the distinct elements identified above. Such committees must balance the needs of individual participants and researchers with the requirements of public health:

(L)RECs are responsible for acting primarily in the interest of potential research participants and concerned communities, but they should also take into account the interests and needs of researchers who are trying to undertake research of a good quality (COREC, 2001).

Risk is very much associated with the relationship of individuals to a social contract. We assume as citizens that certain risks are mediated by government, for example through the regulation of transport, the environment, and health and safety guidance. As a result one would expect research participation to be culturally situated. Risk and regulation however cannot be separated in relation to wider constructs of power and control. Whilst regulation can be perceived as a facilitation of different views, it raises questions again about who has the social capital to ensure their voices are heard.

The Role and Function of Ethical Review Committees

However it is also evident that LRECs serve the function of protecting public organisations.

Research on clients of Social Services (i.e. subjects recruited by virtue of their past or present status as clients of Social Services), including those cared for under contracts with private sector care providers, should have the favourable opinion of a Research Ethics Committee which meets the same general standards as NHS RECs in respect of composition, review process and general operating procedures (Central Office for Research Ethics Committees, 2001).

This has a number of implications for social science research. Firstly, it suggests that social research should receive ethical review and approval to the same standard as that required by health researchers. The underlying reason for this assertion however could be questioned. In this context it is only social science research that uses certain populations which, it is suggested, should undergo review. In relation to 'risk' this extract demonstrates how current provision for ethical review is concerned with assessing the 'risk' to social institutions (Department of Health) rather than managing the risk posed by research to individual participants. In other words, it illustrates how specific governmental departments can only regulate certain institutions.

The Case for Ethical Review of Social Research?

A weakness of the reliance on self-regulation is the lack of ethical review based on ethical principles.

Social science professional organisations are typically guided by a code of ethics that governs how research is to be conducted by members. Such codes do not as a rule, address the ethical principles on which they are based, nor consider the ethical requirements for specific topics of research (Ringheim 1995) pp. 1691.

Without formalised review, the ethical foundations of social science research go unrecorded. Ringheim (1995) suggests an application of the four ethical principles: respect for persons; beneficence; non-maleficence; and justice, as advocated by the Council for International Organizations of Medical Sciences (CIOMS). It is Ringheim's assertion that ethical review, based on such principles, is frequently absent from the social sciences.

However there are a number of social science researchers, particularly within North America, who are critical of such a review process. Review has been associated with political censorship within academic institutions (Shea 2000, Brainard 2001) and wider society (Shaffer 1977). This claim is most obvious within studies utilising covert participant observation where the whole concept of informed consent is in direct conflict with the epistemological and methodological standpoint of the research process itself. On a practical level, current provision within NHS Local Research Ethics Committees (LREC) in the UK may not be appropriate for social research (and may exacerbate the censorship debate above). It is suggested for example that incorporating social research within the current model will "force qualitative ethnographic studies into a biomedical mold" (Shea 2000, 2). This assertion relates specifically to researchers whose work currently falls between the social and health sciences where they require ethical approval from a health situated body yet are utilising social science based methodologies not predominantly found within a medical setting. This issue has been addressed to some extent within the Health Technology Assessment report (Murphy, Dingwall, et al. 1998). This report, by focusing on the previously underused qualitative methodologies available to health researchers, highlights the predominance of quantitative methodological approaches currently adopted within the health sciences. Secondly, it has been asserted that "research interests are highly subjective and those of one discipline may seem frivolous to another" (Ringheim, 1995; 1691). It is important, on the basis of these two points, to acknowledge how the incorporation of social science research within current review processes will challenge current constructs of knowledge. Whilst at present this could be perceived as a problem for social science based health researchers seeking ethical review it does offer an opportunity to examine how knowledge is constructed within this process and within a wider social context.

This demonstrates a need to consider the review of research, whether social science or not, within a wider social context which recognises how knowledge is constructed and utilised. This is specifically relevant for work located within a multi-disciplinary context (as with our own research). Bearing this point in mind the creation of separate health and social science review processes may polarise the knowledge obtained within each. What seems likely is that in the context of recent political attention on research ethics in health and medicine and the need for academics to obtain public funding for their research (and in some cases access to the health and social services) universities own ethical review processes will come under greater scrutiny. Arguing for independent ethical review of social science is to suggest a need for social scientists to be accountable for the work they produce from the beginnings of the research process at funding application stage to dissemination of results. This accountability should, we believe, be centred around the ethical principles of research involving human subjects. Irrespective of the paradigmatic location of that project within science or social science, researchers have an obligation to ensure that participants are protected, and we believe a process of ethical review could help ensure that this happens. Despite the problems already noted about ethical review committees the dependence on professional regulation is likely to become increasingly politically unacceptable.

In the meantime there is a significant question about the appropriateness of LRECs to cope with an influx of social science research. This relates not only to time and resources, but also in relation to the current structure of LRECs and their process. Forms are constructed predominately for health research which already covers a large spectrum of research from talking to breast cancer survivors about their experiences of the illness and/or treatment, to clinical drugs trials for alzheimers disease. The methods and epistemological framework of these two extremes will be hugely different. Although the current restructuring of LRECs and MRECs, via COREC, has addressed inconsistencies in the format of application forms across committees, it is not yet clear whether this has included a significant review of their applicability to different disciplines. LRECs currently have a disproportionate number of medical representatives[12] and the problems of ensuring lay representation have been highlighted (Edwards 2001). With these problems in mind it may be pertinent for funding bodies to establish ethical review committees specifically for the social sciences as part of their review of research proposals or once funding has been approved. This would enable social science based health researchers to submit to either the funding bodies ethics committee or the LREC. This might go some way to reassure researchers that appropriate expertise in social science methodologies will be represented and that members of the ethics committee will have experience of risks within that context., Such bodies would also need to ensure that their application forms are designed in such a way as to encompass a range of methodological concerns pertinent to social science. Thus they would need to include both quantitative and qualitative methods and ensure that secondary data analysis does not contravene individual participants' rights to privacy, including the rights of participants' family members.

Coomber (2002) argues strongly that in the UK where researchers are able to seek approval from a university research ethics committees (RECs) they are commonly based on a health model of research and make demands on social researchers that are inappropriate and contrary to the interests of both the researchers and the researched. According to him, requesting signed consent forms in certain types of social research where for example the respondents comprise "criminal populations", is tantamount to "opening themselves up to the potential of investigation and prosecution by the criminal justice system". It also, in his view, exposes the researcher to the risk of being "forced to be complicit in the prosecution of research participants" (para 1.2). In addition this practice he says contradicts other ethical criteria and creates a situation "whereby researchers are forced to play a game with REC's in order to get approval of the research project" - a game where the consenting process involves the use of false names and meaningless documentation (para 1.8). In his analysis the greatest risk to these respondents is the risk of being prosecuted for their criminal activities and the researcher has a responsibility to protect them from that. His main criticism then, is that where REC's use standardised procedures based on the health model of research this jeopardises the effective and ethical practices of social researchers. While we would agree with him that there is a need for ethical review processes to take account of diverse methodologies his analysis of the ethical issues at stake here and the merits of ethical review processes is extremely limited. The assessment of harm or risks to research participants is clearly not straightforward and the suggestion that researchers are forced to 'play games' with ethics committees undermines both the review process and the professional integrity of the researchers. His proposal that social researchers engage more fully in the process of establishing and operating ethical review processes in UK universities is one that we endorse.


This paper has considered the issue of ethical review within the social sciences by comparing the current provision with that found within health research. Some social science researchers, for example those conducting research that includes participants who are clients of social service departments, are expected to adhere to the same standards of review as clinical drugs trials. Whether they currently do or not is another issue. For our own social research project we sought independent ethical approval from a NHS LREC in order to demonstrate a willingness to comply with ethical principles which such a review process aims to implement.

Unlike in other countries such as the US, in the UK social science research currently relies on a process of professional self-regulation and the internalisation of a set of professional values. Peer review processes, the funding system for research projects, and the convening of advisory/steering groups were considered as possible sites for ethical considerations. However, rarely were such considerations made explicit in these contexts. Whilst evidence suggests that in the UK there has been a reluctance amongst the scientific community to focus on scientific misconduct and an absence of political interest in such matters, recent events point to a changing regulatory climate. Whilst 'academic freedom' and fears of censorship are important these concerns relate, to the wider debate about whose interests do social researchers serve and what is the role of government (trans-national) regulatory bodies in ensuring that standards of ethical practice and good quality science are maintained ?

Probably the biggest fear amongst researchers is that of more bureaucracy which impedes the research process. Having to prepare recruitment materials, information leaflets, consent forms, research questions, and consider issues of archiving at the outset of a project, in a formal way, is difficult. But such a process also has a number of positives. It ensures that research is on track and that methodological and epistemological problems are highlighted at the outset. Most importantly it makes the whole research process more transparent, both to independent ethical reviewers, to other members of the research team, to the funders, to members of the steering group, and finally to the research participants themselves. In the current political and economic climate social scientists can no longer avoid the debate around research governance but must engage with it. We take the view that social scientists might benefit from independent ethical review of their work in that it has the potential to provide additional feedback and ethical guidance on the project. What needs to be made clear is that ethical review has the potential to be beneficial, whether or not it is depends on a number of factors, not least the composition and operation of RECs. Self-regulation of the scientific community clearly has problems too and does not meet the increasing demands for accountability and democratic science. Unless social scientists themselves devise and contribute to a system of review which allows for research ethics based on ethical principles, they may find that as concerns for the ethical protection of participants increases regulations follow. It is noteworthy that the British Medical Journal has recently appointed it's own ethics committee to address research ethics within the studies on which their articles are based (Tonks et al, 2001). If publishers of health research, which already submits to ethical review, are concerned about ethics, perhaps social science researchers, publishers, funders, and reviewers should consider again the ethics review of social science research and the role of peer review in that process.


1This paper is very clearly focusing on the role of ethical review within Britain. Such underlying principles also guide the review process in North America, and Western Europe as a whole. We should not loose sight of the fact however that a number of North American and Western European researchers' [drugs companies, biotechnology companies, medical practitioners, and consultant participant recruit firms] are conducting medical research in countries where inadequate basic health care severely limits the choices patients have. Such a context has serious implications for the possibility of individuals giving informed consent See, [Flaherty, Nelson, et al. 2000].

2For example, some institutions, who have psychology departments, have a research committee to deal specifically with psychological research [whether health related or not] and actively encourage social scientists to utilise it.

3The British Psychology Association also has similar guidance. 'Ethics committees' were absent from an examination of both the Policy Studies Association, and Political Science Association web pages. Members of these associations may well look to the BSA guidelines for advice.

4Personal correspondence with the ESRC.

5For example the Medical Research Council.

6For example see: [Morley & Walsh 1995]; [Bagihole, 1994]; [Merton, 1973].

7In relation to 'Ethics in peer review' there were 3 hits to this specific topic, none of which addressed ethical principles.

8This would include clinical approaches that take a patient/narrative ethics perspective to illness and treatment.

9Wider implications would include the use to which social science research is put. Evaluations may impact on social service provision, debates about political participation, and government policy that influences lifestyle choices. For example, research on family configuration.

10For a discussion of risk in medical research see; Levine, 1988.

11It is important to note here that as with social science review more generally the concept of 'ethics' is being used without a grounding in ethical principles.

12Adequate statistics are not available on the representation of LREC members, however this claim comes from a range of LREC members with experience of their membership. Indeed the new COREC guidelines include points relating to composition of committees in order to ensure that this problem does not happen.


The EPEG project, based in the Centre for Ethics in Medicine at the University of Bristol is funded by the Wellcome Trust.


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