Bureaucracy and Beyond: the Impact of Ethics and Governance Procedures on Health Research in the Social Sciences
by Kate Reed
University of Sheffield
Sociological Research Online 12(5)18
Received: 12 Jun 2007 Accepted: 28 Sep 2007 Published: 30 Sep 2007
This piece has been written in response to a recent article published in the Times Higher Education Supplement (THES) which exposed the red tape restricting health research in the UK's National Health Service (NHS). Whilst the THES article was critical of NHS ethical review and research governance, it still views a streamlined version of the process as necessary for the protection of researchers and respondents. Drawing on the recent experience of applying for ethical approval and research governance for a qualitative study on gender and genetics, this paper examines the review process and the restrictive paperwork and procedures that surround it, focusing in particular on the impact this has on social science research. The argument will be put forward that while all research, whether clinical or social, is hampered by the bureaucracy surrounding the review process, social research is further alienated by it. This is because the paperwork and processes involved are set up to evaluate clinical, not social, research. Furthermore, the process is caught up in a culture of fear that breeds mistrust towards 'outsiders' wishing to conduct research in the NHS. The revision of NHS ethical review has to go further than mere bureaucratic streamlining - it needs to be made more relevant and accessible to health researchers working across a range of disciplines.
Keywords: Bureaucracy, Ethics, Governance, Health Research, Social Sciences
Introduction1.1 Any type of health researcher whether conducting clinical, epidemiological or social inquiry, involving National Health Service (NHS) patients in the UK, staff, property or records must apply for NHS ethical approval and research governance from the relevant health authority. The ethics and governance process in the NHS aims to assess the potential risks to research participants and whether mechanisms are in place to afford them appropriate protection. It also aims to assess the scientific validity of proposals (Kent et al. 2002). In order to apply researchers must download and complete the national research ethics application form and submit this to the relevant research ethics committee (REC). Once the forms have been submitted, the researcher or research team has the opportunity to meet the appropriate REC to discuss the research. Thereafter a decision about approval is made. At the same time as ethical approval is sought, researchers must use associated forms to apply for research governance from the relevant health care trust.
1.2 Since the establishment of the central office of research ethics committees (COREC) in 2000 there has been some debate in the medical and social sciences about the process of NHS ethical review and research governance. Contributions to the debate have come from social scientists who consider the nature of ethical regulation ‘unethical’ (Dingwall 2006), from researchers whose research has been hampered by the process (Elwyn et al. 2005) and also ethics committee members who offer more positive opinions on it (Masterton 2006). Much of the criticism of these review procedures has come from clinicians who have argued that they are bureaucratic and time consuming. The ethical review and governance process has come to be seen as an exercise in cost evaluation to the NHS rather than being concerned with the ethics and scientific quality of research. Overall many authors have argued that it serves to obstruct research rather than protect patients (Wald 2004).
1.3 These issues have been highlighted in a recent central feature in the Times Higher Education Supplement (THES) (25/05/07). The feature drew attention to the ‘bureaucratic nightmare’ currently stifling vital health-related research in the NHS (Tysome 2007). As stated in the article, because the ethics and governance procedures take so long and are so laden with red tape many researchers from a range of disciplines are either being delayed or giving up on their research projects. According to this report academics on average have to set aside about 6 months to get through the checks necessary to begin research in the NHS and those delays are leaving academics beleaguered by the whole process. Despite this critique, the article sees the review and governance process as necessary in this current litigious climate in order to protect patients, health care professionals and researchers themselves. The article advocates the need for long term political changes across the education and health sectors in order to thoroughly address the bureaucracy inherent in NHS research procedures. In the short term however it does see light at the end of the tunnel in the form of ‘bureaucracy- busting initiatives’ from the UK Clinical Research Collaboration set up in 2004 which aims to streamline this incredibly lengthy process.
1.4 The THES is right to shed light on the endemic bureaucracy in ethics and governance procedures; these are incredibly labour intensive and problematic processes. However, it presents the problem in very simplistic terms as simply a problem of too much ‘bureaucracy’, too much time consuming paperwork. If only we can strip this down everything would be ok. However, the picture is far more complex and problematic than presented here, especially for social scientists trying to do research in the NHS. The problems associated with these procedures relate not just to the amount of paperwork but to the nature of it. The ethics and governance forms are not designed to address the ethics and validity of social science health research, nor are RECs themselves which often contain few, if any, social research specialists on their panels. This often means that the ethics of social research projects fail to be properly evaluated. Furthermore, the process is heavily gate-kept by health professionals and managers fearful of litigation, making the process for a social science ‘outsider’ even more difficult, time consuming or simply impossible.
Entering the Lions Den2.1 Having heard about the difficulty of conducting research in the health services, I have spent most of my career so far doing health related research without actually using NHS patients or property. However, it seemed impossible to avoid this any longer for my most recent project, a Wellcome Trust funded study on gender and genetics. The objective is to explore the roles of pregnant women and their partners in antenatal blood screening, examining the impact of these roles on decision-making and selective abortion, and also how they relate to parental feelings of genetic responsibility. The aim of the study is to conduct semi-structured interviews with 20 pregnant women and their partners in a northern city in the UK, gaining access to respondents through community and hospital midwives. In order to conduct this research I needed to apply for ethical approval from the local research ethics committee and research governance from the relevant Primary Care Trust (PCT) and hospital trust.
2.2 My attempts at applying for ethical approval for the study began in June 2006 shortly after the Wellcome Trust grant was awarded, with governance from the relevant PCT and hospital trust being sought shortly afterwards. The paperwork for this process was immense and took several months to complete. The process involved filling out the relevant forms and also collating and submitting a large amount of supporting data including posters, research proposal, interview schedules, consent form, patient information sheet, sponsorship details and indemnity arrangements. The volume of paperwork however was not the main problem; in fact completing a patient information sheet and putting together my interview schedule were actually very useful and forced me to refine my method at an early stage of research, thus enhancing the quality of the research proposal (Van Teijlingen 2006). The difficulty of completing the paperwork relates not so much to the volume, but the content. Most of the questions on the form were largely irrelevant to my research and would be to much other social science research. The questions are based on a particular model of health research; sensitivity and risk for example are ‘measured’ by ticking boxes on issues such as informed consent. As argued by Kent et al. (2002), how do you quantify risk and stress to respondents in social science research as you can in clinical research? Risks in social science research are not comparable to those found in biomedical research (Dingwall 2006). For example, the stress and risk posed to respondents in social science research cannot be solved, for example, by ticking ‘yes’ to a question on informed consent. As argued elsewhere, the process of obtaining informed consent is complex and not always beneficial to respondents. It’s debatable as to whether it can and should be ‘measured’ in such a way (Coomber 2002, Wiles et al. 2007).
2.3 The forms are based on a ‘tick box’ approach to ethics and governance. As Birch and Mauthner (2002) argue, the complexities of researching private lives and placing private accounts in the public realm increasingly highlight ethical issues that are not easily solved by rules and guidelines. This is certainly the case with my project. The main ethical issues in my research relate to the sensitive nature of the topics to be discussed around issues such as screening and diagnostic testing for chromosomal abnormality such as Down’s Syndrome. These issues cannot be evaluated by the tick box approach found on the NHS ethics and governance forms. Sociologists generally adhere to the voluntary and largely self-regulating ethical guidelines of the British Sociological Association (BSA 2002). These are a set of principles designed to act as a guidance to conduct in research. They recognize the diverse nature of ethical issues arising in social research and thus do not attempt to impose a set of ethical rules which can be checked accordingly. The main problem with the NHS ethics and governance procedures as they stand is their restrictive nature. The ‘one (biomedical) model fits all’ approach to ethics and governance makes the process a time consuming endeavour for social scientists who have to spend ages deliberating how to shoehorn the ethical issues found in their research into a particular model of health research. Because of this, many ethical issues arising in social research cannot be completely reviewed.
2.4 The form may be largely irrelevant to many social science projects, particularly those coming from a qualitative perspective. There is however, the opportunity, for further discussion of the form and its content when you meet the relevant local research ethics committee (LREC). LRECs usually comprise 12-18 members, some of which will be health professionals and ‘experts’ and a third of which will be ‘lay’ members (Kent et al. 2002). The meeting with an LREC gives researchers the chance to put their faith in an ‘expert system’ which will further evaluate and tease out problems and issues in their research. In my experience, this is far from true. The panel that met to discuss my research had the wrong application form in front of it, and started asking me questions on the wrong project- which is a breach in ethics itself. Once they did get the right form, no ethical issues were really discussed. Only minor points were made about how often the word ‘men’ appeared in my patient information sheet. This inattention to ethics relates no doubt partly to the time pressures felt by ethics committees who can only allocate a short period of time per research project. It also, however, relates to their limited understanding of ethical issues in social research. As Richards and Schwartz (2002) argue, unlike social scientists, health professionals are generally not trained in the philosophical underpinnings of research and may not be as well placed to make ethical judgments on social science research projects. Again, this renders the process largely irrelevant for many social scientists trying to conduct research in the NHS. Furthermore, in failing to adequately address the ethics of social research it also has the potential to undermine its own aim of affording protection to NHS patients, staff and researchers.
2.5 Ethical approval for my study was finally granted at the end of 2006. Governance from the PCT was awarded shortly afterwards. Gaining governance from the hospital, however, has only recently been granted (almost a year after I started the whole process) and this brings me on to my final point about the review and governance process which relate to issues of fear and trust. During the REC meeting, and also subsequently when applying for governance, it was clear that the health professionals and gate keepers involved were distrustful of me as an NHS outsider. The hospital made me go through several levels of review beyond research governance which included an occupational health assessment, which you only normally do when you apply for a job in an organization. Within the NHS nurses and midwives often talk about the climate of fear and accountability in which they work. Under such conditions health professionals constantly engage in defensive practices which are potentially counter productive for themselves and their patients (Annandale 2002). Such fear and accountability identified by NHS staff can be seen as part of a wider ‘culture of fear’ which has become an ever-expanding part of life in western society. In such a culture we are increasingly encouraged to take extra precautions in order to protect ourselves from perceived risk and danger (Furedi 2002).
2.6 This sense of fear and mistrust certainly translates to the governance and ethical review process. With regards to my experience, it felt at times like I was suggesting doing an expose of the NHS, not a small scale study on pregnant women and their partners’ involvement in screening. There was no sense of ‘trust’ between them as health professionals and myself as an academic researcher. Health professionals seem happy to place trust in the ‘abstract systems’ of these ethics and governance procedures, however, they don’t seem able to place trust in academic researchers themselves. Caution towards research is understandable in the aftermath of the scandal at Liverpool’s Alder Hey children’s hospital where children’s organs were harvested without parents’ consent. However, the level of paranoia among NHS staff towards research makes it seem quite untenable. In the context of my study, I felt that every time I got close to gaining approval a new hurdle was placed in my way, a new piece of paperwork needed to be completed in order for approval to be granted. Again, it was not the amount of bureaucracy needed to gain approval that was the problem, but the politics behind the process which as an NHS outsider placed me at a disadvantage.
Playing the ‘Ethics’ and ‘Governance’ Game
3.1 Despite all the problems I encountered, I did manage to get through the process with a lot of help and encouragement from the NHS research support teams in the relevant care trusts who kept telling me not to give up, and from the midwives who took great interest in my research. Now several months on I have managed to collect some fabulous data that I can’t wait to write up. The issues I have raised in this piece however cannot be ignored. The THES article discusses the need to streamline the governance and ethics process in the NHS in order that researchers can get on with their research. As shown in this discussion piece, however, this only part of the story- not everything can be solved by streamlining. In his work on bureaucracy du Gay (2000) argues that a substantive rational pursuit of moral ends is not always itself ethically desirable- certainly in this context you have to wonder whether streamlining ethics and governance procedures would in fact only serve to make the procedures more restrictive and even less relevant to the social sciences. Despite these criticisms, however, I want to make it clear that I am not advocating that we completing ditch these procedures, nor that we operate a ‘relativist’ approach to ethical review and research governance. There does need to be a set of procedures in place that relate specifically to health research where research subjects and researchers may be in particularly vulnerable positions. As argued elsewhere, a balance needs to be struck in governance and ethical review between flexibility and set regulation (Wiles et al. 2007). This balance could be struck within NHS research by revising existing ethics and governance procedures in order to enable them to reflect the diversity of health related research including social science health research. One way of doing this is to ensure that ethics and governance forms consist of more ‘open ended’ questions relating to the diverse range of ethical issues arising in social science research. Furthermore, the RECs themselves must include more social scientists on their panels that have greater ‘expertise’ in assessing social science research. The BSA perhaps also has a greater role to play too on these committees, circulating its own ethical guidelines to RECs in order that ethical issues relating to social science research are taken into account (see Coomber 2002).
3.2 Regarding the climate of fear surrounding the NHS review process, there is little that can be done about this. As argued earlier, it is merely another more extreme example of a ‘culture of fear’ already endemic to western society (Furedi, 2002). While budgets continue to be cut and staff held accountable, many health professionals will continue to act as gatekeepers of the whole process and this will continue to make it a fraught endeavour, particularly for social scientists working outside the NHS. In the long term it’s hoped that progress can be made on this. With a greater presence of social scientists on ethics committees and with more social science oriented questions on the forms, there may be greater opportunity to build trust relationships between health professionals and social scientists through ‘a mutual process of self-disclosure’ (Giddens 1990, 121). In the short term however, all we can do is try and make the process as bearable as possible and this means perhaps that sociologists like myself need to learn to play the ‘ethics and governance’ game, that is apply for ethical approval before you are awarded funding for a project. This seems to be to be an odd way to go about research but perhaps at least, it keeps the delay of bureaucracy at bay.
Notes1 The National Research Ethics Service was formerly known as the Central Office of Research Ethics Committee (COREC). The changeover from COREC to NRES took place in April 2007. Comments on the ethical review process in this paper relate to the COREC forms and review procedures existing in 2006.
2 For full details about the Alder Hay scandal please see BATTY, D and PERONE, J (2001). ‘Alder Hay organs scandal: The issue explained’ in Guardian Unlimited April 27th, <http://society.guardian.co.uk/alderhey/story/0,,450736,00.html>
ReferencesANNANDALE, E. (2002) ‘Working on the front-line: risk culture in the new NHS’ in s. Nettleton and u. Gustafsson (editors). The Sociology of Health and Illness: A Reader Polity Press: Cambridge.
BIRCH, M and MAUTHNER, M. (2002) Ethics in Qualitative Research, London: Sage.
COOMBER, R. (2002) ‘Signing your life away?: Why research ethics committees (REC) shouldn’t always require written confirmation that participants in research have been informed of the aims of the study and their rights- the case of criminal populations. (Commentary)’
Sociological Research Online, vol. 7, no. 1, <http://www.socresonline.org.uk/7/1/coomber.html>.
DU GAY, P. (2000) In Praise of Bureaucracy: Weber-Organisation-Ethics London: Sage
GIDDENS, A. (1990) The Consequences of Modernity Cambridge: Polity
ELWYN, G., SEAGROVE, A., THORNES, K., AND CHEUNG, WAI YEE. (2005) Ethics and research governance in a multicentre study: add 150 days to your study protocol. BMJ; 330:847 (9TH April).
FUREDI, F. (2002) The Culture of Fear: Risk-taking and the Morality of Low Expectation London: Continuum.
KENT, J., WILLIAMSON, E., GOODNEOUGH, T., and ASHCROFT, R. (2002) ‘Social Science gets the ethics treatment: research governance and ethical review’ Sociological Research Online, Vol 7, no. 4, <http://www.socresonline.org.uk/7/4/williamson.html>.
MASTERTON, G. (2006) Two Decades on an Ethics Committee BMJ 332:615 (11 March)
NATIONAL PATIENT SAFETY AGENCY <http://www.nres.npsa.nhs.uk/applicants/index.htm>.
RICHARDS, H.M., and SCHWARTZ, L.J. (2002) ‘Ethics of qualitative research: are there special issues for health services research?’ Family Practice 19: 135–139.
TYSOME, T. (2007) ‘Health Research buckles under burden of red tape’ in The Times Higher Education Supplement (May 25th,), pages 1 and 12.
WALD, D. (2004) ‘Bureaucracy of ethics applications’. BMJ; 329:282-284 (31st July).
WILES, R., CROW, G,. CHARLES, V,. and HEATH, S. (2007) ‘Informed consent and the research process: following rules or striking balances’ Sociological Research Online, Volume 12, Issue 2, <http://www.socresonline.org.uk/12/2/wiles.html>