John Barry
PhD student
City University, London
j.a.barry@city.ac.uk
http://www.city.ac.uk/
(Doyal 2004, section 4.1).
The above quote sounds as if it has come straight from Heller’s Catch 22, but is in fact from the official draft proposal for guidelines on the regulation of student projects in Britain. You have just entered the crazy world of medical ethics in the UK. If you think this doesn’t apply to you because you are a cognitive psychologist & don’t intend to set foot in a hospital until you are ill, you might be shocked. And if you should find yourself ever daring approach a hospital patient, hospital staff, or even setting foot on hospital grounds with a questionnaire, read on and pay close attention.
At the outset I should state that I have an interest in this issue. In 2002, as part of my MSc Health Psychology at the University of Westminster in London I wanted to study the psychological aspects of polycystic ovary syndrome (PCOS), which required that I recruit patients with this condition from the NHS. Despite having spent the summer reviewing the literature and designing the study, I was not prepared for the fact that the National Health Service (NHS, state run health industry) would delay my study for so long that in the end I didn’t have time to recruit through the hospital they were representing. In fact I would have failed my MSc had it not been for the overwhelmingly positive response from a PCOS support group who came to my rescue at the last moment, volunteering in droves. So who were the ethics committee representing the wishes of? Certainly not women with PCOS, who tend to be extremely concerned at the lack of research into their condition. I have found out since that my MSc experience of RECs (Research Ethics Committees) is one that is all too common in the UK, and predictably I am having similar problems on my current PhD research. But it seems that research at all levels is obstructed by the RECs.
Is the experience of ethical review the same throughout the EU? Hearnshaw (2003) compared the UK to some other countries, namely Austria, Belgium, Denmark, France, Germany, Israel, Netherlands, Portrugal, Slovenia, and Switzerland. Hearnshaw wanted to trial a leaflet intended to improve involvement of older patients with their family doctors. For this non-invasive, non-interventional trial only three of the countries required compulsory ethical approval: Belgium, Slovenia, and the UK – the rest required no notice for this type of study. In Belgium’s defence, at least they didn’t require as much paperwork as Slovenia and the UK. The UK REC process was found to be the most arduous of all the countries, spanning ten weeks, requiring two submissions (as changes were deemed necessary), and five days of administration. The whole wasteful experience left Hearnshaw to ponder that “UK partners may be unwelcome in international studies” (Hearnshaw 2004, p. 140). But curiously, the RECs across Europe & Israel all base their decision-making process on the Europe-wide ethical guidelines based on the Declaration of Helsinki, so how can the decisions be so heterogenous? Despite attempts by some in the UK to fall back on the old excuse of blaming EU interference for bureaucratic messes e.g. Derbyshire & Highfield (2004) it seems on the contrary that nearly every other EU country – using the same guidelines as the UK – has not got this problem of REC delays. Obviously there is more than one way to interpret guidelines, and for some reason the UK makes the harshest possible interpretation.
To put this situation in context, the history of modern ethical guidelines begins with the Nuremburg Code (1949) intended to prevent the gross abuses of human dignity that were seen in Nazi death camp ‘experiments’. The guidelines of the Declaration of Helsinki (in several versions from 1964 to 2002) stemmed from this. So let’s take a reality check for a moment: the ethical decision-making process that Hearnshaw went through with his leaflets designed to help elderly people stay healthy is based on guidelines intended to prevent gross abuses of human dignity that were seen in the Nazi death camps; does anyone else see something wrong with this picture? Do the UK RECs see a Dr Mengele behind every REC application? According to the President of the Royal College of Physicians, RECs should protect patients and encourage research beneficial to patients (Alberti, 2000). Did the UK REC encourage Hearnshaw’s research, which was clearly beneficial to patients? Did the UK REC think that Hearnshaw’s leaflets might damage patients? It is the strictness of interpretation of ethical guidelines that prompts me to describe the ethos as fundamentalism.
You might think furthermore that if a study has no problems in terms of ethics, then the REC would not have a problem with it; wrong. As the RECs are of the view that a poorly designed study would be unethical – it would be a waste of patients’ time and effort – this means that the RECs have a say in the design of the study too, whether you agree with their opinion or not. But it goes further still: though the hospital Trust gives final approval for research, the RECs have the right to review any study that involves NHS patients or their families or their records, NHS staff, NHS premises or equipment, unborn babies and the recently deceased. An application to the REC may be approved, deferred (pending alterations or additional information), or rejected on the basis that it needs to be fundamentally altered. The reasons for rejection are legion, and would seem to the uninitiated to have nothing to do with ethics. Any aspect of the design may be seen to be wanting e.g. not enough participants for sufficient power, or the researchers may be seen as lacking the expertise or funding to carry out the research, or they may have a track record of not completing projects, or the researchers are intending to offer inducements (e.g. cash or the promise of special attention) to participants to take part in the study. This final point does, at least, relate – however weakly – to an ethical dimension of the study!
Rejection however is not as frequent a problem as deferral. Delay in their research has been the bane of many a researcher in the UK. As you can imagine, in a health-care setting delays cost lives. The head of clinical programmes at Cancer Research’s UK, Dr Richard Sullivan has complained that trials of breast and bowel cancer drugs now took five times longer than in the early 1990s due to REC beurocracy (Derbyshire & Highfield, 2003). Even the late Sir Richard Doll – co-author of the first paper linking smoking and cancer – was so incensed by the bureaucracy that had crept into research ethics that he would “without doubt be willing to break the law” to draw attention “to the absurdity of the situation” (Highfield 2004, paragraph 4).
The letters pages of the Lancet, British Medical Journal (BMJ) and other leading publications often have complaints from researchers – mainly undertaking medical research i.e. clinical trials – who are tired and frustrated with the time-wasting tactics of the UK RECs. For example “To delay necessary research without good cause is itself unethical” (Gilbertson 1999, p.7). Another researcher complains that “we now… cannot do our jobs because of ethics committees” (Nicholl 2000, 1217). Others express the opinion that RECs don’t understand research methods (Pearson, 2000, p.1217). This opinion has been reinforced by the recent review of UK RECs which has advised that they should not judge the scientific merit of research proposals; this should be left to experts in the field of research being proposed (Department of Health, 2005). To be fair to the RECs, how could a panel of 7 to 18 committee members – including at least one lay member – be expected to have sufficient knowledge of all areas of research that might come their way in order to be able to come to a sound judgement as to its validity? These people are unpaid and usually have a great amount of work to undertake under time constraints. And there is also the fact that some RECs have a reputation for being more strict than others – it seems that choosing the right REC can be more important in getting your study done within your deadline than making sure the study is sound. Also if your study uses measures unfamiliar to any members of the REC you can expect to have your research delayed while they get you to clarify it for them. Walker et al. (2004) suggest that RECs are often ignorant of complementary and alternative medicine, resulting in the suggestion of unrealistic alterations. “There is at least one ethics committee that refuses all qualitative research proposals at first review” (Walker et al. 2004, p.122).
If professional researchers within the medical establishment (e.g. Doll) have a hard time of it, you can imagine the reception that psychologists – with their weird and unfamiliar psychometric measures – might get: more delays while the point of the study is explained to a degree unnecessary to those with a basic knowledge of psychometrics. And if you are a student wanting to research using NHS patients, staff etc, then it is even tougher. Marvel at this quote from the Working Group on Ethical Review of Student Research in the NHS: “Research is unethical if it is without scientific merit… student projects do not usually have this potential” (Doyal 2004, section 4.1). The NHS seems intimidated by what appears to them an “enormous and growing” area stretching the resources of the already overworked RECs (Doyal 2004, section 1.4). It is as if students are unwanted immigrants attempting to breach the borders of medicine. And it is not entirely flattering to the researchers of tomorrow to read that student research is “not designed to generate new knowledge. Rather… to develop students’ understanding of scientific methods and their skills in applying them. New discoveries may occasionally emerge … but this will usually be an unintended consequence of such work” (Doyal 2004, 1.2). No wonder then that MSc research “all but grinding to a halt” (Minnis 2004, p.122) and that some supervisors advise their students to abandon projects that require REC approval (McKee 2004, p.122). The Working Group express concerns over student clinical psychology & social work/care/policy projects, especially those using qualitative methods: “when undergraduate students interview patients, they risk causing distress and thus potential complications in the patient’s illness or recovery. The fact that such harm may be rare does not obviate the moral importance of avoiding it” (Doyal 2004, 2.3). This applies even if only interviewing staff, who are presumably only vulnerable to an everyday degree. But isn’t this view risk averse in the extreme? In psychology we use probability to guide whether we accept or reject a hypothesis, but it seems the RECs are inclined to reject this kind of study even though the probability of risk is extremely low. In any case, can’t the students’ universities properly regulate the students so that only good quality proposals reach the RECs? Surely psychologists are in a better position to judge the risks inherent in interviews and questionnaires. Doyle et al say that such regulation is “patchy” to “non-existent” (Doyal 2004, 1.3). Their proposed solution to this failure to properly supervise student projects is Student Project Ethics Committees (or SPECs, presumably to correct the short-sightedness with which student projects are designed). These are proposed to run along similar lines to the NHS RECs and “would need to be a joint endeavour between the Department of Health and the university” (Doyal 2004, 5.3). SPECs would govern any project using human participants regardless of whether based in healthcare or not. Is it me, or does this sound like trying to put out a fire with petrol? And why all this extra bureaucracy? Because Doyle et al want to ensure that student projects don’t have the potential to breach the Helsinki Declaration. Despite their recognition that it is important to train researchers somehow, student projects have inferior scientific standards. They view the cost-benefit analysis as weighing against the student, for example the potential distress caused by a questionnaire is usually unseen by both student and supervisor, and can only be safely assessed by an independent committee i.e. SPECs.
But don’t worry, because now we have the new improved EU Directive 2001/20/EC that applies to all EU countries and has promised to improve the situation e.g. by ensuring an REC decision within 60 days of receipt of application. But the decision doesn’t have to be ‘yes’, it may be ‘no’, or require any number of amendments. Once amendments are made, you submit the documentation again (all of it) and the sixty day clock starts ticking once more. But perhaps many psychologists in the EU will not even notice the change, as the directive is supposed to govern clinical trials i.e. should not apply to questionnaire or other non-medical research. Furthermore: “This Directive does not apply to non-interventional trials” (EU Directive 2001/20/EC, p.3). Thus there are no guidelines whatsoever for research involving only questionnaires/leaflets etc. So if a piece of research is non-medical and non-interventional, why do we need the NHS ethics committees to get involved? The answer is that we probably don’t, neither ethically, scientifically, nor legally. But who is going to challenge the NHS on this? The legal expense and paperwork involved would put all but the most resilient off this idea. To confuse matters further it seems that COREC (the Central Office for Research Ethics Committees) view questionnaires as a type of intervention. In defining questionnaires in this unusual way gives RECs some sort of excuse to review questionnaire-based research.
But why should the NHS act in such an unreasonable way? Perhaps it is a knee-jerk reaction to the moral panic that followed Alder Hey and similar scandals in the 1990’s. It has been suggested to me that since Alder Hey the NHS ethics committees have become very sensitive to allowing any research that might leave them open to being sued or blamed for causing distress or harm of any kind to patients or public. If this were true it would imply that the NHS – through the RECs – are as interested in protecting themselves as they are their patients. Again, it seems ridiculous to put questionnaire research in the same bracket as research involving the organs of dead babies, but this is the ridiculous ‘one size fits all’ mentality of the NHS RECs.
As Glasziou and Chalmers (2004) point out (see the Hearnshaw 2003 study), Britain – along with Belgium and Slovenia – have the strictest RECs of the 10 European countries (plus Israel) that they tested. Naturally many parties interested in investing in research can see just how difficult it is to do research in Britain. The result? They will invest elsewhere, in countries that have RECs that appear grounded more in science and less in Kafka. The rot has clearly set in in the UK; could it take hold elsehwhere in Europe?
What can we do in the UK to improve the situation? Well, consider that membership of the REC is voluntary, and one third of the maximum of 18 members may be lay i.e. not necessarily connected to medicine or science in any way. Decisions are made when consensus is reached, at least by the majority on the committee. So why not have a say in the process, and join your local committee? Applications can be made to join an REC by contacting them direct. A list of contact details of RECs in the UK can be found here: http://www.corec.org.uk/recs/contacts/recsgeo.htm
Another option is what is called ‘patient power’ – no, not the kind of patience you need when making an application to a UK REC, but the kind of power exerted when patients realise that their needs are not being met and so they do something constructive about it. This has been the case recently with the breast cancer drug Herceptin, which until patients voiced their protest (34 000 signatures to Downing St), was not available to women with early stage breast cancer. I would predict that the public would protest in a similar way if they realised that every day that the availability of drugs, treatments, and medical knowledge were being delayed by the REC system of review, a system that is crying out to be changed.
Footnotes
1 "clinical trial" means any investigation in human subjects, other than a non-interventional trial, intended -
(a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products,
(b) to identify any adverse reactions to one or more such products, or
(c) to study absorption, distribution, metabolism and excretion of one or more such products, with the object of ascertaining the safety or efficacy of those products (EU Directive 2001/20/EC, p.3).
2 Neither does the more recent Good Clinical Practice directive (2005/28/EC).
3 Prompted by uncertainty around the meaning of the term “non-interventional research” in the latest NHS REC form (Version 5.1) the term has been removed i.e. there is no longer an option for ‘non-interventional research’ (Downing 2006, p.2). The term has been replaced by a new option “research limited to working with human tissue samples and/or data”, which is apparently what COREC had meant by the term all along. This hardly clarifies matters for those of us whose research involves questionnaires. Perhaps the inclusion of an option for “research limited to working with data” would have made things clearer?
4 There was a public outcry when it became known that many babies who died at the Alder Hey Childrens’ Hospital between 1988-1996 had various organs removed for research purposes without the knowledge or permission of parents. This was in breach of existing legislation, the Human Tissue Act of 1961.
5 This is not to say that they have ever been considered a push-over since their inception in 1968.
References
Alberti, K. (2000). BMJ, 320, 1157-1158.
BBC News (2006). Doctors ‘prescribing Herceptin’. http://news.bbc.co.uk/1/hi/health/4677538.stm
Department of Health (2005). Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees. http://www.dh.gov.uk/assetRoot/04/11/24/17/04112417.pdf. Accessed 7-2-06. (a summary is available here: http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesNotices/fs/en?CONTENT_ID=4112425&chk=BXhYLq).
Derbyshire, D. & Highfield, R. (2003) Brussels red tape ‘costs lives of cancer patients’ http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2003/09/12/ncanc12.xml 12/09/2003. Accessed 7-2-06
Downing, J. (2006). http://www.corec.org.uk/applicants/index.htm#060206A. Accessed 7-2-06
Doyal, L. (2004). The Ethical Governance and Regulation of Student Projects: A Draft Proposal Working Group on Ethical Review of Student Research in the NHS. http://www.aaps.ed.ac.uk/committees/REC/2003-04/REC_agenda_190204.pdf
EU Clinical Trials Directive. DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001. http://www.wctn.org.uk/downloads/EU_Directive/Directive.pdf. Accessed 7-2-06
Gilbertson (1999). Ethical review of research. British Journal of Anaesthesia, 82, 1, 6-7.
Hearnshaw, H. (2004). Comparison of requirements of RECs in 11 European countries for a non-invasive interventional study. BMJ, 328, 140-1. http://bmj.bmjjournals.com/cgi/content/full/328/7432/140. Accessed 3-4-04
Highfield, R. (2004). Rules ‘threaten medical research’. http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2004/02/26/nrules26.xml . Accessed 7-2-06
Human Tissue Act (1961) cited in http://news.bbc.co.uk/1/hi/health/1136723.stm. Accessed 3-4-04
Nuremberg Code (1949) cited in http://ethics.sandiego.edu/Resources/htm. Accessed 3-4-04
EU Directive 2001/02/EC (DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) http://www.wctn.org.uk/downloads/EU_Directive/Directive.pdf
WMA (2002). Declaration of Helsinki. http://www.wma.net/e/policy/pdf/17c.pdf. Accessed 10-4-04