International Centre for Nursing Ethics Return to INDEX for ICNE
European Experiences of Constitutional Ethics Committees
(Lecture given at Workshop-conference on ethics committees, School of Nursing, University of Chile, Santiago, Chile, 24 July 2000)
by Verena Tschudin
______
The topic of ethics committees in Europe is a fascinating subject. 'Europe' is a large place with many, many different practices and customs. A good deal of 'digging' was necessary to find the necessary information. Even now most of the material I found concerns the situation in the UK, where indeed ethics committees were first asked for and used.
I will start with a short historical overview of the establishment of ethics committees.
Historical background
It is important first of all to make it clear that the ethics committees in the UK are only concerned with research, that is, they are not committees that one can call on when dealing with a dilemma in practice. A few trusts or hospitals - I know of about five - have established committees which members of staff can call on in times of crisis or need, but they are entirely limited to these local situations.
In 1968 the United Kingdom Department of Health recommended that hospitals should operate ethics committees. Only in 1984 did the Royal College of Physicians produce guidelines for such committees, but the College has continued with its involvement with committees ever since. I think that to begin with, these committees cannot have been well known or not many were about. In 1990 the Royal College of Physicians clarified the aims of such committees and finally gave them a name: Local Research Ethics Committees (LRECs). Their brief now was 'to maintain ethical standards of practice in research, to protect subjects of research from harm, to preserve subjects' rights and to provide reassurance to the public that this is being done' (RCP, 1990). In 1995 the first training conference for research ethics committees took place, which also worked on the procedure to be followed by LRECs in the way they handle applications (Bulletin 111, p. 3-4).
These committees are local, that is, they are usually centred around a trust, that is an area comprising one or more hospitals, and perhaps other services, including social services. A trust is a self-chosen conglomeration of purchasers and providers of services, often with distinct interests. Some trusts are very large, some quite small, depending on the location or the interests of the locality. In 1997 there were 255 such committees in the UK, for a total population of about 60 million people. I do not have more up-to-date numbers, but I think this cannot have changed significantly. What I do know is that these committees work ever harder. In 1982 the average number of projects reviewed by a committee was 12, and in 1992 this was 63 (Bulletin 129, p. 17). While these committees are voluntary in the sense that members are not paid, the workload and the consequent question of payment is constantly in the air.
In 1997 a system of Multi-centre Research Ethics Committees (MRECs) was set up. An MREC is an advisory body providing independent advice on the science and general ethics of multi-centre research proposals. Each multi-centre protocol will be considered by one MREC only. Research is regarded as 'multi-centre' if it is carried out within five or more LRECs' geographical boundaries. The membership of MRECs is similar to that of LRECs, that is, members have to contain a broad range of experience and expertise, with members reflecting a mix of gender, age and ethnic background. They include hospital medical staff, nursing staff, general practitioners, other NHS professional staff, and lay persons (Bulletin 127, p. 4). All the MRECs have paid administrative staff.
MRECs had a difficult job at first. Now they have established a uniformity of procedures and paperwork regarding application forms, patient information sheets and consent forms, approval letters for drug companies and the follow up of approved projects (Bulletin 139, p. 6). This last issue is one I will address later.
With legislation now in place for the different layers of local and multi-centre research ethics committees, the system seems to run more smoothly, but there are still plenty of problems and I will describe these next.
Problems encountered in the UK
Among the problems encountered in LRECs were clear differences between medical research and that undertaken by other health care workers. Physicians have largely based their reputation on the doctor-patient relationship, and therefore the concern is to ensure that patients are protected. The medical profession seems to claim ownership of the person. Medical ethics has been clearly defined within the four principles of beneficence, nonmaleficence, justice and autonomy, thus perhaps creating a climate of paternalism that tended to exclude other views and other frameworks.
In other areas of health care research, different criteria tend to operate. There, it is not so much a set of clear-cut principles that guide people, but often a more a common-sense approach arising in practice. Rather than linear reasoning, the circular approach is favoured, involving discussion and one's peers, perhaps making use of various different approaches that might be suited to the situation concerned.
In the early 1980s nursing research became the hallmark of a profession trying to establish itself more securely in that it claimed academic status. Nurses had real difficulty at the beginning of the ethics committees because of their emphasis on qualitative work. Physicians often did not see the sense of research protocols submitted by nurses, claiming that what was attempted to be researched was obvious already. There is a large amount of literature around that claims that qualitative research was being treated unfairly or was being disadvantaged by ethics committees (Hunt, 1992, p. 350; Parker, 1993; Williams, 1997, p. 18; Lacey, 1998, p. 216; Kent, 1997, p. 186; Lyttle, 1998, p. 42; Gauld and Macmillan, 1999; Gelling, 1999, p. 564). In my own work as editor of the journal Nursing Ethics, however, no-one has ever made any reference about this, and we publish many research articles.
The immediate problem then becomes one of establishing some kind of superiority. Which approach is 'right'? Which profession is 'right'? Being 'right' in medical terms is one thing, but being 'right' in moral terms is 'better'. While medicine needs clearly to establish certain facts that can only be proved by quantitative research, the rest of health care may favour qualitative work and methods. Medicine cannot be judged by qualitative work, and social care cannot be put into the language of quantitative tools. The research ethics committees had to learn that both approaches have their place, but not necessarily at the same time.
One constant problem with the workload of LRECs is that they take a very long time to clear protocols. Sometimes it takes months to get clearance, and this is extremely frustrating for students, whose time of study may run out before they get the clearance. In the last three years there has been a big five-countries study done in Europe on 'Patients' autonomy, privacy and informed consent' and the chief researcher told me a few weeks ago that one main problem was clearance in the UK. In Denmark the researchers waited just two weeks for clearance, but those in the UK waited nine months. This can be very frustrating, particularly for large studies where many people are involved, but also for studies that may be applicable only for a short time, perhaps of an epidemic or other short-term situation.
On the other hand, LRECs complain that because nursing students now have to do research, the value of the actual project, either in terms of any new knowledge found and reported, or educationally for the student, is often not clear enough or even absent, and it may be difficult to see how such projects can be performed ethically (Bulletin 139, p. 6).
To help this, the Scottish Office - Scotland is a separate 'country' within the UK with its own parliament - has prepared guidelines for people applying to MRECs and the Scottish LRECs have also asked researchers to use these guidelines (Bulletin 148, p. 8). I am not aware, however, that other regions or countries in the UK have stipulated the same.
However, the Royal College of Nursing (1998) has produced a very helpful booklet which is short enough for there being no excuse for any nurse not to have read it. This addresses different groups of nurses:
This is a very good starting point, but clearly not enough for those actually having to deal with ethics committees.
The question of funding is still not clearly established. The latest information I have on that is that only commercially-sponsored researchers are being charged for ethics review (Bulletin 139, p. 6). This is a real problem as discrimination could easily make this whole area … well, rather unethical!
It is always possible to take one's project to a different LREC if one is disappointed or has been rejected by one particular LREC. 'Committee shopping' is a well recognised phenomenon in other countries'. For many reasons, therefore, it is imperative that constant vigilance and legislation is needed to avoid problems and to further actual, real and useful research.
I will now outline a few details of what is happening in some other European countries.
The situation in other European countries
In Sweden the basis for ethics committees is simply the Helsinki Declaration. A Research ethics committee (REC) 'assesses the risks to the subjects of a given trial and how they can be reduced must be balanced against possible benefits. Among other things this implies determining whether the question to be considered is important and if it can be answered by the proposed methodology… A poorly defined study is by definition unethical' (Lynoe et al, 1999).
When I enquired of the authors of an article from Turkey, the reply I received was: 'In Turkey there are no ethics committees concerned with patients' rights. Ethics committees mostly control research or stop research. Research that reveals any defect in institutions, such as malpractice, is stopped by these committees. Patents' problems, and problems between patients and health professionals are not mentioned by these committees' (Personal communication).
You may say that my brief is about Europe, and Turkey is in Asia, but Turkey is also shortly to join the European Union and to all intents and purposes is counted as a European country. This description of the situation there must therefore be taken seriously and is probably not so unusual.
The very influential Danish Council of Ethics produces a report each year that not only outlines its activities - which is mainly to do with making policies - but each year also considers one subject in depth, such as genetics or human rights.
A similar situation exists in Portugal, where the Portuguese National Council of Ethics for the Life Sciences publishes regular reports that are translated into French and English. This committee acts as an independent source of advice but it is administratively and financially supported by the Prime Minister's Office (Bulletin 132, p. 8).
The German Federal Medical Council has a central ethics committee, comprising 16 members from medical specialities, philosophy, theology, natural sciences, the law and politics, but has no patient representative. Local research ethics committees which review clinical studies can request advice from the central committee (Bulletin 111, p. 6). There were 16 committees based in the state doctors' chambers, and about 50 committees based in universities. These latter did not meet during the university vacations, which make up about six months of the year, so they are not very user-friendly (Bulletin 131, p. 7). There are some local committees dealing actual situations of ethical need, but they tend to be started by individuals of goodwill.
What I could find about Switzerland is a Manifesto of an independent group of people discussing the ethics of scarce resources. This points to a lack of recognised committees making such decisions.
A royal decree of 1994 'provides a legal obligation to establish an ethics committee in every Belgian hospital. Only very small hospitals, with a medical staff of less than six physicians, are exempted from this obligation' (Nys, 1995). The tasks and functions of a hospital committee are very broad.
They include:
This type of committee is the only one that I have been able to find within Europe, combining the functions of research, policy making, and decision-making in individual cases. Belgium is unique in this instance, but the source I have for that (Nys, 1995) is also very critical of the decree establishing these committees because it is not rigorous enough.
While there are national differences, there are also directives from the European Union on Good Clinical Practice which member states have to adhere to (Bulletin 135, p. 6)
The Netherlands, which alone of European countries has legislation permitting euthanasia, yet has no ethics committees making on the spot decisions. Ethics committees exist 'in almost all health care institutions and organisations but they give only advice on institutional policies and individual or clinical cases. Decisions are made by (boards of) directors' (Arend, personal communication). Thus, the member of an institutional ethics committee who told me this, said that as such a member he wrote a document on resuscitation policy and guidelines. The board of directors and medical staff accepted this document and decisions in individual cases in that institution are now based on those guidelines. Such ethics committees exist all over the Netherlands and they are all involved in various kinds of ethical issues.
There are also regional review committees on euthanasia. They review end-of-life decisions made by specialists and general practitioners based on their reports to municipal coroners. They only evaluate [decisions after the event], mostly with regard to procedures followed. In 1999 - the first year of their functioning - there were no cases brought to court. Nurses are hardly involved and in the annual report, nurses and their contributions to the decision-making process are not mentioned at all.
There is a special committee concerned with xenotransplantation. Public opinion and the committee's discussion are in favour of forbidding every kind of xenotransplantation (Arend, personal communication).
The Netherlands has joined several other European countries in deciding that legislation is needed to ensure adequate control of research on human subjects. The Medical Research Involving Human Subjects Act came into force there on 1 November 1999. This provides for a Central Committee to exist, although it does not detail any other 'lower' committees (Bulletin 152, pp13-18).
In Sweden there are no ethics committees within hospitals dealing directly with on-the-spot situations. Most of the ethics groups are educational, that is, they exist to increase awareness of ethical problems and how to analyse them and deal with them in a general way (Lützén, personal communication).
These are the various practices as I could elicit them. What is interesting is that the Netherlands, with its liberal laws and policies on euthanasia, does not have committees to deal with individual cases. Belgium, on the other hand, seems to be the only country that has ethics committees that attempt to deal with all aspects of health care, and to all intents and purposes, this does not work well.
With the increasing complexity of medical treatments and care, there must come a time when more people will need to have access to committees for advice and decisions, for their own satisfaction and to help staff in arriving at more equitable and transparent decisions.
Since the majority of ethics committees in Europe deal only with research on human subjects, I would now like to tell you of a few of the topics of research articles that we had printed in Nursing Ethics as this will give you a little idea of some of the delicate research that nurses are doing.
Research topics considered in Nursing Ethics
In the journal we have had a great number of articles that describe research, and some of them were on very sensitive subjects. For instance, some Finnish nurses studied families who are abusing children (Paavilainen et al, 1998; 5.3); an article from Switzerland considered the physical restraint used with elderly patients in a nursing home (Hantikainen, 1998; 5.4); a study from the UK researched the experiences of lesbians' and gay men's health care, where the researchers were lesbians and had more than a detached interest (James and Platzer, 1999; 6.1); some nurses in Israel described the sexuality among institutionalised elderly patients with dementia (Ehrenfeld et al, 1999; 6.2); researching the bereaved (Sque, 2000; 7.1). There are also some examples of nurses studying the behaviour of nurses (Sivberg, 1998; 5.2; Merrell and Williams, 1994; 1.3). These topic clearly point to the question of what the outcome is hoped to be, who will benefit from the research, and what harm might possibly be caused and should therefore be avoided. One might also ask why the researchers want to undertake this kind of study, that is, what their own motives are.
Now, therefore, I will say something about the interests that ethics committees serve in health and social care research.
Whose interests do ethics committees serve in health and social care research?
'The responsibility of an ethics committee does not cease with the approval or non-approval of a project, and RECs should monitor the progress of the projects that they have approved in an attempt to ensure that their conduct remains ethical, particularly in the light of any proposed significant deviations from the original protocol or of any unusual or unexpected results that may raise concerns about the continued safety of the research' (Parker, 1994, p. 81).
I would therefore like to present you with a few aspects that have been thrown up by the research described in two more articles that will be published later this year in the journal.
Inevitably, in the course of their work, researchers gain much else besides the strict data they are looking for. This has been very well described in one article from Norway, (Haugen Bunch, 7.6) where the researcher observed an intensive care unit. What she describes as emerging as she watched, is 'drama'. This is not what you see on TV, but the drama of patients getting better, hopes being raised, then getting worse, and then dying. She describes the professionalism of nurses who have learned to use machinery and technical aids like tools, being in charge of the machines, rather than the machines being in charge of patients' lives. This came to light only after a very long time of simply observing. She learned that it takes about a year for a nurse to become competent in that environment. In the UK we have a problem with not enough nurses for intensive care units. Every now and again some politician will say, 'we will hire more nurses with intensive care experience'. This sort of research therefore has implications for policy makers. Nurses with ICU experience cannot be found on the streets and hired overnight. Maybe this is the real outcome of such research, and ethics committees should be in a position to support such findings, and support the researchers in making them public. Perhaps the public should be aware of the limits with hiring ICU nurses. The point is that this is not the kind of data that either researcher or ethics committees can envisage at the outset.
Another author (Grinyer, 7.6) describes the kinds of issues that may present themselves covertly. Studying a certain occupational group may mean that these people volunteer information that the employers will not like to hear. Observational studies in hospitals may highlight the cleanliness or otherwise of ward areas. In the UK, all cleaning services in hospitals are co-ordinated centrally, that is, ward nurses have no access to cleaning materials because the cleaners are no longer controlled by the wards. The possible implications for MRSA may be huge, but this is not what anyone had in mind when studying lifting procedures. What does the researcher do when being told that a whole group of nurses might have been infected with HIV by a certain patient, were tested but never received any results? Or that certain protective clothing was promised but never received? It is in such situations that I would see a clear role for an LREC. I would see this as a kind of support system, whereby a researcher who might run into problems could go and check out what is happening, somewhat in the manner of the American IRB (Institutional Review Board). The idea of clinical supervision has taken on in a big way, and it may be something like this that is also needed for researchers. While they have supervision from their work place, it would seem to me that some kind of supervisory or preceptor role by perhaps one named member of an ethics committee may also be helpful.
I would also see a role for ethics committees at the end of a process. If the findings are truly awful, should it be entirely the researcher's own responsibility to keep the findings, or to publish them? More harm could be done by publication of questionable or potentially harmful material. This is where the whistleblowers come in. All researchers are very conscious of confidentiality, but however confidential they may be, if the findings point to malpractice of any kind, then perhaps publication of findings - and potentially blowing some cover - may hurt a particular individual or institution and be beneficial to a larger public. There have been plenty of examples of this in the media in the UK recently. It seems to me that there is a large gap in accountability between the ethical starting point and finishing point. If a research ethics committee were involved more all along the line, it may not be such a horrendous job for just one individual when dubious practice is discovered. There would be more institutional accountability generally, and that is something that should surely be encouraged.
There is a balance to be struck for ethics committees between being over-protective and watching the researcher's every step on the one hand, and being too unconcerned and detached on the other. That there is room for improvement goes without saying. To my mind, it is the age-old question of institutional accountability that matters more than anything. Institutions have to be ethical as well as their members., --and that, to my mind, includes research ethics committees.
As we have the legislation more or less in order in the UK now, we should begin to think about these wider issues. We should never forget that the main aim of any research committees is to protect the research subjects - individuals and society - from harm. Sometimes individuals have to be protected from society, and sometimes society has to be protected from certain individuals, and that is never an easy choice or decision. The more we are aware of any possible harm, the more ethical all our work becomes.
The fact that the equivalent of institutional review boards does not exist in Europe (apart from in Belgium) seems to me significant. Research ethics committees can be regulated, but IRBs are much harder to regulate. Their advice or decisions are inevitably local and depend on the personalities involved. In Europe we do not like to be over-regulated; but I also think that some of the lack of such committees is due to the still huge influence of medicine and individual members of the medical profession.
The possible existence of ethics committees in hospitals and community concerned only with practice and the day-to-day decisions arising from practice, is a topic that needs to be considered carefully. The problem of members being self-selected, and so either people with too much time or too much power being on to them, needs to be carefully studied. Their brief must be clear, and their activities must be monitored by outside agencies, otherwise they would become a parody.
I believe that some countries have now either started with schemes for a Patient Ombudsman or are considering it. This may be one way of resolving a difficult problem, but no doubt it will also bring different problems. However, Ombudsman schemes in other sectors of life have generally been helpful and useful.
Institutional accountability is more necessary than ever, and a constant review of what one is doing and why is essential. Only by being willing to challenge ourselves and being challenged by others can any committees - and all health care professionals - maintain their ethical integrity.
References
Bulletin of Medical Ethics 1995 (111) 3-4, 6
Bulletin of Medical Ethics 1997 (127) 4
Bulletin of Medical Ethics 1997 (129) 17
Bulletin of Medical Ethics 1997 (131) 7
Bulletin of Medical Ethics 1997 (132) 8
Bulletin of Medical Ethics 1998 (135) 6
Bulletin of Medical Ethics 1998 (139) 6
Bulletin of Medical Ethics 1999 (148) 8
Bulletin of Medical Ethics 1999 (152) 13-18
Bulletin of Medical Ethics 2000 (154) 3
Department of Health ( 1994) Standards for Local Research Ethics Committees: A Framework for ethical review. London: DoH.
Ehrenfeld M, Bronner G, Tabak N, Alpert R, Bergman R. (1999) 'Sexuality among institutionalized elderly patients with dementia'. Nursing Ethics. 6, 2 pp144-149.
Gelling, L. (1999) 'Role of the Research Ethics Committee'. Nurse Education Today 19, 564-569.
Gauld, R., Macmillan, J. (1999) 'Ethics Committees and qualitative health research in New Zealand'. The New Zealand Medical Journal, 299 1437-9
Grinyer A. (2000) 'Ethical dilemmas in non-clinical health research from a UK perspective'. Nursing Ethics, 7, 6 (in print).
Hantikainen V. (1998) 'Physical restraint: a descriptive study in Swiss nursing homes'. Nursing Ethics, 5, 4 pp 330-346.
Haugen Bunch E. (2000) 'Hidden and emerging drama in a Norwegian critical care unit: ethical dilemmas in the context of ambiguity'. Nursing Ethics, 7, 6 (in print).
Hunt, G. (1992) 'Local Research Ethics Committees and nursing: a critical look'. British Journal of Nursing, 314, 1081.
James T, Platzer H. (1999) 'Ethical considerations in qualitative research with vulnerable groups: exploring lesbians' and gay men's experiences of health care - a personal perspective'. Nursing Ethics, 6, 1 pp73-81.
Kent, G. (1997) 'The views of members of Local Research Ethics Committees, researchers and members of the public towards the roles and functions of LRECs'. Journal of Medical Ethics. 23, 186-190.
Lacey, E.A. (1998) 'Social and Medical Research Ethics: is there a difference?'. Social Sciences in Health, 4.4,211-217.
Lynoe, N., Sandlund, M., Jacobsson, L. (1999) Research ethics committees: a comparative study of assessment of ethical dilemmas, Scandinavian Journal of Psychiatry, 2 152-159.
Lyttle, C.P. (1998) 'Elderly consumers' and community nurses' experience of bereavement visiting: navigating, networking and negotiating with a local research ethics committee'. Managing Clinical Nurse, 2, 41-44.
Merrell, J., Williams, A. (1994) 'Participant observation and informed consent: relationships and tactical decision-making in nursing research'. Nursing Ethics, 1, 3 163-172.
Nys, H. (1995) 'Ethics Committees in Belgium'. European Journal of Health Law, 2, 175-176.
Paavilainen E, Astedt-Kurki P, Paunonen M (1998) 'Ethical problems in research on families who are abusing children'. Nursing Ethics, 5, 3 pp200-205.
Parker, B. Research ethics committees, IN: Tschudin, V. (ed) (1994) Ethics; Education and Research. London: Scutari.
Royal College of Nursing (1998) Research Ethics: Guidance for nurses involved in research or any investigative project involving human subjects. London: RCN.
Royal College of Physicians (1990) Guidelines on the practice of ethics committees in medical research involving human subjects. London: RCP. (p. 3).
Sivberg, B. (1998) 'Self-perception and value system as possible predictors of stress'. Nursing Ethics 5 2 103-121.
Sque M. (2000) 'Researching the bereaved: and investigator's experience'. Nursing Ethics, 7, 1 pp 23-34.
Williams, A. (1997) 'Pitfalls on the road to ethical approval'. Nurse Researcher, 5.1 15-22.