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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Politics of Medical Ethics Committees: seriously adverse consequences!
- Dr. Naseem A. Qureshi, MD, IMAPA, LMIPS (21 May 2004)
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Yet more forms
- Neville W Goodman (26 May 2004)
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A National Research Ethics Committee for the UK
- Stephen D Keay, Mark Bratton Senior Chaplain University of Warwick (8 June 2004)
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Re: A National Research Ethics Committee for the UK
- John Saunders (12 June 2004)
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An Ethical Cancer Data Base has been Set Up In Wales
- susanne McCabe (14 June 2004)
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Research Ethics Committees and other 'watchdog organisations' need to demostrate total independance from political interference.
- susanne McCabe (14 June 2004)
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Dr. Naseem A. Qureshi, MD, IMAPA, LMIPS, Medical Director [A], Director, CME&R Medical Director[A] & Director of CME&R,
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Sir: I read carefully the editorial by Richard Nicholson (2004) who articulately informed us about the threat to research in the UK. Evidently, the repercussions of bureaucratic regulations, EU research directives, guidelines, paper work overload and most disastrously the control of political body over the Medical Ethics Research committees will be felt throughout the EU. As a result of political interference, firstly medical ethics committees will not have any more independence status and secondly researchers have to have informed consents from prospective participants in research having incapacitated illnesses. Here, the issues of conflicting interests will emerge and due to tricky problems many incapacitated participants will be dropped from the research. Unfortunately, incapacitated patients need urgent medical help that can come only through well conducted research and hence their participation in relevant research is of high import. By and large, political interference in medical research has been antagonistic and in the light of their such aggrandized, horrible pursuits, only ultimately patients suffer. Therefore, patients organizations and medical organizations in EU should reach the political leaders in order to put their justified demands, one of which is to make the Medical Ethics Committees completely independent free from "dirty" politics. Reference: Richard Nicholson. Another threat to research in the United Kingdom. BMJ 2004; 328: 1212-1213 Competing interests: Pro-researcher |
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Neville W Goodman, Consultant Anaesthetist Southmead Hospital, Bristol, BS10 5NB
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Richard Nicholson is a little out of date in his description of COREC's micromanagement. We newly have a 'Recruitment Package', consisting of 28 standard advertisements for media and walls, letters of invitation and acceptance, and so on. So far these are 'advice on good practice and not policy at this stage'. We await advice on suitable clothes to wear during committee meetings, and the ambient temperature at which male members of the committee are allowed to remove their ties. Competing interests: Chair of Southmead REC |
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Stephen D Keay, Senior Lecturer in Obstetrics & Gynaecology Department of Biological Sciences, Mark Bratton Senior Chaplain University of Warwick
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Dr Nicholson's article highlights some very important concerns surrounding medical research in the UK. The view regarding the question of the independence of Local Research Ethics Committees(LREC)'s is premised on what he sees as an inadequate transmutation into domestic law (through Regulations) of the provisions of the European Directive. His views on the involvement of incompetent adults in clinical research also raise important issues. As the law stands, there is no proxy consent for incompetent adults nor a jurisdiction comparable to a wardship jurisdiction for children. The treatment of an incompetent adult patient or the involvement of such a patient in research has always been subject to the legal and ethical test of 'best interests' (albeit defined more expansively in the case of research). This has always been a clinical judgement usually made by somebody with a direct involvement in the patient's care. What test would this new-fangled legal representative apply? The legal representative's own view of the patient's best interests? His own speculation as to what the patient himself might have wanted had he been competent (some form of substituted judgement)? To what extent would any choice (albeit the patient is legally incompetent) evinced by the patient carry weight ? There are a host of questions that need to be addressed. The proposal of a central, national committee dealing with complex ethical issues is appealing but practicalities such as convening meetings and reaching a decision within the time laid down by COREC (60 days from submission) may be difficult. This problem might be overcome if there were provision for a suspension of the timetable pending a determination on the problem referred. This might not be popular amongst researchers, but one could argue that it is better to resolve the ethical difficulties properly than for LREC's to determine them themselves, perhaps against the applicant. There would be costs involved in assembling experts for a national committee and even a small secretariat would require offices (probably London-based) and salaries. Inspecting LREC's would require visits around the regions and inevitably involve hard-pressed LREC administrators with significant preparation. The Human Fertilisation and Embryology Authority (HFEA) is suggested as an example of an organisation akin to the proposed National Ethics Committee. The HFEA levies £100 per IVF cycle which is borne by the patients (if self -funded) or Primary Care Trust (if NHS funded) and invoiced to the licensed IVF centre. How the cost of LREC licensing would be met is of interest perhaps through a fee charged to the Principal Investigator or to the LREC's ? There is real merit in the proposal for a National Ethics committee of experts but it is worth exploring existing models in other European countries to decide on which works best. A system of electronic data interchange would aid the speed and effectiveness of communication between a National committee and LREC's (this has still to be introduced by the HFEA). A further consequence of the recent COREC changes is that members cannot now serve for more than 10 years on the same LREC resulting in long -standing members being forced to resign, diminishing the LREC's experience but ensuring that there are plenty of experts in Research Ethics available to serve on any national ethics committee. Stephen D Keay
Mark Bratton
Reference Nicholson R Another threat to research in the United Kingdom BMJ 2004;328:1212-1213. Competing interests: SK is a member of an LREC, works in an IVF unit and undertakes medical research. MB is a member of an LREC |
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John Saunders, Chairman, MREC for Wales / consultant physician MREC for Wales, Temple of Peace & Health, Cardiff CF10 3NW / Nevill Hall Hosp, Abergavenny NP7 7AG
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If Richard Nicholson were better informed, he would not be so paranoid about political control of research ethics committees. The MREC for Wales, for example, has always been directly appointed by the responsible political body in Wales - initially the Welsh Office and now the National Assembly Government. Members' letters of appointment are signed by the Health Secretary, Jane Hutt. We are fully independent and the suggestion that our mode of appointment compromises our functioning is absurd - any more than the High Court lacks independence because judges are appointed by a cabinet minister, the Lord Chancellor. UKECA is little more than an administrative convenience to meet requirements of the EU directive that "member states" (and not devolved administations) "take measures necessary for establishment and operation of Ethics Committees". There is no reason to believe the Directive will affect the deliberations of ethics committees - although I think the research community might welcome a little more consistency of practice. Competing interests: chairman, MREC for Wales; member of sundry working groups relating to ethical review, COREC & DH |
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susanne McCabe, gardener cardiff cf24 3pf
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Wales is leading the field in showing it is perfectly possible to set up a massive 'Cancer Data Base' in several centres in Wales - with the express consent of women who agree to donate their breast tissue. Ethical approval includes a transparent consent procedure which treats women with proper respect as equal partners in research which will benefit thousands of others. Those who are still wasting time in attempting to block the individual's right to consent to use of their body tissue could maybe catch up with researchers who worked closely together with womens' groups, and the Ethics Committees which gave approval in Wales. Competing interests: None declared |
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susanne McCabe, gardener crdiff cf24 3pf
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It was interesting to read the concerns of Richard Nicholson because as the respondent from Wales points LREC's have never been independant of politicians in Wales. (Neither have Community Health Councils for that matter by the way). The way they have been appointed has been through open advertising, yes, but only with the rubber stamping of apppointments by politicians, who often know or know of some of those applying for positions. The most surprising information after enquiries to a local LREC was to find that there was no formal way of appointing the Chair in the past anyway. S/he was simply appointed by the rest of the committee as one Chair left the post. There are some in Wales who do agree the involvement of politicians is problematic. It is necessary to air uncomfortable things at times and one which arises in a small Nation like Wales is the fact that groups of people, including those who work in positions of influence now in the Welsh Assembly, have tended to develop relationships with people who sit on various committees,from working together in various positions in both the statutory and voluntary sectors in Wales over many years, often decades. Allegiances and loyalties are formed which are not always helpful in developing trust in total independance. We have one of the largest research establishements in UK based in Cardiff.The Welsh Assembly accrues much prestige from some of the work carried out there. It is necessary to ensure that political needs do not compromise the ethical concerns. Competing interests: None declared |
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