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Rapid Responses: Rapid Responses published:
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Who monitors Ethics Committees
- susanne stevens, n/a (1 June 2003)
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Ethics Committees are not the Science Police
- Allison R Nyssens (5 June 2003)
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Re: Further topics for research ethics committees
- Bruno M. Cesana, Ettore Marubini, PhD Istituto di Biometria e Statistica Medica, Università degli Studi di Milano, Via G. Venezian 1, 20133 Milan, Italy (26 June 2003)
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Unnecessary hurdles placed by ethics committees.
- Daniel A Ashdown, Anne Dancey (30 June 2003)
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Who monitors Ethics Committees
- susanne stevens, NONE (17 July 2003)
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susanne stevens, retitred cardiff cf24 3pf, n/a
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Firstly we need to look at who sits on Ethics Committees in order to decide how impartial or truly independant they can be in protecting the interests of research 'participants'and the quality of research. The Chair of the Ethics Committee of St Georges Trust was informed that there had been a breach of DPA by a member of the psychology department. After the most apalling run about by St Georges, including the Dean of the Medical School, the Chief Executive and Caldicott Manager, the Chair of the LREC concurred with them that there was no problem. The matter was then passed to the Information Commissioner who wrote to St Georges advising them that there was indeeed a problem, and highlighted their their duty to comply with the law with respect to the rights of people under the Data Protection Act. The Chair did at no time declare that he had in fact contributed to a book which included material written by members of the psychology department. He did agree to forward a copy of the next LREC Annual Report. After much delay and failure to return calls it transpires that no LREC Report has been produced by the Ethics Committee at St Georges. The Chief Executive and other managers seem unconcerned, COREC's response was 'what do you expect us do do about it? 2 Recently a group of doctors who are promoting the expansion f psychoanalytic practice in primary care have been publishing personal information without consent, again at the Tavistock.The Research was described as taking place at the Tavistock and elsewhere. The Chief Executive and the Chair of the LREC were unhelpful to say the least. No approval had been requested from a research ethics committee and no willingness to take action was demonstrated. The case was referred to the GMC which found a GP in breach of GMC guidelines. The Tavistock LREC is administered by the Secretary to the Dean. When a request for a copy of the Anual Report was made an attempt to withhold it as being'confidential' was made, then only part was forwarded until the Chair intervened and sent the whole document.Their was a clear conflict of role s demonstrated by the LREC. The actual report was one of the flimsiest any Trust has produced. The Chair is an ex Executive member of th Trust who was asked in a rather informal manner to take the Chair after resigning his Executive post. He is hardly demnstrating independance. The other committeee members (except lay members who have not declared any interests)are all involved with with the same work at the Tavistock and similar projects as their colleagues ,who request approval from them, for their studies. None have declared their self interests. Practitioners involved with the TAvistock have had several successful complaints upheld against them by the Information Commissioner, the GMC and other bodies. When the issue was referred to COREC they took no action and Terry Stacey advised it is the resposiblity of the Strategic Health Authority to investigate. The MAnager of the S.H.A has advised that guidelines concerning the composition of LRECs comittees will change when European directives come in. They cannot be soon enough and hopefully will also be monitoring COREC' role too. Competing interests: None declared |
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Allison R Nyssens, Solicitor to LREC Bromley Primary Care Trust
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I did not find Garattini and Bertele's article useful, mainly because it was far too technical for ethics committees to read. Some ethics committee members are clinically qualified; the remainer hail from a varied background, professional and non-professional. Committee members evaluate research from their own framework of knowledge, but are not expected to possess deep scientific knowlege of pharmaceuticals. It is for the research physician to verify that his research proposal has passed some form of peer review. The ethics committee would not necessarily know what reaction a certain drug had in comparison to another, the outcome of original trials (as opposed to comparitive trials), nor would members take into account expected side effects of a drug in comparison to the "established" treatment. That is all peer review material. Competing interests: None declared |
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Bruno M. Cesana, Biostatistician, MD Ospedale Maggiore di Milano, IRCCS, Laboratorio epidemiologico, Via F.Sforza 28, 20122 Milan, Italy, Ettore Marubini, PhD Istituto di Biometria e Statistica Medica, Università degli Studi di Milano, Via G. Venezian 1, 20133 Milan, Italy
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Sir, Garattini et al1 deserve to be complimented on their paper; however, we think that some points deserve further consideration. According to the Declaration of Helsinki2, the primary purpose of medical research is to improve procedures for patients, and so equivalence or non- inferiority trials not aimed at “improvements” should not be carried out. But the authors state that equivalence or non-inferiority trials are “appropriate and without ethical problems” on the grounds of ease of administration (focus on the patient) or lower cost (focus on the public health), and it can also be added that physicians need at least equivalent therapeutic alternatives for patients who do not respond to standard drugs or who cannot be treated with them because of experienced adverse events such as allergic reactions. It therefore seems that there at least two (individual and collective) “aspects of ethics” in clinical research that are at least partially conflicting. The plain fact is that physicians can ethically perform controlled clinical trials only if they are in the equipoise situation (the drugs are equivalent), but are confident that the experimental drug will turn out to be better than the current standard and this still has to be proved scientifically (the controlled clinical trial model). It is difficult to establish the extent to which physicians are confident about this superiority or conservatively accept that the difference will be around zero but within the limits of clinical equivalence (appropriately fixed by panel expert committees, regulatory organisms, etc., rather than the pharmaceutical industry). We agree with Garattini et al.1 that medical research has to be carried out “if the research question reflects a real need”, but this applies to any model of clinical trials, not only to equivalence or non-inferiority trials. In addition, we would like to comment on a very important issue. If a superiority study is negative (i.e. without a statistically significant result), the tendency is to conclude equivalence between the new and standard drug as reported for instance in the Gusto III trial3: “…reteplase is not superior to alteplase for the treatment of acute myocardial infarction. However, in terms of 30-day mortality, … the results of reteplase therapy were similar to those of alteplase therapy. Furthermore, because the long half-life of reteplase allows for bolus therapy, it is easier to administer”. Apart from the fact that this conclusion comes from mistakenly considering that a failure to disprove a null hypothesis means its acceptance, this approach is potentially flawed as a study may have insufficient power to demonstrate a difference that has to be considered greater than the clinically acceptable threshold for equivalence. Equivalence or non-inferiority trials ending with a result that is not statistical significant therefore allow a definite conclusion of inferiority, unlike superiority trials that may be incorrectly and unethically read as supporting non-inferiority. In conclusion, a result of “equivalence” coming from an appropriately designed, powered and conducted equivalence study can be considered ethically and scientifically sounder than a conclusion of “equivalence” coming from a negative superiority study. References: 1 Garattini S, Bertele V, Li Bassi L. How can research ethics committees protect patients better ?. BMJ 2003; 236: 1199-01. 2 World Medical Association. The Declaration of Helsinki (2000) (accessed May 2003). 3 A comparison of Reteplase with Alteplase for acute myocardial infarction. N Engl J Med 1997; 337: 1118-23. Competing interests: None declared |
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Daniel A Ashdown, SHO Urology Department of Urology,City Hospital, Newcastle Road, Stoke on Trent, ST4 7LN, Anne Dancey
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EDITOR- The paper by Garattini et al “How can ethics committees protect patients better?” raises the important point that research ethics committees are an essential component of a system that should protect individual patients, but should concentrate on key aspects that make a study ethically and scientifically justifiable (1). My colleague and I are concerned about the unnecessary hurdles placed by ethics committees, in the way of doctors wishing to perform simple research and audit within the hospital setting. Our department decided to look at the effectiveness of embolisation for testicular pain secondary to varicoceles. We decided we should send a simple retrospective pain questionnaire to the 105 patients who had undergone this procedure. We are still awaiting final ethics committee approval, having filled in 26 pages of forms and obtained 8 different signatures from 7 departments and having had the proposal was rejected twice. The reasons for these rejections were the use of the word “groin”, which was felt to be a medical term, and “important study” which was felt would put undue pressure on patients to take part. Most doctors agree that patients need representation when taking part in research, and that research should be appropriately governed. However in today’s culture of appraisal and revalidation it is increasingly important for us to show that our practice is effective and evidence based, and we need to reduce unnecessary barriers that stop us from achieving this aim. Surely most patients would be willing to offer some feed back into the quality of their care. Those patients not wishing to participate will simply not respond. Is all this bureaucracy really representing the views of our patients or is it merely dissuading doctors from participating in any form of research? 1) Garattini S, Bertele V, Li Bassi L. How can research ethics committees protect patients better? BMJ 2003; 326:1199-1201. (31 May.) Competing interests: None declared |
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susanne stevens, retired cardiff cf24 3pf, NONE
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I would like to correct an error in my initial response to this article. The Chair of the LREC of the Tavistock was still in post as a non- executive (paid) member of the Executive according to the Annual Report 2001. (ie not 'recently resigned' as I initially described), when he was asked to take over the Chair of the Tavistock LREC. I do not know who made the request. He also in his non-executive role assisted in drawing up the Annual Report and the Audit.Perhaps this is not unusual but perhaps there should be a clear separation.There was no mention in that Report of the activities of a private therapy organisation with which the Tavistock is heavily involved and which bases some of it's work there. Obviously with the agreement of the Tavistock some of whom are members of this organisation - it could hardly use the resources there otherwise, although there are descriptions of other activities by other groups.Some of the work of the LREC was carried out by the Chair from his home address rather than through the administrator at the Tavistock. This address is given by a person with the same surname who practices as a therapist in an organisation with ties to the Tavistock. Nevertheless the Chair has not only stated in the LREC Annual Reposrt that none of the members of the Committee had anything to declare but he has totally failed to declare any of his own self interests. Perhaps the new person from OREC who takes over in September should look through the proposals submitted to this committee to see how far they complied with ethical standards.None of those involved with this LREC took any steps to ensure what even commonsense would tell most people - that such a committee could not possibly function as a realistic Ethics Committee. Competing interests: None declared |
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