Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Need for a third way
- R K Mohindra (30 July 2004)
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Ethical review of genetic research – practical examples of real life in the NHS.
- Patrick J Morrison (1 August 2004)
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A view from clinician/researcher/ REC member
- Anneke M Lucassen, I. Karen Temple (1 August 2004)
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Clinical testing vs research - intent is the key
- Edwin P Kirk (2 August 2004)
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R K Mohindra, SpR Cardiology James Cook University Hospital, TS4 3BW
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In theory I would argue that the boundary between clinical investigation and research lies at the point that a clinical problem fails to yield to the current knowledge base. Part of the problem in this case arises from the initial aim of the clinical scientist to solve a clinical problem. Sometimes this requires the acquisition of new scientific knowledge as evidenced here by the failure of the problem to yield to standard approaches. At this level it appears that the definition of research encompasses the search for such new scientific knowledge. The practical problem is that there is a watershed in the requirements for consent, anonymity and methodology as one moves from clinical investigation to research. The best solution to this would not be to distort the underlying ethical structure but to support research efficacy by reviewing and resolving the practical difficulties faced by researchers as they move across this boundary. Pragmatically, if such work was used purely to solve the clinical problem then it must amount to clinical investigation. If it is used to add to the present corpus of knowledge then it must amount to research. Here the key then lies in the hands of the peer review journal editors. They should not publish such work unless there is evidence of adequate ethics approval. In the long run it would be better to solve practical problems at the practical level and avoid distortion of the underlying theoretical structures using consequentialist arguments. Competing interests: None declared |
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Patrick J Morrison, Consultant in clinical Genetics & Professor of Human Genetics Department of Medical genetics, Belfast City Hospital Trust, Belfast BT9 7AB UK
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I am a clinical geneticist with an honorary professorial contract, and am paid solely by the National Health Service. I am motivated primarily to help prevent disease in patients with genetic disorders - doing world-class research is well down the priority list and only gets done in my spare time. Increasingly, genetic testing for newly discovered or recognised genes is only available in certain laboratories in the world. The increasing beurocracy introduced by the new ethics committees has limited my availability to help patients and is therefore reducing patient care. As an example of real clinical practice, for the four years from 2000 -2003 I on average each year filled out 4 full ethical submissions and 4 ‘annex D’ forms (these allow me to participate in someone else’s MREC proposal locally). Each full submission took me on average 4 hours (– a mornings work), with an ‘annex D’ taking 2 hours. Most of these proposals would allow me to either have DNA analysed locally in a research study or send DNA from a family to another centre for clinical benefit as both types of DNA testing would not be available on the NHS. So far this year I have only been able to fill in 1 annex D equivalent – (the new ‘form C only’) and 1 full proposal. The ‘form C only’ took 8-9 hours as even though it had helpfully mostly been completed by the lead researcher elsewhere using ‘Form Filler version 2’ and emailed to me, my local COREC committee (once I had been on line several times using my NHS internet connection which is very slow) refused to accept anything other than an electronic version 3 (they eventually kindly relented as a ‘one- off’ exception with the version 2 submitted and a verbal warning). The full application related to 6 families with autosomal dominant renal cancer - in order to send 6 DNA samples to a researcher in the USA with the hope that if renal cancer genes were isolated in the index cases, the other family members would be able to be screened for mutations in their DNA allowing 50% of cases to be reassured, and spared screening, and the other 50% to have targeted screening which hopefully would reassure if clear, or pick up the cancers early and ‘save lives’. To do this my ethics committee required a full proposal which took me around 19 hours to submit and get accepted (took 8 months in time from start to finish). Having then sent the committee approved documentation to the USA researcher, I then had to wait another 4 months before I could become an ‘accredited investigator’ through the American ethics system (all this done so that I could not be sued for DNA theft, or closure of my or the USA institution through penalty etc. even though the families were very keen for this testing to be done). At the end of almost 1 year of the process, I have lost touch with 1 family, 2 index cases in another family have died, and the other 3 families are now being consented with the long ethically approved consent form having waited some time even on our urgent outpatient waiting list to be seen. The last straw is that the new consultant contract is being introduced in our hospital and I am now not supposed to be doing this sort of ‘research’ during my NHS time. Your articles by Parker et al [1] and Jamrozik [2], illustrate how most newly constituted ethics committees will soon deal easily with their workload, as submissions from clinicians like myself and my colleagues hoping to improve patient care will completely cease. Surely this in itself is unethical? 1. Parker M, Ashcroft R, Wilkie AOM, Kent A. Ethical review of research into rare genetic disorders. BMJ 2004;329:288-9 2. Jamrozik K Research ethics paperwork: what is the plot we seem to have lost? BMJ 2004;329:286-7 Competing interests: None declared |
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Anneke M Lucassen, senior lecturer Southampton Wessex Clinical Genetics Service, Southampton SO16 5YA, I. Karen Temple
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For many individuals or families referred to clinical genetics, the question is; what is my diagnosis? Or, Can you confirm my clinical diagnosis so that other family members can be tested to see whether or not they might develop it? Although the range of available testing is constantly expanding, there are many genetic conditions for which there is currently no routine NHS genetic testing. In such circumstances we often turn to colleagues who have a research interest in a particular condition. A research lab may thus be able to provide a diagnosis where the NHS cannot (yet). The techniques used may be no different between a research lab or an NHS lab. As clinicians, we have over the past decade or so sent samples to research labs and viewed this as an extension of the clinical service we offer patients. We accept that the quality assurance in a research lab may be less rigorous and our standard practice would be to confirm any research findings in an NHS lab (such confirmation can often be done relatively easily, even if no routine service for a particular condition exists). Patients are informed about the advantages and limitations of testing in a research laboratory and this would only ever be considered if adequate consent is given. Parker et al are right to comment on the difficulties in delineating a boundary between clinical practice and research in clinical genetics. However, they conclude ‘Once an investigation moves from a single family to the solicitation of affected but unrelated individuals it has undeniably become research’. If researchers present their results at genetic conferences, does this become ‘solicitation’? How else might clinicians know such research is taking place? Such specific guidance is likely to lead to more confusion for ethics committees. As local REC members we believe that the REC process plays an invaluable role in protecting patients taking part in research. REC approval for a research programme is important but RECs do need to realise that clinicians work at this interface between clinical and research environments and we agree that the REC process could be simplified whilst maintaining ethical protection of patients. Clinically we encounter many different rare genetic diseases and a 60+ page research ethics submission every time we try to facilitate the confirmation of a diagnosis would, we believe disadvantage our patients as well as being an unnecessary bureaucratic nightmare. Competing interests: None declared |
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Edwin P Kirk, Staff Specialist Dept of Medical Genetics, Sydney Children's Hospital, High St, Randwick NSW 2031
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Parker et al have made a valuable contribution in highlighting a dilemma which confronts clinical geneticists (and others) on a daily basis. Is the test I am ordering part of clinical practice or is it research? In my view, the answer is often “yes” to both questions – a test can be both things at once, depending on the intentions of those involved. In the scenario given by Parker et al at the start of their paper, the intent of the clinician is clinical - the goal is to define the nature of the disorder in the patient, inform genetic counselling in the family, and so on. On the other hand, the intent of the laboratory scientist is to do research - specifically, to work out the genetic basis of the disorder in question. It follows that in such cases, the scientist needs to obtain ethical review, but the clinician does not. The clinician is still obliged to obtain fully informed consent and, as Parker et al point out, this will necessarily involve explaining the laboratory's goals, and the limitations of testing in a research setting. This may mean completing a specific consent form. Clearly, if a clinician wishes to actively recruit patients with the disorder in question for the purpose of testing, the line between clinician and clinical scientist has been crossed and the ethical review will need to encompass both clinician and laboratory. But most of us, most of the time, are not doing research and should not need ethics review before we request such a test. Competing interests: None declared |
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