Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
The most important ingredient for research
- Callum Livingstone (2 August 2004)
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Time to Face Research Governance
- Tracy M Elliott (2 August 2004)
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Why research governance matters, throughout the 'life' of a project.
- Woody Caan (2 August 2004)
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Research governance is about protection, not convenience
- Justin T Denholm (8 August 2004)
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Research governance and multi-centre studies
- Brenda Leese, Jenni Burt, Department of Palliative Care and Policy, Guy's, King's and St Thomas' School of Medicine (10 August 2004)
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Research at a District Hospital?
- Stephen Dealler (12 August 2004)
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Letter to researchers
- Andrew J Taylor (17 August 2004)
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Callum Livingstone, Consultant Chemical Pathologist Royal Surrey County Hospital, Guildford, GU2 7XX
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As has been stated, research governance procedures have burgeoned particularly since March 2004 with the introduction of new research ethics approval procedures 1,2. I have no doubt that these have been designed out of the best motives, yet something vitally important has been forgotten along the way. As I battle through the bureaucracy, I find my enthusiasm for what was a very exciting research idea steadily waning. Let us not forget that the researcher's own enthusiasm is after all the most important ingredient for research. We erode it at our peril. I would also point out that those of us who are joint appointees between the NHS and University Departments are required to apply to University Ethics Committees as well as to a Local Research Ethics Committee (LREC) when we wish to carry out cross-site research. Is one 57 page form not enough? 1. Jones AM, Bamford B. The other face of research governance. Brit Med J 2004; 329: 280-281 2. Wald DS. Bureaucracy of ethics applications. Brit Med J 2004; 329: 282-284 Competing interests: None declared |
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Tracy M Elliott, Research Manager Sheffield Children's NHS Trust Western Bank Sheffield S10 2TH
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I read this article with some interest and find it quite worrying that researchers genuinely feel that having gained research ethics and trust approvals for their work they are then free to change the protocol and the conduct of the study in whatever manner they choose, to fit with any further hypotheses that come along as the research progresses. Having recognised that the original proposal required these approvals before the research commenced, it should be quite clear that asking patients personal questions about social contacts, relationships, family and employment may be emotive and judgements about whether these questions are acceptable in the context of the research should surely be left to the ethics committees, not to individual researchers, to decide. It is essential that other bodies, such as ethics and the governance team on behalf of the trust, are aware of the exact nature of the intervention being applied to the participants, whether in the form of a questionnaire or a new drug. This article asserts that the actions of the trust’s research office had a major effect on the study, when in fact it could equally be stated that these effects were as a result of the researchers not going through the correct procedures for protocol amendment. Research Governance was introduced to protect patients and ensures the transparent, safe and fair conduct of research. We must acknowledge that these procedures are now a compulsory part of the research process and instead of arguing about their relevance, researchers and governance teams need work together to ensure their smooth integration. Competing interests: None declared |
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Woody Caan, Professor of public health APU, Chelmsford, Essex CM1 1SQ.
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Transparent ethical scrutiny should come early in the 'life' of a research project, preferably at a sufficiently early stage that management of any risks to the public can be readily build into the design. A feeding frenzy for funding opportunities can make it difficult to organize scrutiny at such an early stage of developing ideas, although real involvement 'ab initio' of patients and patient groups in research can provide a good framework for subsequent ethical judgements. The BMJ's 31 July issue abounds with examples of a new problem: the paralysis of research by bureaucracy associated with ethics committees [1]. Even the committee members seem helplessly entangled in the new national procedures [2]. Hopefully these BMJ voices will help to loose the Gordian Knot created by the central 'COREC' procedures. However, the essence of Research Governance goes far beyond the inefficiency of a particular committee and is unfairly caricatured by the 'face' published here [3]. At the heart of governance in health and social care research is accountability [4]. The scientific community owes this accountability to the patients and wider public who support research activities. Without their trust and goodwill, academic medical research would die - or else, possibly, degenerate into the coercive horror of the Nazi doctors' 'research' detailed at Nuremburg. At all stages of planning, implementing and reporting health research we have a duty to consider: the safety and dignity of the participants; the relevance of research findings to both clinical and public health improvements; our openness to critical reflection and refinement of our work. Mea culpa: I dread criticism of my cherished ideas- but that sharing is how science and practice flourish. Both academic and professional peers deserve to know what is going on, in areas that affect them. If a patient (say the reader's grandmother or son) puts their trust in the benevolence of a health service, then that service needs to accept responsibility for overseeing the clinical research that it 'hosts'. It is only four years since the UK policy 'Research and Development for a First Class Service' sketched out a need to improve research governance. Even modest improvements in the quality of projects have required much hard work, across the health service. Some efforts have gone into dead ends: conflating the quality of management, ethics and science into one formula is clearly one such failure! But learning to improve our governance of research is a vital step to better research and wiser researchers. Professional bodies have an important role in promoting learning in a Real World context [5]. What is the BMA doing to develop good governance? 1 Wald DS. Bureaucracy of ethics applications. BMJ 2004; 329: 282-5. 2 Goodman NW. We have no control. BMJ eletter 30 July 2004. 3 Jones AM, Bamford B. The other face of research governance. BMJ 2004; 329: 280-281. 4 Caan W. Accountability a must. Times Higher 2004; 5 March: 19. 5 Appleton J, Caan W. Guidance on research governance. Community Practitioner 2004; 77: 303-305. Competing interests: a) Involved in a number of research governance initiatives, beginning with facilitating a workshop on Health & Safety issues for NHS R&D at the first Research Governance Conference (London, 29 May 2001). b) Our latest application to an NHS Ethics Committee, for an unfunded student project, has just been bounced back requiring a list of 20 changes (of which perhaps one is something to do with Ethics). |
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Justin T Denholm, Hospital Medical Officer Austin Hospital, Heidelberg, Victoria, Australia, 3081
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Jones and Bamford express surprise and frustration that their study was temporarily halted after they introduced an interview to the existing protocol without research ethics committee approval. They do not seem to have recognised the fact that introducing a completely new aspect to their project may bring with it both additional ethical considerations and problems for their existing research aims. As they state in their article, they did not mention this interview in the patient information sheets or consent forms, and they appear to have introduced it after data collection had already begun. It is unclear whether the interview itself had significant ethical problems that required consideration; that, however, is why ethics committee approval is required before beginning a research project. In addition, it is entirely possible that their interview, however well meant, may have asked sensitive or inappropriate questions which might impact on the validity of the data they were collecting. This is not an issue of researchers accidentally filling in the wrong form or some other minor deviation. Jones and Bamford began what is in effect a new study without approval from the research ethics committee. Their intentions were no doubt good, and no harm may have ultimately resulted, but the ethics committee has a responsibility to assess research on ethical grounds before allowing it to proceed. What this article has demonstrated is that research governance is, in fact, working well. Far from being an “over-reaction” that destroyed “the quality of the research”, a potential breach of care for research subjects was identified and needed to be considered, just as a new project must be. There may well be more efficient and satisfying ways to resolve research governance issues, however, the primary concern of the research ethics committee must be to protect research participants. Any ethical implications related to loss of time and money to the researchers, although clearly frustrating, are secondary and should not cloud the issues. Competing interests: None declared |
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Brenda Leese, Reader in Primary Care Research University of Leeds, Centre for Research in Primary Care, 71-75 Clarendon Road, Leeds LS2 9PL, Jenni Burt, Department of Palliative Care and Policy, Guy's, King's and St Thomas' School of Medicine
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Our experience of research governance mirrors that of Jones and Bamford(1). We conducted a Department of Health funded evaluation which included a national postal survey, sending a questionnaire about the primary care cancer lead (PCCL) role to every PCCL and PCT chief executive in England; two per PCT. The most serious problem encountered was the wide variation in research governance requirements. We sought approval from each of the 59 Research Management and Governance Organisations (RM&Gs), and from those PCTs not part of an RM&G. We sent an email detailing our study to each RM&G and the subsequent process of approval took 5 months. It required the input of a half time researcher, significantly adding to the costs of the study. We received 25 forms, all differing in content and layout. Despite clear guidance to RM&Gs as to the information required to approve a project, each imposed very different requirements (2,3) Some simply said go ahead, whereas others required details of indemnity, financial probity, the resource implications for PCTs, and the study’s independent reviews. One RM&G conducted their own independent review of our study and suggested changes. Such variations reflected considerable confusion about what is required of externally funded and managed multi-centre projects, as opposed to single site local projects. Most made no distinction between studies involving patients in medical procedures and studies such as ours where there was no possibility of harm. Lack of staff with research experience was a major problem. Our most sympathetic responses were from those RM&Gs with researchers in post. In several instances, staff left and were not replaced and the whole process of approval ceased. Although we have no problem with the concept of research governance, it is essential that the process is streamlined, particularly for national surveys, otherwise such research will no longer be viable. 1. Jones A, Bamford B. The other face of research governance. British Medical Journal 2004; 329: 280-2. 2. Department of Health. Research governance framework for health and social care. (Second draft). London: Department of Health, 2003. 3. Department of Health. Development of research management and governance in primary and community care. Information for primary care trusts. London: Department of Health, 2002. Competing interests: None declared |
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Stephen Dealler, Consultant Medical Microbiologist Royal Lancaster Infirmary LA1 4RP
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Jones and Bamford (BMJ 2004;329:280-1) explain the loss of useful research due to ethical committee action. These committees seem to act without realising that scientific facts are there anyway, whether we discover them or not and it now seems that researchers are no longer trusted to be responsible for their action by making reasonable decisions with sensible advice. This must be realised when an Ethics Committee or any other takes control of what should proceed. DGH research seems to have been damaged for many governance reasons. Even minor research projects e.g. a decision to compare 2 different test procedures in the laboratory, now require permission from a series of officials and committees. What this leads to generally is that studies now do not take place. The application for a scientific project in the DGH goes through the Scientific Steering Committee (SSC), the Financial department, the Statistics group, the permission of the hospital department where it is taking place, the ethics committee, the Chief Executive for the Trust, and via the creation (and official acceptance) of standard items (e.g. forms). Why for minor bacteriological projects do I ask a SSC for permission to go ahead when their opinion adds little to peer discussion? Indeed ethical aspects could commonly be made plain and advice given easily without a committee. Due to the simple excess of opportunities to trip up even minimal projects, and almost impossibility of fast tracking preliminary studies, we are watching as UK clinical research collapses e.g. the 80% drop in clinical research since 1999. Because of the beurocratic difficulty the number of applications to our local research ethical committee (LREC) in Lancaster, has decreased until now it has been disbanded. I would expect that it takes around 6 months to organise a project now – far longer than acceptable in a fast racing scientific world- and competitors around the scientist’s world may have trumped the work. Scientists in a DGH know that to make a significant advance and be looked on by peers as a success they must jump over an unclear path. Generally only the work that commences uncertain, and may find no data whatever, that is likely to create advance. Unfortunately the researchers that aim down this road are not the ones that will wait 6 months while a series of committees decide the project’s fate. Imaginative scientists do not live a life of governance forms, of 69 page ethics applications, or the justifying of their work to the Chief Exec. Ideas tend to appear to the luck of the individual and must be fulfilled rapidly or never will. Six months tied up, even for the simplest project is so long as to poison almost any stallion. To some degree, in order to progress we must assume an element of trust in medical researchers and give them responsibility for them actions. If we don’t we will just see clinical research in the UK stop in one DGH after another. The scientific facts are there but currently we are hardly allowed to look. Competing interests: None declared |
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Andrew J Taylor, Chair, Bath REC Royal United Hospital Bath NHS Trust BA1 3NG
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As Chairman of the Bath Research Ethics Committee that approved the study that gave rise to Alyson M Jones’ and Bryony Bamford’s article ‘The other face of research governance’, I would like to respond to a crucial point in their argument. They say that they were unaware of the requirement to submit protocol changes for approval. The original ethics approval letter was clear in this regard and stated ‘Any changes or extensions to the protocol, or additional investigators should be notified to the Committee for approval’. When the amended protocol was submitted, we acted promptly and an executive sub-committee reviewed and approved the changes. Competing interests: None declared |
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