Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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New ethics form will kill off normal volunteer studies in the universities and the NHS - is change possible?
- Jan K. Melichar (14 September 2004)
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Research Bureacracy-- a damaging divide between researchers and administrators
- David S Wald (17 September 2004)
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What beaurocracy - my research doesn't require ethical approval!
- Phillip A. Smith, Julie L. Scott, Sandip K. Pal (11 October 2004)
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Speeding up ethical and Trust approval - use risk assessment
- Phillip A. Smith, Julie L. Scott, Sandip K. Pal (11 October 2004)
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Developing the face of research governance
- Tony Soteriou, Alysun M. Jones (10 January 2005)
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Jan K. Melichar, Clinical Lecturer & Locum Consultant in Psychiatry University of Bristol, BS8 1TD
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A brief suggestion with regards to the letter Prof Pattison wrote regarding the ethics form (1), which he praises highly (clearly, he has not spent time filling it in). His last two paragraphs hold out a ray of hope for those of us struggling to put through ethics applications for small, non-commercial studies in normal volunteers i.e. the core of clinical research in the University/NHS sector, from which studies using patients then develop. The form, as it stands, clearly does not meet this need, as it is structured with the view that patients will be used in drug company studies. Could there, therefore, be a shorter form specifically directed at normal volunteer studies which are not investigating new drugs or devices? These are usually very simple small studies which have only minor ethical issues (which are the same for any normal volunteer study of this type), as they usually do not involve any significant risk to the volunteers. They were, in times past, done by students as part of their degree and the ethics application, locally, came to <20 sides, all relevant and with little extra paperwork needed. Now the ethics form is obese, mostly irrelevant and requires so much additional paperwork as to make the small studies uneconomic, from the researcher's point of view. This is because these studies are normally conceived on the margins of what the researcher involved is doing, so adding 2-3 days of full time effort to gather all the details is too much and seems absurd. To force researchers to become one of Prof Pattison's 'silent majority' is all very well, but the form takes up a lot of time. The oversight required for a multi-centre industry sponsored novel drug study is surely not required for a small scale normal volunteer study? Therefore I applaud Professor Pattison's foresight in noting that 'No one pretends the current application form or the process is perfect'. I look forward to his promised smaller form, though I do hope it will be introduced quickly, to ensure that small studies continue to happen. Competing interests: I have completed ethics forms over the past 10 years. It took 2-3 days of full-time work to complete this one and the associated paperwork - a record for me. Over 80 pages of documentation for a study that previously only took <20 pages. I am seriously considering not doing any more blue-sky research 'on the margins' as the form takes too long. |
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David S Wald, Specialist Registrar and Clinical Research Fellow in Cardiology Wolfson Institute of Preventive Medicine, St. bartholomews Hospital, Charterhous Square London EC1M
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EDITOR-The bureaucracy of research ethics application is a serious problem that is obstructing clinical research in the United Kingdom. This was the subject of my article and several others published in the 31 July 2004 edition of the BMJ. 1 The letters published in the 11 September issue of the BMJ in response to these articles minimise the problem. They were published without giving the authors of the original articles an explicit opportunity to respond. Furthermore there was a lack of balance because even though all but one of the 14 rapid responses to my article published on bmj.com supported the view that the current research ethics application procedure is unnecessarily bureaucratic and damaging to research, only that one dissenting voice 2 was published in the printed version together with five others that supported the current COREC (Central Office for Research Ethics Committees) procedure and one that did not. The published correspondence also included a number of incorrect statements. Walsh and Hewitt’s assertion that “ethics committees are out of control and discouraging research” misses the point that it is the complexity of the process that is the problem and this has been thrust on ethics committees as much as researchers. 3 Pattison and Stacey suggest that “had I read the question specific guidance” on the COREC website I would have saved myself a lot of time, effort and phone calls”, a comment echoed in the letter by Reid. 2,4 However Pattison, Stacey and Reid all fail to say that when I completed the new COREC application (March 2004) the website was incomplete and did not provide the necessary information. It may do so now but this avoids the central issue that much of what has to be done is time-consuming and unnecessary. A divide is emerging between researchers and research administrators which is surely unhelpful and against the public interest. The processes need substantial simplification if medical research in the UK is not to suffer. I believe that this view is widely held by established researchers. It is certainly often expressed. David S Wald
1. Wald D.S. Bureaucracy of ethics applications. BMJ 2004;329:282-284 2. Reid C. M. Ask for help. BMJ 2004;329:624 3. Walsh D.A, Hewitt M. Ethics committees have important roles in research. BMJ 2004;329:623 4. Pattison J, Stacey. T Seeking a balance: response from the Department of Health and COREC. BMJ 2004;329:622 Competing interests: None declared |
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Phillip A. Smith, R&D Co-ordinator Broomfield Hospital, Mid Essex Hospital Services NHS Trust, Essex, CM1 7WE, Julie L. Scott, Sandip K. Pal
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EDITOR- There has been much discussion relating to research governance and ethics (1. Much of this has considered the time taken to gain ethical approval. There is, however, a more basic problem: some researchers do not seem to know that if their research in the UK involves access to the National Health Service (NHS) then they require ethical and NHS Trust (hospital) approval. This is worrying. In the UK all NHS Trusts are required to approve research before it goes ahead. At Mid Essex Hospital Services NHS Trust (MEHT) this policy is disseminated through a variety of means (via an R&D training day, information sent direct to researchers and general information to the entire organisation. The effectiveness of this communication was assessed via a questionnaire sent to 369 staff. The response rate was 41%; 29 had attended training, 46 were researchers and 79 were neither researchers nor had received training. There was no statistical difference (P>0.05, ANOVA) in Research Governance Awareness (as assessed by correct responses to some of the questions) between the group that had been trained (mean score 7.3, 95% cfl 6.5-8.2) and researchers (mean score 7.2, 95% cfl 6.3- 8.0), but both were significantly greater (P<0.001, Bonferroni post hoc test) than those that had neither received training or were researchers (mean score 4.7, 95% cfl 4.0-5.3). Of importance, 15% of researchers were not aware of the Trust’s R&D policy, 28% did not know they needed ethical approval and 28% did not know they needed Trust approval. If the data obtained here are representative then this reinforces the need for more effective communication. It also demonstrates that R&D training can work. 1 Pattison J, Stacey, R Seeking a balance: response from the Department of Health and COREC. BMJ 2004;329:622 (11 Sept.) Competing interests: PS is a member of the National NHS R&D Forum. In case you were wondering, the questionnaire described in this letter was reviewed by the South Essex Local Research Ethics Committee (Ref 03/67d) on 17 Dec 2003 and was given a favourable opinion on 18 Dec 2003. It was also Trust-approved. |
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Phillip A. Smith, R&D Co-ordinator Broomfield Hospital, Mid Essex Hospital Services NHS Trust, Essex, CM1 7WE, Julie L. Scott, Sandip K. Pal
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EDITOR- There is a perceived need to obtain quicker approval for research (1). Within the UK research involving NHS patients is subject to ethical review by an appropriate Research Ethics Committee. In addition, each NHS Trust (hospital) must ensure that the research is approved via delegated responsibility from the chief executive officer. This is because there are more than just ethical issues to consider before allowing a research project to proceed. At Mid Essex Hospital Services NHS Trust (MEHT), the R&D Department audited the time taken for Trust approval for 121 projects approved between 27 Sept 01 and 1 May 04. There were a number of possible time-frames to consider but we chose two main start dates: a) date the R&D Department receiving the request for project approval and b) the date of local research ethics approval. Median durations were 50 and 30 calendar days respectively. The higher median for trust-approval may, in part, be due to the wider range of issues that a trust has to consider, but some researchers only recognise the need for trust approval when they see it as a condition of ethical approval. To reduce the time for approval, MEHT has developed research governance pathways for five types of study: clinical trial of a medicinal product; student research; Department of Health sponsored surveys (i.e. staff and patient surveys), externally sponsored studies and those sponsored by MEHT. It is anticipated that the explicit identification of risk for each type of research will enable NHS organisations to improve the time it takes to issue Trust Approval. Competing interests: PS is a member of the National NHS R&D Forum |
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Tony Soteriou, Director of Research Avon and Wiltshire Mental Health Partnership NHS Trust, Bristol, BS16 1QY, Alysun M. Jones
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Editor- Recent BMJ articles and correspondence on NHS research ethics and research governance have helpfully highlighted the apparent polarisation of views between researchers working in the NHS, and the governance requirements of research ethics and governance (1). The written and email responses to the BMJ articles highlighting research administration, to which the present authors contributed (2 & 3), made for interesting reading. On one hand, many researchers and research- interested clinicians, appear to consider that the administrative burden is currently over bureaucratic. On the other, NHS R&D governance managers, NHS research ethics Committees, and other regulatory bodies, whilst in many cases recognising researchers’ grievances about bureaucracy, consider that the arrangements under research governance and ethics are necessary and designed to safeguard the public and NHS patients (4). This polarisation of views can only contribute negatively to NHS research. Following our exchange of articles, we (the researcher and R&D Director) met for a series of frank and open meetings to discuss our experiences and the issues raised in the research ethics correspondence. Care had to be taken, as these meetings had the possibility of generating tensions. However, as a result of this in-depth dialogue there was increased common understanding of the framework within which both researchers and NHS R&D managers currently work. The researchers stressed the difficulties of undertaking research within a demanding clinical context and the rapidly changing demands of research governance. The R&D Director highlighted that the Trust had to implement the framework of research governance throughout the Trust, and be able to demonstrate this to the Trust Board and the Department of Health. This had entailed a steep learning curve for the NHS Trust, and the case highlighted by Jones and Bamford (2) had been the Trust’s first formal case of disagreement with researchers about the need for ethics review. This improved understanding led both parties to have a greater appreciation of the need for research governance and the role R&D Departments can play in facilitating this process. Day to day practice in carrying out current research has directly benefited from this increased dialogue, for example with the researcher being willing to consult with the R&D Office more readily on research issues that might require ethics review. Likewise, the R&D Management has benefited improved research governance training and information. There was also an acknowledgement that debate and liaison was required in the implementation of research governance. It was heartening for the researcher to hear that attempts were being made to work on ways that projects can be graded as to ethical risk, and that the new draft 2nd edition of the Research Governance Framework (5) highlights the needs for monitoring and management arrangements to be proportionate to risk. Similarly, the current UK Ministerial review of research ethics arrangements is very welcome (6). The review will examine the systems that support NHS Research Ethics Committees in England, and make recommendations for further steps to improve their operation, building on changes already under way. The group first met in November and will report to UK Health Ministers by the end of March 2005. A number of important lessons emerged from these meetings: Firstly, the difficulties that we have experienced are not an unusual occurrence. We are aware that many R&D Departments and many clinicians attempting to conduct research within NHS settings come into conflict regarding issues of research governance and administration. The recent exchange of articles in BMJ bears witness to this. We hope that through writing this article we can help others facing similar difficulties. Secondly it needs to be acknowledged that it is often difficult for clinicians to be fully cognisant of all the necessities of the research undertaking, and the rapid changes in governance and ethics. However, many R&D management staff find it hard to imagine that researchers have not kept up to date with these regulations. Therefore, at the suggestion of clinician researchers, our NHS Trust R&D Department has taken the initiative to provide a formal training to all clinicians in receipt of grants. Whilst this may initially add to the clinician researchers’ time needed for undertaking research, it will hopefully help researchers to know what they need to know. Thirdly, many of the restraints imposed on research by ethics committees and NHS research offices are not generated directly by these bodies, but are in reality requirements imposed by the Department of Health or legislation. For example the highly topical issues surrounding confidentiality and access to patients and their information by researchers, as highlighted by Ward and colleagues (7). Finally it should be stressed that ultimately both researchers and NHS research managers are working towards the same goal, although it is easy to lose sight of this. The goal is to facilitate high quality research in the NHS. Perhaps researchers and manager have more in common than differences. References 1. Warlow C. Researchers Drowning Bureaucracy BMJ 2004; 329: 241-242. 2. Jones AM & Bamford B The other face of research governance. BMJ 2004; 329: 280 – 281. 3. Soteriou T. View from the research and development office. BMJ 2004; 329: 281 - 282. 4. Pattison J. & Stacey T. Research bureaucracy in the United Kingdom 2004 BMJ; 329: 622. 5. Department of Health. Draft document Research Governance Framework for Health and Social Care. 2nd Edition. Department of Health, London 2003. 6. Department of Health. Ministerial Statement: Advisory group on the on the operation of the NHS research ethics committee system. Department of Health, London 2004. 7. Ward HJT., Cousens SN, Smith-Bathgate B, Leitch M, Everington D, Will RG, Smith PJ. Obstacles to conducting epidemiological research in the UK general population. BMJ 2004; 329: 277-279. Competing interests: None declared |
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