Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Can clinicians not be trusted with ethical responsibilities of research?
- Arun Natarajan (8 July 2007)
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Building on Improvement: where COREC leads, NHS Trusts must follow
- Helen Statham, Ruth H Graham, Judith M Rankin, Stephen C Robson (9 July 2007)
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Need to build evidence of what works
- Ike Anya (10 July 2007)
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Role of the supervisor in undergraduate applications
- Margaret C Rees, Robert King (10 July 2007)
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Impact of MMC on Post Graduate Research
- Laura R Newton (10 July 2007)
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NHS Trust Approval requires urgent attention also
- Phillip A Smith (11 July 2007)
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NHS Research Ethics Committees
- John S Lilleyman (13 July 2007)
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NHS Research Committees: Authors' response to correspondence
- Louise Robinson, Deborah Murdoch Eaton and Yvonne Carter (13 July 2007)
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Bureaucracy is still killing research in the NHS
- Nikolaos Gkioulekas, Ioannis Korkontzelos, Charalampos Stamatopoulos, Nawar Al-Shabibi, Adam Magos (11 April 2008)
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Developing commensurate research regulation and review
- Hugh T Davies (22 April 2008)
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Arun Natarajan, Specialist registrar in cardiology South Tyneside District Hospital
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I cannot understand why clinicians cannot be trusted with the ethical implications of research. One must remember that clinicians handle patient -sensitive information and grapple with ethical conundrums on a daily basis. In my opinion, their discretionary abilities to envisage and conduct research without posing risk to patients or their identities, are quite satisfactory. Interventional trials and industry-funded projects are of course, a different kettle of fish, which must be closely scrutinised. The burden of the ethical values of research must be placed on individual departments and/or trusts. This will encourage clinicians, who are currently bogged down by bureaucracy and paperwork, to take their innovative ideas forward. Competing interests: I am a clinician |
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Helen Statham, Senior Research Associate Centre for Family Research, University of Cambridge, CB2 3RF UK, Ruth H Graham, Judith M Rankin, Stephen C Robson
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‘Building on Improvement’ as discussed by Robinson and colleagues (http://bmj.com/cgi/content/short/335/7609/6?etoc) may facilitate ethical approval for some studies but significant obstacles remain. We are undertaking a survey of consultants in specialist units located across 22 NHS Trusts. The study is funded through university research funds and a faculty program to support newly appointed academic staff. The protocol and instruments have been peer-reviewed and the study has sponsorship from the host University and NHS Trust where the Principal Investigator has a ‘letter of responsibility’, which replaces the traditional honorary contract for studies that do not involve patient contact or patient data. The work entails sending a short questionnaire by email, with a reminder by post, to 1-7 consultants in each unit. Consent is presumed from those completing a questionnaire. Responses will be anonymous; respondents who reply by email will have all identifying information removed. This is the sort of study that may well no longer require formal ethical review but in fact the study received Multi Centre Research Ethics Comittee (MREC) approval relatively speedily. The significance of there being only one ‘approval’ required cannot be overstated. To establish and comply with the research governance requirements of the trusts has been an enormously time and resource consuming process both for us as researchers but equally so for the NHS. The Trust Research & Development (R&D) officers have been helpful, professional and supportive but the variety in requirements is astounding. Most have asked for extensive submissions though, thankfully, often this can be by email alone. Others however require signatures from already busy local clinicians and even establishing which local clinician should sign our form has taken more than a month in some trusts. There are extremes in requirements. Trust A said they would register the project after we had provided them with a copy of the protocol, a copy of the MREC application, a copy of the MREC approval, copies of the Participant Information Sheets and Informed Consent Forms, evidence of peer review, data protection approval, a completed and signed off project detail form (signed by the Principal Investigator and then by Trust’s R&D Coordinator and Clinical Lead for the area), a copy of the award letter for funding and a completed sponsor identification form. This Trust initially required an honorary contract, with Health clearance and possibly an additional Criminal Record Bureau check, for the Principal Investigator, this in addition to the authorization she has from the Sponsoring institution, but after further discussion, this was deemed unecessary. On the other hand, Trust B confirmed that no R&D registration was needed for this study, as it is a ‘no local investigator’ project and does not involve any Trust resources. Registration by Trust A will use considerable resources with no benefit to patients or to the Trust. Surely the time has come for some rationalization of procedures when the same study can require such different responses from trusts interpreting the same guidance from the NHS (http://www.dh.gov.uk/assetRoot/04/12/24/27/04122427.pdf). We would strongly suggest that for a study where the potential participants are consultants and no researcher is going onto any NHS facility the approach adopted by Trust B is eminently sensible. There was a time when applying for ethical approval to undertake research in many locations was as confused and inconsistent. The system of applying to MRECs for ethical approval has streamlined this. Is it not time to bring common sense to bear in R&D applications as well? Competing interests: None declared |
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Ike Anya, Specialist Registrar in Public Health Medicine Health Care Evaluation Group Dept of Epid. & Public Health, University College London WC1E 6BT
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Robinson and her co-authors(1) review the new proposals for research ethics systems in the National Health Service and conclude that while some progress has been made, opportunities have been missed to reduce bureaucracy. There is however another key question that is not fully addressed which is the central question of what research ethics committees exist to do, what kinds of research they should review and how best their effectiveness can be assured. The general consensus would be that research ethics systems are in place to protect the vulnerable and prevent the abuse of power that can occur in an unregulated system. Yet there is little evidence to confirm that the burgeoning in research ethics systems and processes over the last decade have achieved that. We know that nearly two decades after the Nuremberg Code of Ethics was instituted, Henry Beecher still found several examples of research being carried out in renowned institutions that did not meet those standards (2). Similarly the infamous Tuskegee Syphilis experiment continued through the 1960s and the reforms in ethics review processes at that time until 1972 when it was exposed in a newspaper article (3). This suggests that the mere existence of ethics review systems and processes is not enough to protect the vulnerable. It is important to examine how effective these processes are. The system of quality assurance through peer review proposed in Building for Improvement (4) is a useful starting point, but more rigorous evaluation of ethics committees and their functioning should also be considered, including cost-effectiveness analyses. In the current climate of competition for scarce resources, we need to know that our efforts to improve ethics review are worth it. It would be useful if robust evaluation systems are built into the new process to help provide this vital information and to ensure that the next time a review of ethics processes is carried out, that any changes made are actually based on the evidence of what works. 1.Robinson L, Murdoch-Eaton D,Carter YH. NHS research ethics committees. BMJ 2007;335:6 2. Beecher HK. Ethics and clinical research. N Engl J Med. 1966;274(24):1354–1360 3. Rothman DJ Were Tuskegee & Willowbrook 'Studies in Nature'?The Hastings Center Report 1982;Vol. 12, No. 2:5-7 4. Central Office for Research Ethics Committees. Building on improvement: implementing the recommendations of the report of the ad hoc advisory group on the operation of NHS research ethics committees. London: Central Office for Research Ethics Committees, 2006. Competing interests: None declared |
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Margaret C Rees, Reader in Reproductive Medicine Women's Centre,John Radcliffe Hospital,Oxford, OX3 9DU UK, Robert King
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Responding as chair and vice chair of a an NHS Research Ethics Committee and researcher who has completed ethics forms for over 25 years, we find that Robinson and colleagues have not considered the role of the supervisor in undergraduate applications. The standard form and instructions on the National Patient Safety Agency web site have made the process much clearer http://www.nres.npsa.nhs.uk/applicants/index.htm. However these are not always taken into account, and in our experience, especially with undergraduate applications. It is therefore the role of the supervisor to guide the student and check that the application, patient information sheet and consent comply with the instructions. Competing interests: Margaret Rees is Chair of Oxford Research Ethics Committee B and undertakes research Robert King is Vice chair of Oxford Research Ethics Committee B |
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Laura R Newton, FY2 Academic Rheumatology City Hospital, Birmingham, B18 7QH
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Modernising Medical Careers has seen the introduction of 4 month academic posts in the Foundation Years 1 and 2. These allow junior doctors with an interest in research to acquire valuable skills for future academic and also non-academic careers. Although the simplified 'COREC' form includes a 60 day turn around period, this clock only starts once the form is booked in with an LREC (Local Research Ethics Committee) that has space to discuss the research at its next meeting. With the volume of research projects to be discussed, and the recent reshuffle and subsequent closure of LRECs in our area: this has lead to meetings filling up quickly and extra delays in starting the ethical application process despite the best efforts of everyone involved. After the initial flurry of activity, there is then a waiting period until the research is approved, and only then can patients start being recruited. A 4 month academic foundation post can accommodate the valuable experience of an ethics application, but may not allow actual research to be performed by that doctor in the time period. A 'fast track' system for junior postgraduate doctors, as well as undergraduates, is needed to allow foundation year academics to make the most of their 4 month posts. Competing interests: None declared |
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Phillip A Smith, Assistant Director of R&D The Ipswich Hospital NHS Trust
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The call for more common sense and less bureaucracy relating to NHS Research is to be welcomed. Focusing effort on NHS research ethics committees is worthwhile and necessary. The requirement for gaining NHS Trust Approval (1), however, needs urgent consideration. This is because ethical approval alone does not, and indeed should not, be seen as a ‘green light’ for research to proceed. I would guess that all NHS Trusts would like more research to take place: there are obvious benefits for the organisation, staff and patients. Regulation of research in the NHS is, however, complex. Each NHS Trust has to consider issues such as research quality, ethics, local capacity, finance, agreements/contracts and legislative compliance. Quality and ethics are fairly easy to address. The former is achieved through by peer review of research proposals and the latter by a research ethics committee. Assessing if the project is locally feasible is also fairly straightforward – it just requires agreement from the local manager and clinician. It starts to get a bit more difficult when it comes to financial matters. NHS Trusts are increasingly looking at the resources required to conduct research. Whilst is relatively easy to identify what a project may cost, it is less easy to work out where the monies are to come from. There is an increasing amount of research agreements between organisations. These attempt to say ‘who does what’. Unfortunately each Research Sponsor seems to have their own particular form of agreement. Again, quite confusing. All NHS Trusts have good local systems to ensure that what they do complies with the law. Trust employees usually have a period of mandatory induction and line management to ensure that they understand local policy and process. However, each Trust may have a differing policy on how to comply with, for example, Data Protection legislation. It is therefore easy to see how research can be designed without taking take into account the widespread variation in interpretation of legislation. In consideration of the above, NHS Trusts have to take into account the Department of Health’s Research Governance Framework for Health & Social Care (1) when discharging their duty of quality under Section 45 of the Health and Social Care (Community Health and Standards) Act 2003. Approval by a Research Ethics Committee is a pre-requisite for a research project but such approval does not indicate that the research is lawful (2), financially viable, locally feasible or if the proposed agreements/ contracts make sense. The DH has produced a strategy (3) to address these issues and one measure includes the establishment of a ‘central sign-off’ process to ensure that, for the projects adopted by the DH's Clinical Research Network Portfolio (4), all non-local issues are addressed by Comprehensive Local Research Networks. With appropriate local involvement, and through the use of standard agreements and project costing / payment, one can envisage a much quicker Trust Approval for such research. The trick will then be to apply the same principles to 'non-portfolio' research. This should benefit researchers, NHS Trusts and patients. 1. Department of Health 2005 Research Governance Framework for Health & Social Care 2nd edition. 2. Department of Health 2001 Governance Arrangements for Research Ethics Committees. 3. Department of Health 2006 Best Research for Best Health: A new national health research strategy. 4. Department of Health 2007 Eligibility for inclusion of studies in the NIHR Clinical Research Network Portfolio. http://www.ukcrn.org.uk/index/clinical/portfolio/mainColumnParagraphs/03/document/Eligibility.pdf Competing interests: I review research projects for The Ipswich Hospital NHS Trust and The Suffolk Mental Health Partnership NHS Trust |
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John S Lilleyman, Strategic Advisor, NRES NRES, 2nd Floor, 50 Eastbourne Terrace, London W2 6LG
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The recent editorial by Robinson, Murdoch-Eaton and Carter about research ethics committees points out that current plans for re- engineering the system into a National Research Ethics Service with built in proportionality of review may nevertheless fail to help the problems faced by undergraduates. With the necessary short time scales and (usually) ethically unchallenging projects with which students are involved, these authors suggest that a student-specific fast track review of a simplified application form is needed. Without that they fear coverage of research methodology in the undergraduate medical curriculum will be compromised. While what they suggest is intuitively appealing we decided against setting up a separate system just for undergraduates for two reasons. First, it would involve a parallel bureaucracy and provoke debate over which students were eligible to apply. Secondly, and more importantly, the ethics of research depend primarily on what is being done, not who is doing it. In other words if a student is involved in some aspect of an early phase drug trial there can be no corner cutting. We hope that when the new system is up and running most undergraduate projects will be fast- tracked as will those of postgraduates where there are no material ethical dimensions. This will leave committees able to focus on the more difficult applications. As for the complexity of the application form, the evolving on-line system is becoming more adaptive and shortens itself for simple projects to a degree that undergraduates should be able to navigate with ease. If projects are not so simple, then an understanding of the need for more information will arguably better equip students for the real world of research. It might also help to prepare them for self- assessment of their income tax in later life. Competing interests: None declared |
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Louise Robinson, Senior Lecturer in Primary Care Institute of Health and Society, Newcastle University, Deborah Murdoch Eaton and Yvonne Carter
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We welcome the responses to our editorial(1). We agree whole heartedly with Smith; Stathan et al regarding the urgent need to streamline Trust research governance processes,and the necessity for consistency in the requirements requested by different trusts. The Department of Health (DH)strategy to ensure a central "sign off process" for projects adopted by the DH Clinical Research Network Portfolio, should as Smith suggests, produce a more streamlined system for Trust approval but will not address the problem for studies which are not adopted! Rees states that the undergraduate educational supervisor has a major role in facilitating their students' understanding of research governance issues and the completion of relevant documentation. Unfortunately in a qualitative study exploring supervisors' views on research governance, we found that supervisors were adopting "opt out" strategies i.e withdrawl from supervison of undergraduate research or proposing audit projects, instead of completing the relevant ethical application form for research projects(2). We sincerely hope, as Lilleyman suggests, that the re- engineering of the ethical review system will allow fast tracking of undergraduate projects and that the evolving on-line application form will blossom, but we suspect that most people would choose an accountant to complete their tax assessment form than attempt to do it themselves! 1)Robinson L, Murdoch-Eaton D, Carter Y. NHS Research Ethics Committees. BMJ 2007;335:6. 2)Robinson L, Drewery S, Ellershaw J, Smith J, Whittle S,Murdocj- Eaton D. Research Governance - impeding both research and teaching? A survery of impact on medical student experience. Medical Education 2007(in press). Competing interests: None declared |
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Nikolaos Gkioulekas, Research Fellow Royal Free Hospital, Hampstead, London NW3 2QG, UK, Ioannis Korkontzelos, Charalampos Stamatopoulos, Nawar Al-Shabibi, Adam Magos
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In 2004 and 2007, the BMJ carried a series of editorials, articles, debates and letters following the introduction of a new, centralised ethical approval process in the UK for clinical research (COREC)(1,2). The overwhelming tone was negative, with a feeling that the European Union inspired system was too complex, too bureaucratic and too labour intensive as reflected in the headlines such as “Bureaucracy of ethics applications“, “Frustrating bureaucracy in clinical research”, and “Research ethics paperwork: what is the plot we seem to have lost?” to name but three (3-5). In 2008, we are sad to report that the situation has not improved since COREC was repackaged as NRES (National Research Ethics Service) in April 2007, and the process for ethical approval continues to impede and delay just as it did in 2004. We are currently in the process of trying to obtain Research & Development (R&D) and NRES approval for a small observational study assessing the value of providing patients with an edited video CD of their surgery (6). The study does not affect the treatment the patients receive, does not require any outside funding as the material costs are negligible, and there are no staffing costs as the project is being done by in-house clinical staff. However, before such a modest study can be started, an extremely complex and time consuming process has still to be negotiated, involving the following 10 stages: 1. Submission of a signed Project Registration Documentation for R&D
(Guidance Notes: 11 pages, Documentation: 13 pages).
In order to submit all the necessary documentation, we had to read 21 pages of instructions and 68 pages of documents, fill in 154 domains, and submit 15 additional documents (e.g. check lists) to the R&D and NRES offices. We would estimate that the time taken to complete all the forms, forms which frustratingly contained considerable overlap and repetition, was approximately six hours. Should our application need amendment, which as we all know is not uncommon, there will be yet more paper work. We have no choice, however, because we know that we can only start our small study when all 10 stages have been completed successfully and approval obtained from R&D and NRES; we only hope that ethical approval will take less than the maximum allowed of 60 days. The current arrangement might be appropriate for a large, costly study funded by a drug company or bodies such as the Medical Research Council, but is surely inappropriate for a small clinical study such as ours? We don’t have the services of “professional” grant writers or “research assistants” whose role is just that, to get funding and obtain R&D and Ethical approval. Instead, we are busy clinicians who would like to integrate some modest clinical research in to our daily work, and for us the mechanism for R&D and ethical approval is unnecessarily complex and time-consuming. It has got to the stage that we sometimes wonder if fighting through all the bureaucratic hoops is really worth it, a feeling that was already voiced four years ago (7). We fear that if the system is not simplified considerably, many clinicians will no longer bother. If that happens, much useful clinical research will never take place, which would be a great pity for our profession and patients alike. 1. Nicholson R. Another threat to research in the United Kingdom. BMJ 2004;328:212-213. 2. Robinson L, Murdoch-Eaton D, Carter Y. NHS research ethics committees. BMJ 2007;335:6. 3. Wald DS. Bureaucracy of ethics applications. BMJ 2004;329:282-4. 4. Goulden P. Frustrating bureaucracy in clinical research. http://www.bmj.com/cgi/eletters/329/7460/241#70586. 5. Jamrozick K. Research ethics paperwork: what is the plot we seem to have lost? BMJ 2004;329:286-7. 6. Papadopoulos N, Polyzos D, Gambadauro P, Papalampros P, Chapman L, Magos A. Do patients want to see recordings of their surgery? Eur J Obstet Gynecol Reprod Biol. (in press). 7. Furness PN. In research, one size will not fit all. http://www.bmj.com/cgi/eletters/329/7460/241#70345. Competing interests: None declared |
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Hugh T Davies, Consultant paediatrician and Research Ethics Advisor National Research Ethics Service 4 to 8 Maple St, London W1T 5HD
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NRES recognises the importance of clinical research and our aim is to facilitate this whilst ensuring the protection of research participants by robust and efficient ethical review. We are therefore developing what Gkioulekas requests, commensurate review. Like Furness, we see that "one size doesnt fit all". To this effect we have taken the lead in creating a unified application form, coordinating this with others such as Research and Development NHS and the Medicines and Health Care Regulatory Authority. We have also defined and differentiated research (which requires review), audit and service evaluation which don't (http://www.nres.npsa.nhs.uk/applicants/guidance/ "Defining research" ). While we can't deliver an opinion on the basis of a letter to the BMJ, it might be that the work Gkioulekas has undertaken is more akin to service evaluation and exempt from the review and work Gkioulekas describes. Prospectively, if there is uncertainty, researchers can discuss this with their local R&D manager, or through NRES to their local REC chair or our queries line queries@nres.npsa.nhs.uk to obtain our guidance. Thirdly we are completing a project exploring expedited review and will begin a pilot implementation in South London from September. Similar application details will be needed but we hope this will provide researchers a faster response. Competing interests: Research Ethics Advisor at the National Research Ethics Service |
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