Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Disability discrimination legislation will require reform of ethics application procedures.
- John M Starr (30 July 2004)
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Site-specific assessments - yet another barrier to research
- Karen Spilsbury, Jill Pattenden (30 July 2004)
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Ethical Regress?
- Ramesh P Arasaradnam, Bernard M Corfe (31 July 2004)
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Ethics committees: a solution for juniors
- Simon N Madge (1 August 2004)
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It doesn't have to be this way
- Andrew J. Lotery (1 August 2004)
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Bureaucratic nightmare.
- Linda M. Bailey (3 August 2004)
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Re: Bureaucracy of ethics applications
- Robert Dingwall, Emma Rowley (3 August 2004)
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Bureaucracy of research governance
- Stephen Goodall, Melanie Chalder, Chris Salisbury (4 August 2004)
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RECs - the 'conspiracy theory'
- Sanju George (10 August 2004)
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It's no better over here
- Anna Fierz (12 August 2004)
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10 top tips for completing the COREC form
- Julie L Scott, Phillip A. Smith, Sandip K. Pal (12 August 2004)
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Ask for help!
- Colette M Reid (18 August 2004)
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Re: Site-specific assessments - yet another barrier to research
- Chris Speed (19 August 2004)
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Questionnaire Quibbles
- Simon J Quantrill, Natalie Cheng, Complementary Medicine student (24 August 2004)
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John M Starr, Reader in Geriatric Medicine & Health Foundation Research Fellow Geriatric Medicine unit, Royal Victoria Hospital, Craigleith Road, Edinburgh. EH4 2DN.
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Charles Warlow outlines several causes of ethics committees impeding research [1]. He mentions one way forward is to involve patients and patients’ organisations. Participatory research has advantages of bringing the unique expertise of the ‘user’, a perspective usually available only indirectly to those who sit on ethics committees. This is highlighted for people with Learning Disabilities, where participatory research may be especially empowering [2]. However, as Wald eloquently describes [3], the process for obtaining ethics permission is far from ‘user’ friendly. In the UK the Disability Discrimination Act 1995 requires equality of access for people with disabilities to NHS services from service providers. Ethics committees fall under the aegis of the NHS. Their services should thus be available to all potential investigators, professional and non- professional, including those with Learning Disabilities. The challenge of providing application procedures that can be understood and used by people with Learning Disabilities should benefit all researchers as it forces UK ethics committees to focus on the essential questions. References 1 Warlow C. Clinical research under the cosh again. BMJ 2004;329:241- 2. 2 Richardson M. Involving people in the analysis: listening, reflecting, discounting nothing. J Learning Disabil 2002;6:47-60. 3 Wald DS. Bureaucracy of ethics applications. BMJ 2004;329:282-4. Competing interests: Dr John Starr is currently applying to MREC Scotland for ethics permission for a participatory research study with people with Learning Disabilities. |
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Karen Spilsbury, Research Fellow Department of Health Sciences, University of York, YO10 5DD, Jill Pattenden
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David Wald’s article1 paints a vivid portrait of the pain of completing COREC’s new application form. In his article he alludes to the relative painlessness of completing Part C (the site specific assessment - SSA); however, such a pain free experience is not a characteristic of all parts of the MREC approval process. Five months ago, as part of a evaluating the impact of primary care heart failure specialist nurses in England, we submitted an application for MREC approval. Because of our desire to minimise selection bias and maximise the involvement of older people in the study we wanted to use the specialist nurses themselves in the patient consenting process. Consequently, our request for ‘no local investigator status’ was declined. We were informed that we would require SSAs to be carried out in 26 lead Primary Care Trusts. However, on commencement, LREC administrators informed us that SSAs for each participating PCT were required – this meant 62 SSAs. Our experience highlights the huge variability in interpretation of research governance regulations by LRECs. There were inconsistencies relating to the named Principal Investigator (PI) - with some LRECs accepting the name of the PI at York, whilst others wanted the names and CVs of the specialist nurses in the sites; and the provision of an identification number to validate the SSA form - some LRECs wanted this to be entered on the form before submission whilst others during processing of the form. For one SSA application the PI had 12 telephone conversations, nine email correspondences and needed to submit the SSA application and her CV three times - all due to conflicting advice from one LREC. Frustrated, we appealed to MREC. Consequently, our application for no local investigator status is being reconsidered and the specialist nurses have been removed from the consenting process (with the consequent potential for a reduction in the quality of the study). Our experience highlights the implications for researchers wishing to use local researchers rather than local collaborators. The distinction may appear cursory, but researchers should be aware of the consequences of the local researcher option in multi-centre studies. 1 Wald DS Bureaucracy of ethics applications. BMJ 2004; 329:282-284 Competing interests: None declared |
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Ramesh P Arasaradnam, Specialist Registrar in Gastroenterology Sheffield Teaching Hospitals, Northern General Hospital, Sheffield S5 7AU, Bernard M Corfe
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Dr Wald's comments regarding bureaucracy of ethical applications was delightfully refreshing and we fully reverberate his concerns. Our experience has been equally dissapointing particularly with the advent of the new COREC forms as of March 2004. We had previously already obtained ethical approval last year to analyse colorectal adenomatous polyp tissue using a proteomic approach. As progress was made we decided to develop the study further using DNA micoroarray techniques. An ethical ammendment was applied with emphasis that no heritable condition were to be analysed but was rejected. Thus we now had to reapply using the new COREC forms for what is essentially the same study involving the same cohort of patients simply because our analysis now involved a different technique. Clearly this is an ineffcient use of time and effort. How can clinical research progress if such stumbling blocks are placed? Truly we have entered an era of Ethical Regress. Competing interests: None declared |
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Simon N Madge, SpR Ophthalmology Musgrove Park Hospital, Taunton TA1 5DA
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Editor, The BMJ is to be congratulated for its long overdue focus on the excessive red tape of ethics committees. However, more problems than solutions were mooted in the various articles (1,2), which, although providing some interesting reading, do not lead us any further forward as a profession. It must be remembered that it is not only high-ranking, ground- breaking interventional research that is falling foul of the stifling quagmires that are ethics committees. “Publish or perish” has long been a motto of junior doctors attempting to climb the ever-changing career ladder. In the face of the 68 page COREC document, we will almost certainly find that more juniors may choose career hara-kiri than attempting to conduct any meaningful research. I am still fatigued from completing an ethics application form for a very short and simple questionnaire study regarding the refractive expectations of patients about to undergo cataract surgery. Studies of this nature, previously often deemed “SHO projects”, are non-invasive, harmless and of surely only equivocal interest to even the most interrogative of ethics committees. For such simple studies, where it is immediately clear to anyone that there are essentially no ethical considerations worth discussing, I propose a grossly-simplified and shortened application form (at most two pages) to be considered by a single member of the local ethics committee. If such a suitably-empowered independent adjudicator were to feel that perhaps there may in fact exist an ethical dilemma worth pursuing, then the application could be rejected and a request for a full CORECing issued. Of course, in the case of such simple projects, it is often possible to dress up such work as clinical audits, thus bypassing ethics committees. Surely it is high time that the bureaucrats decided to spoil our audit fun too? Simon Madge Specialist Registrar Department of Ophthalmology Musgrove Park Hospital Taunton TA1 5DA smadge007@yahoo.co.uk 1. Wald DS. Bureaucracy of ethics applications. BMJ 2004; 329: 282- 4. 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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Andrew J. Lotery, Professor of Ophthalmology University of Southampton
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Editor- I congratulate the BMJ on highlighting the plight of British researchers as they attempt to perform world class research while having their efforts thwarted with unnecessary bureaucracy. When I worked in the United States I had to submit my research applications to one committee - the local Institutional Review Board. This compares to the situation in the United Kingdom where five unrelated committees need to be informed of my applications. These are a peer review group in my clinical directorate, the research and developmental office and the data protection office of my hospital trust, my University research office and of course the local research ethics committee. The massive administration required to satisfy these five committees (all asking for similar information in slightly different ways and on different forms) necessitates employing additional staff at great cost to the NHS and significantly delays research projects. It also prevents junior doctors accomplishing any useful research in 6 month attachments as the forms are rarely finished prior to them leaving their posts. This is utter maddness. Could government please listen, take control of this mess and reduce these five committees to one. Otherwise clinical research in the United Kingdom will die. Competing interests: None declared |
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Linda M. Bailey, Public Health Specialist Trainee London WC1N 1DZ
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I have read the articles on research ethics approval in this week's BMJ with interest, having had to submit an application to COREC in March this year. My project involved qualitative interviews with a handful of NHS staff involved in the care of pregnant women and new babies in London. The staff I wished to interview included community and Health Protection Agency (HPA) Staff, as well as those in the acute sector. I was also particularly keen to interview at least one member of staff working with women who were, or had been, intravenous drug users. These services were the remit of the local mental health trust. Going through the COREC and local Research Governance approval process to interview seven people working in the NHS and HPA, but across different employing organisations, albeit in the same part of London, was long winded and painful. I had to complete 54 pages of the COREC form as well as making a further application to two acute NHS Trust ethics committees for site specific approval. I also had to fill in the forms required by the Local Research Governance Support Unit. And then wait for the outcome. Because of a computer "glitch" on the COREC form, which the COREC office acknowledged they were aware of, the electronic form inadvertently recorded that I wished to interview "vulnerable adults" and asked questions about whether I intended to contact my interviewee's GPs for information. I was not sure that the local NHS Consultants I wanted to approach would even tell me who their GPs were, let alone consent to them being approached! However it was impossible to complete this form without answering this question. Further, there was a lack of clarity about who to approach for permission to interview staff in the Primary Care Trusts, and the HPA. And I have been waiting since April for Site Specific Approval from the Mental Health Trust. In all, I probably spent about three or four days going through the process of gaining ethics approval. All this for one small MSc dissertation, involving only NHS and HPA staff! I fully support the most stringent and rigorous checks on research where patients or healthy volunteers are involved, particularly if the research involves new drugs or treatments. But the COREC process which was established in March this year had shown that a "one size fits all" approach is the wrong approach. Competing interests: MSc Student |
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Robert Dingwall, Director of IGBiS, Professor of Sociology University of Nottingham, NG7 2RD, Emma Rowley
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Editor, Wald’s closing paragraph is all to familiar: “COREC and the European directive claim to support research, but their ethics forms serve more to obstruct research than protect patients. The current COREC requirements add to a level of regulation that is making it increasingly difficult for practising clinicians to conduct small-scale clinical research. Action is urgently needed to reduce a research bureaucracy that has largely lost sight of the patient, advancing medical knowledge, and improving medical care” (2004:284). We have recently been commissioned by the Department of Health’s Patient Safety Research Programme to undertake an investigation of the re- use of medical consumables designated as single use. The commissioners requested a national census of re-use in all NHS anaesthetic and theatre departments in England, in addition to a follow-up interview study, all to be completed within 18 months. We are now 2 months into this schedule and have discovered that it has now become practically impossible to carry out a national survey of anything in the NHS. In addition to MREC approval (and SSA approval for the interview phase of the study), we will need honorary contracts and R&D approval from each trust, resulting in yet more forms requiring completion, cost assessments (even though there are no costs incurred by the NHS) and signatures from various members of trust staff. We have been warned that the R&D process is inconsistent, with many trusts refusing to accept COREC part D in favour of their own form. The Guardian (30 July 2004) recently reported a survey of all NHS Hospital Trusts about junior doctors’ working hours, to which 75/173 replied, despite the work involved, in the depths of the summer. When journalists do this, there is no regulation: when social scientists commissioned by the Department of Health itself undertake an identical exercise, the result is 350 honorary contracts, 350 R&D forms, 350 sets of costings and 1400 signatures before the research can even start. Moreover, we have recently learnt that our questionnaire also has to be assessed by the Gateway team in Leeds, who will examine this, Department of Health-commissioned study to determine whether it will be too burdensome or similar to NHS data already being collected, and can refuse access. Lastly, we have learnt that, unlike journalists, we must not approach our sample directly, but will have to rely upon clinical directors inviting their staff to participate in the research – surely a process which will have a greater negative resource impact upon NHS than the supposed ‘harm’ that us directly approaching public employees identified by job title might have. Although it is of some comfort to know that we are not alone in the struggle we face, it remains that the Research Governance Framework and the ICH Good Clinical Practice guidelines, whilst introduced with very good intentions, have in practice, severely hindered the capacity to carry out large scale survey research in the NHS. References: Wald, D.S. (2004) Bureaucracy of Ethics Applications British Medical Journal 329: pp 282-284. Carvel, J. (2004) NHS hit by crisis over doctors' hours The Guardian Online (http://society.guardian.co.uk/NHSstaff/story/0,7991,1272457,00.html) Competing interests: None declared |
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Stephen Goodall, Post-doctoral Research Associate Primary Health Care, University of Bristol, BS6 6JL, Melanie Chalder, Chris Salisbury
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Ethical approval is only part of the tortuous path of clinical research. Bureaucracy associated with research governance wastes resources, delays and sometimes undermines research itself. We are currently seeking approval within numerous primary and secondary care Trusts around England. Finding the right research governance contact can be difficult, confounded by some Trusts not understanding their responsibilities. Trusts request numerous forms in different formats. For one project it was necessary to send 44 documents to each PCT, almost all duplicating material already considered by the ethics committee. Misunderstandings about data protection requirements are common. Despite guidance to the contrary, some Trusts will not consider research governance applications until ethical approval is obtained, and insist on researchers applying for multiple honorary contracts from different Trusts. We fully support the need for quality and accountability in research, but feel that the responsibilities of the various participants set out in the Research Governance Framework1 are not reflected in the approvals process. We would suggest the following changes. Since sponsors approve the quality of research and ethics committees appraise ethical issues, Trusts only need to consider the financial, workload, indemnity and operational aspects of the project. These are all covered by Form D of the ethics application, so Trusts should only request this standard form, the protocol and approvals from the ethics committee and sponsor. Ethics approval should include consideration of data protection issues so that this does not have to be reconsidered at every local site. There should be a database on the COREC website of the research governance contact details for every Trust in England. Research governance approval should be subject to the same 60 day deadline as for MREC applications, and should run in parallel. A standard honorary contract for each researcher should be administered by one NHS organisation and be accepted by all others. Until these problems are resolved patients will continue to receive treatment that is pointless or harmful because it is not evidence-based. The benefits to be gained from research governance must be weighed against the harm of obstructing research. 1 Department of Health. Research Governance Framework for Health and Social Care. London: Department of Health, (2001). Competing interests: None declared |
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Sanju George, Specialist Registrar & Honorary Clinical Lecturer in Psychiatry , University of Birmingham Sandwell Outreach Team, West Midlands, B 69 4 AL
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As an aspiring part-time researcher myself, I share the frustration and disillusionment of many of my colleagues at the recent changes in the REC application and approval process. However dispassionate, one cannot but agree that the new process is cumbersome and cost-ineffective. It also leads one to suspect if the bodies (? DOH) that implement or oversee these changes have a hidden agenda – i.e. to dissuade clinicians who are engaged in part-time research, from doing research and thereby get them to spend more time on clinical work. The significance of this, in the form of shorter waiting lists, meeting more of the government targets etc, to politicians is immense and for them is of more direct and personal benefit, than doctors doing part-time research. Extrapolating my ‘conspiracy theory’ further, maybe the so-called ‘academic elite’, who are already an exclusive club, also play a role in determining such policy. By increasing such bureaucratic and administrative obstacles, it becomes very difficult for ‘small-scale’ researchers to conduct any meaningful research. Thus research, grants, publication and any other positive outcome that follows, will become the exclusive ‘property’ of those academics in the ‘powerful’ centres around the UK. Having stated my ‘conspiracy theory’, I will briefly discuss my experience of sitting in as an observer at one of the LREC meetings and the lessons I learnt. The committee discussed 10 applications and there was also an opportunity for researchers (pre-arranged) to clarify certain aspects of their protocol. The committee members were very well prepared, had a good skill mix and an excellent understanding of the basic research principles. Most of the suggestions given were sensible, practical and easy to implement. Some recommendations like ‘piloting the questionnaire’, ‘seeking expert advice for qualitative analysis’, ‘ having to do a sample size calculation’, etc would have improved the methodological rigour of the respective projects. No proposal was needlessly or merely for administrative reasons rejected or send for amendments. I learned some important lessons on how not to fill a REC application form. I would urge any junior researcher (like myself) to attend at least one LREC meeting, for it’s definitely a fruitful exercise. The inferences that can be drawn from my experience of observing one meeting are limited. However, it suggests that RECs are not to be blamed for all research applications being unduly delayed and maybe the research governance framework and other wider policies and policy makers need to share the blame. Upholding the principle that even if few ethically – ‘correct’ applications are wrongly delayed (though not by much!), if one ethically ‘wrong’ application can be rightly prevented from going through (which could potentially harm research subjects), I feel that ultimately it is all well worth it. For we all know the direction research could take in the absence of regulatory bodies! Competing interests: None declared |
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Anna Fierz, Ophthalmologist in private practice 8037 Zürich, Switzerland
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My heartfelt thanks to the BMJ and to all the authors with the courage to criticize the ethical red tape! Although I have never had the misfortune to encounter a COREC form, the system is almost exactly the same in little Switzerland. Or at least it was when I still had any academic ambitions. In the late nineties, my boss wanted to find out whether asymptomatic swelling of the optic discs occurs in patients on minocycline, the background being that "idiopathic" intracranial hypertension is a rare but well-known side-effect of this drug. We were submitted to a one-fits-all procedure that would have been the same had we proposed experimental brain surgery. How dangerous is an ophthalmoscope, expletive deleted? We ended up not doing the study. Among other things, the ethics committee asked us to explain what we meant by idiopathic intracranial hypertension... I have a hard time remaining polite when the subject comes up, and I am grateful to all of you for pointing out the problem. Keep up the good work! Competing interests: None declared |
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Julie L Scott, R&D Project Officer Mid Essex Hopsital Services NHS Trust, Phillip A. Smith, Sandip K. Pal
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As the R&D Department at an acute NHS Trust, part of our role is to assist researchers with applications to ethics committees. It is fair to say that our jobs have become more challenging following the introduction of the new electronic ethics form. Others have described the difficulties but we decided it was important to be positive. Whilst we emphasise with the difficulties faced by researchers we can see the benefits of a form that addresses a wide range of potential issues and feel that the process of completing the application may help researchers to clarify project-related issues. We have even had some positive feedback from one of our researchers about the process, although admittedly this was after she had virtually completed the form and had had time to reflect. We have recently offered assistance to researchers completing the form for their BSc projects. One of the researchers has obtained ethical approval subject to minor amendments and the other is due to submit the application in the near future. It has been as much a learning experience for us as for them and we decided it might be helpful to share the knowledge we have acquired. We have therefore compiled ten tips for the ethics procedure. We have, in some places, used direct reference to the COREC Form questions - for example A45 refers to question 45 in section A. Please note that these tips may not be applicable to all organisations. We cannot be held responsible for any incorrect information researchers may submit to ethical committees on the basis of this letter. Ten Tops for the New Ethics Form 1. The form is available either on-line or by downloading form filler at www.corec.org.uk. At our Trust there were many problems downloading a compressed executable file and we found the online version easier to use. With this you need to register with a user name and password. This can take 10 minutes or so but allow longer. If you forget your password, there is a facility for emailing COREC who will send you a reminder. 2. It is important to be clear whether your study should be submitted to your local ethics committee or if you need to proceed via the central allocation system. This will depend on the type of study and further information can be obtained from the main COREC website. The form consists of Parts A to C and where the various sections should be sent to depend on whether the submission is to a local ethics committee or via the central allocation system. Parts A and B are generic and Part C is a locality assessment. Part D may be used by the hosting NHS Trust, but is not required for review by the ethics committee. If you have to use it then be careful - it is currently not on-line, has to be downloaded as a compressed executable file and is not linked to Parts A to C. However, text can be manually cut and pasted from parts A to C. 3. Various signatures are required on the COREC form. For example, if you are carrying out a student project you will require your Academic Supervisor’s signature. It is therefore important to take this into account when planning time-scales for completion. August can be difficult for locating academics! 4. You need to submit the checklist of information with your ethics application. This is available on the COREC web-page. You will not necessarily need to submit all the documents on the list but if a document is not applicable to your study you should indicate this, otherwise it may appear as if you application is incomplete. It is advisable to look at the checklist before you start the application form as there may be some documents, for example the letter from Sponsor, that take a while to obtain. 5. All research now requires an identified Sponsor according to guidelines from the Department of Health. Question A59 (P21) of the COREC forms refers to whether the funder of the research has agreed to act as Sponsor as set out in the Research Governance Framework and you also need to submit a declaration from an organisation stating they will act as Sponsor, which should be signed by the Chief Executive of the organisation or somebody who authority has been delegated to. It is important to clarify who will act as Sponsor at an early stage but the general guide we use is as follows: · For student projects, the university should act as Sponsor as suggested by the Department of Health. · For single site studies funded by and taking place at an NHS Trust the Trust may act as Sponsor. · For non-commercial externally funded research the external funder would usually act as Sponsor but in exceptional circumstances, the Trust may act as Sponsor. · For commercial externally funded research the external funder should act as Sponsor. 6. As the form is intended for all types of projects, not all questions may be applicable to a given study. It is not necessary to have addressed all the issues raised in the questions for all projects, as the requirements of a multi centre clinical trial differ greatly from those of a single-site research project such as a questionnaire. If a question is not applicable you should state this and provide justification if necessary. For example, useful reference numbers are asked for in A65 (P23) but not all projects will have all of these. Similarly, in some cases it may not be necessary for student projects to have an external peer review (A45, P17) as they should be reviewed by the Academic Supervisor. 7. We were originally slightly confused by Question A31 (P13) relating to whether the study has, or requires approval of PIAG (Patient Information Advisory Group) or other bodies with a similar remit. As our Trust has a patient representative group with a similar name we initially wondered whether this question referred to this group. However, we clarified this issue with the Department of Health and the question refers specifically to Section 60 of the Health and Social Care Act with respect to the use of personally identifiable information without anonymising the data or without obtaining consent. Further information on PIAG can be obtained from the Department of Health website http://www.dh.gov.uk. 8. Questions A35 and A36 (P14) relate to indemnity and some general guidelines are as follows. · The Sponsor is generally required to take on the responsibility of non-negligent harm. · For research sponsored by the NHS normal NHS indemnity will usually apply. · With respect to research sponsored by a commercial company or other organisation, they should provide indemnity for non-negligent harm. · For negligent harm, the NHS is responsible for NHS employees, even when sponsored by another organisation. The above information should be made explicit on the patient information sheet. 9. Once you have completed the form you need to lock it before printing it out. This is to prevent the form being changed after signatures have been obtained. Before locking the form you need to telephone either the central allocation system or the ethics committee (depending on which of these you have to submit to) for a project number. You will also require an R&D number from the host organisation before you lock the form - so request this number early on. 10. The ethics committee will only accept a complete and valid submission. Version number and dates need to be on all relevant documents and you need to ensure you have included all applicable documents. Further information We hope you have find the above helpful. The R&D Department at Mid Essex Hospital Services NHS Trust have compiled a document on completing the new ethics form, which has been given positive feedback by COREC. If you would like a copy of this document please contact Julie Scott on email address Julie.Scott@meht.nhs.uk or telephone number 01245 514891. The above tips are intended as a summary only and detailed instructions can be found on the website at www.corec.org.uk. End note Although we recognise that there are difficulties with the new ethical procedure we feel these will become easier over time once people have gained familiarity with the form, although we do not underestimate the problems it will create for first-time researchers. However, the system is now in place and we feel it is more beneficial to try and work with it rather than against it. Above all please remember, keep smiling, consider NHS R&D Teams as helpful and communicate with COREC. Competing interests: Phillip Smith is a member of the National NHS Research and Development Forum's Research Governance working group and is a Visiting Fellow to Anglia Polytechnic University. |
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Colette M Reid, Research Fellow Department of Palliative Medicine Bristol Haematology and Oncology Centre Horfield Rd Bristol BS28ED
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Editor, I read the article by Wald[1] with compassion, having recently taken a similar length of time to complete a 60 page COREC form for a study comparing two different approaches to the management of cancer pain. However, I feel that at times he was unduly harsh on the process and available support. Perhaps I have been lucky, but I have had invaluable help from our trust Research and Effectiveness Unit, based at the Bristol Royal Infirmary. Involving them at the protocol development stage undoubtedly facilitated this. I have also received useful (and money-saving) advice from the Medicines and Healthcare Regulatory Agency (MHRA), and like Wald was able to apply for a Doctors and Dentists Exemption (DDX) which was rolled over to a Clinical Trials Authorisation on May 1st, thereby saving approximately £2000. It was not a surprise that because other researchers were doing likewise (the MHRA’s workload was quadrupled for that period)[2], this resulted in some delay in issuing the certificates. The COREC IT help-line staff have been both helpful and friendly, even on the two occasions when it became clear that the technological problems I had in completing the form were due to errors that I had made. In his article, Wald refers to his difficulties with Part A of the form, in particular the reference numbers requested. The COREC form website has Frequently Asked Questions and Question Specific Advice documents, both highlighted when logging-on to the system for the first time. These state clearly the nature of the reference numbers requested and what to do if they are not required or available for a study. I wonder if “resorting” to phoning local research and development offices and referring to available guidelines are the academic equivalent of asking for directions when lost? 1. Wald DS. Bureaucracy of ethics applications. BMJ 2004; 329: 282-4 2. MHRA personal communication Competing interests: None declared |
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Chris Speed, Trial Manager Centre for Health Services Research, University of Newcastle , NE2 4AA
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For anyone with experience of COREC’s new application form, David Wald’s article and the responses and reflections it has generated will be, to a greater or lesser extent, all too familiar. I am sure that the research community will be nodding in collective agreement and it has come as a welcome relief that ‘I am not alone’. However, rather than reflecting on my negative experiences with the process, I would like to pick up on Karen Spilsbury’s comments relating to Site Specific Assessments (SSAs) and offer some advice on a potential route over this hurdle. With MREC approval in place (and having failed in the ‘no local researcher’ attempt), I set about completing Part C. Being unsure as to what exactly a constituted a ‘site’ in a SSA, I took advice. Two calls generated two different responses. The first response was that a PCT was a site; the second was that a site was in fact an individual practice. Naively, I thought that the PCT option would be better for me; after all I would need to complete fewer SSAs. However, telephone calls to various Trusts to discuss the possibility of ‘a member’ being our study Principal Investigator (PI) proved fruitless. No takers. Needing to recruit approximately sixty practices to the trial, I was faced with convincing sixty GPs that not only did they want to take part in the study, but that they wanted to be responsible for the day to day running of the study in their ‘site’ and wanted to give me a copy of their current CV (maximum of two pages) to accompany Part C. To soften the blow (absorbing yet more tasks into the research process), I set about designing an electronic CV template. We would complete what we could, email it to PIs who would then fill in the blanks and send it back to us. More work, but at least it was possible to complete our SSAs. A casual remark from a Local REC secretary, during another telephone conversation, about two or more sites ‘working together’ opened up another possibility. I could try and find out whether practices would collaborate and therefore have one PI assuming responsibility for more than one site. A GP colleague said that he would be willing to do this for all practices in his PCT. Close scrutiny of the COREC Standard Operating Procedures (paragraph 4.15) suggested that it was acceptable to have a research consortium with one PI responsible for the research in that consortium. We are fortunate in the North East to have an active Northern Primary Care Research Network (NoReN) - with an equally active Director. With support from the Director and the Network (and response from the Regional OREC Manager to confirm acceptability) we have our consortium, we have our PI and we have submitted our SSAs. The key point for our research has been the reinterpretation of a 'site'. I would encourage any other researchers engaged in multi-practice research to ‘reinterpret’ and to work closely with your local (Primary Care) Research Networks. Competing interests: None declared |
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Simon J Quantrill, Consultant Physician Chest Clinic, Whipps Cross University Hospital, Leytonstone, London E11 1NR, Natalie Cheng, Complementary Medicine student
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EDITOR-We have great sympathy with David Wald and colleagues in their fight against the bureaucracy of ethics applications and would like to contribute our own experience. We too clocked up about the same number of hours completing and submitting the 68 page COREC form, and would have incurred the same expenses had our staff been salaried. Our study, though, constituted a simple 10-point questionnaire survey relating to complementary medicine usage, on one sheet of A4 paper, to be administered within our own chest clinic. Due to huge problems related to the on-line application and difficulties with downloading our completed form etc, we nearly gave up altogether. Whilst it may just be possible to understand the need for a lengthy ethics form in relation to a randomised controlled trial involving drugs, what about for a small questionnaire study such as ours? Such surveys used to be passed on a sensible ethics committee chairperson's approval, having been sent the protocol, questionnaire and patient information sheet. The submission process is now incredibly laborious and out of all proportion to the size and nature of the study. We suggest that those responsible conceive alternative more simple means of obtaining ethical approval for questionnaire surveys and similar small research projects. Competing interests: None declared |
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