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EDUCATION AND DEBATE: Susan Kerrison, Nick McNally, and Allyson M Pollock United Kingdom research governance strategy BMJ 2003; 327: 553-556 [Full text]

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What about GAfREC and COREC?

Neville W Goodman   (13 September 2003)

Reforming clinical research and development in England

Richard Sullivan   (30 September 2003)

Authors' response to Dr Richard Sullivan

Nick J McNally, Susan Kerrison, Allyson M Pollock   (10 October 2003)

Drowning not waving: implementing research governance within primary care

Jenni Burt, Cathy Shipman, Julia Addington-Hall, Irene Higginson, Brenda Leese, and Patrick White   (21 November 2003)

Research, researchers or policy makers. Who should be regulated?

Magdy Sakr, Pat Overton-Browen. NurseConsultant   (21 April 2004)

What about GAfREC and COREC? 13 September 2003
Neville W Goodman, Consultant Anaesthetist Southmead Hospital, Bristol, BS10 5NB Send response to journal: Re: What about GAfREC and COREC?	Surely, the independence of Research Ethics Committees will be protected by their new governance arrangements (GAfREC) and their being brought together by the Central Office for Research Ethics Committees (COREC)? If not, one wonders what the hard work of COREC (available at www.corec.org.uk)is for. Competing interests:   None declared
Reforming clinical research and development in England 30 September 2003
Richard Sullivan, Head of Clinical Programmes Cancer Research UK, 61 Lincon's Inn Fields, London WC2A 3PX Send response to journal: Re: Reforming clinical research and development in England	We should like to draw your attention to a number of misconceptions and errors propagted by McNally et al.1 The authors assert that, "In cancer, research priorities are now set by the National Cancer Research Institute." The NCRI is an outstanding forum for partnership and joint strategic projects, but it does not set the research strategies of its partners. Likewise the authors fail to understand either the mission or operational details of the National Cancer Research Network (NCRN) and the National Translational Cancer Research Network (NTRAC). The NCRN’s mission has been to double the number of patients entering cancer clinical trials by 2005 (a target it has already surpassed); whilst NTRAC’s establishment, in collaboration with Cancer Research UK (CR-UK), of the National Cancer Tissue Resource will make available tissues from common tumours for bona fide academic studies, and not commercial ventures. The authors suggest that the setting up of the formal research networks in cancer was the result of the outcomes of the Pharmaceutical Industry Competitiveness Taskforce (PICTF). This is incorrect. The NCRI, NCRN and NTRAC were created as a result of the high political profile that was achieved with the publication of the EUROCARE II data and the subsequent partnership with major governmental and non- governmental cancer research funders (the Cancer Collaborative Funders Forum). PICTF’s conclusions, on the other hand, post-date the setting up of the NCRI. Equally, the suggestion that "the private sector will have an important role in identifying and implementing research priorities in other disease groups", seems misleading. The private sector, whilst bringing substantial and welcome funding to cancer research, does not set the overall NHS research priority. Industry by its very nature is partisan and only concerned with those areas that are commercially viable. Governmental (e.g. Medical Research Council) and charity (e.g. CR-UK, Wellcome Trust), as well as NHS R&D, have wider concerns for all cancer research, whether it is commercially viable or not. Other interested stakeholders, for example the Association of Medical Research Charities, British Heart Foundation and Health Technology Assessment Programme, might take exception at the suggestion that the private sector will somehow set their research agenda. The authors’ assessment of the Research Governance Framework (RGF) also contains errors. The RGF has had a complex evolution and it remains in draft format, its implementation date having been postponed from this May 2003 to May 2004. The authors link the creation of the UK Ethics Committee Authority (UKECA) with the RGF, but the UKECA is in fact being created as part of the UK’s implementation of the requirements of the European ‘Clinical Trials’ Directive (Directive / 2001/ 185), specifically Article 6. The statement that these partnerships will provide, "much needed strategic direction" and the apparent concern that industry will somehow lead the UK down the US path also need careful scrutiny. Firstly the jury remains out as to whether changes to R&D and trans-national research networks will improve strategic direction. In fact there is serious concern that current organisational changes will lead to the opposite. With fiscal control mainly at the primary care trust level and with the need for Strategic Health Authroities to hit substantial service targets R&D could become a low priority unless it is specifically mandated for by government. The points made by the authors with respect to the needs of clinicians and patients are not clear. Industry already puts substantial investment into the NHS for the benefit of both patients and research. However, this is only one side of the coin and there is an equally powerful publicly-funded research ethos which is strategically- driven by the needs of patients. Certainly the new cancer research networks are very much accountable for their spending, and great care is taken on any suggestion that direct public funding is somehow being siphoned off into industry. Likewise industry do have legitimate concerns about the cost of conducting clinical trials in the UK that need to be addressed. Finally the situation in the USA is as much to do with how their healthcare system is set up in terms of treatment reimbursement, organisation (Comprehensive Cancer Centres, etc) as it is to do with R&D accountability. Finally, the "Summary points" state "Research governance means a change of emphasis from professional codes of conduct to legal rules". This is wrong on several counts and misleading. Firstly, it implies either that new laws will be enacted to make performance of the RGF a legal duty, or that the RGF itself will form a contract between, say, a charity and a university - neither of these statements are true, and nor is it true to say that what is contained within it is currently a set of professional codes of conduct. Secondly, the statement implies that the distilled ethos of the RGF is to formalise matters, a conclusion that is not suported by the DH. Richard Sullivan, Head of Clinical Programmes Cancer Research UK, 61 Lincoln’s Inn Fields, London WC2A 3PX richard.sullivan@cancer.org.uk Competing Interest: The views expressed in this letter are the authors own. References 1. McNally N, Kerrison S, Pollock AM. BMJ, 2003;327:550 Competing interests:   The views expressed in this response are entirely the authors
Authors' response to Dr Richard Sullivan 10 October 2003
Nick J McNally, Assistant Director of Research & Development R&D Directorate, University College London Hospitals NHS Trust, NW1 2LT, Susan Kerrison, Allyson M Pollock Send response to journal: Re: Authors' response to Dr Richard Sullivan	Dr Sullivan disputes the extent to which industry is currently informing research strategy and research priorities across the NHS. The purpose of our paper was in part to highlight the increasingly important role that industry is playing in NHS research and the conflicts for researchers. Dr Sullivan might like to note the influential Baker report to the Treasury in 1999 which had a remit ’to investigate the commercialisation of research in the Government’s Public Sector Research Establishments (PSREs) and make recommendations for increasing the rate at which PSRE research outputs are successfully commercialised, consistent with other Government objectives for PSREs’ 1. Its recommendations have informed every subsequent report on R&D and higher education, including the Pharmaceutical Industry Competitiveness Taskforce (PICTF) 2,3 and the recent Higher Education white paper 4. In its Science and Innovation Strategy the DH makes clear its intent to ‘form a platform to bring in other players from industry and the science base on a collaborative basis to maximise opportunities for innovation and research’ 5. More recently the DH has given powers to NHS Trusts to enter into joint ventures and to create spin off companies. In 2002 it produced a framework for the management of intellectual property in the NHS within which NHS organisations are required to ensure that their IP is identified and exploited for commercial gain 6. Dr Sullivan may be correct in noting a powerful publicly funded research ethos driven by the needs of patients, but without public resources how will it be protected? Government funding for NHS R&D is largely embedded within the clinical service budgets of NHS Trusts and is not available as a ‘fluid’ funding source to support new research ideas. Such new moneys as there are (£20 million per annum in the example of cancer research) are being channelled through networks - the main ones of which are National Cancer Research Network (NCRN) and National Translational Cancer Research Network (NTRAC). National Cancer Research Institute (NCRI) was established in 2001 to take a strategic oversight of cancer research in the UK, identify gaps and opportunities in current research, facilitate collaboration between funding bodies and monitor progress. Industry is represented on the NCRI Board. As Dr Sullivan points out the establishment of NCRI predates the PICTF reports 2,3, however, the overall policy goals are consistent across PICTF, NCRN and NTRAC, namely the drive to increase subject recruitment to trials and to translate new products more quickly to clinical trials. Indeed collaboration with industry is embedded within the name of NTRAC – National Translational Cancer Research Network - since it presupposes a role for industry in developing products for clinical use. Given the government’s policy intent, we and others 7,8 have noted that these increased collaborative relationships with industry will alter the strategic direction of research. One need look no further than the UK Commission on IP which noted how access to essential medicines, public health priorities and the needs of millions across the world have been subsumed to the needs of an industry whose focus is on the most profitable patients and treatments 9. What is occurring in medical research in the UK is simply a microcosm of research globally. Dr Sullivan appears not to have understood our second paper. A careful reading would show that we link the proposals for reform of research ethics committees with requirements of the European Union Clinical Trials Directive (see page 554 column 2). We also show how the DH draft research governance strategy is rooted in a raft of policies and laws which will have the effect of transferring the control of research from individual clinical researchers to institutions. Contrary to Dr Sullivan’s claim we have not argued that implementation of the DH framework will require new laws, but rather that there is an increasing amount of regulatory law governing research, such as the Human Tissue Bill, EU Clinical Trials Directive and further EU Directives on Good Clinical Practice and Good Manufacturing Practice. When regulated, a study must be conducted according to the rules laid down by the regulator not to the investigators’ own rules. This is why we argued that professional codes are currently being replaced by legal rules. Finally, by April 2004 UCLH will have to have in place framework agreements with over 200 organisations with which it has collaborative research relationships. Irrespective of whether it is the government’s intent to formalise research, implementation of the framework will have that effect. References 1. http://www.hm-treasury.gov.uk/Documents/Enterprise_and_Productivity/Research_and_Enterprise/ent_sme_baker.cfm 2. Pharmaceutical Industry Competitiveness Taskforce. Final report. London: DoH, 2001. 3. Pharmaceutical Industry Competitiveness Taskforce. Clinical research report. London: DoH, 2002. 4. Department for Education and Skills. The future of higher education. London: HMSO, 2003 5. Department of Health. Science and innovation strategy. London: DoH, 2001. 6. Department of Health. The NHS as an innovative organisation: a framework and guidance on the management of intellectual property in the NHS. London: DoH, 2002. 7. Harrison A, New B. Public interest, private decisions: health-related research in the UK. London: King’s Fund, 2002. 8. Wilison D. Privacy and the secondary use of data for health research: experience in Canada and suggested directions forward. Journal of Health Service Research and Policy. 8 Suppl.1, 2003. 9. http://www.iprcommission.org/graphic/documents/final_report.htm Competing interests:   None declared
Drowning not waving: implementing research governance within primary care 21 November 2003
Jenni Burt, Research Associate Department of Palliative Care & Policy, King's College London, London, SE5 9RJ, UK, Cathy Shipman, Julia Addington-Hall, Irene Higginson, Brenda Leese, and Patrick White Send response to journal: Re: Drowning not waving: implementing research governance within primary care	Research governance is essential, but implementation of the new Department of Health Research Governance Framework (RGF) threatens research in the community (1). Kerrison at al summarise the new strategy from the perspective of research and development at an acute NHS Trust (2). However, there has been little understanding or debate about its real impact. Having battled with the framework in Primary Care Trusts (PCTs) across England, we feel it necessary to highlight the consequences of the RGF for research within primary care. We cannot be alone. Under the RGF, researchers must gain research governance approval from each PCT in which they intend to work. There is no central system for approval, although many PCTs have formed local RGF groupings with one lead PCT. For national studies, over 60 lead and individual PCTs must be approached. There is no standardised application process and current requirements range from: A. No RGF procedures yet in place B. Two page forms requiring a summary of the proposed research and an understanding of key RGF requirements C. Fifteen page forms covering the proposed research, statement of local relevance, detailed project budget, projected PCT costs (e.g. time spent completing questionnaires, diagnostic tests and use of PCT meeting rooms), data protection procedures, health and safety considerations and procedures for informed consent. Submitted along with copies of ethical application and approval documents, intellectual property agreement, copy of independent peer review, and applications for honorary contracts, including occupational health clearance. This lack of consistency extends to differentiation between study types: some PCTs insist all go through the full process, while others will swiftly approve studies not directly impacting on patients. It has taken an average of three months to obtain all necessary research governance approvals for multi-centre studies. We estimate the financial cost of this to be £1000 to £2000, representing 50 to 100 hours of a Research Associate’s time. The RGF represents a genuine attempt to improve research quality. However, its bureaucracy could threaten some community research, with short-term projects and national surveys particularly hindered by the timeframe needed to obtain approval, and the complexity of the system. While flexibility is important to enable awareness of local PCT issues, central processes must be devised for multi-centre studies. Funders will need to recognise the time lag and additional costs incurred, and researchers must endeavour to ensure the emerging system does not stifle or bias essential research. 1. Department of Health. Research Governance Framework for Health and Social Care. London: Department of Health, 2001 2. Kerrison S, McNally N, Pollock A. United Kingdom research governance strategy. BMJ 2003; 327:553-556 Competing interests: None declared
Research, researchers or policy makers. Who should be regulated? 21 April 2004
Magdy Sakr, Consultant University Hospitals of Coventry and Warwickshire, Pat Overton-Browen. NurseConsultant Send response to journal: Re: Research, researchers or policy makers. Who should be regulated?	Dear editor We read with interest the papers published in the BMJ regarding research governance(1-3) and also the paper on the progress of the Randomised controlled trials in the UK(4). These papers reflect the current deteriorations and the many obstacles facing researchers in this country. It also brings to memory the saying that if you want kill any idea put it through a committee. As clinicians we endeavour to do research, we believe that medicine and health care has progressed through research. It was research that made the breakthrough in medicine and the reason behind all the advances we have in our hands at the present time. Research in this country is under funded. However under funding is a perennial and international problem caused mainly by the shift of money allocated for research to the clinical service. But now this is not the only problem, many clinical researchers face delays caused by Ethics Committee review that takes months. There is also a new hurdle. This is the Research Governance. Research Governance was introduced to regulate research and probably researchers, this may seem good. But several questions however need addressing. what is the role of the Ethics Committee then? Are we duplicating the regulators? Are we putting clinicians off research? Who will benefit from that? Many good ideas for research originate from young doctors and other health care professionals in training; they are usually in post for a short time as they rotate for training purposes. Their ideas will not see the light as it takes a very long time to get approval from the Ethics Committee and then the Research Governance. We wish to see how long does the journey take from the first draft of the protocol of a research project submitted by a clinician till it is approved by the Research Governance, in our experience it is more than a year! This will definitely have a negative impact on the research and development in this country and consequently the patient care. The frustration of those who have good ideas may push them to go somewhere where research is supported and encouraged. Unfortunately some policy makers don’t see the research role in medicine. They probably think it is a waste of time. Some may believe that we have enough evidence and there is no need to generate any more. Some believe that clinicians’ duty is to serve the political targets rather than advance medicine and improve the quality of patients’s care. This is the dangerous part and if we are to continue advancing in medicine we should resist such simplistic approach. 1. Susan Kerrison, Nick McNally, and Allyson M Pollock United Kingdom research governance strategy BMJ 2003; 327: 553-556 2. Nick McNally, Susan Kerrison, and Allyson M Pollock Reforming clinical research and development in England BMJ, Sep 2003; 327: 550 - 553. 3. Paul M Stewart Improving clinical research BMJ, Nov 2003; 327: 999 - 1000. 4. Iain Chalmers, Cath Rounding, and Kate Lock Descriptive survey of non- commercial randomised controlled trials in the United Kingdom, 1980-2002 BMJ, Nov 2003; 327: 1017 - 0. Competing interests: None declared