Q J Med 2004; 97: 113-114
QJM vol. 97 no. 3 (c) Association of Physicians 2004; all rights reserved.
Editorial |
Research governance: a barrier to ethical research?
‘Research is essential to the successful promotion of health and well-being’ (Research Governance Framework for Health and Social Care1).Following the introduction of the NHS Research Governance Framework, all research projects must now gain permission from relevant NHS Trusts before any research can proceed. This framework aims to ensure high ethical, scientific and financial standards in research on NHS patients, staff and related services, and outlines the roles of those involved in the research process, from the funding bodies (who as sponsors, now take on increased responsibility for ensuring study ethics) through to researchers themselves. It applies to a plethora of research, ranging from individual student projects to large commercially funded trials, with the overall aim of minimizing the risk associated with research while ensuring high-quality output.
The impetus for research governance was born partly from concerns about the increased amount of commercial research within the NHS, and the requirement of systems to facilitate and monitor this involvement to protect both patients and NHS interests.2 Well-publicized cases of research misconduct have further highlighted the need for a rigorous monitoring process. However, while we can all support a process that aims to improve ethical and scientific standards in health research at a national level, there is enormous scope for improvement in its implementation.
Although some regional Trusts have liaised and produced joint research governance procedures, generally research governance has been implemented in a number of different ways, and consequently, Trusts’ application forms can vary dramatically. Some consist of simple headings pertaining to details about the research project, but most are more structured forms each requiring different amounts and type of information. The heterogeneity of the forms highlights the fragmented way in which the framework has been implemented, and the resulting vast variations in application requirements from Trust to Trust. Applying for research governance in multi-centred studies has a huge impact on researchers time at the beginning of a research project, and can delay the start of work.
This heterogeneous application process is exacerbated by a lack of clear information available from a central body. Where as the Central Office for Research Ethics Committees offers guidance on ethical submissions, including relevant contact details for local research ethics committees, there is no equivalent for research governance, where any queries must currently be addressed by suitable Trust staff. Such staff can often be difficult to identify, and may have had limited guidance themselves. This means that it can be extremely time-consuming to get clear advice, and even then the advice is only relevant to a specific application, and can not be assumed to relate to all applications
A medium-sized clinical trial that we are undertaking has eleven centres covering both primary and acute care, and thus requires approval from several Trusts. Because applications forms and procedures are not uniform, this process has substantially increased researchers workload (and Trusts' workload), and will delay the start of the study in some centres. Following multi-centre research ethics committee approval, local research ethics committee and research governance applications were made at the same time. While all the local research ethics committee applications have been approved, to date only four research governance applications have been considered. This delay may have direct consequences for patients’ health care: if the trial intervention is ultimately shown to be effective, many patients will have been denied the best treatment. Or conversely, as this trial is evaluating a treatment already being used in some parts of the NHS, without adequate evidence to supports its use, the exposure of patients to a potentially ineffective or harmful treatment might continue for longer. In a second multi-centred trial, the mean time to receiving research governance approval from 22 Trusts is currently 55 days (median 54 days; range 3–150 days), but not all responses have yet been received.
It seems that the process of research governance will be useful in monitoring and guiding research that takes place in the UK health system in a structured way. The process is also valuable in ensuring that those involved in research are suitably qualified and aware of their responsibilities. This is especially true of studies (e.g. commercial studies, student studies) that do not receive external funding and therefore do not always undergo peer-review, although they will often require ethics committee approval. However, although the requirements of the Research Governance Framework are clear, a more uniform and user-friendly application process could have been used. Just as multi-centre regional ethics committees were introduced to streamline ethics applications for multi-centred studies, the research governance application process needs to be made more practical. Since the framework requirements are the same for all Trusts, the production of an agreed application procedure at a national level would be the most sensible approach for all involved, with a standard form for all health-care Trusts. This would save the time of both researchers and Trust staff, and ensure that the framework was being correctly applied in all Trusts.
The current complexity of research governance procedures will make research much more expensive and may even prohibit it from being carried out. This is especially true where studies cover a large number of Trusts, and where the procedures may be so time-consuming that the research becomes unfeasible. Since multi-centred studies allow the recruitment of enough participants to gain meaningful results, making these more difficult could prevent important research from taking place, or reduce the quality of research. Standardization and streamlining of the research governance procedure is urgently required, otherwise patients health care will be affected.
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York Trials Unit Department of Health Sciences University of York York e-mail: jd34{at}york.ac.uk
References
1. Department of Health. Research governance framework for health and social care (draft). London DoH, 2003 [www.doh.gov.uk/research/documents/rd3/rgf2ndeditionv22300403.doc] Accessed 24 October 2003.
2. Kerrison S, McNally N, Pollock AM. United Kingdom research governance strategy. Br Med J 2003; 273:553–6.
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