Abstract
BackgroundRecent developments aiming to standardise and streamline processes of gaining the necessary approvals to carry out research in the National Health Service (NHS) in the United Kingdom (UK), have resulted in lengthy and costly delays. The national UK governmental Department of Health’s Research Governance Framework (RGF) for Health and Social Care requires that appropriate checks be conducted before research involving human participants, their organs, tissues or data can commence in the NHS. As a result, medical research has been subjected to increased regulation and governance, with the requirement for approvals from numerous regulatory and monitoring bodies. In addition, the processes and outcomes of the attribution of costs in NHS research have caused additional difficulties for researchers. The purpose of this paper is to illustrate, through three trial case studies, the difficulties encountered during the set-up and recruitment phases of these trials, related to gaining the necessary ethical and governance approvals and applying for NHS costs to undertake and deliver the research.MethodsEmpirical evidence about delays and difficulties related to regulation and governance of medical research was gathered during the period 2009–2010 from three UK randomised controlled trials with sites in England, Wales and Scotland (1. SAFER 2- an emergency care based trial of a protocol for paramedics to refer patients directly to community based falls services; 2. COnStRUCT- a trial of two drugs for acute ulcerative colitis; and 3. Family Links - a trial of a public health intervention, a 10 week community based parenting programme). Findings and recommendations were reported in response to a call for evidence from The Academy of Medical Sciences regarding difficulties encountered in conducting medical research arising from R&D governance and regulation, to inform national policy.ResultsDifficulties and delays in navigating and gaining the appropriate approvals and NHS costs required to undertake the research were encountered in all three trials, at various points in the bureaucratic processes of ethical and research and information governance approvals. Conduct of each of the three trials was delayed by at least 12 months, with costs increasing by 30 – 40%.ConclusionsWhilst the three trials encountered a variety of challenges, there were common issues. The processes for gaining approvals were overly complex and differed between sites and UK countries; guidance about processes was unclear; and information regarding how to define and claim NHS costs for undertaking the research was inconsistent. The competitive advantage of a publicly funded, open access health system for undertaking health services research and clinical trials within the UK has been outweighed in recent years by stifling bureaucratic structures and processes for governance of research. The recommendations of the Academy of Medical Sciences are welcomed, and the effects of their implementation are awaited with interest.Trial Registration numbersSAFER 2: ISRCTN 60481756; COnStRUCT: ISRCTN22663589; Family Links: ISRCTN 13929732
Highlights
Recent developments aiming to standardise and streamline processes of gaining the necessary approvals to carry out research in the National Health Service (NHS) in the United Kingdom (UK), have resulted in lengthy and costly delays
McKinsey [1] and Cooksey [2] advocated and achieved substantial investment in the infrastructure for medical research within the United Kingdom (UK). They applauded the excellent opportunities for world-class medical research within the National Health Service (NHS), and recognised widespread failure to exploit these opportunities through cumbersome regulations and processes
Research Ethics Committee (REC) approvals We experienced problems gaining a positive ethical decision at the outset of the SAFER 2 trial because, in this cluster randomised controlled trial, we had proposed an opt-out consent process to access medical records in order to follow up patient outcomes
Summary
Recent developments aiming to standardise and streamline processes of gaining the necessary approvals to carry out research in the National Health Service (NHS) in the United Kingdom (UK), have resulted in lengthy and costly delays. McKinsey [1] and Cooksey [2] advocated and achieved substantial investment in the infrastructure for medical research within the United Kingdom (UK) They applauded the excellent opportunities for world-class medical research within the National Health Service (NHS), and recognised widespread failure to exploit these opportunities through cumbersome regulations and processes. Research within the UK health services has seen a shift in recent years from being a largely unregulated activity, carried out independently of external controls to becoming a formalised, regulated and institutionalised process [6] This has centred largely around the publication in 2005 of the Department of Health’s Research Governance Framework (RGF) for Health and Social Care that requires, in line with European Union and wider international standards, that appropriate checks be carried out before research involving human participants, their organs, tissues or data can commence [7]. Researchers within the UK have to seek approvals from Research Ethics Committees (RECs) and local Research and Development (R&D) committees prior to starting their research in the NHS
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