Researchers and service evaluation: the twilight zone

Abstract

BackgroundIn the UK, over recent years, there have been wholesale changes to the system of gaining ethical and research governance approvals. These have taken place under the auspices of bureaucracy busting, one of the goals of Best Research for Best Health (DH 2006). The decision to seek ethical committee approval is based on the principle that the investigation is defined as research.Research interventions that are undertaken with patients (such as Randomised Controlled Trials) undisputedly require ethical approval. Small scale desk based research does not. But in between are a range of projects that fall into a 'grey area' often referred to as service evaluation, service improvement or practice development. Projects that are classified evaluation, for example, may not require National Health Service National Research Ethics Service (NHS NRES) approval, but are managed through other systems within their host organisations. We argue that in some cases, the nomenclature of design can bypass NRES approval entirely, or can enforce it unnecessarily. This workshop will debate whether either stance in fact matters.One argument is that the processes, inherent in ethical and governance review, offers crucial and critical external scrutiny to a project. This also ensures lay review of the project and ensures that the organisation is fully aware of the implications of the project taking place in terms of data protection, employment and finance. It also allows the investigators to state the generalisability of the research across the desired context. These are surely positives for any project. So why should service evaluation be excluded from such robust processes? Alternatively, is that level of scrutiny necessary for investigations that present little ethical concern and lack scientific reliability and validity albeit while potentially delivering real value for organisations.Focus of WorkshopTo explore through facilitated examples the different paths projects are handled within the NHS, attendees will be encouraged to draw on their own experiences of submitting projects to add to the debate.Specific attention will be drawn to:1.\tHow and who arbitrates the decision making process to determine if a project is or isn’t defined as research, this will reference such excellent work as the ‘simple rules toolkit’ (STH 200X) and guidance created by NRES (2008)2.\tHow projects proceed once this decision has been made, and the differences between processes3.\tCommon factors of all projects around ethical principles and legal requirements4.\tCurrent and future challenges of the processes as described, specifically looking to innovative approaches to address the complex issues describedWe propose, in this workshop, to debate the issues surrounding the significance of ethical approval as defining what is the status of a project, the impact of that decision on dissemination and impact, and game playing surrounding the twilight zone of service evaluation.Julie’s CV(1000 words max)References•\tDepartment of Health 2006 Best Research for Best Health: A new national health research strategy, London: HMSO•\tSimple Rules Toolkit (ref to follow)•\tDefining Research, 2008, National research Ethics Service, National Patient Safety Agency http://www.nres.npsa.nhs.uk/EasySiteWeb/GatewayLink.aspx?alId=355, Accessed 02 Nov 09 23:30Authorso\tTaylor, J, School of Nursing and Midwifery, University of Dundee (Chair)o\tTopping, A, Centre for Health and Social Care Research, University of Huddersfield.o\tWolstenholme, D, Professional Services, Sheffield Teaching Hospitals NHS Foundation Trust