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Quality assurance for clinical research: challenges in implementing research governance in UK hospitals

Linda S. Franck (Professor and Chair of Children's Nursing Research, at the Institute of Child Health and Great Ormond Street Hospital for Children NHS Trust, London, UK)
Emma Pendleton (Head of Research and Development, at the Institute of Child Health and Great Ormond Street Hospital for Children NHS Trust, London, UK)
Barbara Pittam (Director of Administration, at the Institute of Child Health and Great Ormond Street Hospital for Children NHS Trust, London, UK)
Michael Preece (Joint Chairman of the Acute Medical Services Division at the Institute of Child Health and Great Ormond Street Hospital for Children NHS Trust, London, UK)
Al Aynsley‐Green (Nuffield Professor of Child Health, at the Institute of Child Health and Great Ormond Street Hospital for Children NHS Trust, London, UK)

International Journal of Health Care Quality Assurance

ISSN: 0952-6862

Article publication date: 1 August 2004

Abstract

The oversight of clinical research in the UK is currently in a state of flux. Discusses the quality assurance problems that have arisen in the management of research and the protection of the rights of human participants. Contrasts clinical governance and regulatory approaches to research quality assurance and performs a critical analysis of the Department of Health (England) Research Governance Framework (RGF) to see where it falls within the continuum. Highlights the implications for UK hospitals engaged in clinical research through the presentation of a case study in implementing the RGF. Concludes by suggesting the priority areas that need to be addressed and invites further debate regarding the merits of a clinical governance or regulatory approach to research quality assurance.

Keywords

Citation

Franck, L.S., Pendleton, E., Pittam, B., Preece, M. and Aynsley‐Green, A. (2004), "Quality assurance for clinical research: challenges in implementing research governance in UK hospitals", International Journal of Health Care Quality Assurance, Vol. 17 No. 5, pp. 239-247. https://doi.org/10.1108/09526860410549344

Publisher

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Emerald Group Publishing Limited

Copyright © 2004, Emerald Group Publishing Limited