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Quality assurance for clinical research: challenges in implementing research governance in UK hospitals.
Int J Health Care Qual Assur Inc Leadersh Health Serv
November 2004
Institute of Child Health and Great Ormond Street Hospital for Children NHS Trust, London, UK.
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.
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