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

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.