A new pathway for the regulation and governance of health research

A review of the regulation and governance of UK health research involving human participants, their tissue or their data.

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'A new pathway for the regulation and governance of health research' was published in January 2011. The report was prepared by a working group, chaired by Professor Sir Michael Rawlins FMedSci, convened in response to an invitation from Government to review the regulation and governance of UK health research involving human participants, their tissue or their data.The report proposes four key principles that should underpin the regulation and governance framework around health research in the UK, and makes recommendations to:

  • Create a new Health Research Agency (HRA) to rationalise the regulation and governance of all health research.
  • Include within the HRA a new National Research Governance Service to facilitate timely approval of research studies by NHS Trusts.
  • Improve the UK environment for clinical trials.
  • Provide access to patient data that protects individual interests and allows approved research to proceed effectively.
  • Embed a culture that values research within the NHS.

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