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Chapter 27 - Research governance

Published online by Cambridge University Press:  05 March 2012

Rory Shaw
Affiliation:
North West London NHS Trust
Vino Ramachandra
Affiliation:
Northwick Park Hospital
Nuala Lucas
Affiliation:
Northwick Park Hospital
Neville Robinson
Affiliation:
Northwick Park Hospital
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Summary

Research is the key mechanism for the development and advancement of innovative medicines, clinical practice, exploratory treatments, novel therapies and healthcare delivery. The process of research is not isolated, but is governed by a range of legislations, policies, frameworks and directives, which are described in the Research Governance Framework (RGF, 2005). The RGF facilitates the national and legal standards for the conduct of research within the NHS, harmonizes the applicable regulations and ensures that the standards derived from this are implemented and maintained.

Research governance is needed to:

  • Protect the wellbeing, health and safety of research participants

  • Fortify accurate reporting, quality assurance and control

  • Ensure the generation of reliable and valid data

  • Ensure that research activities are ethical, legal and of good scientific quality

  • Ensure that the appropriate liabilities and accountabilities are identified and put in place

  • Promote pharmacovigilance to enhance reporting, reduce adverse events and protocol misconduct

  • Encourage good clinical practice

  • Ensure that research is monitored and audited, which supports both good clinical practice and the wellbeing of the patients.

Type
Chapter
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Publisher: Cambridge University Press
Print publication year: 2011

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References

CP 1997 http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4068403
Declaration of Helsinki 2008 http://www.wma.net/en/30publications/10policies/b3/17c.pdf
DPA 1998 http://www.opsi.gov.uk/acts/acts1998/ukpga_19980029_en_1
HTA 2004 http://www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_1
RGF 2005 http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4108962
SI No. 1031 (Statutory Instrument)http://www.opsi.gov.uk/si/si2004/20041031.htm
SI No. 1928 (Statutory Instrument)http://www.opsi.gov.uk/si/si2006/20061928.htm

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