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New Pathway for the Regulation and Governance of Health Research 11/01/2011

Posted by Shirley Hallam in Approvals, Regulatory.
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The Academy for Medical Sciences, chaired by Prof Michael Rawlins, has unveiled its recommendations for a streamlining the systems of approvals and governance for health research, including clinical trials. The main suggestion is the creation of a new Health Research Agency to rationalise the approvals required to conduct research.

The introduction of the report criticises the current barriers to research, specifically:

  • Delays and duplication in obtaining research permissions from NHS Trusts.
  • Complexity and inconsistency across the regulation pathway.
  • A lack of proportionality in the regulation of clinical trials.
  • Inappropriate constraints on access to patient data.
  • A healthcare culture that fails to fully support the value and benefits of health research.

The new Health Research Agency should have two major functions:

  • A National Research Governance Service that would eliminate inefficiency and support NHS Trusts and researchers by undertaking all NHS research governance checks just once.
  • A single system for ethical approvals. This system would encompass the responsibilities for both general ethical approval (the National Research Ethics Service), as well as specialist approvals and licenses

The report also calls for:

  • A reduction in the scope of the European Clinical Trials Directive, with risk based monitoring and a simplification of the requirements for drug safety reporting.
  • Greater access to patient data for research purposes.
  • The embedding of health research to be embedded into NHS leadership and governance processes, ensuring that within each Trust there is an executive director with specific responsibilities to promote health research.

Full Report: http://www.acmedsci.ac.uk/index.php?pid=47&prid=88

Comments»

1. Shirley Hallam - 11/01/2011

The heart of this report is clearly in the right place. But it is a little ironic that its proposal to cut through the bureaucracy is to set up yet another agency.


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