Policy

A new pathway for the regulation and governance of health research

Summary| Project Downloads

'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.

Government response

In response to the review, the Government has announced steps to streamline the regulation and governance of health research as part of the Plan for Growth, which was published alongside the budget in March 2010. Key actions announced include:

• The creation of a new Health Research Regulatory Agency to streamline regulation and improving the cost effectiveness of clinical trials.
• The introduction of new incentives for efficiency in research initiation and delivery.
• A commitment to increasing the proportionality of the EU Clinical Trials Directive and its implementation.

In May 2012 it was announced in the Queen’s speech that the Government would bring forward draft legislation to establish the Health Research Authority on a stable and independent footing.

As part of follow-up activity in this area, the Academy contributed to three responses to the European Commission's concept paper on changes to the Clinical Trials Directive.

Updates

RegReview update Feb 2011

RegReview update May 2011

RegReview update July 2011

Media comment

Jan 2011 - A new pathway for the regulation and governance of health research

Mar 2011 - Budget announcement

Jun 2011 - Academy welcomes research-focused revisions to the Health Bill

Dec 2011 - Academy welcomes the Prime Minister’s commitments to the life sciences

May 2012 - Academy welcomes the creation of the HRA in the Queen's speech

May 2012 - More action needed to transform regulation and governance of health research - report of a meeting assessing 1 year of progress

 

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• A new pathway for the regulation and governance of health research [1.31mb]
• A new pathway for the regulation and governance of health research - press release [72.01k]
• Responses to the report [53.7k]
• First call for evidence [137.61k]
• Second call for evidence [279.27k]

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