The Academy's report 'A new pathway for the regulation and governance of health research' launched in January 20111. The report set out a new regulatory and governance framework to eliminate unnecessary bureaucracy and increase the speed at which healthcare interventions become available to patients. We propose four key principles and make 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.
The report was produced by an expert working group chaired by Professor Sir Michael Rawlins FMedSci.
The recommendations were welcomed by Government and the scientific community, with Rt Hon Andrew Lansley MP, Secretary of State for Health, stating: "The report makes the case for simplification under a health research agency that will streamline and co-ordinate regulatory and governance processes. The Government welcomes the report and will consider carefully how to implement its recommendations."
The report received extensive media coverage with broadcast items on the Today programme, 5 Live and Material World. Coverage by national broadsheets included The Times, Guardian and Financial Times (including a front page leader). A commentary and editorial appeared in The Lancet and the BMJ ran an interview with Sir Michael. The report was also covered online by journals including Nature,Science and New Scientist.
We look forward to working with others to encourage implementation of the recommendations. Completed within 8 months and involving over 300 written submissions from across the scientific community, the project further demonstrates the Academy's success in delivering high-profile commissions and