The Academy’s review, ‘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.
In gathering opinions and evidence across academia, industry, the NHS, charities and public bodies, there was a broad consensus on the key problems and a clear desire to see the position improve
A summary of the report outlines 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.
This is an important report to BioKinetic Europe as we operate within the UK Regulatory framework for the conduct of our Phase I/II clinical trials. We advocate the favourable UK regulatory environment to our clients abroad and support the UK as a centre of excellence for the Life Sciences industry. We continue to lobby stakeholders into the importance of streamlining the UK process and change traditional mindsets. We need to appreciate the commercial objectives of the drug development process are important to grow expertise and employment within the UK and the outcomes are beneficial to the global health industry. These objectives can be met through time and resource efficiencies that do not undermine the integrity of the clinical trial nor the safety of the research subject who is of paramount importance in any research project.
Outsourcing in Clinical Trials for Nordic Companies, 11-12 September, Copenhagen
BioPartnering Future Europe, 13-16 October, Stockholm