A new report to the UK government by the Academy of Medical Sciences (AMS) has set out proposals for a new overarching regulatory body for health research.
A new pathway for the regulation and governance of health research is the result of an inquiry led by Sir Michael Rawlins, who said they had found “unequivocal evidence that health research in this country is being jeopardised by a regulatory and governance framework that has become unnecessarily complex and burdensome” coupled with a lack of evidence for increased safety for research subjects as a result of this regulation.
The report recommends that a new independent Health Research Agency (HRA) be established with two key, integrated national functions: research governance and ethics approval, including specialized forms of research ethics regulation. The new HRA would incorporate the functions of multiple existing regulatory groups previously listed as facing closure (see previous news), including the Human Fertilisation and Embryology Authority (HFEA), Human Tissue Authority (HTA) and Gene Therapy Advisory Committee. The aim would be to substantially reduce the regulatory burden and delay imposed by current arrangements for medical research – for example, the necessity to obtain approval from multiple individual health trusts for large multi-centre studies, or from multiple – reducing average approval time from years to months.
Other key measures outlined in the report include an improved UK environment for clinical trials, calling for the proposed HRA to work with the Medicines and Healthcare Products Regulatory Agency (MHRA) in this area, and for efforts to reform the 2004 EU Clinical Trials Directive. The AMS group also calls for a new approach to accessing patient data for research purposes that balances individual protection and public benefit, and for measures to create and embed a new culture that values health research within the National Health Service (NHS).
Health Secretary Andrew Lansley MP said that the Government welcomed the report and would consider carefully how to implement the recommendations, whilst Minister of State for Universities and Science David Willetts commented: “As the government works to rebalance and grow the economy, it is vital that the UK continues to be an attractive environment to undertake clinical trials”.