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Bureaucracy is killing UK health research

Scientists call for new system to improve process in the UK

Jo Carlowe

Tuesday, 11 January 2011

Medical advances in the UK are being stifled by bureaucracy according to a new report.

The Academy of Medical Sciences today said urgent changes are needed because the current system causes unnecessary delays and does not benefit patients. The Academy set out a new regulatory and governance pathway which it says will increase the speed at which healthcare innovations become available to patients, whilst eliminating unnecessary bureaucracy.

Professor Sir Michael Rawlins, Chair of the Academy of Medical Sciences working group that prepared the report, said: “A fertile research environment is vital for the health and wealth of the UK. The current system of regulation is making it increasingly difficult to initiate health research in the UK and is preventing patients from participating in studies. This is ultimately denying patients early access to new drugs and hindering improvements to public health for the wider society.

“We have 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. Further, we received no evidence that this increased regulatory and governance burden has led to enhanced safeguards for participants in research. The changes we propose will streamline and improve the process to create a better environment for research, while protecting the interests of patients and the public.”

The report recommends the establishment of a new independent Health Research Agency (HRA) to bring together existing approval processes. The Agency would work with regulatory and governance bodies in the devolved nations to develop an integrated approvals system for the UK.

The Department of Health should establish a new National Research Governance Service (NRGS) for England, to be housed within the HRA, states the report. The NRGS would facilitate rapid approval of research studies conducted in single or multiple NHS sites by assuming responsibility for all study-wide checks that are currently duplicated by each participating NHS Trust.

Sir Michael added, “The delay in obtaining NHS permissions is a major failure of the current pathway and is the biggest single barrier to all types of health research studies. There is a highly inefficient emphasis on process rather than outcomes, which has led to delays of over a year to gain permissions for simple studies.”

The report noted that the UK’s share of world citations in both the clinical and health sciences is currently second only to the US. However, recent data has shown a decline in its global share of clinical research activity, and the Agency says the regulatory and governance framework is one of the main contributing factors to this decline.

Professor Sir John Bell, President of the Academy of Medical Sciences, said, “A cumbersome regulatory and governance environment is driving this work abroad. Health research must be subject to robust regulation that both protects patients and facilitates globally-competitive research. This report sets out a realistic and achievable framework by which this can be achieved.”

Health Secretary Andrew Lansley has said he welcomes the report and that the government will ‘consider carefully how to implement its recommendations.”

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