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New UK research agency recommended

The UK's Academy of Medical Sciences has recommended the creation of a Health Research Agency as part of changes to research regulation

A report from the UK's Academy of Medical Sciences has recommended the creation of a Health Research Agency as part of changes to the way medical research is regulated and governed.

'A new pathway for the regulation and governance of health research', lead by National Institute for Health and Clinical Excellence (NICE) chairman Professor Sir Michael Rawlins, suggests 'urgent changes' are necessary for health research in the UK, with potential advancements affected by the bureaucracy of the current system. Such issues could lead to research being driven abroad according to the paper.

The report shows that a fall in the UK's global share of patients participating in clinical trials was seen as a particularly negative development, with the time and cost involved in the research approval process also criticised. Recent figures from Cancer Research UK were cited, with findings claiming it takes an average of 621 days to recruit the first patient in a clinical trial after funding has been agreed.

An alternative regulatory and governance pathway is suggested in the report, with a focus on decreasing the time before medical innovations become available to patients.

"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," said Prof Rawlins. "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 introduction of a new independent Health Research Agency is part of the report's planned proposals, with an aim to bring together existing approval processes. This agency would work with established bodies in the four UK nations to develop a wider integrated system for research approval.

The Department of Health is also recommended to establish a National Research Governance Service (NRGS) for England as part of the Health Research Agency. This body would take responsibility for all research governance checks that are currently conducted by each separate NHS Trust participating in the study, ensuring common standards and allowing Trusts to focus on other issues, such as monitoring study performance.

Health Secretary, Andrew Lansley, commented on the recommendations: "The Academy's 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 Association of the British Pharmaceutical Industry (ABPI), also welcomed the report addressing key issues in the streamlining of clinical trials and addressing 'cultural issues' within parts of the NHS.

Allison Jeynes-Ellis, medical and innovation director for the industry body said: "The timely endorsement and implementation of this report by all stakeholders is vital if the UK is to be seen as a serious player in clinical research in an increasingly competitive arena."

The Academy of Medical Sciences has the paper available to download, as well as further responses.

11th January 2011

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