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Study of medical research regulation announced

BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c1853 (Published 07 April 2010) Cite this as: BMJ 2010;340:c1853

The Academy of Medical Sciences is to conduct a rapid independent review of the regulation and governance of medical research, secretary of state for health Andy Burnham has announced.

The academy, which had called for the review, has welcomed the move. “Health care in the United Kingdom is being jeopardised by a stifling regulatory and governance framework for medical research,” said its president John Bell. “Ultimately this is harming patients by denying them access to new medicines.”

A cumbersome regulatory environment is driving this work abroad, says the academy, which wants to see regulation that protects patients but also facilitates globally competitive research.

“It is imperative that we gain a full understanding of where the problems lie in order to identify effective solutions,” said Professor Bell. “Our robust review will aim to identify the research and governance framework that will allow the UK to realise the health and economic benefits of medical research without the need for major financial investment or compromising patient safety.”

Michael Rawlins, fellow of the Academy of Medical Sciences and chairman of the National Institute for Health and Clinical Excellence (NICE), has been asked to undertake the study.

“There is widespread and increasing concern that the process of medical research is being seriously threatened by a legal and regulatory framework that has become unnecessarily complex and burdensome,” he said. “Streamlining and improving current regulation represents a cost effective approach to creating a more fertile and productive environment for academic and commercial research.

“If we can identify the key regulatory problems and eliminate them, we can have a huge impact on how quickly and efficiently research delivers new and improved patient treatments.”