Policy

Review of the regulation and governance of medical research

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Following the publication of the Department of Health's 'Report on the arm's-length bodies review', the Academy has launched a second call for evidence.

In March 2010, then Health Secretary Andy Burnham announced a Government commission for the Academy of Medical Sciences to conduct an independent review of the regulation and governance of UK medical research. The Academy had highlighted the need for this review in ‘Reaping the rewards: a vision for UK medical science’, published on Monday 11 January 2010.

Following the change in Government support for the study was given by Rt Hon David Willetts MP, Minister for Universities and Science at a press briefing in May 2010.

The Department of Health has since highlighted the study in its Health White Paper - Equity and excellence: Liberating the NHS and Liberating the NHS: Report of the arm's-length bodies review.

The Academy review will concentrate on research involving human participants, their tissues or data and will not deal in detail with the regulation and governance surrounding the use of animals in research. In addition to the focus on all stages of clinical trials, the review will also consider experimental medicine and epidemiological studies.

The Academy's review will be informed by written and oral evidence. Following the publication of the Department of Health's proposals for ALBs, the Academy has issued a second call for evidence to provide all interested parties with an opportunity to comment on the proposals. Information on the second call for evidence is provided below.

For further information on the review please contact Dr Robert Frost (robert.frost@acmedsci.ac.uk or tel. +44(0)2079695284).

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Professor Sir Michael Rawlins FMedSci, Emeritus Professor, University of Newcastle

Professor Deborah Ashby, Professor of Medical Statistics and Clinical Trials, Imperial

Dr Mary Baker, President, European Federation of Neurological Associations

Professor Rory Collins FMedSci, Professor of Medicine and Epidemiology, University of Oxford

Professor Janet Darbyshire FMedSci, Joint Director NIHR CRN.

Professor Carol Dezateux FMedSci, Professor of Paediatric Epidemiology, ICH

Professor Stephen Evans, Professor of Pharmacoepidemiology, LSHTM

Mr Mike Farrar, Chief Executive of NHS North West

Professor Gary Ford, Jacobson Chair of Clinical Pharmacology, University of Newcastle

Dr David Gillen, Vice President, Primary Care BU Medical Teams, Europe Canada Australia and NZ Pfizer

Professor Peter Johnson, CRUK Chair of Medical Oncology, University of Southampton

Professor Shitij Kapur FMedSci, Vice Dean, Institute of Psychiatry

Professor Jonathan Knowles, Chief Scientific Officer, Caris Life Sciences

Professor Mike Parker, Professor of Bioethics, University of Oxford

Professor Genevra Richardson, FBA, Professor of Law, KCL

Mr Paddy Storrie, Lay member

Professor Patrick Vallance FMedSci, Senior Vice-President, GSK

Professor David Webb FMedSci, Christison Professor of Therapeutics and Clinical Pharmacology, University of Edinburgh

Professor Paul Wallace, Vice Dean for Primary Care, Royal Free and University College Medical School

Working group members participate in a personal capacity.

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We will:

• Review the regulatory and governance environment for medical research in the UK, with a particular focus on clinical trials.
• Identify key problems and their causes, including unnecessary process steps, delays, barriers, costs, complexity, reporting requirements and data collection.
• Make recommendations with respect to the regulatory and governance framework that will: increase the speed of decision-making; reduce complexity; and eliminate unnecessary bureaucracy and cost.

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• R&G review 2nd call for evidence [279.27k]
• Background press briefing [120.91k]

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