Policy

Microbial challenge studies

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In 2002 the Academy of Medical Sciences organized a meeting in Oxford to provide a forum for critical discussion of the risks, benefits and conduct of microbial challenge studies of human volunteers, with particular emphasis on the role of such studies to facilitate the research and development of vaccines.

Subsequently, the Academy Council convened a working group to consider the issues further and prepare a position paper on the proper conduct of such studies. A draft Report was circulated to key stakeholders for consultation in the Spring of 2004 with a wider general call for evidence being issued that summer. The Academy’s review procedure was initiated in August 2004 with final copy of the Report being submitted for publication in July 2005.

The Report recommends that a National Expert Advisory Body be set up to identify mechanisms to ensure the safety and welfare of human subjects involved in the microbial challenge studies of humans.

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Professor Richard Moxon FMedSci (Chair)
Action Research Professor of Paediatrics University of Oxford

Professor Sir Leszek Borysiewicz FMedSci
Principal, Faculty of Medicine
Imperial College London

Professor Janet Darbyshire FMedSci
Director
MRC Clinical Trials Unit

Professor Adrian Hill FMedSci
Wellcome Trust Principal Research Fellow, University of Oxford

Professor Tony Hope
Professor of Medical Ethics
University of Oxford

Professor Stephen Inglis
Director
National Institute for Biological Standards and Control

Dr David Lewis
Reader in Infectious Diseases & Medicine
St George’s Hospital Medical School

Professor Elizabeth Miller OBE
Head of Communicable Disease Surveillance Centre’s Immunisation Department
Health Protection Agency

Professor Karl Nicholson
Professor of Infectious Disease, Leicester Royal Infirmary

Professor Sir John Skehel FRS FMedSci
Director and Head of Infectious Immunity Group
MRC National Institute for Medical Research

Professor Hilton Whittle FMedSci
Emeritus Scientist, MRC Laboratories, Gambia

Secretariat

Dr Robin Fears
Senior Policy Advisor
Academy of Medical Sciences

Laurie Smith
Policy Officer
Academy of Medical Sciences

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• To identify the facets of microbial challenge studies and their implications, that differentiate them from other clinical research using human volunteers.
• To consider the scientific, ethical and legal issues (theory and practice) of conducting microbial challenge studies in human volunteers.
• To take account of relevant activities by other bodies and to identify the particular value to be added by the Academy of Medical Sciences.
• To take into account and consider the issues for such studies in the context of existing national, European and international guidelines, with the aim of differentiating challenge studies from other clinical Research and Development (R&D).
• To consider how to promote and facilitate public accountability and transparency.
• To compile a guidance document to promote and facilitate public accountability and transparency.
• To compile a guidance document to promote and facilitate high standards of conduct of microbial challenge studies of human volunteers.

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Sir Colin Dollery FMedSci (Chair)
Senior Consultant
GlaxoSmithKline

Professor Jonathan Cohen FMedSci
Dean
Brighton and Sussex Medical School

Professor George Griffin FMedSci
Head of Department, Infectious Disease Division
St. George’s Hospital Medical School

Professor Sir Peter Lachmann FRS FMedSci
Emeritus Sheila Joan Smith Professor of Immunology
University of Cambridge

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• Microbial Challenge Studies Report [226.25k]
• Microbial Challenge Studies Media Release [68.39k]

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