Working group report on microbial challenge studies of human volunteers
Microbial challenge studies
This project page contains information on the Academy report on microbial challenge studies, published in 2005. In 2018, the Academy conducted further work in this area - please view our page on Controlled Human Infection Model studies.
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 Report was published in 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.
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
- 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.
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
Sir Peter Lachmann, FRS, FMedSci
Emeritus Sheila Joan Smith Professor of Immunology, University of Cambridge
With support from the Academy’s Executive Director (Mrs Mary Manning), Senior Policy Advisor (Dr Robin Fears), Policy Officer (Mr Laurie Smith) and in consultation with the Officers of the Academy.