Microbial challenge studies

Working group report on microbial challenge studies of human volunteers

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.

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