The origin of the Tool Kit
Over the last 10 years the research environment has changed considerably with the advent of new legislative and good practice requirements. It is often difficult to place experimental medicine studies appropriately within this developing legislative and best practice environment. This is partly due to such research involving a variety of Regulatory authorities and partly due to the nature of the research which often from the routine studies reviewed by these Regulators. Indeed defining what constitutes best practice in the planning, initiation, conduct and closure of experimental medicine studies is often difficult. As a consequence, experimental medicine investigators often experience significant delays in study start up, and therefore struggle to complete studies within planned timeframes.
Best practice in the conduct of a specific type of experimental medicine study, microbial challenge studies of human volunteers, was published by the Academy of Medical Sciences in 2005. This report addressed the risks, benefits and conduct of microbial challenge studies specifically. The MRC recognised that much of the guidance contained within it was more generally applicable to experimental medicine studies.
In 2007 the MRC, working in partnership with the National Institute for Health Research in England, under the oversight of the Translational Medicine Board of OSCHR, put in place a new translational research strategy, which includes experimental medicine, methodology, training, and stem cells. The MRC is the lead organisation for experimental medicine, discovery and exploratory development towards large scale evaluation and implementation.
In response to further requests from the experimental medicine community, the MRC Regulatory Support Centre has developed this Tool Kit, containing practical guidance, modeled on the Clinical Trials Tool Kit (developed by MRC in 2004 to disseminate the work of the MRC/Department of Health Joint Project on EU Clinical Trials Directive) and the MRC Data and Tissues Tool Kit (launched in 2007). The Experimental Medicine Tool Kit should be used in combination with these other Tool Kits; users will be directed towards them when appropriate.
Development of the Tool Kit was based on the AMS report ‘Microbial Challenge Studies of Human Volunteers’ and has been informed by consultation with experimental medicine researchers and regulators. The aims of the Tool Kit are to:
- Provide the EM community with a means to share best practice;
- Provide guidance to researchers, research managers and Research Ethics Committees; and
- Support risk proportionate management and monitoring of studies