Scope of the Tool Kit
The MRC define Experimental Medicine as ‘Investigations undertaken in humans, relating where appropriate to model systems, to identify mechanisms of pathophysiology or disease, or to demonstrate proof-of-concept evidence of the validity and importance of new discoveries or treatments.’ On this site you will find practical help with the legislative and good practice requirements relating to experimental medicine studies in the UK. The Tool Kit is specifically designed to support experimental medicine studies that are:
- Academic led
- Small scale
- Involve humans, either healthy volunteers and/or patients
The information provided here is based on the AMS report 'Microbial challenge studies of human volunteers' (see linked file below), published in 2005, with significant input from experimental medicine investigators, microbial challenge investigators, and regulators. The Tool Kit leads users through a formal risk assessment of studies, and encourages the development of risk proportionate management and monitoring. Appropriate risk assessment and risk management is central to Good Clinical Practice (GCP).
Information on how to comply with the Medicines for Human Use (Clinical Trials) Regulations, Human Tissue Acts and the laws surrounding data protection and confidentiality is provided elsewhere (in the NIHR Clinical Trials Toolkit and the MRC Data and Tissues Tool Kit). The Experimental Medicine Tool Kit supports users in identifying relevant legal frameworks within the UK and directs them to further sources of information that provide practical help on how to comply with the law. The Experimental Medicine Tool Kit can, and should, be used in conjunction with these other sources of information where appropriate.
The Tool Kit does not offer explicit advice as to the issues involved in conducting international experimental medicine studies. However, guidance is available from the MRC website.
Much of the information is held in Route Maps, which provide an overall picture of the issues to consider, you can then drill down for more information by clicking on each station. As the Tool Kit is designed to support a wide variety of experimental medicine studies, not all stations will be applicable to all studies; however stations should be excluded on an informed basis.
The Route Maps emphasise the planning and approvals stages of setting up an experimental medicine study. It is important to have identified all relevant issues before securing funding to ensure that all the required expenses are planned. Funders, like the MRC, require that studies are ethical, meet regulatory requirements, are well-managed such that they can be delivered on time; and accept that additional funds may be needed to meet these objectives. At the same time, such funders would expect that host organisations have systems in place to support their research activity promoting quality and ensuring that the necessary standards are met.
The site has been developed for the UK research community in its widest sense, including researchers, research managers, research ethics committee members and interested members of the public. It was developed by the MRC, in close collaboration with UKCRC partners.