Good practice in research

Annex B: Key elements of the legislation on clinical trials of investigational medicinal products

This annex highlights some of the specific legal requirements for conducting clinical trials of investigational medicinal products in the UK. It complements the high-level principles set out in Good practice in research and Consent to research. It is not intended to be a comprehensive statement of the law or a list of all legislative requirements, nor is it a substitute for independent, up-to-date legal advice. 

Consent to research gives further advice about involving adults who lack capacity in clinical trials of investigational medicinal products (see paragraphs 23-35). 

The Medicines for Human Use (Clinical Trials) Regulations 2004 set out good clinical practice in the conduct of clinical trials of investigational medicinal products for human use (see schedule 1 of the regulations for the conditions and principles which apply to all trials). They apply in all four UK countries. You must be familiar with and follow the regulations at all times when conducting clinical trials of investigational medicinal products in the UK.

You should also be familiar with the guidance about conducting clinical trials of investigational medicinal products published by other organisations, such as the Medical Research Council and the Medicines and Healthcare products Regulatory Agency (MHRA). 

Before starting a trial

The regulations prohibit anyone from starting or conducting a clinical trial of investigational medicinal products, and from beginning the process of recruiting participants to such a trial, until there is approval from a research ethics committee and authorisation from the MHRA. The research ethics committee must be one recognised by the United Kingdom Ethics Committee Authority.

It is a requirement for clinical trials of investigational medicinal products to be registered on the European Clinical Trials database (Eudract). 

Participant safety

If urgent safety measures are introduced to protect participants against harm to their health or safety during a clinical trial of investigational medicinal products, the regulations require that the sponsor must immediately notify, in writing, the MHRA and the research ethics committee of the measures taken and why they were needed. 

There are specific requirements to record, notify, assess, report, analyse and manage adverse events in trials. In particular, it is a requirement for the research investigator to immediately report to the sponsor any serious adverse event that occurs to a participant, unless the protocol sets out that the event does not need to be reported immediately. The sponsor is required to make sure that all relevant information about a suspected unexpected serious adverse reaction that occurs during a clinical trial of investigational medicinal products is reported within a specified period to the MHRA and the relevant research ethics committee.