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).
Seeking and withdrawing consent
It is a legal requirement to get written consent from a person to participate in a clinical trial of investigational medicinal products. The person with parental responsibility or a legal representative must give written consent for a child or young person, or for an adult who lacks capacity, to participate in a trial.
The regulations require that a person, or if relevant the person with parental responsibility or a legal representative, must have an interview with a member of the research team. The interviewer is required to give them the information they need to understand the aims, risks and burdens of the trial, and the conditions under which it will be conducted. The person must be informed of their right to withdraw themselves, or the person they represent or have parental responsibility for, from the trial at any time. It is a requirement that the person, or if relevant the person with parental responsibility or a legal representative, must be given a contact point where they can get further information about the trial.
The regulations prohibit offering any incentive, except compensation for injury or loss, to:
- a child or young person under 16
- the person with parental responsibility for them
- a legal representative for a child or young person under 16 or for an adult who lacks capacity.
In emergency situations, the regulations permit treatment to be given as part of a trial to a child or young person or to an adult who lacks capacity before getting consent only when:
- the trial needs to be undertaken urgently
- it is not reasonably practical to get consent, and
- an appropriate research ethics committee has given approval for such recruitment.
In these circumstances, it is a legal requirement to get consent from the person with parental responsibility or the legal representative (or the adult if they recover capacity) as soon as possible. If consent is withheld, the person must be withdrawn from the trial.
People participating in a trial can withdraw from the trial at any time. The person with parental responsibility or a legal representative can withdraw a child or young person or adult who lacks capacity from the trial at any time.
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.
