Last updated: 04 October 2011
People running clinical trials have legal obligations that are set out in The Medicines for Human Use (Clinical Trials) Regulations 2004. Conditions apply, including:
- Anyone taking part in a trial must have a full understanding of the objectives of the research and any risks and potential inconveniences they may experience when taking part. This information will be given to them at a meeting with a member of the research team.
- A contact point must be provided so that patients can obtain more information about the trial.
Before a clinical trial of a new medicine (a drug trial) can begin, all of the following need to take place:
- The science the research is based on must be reviewed by experts.
- The researchers must secure funding.
- An organisation, such as a hospital or research institute, must agree to provide a home base for the trial.
- The Medicines and Healthcare products Regulatory Agency (MHRA) needs to review and approve the trial and issue a clinical trial authorisation (CTA).
- A recognised ethics committee must review the trial and approve it to proceed.
The MHRA inspects sites where trials take place to make sure they are conducted in line with good clinical practice (an international quality standard).
All trials are regulated whether or not they take place within the NHS. The Association of the British Pharmaceutical Industry (ABPI) has issued revised guidelines on phase one trials. Other guidelines on clinical trials can be found on the ABPI website.
Trials of other treatments
The Research governance framework for health and social care(external link) describes how researchers and others are expected to work within a framework of ethical and scientific standards. This applies to all health and social research. It includes:
- promoting good practice,
- reducing adverse incidents and ensuring lessons are learned, and
- preventing poor performance and misconduct.
Continue to next section: Ethics committees