Every clinical trial is covered by regulation that protects the health, safety and dignity of those taking part.
Research ethics committees
All medical research involving people in the UK, whether it is done in the NHS or the private sector, has to be approved by an independent research ethics committee. The committee protects the rights and interests of the people who will be in the trial.
The committees are often based at local hospitals and are formed of local people, such as health professionals, patients, lawyers and members of the public. They have to include members who are not health professionals.
Submitting a protocol
Before they start a trial, researchers have to submit a protocol (a detailed plan of their proposed research) to a recognised research ethics committee. They may also need approval from other regulators.
All clinical trials of medicines need to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA), as do studies on medical devices.
An online system called The Integrated Research Application System allows researchers to use a single set of information to apply to the research ethics committee and to other regulators.
Researchers have to prepare an information leaflet about their trial for patients. The research ethics committee checks that this is clear and accurate.
All those who take part in a trial are given the leaflet, with an opportunity to take it away and discuss it with friends and relatives.
The leaflet has to be in plain language, avoiding technical medical words. It has to make clear:
- the research questions that the trial is trying to answer,
- who can take part in the trial and who cannot,
- how those taking part in the trial will be treated and what they will need to do,
- what treatment or other intervention is being used,
- what type of research it is,
- what the possible risks are to participants,
- what the possible benefits are to participants,
- who is carrying out the trial and who is funding it, and
- who participants should talk to if they have further questions.
Until a research ethics committee approves a clinical trial, researchers cannot ask any participants to join it.
The committees are independent both of the researchers whose work they are reviewing and of those who pay for the research.
The ethics committees that review clinical trials in the NHS are part of the National Research Ethics Service. This service is beginning to publish plain-language summaries of clinical trials that are understandable by anyone.