How clinical trials are approved
This page tells you how clinical trials are approved. There is information on
Independent scientific review
Before a clinical trial can take place, it must be approved. First, the plan (protocol) should be approved by a group of researchers who are not involved in the trial. This is called 'independent scientific review' or 'peer review'.
The trial protocol is then reviewed by a National Research Ethics Service (NRES) Research Ethics Committee, or REC. NRES RECs look after the rights, safety, dignity and well being of those taking part in research in the NHS. Each committee is made up of between 7 and 18 volunteer members. At least 1 in 3 people (one third of the committee) must be someone whose main interest or professional interest isn't in research. These members are called lay members. Lay members are very important as they look at the trial from an outsider's point of view.
The committee decides if the trial is safe and ethical to do and whether it can go ahead or not. They look at the patient information sheet and consent form as well as the protocol. The committee must make sure the information includes everything that a patient would need to know before deciding whether to take part or not. And that the information is easy to understand.
They may ask the research team to make a few changes to the protocol or the patient information sheet before they give the final go ahead.
The role of the ethics committee includes making sure that the
- Researchers are qualified to carry out the trial
- Trial is well planned
- Likely benefits of the new treatment are greater than the probable side effects
- Information for patients taking part is complete and easy to understand
- Patients will be recruited correctly
- Researchers have arranged for compensation to be paid if anything should go wrong
The researchers are not allowed to change the protocol without telling the ethics committee. They must also tell them if there are any serious unexpected side effects. The committee (along with the data monitoring committee) can stop the trial at any time if they have any concerns about the welfare of the patients taking part. At the end of the trial, the ethics committee gets a report on the results.
Depending on the trial, the research team may also need to get the go ahead from other groups as well as an ethics committee. For example, if the trial will be using scans or treatment that would expose the people taking part to radiation that they would not have had otherwise, the team must get a certificate from a specialist committee, giving them permission to do this.
All clinical trials of medicines and studies on medical devices also need to be authorised by an organisation called the Medicines and Healthcare products Regulatory Agency (MHRA).
Each hospital that wants to take part in the trial has a check called a site specific assessment (SSA). This is done by their NHS Research and Development (R and D) department. The assessment makes sure that the hospital has the staff, equipment and expertise to carry out the trial. SSA's must be done for all trials of new treatments or procedures.