Read press release Getting the go ahead
This page tells you how clinical trials are approved. There is information on
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 the multicentre research ethics committee, or MREC. The committee decide if the trial is 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.
Once a trial has approval from the multicentre ethics committee, each hospital that wants to take part has a site specific assessment (SSA) done by their local research ethics committee, or LREC. 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.
Each health authority has an LREC. The committee is made up of health professionals, experts in statistics and ethics and members of the public.
What ethics committees do
The job 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.
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