5. Who is in charge of an approved clinical trial?


The Principal Investigator is the person who has thought up and designed the trial. This person is a doctor or another healthcare professional that understands your disease or illness and is looking at ways to improve treatment.


Before any trial can start, it must first be approved by an ethics committee. An ethics committee is an independent group of doctors, nurses, researchers and non-medical people. They carefully examine a detailed description of the study to decide whether it is of good quality and fair to ask people to take part in it.


The Irish Medicines Board (IMB) has been given the job of looking after the safety of clinical trials involving medicines by the Irish Government. They must also study a detailed description of each clinical trial and give their permission before a trial involving medicines can go ahead.


Researchers must send in regular reports to the ethics committee and to the IMB to ensure the safety of people in the study.


Strict rules are in place to protect the rights, safety, well-being and dignity of people taking part in clinical trials. All patients are monitored carefully throughout the trial and their safety and well-being is everyone's priority.