Who is responsible for approving a clinical trial?
The principal researcher (IP) is the person who has thought and designed the study. He is usually a doctor or another health care professional who has knowledge about the disease related with the treatment that will be studied.
Before a clinical trial begins, it must be approved by an Ethical Medical Research Committee (CEIm) and by the Spanish Agency for Medication and Healthcare Products. The committee is independent of the group of doctors, nurses, researchers and non-medical professionals who will participate in the execution of the trial. The comittee will examine the study in great detail to evaluate its quality and assess the benefits and risks involved.
The IP will send the reports of its clinical trial proposal to the CEIm of the correspondent research centre, so that they are evaluated and the authorization for their initiation is achieved.
There are strict rules that protect the rights, safety, well-being and dignity of the people involved in a clinical trial. All patients are carefully observed during the study, because their safety and well-being is a priority. For this reason, more tests and medical appointments are performed during a clinical trial.