Regulation of Clinical Trials
Clinical trials are regulated by a number of groups and processes to help protect patient safety and the ethicality of scientific research. Requirements of these regulatory groups and processes include:
- Full disclosure: The pros and cons of a clinical trial must be explained to each patient considering enrolling in it.
- Informed Consent: The Informed Consent form is designed to fully inform the patient and to facilitate communication between the patient and the research team. After talking with family, friends and doctors, it is up to the patient to decide whether to participate in the clinical trial. If the patient decides to participate, she/he is asked to sign the Informed Consent form, once all the risks of the particular trial are fully understood.Participants can participate in clinical trials only after signing the informed consent, and they have the right to voluntarily withdraw from a clinical trial at any time, and for any reason.
Periodically, the research team will go over the form with the patient again to make sure the individual still wants to continue her/his participation. The patient’s health is continually monitored during the course of the treatment in the clinical trial.