Consent

Informed consent refers to the communication process that occurs to allow a patient to make an informed choice about participating in a clinical trial. The trial is explained in detail, including the treatment plan, all the possible benefits and known risks, required tests, frequency of visits, and other treatment options. The patient and family members are encouraged to ask questions and will have them answered.

A document called an "informed consent form" which contains specific required information about the trial is given to the patient and family to take home with them and consider, away from the clinical setting.

The patient signs this form in the presence of the research nurse only after they feel they completely understand it.

Further tests may have to be done to determine whether the patient is eligible to go on the trial. When the patient is found to be eligible, he or she is entered on the trial.