Informed consent is a written agreement by which a subject voluntarily confirms his or her willingness to participate in a particular clinical trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate.
Informed consent is documented by means of a written, signed and dated informed consent form.
Acting as Subjects
It is very important for people thinking about participating in a clinical trial to understand their role in the study. These studies are intended to test the safety and effectiveness of new treatments and therapies on people. Because of this, participants must understand that they are acting as subjects in a research study and not as patients.