Informed consent is documented by means of a written, signed and dated informed consent form. In our modern ethical conception, all research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent, which is a process by which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate”, as stated in the International Council for Harmonisation Good Clinical Practice guidelines. Current biomedical research on human subjects requires clinical trial, which is defined as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes”.
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