Informed consent means that the investigator explains to the person who will participate in the clinical trial (subject) for the purpose of obtaining his/her cooperation in the clinical trial. When obtaining consent, the investigator explains to the subject using an Informed Consent Form (ICF) that contains sufficient details in plain language and obtains consent for participation in the clinical trial of his/her own free will.

The law stipulates that this consent can be withdrawn at any time of the subject's free will, and that there will be no disadvantage to the subject. In addition, both the investigator and the subject are required to sign the ICF and keep it in document.