(informed consent obtained) Consent given by a subject, or in the case of an individual that can only give assent, by a parent or legal guardian, for the participation in a clinical study only after having achieved an understanding of both the relevant medical facts and the relevant risks involved.

A process in which a person is given important facts about a medical procedure or treatment, a clinical trial, or genetic testing before deciding whether or not to participate. It also includes informing the patient when there is new information that may affect his or her decision to continue. Informed consent includes information about the possible risks, benefits, and limits of the procedure, treatment, trial, or genetic testing.

An ongoing process that provides the subject with explanations that will help in making educated decisions about whether to begin or continue participating in a trial. informed consent is an ongoing, interactive process rather than a one-time information session. NOTE: Under 21 CFR 50.20, no informed consent form may include any "language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence." In some cases, when the prospective subject is unable to provide legal consent, permission to participate may be obtained from a legally-authorized representative. See also consent form.

Consent by a patient to a surgical or medical procedure or participation in a clinical study after achieving an understanding of the relevant medical facts and the risks involved.

Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.

Consent of the patient is a prerequisite for any medical intervention. However, that consent often does not need to be explicit. For emergency care, consent is normally presumed, referred to as the doctrine of presumed consent. For interventions considered routine and unlikely to cause harm (eg, routine phlebotomy, placement of an IV...