(1) "Eligible patient" means a person who meets the requirements of Code Section 31-52-4.
(2) "Investigational drug, biological product, or device" means a drug, biological product, or device which has successfully completed Phase I of a federal Food and Drug Administration approved clinical trial but has not yet been approved for general use by the federal Food and Drug Administration and currently remains under investigation in a federal Food and Drug Administration approved clinical trial.
(3) "Physician" means a person licensed to practice medicine pursuant to Article 2 of Chapter 34 of Title 43.
(4) "Terminal illness" means a disease that, without life-sustaining procedures, will result in death in the near future and is not considered by a treating physician to be reversible even with administration of current federal Food and Drug Administration approved and available treatments.
(5) "Written informed consent" means a written document that:
(A) Is signed by the patient; parent, if the patient is a minor; legal guardian; or health care agent designated by the patient in an advance directive for health care executed pursuant to Chapter 32 of Title 31;
(B) Is attested to by the patient's physician and a witness; and
(C) Meets the requirements of Code Section 31-52-5.
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