31-52-20. Definitions.

As used in this article, the term:

“Eligible facility” means an institution that is currently operating under the Federalwide Assurance for the Protection of Human Subjects under 42 U.S.C. Section 289(a) and 45 C.F.R. Part 46 and is subject to federal laws, regulations, policies, and guidelines, including renewals and updates.#

“Eligible patient” means a person who meets the requirements of Code Section 31-52-21.#

“Individualized investigational treatment” means a drug, biological product, or device that is unique to and produced exclusively for an individual patient based on his or her own genetic profile. Such term includes, but is not limited to, individualized gene therapy, individualized investigational antisense oligonucleotides, and individualized neoantigen vaccines or individualized neoantigen therapy. Such term includes any drug, biological product, or device derived from human perinatal tissues, cells, and secreted factors, provided that such substances are not obtained from an abortion. Such term does not include any drug, biological product, or device derived from human primary or secondary embryonic stem cells or cell lines.#

“Life-threatening illness” means a disease or condition where the likelihood of death is high unless the course of the disease is interrupted or a disease or condition with a potentially fatal outcome, where the end point of clinical trial analysis is survival. Such term shall not include the natural process of aging.#

“Manufacturer” means a person or entity engaged in the manufacturing of individualized investigational treatments in an eligible facility.#

“Physician” means a person licensed to practice medicine pursuant to Article 2 of Chapter 34 of Title 43.#

“Severely debilitating illness” means a disease or condition that causes major irreversible morbidity.#

“Written informed consent” means a written document that:#

1. (A)

   Is signed by the patient; parent, if the patient is a minor; legal guardian; or healthcare agent designated by the patient in an advance directive for healthcare executed pursuant to Chapter 32 of this title;#

2. (B)

   Is attested to by the patient’s physician and a witness; and#

3. (C)

   Meets the requirements of Code Section 31-52-22.#