36-1331. Definitions

627 words·~3 min read·/az/title-36/36-1331

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

In this chapter, unless the context otherwise requires:

1. "Eligible facility" means a health care institution that operates under a federalwide assurance for the protection of human subjects pursuant to 45 Code of Federal Regulations part 46 and that is subject to the federal federalwide assurance regulations, policies and guidelines, including renewals or updates.

2. "Eligible patient" means a patient who meets all of the following conditions:

(a)Has a life-threatening disease or condition or a severely debilitating illness, attested to by the patient's physician.

(b)Has considered all other treatment options currently approved by the United States food and drug administration.

(c)Has received a recommendation from the patient's physician for an individualized investigational treatment based on an analysis of the patient's genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products, such as enzymes and other types of proteins, or metabolites.

(d)Has given written informed consent for the use of the individualized investigational drug, biological product or device.

(e)Has documentation from the patient's physician that the patient meets the requirements of this paragraph.

3. "Individualized investigational treatment":

(a)Means a drug, biological product or device that is unique to and produced exclusively for use by an individual patient based on the patient's own genetic profile.

(b)Includes individualized gene therapy, antisense oligonucleotides and individualized neoantigen vaccines.

4. "Life-threatening disease or condition" means a disease or condition that both:

(a)Has a high likelihood of death unless the course of the disease or condition is interrupted.

(b)Has a potentially fatal outcome and for which the end point of clinical trial analysis is survival.

5. "Severely debilitating illness" means a disease or condition that causes major irreversible morbidity.

6. "Written informed consent" means a written document that is signed by a patient, the patient's parent if the patient is a minor, the patient's legal guardian or the patient's advocate designated by the patient, that is attested to by the patient's physician and a witness and that, at a minimum, includes all of the following:

(a)An explanation of the currently approved products and treatments for the disease or condition from which the patient suffers.

(b)An attestation that the patient concurs with the patient's physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life.

(c)Clear identification of the specific proposed individualized investigational drug, biological product or device that the patient is seeking to use.

(d)A description of the potentially best and worst outcomes of using the individualized investigational drug, biological product or device and a realistic description of the most likely outcome, including the possibility that new, unanticipated, different or worse symptoms might result and that death could be hastened by the proposed treatment. The description shall be based on the physician's knowledge of the proposed treatment in conjunction with an awareness of the patient's condition.

(e)A statement that the patient's health plan or a third-party administrator and provider are not obligated to pay for any care or treatment consequent to the use of the individualized investigational drug, biological product or device unless specifically required to do so by law or contract.

(f)A statement that the patient's eligibility for hospice care may be withdrawn if the patient begins curative treatment with the individualized investigational drug, biological product or device and that care may be reinstated if this treatment ends and the patient meets hospice eligibility requirements.

(g)A statement that the patient understands that the patient is liable for all expenses consequent to the use of the individualized investigational drug, biological product or device and that this liability extends to the patient's estate unless a contract between the patient and the manufacturer of the drug, biological product or device states otherwise.