50-12-105. Informed consent required.
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50-12-105 . Informed consent required.
(1)A patient or a patient's legal guardian shall provide informed consent to receive an experimental treatment.
(2)At a minimum, the informed consent must include:
(a)an explanation of the currently approved products, treatments, and services relevant to the patient's disease, condition, or desired health outcomes;
(b)an attestation that the patient concurs with the treating health care provider in believing that currently approved and conventionally recognized treatments are either unlikely to achieve the patient's desired health outcomes or are otherwise impractically available;
(c)clear identification of the specific experimental treatment that the patient is seeking to use;
(d)a description of the potentially best and worst outcomes of receiving the experimental treatment and a realistic description of the most likely outcome;
(e)a statement that the patient's health plan or third-party administrator and provider are not obligated to pay for any care or treatments consequent to the use of the experimental treatment unless they are specifically required to do so by law or contract;
(f)as applied to patients potentially eligible for hospice care, a statement that the patient's eligibility for hospice care may be withdrawn if the patient begins curative treatment with the experimental treatment and that hospice care may be reinstated if the treatment ends and the patient meets hospice eligibility requirements;
(g)a statement that the patient understands that the patient is liable for all expenses related to the use of the experimental treatment and that the liability for expenses extends to the patient's estate, unless a contract between the patient and the manufacturer, health care provider, or health care facility providing the experimental treatment states otherwise; and
(h)a statement that the patient acknowledges that the experimental treatment cannot be used to assist with ending the patient's natural life.
(3)The informed consent must:
(i)be signed by:
(A)the patient;
(B)a parent or legal guardian, if the patient is a minor; or
(C)a legal guardian, if a guardian has been appointed pursuant to Title 72, chapter 5; and
(ii)be attested to by the patient's treating health care provider and a witness; or
(b)include verified comprehension and consent through interactive discussions with the individuals set forth in subsection (3)(a) that have been recorded using audio, video, or any other digital platform.
(4)For transparency and quality purposes, it is recommended that health care providers and health care facilities utilize the enhanced informed consent process set forth in subsection (3)(b).