Informed Consent

Sec. 491.053. INFORMED CONSENT. (a) An eligible patient may not access an individualized investigational treatment unless the patient provides written informed consent. If the patient is a minor or lacks the mental capacity to provide informed consent, a parent, legal guardian, managing conservator, or patient's agent as defined by Section 166.151 may provide written informed consent on the patient's behalf. (b) Informed consent under this chapter must be attested to in writing by the patient's physician and a witness. (c) Informed consent under this chapter must include at a minimum: (1) an explanation of the currently approved treatments for the patient's disease or condition; (2) the patient's attestation that the patient concurs with the assessment of the patient's physician that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life; (3) clear identification of the specific proposed individualized investigational drug, biological product, or device the patient's physician recommends; (4) a description, based on the physician's knowledge of the proposed treatment in conjunction with an awareness of the patient's disease or condition, of the potentially best and worst outcomes of using the treatment, and 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 treatment; (5) a statement that the patient's health benefit plan issuer or third-party administrator and provider are not obligated to pay the cost of any care related to the use of the treatment unless payment is specifically required by law or contract; (6) a statement that the patient's eligibility for hospice care may be withdrawn if the patient begins the treatment and that care may be reinstated if the treatment ends and the patient meets hospice eligibility requirements; and (7) a statement that the patient understands the patient is liable for all expenses related to the use of the treatment and the liability extends to the patient's estate, unless a contract between the patient and the manufacturer of the treatment provides otherwise. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984), Sec. 1, eff. September 1, 2025.