Sec. 489.052. INFORMED CONSENT. (a) Before receiving an investigational drug, biological product, or device, an eligible patient must sign a written informed consent. If the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian may provide informed consent on the patient's behalf.
(b) The executive commissioner of the Health and Human Services Commission by rule may adopt a form for the informed consent under this section.
Added by Acts 2015, 84th Leg., R.S., Ch. 502 (H.B. 21), Sec. 2, eff. June 16, 2015.
Structure Texas Statutes
Title 6 - Food, Drugs, Alcohol, and Hazardous Substances
Subtitle C - Substance Abuse Regulation and Crimes
Chapter 489 - Access to Investigational Treatments for Patients With Terminal Illnesses
Section 489.051. Patient Eligibility
Section 489.052. Informed Consent
Section 489.053. Provision of Investigational Drug, Biological Product, or Device by Manufacturer