(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, guardian, or conservator may provide informed consent on the patient’s behalf.
(b) The commissioner may prescribe a form for the informed consent required under this section.

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Terms Used In Texas Health and Safety Code 490.052

  • Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
  • Written: includes any representation of words, letters, symbols, or figures. See Texas Government Code 311.005