(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.

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Terms Used In Texas Health and Safety Code 489.052

  • 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.
  • Rule: includes regulation. See Texas Government Code 311.005
  • Written: includes any representation of words, letters, symbols, or figures. See Texas Government Code 311.005
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