- (a) A physician administering an investigational stem cell treatment under this subchapter shall provide a written informed consent to the eligible patient. The written informed consent must meet or exceed the requirements found in 45 CFR §46.116.
- (b) The patient must sign the informed consent form. If the patient is a minor or lacks the mental capacity to provide informed consent, a parent, guardian, or conservator, shall sign the informed consent form.
- (c) The informed consent form must be maintained in the patient's medical record.
Source Note:The provisions of this §1.462 adopted to be effective July 10, 2018, 43 TexReg 4986.