| (a) Pursuant to Texas Health and Safety Code §490.052(b),
the department adopts a written informed consent form for use by physicians
and patients receiving an investigational drug, biological product,
or device. A physician may use a different informed consent form if
it contains, at a minimum, the same information as the department
form. The written informed consent form is available on the department
website at www.dshs.texas.gov/chronic/.
(b) A patient eligible to access and use an investigational
drug, biological product, or device must sign a written informed consent
form. If the patient is a minor or lacks the mental capacity to provide
written informed consent, a parent, guardian, or conservator may provide
written informed consent on the patient's behalf.
(c) A patient must provide a signed, written informed
consent form to a manufacturer of an investigational drug, biological
product, or device before the manufacturer may make the investigational
drug, biological product, or device available to the patient.
(d) The written informed consent form must be maintained
in the medical record of the treating physician in accordance with
the applicable records retention requirements.
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