1. (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/.
2. (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.
3. (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.
4. (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.

Source Note:The provisions of this §1.4 adopted to be effective August 19, 2024, 49 TexReg 6215.