TITLE 25HEALTH SERVICES - Texas Health and Human …



TITLE 25HEALTH SERVICESPART 1DEPARTMENT OF STATE HEALTH SERVICESCHAPTER 1MISCELLANEOUS PROVISIONSSUBCHAPTER VAUTOLOGOUS ADULT STEM CELLS§1.462. Informed Consent for Investigational Stem Cell Treatment.(a) Pursuant to Texas Health and Safety Code, §1003.054(c), the Department of State Health Services adopts a written informed consent form for use by physicians and patients administering investigational stem cell treatment under Texas Health and Safety Code, Chapter 1003, Subchapter B. The informed consent form is available on the Department of State Health Services website at dshs.chronic/.(b) The physician shall obtain any additional written informed consent required to meet the standard of care or comply with other laws or rules established by Texas Health and Safety Code, Chapter 1003.(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.NOTE: For purposes of informal comment, the consent form is included below. Once adopted, the consent form will be available on the Department of State Health Services website, noted in 25 Texas Administrative Code §1.462(a).DEPARTMENT OF STATE HEALTH SERVICES INFORMED CONSENTInvestigational Stem Cell TreatmentTexas Health and Safety Code, §1003.054, requires an eligible patient to sign a written informed consent before receiving a voluntary investigational stem cell treatment. The Department of State Health Services oversees the informed consent requirements established by this statute. Investigational stem cell treatment, as defined by Texas Health and Safety Code, §1003.051, means an adult stem cell treatment that (A) is under investigation in a clinical trial and being administered to human participants in that trial; and (B) has not yet been approved for general use by the United States Food and Drug Administration.The risks and hazards of this treatment have been described to me and I voluntarily agree to receive an investigational stem cell treatment for my documented, diagnosed medical condition. I request and authorize my physician, certified under Texas Health and Safety Code, §1003.055, to treat my condition, which is documented in my medical record, and is eligible for investigational stem cell treatments pursuant to 25 Texas Administrative Code §1.461. Patient Name _______________________________________________________________Physician Name _____________________________________________________________Treatment Information ______________________________________________________I have read, understand and acknowledge that (initial below): _____ This stem cell treatment is under investigation in a clinical trial and has not been approved for general use by the United States Food and Drug Administration. _____ I have read, understand, and signed a disclosure of the risks and hazards in continuing my present condition without treatment. The disclosure is attached to this form. _____ I have been provided and signed a disclosure of the risks and hazards related to the performance of the investigational stem cell treatment planned for me. The disclosure is attached to this form._____ I have been given an opportunity to ask questions about my condition, alternative forms of treatment, risks of nontreatment, the procedures to be used, and the risks and hazards involved, and believe that I have sufficient information to give this informed consent._____ This informed consent form and attached disclosure have been fully explained to me. By signing this, I acknowledge I have read and understand this consent form and voluntarily agree to receive the investigational stem cell treatment listed in this form.__________________________________________________________________________Patient (or Parent/Guardian/Conservator) Signature__________________________________________________________________________Patient Name (Print)__________________________________________________________________________Address (Street or P.O. Box)__________________________________________________________________________DateA physician or health care provider must ensure this informed consent is signed in conjunction with the investigational stem cell treatment disclosure form that meets or exceeds the requirements found in 45 CFR §46.116, as applicable.__________________________________________________________________________Physician Signature__________________________________________________________________________Physician Name (Print)__________________________________________________________________________Address (Street or P.O. Box)__________________________________________________________________________DateA copy of this signed informed consent and a copy of the investigational stem cell treatment disclosure must be kept in the patient’s medical record. ................
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