Texas Register September 11, 2020 Volume: 45 Number: 37

Governor

 

Appointments

Governor reappoints one member and appoints two new members to the Texas Board of Respiratory Care

Appointments for August 20, 2020Appointed to the Texas Board of Respiratory Care for terms to expire February 1, 2025:Samuel L. Brown, Jr. of Marshall, Texas (replacing Joe Ann Clack of Missouri City, whose term expired); Debra E. Patrick of McKinney, Texas (Ms. Patrick is being reappointed); Hammad Nasir Qureshi, M.D. of Tomball, Texas (replacing James M. “Jim” Stocks of Tyler, whose term expired).


Texas Department of State Health Services

Proposed Rules

Amending 25 TAC §1.462 to update informed consent requirements for investigational stem cell treatment

CHAPTER 1. MISCELLANEOUS PROVISIONSSUBCHAPTER V. [AUTOLOGOUS] ADULT STEM CELLS25 TAC §1.462OVERVIEWThe Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes an amendment to §1.462, concerning Informed Consent for Investigational Stem Cell Treatment.SECTION-BY-SECTION SUMMARYThe proposed amendment to §1.462 requires an eligible patient to sign a DSHS informed consent form before receiving a voluntary investigational stem cell treatment.Proposed amendment to subsection (a) adopts the DSHS written informed consent form for use by physicians administering and patients receiving investigational stem cell treatments. It also announces that the informed consent form is available on the DSHS website. This amendment replaces current subsection (a) requiring the physician to provide the written consent, which must meet or exceed the requirements found in 45 CFR §46.116.Proposed amendment to subsection (b) requires the physician to obtain additional written informed consent required to comply with other laws or rules established by Texas Health and Safety Code, Chapter 1003. This subsection is necessary to ensure patients receive complete information about risks and hazards specific to their treatment. DSHS is unable to produce a comprehensive form applicable to all investigational stem cell treatments, or a form that can remain current with treatments at various stages of research or clinical trials. Current subsection (b) is deleted with this proposed amendment. It requires the patient to sign the informed consent form. This language is considered redundant, as a signature is required in the proposed DSHS informed consent form.BACKGROUND AND JUSTIFICATION The proposal is necessary to comply with House Bill (H.B.) 3148, 86th Legislature, Regular Session, 2019, which amended Texas Health and Safety Code, §1003.054(c) to require the Executive Commissioner of HHSC, by rule, to adopt an informed consent form that must be signed by an eligible patient before receiving an investigational stem cell treatment. The Executive Commissioner delegated the rule amendment and development of the informed consent form to DSHS. H.B. 3148 requires the informed consent form to provide notice that DSHS administers provisions relating to the administration and oversight of investigational stem cell treatment to certain patients.Before this proposed amendment, Texas Health and Safety Code, Chapter 1003, did not require DSHS to adopt an informed consent form. Under the current §1.462, physicians are required to provide a written informed consent to the eligible patient. The proposed amendment and informed consent form help ensure that eligible patients are informed about the potential risks and hazards of investigational stem cells treatments not approved for general use by the United States Food and Drug Administration.


Governor

Appointments

Governor appoints three new members to the Statewide Health Coordinating Council

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Texas Department on Aging and Disability Services

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