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A BILL TO BE ENTITLED
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AN ACT
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relating to investigational stem cell treatment. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Section 1003.051(1), Health and Safety Code, is |
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amended to read as follows: |
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(1) "Investigational stem cell treatment" means an |
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adult stem cell treatment that: |
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(A) is under investigation in a clinical trial |
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and being administered to human participants in that trial; [and] |
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(B) has not yet been approved for general use by |
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the United States Food and Drug Administration; and |
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(C) uses only adult stem cells that satisfy |
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current good manufacturing practices adopted by the United States |
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Food and Drug Administration. |
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SECTION 2. Section 1003.054(c), Health and Safety Code, is |
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amended to read as follows: |
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(c) The executive commissioner by rule shall adopt a form |
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for the informed consent under this section. The form must provide |
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notice that: |
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(1) the department administers this subchapter; and |
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(2) the investigational stem cell treatment has not |
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been approved for general use by the United States Food and Drug |
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Administration. |
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SECTION 3. Sections 1003.055(a) and (d), Health and Safety |
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Code, are amended to read as follows: |
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(a) Treatment provided under this subchapter must be: |
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(1) administered directly by a physician certified |
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under Subsection (c); |
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(2) overseen by an institutional review board |
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described by Subsection (d); and |
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(3) provided [at]: |
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(A) at a hospital licensed under Chapter 241; |
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(B) at an ambulatory surgical center licensed |
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under Chapter 243; [or] |
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(C) at a medical school, as defined by Section |
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61.501, Education Code; or |
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(D) in an outpatient setting, as defined by |
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Section 162.101, Occupations Code, listed by a physician registered |
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under Section 162.104, Occupations Code, to provide level II |
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anesthesia services in that setting. |
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(d) An institutional review board that oversees |
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investigational stem cell treatments administered under this |
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subchapter must meet one of the following conditions: |
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(1) be affiliated with a medical school, as defined by |
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Section 61.501, Education Code; |
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(2) be affiliated with a hospital licensed under |
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Chapter 241 that has at least 150 beds; |
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(3) be accredited by the Association for the |
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Accreditation of Human Research Protection Programs; |
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(4) be registered by the United States Department of |
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Health and Human Services, Office for Human Research Protections, |
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in accordance with 21 C.F.R. Part 56; [or] |
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(5) be accredited by a national accreditation |
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organization acceptable to the Texas Medical Board; or |
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(6) be registered by the United States Department of |
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Health and Human Services, Office for Human Research Protections, |
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in accordance with 21 C.F.R. Part 56. |
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SECTION 4. Section 1003.059(b), Health and Safety Code, is |
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amended to read as follows: |
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(b) Each institutional review board overseeing an |
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investigational stem cell treatment under this subchapter shall |
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submit to the Texas Medical Board an annual report on any serious |
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adverse events related to the treatment and [to the Texas Medical |
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Board on] the review board's findings based on records kept under |
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Subsection (a). The report may not include any patient identifying |
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information [and must be made available to the public in both |
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written and electronic form]. |
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SECTION 5. This Act takes effect September 1, 2025. |