89R12486 MCF-F     By: King H.B. No. 5147       A BILL TO BE ENTITLED   AN ACT   relating to investigational stem cell treatment.          BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:          SECTION 1.  Section 1003.051(1), Health and Safety Code, is   amended to read as follows:                (1)  "Investigational stem cell treatment" 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; and                      (C)  uses only adult stem cells that satisfy   current good manufacturing practices adopted by the United States   Food and Drug Administration.          SECTION 2.  Section 1003.054(c), Health and Safety Code, is   amended to read as follows:          (c)  The executive commissioner by rule shall adopt a form   for the informed consent under this section.  The form must provide   notice that:                (1)  the department administers this subchapter; and                (2)  the investigational stem cell treatment has not   been approved for general use by the United States Food and Drug   Administration.          SECTION 3.  Sections 1003.055(a) and (d), Health and Safety   Code, are amended to read as follows:          (a)  Treatment provided under this subchapter must be:                (1)  administered directly by a physician certified   under Subsection (c);                (2)  overseen by an institutional review board   described by Subsection (d); and                (3)  provided [at]:                      (A)  at a hospital licensed under Chapter 241;                      (B)  at an ambulatory surgical center licensed   under Chapter 243; [or]                      (C)  at a medical school, as defined by Section   61.501, Education Code; or                      (D)  in an outpatient setting, as defined by   Section 162.101, Occupations Code, listed by a physician registered   under Section 162.104, Occupations Code, to provide level II   anesthesia services in that setting.          (d)  An institutional review board that oversees   investigational stem cell treatments administered under this   subchapter must meet one of the following conditions:                (1)  be affiliated with a medical school, as defined by   Section 61.501, Education Code;                (2)  be affiliated with a hospital licensed under   Chapter 241 that has at least 150 beds;                (3)  be accredited by the Association for the   Accreditation of Human Research Protection Programs;                (4)  be registered by the United States Department of   Health and Human Services, Office for Human Research Protections,   in accordance with 21 C.F.R. Part 56; [or]                (5)  be accredited by a national accreditation   organization acceptable to the Texas Medical Board; or                (6)  be registered by the United States Department of   Health and Human Services, Office for Human Research Protections,   in accordance with 21 C.F.R. Part 56.          SECTION 4.  Section 1003.059(b), Health and Safety Code, is   amended to read as follows:          (b)  Each institutional review board overseeing an   investigational stem cell treatment under this subchapter shall   submit to the Texas Medical Board an annual report on any serious   adverse events related to the treatment and [to the Texas Medical   Board on] the review board's findings based on records kept under   Subsection (a).  The report may not include any patient identifying   information [and must be made available to the public in both   written and electronic form].          SECTION 5.  This Act takes effect September 1, 2025.