1 | 1 | | 81R2463 JSC-D |
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2 | 2 | | By: Shapleigh S.B. No. 208 |
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3 | 3 | | |
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4 | 4 | | |
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5 | 5 | | A BILL TO BE ENTITLED |
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6 | 6 | | AN ACT |
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7 | 7 | | relating to the regulation of the use of human cells and tissue, |
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8 | 8 | | including a ban on human cloning; providing penalties. |
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9 | 9 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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10 | 10 | | SECTION 1. Subtitle H, Title 2, Health and Safety Code, is |
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11 | 11 | | amended by adding Chapter 176 to read as follows: |
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12 | 12 | | CHAPTER 176. BIOMEDICAL RESEARCH OVERSIGHT |
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13 | 13 | | SUBCHAPTER A. GENERAL PROVISIONS |
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14 | 14 | | Sec. 176.001. DEFINITIONS. In this chapter: |
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15 | 15 | | (1) "Fertilization" means the fusion of a female germ |
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16 | 16 | | cell containing a haploid nucleus with a male gamete or sperm cell. |
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17 | 17 | | (2) "Human cloning" means implanting or attempting to |
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18 | 18 | | implant into a uterus or the functional equivalent of a uterus a |
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19 | 19 | | human embryo created by a method other than fertilization. |
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20 | 20 | | (3) "Human embryo" means an organism of the species |
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21 | 21 | | homo sapiens from the single cell stage to eight weeks of |
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22 | 22 | | development. |
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23 | 23 | | (4) "Oocyte" means the female germ cell, the egg. |
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24 | 24 | | [Sections 176.002-176.050 reserved for expansion] |
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25 | 25 | | SUBCHAPTER B. HUMAN CLONING |
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26 | 26 | | Sec. 176.051. HUMAN CLONING PROHIBITED. A person may not |
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27 | 27 | | engage in or attempt to engage in human cloning. |
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28 | 28 | | Sec. 176.052. LICENSED VIOLATORS. A person licensed by a |
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29 | 29 | | state agency as a health care practitioner or health care facility |
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30 | 30 | | who violates Section 176.051 is subject to the same consequence, |
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31 | 31 | | other than a civil penalty, that the person would be subject to if |
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32 | 32 | | the person had violated the licensing law applicable to the person |
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33 | 33 | | or rules adopted under that law. |
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34 | 34 | | Sec. 176.053. CIVIL PENALTY. (a) A person who violates |
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35 | 35 | | Section 176.051 is liable to the state for a civil penalty of not |
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36 | 36 | | more than $10 million for each violation. |
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37 | 37 | | (b) The amount of the penalty shall be based on: |
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38 | 38 | | (1) the seriousness of the violation; |
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39 | 39 | | (2) the history of previous violations; |
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40 | 40 | | (3) the amount necessary to deter a future violation; |
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41 | 41 | | and |
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42 | 42 | | (4) any other matter that justice may require. |
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43 | 43 | | (c) The attorney general may sue to collect a civil penalty |
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44 | 44 | | under this section. In the suit the attorney general may recover |
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45 | 45 | | the reasonable expenses incurred in obtaining the penalty, |
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46 | 46 | | including investigation and court costs, reasonable attorney's |
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47 | 47 | | fees, witness fees, and other expenses. |
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48 | 48 | | Sec. 176.054. CRIMINAL OFFENSE. A person commits an |
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49 | 49 | | offense if the person intentionally engages in or attempts to |
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50 | 50 | | engage in human cloning. An offense under this section is a felony |
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51 | 51 | | of the first degree. |
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52 | 52 | | [Sections 176.055-176.100 reserved for expansion] |
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53 | 53 | | SUBCHAPTER C. RESEARCH USING CERTAIN HUMAN CELLS OR TISSUES |
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54 | 54 | | Sec. 176.101. PROTECTION OF RESEARCH. This chapter does |
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55 | 55 | | not restrict or prohibit: |
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56 | 56 | | (1) scientific research, including nuclear |
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57 | 57 | | transplantation, to develop regenerative or reparative medical |
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58 | 58 | | therapies or treatments; or |
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59 | 59 | | (2) any other research not specifically prohibited by |
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60 | 60 | | this chapter. |
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61 | 61 | | Sec. 176.102. RESEARCH OVERSIGHT. Research described by |
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62 | 62 | | Section 176.101(1) must be: |
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63 | 63 | | (1) conducted with full consideration for the ethical |
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64 | 64 | | and medical implications of the research; and |
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65 | 65 | | (2) reviewed, in each case, by an institutional review |
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66 | 66 | | board for compliance with applicable state and federal law and |
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67 | 67 | | after consideration of applicable ethical guidelines developed by |
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68 | 68 | | the National Institutes of Health and the guidelines developed |
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69 | 69 | | under Section 176.103. |
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70 | 70 | | Sec. 176.103. ADVISORY COMMITTEE ON RESEARCH TO DEVELOP |
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71 | 71 | | REGENERATIVE OR REPARATIVE MEDICAL THERAPIES OR TREATMENTS. (a) |
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72 | 72 | | The executive commissioner of the Health and Human Services |
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73 | 73 | | Commission shall establish an advisory committee to develop |
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74 | 74 | | guidelines for research described by Section 176.101(1). |
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75 | 75 | | (b) The advisory committee consists of members appointed by |
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76 | 76 | | the executive commissioner of the Health and Human Services |
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77 | 77 | | Commission as follows: |
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78 | 78 | | (1) seven scientists with experience in biomedical |
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79 | 79 | | research in the fields of cell differentiation, nuclear |
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80 | 80 | | reprogramming, tissue formation and regeneration, stem cell |
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81 | 81 | | biology, developmental biology, regenerative medicine, or related |
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82 | 82 | | fields; |
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83 | 83 | | (2) one representative from each health science center |
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84 | 84 | | in this state; |
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85 | 85 | | (3) one person who is a member of or leader in the |
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86 | 86 | | biotechnology industry; |
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87 | 87 | | (4) one medical ethicist; |
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88 | 88 | | (5) one person with a background in legal issues |
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89 | 89 | | related to research described by Section 176.101(1), in vitro |
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90 | 90 | | fertilization, or family law, as it applies to the donation of |
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91 | 91 | | embryos and oocytes; and |
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92 | 92 | | (6) one person who is a member or leader of a religious |
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93 | 93 | | organization. |
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94 | 94 | | (c) The advisory committee shall revise and update the |
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95 | 95 | | guidelines developed under this section as necessary. |
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96 | 96 | | (d) The advisory committee may work with existing |
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97 | 97 | | institutional review boards in developing guidelines. |
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98 | 98 | | (e) Section 2110.008, Government Code, does not apply to the |
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99 | 99 | | advisory committee. |
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100 | 100 | | Sec. 176.104. VOLUNTARY DONATION OF OOCYTES. A person may |
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101 | 101 | | not use an oocyte in nuclear transplantation research unless the |
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102 | 102 | | oocyte was donated voluntarily by and with the informed consent of |
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103 | 103 | | the woman donating the oocyte. |
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104 | 104 | | [Sections 176.105-176.150 reserved for expansion] |
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105 | 105 | | SUBCHAPTER D. DISPOSITION OF HUMAN EMBRYOS |
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106 | 106 | | Sec. 176.151. DONATION OF HUMAN EMBRYO. (a) A person may |
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107 | 107 | | donate an embryo created in the course of fertility treatment for |
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108 | 108 | | the purpose of assisted reproduction, as defined by Section |
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109 | 109 | | 160.102, Family Code, to be used in scientific research or to be |
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110 | 110 | | used by an intended mother for the purpose of conceiving a child. |
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111 | 111 | | (b) If both a man and a woman contracted for the creation of |
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112 | 112 | | the embryo, both parties must consent to the donation. |
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113 | 113 | | (c) Consent to the donation under Subsection (c) terminates |
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114 | 114 | | any parent-child relationship with respect to the embryo. |
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115 | 115 | | Sec. 176.152. SALE OF HUMAN EMBRYO PROHIBITED; CRIMINAL |
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116 | 116 | | PENALTY. (a) A person may not purchase, sell, or otherwise |
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117 | 117 | | transfer for valuable consideration a human embryo. |
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118 | 118 | | (b) In this section, "valuable consideration" does not |
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119 | 119 | | include reasonable payments associated with the transportation, |
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120 | 120 | | processing, preservation, or storage of the human embryo. |
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121 | 121 | | (c) A person commits an offense if the person knowingly |
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122 | 122 | | violates Subsection (a). An offense under this subsection is a |
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123 | 123 | | felony of the first degree. |
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124 | 124 | | SECTION 2. (a) The executive commissioner of the Health and |
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125 | 125 | | Human Services Commission shall appoint members to the advisory |
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126 | 126 | | committee as required by Section 176.103, Health and Safety Code, |
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127 | 127 | | as added by this Act, not later than November 1, 2009. |
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128 | 128 | | (b) The advisory committee shall adopt research guidelines |
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129 | 129 | | as required by Section 176.103, Health and Safety Code, as added by |
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130 | 130 | | this Act, not later than June 1, 2010. |
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131 | 131 | | SECTION 3. This Act takes effect September 1, 2009. |
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