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3 | 3 | | 3 |
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4 | 4 | | _______________________________. _______________________________ 4 |
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5 | 5 | | Councilmember Trayon White, Sr Councilmember Vincent C. Gray 5 |
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6 | 6 | | 6 |
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7 | 7 | | A BILL 7 |
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9 | 9 | | 9 |
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10 | 10 | | _____ 10 |
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11 | 11 | | 11 |
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12 | 12 | | 12 |
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13 | 13 | | IN THE COUNCIL OF THE DISTRICT OF COLUMBIA 13 |
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14 | 14 | | 14 |
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15 | 15 | | 15 |
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16 | 16 | | _____16 |
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17 | 17 | | 17 |
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18 | 18 | | 18 |
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19 | 19 | | To amend the Department of Health Functions Clarification Act of 2001 to establish a thymus 19 |
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20 | 20 | | imaging study for the purpose of studying differing life expectancies between Southeast 20 |
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21 | 21 | | and Northwest DC, and to create the first comprehensive data inventory for thymus gland 21 |
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22 | 22 | | size and weight and epigenetic biological age at different ages, sexes, and racial and 22 |
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23 | 23 | | socio-economic backgrounds. 23 |
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24 | 24 | | 24 |
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25 | 25 | | BE IT ENACTED BY THE COUNCIL OF THE DISTRICT OF COLUMBIA, That this 25 |
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26 | 26 | | act may be cited as the “Pioneer Initiative for Thymus and Health Equity Amendment Act of 26 |
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27 | 27 | | 2024”. 27 |
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28 | 28 | | Sec. 2. The Department of Health Functions Clarification Act of 2001, effective October 28 |
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29 | 29 | | 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 et seq.), is amended by adding new 29 |
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30 | 30 | | sections 4961 through 4964 to read as follows: 30 |
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31 | 31 | | “Sec. 4961. Thymus imaging study and establishment of consortium. 31 |
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32 | 32 | | “(a)(1) The Department of Health shall establish a consortium. 32 |
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33 | 33 | | “(2) The consortium shall consist of hospitals, schools, health organizations, and 33 |
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34 | 34 | | their associated hospitals or health clinics, or hospitals and health clinics with which they have 34 |
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35 | 35 | | partnerships, within Washington, DC. 35 |
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36 | 36 | | |
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37 | 37 | | 2 |
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38 | 38 | | “(3) Participating schools and hospitals must formally join the consortium to be 36 |
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39 | 39 | | eligible to apply for funding under this title, through the Department of Health. To be eligible, 37 |
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40 | 40 | | participating schools and hospitals must meet the following criteria: 38 |
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41 | 41 | | “(A) They must be legally recognized entities with established operations 39 |
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42 | 42 | | within Washington, DC; 40 |
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43 | 43 | | “(B) They must demonstrate the capacity to collect, manage, and report 41 |
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44 | 44 | | data from District residents, specifically for the purposes of the thymus imaging study as 42 |
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45 | 45 | | described in section 4962; 43 |
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46 | 46 | | “(C) They must have a track record of conducting health-related research 44 |
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47 | 47 | | or clinical studies involving human participants; 45 |
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48 | 48 | | “(D) They must possess the necessary infrastructure, personnel, and 46 |
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49 | 49 | | expertise to effectively participate in the consortium’s activities, ensuring the integrity and 47 |
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50 | 50 | | accuracy of the data collected; and 48 |
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51 | 51 | | “(E) They must comply with all relevant local and federal laws and 49 |
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52 | 52 | | regulations regarding the protection of human subjects and data privacy. 50 |
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53 | 53 | | “(4) The consortium shall conduct a cross-sectional thymus imaging study, 51 |
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54 | 54 | | described in section 4962, to assess the relationship between biological age and the thymus 52 |
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55 | 55 | | gland’s weight, size, T-Cell output, and function. 53 |
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56 | 56 | | “(5) The consortium shall also ensure that members collect data from at least 100 54 |
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57 | 57 | | participants per subgroup. A subgroup is a group of participants who share the same sex, race, 55 |
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58 | 58 | | age group, and standardized life-expectancy area. 56 |
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59 | 59 | | |
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60 | 60 | | 3 |
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61 | 61 | | “(6) Members of the consortium shall work together to agree on the best methods 57 |
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62 | 62 | | for effectively and efficiently collecting the data for the study described in section 4962, 58 |
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63 | 63 | | attracting and retaining study participants, and communicating budgetary and legislative needs. 59 |
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64 | 64 | | “(b) The Department of Health shall be responsible for issuing grants to members of the 60 |
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65 | 65 | | consortium to collect and report the data described in section 4962. 61 |
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66 | 66 | | “(c) The structure of the consortium shall be as follows: 62 |
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67 | 67 | | “(1) Governance: 63 |
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68 | 68 | | “(A) the Consortium shall be governed by a Board of Directors, composed 64 |
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69 | 69 | | of representatives from each member institution, including hospitals, schools, health 65 |
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70 | 70 | | organizations, and associated health clinics within Washington DC. 66 |
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71 | 71 | | “(B) The Board shall include one representative appointed by the Mayor, 67 |
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72 | 72 | | one representative appointed by the Council, and one representative from the Department of 68 |
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73 | 73 | | Health. 69 |
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74 | 74 | | “(C) The board shall elect a Chairperson from among its members to serve 70 |
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75 | 75 | | a term of two years. 71 |
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76 | 76 | | “(2) Executive Committee: 72 |
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77 | 77 | | “(A) An Executive Committee, elected by the Board of Directors, shall be 73 |
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78 | 78 | | responsible for the day-to-day management and operation of the consortium. 74 |
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79 | 79 | | “(B) The Executive Committee shall include a President, Vice President, 75 |
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80 | 80 | | Secretary, and Treasurer, who shall each serve two-year terms. 76 |
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81 | 81 | | “(3) Advisory Panels: 77 |
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82 | 82 | | |
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83 | 83 | | 4 |
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84 | 84 | | “(A) The consortium shall establish advisory panels as needed, consisting 78 |
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85 | 85 | | of experts in relevant fields, to provide guidance on research methods, data collection, and other 79 |
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86 | 86 | | technical aspects of the consortium’s activities. 80 |
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87 | 87 | | “(B) Members of the Advisory Panels shall be appointed by the Executive 81 |
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88 | 88 | | Committee and shall serve in an advisory capacity without voting rights on the Board of 82 |
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89 | 89 | | Directors. 83 |
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90 | 90 | | “(4) Membership: 84 |
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91 | 91 | | “(A) Membership in the consortium shall be open to any legally 85 |
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92 | 92 | | recognized school or hospital within Washington, DC. that meets eligibility criteria outlined in 86 |
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93 | 93 | | subsection (a)(3). 87 |
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94 | 94 | | “(B) Member institutions must enter into a formal agreement with the 88 |
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95 | 95 | | Department of Health, committing to the consortium’s goals and adhering to its bylaws. 89 |
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96 | 96 | | “(5) Funding: 90 |
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97 | 97 | | “(A) The Consortium shall be funded through grants issued by the 91 |
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98 | 98 | | Department of Health, as well as other federal, state, and private funding sources. 92 |
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99 | 99 | | “(B) The Board of Directors shall oversee the allocation and management 93 |
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100 | 100 | | of funds, ensuring that resources are used efficiently and to achieve the consortium’s objectives. 94 |
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101 | 101 | | “(6) Transparency and Reporting: 95 |
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102 | 102 | | “(A) The consortium shall maintain transparency in its operation, 96 |
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103 | 103 | | including regular public reporting of its activities, fundings, and financial statements. 97 |
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104 | 104 | | “(B) An annual report detailing the consortium’s progress, financial status, 98 |
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105 | 105 | | and future plans shall be submitted to the Department of Health, the Council, and the Mayor. 99 |
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106 | 106 | | |
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107 | 107 | | 5 |
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108 | 108 | | “(7) Compliance and Accountability: 100 |
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109 | 109 | | “(A) The consortium and its members shall comply with all applicable 101 |
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110 | 110 | | local and federal law and regulations, including those pertaining to research ethics, data 102 |
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111 | 111 | | protection, and antitrust laws. 103 |
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112 | 112 | | “(B) The Board of Directors shall establish mechanisms for accountability, 104 |
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113 | 113 | | including regular audits and reviews of the consortium’s activities and finances. 105 |
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114 | 114 | | “Sec. 4962. Thymus imaging study criteria and methodology. 106 |
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115 | 115 | | “(a) The cross-sectional thymus imaging study shall include: 107 |
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116 | 116 | | “(1) Cisgender men and women; 108 |
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117 | 117 | | “(2) Individuals in the following age categories: ≤29, 30-39, 40-49, 50-59, 60-69, 109 |
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118 | 118 | | or ≥70 years; 110 |
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119 | 119 | | “(3) The following racial and ethnic categories: 111 |
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120 | 120 | | “(A) Non-Hispanic Black; 112 |
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121 | 121 | | “(B) White; and 113 |
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122 | 122 | | “(C) Hispanic/Latino; and 114 |
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123 | 123 | | “(4) Natural born residents from one of 5 standardized life-expectancy areas, 115 |
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124 | 124 | | ranging from the highest to the lowest measured life-expectancy zip codes in the District. 116 |
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125 | 125 | | “(b) Notwithstanding subsection (a) of this section, the thymus imaging study shall 117 |
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126 | 126 | | exclude individuals who: 118 |
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127 | 127 | | “(1) Are currently on HRT or hormone blockers; 119 |
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128 | 128 | | “(2) Have an HIV infection; 120 |
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129 | 129 | | “(4) Chronically use or are currently using glucocorticoid therapy; 121 |
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130 | 130 | | |
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131 | 131 | | 6 |
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132 | 132 | | “(5) Are pregnant; 122 |
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133 | 133 | | “(6) Are currently experiencing a substance use disorder; 123 |
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134 | 134 | | “(7) Are not natural born citizens of the United States; 124 |
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135 | 135 | | “(8) Are unwilling or unable to give voluntary informed consent, unless they are 125 |
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136 | 136 | | 18 or younger and the consent of their parent or guardian is able to be obtained; 126 |
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137 | 137 | | “(9) Have uncorrected hypothyroidism; 127 |
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138 | 138 | | “(10) Have Type 1 Diabetes; 128 |
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139 | 139 | | “(11) Have used Growth Hormone in the last 5 years; 129 |
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140 | 140 | | “(12) Have a known growth hormone deficiency based on stimulation testing; 130 |
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141 | 141 | | “(12) Are currently undergoing chemotherapy or radiation treatment; and 131 |
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142 | 142 | | “(13) Have been diagnosed with DiGeorge Syndrome, CHARGE syndrome, 132 |
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143 | 143 | | chromosome 22q11.2 microdeletion syndrome, Down Syndrome, Hutchinson-Gilford Progeria 133 |
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144 | 144 | | Syndrome, or any other chromosomal deletion or duplication related, or diagnosed genetic 134 |
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145 | 145 | | disorder which is known to affect the thymus or the process of aging. 135 |
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146 | 146 | | “(c) The thymus imaging study shall collect the following data for each participant: 136 |
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147 | 147 | | “(1) Detailed Thoracic MRI assessments of the Thymus to determine weight, size, 137 |
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148 | 148 | | and fat percentage; 138 |
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149 | 149 | | “(2) Complete blood count; 139 |
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150 | 150 | | “(3) Complete endocrine panel; 140 |
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151 | 151 | | “(4) Comprehensive metabolic panel; 141 |
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152 | 152 | | “(5) Body mass index measurements; 142 |
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153 | 153 | | “(6) Waist circumference; 143 |
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154 | 154 | | |
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155 | 155 | | 7 |
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156 | 156 | | “(10) Telomere length measurement. 144 |
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157 | 157 | | “(11) T-Cell receptor excision circle (“TREC”) analysis; 145 |
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158 | 158 | | “(12) Lymphocyte phenotypes panel; 146 |
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159 | 159 | | “(13) Epigenetic biological age; and 147 |
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160 | 160 | | “(14) Information contained in a questionnaire, which may be answered by the 148 |
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161 | 161 | | participant, their guardian, or by a medical professional on behalf of the participant, that shall 149 |
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162 | 162 | | include at least the following questions: 150 |
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163 | 163 | | “(A) Personal Information: 151 |
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164 | 164 | | “(i) Age 152 |
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165 | 165 | | “(ii) Sex 153 |
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166 | 166 | | “(iii) Race/Ethnicity 154 |
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167 | 167 | | “(iv) Height 155 |
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168 | 168 | | “(v) Weight 156 |
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169 | 169 | | “(vi) Socioeconomic Background 157 |
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170 | 170 | | “(vii) Educational Level 158 |
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171 | 171 | | “(viii) Employment Status 159 |
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172 | 172 | | “(viiii) Household Income 160 |
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173 | 173 | | “(ix) Zip Code 161 |
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174 | 174 | | “(x) Zip Code of the hospital or place where you were born 162 |
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175 | 175 | | “(B) Health History: 163 |
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176 | 176 | | “(i) Have you ever been diagnosed with any chronic diseases? If 164 |
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177 | 177 | | so, please list them. 165 |
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178 | 178 | | |
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179 | 179 | | 8 |
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180 | 180 | | “(ii) Have you ever had a thymectomy? If so: 166 |
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181 | 181 | | “(I) At what age? 167 |
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182 | 182 | | “(II) What was the reason for the thymectomy? 168 |
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183 | 183 | | “(iii) Do you have a history of autoimmune diseases? If so, please 169 |
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184 | 184 | | list them. 170 |
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185 | 185 | | “(iv) Have you been diagnosed with any form of cancer? If so: 171 |
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186 | 186 | | “(I) At what age(s) were you diagnosed? 172 |
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187 | 187 | | “(II) What was your diagnosis? 173 |
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188 | 188 | | “(III) What is your current remission and Minimal Residual 174 |
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189 | 189 | | Disease status? 175 |
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190 | 190 | | “(v) Do you have a history of infection, particularly viral infections 176 |
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191 | 191 | | (e.g., HIV, hepatitis, etc.)? If so: 177 |
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192 | 192 | | “(I) At what age(s)? 178 |
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193 | 193 | | “(II) What was your diagnosis? 179 |
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194 | 194 | | “(vi) Have you undergone chemotherapy or radiation therapy? If 180 |
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195 | 195 | | so: 181 |
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196 | 196 | | “(I) At what age(s)? 182 |
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197 | 197 | | “(II) If possible, please list them and the reason for their 183 |
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198 | 198 | | use. 184 |
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199 | 199 | | “(vii) Do you have a history of hormone replacement therapy or 185 |
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200 | 200 | | glucocorticoid therapy? If so: 186 |
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201 | 201 | | “(I) At what age(s)? 187 |
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202 | 202 | | |
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203 | 203 | | 9 |
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204 | 204 | | “(II) If possible, please list them and the reason(s) for their 188 |
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205 | 205 | | use. 189 |
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206 | 206 | | “(viii) Do you have any known genetic disorders? If so, please list 190 |
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207 | 207 | | them. 191 |
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208 | 208 | | “(viiii) Are you currently on birth control? If so: 192 |
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209 | 209 | | “(I) At what age(s)? 193 |
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210 | 210 | | “(II) If possible, please list them and the reason(s) for their 194 |
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211 | 211 | | use. 195 |
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212 | 212 | | “(C) Current Health Status: 196 |
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213 | 213 | | “(i) Are you currently taking any medications? If so, please list 197 |
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214 | 214 | | them. 198 |
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215 | 215 | | “(ii) Do you currently have any health conditions? If so, please list 199 |
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216 | 216 | | them. 200 |
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217 | 217 | | “(iii) Do you have any known allergies? If so, please list them. 201 |
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218 | 218 | | “(iv) Have you experienced any recent infections or illnesses? If 202 |
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219 | 219 | | so, please list them. 203 |
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220 | 220 | | “(D) Lifestyle and Habits: 204 |
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221 | 221 | | “(i) Do you smoke? If so, how many cigarettes per day and for 205 |
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222 | 222 | | how many years? 206 |
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223 | 223 | | “(ii) Do you consume alcohol? If so, how often and how much? 207 |
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224 | 224 | | “(iii) Do you use recreational drugs? If so, which ones and how 208 |
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225 | 225 | | often? 209 |
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226 | 226 | | |
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227 | 227 | | 10 |
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228 | 228 | | “(iv) Describe your typical diet (e.g., vegetarian, vegan, 210 |
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229 | 229 | | omnivorous, high fat, high sugar). 211 |
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230 | 230 | | “(v) How many servings of fruits and vegetables do you consume 212 |
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231 | 231 | | per day? 213 |
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232 | 232 | | “(vii) How often do you consume processed foods? 214 |
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233 | 233 | | “viii7) On average, how many meals do you eat per day? 215 |
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234 | 234 | | “(viiii) Do you have any dietary restrictions or special diets (e.g., 216 |
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235 | 235 | | gluten-free, ketogenic)? 217 |
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236 | 236 | | “(E) Physical Activity: 218 |
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237 | 237 | | “(i) How often do you exercise? 219 |
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238 | 238 | | “(ii) What types of exercise do you engage in (e.g., aerobic, 220 |
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239 | 239 | | strength training, flexibility exercises)? 221 |
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240 | 240 | | “(iii) On average, how many hours per week do you spend 222 |
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241 | 241 | | exercising? 223 |
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242 | 242 | | “(iv) Do you have any physical limitations or disabilities that affect 224 |
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243 | 243 | | your ability to exercise? 225 |
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244 | 244 | | “(F) Mental Health: 226 |
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245 | 245 | | “(i) Have you ever been diagnosed with any mental health 227 |
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246 | 246 | | conditions (e.g., depression, anxiety, bipolar disorder)? If so, please list them. 228 |
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247 | 247 | | “(ii) Are you currently receiving treatment for any mental health 229 |
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248 | 248 | | conditions? If so, please list them. 230 |
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249 | 249 | | “(iii) Do you experience high levels of stress? 231 |
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250 | 250 | | |
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251 | 251 | | 11 |
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252 | 252 | | “(iv) How do you typically manage stress (e.g., exercise, 232 |
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253 | 253 | | meditation, therapy)? 233 |
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254 | 254 | | “(G) Sleep Patterns: 234 |
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255 | 255 | | “(i) On average, how many hours of sleep do you get a night? 235 |
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256 | 256 | | “(ii) Do you have any sleep disorders (e.g., insomnia, sleep 236 |
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257 | 257 | | apnea)? If so, please list them. 237 |
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258 | 258 | | “(iii) Do you feel rested when you wake up? 238 |
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259 | 259 | | “(H) Obesity-Related Factors 239 |
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260 | 260 | | “(i) Have you ever been diagnosed with obesity or overweight? 240 |
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261 | 261 | | “(ii) Have you ever received treatment for obesity (e.g., bariatric 241 |
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262 | 262 | | surgery, weight loss programs)? 242 |
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263 | 263 | | “(iii) Do you have a history of metabolic syndrome? 243 |
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264 | 264 | | “(I) Family Medical History: 244 |
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265 | 265 | | “(i) Is there a family history of chronic diseases (e.g., heart disease, 245 |
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266 | 266 | | diabetes, cancer)? If so, please provide a list of each member, their familial 246 |
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267 | 267 | | relation to yourself, and their respective diagnosis. 247 |
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268 | 268 | | “(ii) Is there a family history of autoimmune diseases? If so, please 248 |
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269 | 269 | | provide a list of each member, their familial relation to yourself, and their 249 |
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270 | 270 | | respective diagnosis. 250 |
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271 | 271 | | “(iii) Is there a family history of obesity? If so, please provide a list 251 |
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272 | 272 | | of each member, their familial relation to yourself, and whether you have ever co-252 |
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273 | 273 | | habited with them. 253 |
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274 | 274 | | |
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275 | 275 | | 12 |
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276 | 276 | | “(J) Health Behaviors: 254 |
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277 | 277 | | “(i) How often do you visit a healthcare provider for check-ups or 255 |
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278 | 278 | | preventive care? 256 |
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279 | 279 | | “(ii) Do you participate in any regular health screenings (e.g., 257 |
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280 | 280 | | mammograms, colonoscopies)? 258 |
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281 | 281 | | “(iii) Have you been vaccinated according to the recommended 259 |
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282 | 282 | | schedule? If not, why? 260 |
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283 | 283 | | “(K) Additional Information: 261 |
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284 | 284 | | “(i) Is there anything else you believe is relevant to your health or 262 |
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285 | 285 | | lifestyle that we should know? 263 |
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286 | 286 | | “(d) The consortium may make any changes deemed necessary to the Questionnaire, if it 264 |
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287 | 287 | | is in the interest of the study. 265 |
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288 | 288 | | “(e) The consortium may expand the scope of testing, if it is in the interest of the study. 266 |
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289 | 289 | | “(f) The consortium may alter subsection (a)(4) to lower the number of life expectancy 267 |
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290 | 290 | | areas, if it is in the interest of the study. 268 |
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291 | 291 | | “Sec. 4963. Data anonymization and public access. 269 |
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292 | 292 | | “(a) All data collected from the study shall be anonymized to protect the privacy of 270 |
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293 | 293 | | participants. 271 |
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294 | 294 | | “(b) The anonymized data shall be made publicly accessible in a manner that allows 272 |
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295 | 295 | | researchers, policymakers, and laymen to analyze the findings. Additionally, the public should 273 |
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296 | 296 | | also be able to access the anonymized raw results of the study to perform their own statistical 274 |
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297 | 297 | | analyses. 275 |
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298 | 298 | | |
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299 | 299 | | 13 |
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300 | 300 | | “(c) The Department of Health and the consortium shall establish protocols to ensure the 276 |
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301 | 301 | | secure storage and dissemination of the anonymized data. 277 |
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302 | 302 | | “Sec. 4964. Reporting requirements. 278 |
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303 | 303 | | “(a) The consortium shall submit annual reports to the Council and the Department of 279 |
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304 | 304 | | Health detailing the progress and preliminary findings of the study, and financial expenditures. 280 |
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305 | 305 | | “(b) A final comprehensive report shall be submitted at the conclusion of the cross-281 |
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306 | 306 | | sectional study, summarizing all findings and providing recommendations for future research and 282 |
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307 | 307 | | policy initiatives. 283 |
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308 | 308 | | Sec. 3. Fiscal Impact Statement. 284 |
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309 | 309 | | The Council adopts the fiscal impact statement as the fiscal impact statement in the 285 |
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310 | 310 | | committee report as required by section 4a of the General Legislative Procedures Act of 1975, 286 |
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311 | 311 | | approved October 16, 2006 (120 Stat. 2038; D.C. Official Code § 1-301.47a). 287 |
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312 | 312 | | Sec. 4. Effective Date. 288 |
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313 | 313 | | This act shall take effect upon its approval by the Mayor (or in the event of veto by the 289 |
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314 | 314 | | Mayor, action by the Council to override the veto) and a 30-day period of congressional review 290 |
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315 | 315 | | as provided in section 602(c)(1) of the District of Columbia Home Rule Act, approved December 291 |
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316 | 316 | | 24, 1973 (87 Stat. 813; D.C. Official Code § 1-206.02(c)(1)). 292 |
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