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