| 1 | A bill to be entitled |
| 2 | An act relating to stem cell research; creating s. 381.99, |
| 3 | F.S.; providing a short title; providing definitions; |
| 4 | creating the Stem Cell Research and Ethics Advisory |
| 5 | Council within the Department of Health; providing for |
| 6 | membership and terms; providing duties and |
| 7 | responsibilities; providing per diem and travel expenses, |
| 8 | subject to a specific appropriation; requiring the |
| 9 | Secretary of Health to make grants-in-aid from the |
| 10 | Biomedical Research Trust Fund for stem cell research |
| 11 | subject to a specific appropriation; providing |
| 12 | requirements relating to applications for and awards of |
| 13 | such grants-in-aid; providing specifications for moneys to |
| 14 | be made available from the trust fund for stem cell |
| 15 | research grants-in-aid; providing restrictions and |
| 16 | requirements for uses of funds from such grants-in-aid; |
| 17 | amending s. 20.435, F.S.; revising provisions relating to |
| 18 | funding sources of and use of funds in the Biomedical |
| 19 | Research Trust Fund; amending s. 381.86, F.S.; providing |
| 20 | an exception to the Institutional Review Board's exclusive |
| 21 | authority to review certain biomedical and behavioral |
| 22 | research on human subjects to allow for the Stem Cell |
| 23 | Research and Ethics Advisory Council's duties and |
| 24 | responsibilities with respect to such research; requiring |
| 25 | the Department of Health to prepare and distribute, |
| 26 | subject to a specific appropriation, a publication |
| 27 | regarding the process, options, medical uses, risks, and |
| 28 | benefits of umbilical cord blood collection; providing an |
| 29 | effective date. |
| 30 |
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| 31 | Be It Enacted by the Legislature of the State of Florida: |
| 32 |
|
| 33 | Section 1. Section 381.99, Florida Statutes, is created to |
| 34 | read: |
| 35 | 381.99 Florida Hope Offered through Principled, Ethically |
| 36 | Sound Stem Cell Research Act.-- |
| 37 | (1) SHORT TITLE.--This section may be cited as the |
| 38 | "Florida Hope Offered through Principled, Ethically Sound Stem |
| 39 | Cell Research Act." |
| 40 | (2) DEFINITIONS.--As used in this section, the term: |
| 41 | (a) "Adult stem cell" means a cell found within |
| 42 | differentiated tissue or an organ that can renew itself and give |
| 43 | rise to the major cell types of the tissue or organ. This |
| 44 | includes cells from the fetal to adult stages of development, |
| 45 | including bone marrow. |
| 46 | (b) "Amniotic stem cell" means a stem cell extracted from |
| 47 | human amniotic fluid. |
| 48 | (c) "Cord blood stem cell" means a stem cell extracted |
| 49 | from a human umbilical cord. |
| 50 | (d) "Placental stem cell" means a stem cell extracted from |
| 51 | a human placenta. |
| 52 | (e) "Embryonic stem cell" means a stem cell obtained from |
| 53 | the undifferentiated inner mass of an early stage embryo. |
| 54 | (f) "Stem cell" means a cell that can renew itself and |
| 55 | retains the potential to generate some or all other cell types. |
| 56 | (3) STEM CELL RESEARCH AND ETHICS ADVISORY COUNCIL.--There |
| 57 | is created the Stem Cell Research and Ethics Advisory Council |
| 58 | within the Department of Health. |
| 59 | (a)1. The advisory council shall consist of the Secretary |
| 60 | of Health or his or her designee, who shall act as chair, and |
| 61 | six additional members, who shall be appointed as follows: |
| 62 | a. Two persons appointed by the Governor, one of whom |
| 63 | shall be an academic researcher in the field of stem cell |
| 64 | research and one of whom shall have a background in bioethics. |
| 65 | b. One person appointed by the President of the Senate, |
| 66 | who shall have a background in private-sector stem cell funding |
| 67 | and development or public-sector biomedical research and |
| 68 | funding. |
| 69 | c. One person appointed by the Speaker of the House of |
| 70 | Representatives, who shall have a background in private-sector |
| 71 | stem cell funding and development or public-sector biomedical |
| 72 | research and funding. |
| 73 | d. One person appointed by the President of the Senate, |
| 74 | who shall have a background and experience in either public- |
| 75 | sector or private-sector stem cell research and development. |
| 76 | e. One person appointed by the Speaker of the House of |
| 77 | Representatives, who shall be an executive of a biotech company, |
| 78 | or his or her designee. |
| 79 | 2. Each member shall demonstrate knowledge and |
| 80 | understanding of the ethical, medical, and scientific |
| 81 | implications of stem cell research. Each member shall serve a |
| 82 | term of 2 years commencing on July 15, 2007. No member shall |
| 83 | serve for more than two consecutive 2-year terms; however, for |
| 84 | the purpose of providing staggered terms, of the initial |
| 85 | appointments, three members shall be appointed to a 1-year term |
| 86 | and three members shall be appointed to a 2-year term. Any |
| 87 | vacancy on the advisory council shall be filled in the same |
| 88 | manner as the original appointment. All initial appointments |
| 89 | shall be made by July 15, 2007. The first meeting shall take |
| 90 | place no later than August 15, 2007. All meetings are subject to |
| 91 | the call of the chair. Members shall meet at least twice a year |
| 92 | or as often as necessary to discharge their duties but shall |
| 93 | have no more than four meetings during any 12-month period. |
| 94 | Members shall serve without compensation but may be reimbursed |
| 95 | for per diem and travel expenses in accordance with s. 112.061, |
| 96 | subject to a specific appropriation in the General |
| 97 | Appropriations Act. |
| 98 | (b) The advisory council shall: |
| 99 | 1. Develop a donated funds program for recommendation to |
| 100 | the Secretary of Health to encourage the development of funds |
| 101 | other than state appropriations for human adult, amniotic, cord |
| 102 | blood, and placental stem cell research in the state. |
| 103 | 2. Examine and identify specific ways to improve and |
| 104 | promote for-profit and not-for-profit human adult, amniotic, |
| 105 | cord blood, and placental stem cell and related research in the |
| 106 | state, including, but not limited to, identifying both public |
| 107 | and private funding sources for such research, maintaining |
| 108 | existing human adult, amniotic, cord blood, and placental stem |
| 109 | cell-related businesses, recruiting new human adult, amniotic, |
| 110 | cord blood, and placental stem cell-related businesses to the |
| 111 | state, and recruiting scientists and researchers in such fields |
| 112 | to the state and state universities. |
| 113 | 3. Develop a biomedical research grant program for |
| 114 | recommendation to the Secretary of Health that shall provide |
| 115 | grants-in-aid to eligible state institutions for the advancement |
| 116 | of human adult, amniotic, cord blood, and placental stem cell |
| 117 | research. |
| 118 | 4. Develop, no later than September 15, 2007, an |
| 119 | application for grants-in-aid under this section for |
| 120 | recommendation to the Secretary of Health for the purpose of |
| 121 | conducting human adult, amniotic, cord blood, and placental stem |
| 122 | cell research. |
| 123 | 5. Review applications from eligible institutions for |
| 124 | grants-in-aid on and after September 15, 2007, and provide to |
| 125 | the Secretary of Health recommendations for grant awards. |
| 126 | 6. Review the stem cell research conducted by eligible |
| 127 | institutions that receive such grants-in-aid. |
| 128 | 7. Review all stem cell research that is funded or |
| 129 | supported in any manner through the Biomedical Research Trust |
| 130 | Fund to ensure the adherence to ethical and safety guidelines |
| 131 | and procedures as set forth by federal ethical standards |
| 132 | established by the United States Department of Health and Human |
| 133 | Services. |
| 134 | (c) The advisory council shall submit an annual progress |
| 135 | report on the status of biomedical research in the state to the |
| 136 | Florida Center for Universal Research to Eradicate Disease and |
| 137 | to the Governor, the Secretary of Health, the President of the |
| 138 | Senate, and the Speaker of the House of Representatives by June |
| 139 | 30. The report must include: |
| 140 | 1. The amount of grants-in-aid awarded to eligible |
| 141 | institutions from the Biomedical Research Trust Fund. |
| 142 | 2. The names of the recipients of such grants-in-aid. |
| 143 | 3. The current status and progress of stem cell research |
| 144 | in the state. |
| 145 | 4. A list of research projects supported by grants-in-aid |
| 146 | awarded under the program. |
| 147 | 5. A list of publications in peer-reviewed journals |
| 148 | involving research supported by grants-in-aid awarded under the |
| 149 | program. |
| 150 | 6. The total amount of biomedical research funding |
| 151 | currently flowing into the state. |
| 152 | 7. New grants for biomedical research that were funded |
| 153 | based on research supported by grants-in-aid awarded under the |
| 154 | program. |
| 155 | 8. All other materials the advisory council deems |
| 156 | advisable to include. |
| 157 | (d) Advisory council members shall disclose any conflict |
| 158 | of interest or potential conflict of interest to the Secretary |
| 159 | of Health. |
| 160 | (e) The Department of Health shall provide administrative |
| 161 | staff to assist the advisory council in developing the |
| 162 | application for the grants-in-aid, reviewing the applications, |
| 163 | preparing the written consent form described in paragraph |
| 164 | (5)(b), and performing other administrative functions as the |
| 165 | advisory council requires. |
| 166 | (4) BIOMEDICAL RESEARCH TRUST FUND AND GRANTS-IN-AID.-- |
| 167 | (a) The Secretary of Health shall make grants-in-aid from |
| 168 | the Biomedical Research Trust Fund in accordance with the |
| 169 | provisions of this section, subject to a specific appropriation |
| 170 | in the General Appropriations Act. |
| 171 | (b) The Department of Health shall require any applicant |
| 172 | for a grant-in-aid under this section, for the purpose of |
| 173 | conducting stem cell research, to submit a complete description |
| 174 | of the applicant's organization, the applicant's plans for stem |
| 175 | cell research, the applicant's proposed funding for such |
| 176 | research from sources other than the state, and the applicant's |
| 177 | proposed arrangements concerning financial benefits to the state |
| 178 | as a result of any patent, royalty payment, or similar right |
| 179 | resulting from any stem cell research made possible by the |
| 180 | awarding of the grant-in-aid. The advisory council shall provide |
| 181 | recommendation to the Secretary of Health with respect to |
| 182 | awarding such grants-in-aid. |
| 183 | (5) USE OF FUNDS; REQUIREMENTS AND RESTRICTIONS.-- |
| 184 | (a) Funds provided under this section may only be used for |
| 185 | research involving: |
| 186 | 1. Human adult stem cells. Funding for research may be |
| 187 | given for human adult stem cells derived from postmortem |
| 188 | tissues, other than from medically induced abortions. Funds may |
| 189 | be used for studies of human adult stem cells obtained from |
| 190 | either normal or transformed tissues. |
| 191 | 2. Amniotic stem cells extracted from human amniotic fluid |
| 192 | that are otherwise discarded after birth. |
| 193 | 3. Cord blood stem cells extracted from a human umbilical |
| 194 | cord that are otherwise discarded after birth. |
| 195 | 4. Placental stem cells extracted from a human placenta |
| 196 | that are otherwise discarded after birth. |
| 197 | (b) Adult, amniotic, cord blood, and placental stem cell |
| 198 | material may only be donated for research purposes with the |
| 199 | informed consent of the donor. |
| 200 | (c) No funds shall be used for research with human |
| 201 | embryonic stem cells that are derived by a process entailing the |
| 202 | donor embryo's death or destruction. |
| 203 | (d) Funds provided under this section may only be used for |
| 204 | research that is conducted in facilities located in this state. |
| 205 | Section 2. Paragraph (h) of subsection (1) of section |
| 206 | 20.435, Florida Statutes, is amended to read: |
| 207 | 20.435 Department of Health; trust funds.-- |
| 208 | (1) The following trust funds are hereby created, to be |
| 209 | administered by the Department of Health: |
| 210 | (h) Biomedical Research Trust Fund. |
| 211 | 1. Funds to be credited to the trust fund shall consist of |
| 212 | funds deposited pursuant to ss. s. 215.5601, 288.955, and 381.99 |
| 213 | and any other funds appropriated by the Legislature. Funds shall |
| 214 | be used for the purposes of the James and Esther King Biomedical |
| 215 | Research Program, and the William G. "Bill" Bankhead, Jr., and |
| 216 | David Coley Cancer Research Program, and the Florida Hope |
| 217 | Offered through Principled, Ethically Sound Stem Cell Research |
| 218 | Act as specified in ss. 215.5602, 288.955, and 381.922, and |
| 219 | 381.99. The trust fund is exempt from the service charges |
| 220 | imposed by s. 215.20. |
| 221 | 2. Notwithstanding the provisions of s. 216.301 and |
| 222 | pursuant to s. 216.351, any balance in the trust fund at the end |
| 223 | of any fiscal year shall remain in the trust fund at the end of |
| 224 | the year and shall be available for carrying out the purposes of |
| 225 | the trust fund. The department may invest these funds |
| 226 | independently through the Chief Financial Officer or may |
| 227 | negotiate a trust agreement with the State Board of |
| 228 | Administration for the investment management of any balance in |
| 229 | the trust fund. |
| 230 | 3. Notwithstanding s. 216.301 and pursuant to s. 216.351, |
| 231 | any balance of any appropriation from the Biomedical Research |
| 232 | Trust Fund which is not disbursed but which is obligated |
| 233 | pursuant to contract or committed to be expended may be carried |
| 234 | forward for up to 3 years following the effective date of the |
| 235 | original appropriation. |
| 236 | 4. The trust fund shall, unless terminated sooner, be |
| 237 | terminated on July 1, 2008. |
| 238 | Section 3. Subsection (1) of section 381.86, Florida |
| 239 | Statutes, is amended to read: |
| 240 | 381.86 Institutional Review Board.-- |
| 241 | (1) The Institutional Review Board is created within the |
| 242 | Department of Health in order to satisfy federal requirements |
| 243 | under 45 C.F.R. part 46 and 21 C.F.R. parts 50 and 56 that an |
| 244 | institutional review board review all biomedical and behavioral |
| 245 | research on human subjects which is funded or supported in any |
| 246 | manner by the department, except that a separate Stem Cell |
| 247 | Research and Ethics Advisory Council shall be appointed under s. |
| 248 | 381.99. |
| 249 | Section 4. (1) The Department of Health shall prepare an |
| 250 | educational publication, subject to a specific appropriation in |
| 251 | the General Appropriations Act, that includes objective |
| 252 | information regarding: |
| 253 | (a) The medical processes involved in the collection of |
| 254 | umbilical cord blood; |
| 255 | (b) The medical risks to the mother and her newborn child |
| 256 | of umbilical cord blood collection; |
| 257 | (c) The options available to a mother relating to stem |
| 258 | cells that are contained in the umbilical cord blood after the |
| 259 | delivery of her newborn, including: |
| 260 | 1. Discarding the stem cells; |
| 261 | 2. Donating the stem cells to a public umbilical cord |
| 262 | blood bank; |
| 263 | 3. Storing the stem cells in a family or private umbilical |
| 264 | cord blood bank for use by family members; or |
| 265 | 4. Storing the stem cells for family use through a family |
| 266 | or sibling donor banking program that provides free collection, |
| 267 | processing, and storage where there is a medical need; |
| 268 | (d) The current and potential future medical uses, risks, |
| 269 | and benefits of umbilical cord blood collection to a mother, her |
| 270 | newborn child, and her biological family; |
| 271 | (e) The current and potential future medical uses, risks, |
| 272 | and benefits of umbilical cord blood collection to persons who |
| 273 | are not biologically related to a mother or her newborn child; |
| 274 | (f) Any costs that may be incurred by a pregnant woman who |
| 275 | chooses to make an umbilical cord blood donation; |
| 276 | (g) Options for ownership and future use of the donated |
| 277 | umbilical cord blood; and |
| 278 | (h) The average cost of public and private umbilical cord |
| 279 | blood banking. |
| 280 | (2) The department shall update the publication as |
| 281 | necessary. |
| 282 | (3) The department shall distribute the publication free |
| 283 | of charge to physicians and health care institutions on request |
| 284 | and shall make the publication available on its website in a |
| 285 | printable format. |
| 286 | (4) The department shall encourage health and maternal |
| 287 | care professionals providing health care services to a pregnant |
| 288 | woman, when those health care services are directly related to |
| 289 | her pregnancy, to provide the pregnant woman with the |
| 290 | publication by the end of her second trimester. |
| 291 | Section 5. This act shall take effect July 1, 2007. |