| 1 | A bill to be entitled |
| 2 | An act relating to biomedical research; amending s. |
| 3 | 20.435, F.S.; deleting a reference to conform to the |
| 4 | provisions of this act; amending s. 215.5601, F.S.; |
| 5 | revising a provision relating to the Lawton Chiles |
| 6 | Endowment Fund to conform to the provisions in this act; |
| 7 | amending s. 215.5602, F.S.; providing legislative findings |
| 8 | and intent; revising provisions relating to the James and |
| 9 | Esther King Biomedical Research Program; revising |
| 10 | provisions relating to program funds and funding; revising |
| 11 | long-term goals of the program; revising membership |
| 12 | provisions relating to the Biomedical Research Advisory |
| 13 | Council; providing that the council serves as the |
| 14 | exclusive source of certain biomedical research grant and |
| 15 | fellowship awards; requiring the council to create |
| 16 | committees; providing requirements for the committees; |
| 17 | revising duties of the council; deleting references to |
| 18 | conform to the provisions of this act; revising a |
| 19 | requirement relating to the council's annual progress |
| 20 | report; prohibiting the use of funds for certain research |
| 21 | with human embryonic stem cells or for human cloning; |
| 22 | amending s. 381.853, F.S.; providing a requirement for the |
| 23 | Florida Center for Brain Tumor Research relating to the |
| 24 | use of state-appropriated funds for biomedical research; |
| 25 | amending ss. 381.912 and 381.98, F.S.; revising references |
| 26 | to conform to the provisions of this act; amending s. |
| 27 | 381.922, F.S.; creating the William G. "Bill" Bankhead, |
| 28 | Jr., and David Coley Cancer Research Council, also cited |
| 29 | as the "Bankhead-Coley Cancer Council," within the |
| 30 | Department of Health; providing for duties and functions |
| 31 | of the council; providing for membership; providing a |
| 32 | requirement for the council to issue an annual report; |
| 33 | creating s. 381.923, F.S.; providing the mission and |
| 34 | duties of the Bankhead-Coley Cancer Council; amending s. |
| 35 | 430.501, F.S.; providing a requirement for the Alzheimer's |
| 36 | Disease Advisory Committee relating to the use of state- |
| 37 | appropriated funds for biomedical research grants or |
| 38 | fellowships; amending s. 430.502, F.S.; requiring memory |
| 39 | disorder clinics supported by state funds to apply for a |
| 40 | biomedical research grant or fellowship through the James |
| 41 | and Esther King Biomedical Research Program; amending s. |
| 42 | 1004.445, F.S.; deleting requirements relating to a |
| 43 | competitive grant process for Alzheimer's disease |
| 44 | research; providing a requirement for the Johnnie B. Byrd, |
| 45 | Sr., Alzheimer's Center and Research Institute relating to |
| 46 | the use of state-appropriated funds for biomedical |
| 47 | research grants or fellowships; repealing s. 381.855, |
| 48 | F.S., relating to the Florida Center for Universal |
| 49 | Research to Eradicate Disease; repealing s. 381.92, F.S., |
| 50 | relating to the Florida Cancer Council; repealing s. |
| 51 | 381.921, F.S., relating to the Florida Cancer Council's |
| 52 | mission and duties; providing for severability; providing |
| 53 | an effective date. |
| 54 |
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| 55 | WHEREAS, the Legislature finds that the health of |
| 56 | Floridians is of utmost importance, and |
| 57 | WHEREAS, continuing and promoting biomedical research in |
| 58 | the state is key to finding cures for the most deadly and |
| 59 | widespread acute, chronic, and degenerative diseases affecting |
| 60 | millions of Floridians, and |
| 61 | WHEREAS, there are a number of agencies, councils, |
| 62 | committees, and other nonprofit entities within the state that |
| 63 | are currently awarding state dollars for grants or fellowships |
| 64 | for biomedical research in order to find cures for and improve |
| 65 | treatment of various diseases affecting Floridians, and |
| 66 | WHEREAS, the most effective and efficient use of state |
| 67 | biomedical research dollars is to establish a single, |
| 68 | comprehensive program to review grant and fellowship proposals |
| 69 | and make recommendations to the Legislature for funding of |
| 70 | biomedical research grants and fellowships using state- |
| 71 | appropriated funds, and |
| 72 | WHEREAS, the consolidated process for awarding state-funded |
| 73 | grants and fellowships for biomedical research in the state of |
| 74 | Florida will also serve to enhance, encourage, and coordinate |
| 75 | biomedical research programs within the state and foster |
| 76 | improved transfer of research findings into clinical trials and |
| 77 | widespread public use, NOW, THEREFORE, |
| 78 |
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| 79 | Be It Enacted by the Legislature of the State of Florida: |
| 80 |
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| 81 | Section 1. Paragraph (h) of subsection (1) of section |
| 82 | 20.435, Florida Statutes, is amended to read: |
| 83 | 20.435 Department of Health; trust funds.-- |
| 84 | (1) The following trust funds are hereby created, to be |
| 85 | administered by the Department of Health: |
| 86 | (h) Biomedical Research Trust Fund. |
| 87 | 1. Funds to be credited to the trust fund shall consist of |
| 88 | funds deposited pursuant to s. 215.5601 and any other funds |
| 89 | appropriated by the Legislature. Funds shall be used for the |
| 90 | purposes of the James and Esther King Biomedical Research |
| 91 | Program and the William G. "Bill" Bankhead, Jr., and David Coley |
| 92 | Cancer Research Program as specified in ss. 215.5602 and, |
| 93 | 288.955, and 381.922. The trust fund is exempt from the service |
| 94 | charges imposed by s. 215.20. |
| 95 | 2. Notwithstanding the provisions of s. 216.301 and |
| 96 | pursuant to s. 216.351, any balance in the trust fund at the end |
| 97 | of any fiscal year shall remain in the trust fund at the end of |
| 98 | the year and shall be available for carrying out the purposes of |
| 99 | the trust fund. The department may invest these funds |
| 100 | independently through the Chief Financial Officer or may |
| 101 | negotiate a trust agreement with the State Board of |
| 102 | Administration for the investment management of any balance in |
| 103 | the trust fund. |
| 104 | 3. Notwithstanding s. 216.301 and pursuant to s. 216.351, |
| 105 | any balance of any appropriation from the Biomedical Research |
| 106 | Trust Fund which is not disbursed but which is obligated |
| 107 | pursuant to contract or committed to be expended may be carried |
| 108 | forward for up to 3 years following the effective date of the |
| 109 | original appropriation. |
| 110 | 4. The trust fund shall, unless terminated sooner, be |
| 111 | terminated on July 1, 2008. |
| 112 | Section 2. Paragraph (d) of subsection (1) of section |
| 113 | 215.5601, Florida Statutes, is amended to read: |
| 114 | 215.5601 Lawton Chiles Endowment Fund.-- |
| 115 | (1) LEGISLATIVE INTENT.--It is the intent of the |
| 116 | Legislature to: |
| 117 | (d) Provide funds to help support public-health and |
| 118 | biomedical research for the prevention, diagnosis, treatment, |
| 119 | and cure of diseases related to tobacco use by creating an |
| 120 | annual and perpetual source of funding for biomedical research |
| 121 | in the state through the James and Esther King Biomedical |
| 122 | Research Program in order to expand the foundation of biomedical |
| 123 | knowledge relating to the prevention, diagnosis, treatment, and |
| 124 | cure of diseases related to tobacco use, including cancer, |
| 125 | cardiovascular disease, stroke, and pulmonary disease; improve |
| 126 | the quality of the state's academic health centers by bringing |
| 127 | the advances of biomedical research into the training of |
| 128 | physicians and other health care providers; and increase the |
| 129 | state's per capita funding for biomedical research by |
| 130 | undertaking new initiatives in biomedical research which will |
| 131 | attract additional funding from outside the state while also |
| 132 | stimulating economic activity in the state in areas related to |
| 133 | biomedical research, such as the research and production of |
| 134 | pharmaceuticals, biotechnology, and medical devices. |
| 135 | Section 3. Section 215.5602, Florida Statutes, is amended |
| 136 | to read: |
| 137 | 215.5602 James and Esther King Biomedical Research |
| 138 | Program.-- |
| 139 | (1) The Legislature finds that an estimated 128 million |
| 140 | Americans suffer from acute, chronic, and degenerative diseases |
| 141 | and that biomedical research is the key to finding cures for |
| 142 | these diseases that affect Floridians. The Legislature further |
| 143 | finds that the biomedical technology sector meets the criteria |
| 144 | of a high-impact sector, pursuant to s. 288.108, having high |
| 145 | importance to this state's economy with a significant potential |
| 146 | for growth and contribution to the state's universities and |
| 147 | quality of life. |
| 148 | (2) It is the intent of the Legislature that this state |
| 149 | strive to become the nation's leader in biomedical research and |
| 150 | commit itself to being the state to find cures for the most |
| 151 | deadly and widespread diseases. Moreover, it is the intent of |
| 152 | the Legislature to expand the state's economy by attracting |
| 153 | biomedical researchers and research companies to this state. |
| 154 | (3)(1) There is established within the Department of |
| 155 | Health the James and Esther King Biomedical Research Program |
| 156 | funded by the proceeds of the Lawton Chiles Endowment Fund |
| 157 | pursuant to s. 215.5601 and the Biomedical Research Trust Fund |
| 158 | within the Department of Health pursuant to s. 20.435(1)(h). The |
| 159 | purpose of the James and Esther King Biomedical Research program |
| 160 | is to provide an annual and perpetual source of funding for |
| 161 | biomedical in order to support research initiatives that address |
| 162 | the health care problems of Floridians in the areas of tobacco- |
| 163 | related cancer, cardiovascular disease, stroke, and pulmonary |
| 164 | disease. The long-term goals of the program are to: |
| 165 | (a) Improve the health of Floridians by researching better |
| 166 | prevention, diagnoses, treatments, and cures for the most deadly |
| 167 | and widespread diseases, including, but not limited to, tobacco- |
| 168 | related diseases, cancer, cardiovascular disease, stroke, and |
| 169 | pulmonary disease, diabetes, autoimmune disorders, and |
| 170 | neurological disorders, including Alzheimer's disease, epilepsy, |
| 171 | and Parkinson's disease. |
| 172 | (b) Expand the foundation of biomedical knowledge relating |
| 173 | to the prevention, diagnosis, treatment, and cure of diseases |
| 174 | related to tobacco use, including cancer, cardiovascular |
| 175 | disease, stroke, and pulmonary disease. |
| 176 | (c) Expand the foundation of biomedical knowledge relating |
| 177 | to the prevention, diagnosis, treatment, and cure of the most |
| 178 | deadly and widespread diseases affecting Floridians. |
| 179 | (d)(c) Improve the quality of the state's academic health |
| 180 | centers by bringing the advances of biomedical research into the |
| 181 | training of physicians and other health care providers. |
| 182 | (e)(d) Increase the state's per capita funding for |
| 183 | research by undertaking new initiatives in public health and |
| 184 | biomedical research that will attract additional funding from |
| 185 | outside the state. |
| 186 | (f)(e) Stimulate economic activity in the state in areas |
| 187 | related to biomedical research, such as the research and |
| 188 | production of pharmaceuticals, biotechnology, and medical |
| 189 | devices. |
| 190 | (g) Facilitate communication among biomedical researchers |
| 191 | and health care providers in order to ensure an ongoing dialogue |
| 192 | between researchers, treatment providers, and the department. |
| 193 | (h) Coordinate, improve, expand, and monitor all |
| 194 | biomedical research programs within the state, facilitate |
| 195 | funding opportunities, and foster improved technology transfer |
| 196 | of research findings into clinical trials and widespread public |
| 197 | use. |
| 198 | (i) Hold periodic biomedical technology summits in this |
| 199 | state at which biomedical researchers, biomedical technology |
| 200 | companies, business incubators, pharmaceutical manufacturers, |
| 201 | and others around the nation and world are invited to share |
| 202 | biomedical research findings in order to expedite the discovery |
| 203 | of cures. Summit attendees shall cover the costs of such |
| 204 | attendance or obtain sponsorship for such attendance. |
| 205 | (j) Encourage clinical trials in this state on research |
| 206 | that holds promise of curing a disease or condition. |
| 207 | (k) Encourage partnerships among researchers in this state |
| 208 | and institutions in other states and countries in which research |
| 209 | with rare plants or animals could lead to cures. |
| 210 | (l) Encourage agricultural colleges and agricultural |
| 211 | businesses in this state to be active in the search for cures |
| 212 | and in providing information to the public about disease |
| 213 | prevention. |
| 214 | (m) Encourage partnerships among researchers working to |
| 215 | cure all types of diseases, including those that are prevalent |
| 216 | in developed countries and those that occur mainly in developing |
| 217 | countries. |
| 218 | (n) Encourage the discovery and production in this state |
| 219 | of vaccines that prevent disease. |
| 220 | (4)(2) Funds appropriated for the James and Esther King |
| 221 | Biomedical Research Program shall be used exclusively for the |
| 222 | award of grants and fellowships as established in this section; |
| 223 | for research relating to the prevention, diagnosis, treatment, |
| 224 | and cure of diseases affecting Floridians related to tobacco |
| 225 | use, including cancer, cardiovascular disease, stroke, and |
| 226 | pulmonary disease; and for expenses incurred in the |
| 227 | administration of this section. Priority shall be granted to |
| 228 | research designed to prevent or cure disease. Beginning July 1, |
| 229 | 2008, funds appropriated for the James and Esther King |
| 230 | Biomedical Research Program shall be the exclusive source of |
| 231 | state funds used for the award of biomedical research grants and |
| 232 | fellowships in this state, as established in this section; for |
| 233 | research relating to the prevention, diagnosis, treatment, and |
| 234 | cure of diseases affecting Floridians; and for expenses incurred |
| 235 | in the administration of this section. |
| 236 | (5)(3) There is created within the James and Esther King |
| 237 | Biomedical Research Program in the Department of Health the |
| 238 | Biomedical Research Advisory Council. |
| 239 | (a) The council shall consist of 36 11 members, including: |
| 240 | the Secretary of the Department of Health, or a designee; the |
| 241 | chief executive officer of Enterprise Florida, Inc., or a |
| 242 | designee; the chief executive officer of the Florida Division of |
| 243 | the American Cancer Society, or a designee; the chief executive |
| 244 | officer of the Florida/Puerto Rico Affiliate of the American |
| 245 | Heart Association, or a designee; and the chief executive |
| 246 | officer of the American Lung Association of Florida, or a |
| 247 | designee; the chief executive officer of the H. Lee Moffitt |
| 248 | Cancer Center, or a designee; the director of the University of |
| 249 | Florida Shands Cancer Center, or a designee; the chief executive |
| 250 | officer of the University of Miami Sylvester Comprehensive |
| 251 | Cancer Center, or a designee; the chief executive officer of the |
| 252 | Mayo Clinic, Jacksonville, or a designee; the president of the |
| 253 | Florida Society of Clinical Oncology, or a designee; the |
| 254 | president of the American College of Surgeons, Florida Chapter, |
| 255 | or a designee; and the chair of the Florida Dialogue on Cancer, |
| 256 | or a designee. The remaining 24 8 members of the council shall |
| 257 | be appointed as follows: |
| 258 | 1. The Governor shall appoint twelve four members, two |
| 259 | members with expertise in the field of biomedical research, one |
| 260 | member from a research university in the state, one |
| 261 | representative of the Epilepsy Foundation, one representative of |
| 262 | the Florida Medical Foundation, one representative of the |
| 263 | American Liver Foundation, one representative of the Florida |
| 264 | Academy of Family Physicians, one public health academic, one |
| 265 | representative of the Florida Public Health Association, one |
| 266 | representative of the Florida Council for Behavioral Health |
| 267 | Care, Inc., one representative of the Florida Association of |
| 268 | County Health Officers, and one member representing the general |
| 269 | population of the state. |
| 270 | 2. The President of the Senate shall appoint six two |
| 271 | members, one former member of the Senate, one member with |
| 272 | expertise in the field of behavioral or social research, one |
| 273 | representative of BioFlorida, one representative of |
| 274 | Pharmaceutical Research and Manufacturers of America, one |
| 275 | representative of the South Coastal Region of the American |
| 276 | Diabetes Association, and one representative from a cancer |
| 277 | program approved by the American College of Surgeons. |
| 278 | 3. The Speaker of the House of Representatives shall |
| 279 | appoint six two members, one former member of the House of |
| 280 | Representatives, one representative of the National Parkinson |
| 281 | Foundation, one representative of the Alzheimer's Association, |
| 282 | one representative of the Florida Research Consortium, one |
| 283 | member from a professional medical organization, and one |
| 284 | representative from a cancer program approved by the American |
| 285 | College of Surgeons. |
| 286 |
|
| 287 | In making these appointments, the Governor, the President of the |
| 288 | Senate, and the Speaker of the House of Representatives shall |
| 289 | select primarily, but not exclusively, Floridians with |
| 290 | biomedical and lay expertise in the general areas of cancer, |
| 291 | cardiovascular disease, stroke, and pulmonary disease, diabetes, |
| 292 | autoimmune disorders, and neurological disorders, including |
| 293 | Alzheimer's disease, epilepsy, and Parkinson's disease. The |
| 294 | appointments shall be for a 3-year term and shall reflect the |
| 295 | diversity of the state's population. An appointed member may not |
| 296 | serve more than two consecutive terms. |
| 297 | (b) Beginning July 1, 2008, the council shall serve as the |
| 298 | exclusive source of awarding or recommending the award of grants |
| 299 | or fellowships for biomedical research in the state using state- |
| 300 | appropriated funds. This paragraph shall not preclude another |
| 301 | grant or fellowship program in the state from awarding grants |
| 302 | from funds received from private or federal sources where |
| 303 | permitted by state law. |
| 304 | (c)1. The council shall create the following committees, |
| 305 | and may create other committees as it deems necessary: |
| 306 | a. Committee on Tobacco-related Diseases. |
| 307 | b. Bankhead-Coley Committee on Cancer. |
| 308 | c. Committee on Strokes. |
| 309 | d. Committee on Cardiovascular Disease. |
| 310 | e. Committee on Pulmonary Disease. |
| 311 | f. Committee on Diabetes. |
| 312 | g. Committee on Autoimmune Disorders. |
| 313 | h. Johnnie B. Byrd, Sr., Committee on Alzheimer's Disease. |
| 314 | i. Committee on Parkinson's Disease. |
| 315 | j. Committee on Neurological Disorders. |
| 316 | 2. The committees shall be comprised of council members |
| 317 | and shall focus on issues and proposed research related to that |
| 318 | committee. The committees shall report findings and make |
| 319 | recommendations to the council regarding the award of grants and |
| 320 | the areas of focus or need for future grants and fellowships. |
| 321 | (d)(b) The council shall adopt internal organizational |
| 322 | procedures as necessary for its efficient organization, |
| 323 | including procedures for assigning council members to committees |
| 324 | and coordination between the council and committees. |
| 325 | (e)(c) The department shall provide such staff, |
| 326 | information, and other assistance as is reasonably necessary to |
| 327 | assist the council, including its committees, in carrying out |
| 328 | its responsibilities. |
| 329 | (f)(d) Members of the council shall serve without |
| 330 | compensation, but may receive reimbursement as provided in s. |
| 331 | 112.061 for travel and other necessary expenses incurred in the |
| 332 | performance of their official duties. |
| 333 | (6)(4) The council shall, after considering the |
| 334 | recommendations of its committees, determine advise the |
| 335 | Secretary of Health as to the direction and scope of the |
| 336 | biomedical research program. The responsibilities of the council |
| 337 | may include, but are not limited to: |
| 338 | (a) Establishing Providing advice on program priorities |
| 339 | and emphases. |
| 340 | (b) Evaluating the Providing advice on the overall program |
| 341 | budget and making recommendations to the Legislature for future |
| 342 | appropriations. |
| 343 | (c) Conducting Participating in periodic program |
| 344 | evaluation. |
| 345 | (d) Developing Assisting in the development of guidelines |
| 346 | to ensure fairness, neutrality, and adherence to the principles |
| 347 | of merit and quality in the conduct of the program. |
| 348 | (e) Developing Assisting in the development of appropriate |
| 349 | linkages to nonacademic entities, such as voluntary |
| 350 | organizations, health care delivery institutions, industry, |
| 351 | government agencies, and public officials. |
| 352 | (f) Developing criteria and standards for the award of |
| 353 | research grants. |
| 354 | (g) Developing administrative procedures relating to |
| 355 | solicitation, review, and award of research grants and |
| 356 | fellowships, to ensure an impartial, high-quality peer review |
| 357 | system. |
| 358 | (h) Developing and supervising research peer review |
| 359 | panels. |
| 360 | (i) Reviewing reports of peer review panels and making |
| 361 | recommendations for research grants and fellowships. |
| 362 | (j) Developing and providing oversight regarding |
| 363 | mechanisms for the dissemination of research results. |
| 364 | (k) Monitoring the supply and demand needs of researchers |
| 365 | relating to stem cell research and other types of human tissue |
| 366 | research consistent with this section. If the council determines |
| 367 | that there is a need for increased donation of stem cells or |
| 368 | human tissue, it shall notify hospitals licensed pursuant to |
| 369 | chapter 395 that have entered into partnership agreements with |
| 370 | research institutes conducting stem cell research located in the |
| 371 | same geographic region as the researchers needing the stem |
| 372 | cells, placentas, or cord blood. |
| 373 | (l) Maintaining a website with links to peer-reviewed |
| 374 | biomedical research and future opportunities to apply for an |
| 375 | award of a biomedical research grant from the council. The |
| 376 | website shall also contain guidelines for the awarding of grants |
| 377 | and fellowships, including application review procedures, |
| 378 | evaluation criteria, funding methods, and grant administration |
| 379 | procedures. Application forms shall be available on the website |
| 380 | through an online application system. The website shall also |
| 381 | provide a list of all known biomedical research being conducted |
| 382 | in this state and shall facilitate communication among |
| 383 | researchers and other interested parties. |
| 384 | (m) Disseminating breakthrough findings in, and |
| 385 | information about, innovative biomedical research and clinical |
| 386 | trials that will assist in making Floridians and their treatment |
| 387 | providers aware of specified diseases and conditions and |
| 388 | available methods of preventing, diagnosing, treating, and |
| 389 | curing such diseases and conditions. |
| 390 | (7)(5)(a) Applications for biomedical research funding |
| 391 | under the program may be submitted from any university or |
| 392 | established research institute in the state. All qualified |
| 393 | investigators in the state, regardless of institution |
| 394 | affiliation, shall have equal access and opportunity to compete |
| 395 | for the research funding. Beginning September 1, 2007, the James |
| 396 | and Esther King Biomedical Research Program shall establish and |
| 397 | publish on the council's website criteria for the award of |
| 398 | biomedical research grants for fiscal year 2008-2009, which |
| 399 | grants may be awarded to any university or established research |
| 400 | institute in the state. All qualified investigators in the |
| 401 | state, regardless of institution affiliation, shall have equal |
| 402 | access and opportunity to compete for the research funding. |
| 403 | (b) For grants or fellowships related to biomedical |
| 404 | research for fiscal year 2008-2009, the application deadline |
| 405 | shall be posted on the council's website at least 90 days prior |
| 406 | to the deadline. Applicants shall submit a completed and signed |
| 407 | application provided by the council and meet all deadlines. |
| 408 | (c)(b) Beginning in 2008 and continuing each year |
| 409 | thereafter, the council shall submit to the Legislature by |
| 410 | February 1 a priority list of biomedical research projects for |
| 411 | funding by the Legislature based on the applications received. |
| 412 | Recommendations to the Legislature shall be made Grants and |
| 413 | fellowships shall be awarded by the Secretary of Health, after |
| 414 | consultation with the council, on the basis of scientific merit, |
| 415 | as determined by an open competitive peer review process that |
| 416 | ensures objectivity, consistency, and high quality. The |
| 417 | following types of applications shall be considered for funding: |
| 418 | 1. Investigator-initiated research grants. |
| 419 | 2. Institutional research grants. |
| 420 | 3. Predoctoral and postdoctoral research fellowships. |
| 421 | (d) Any program, board, commission, council, advisory |
| 422 | group, or committee created by state law that currently awards |
| 423 | or intends to award in the future grants for biomedical research |
| 424 | programs or any program, board, commission, council, advisory |
| 425 | group, or committee created by state law that facilitates or |
| 426 | recommends the award of biomedical research grants from programs |
| 427 | using state-appropriated funds, shall, for fiscal year 2008-2009 |
| 428 | and any fiscal year thereafter, apply for grants or make |
| 429 | recommendations to the council for the prioritization and award |
| 430 | of grants through the James and Esther King Biomedical Research |
| 431 | Program. |
| 432 | (8)(6) To ensure that all proposals for research funding |
| 433 | are appropriate and are evaluated fairly on the basis of |
| 434 | scientific merit, the Secretary of Health, in consultation with |
| 435 | the council, shall appoint a peer review panel of independent, |
| 436 | scientifically qualified individuals to review the scientific |
| 437 | content of each proposal and establish its scientific priority |
| 438 | score. The priority scores shall be forwarded to the council and |
| 439 | its committees and must be considered in determining which |
| 440 | proposals shall be recommended for funding. |
| 441 | (9)(7) The council, the committees, and the peer review |
| 442 | panel shall establish and follow rigorous guidelines for ethical |
| 443 | conduct and adhere to a strict policy with regard to conflict of |
| 444 | interest. A member of the council or panel may not participate |
| 445 | in any discussion or decision with respect to a research |
| 446 | proposal by any firm, entity, or agency with which the member is |
| 447 | associated as a member of the governing body or as an employee, |
| 448 | or with which the member has entered into a contractual |
| 449 | arrangement. Meetings of the council and the peer review panels |
| 450 | shall be subject to the provisions of chapter 119, s. 286.011, |
| 451 | and s. 24, Art. I of the State Constitution. |
| 452 | (10) The council shall take into consideration the |
| 453 | following factors when prioritizing grant or fellowship awards: |
| 454 | (a) Research applications that appear to have the most |
| 455 | profound impact on the most deadly and widespread diseases |
| 456 | affecting Floridians at the time the grant or fellowship is |
| 457 | awarded. |
| 458 | (b) Research applications that meet the priorities of the |
| 459 | program while proposing the best and most efficient use of state |
| 460 | funds. |
| 461 | (11)(8) The department may contract on a competitive-bid |
| 462 | basis with an appropriate entity to administer the program. |
| 463 | Administrative expenses may not exceed 15 percent of the total |
| 464 | funds available to the program in any given year. |
| 465 | (12)(9) The department, after consultation with the |
| 466 | council, may adopt rules pursuant to ss. 120.536(1) and 120.54 |
| 467 | as necessary to implement this section. |
| 468 | (13)(10) In addition to its recommendations to the |
| 469 | Legislature to award grants pursuant to its priority list |
| 470 | submitted by February 1 of each year, the council shall submit |
| 471 | an annual progress report on the state of biomedical research in |
| 472 | this state to the Florida Center for Universal Research to |
| 473 | Eradicate Disease and to the Governor, the Secretary of Health, |
| 474 | the President of the Senate, and the Speaker of the House of |
| 475 | Representatives by February 1. The report must include: |
| 476 | (a) A list of research projects supported by grants or |
| 477 | fellowships awarded under the program. |
| 478 | (b) A list of recipients of program grants or fellowships. |
| 479 | (c) A list of publications in peer reviewed journals |
| 480 | involving research supported by grants or fellowships awarded |
| 481 | under the program. |
| 482 | (d) The total amount of biomedical research funding |
| 483 | currently flowing into the state. |
| 484 | (e) New grants for biomedical research which were funded |
| 485 | based on research supported by grants or fellowships awarded |
| 486 | under the program. |
| 487 | (f) Progress in the prevention, diagnosis, treatment, and |
| 488 | cure of the most deadly and widespread diseases, including |
| 489 | cancer, cardiovascular disease, stroke, pulmonary disease, |
| 490 | diabetes, autoimmune disorders, and neurological disorders, |
| 491 | including Alzheimer's disease, epilepsy, and Parkinson's disease |
| 492 | diseases related to tobacco use, including cancer, |
| 493 | cardiovascular disease, stroke, and pulmonary disease. |
| 494 | (11) The council shall award grants for cancer research |
| 495 | through the William G. "Bill" Bankhead, Jr., and David Coley |
| 496 | Cancer Research Program created in s. 381.922. |
| 497 | (14)(12) Beginning in fiscal year 2006-2007 and ending |
| 498 | June 30, 2007, the sum of $6 million is appropriated annually |
| 499 | from recurring funds in the General Revenue Fund to the |
| 500 | Biomedical Research Trust Fund within the Department of Health |
| 501 | for purposes of the James and Esther King Biomedical Research |
| 502 | Program pursuant to this section. From these funds up to |
| 503 | $500,000 $250,000 shall be available for the operating costs of |
| 504 | the James and Esther King Biomedical Research Program Florida |
| 505 | Center for Universal Research to Eradicate Disease. Beginning in |
| 506 | fiscal year 2008-2009, the Legislature may appropriate funds |
| 507 | from recurring funds in the General Revenue Fund to the |
| 508 | Biomedical Research Trust Fund within the department for |
| 509 | purposes of the James and Esther King Biomedical Research |
| 510 | Program. From any funds that may be appropriated by the |
| 511 | Legislature, up to $500,000 shall be available for the operating |
| 512 | costs of the James and Esther King Biomedical Research Program. |
| 513 | Any biomedical research grants awarded pursuant to this section |
| 514 | for cancer research shall be named "Bankhead-Coley Cancer |
| 515 | Research Grants," and any research grants awarded pursuant to |
| 516 | this section for Alzheimer's research shall be named "Johnnie B. |
| 517 | Byrd, Sr., Alzheimer's Grants." |
| 518 | (15)(13) By June 1, 2009, the Division of Statutory |
| 519 | Revision of the Office of Legislative Services shall certify to |
| 520 | the President of the Senate and the Speaker of the House of |
| 521 | Representatives the language and statutory citation of this |
| 522 | section, which is scheduled to expire January 1, 2011. |
| 523 | (16)(14) The Legislature shall review the performance, the |
| 524 | outcomes, and the financial management of the James and Esther |
| 525 | King Biomedical Research Program during the 2010 Regular Session |
| 526 | of the Legislature and shall determine the most appropriate |
| 527 | funding source and means of funding the program based on its |
| 528 | review. |
| 529 | (17)(15) This section expires January 1, 2011, unless |
| 530 | reviewed and reenacted by the Legislature before that date. |
| 531 | Section 4. Paragraph (g) of subsection (4) of section |
| 532 | 381.853, Florida Statutes, is amended to read: |
| 533 | 381.853 Florida Center for Brain Tumor Research.-- |
| 534 | (4) The Florida Center for Brain Tumor Research is |
| 535 | established within the Evelyn F. and William L. McKnight Brain |
| 536 | Institute of the University of Florida. |
| 537 | (g) The center shall be funded through private, state, and |
| 538 | federal sources. Beginning in fiscal year 2008-2009, if the |
| 539 | center seeks to conduct biomedical research using state- |
| 540 | appropriated funds or intends to award or make recommendations |
| 541 | for the award of state-appropriated funds for biomedical |
| 542 | research grants or fellowships, the center shall apply for |
| 543 | grants or fellowships from, or make recommendations for the |
| 544 | award of grants or fellowships to, the Biomedical Research |
| 545 | Advisory Council in the James and Esther King Biomedical |
| 546 | Research Program pursuant to s. 215.5602. |
| 547 | Section 5. Subsection (1) of section 381.912, Florida |
| 548 | Statutes, is amended to read: |
| 549 | 381.912 Cervical Cancer Elimination Task Force.-- |
| 550 | (1) Effective July 1, 2004, the Cervical Cancer |
| 551 | Elimination Task Force is established for the purpose of |
| 552 | recommending strategies and actions to reduce the costs and |
| 553 | burdens of cervical cancer in Florida. The task force shall |
| 554 | present interim reports to the William G. "Bill" Bankhead, Jr., |
| 555 | and David Coley Cancer Research Council Florida Public Health |
| 556 | Foundation, Inc., the Florida Cancer Council, the Center for |
| 557 | Universal Research to Eradicate Disease, the Governor, the |
| 558 | President of the Senate, and the Speaker of the House of |
| 559 | Representatives on January 1, 2006, and July 1, 2007, with a |
| 560 | final report due on June 30, 2008. After submitting its final |
| 561 | report on or before June 30, 2008, the task force is dissolved. |
| 562 | Section 6. Section 381.922, Florida Statutes, is amended |
| 563 | to read: |
| 564 | (Substantial rewording of section. See s. 381.922, F.S., |
| 565 | for present text) |
| 566 | 381.922 William G. "Bill" Bankhead, Jr., and David Coley |
| 567 | Cancer Research Council.-- |
| 568 | (1) Effective July 1, 2007, the William G. "Bill" |
| 569 | Bankhead, Jr., and David Coley Cancer Research Council, which |
| 570 | may be cited as the "Bankhead-Coley Cancer Council," is created |
| 571 | within the Department of Health for the purpose of making the |
| 572 | state a center of excellence for cancer research. |
| 573 | (2)(a) The council shall be representative of the state's |
| 574 | cancer centers, hospitals, and patient groups and shall be |
| 575 | organized and shall operate in accordance with this section. |
| 576 | (b) The Bankhead-Coley Cancer Council may create not-for- |
| 577 | profit corporations to receive, hold, invest, and administer |
| 578 | property and any moneys acquired from private, local, state, and |
| 579 | federal sources, as well as technical and professional income |
| 580 | generated or derived from the mission-related activities of the |
| 581 | council. |
| 582 | (c) The members of the council shall consist of: |
| 583 | 1. The chair of the Florida Dialogue on Cancer, who shall |
| 584 | serve as the chair of the council. |
| 585 | 2. The Secretary of Health or his or her designee. |
| 586 | 3. The chief executive officer of the H. Lee Moffitt |
| 587 | Cancer Center or his or her designee. |
| 588 | 4. The director of the University of Florida Shands Cancer |
| 589 | Center or his or her designee. |
| 590 | 5. The chief executive officer of the University of Miami |
| 591 | Sylvester Comprehensive Cancer Center or his or her designee. |
| 592 | 6. The chief executive officer of the Mayo Clinic, |
| 593 | Jacksonville, or his or her designee. |
| 594 | 7. The chief executive officer of the American Cancer |
| 595 | Society, Florida Division, Inc., or his or her designee. |
| 596 | 8. The president of the American Cancer Society, Florida |
| 597 | Division, Inc., Board of Directors or his or her designee. |
| 598 | 9. The president of the Florida Society of Clinical |
| 599 | Oncology or his or her designee. |
| 600 | 10. The president of the American College of Surgeons, |
| 601 | Florida Chapter, or his or her designee. |
| 602 | 11. The chief executive officer of Enterprise Florida, |
| 603 | Inc., or his or her designee. |
| 604 | 12. Five representatives from cancer programs approved by |
| 605 | the American College of Surgeons. Three of the five shall be |
| 606 | appointed by the Governor, one shall be appointed by the Speaker |
| 607 | of the House of Representatives, and one shall be appointed by |
| 608 | the President of the Senate. |
| 609 | 13. One member of the House of Representatives, to be |
| 610 | appointed by the Speaker of the House of Representatives. |
| 611 | 14. One member of the Senate, to be appointed by the |
| 612 | President of the Senate. |
| 613 | (d) Appointments made by the Speaker of the House of |
| 614 | Representatives and the President of the Senate pursuant to |
| 615 | paragraph (c) shall be for 2-year terms, concurrent with the |
| 616 | bienniums in which they serve as presiding officers. |
| 617 | (e) Appointments made by the Governor pursuant to |
| 618 | paragraph (c) shall be for 2-year terms, although the Governor |
| 619 | may reappoint members. |
| 620 | (f) Members of the council shall serve without |
| 621 | compensation, and each organization represented on the council |
| 622 | shall cover the expenses of its representatives. |
| 623 | (3) The council shall issue an annual report to the James |
| 624 | and Esther King Biomedical Research Program, the Governor, the |
| 625 | Speaker of the House of Representatives, and the President of |
| 626 | the Senate by December 15 of each year, with policy |
| 627 | recommendations regarding cancer research capacity in the state |
| 628 | and related issues. |
| 629 | Section 7. Section 381.923, Florida Statutes, is created |
| 630 | to read: |
| 631 | 381.923 Bankhead-Coley Cancer Council mission and |
| 632 | duties.--The council shall ensure that the goals of the council |
| 633 | are advanced and shall endeavor to dramatically improve cancer |
| 634 | research and treatment in this state through: |
| 635 | (1) Efforts to significantly expand cancer research |
| 636 | capacity in the state by: |
| 637 | (a) Identifying ways to attract new research talent and |
| 638 | attendant national grant-producing researchers to cancer |
| 639 | research facilities in this state. |
| 640 | (b) Encouraging the employment of bioinformatics in order |
| 641 | to create a cancer informatics infrastructure that enhances |
| 642 | information and resource exchange and integration through |
| 643 | researchers working in diverse disciplines, to facilitate the |
| 644 | full spectrum of cancer investigations. |
| 645 | (c) Facilitating the technical coordination, business |
| 646 | development, and support of intellectual property as it relates |
| 647 | to the advancement of cancer research. |
| 648 | (d) Aiding in other multidisciplinary research-support |
| 649 | activities as they inure to the advancement of cancer research. |
| 650 | (2) Efforts to improve both research and treatment through |
| 651 | greater participation in clinical trials networks by: |
| 652 | (a) Identifying ways to increase adult enrollment in |
| 653 | cancer clinical trials. |
| 654 | (b) Supporting public and private professional education |
| 655 | programs designed to increase the awareness and knowledge about |
| 656 | cancer clinical trials. |
| 657 | (c) Providing tools to cancer patients and community-based |
| 658 | oncologists to aid in the identification of cancer clinical |
| 659 | trials available in the state. |
| 660 | (d) Creating opportunities for the state's academic cancer |
| 661 | centers to collaborate with community-based oncologists in |
| 662 | cancer clinical trials networks. |
| 663 | (3) Efforts to reduce the impact of cancer on disparate |
| 664 | groups by: |
| 665 | (a) Identifying those cancers that disproportionately |
| 666 | impact certain demographic groups. |
| 667 | (b) Building collaborations designed to reduce health |
| 668 | disparities as they relate to cancer. |
| 669 | Section 8. Subsections (8) and (12) of section 381.98, |
| 670 | Florida Statutes, are amended to read: |
| 671 | 381.98 The Florida Public Health Foundation, Inc.; |
| 672 | establishment; purpose; mission; duties; board of directors.-- |
| 673 | (8) The corporation, in consultation with the Department |
| 674 | of Health and the Florida Center for Universal Research to |
| 675 | Eradicate Disease, shall facilitate communication between |
| 676 | biomedical researchers and health care providers each month |
| 677 | according to the health awareness schedule established by the |
| 678 | Florida Public Health Foundation, Inc., in order to ensure |
| 679 | ongoing dialogue between researchers, treatment providers, and |
| 680 | the department. |
| 681 | (12) The corporation shall provide an annual report |
| 682 | concerning its activities and finances to the Florida Center for |
| 683 | Universal Research to Eradicate Disease and shall provide copies |
| 684 | of the annual report to the Governor, the President of the |
| 685 | Senate, and the Speaker of the House of Representatives. |
| 686 | Section 9. Subsection (4) of section 430.501, Florida |
| 687 | Statutes, is amended to read: |
| 688 | 430.501 Alzheimer's Disease Advisory Committee; research |
| 689 | grants.-- |
| 690 | (4) If funds are made available through gifts, grants, or |
| 691 | other sources, the Department of Elderly Affairs shall deposit |
| 692 | such funds into its Grants and Donations Trust Fund and shall |
| 693 | award research grants to qualified profit or nonprofit |
| 694 | associations and institutions or governmental agencies in order |
| 695 | to plan, establish, or conduct programs in Alzheimer's disease |
| 696 | control or prevention, education and training, and research. The |
| 697 | department may adopt rules necessary to carry out these duties. |
| 698 | Beginning in fiscal year 2008-2009, if the committee seeks to |
| 699 | award biomedical research grants or fellowships using state- |
| 700 | appropriated funds or makes recommendations for the award of |
| 701 | state-appropriated funds for biomedical research grants or |
| 702 | fellowships, the committee shall apply for grants or fellowships |
| 703 | from, or make recommendations for the award of grants or |
| 704 | fellowships to, the Biomedical Research Advisory Council in the |
| 705 | James and Esther King Biomedical Research Program pursuant to s. |
| 706 | 215.5602. |
| 707 | Section 10. Subsection (2) of section 430.502, Florida |
| 708 | Statutes, is amended to read: |
| 709 | 430.502 Alzheimer's disease; memory disorder clinics and |
| 710 | day care and respite care programs.-- |
| 711 | (2) It is the intent of the Legislature that research |
| 712 | conducted by a memory disorder clinic and supported by state |
| 713 | funds pursuant to subsection (1) be applied research, be |
| 714 | service-related, and be selected in conjunction with the |
| 715 | department. Such research may address, but is not limited to, |
| 716 | diagnostic technique, therapeutic interventions, and supportive |
| 717 | services for persons suffering from Alzheimer's disease and |
| 718 | related memory disorders and their caregivers. A memory disorder |
| 719 | clinic shall conduct such research in accordance with a research |
| 720 | plan developed by the clinic which establishes research |
| 721 | objectives that are in accordance with this legislative intent. |
| 722 | Beginning in fiscal year 2008-2009, if a memory disorder clinic |
| 723 | supported by state funds pursuant to subsection (1) performs or |
| 724 | seeks to perform any biomedical research, the memory disorder |
| 725 | clinic shall apply for a research grant or fellowship through |
| 726 | the James and Esther King Biomedical Research Program pursuant |
| 727 | to s. 215.5602. A memory disorder clinic shall also complete and |
| 728 | submit to the department a report of the findings, conclusions, |
| 729 | and recommendations of completed research. This subsection does |
| 730 | not apply to those memory disorder clinics at the three medical |
| 731 | schools in the state or at the major private nonprofit research- |
| 732 | oriented teaching hospital or other affiliated teaching |
| 733 | hospital. |
| 734 | Section 11. Subsections (9) through (15) of section |
| 735 | 1004.445, Florida Statutes, are renumbered as subsections (8) |
| 736 | through (14), respectively, and present subsections (8) and (12) |
| 737 | of that section are amended to read: |
| 738 | 1004.445 Johnnie B. Byrd, Sr., Alzheimer's Center and |
| 739 | Research Institute.-- |
| 740 | (8)(a) Applications for Alzheimer's disease research |
| 741 | funding may be submitted from any university or established |
| 742 | research institute in the state. All qualified investigators in |
| 743 | the state, regardless of institutional affiliation, shall have |
| 744 | equal access and opportunity to compete for the research |
| 745 | funding. Grants shall be awarded by the board of directors of |
| 746 | the not-for-profit corporation on the basis of scientific merit, |
| 747 | as determined by an open, competitive peer review process that |
| 748 | ensures objectivity, consistency, and high quality. The |
| 749 | following types of applications shall be considered for funding: |
| 750 | 1. Investigator-initiated research grants. |
| 751 | 2. Institutional research grants. |
| 752 | 3. Collaborative research grants, including those that |
| 753 | advance the finding of cures through basic or applied research. |
| 754 | (b) Preference may be given to grant proposals that foster |
| 755 | collaboration among institutions, researchers, and community |
| 756 | practitioners because these proposals support the advancement of |
| 757 | cures through basic or applied research, including clinical |
| 758 | trials involving Alzheimer's patients and related networks. |
| 759 | (c) To ensure that all proposals for research funding are |
| 760 | appropriate and are evaluated fairly on the basis of scientific |
| 761 | merit, the board of directors of the not-for-profit corporation, |
| 762 | in consultation with the council of scientific advisors, shall |
| 763 | appoint a peer review panel of independent, scientifically |
| 764 | qualified individuals to review the scientific content of each |
| 765 | proposal and establish its scientific priority score. The |
| 766 | priority scores shall be forwarded to the council and must be |
| 767 | considered by the board of directors of the not-for-profit |
| 768 | corporation in determining which proposals shall be recommended |
| 769 | for funding. |
| 770 | (d) The council of scientific advisors and the peer review |
| 771 | panel shall establish and follow rigorous guidelines for ethical |
| 772 | conduct and adhere to a strict policy with regard to conflict of |
| 773 | interest. All employees, members of the board of directors, and |
| 774 | affiliates of the not-for-profit corporation shall follow the |
| 775 | same rigorous guidelines for ethical conduct and shall adhere to |
| 776 | the same strict policy with regard to conflict of interest. A |
| 777 | member of the council or panel may not participate in any |
| 778 | discussion or decision with respect to a research proposal by |
| 779 | any firm, entity, or agency with which the member is associated |
| 780 | as a member of the governing body or as an employee or with |
| 781 | which the member has entered into a contractual arrangement. |
| 782 | Meetings of the council and the peer review panels are subject |
| 783 | to chapter 119, s. 286.011, and s. 24, Art. I of the State |
| 784 | Constitution. |
| 785 | (11)(12) Beginning in fiscal year 2006-2007 and ending |
| 786 | June 30, 2007, the sum of $15 million is appropriated annually |
| 787 | from recurring funds in the General Revenue Fund to the Grants |
| 788 | and Donations Trust Fund within the Department of Elderly |
| 789 | Affairs for the Johnnie B. Byrd, Sr., Alzheimer's Center and |
| 790 | Research Institute at the University of South Florida for the |
| 791 | purposes as provided under paragraph (6)(a), conducting and |
| 792 | supporting research, providing institutional research grants and |
| 793 | investigator-initiated research grants, developing and operating |
| 794 | integrated data projects, and providing assistance to |
| 795 | statutorily designated memory disorder clinics as provided under |
| 796 | s. 430.502. Not less than 80 percent of the appropriated funds |
| 797 | shall be expended for these purposes, and not less than 20 |
| 798 | percent of the appropriated funds shall be expended for peer- |
| 799 | reviewed investigator-initiated research grants. Beginning in |
| 800 | fiscal year 2008-2009, if the Johnnie B. Byrd, Sr., Alzheimer's |
| 801 | Center and Research Institute seeks to conduct biomedical |
| 802 | research using state-appropriated funds or intends to award |
| 803 | grants or fellowships for biomedical research using state- |
| 804 | appropriated funds, the Johnnie B. Byrd, Sr., Alzheimer's Center |
| 805 | and Research Institute shall apply for grants or fellowships |
| 806 | from, or make recommendations for the award of grants or |
| 807 | fellowships to, the Biomedical Research Advisory Council in the |
| 808 | James and Esther King Biomedical Research Program pursuant to s. |
| 809 | 215.5602. |
| 810 | Section 12. Sections 381.855, 381.92, and 381.921, Florida |
| 811 | Statutes, are repealed. |
| 812 | Section 13. If any provision of this act or the |
| 813 | application thereof to any person or circumstance is held |
| 814 | invalid, the invalidity does not affect other provisions or |
| 815 | applications of the act which can be given effect without the |
| 816 | invalid provision or application, and to this end the provisions |
| 817 | of this act are declared severable. |
| 818 | Section 14. This act shall take effect July 1, 2007. |