| 1 | A bill to be entitled |
| 2 | An act relating to biomedical research programs; amending |
| 3 | s. 215.5602, F.S.; deleting provisions requiring that the |
| 4 | James and Esther King Biomedical Research Program be |
| 5 | funded by proceeds from the Lawton Chiles Endowment Fund; |
| 6 | modifying the terms and membership and establishing a |
| 7 | staggered membership for appointed members of the |
| 8 | Biomedical Research Advisory Council; authorizing the |
| 9 | Biomedical Research Advisory Council to recommend a |
| 10 | portion of the allocation for the James and Esther King |
| 11 | Biomedical Research Program for specified purposes; |
| 12 | reducing the percentage of funds available for |
| 13 | administrative expenses of the James and Esther King |
| 14 | Biomedical Research Program; requiring the Department of |
| 15 | Health to adopt rules to administer the James and Esther |
| 16 | King Biomedical Research Program and the William G. "Bill" |
| 17 | Bankhead, Jr., and David Coley Cancer Research Program; |
| 18 | increasing the funding available to the Florida Center for |
| 19 | Universal Research to Eradicate Disease; allocating a |
| 20 | certain amount of money to the James and Esther King |
| 21 | Biomedical Research Program and the William G. "Bill" |
| 22 | Bankhead, Jr., and David Coley Cancer Research Program; |
| 23 | authorizing the Department of Health to accept and use |
| 24 | gifts for awards under the James and Esther King |
| 25 | Biomedical Research Program; deleting obsolete provisions; |
| 26 | deleting a provision providing for the future expiration |
| 27 | of the James and Esther King Biomedical Research Program; |
| 28 | repealing s. 381.912, F.S., relating to the Cervical |
| 29 | Cancer Elimination Task Force; repealing s. 381.92, F.S., |
| 30 | relating to the Florida Cancer Council; repealing s. |
| 31 | 381.921, F.S., relating to the mission and duties of the |
| 32 | Florida Cancer Council; amending s. 381.922, F.S.; |
| 33 | revising the purpose of the William G. "Bill" Bankhead, |
| 34 | Jr., and David Coley Cancer Research Program; revising the |
| 35 | duties and goals of the William G. "Bill" Bankhead, Jr., |
| 36 | and David Coley Cancer Research Program; revising the |
| 37 | types of applications considered for funding; authorizing |
| 38 | the Biomedical Research Advisory Council to recommend a |
| 39 | portion of the allocation for the William G. "Bill" |
| 40 | Bankhead, Jr., and David Coley Cancer Research Program for |
| 41 | specified purposes; requiring the department to submit to |
| 42 | the Governor and Legislature a report by a specified date; |
| 43 | providing a funding source for the William G. "Bill" |
| 44 | Bankhead, Jr., and David Coley Cancer Research Program; |
| 45 | reducing the percentage of funds available for |
| 46 | administrative expenses of the William G. "Bill" Bankhead, |
| 47 | Jr., and David Coley Cancer Research Program; authorizing |
| 48 | the Department of Health to accept and use gifts for |
| 49 | awards under the William G. "Bill" Bankhead, Jr., and |
| 50 | David Coley Cancer Research Program; deleting obsolete |
| 51 | provisions; deleting provisions providing for the future |
| 52 | expiration of the William G. "Bill" Bankhead, Jr., and |
| 53 | David Coley Cancer Research Program; creating s. 381.923, |
| 54 | F.S., relating to the Florida Comprehensive Cancer Control |
| 55 | Act; providing a short title; providing legislative |
| 56 | intent; providing definitions; creating the Florida Cancer |
| 57 | Control and Resource Advisory Council; providing |
| 58 | membership of the council; providing the composition of |
| 59 | the executive committee of the council; providing for |
| 60 | terms of the council and meetings; providing for |
| 61 | reimbursement for per diem and travel expenses; |
| 62 | prohibiting a member of the council from participating in |
| 63 | any discussion or decision to recommend any type of award |
| 64 | or contract to any qualified nonprofit association or to |
| 65 | any agency of this state or its political subdivisions |
| 66 | with which the member is associated as a member of the |
| 67 | governing body or as an employee or with which the member |
| 68 | has entered into a contractual arrangement; providing the |
| 69 | duties and responsibilities of the council; requiring the |
| 70 | council to report findings and recommendations to the |
| 71 | Governor, the Legislature, and the State Surgeon General; |
| 72 | requiring that the H. Lee Moffitt Cancer Center and |
| 73 | Research Institute, Inc., have a executive director; |
| 74 | allocating a specified amount of money from the William G. |
| 75 | "Bill" Bankhead, Jr., and David Coley Cancer Research |
| 76 | Program to the H. Lee Moffitt Cancer Center and Research |
| 77 | Institute, Inc., for administrative costs and staff |
| 78 | support; authorizing the Department of Health to |
| 79 | administer the act; requiring the department to produce |
| 80 | the Florida Cancer Plan in consultation with the Florida |
| 81 | Cancer Control and Resource Advisory Council; creating the |
| 82 | Cancer Control Collaborative Program within the Department |
| 83 | of Health; providing the responsibility and mission of the |
| 84 | program; requiring the department to appoint a director; |
| 85 | providing duties for each collaborative; requiring the |
| 86 | collaborative program to submit to the Florida Cancer |
| 87 | Control and Resource Advisory Council an annual report by |
| 88 | a specified date; requiring the Cancer Control |
| 89 | Collaborative Program to serve as the infrastructure for |
| 90 | expansion or adaption as federal programs or other |
| 91 | opportunities arise for future cancer control initiatives; |
| 92 | amending ss. 381.855, 458.324, and 459.0125, F.S.; |
| 93 | deleting obsolete provisions; repealing s. 1004.435, F.S., |
| 94 | relating to cancer control and research; providing an |
| 95 | effective date. |
| 96 |
|
| 97 | Be It Enacted by the Legislature of the State of Florida: |
| 98 |
|
| 99 | Section 1. Section 215.5602, Florida Statutes, is amended |
| 100 | to read: |
| 101 | 215.5602 James and Esther King Biomedical Research |
| 102 | Program.- |
| 103 | (1) There is established within the Department of Health |
| 104 | the James and Esther King Biomedical Research Program funded by |
| 105 | the proceeds of the Lawton Chiles Endowment Fund pursuant to s. |
| 106 | 215.5601. The purpose of the James and Esther King Biomedical |
| 107 | Research Program is to provide an annual and perpetual source of |
| 108 | funding in order to support research initiatives that address |
| 109 | the health care problems of Floridians in the areas of tobacco- |
| 110 | related cancer, cardiovascular disease, stroke, and pulmonary |
| 111 | disease. The long-term goals of the program are to: |
| 112 | (a) Improve the health of Floridians by researching better |
| 113 | prevention, diagnoses, treatments, and cures for cancer, |
| 114 | cardiovascular disease, stroke, and pulmonary disease. |
| 115 | (b) Expand the foundation of biomedical knowledge relating |
| 116 | to the prevention, diagnosis, treatment, and cure of diseases |
| 117 | related to tobacco use, including cancer, cardiovascular |
| 118 | disease, stroke, and pulmonary disease. |
| 119 | (c) Improve the quality of the state's academic health |
| 120 | centers by bringing the advances of biomedical research into the |
| 121 | training of physicians and other health care providers. |
| 122 | (d) Increase the state's per capita funding for research |
| 123 | by undertaking new initiatives in public health and biomedical |
| 124 | research that will attract additional funding from outside the |
| 125 | state. |
| 126 | (e) Stimulate economic activity in the state in areas |
| 127 | related to biomedical research, such as the research and |
| 128 | production of pharmaceuticals, biotechnology, and medical |
| 129 | devices. |
| 130 | (2) Funds appropriated for the James and Esther King |
| 131 | Biomedical Research Program shall be used exclusively for the |
| 132 | award of grants and fellowships as established in this section; |
| 133 | for research relating to the prevention, diagnosis, treatment, |
| 134 | and cure of diseases related to tobacco use, including cancer, |
| 135 | cardiovascular disease, stroke, and pulmonary disease; and for |
| 136 | expenses incurred in the administration of this section; and as |
| 137 | provided in subsections (5) and (12). Priority shall be granted |
| 138 | to research designed to prevent or cure disease. |
| 139 | (3) There is created within the Department of Health the |
| 140 | Biomedical Research Advisory Council. |
| 141 | (a) The council shall consist of 13 11 members, including: |
| 142 | the chief executive officer of the Florida Division of the |
| 143 | American Cancer Society, or a designee; the chief executive |
| 144 | officer of the Greater Southeast Florida/Puerto Rico Affiliate |
| 145 | of the American Heart Association, or a designee; and the chief |
| 146 | executive officer of the American Lung Association of Florida, |
| 147 | or a designee; the chief executive officer of Enterprise |
| 148 | Florida, or a designee; and the chief executive officer of |
| 149 | BioFlorida, or a designee. The remaining 8 members of the |
| 150 | council shall be appointed as follows: |
| 151 | 1. The Governor shall appoint four members, two members |
| 152 | with expertise in the field of biomedical research, one member |
| 153 | from a research university in the state, and one member |
| 154 | representing the general population of the state. |
| 155 | 2. The President of the Senate shall appoint two members, |
| 156 | one member with expertise in the field of behavioral or social |
| 157 | research and one representative from a cancer program approved |
| 158 | by the American College of Surgeons. |
| 159 | 3. The Speaker of the House of Representatives shall |
| 160 | appoint two members, one member from a professional medical |
| 161 | organization and one representative from a cancer program |
| 162 | approved by the American College of Surgeons. |
| 163 |
|
| 164 | In making these appointments, the Governor, the President of the |
| 165 | Senate, and the Speaker of the House of Representatives shall |
| 166 | select primarily, but not exclusively, Floridians with |
| 167 | biomedical and lay expertise in the general areas of cancer, |
| 168 | cardiovascular disease, stroke, and pulmonary disease. The |
| 169 | appointments shall be for 4-year staggered terms a 3-year term |
| 170 | and shall reflect the diversity of the state's population. An |
| 171 | appointed member may not serve more than two consecutive terms. |
| 172 | The first two appointments by the Governor and the first |
| 173 | appointment by the President of the Senate and the Speaker of |
| 174 | the House of Representatives on or after July 1, 2010, shall be |
| 175 | for a term of 2 years. |
| 176 | (b) The council shall adopt internal organizational |
| 177 | procedures as necessary for its efficient organization. |
| 178 | (c) The department shall provide such staff, information, |
| 179 | and other assistance as is reasonably necessary to assist the |
| 180 | council in carrying out its responsibilities. |
| 181 | (d) Members of the council shall serve without |
| 182 | compensation, but may receive reimbursement as provided in s. |
| 183 | 112.061 for travel and other necessary expenses incurred in the |
| 184 | performance of their official duties. |
| 185 | (4) The council shall advise the State Surgeon General as |
| 186 | to the direction and scope of the biomedical research program. |
| 187 | The responsibilities of the council may include, but are not |
| 188 | limited to: |
| 189 | (a) Providing advice on program priorities and emphases. |
| 190 | (b) Providing advice on the overall program budget. |
| 191 | (c) Participating in periodic program evaluation. |
| 192 | (d) Assisting in the development of guidelines to ensure |
| 193 | fairness, neutrality, and adherence to the principles of merit |
| 194 | and quality in the conduct of the program. |
| 195 | (e) Assisting in the development of appropriate linkages |
| 196 | to nonacademic entities, such as voluntary organizations, health |
| 197 | care delivery institutions, industry, government agencies, and |
| 198 | public officials. |
| 199 | (f) Developing criteria and standards for the award of |
| 200 | research grants. |
| 201 | (g) Developing administrative procedures relating to |
| 202 | solicitation, review, and award of research grants and |
| 203 | fellowships, to ensure an impartial, high-quality peer review |
| 204 | system. |
| 205 | (h) Developing and supervising research peer review |
| 206 | panels. |
| 207 | (i) Reviewing reports of peer review panels and making |
| 208 | recommendations for research grants and fellowships. |
| 209 | (j) Developing and providing oversight regarding |
| 210 | mechanisms for the dissemination of research results. |
| 211 | (5)(a) Applications for biomedical research funding under |
| 212 | the program may be submitted from any university or established |
| 213 | research institute in the state. All qualified investigators in |
| 214 | the state, regardless of institution affiliation, shall have |
| 215 | equal access and opportunity to compete for the research |
| 216 | funding. |
| 217 | (b) Grants and fellowships shall be awarded by the State |
| 218 | Surgeon General, after consultation with the council, on the |
| 219 | basis of scientific merit, as determined by an open competitive |
| 220 | peer review process that ensures objectivity, consistency, and |
| 221 | high quality. The following types of applications shall be |
| 222 | considered for funding: |
| 223 | 1. Investigator-initiated research grants. |
| 224 | 2. Institutional research and training grants. |
| 225 | 3. Predoctoral and postdoctoral research fellowships. |
| 226 | (c) For any given year, the Biomedical Research Advisory |
| 227 | Council may also recommend up to one-third of the allocation for |
| 228 | the James and Esther King Biomedical Research Program for the |
| 229 | recruitment of cancer, heart, or lung researchers and research |
| 230 | teams to institutions in the state; for operational start-up |
| 231 | grants for newly recruited cancer, heart, or lung researchers |
| 232 | and research teams; and for equipment expenditures related to |
| 233 | the expansion of cancer, heart, or lung research and treatment |
| 234 | capacity in this state. |
| 235 | (6) To ensure that all proposals for research funding are |
| 236 | appropriate and are evaluated fairly on the basis of scientific |
| 237 | merit, the State Surgeon General, in consultation with the |
| 238 | council, shall appoint a peer review panel of independent, |
| 239 | scientifically qualified individuals to review the scientific |
| 240 | content of each proposal and establish its scientific priority |
| 241 | score. The priority scores shall be forwarded to the council and |
| 242 | must be considered in determining which proposals shall be |
| 243 | recommended for funding. |
| 244 | (7) The council and the peer review panel shall establish |
| 245 | and follow rigorous guidelines for ethical conduct and adhere to |
| 246 | a strict policy with regard to conflict of interest. A member of |
| 247 | the council or panel may not participate in any discussion or |
| 248 | decision with respect to a research proposal by any firm, |
| 249 | entity, or agency with which the member is associated as a |
| 250 | member of the governing body or as an employee, or with which |
| 251 | the member has entered into a contractual arrangement. Meetings |
| 252 | of the council and the peer review panels shall be subject to |
| 253 | the provisions of chapter 119, s. 286.011, and s. 24, Art. I of |
| 254 | the State Constitution. |
| 255 | (8) The Department of Health may contract on a |
| 256 | competitive-bid basis with an appropriate entity to administer |
| 257 | the program. Administrative expenses may not exceed 7.5 15 |
| 258 | percent of the total funds available to the program in any given |
| 259 | year. |
| 260 | (9) The Department of Health, after consultation with the |
| 261 | council, shall may adopt rules as necessary to administer |
| 262 | implement this section, taking into consideration the nature of |
| 263 | the program and making allowances in any adopted rules which |
| 264 | enable timely implementation of calls for proposals, proposal |
| 265 | reviews, proposal considerations, and any other program |
| 266 | activities, and which prevent delays in making annual program |
| 267 | awards to grant recipients. |
| 268 | (10) The council shall submit an annual progress report on |
| 269 | the state of biomedical research in this state to the Florida |
| 270 | Center for Universal Research to Eradicate Disease and to the |
| 271 | Governor, the State Surgeon General, the President of the |
| 272 | Senate, and the Speaker of the House of Representatives by |
| 273 | February 1. The report must include: |
| 274 | (a) A list of research projects supported by grants or |
| 275 | fellowships awarded under the program. |
| 276 | (b) A list of recipients of program grants or fellowships. |
| 277 | (c) A list of publications in peer reviewed journals |
| 278 | involving research supported by grants or fellowships awarded |
| 279 | under the program. |
| 280 | (d) The total amount of biomedical research funding |
| 281 | currently flowing into the state. |
| 282 | (e) New grants for biomedical research which were funded |
| 283 | based on research supported by grants or fellowships awarded |
| 284 | under the program. |
| 285 | (f) Progress in the prevention, diagnosis, treatment, and |
| 286 | cure of diseases related to tobacco use, including cancer, |
| 287 | cardiovascular disease, stroke, and pulmonary disease. |
| 288 | (11) The council shall award grants for cancer research |
| 289 | through the William G. "Bill" Bankhead, Jr., and David Coley |
| 290 | Cancer Research Program created in s. 381.922. |
| 291 | (12)(a) From funds appropriated to accomplish the goals of |
| 292 | this section, up to $500,000 $250,000 shall be available for the |
| 293 | operating costs of the Florida Center for Universal Research to |
| 294 | Eradicate Disease. |
| 295 | (b)(a) Beginning in the 2010-2011 2009-2010 fiscal year |
| 296 | and thereafter, 5 percent of the revenue deposited into the |
| 297 | Health Care Trust Fund pursuant to ss. 210.011(9) and 210.276(7) |
| 298 | shall be reserved for research of tobacco-related or cancer- |
| 299 | related illnesses through the James and Esther King Biomedical |
| 300 | Research Program and the William G. "Bill" Bankhead, Jr., and |
| 301 | David Coley Cancer Research Program. The sum of $25 million |
| 302 | shall be allocated annually to each of these programs; however, |
| 303 | the sum of the revenue reserved pursuant to ss. 210.011(9) and |
| 304 | 210.276(7) may not exceed $50 million in any fiscal year. |
| 305 | (b) In the 2009-2010 fiscal year, 2.5 percent, not to |
| 306 | exceed $25 million, of the revenue deposited into the Health |
| 307 | Care Trust Fund pursuant to this subsection shall be transferred |
| 308 | to the Biomedical Research Trust Fund within the Department of |
| 309 | Health for the James and Esther King Biomedical Research |
| 310 | Program. |
| 311 | (13) The Department of Health may accept gifts made |
| 312 | unconditionally by will or otherwise, deposit them into the |
| 313 | Biomedical Research Trust Fund, and use them for grant or |
| 314 | fellowship awards in the James and Esther King Biomedical |
| 315 | Research Program. Any gift made under conditions that, in the |
| 316 | judgment of the department, upon consultation with the council, |
| 317 | are proper and consistent with this section, the laws of the |
| 318 | United States, and state law, may be accepted and shall be held, |
| 319 | invested, reinvested, and used in accordance with the conditions |
| 320 | of the gift. By June 1, 2009, the Division of Statutory Revision |
| 321 | of the Office of Legislative Services shall certify to the |
| 322 | President of the Senate and the Speaker of the House of |
| 323 | Representatives the language and statutory citation of this |
| 324 | section, which is scheduled to expire January 1, 2011. |
| 325 | (14) The Legislature shall review the performance, the |
| 326 | outcomes, and the financial management of the James and Esther |
| 327 | King Biomedical Research Program during the 2010 Regular Session |
| 328 | of the Legislature and shall determine the most appropriate |
| 329 | funding source and means of funding the program based on its |
| 330 | review. |
| 331 | (15) This section expires January 1, 2011, unless reviewed |
| 332 | and reenacted by the Legislature before that date. |
| 333 | Section 2. Section 381.912, Florida Statutes, is repealed. |
| 334 | Section 3. Section 381.92, Florida Statutes, is repealed. |
| 335 | Section 4. Section 381.921, Florida Statutes, is repealed. |
| 336 | Section 5. Section 381.922, Florida Statutes, is amended |
| 337 | to read: |
| 338 | 381.922 William G. "Bill" Bankhead, Jr., and David Coley |
| 339 | Cancer Research Program.- |
| 340 | (1) The William G. "Bill" Bankhead, Jr., and David Coley |
| 341 | Cancer Research Program, which may be otherwise cited as the |
| 342 | "Bankhead-Coley Program," is created within the Department of |
| 343 | Health. The purpose of the program shall be to advance progress |
| 344 | towards cures for cancer using through grants awarded through a |
| 345 | peer-reviewed, competitive process and to expand cancer research |
| 346 | and treatment capacity in this state. |
| 347 | (2) The program shall provide grants for cancer research, |
| 348 | including cancer clinical trials projects as provided in this |
| 349 | section, to further the search for cures for cancer; for |
| 350 | recruiting cancer researchers and research teams to institutions |
| 351 | in the state; for operational start-up grants for newly |
| 352 | recruited cancer researchers and research teams; or for |
| 353 | equipment expenditures related to the expansion of cancer |
| 354 | research and treatment capacity in the state. |
| 355 | (a) Emphasis shall be given to the following goals that |
| 356 | are designed to foster dramatic improvement in cancer research |
| 357 | capacity in the state enumerated in s. 381.921, as they those |
| 358 | goals support the advancement of such cures:. |
| 359 | 1. Significantly expand cancer research capacity in the |
| 360 | state by identifying ways to attract new research talent and |
| 361 | attendant national grant-producing researchers to cancer |
| 362 | research facilities in this state; implement a peer-reviewed, |
| 363 | competitive process to identify and fund the best proposals to |
| 364 | expand cancer research institutes in this state; fund through |
| 365 | available resources those proposals that demonstrate the |
| 366 | greatest opportunity to attract federal research grants and |
| 367 | private financial support; encourage the employment of |
| 368 | bioinformatics in order to create a cancer informatics |
| 369 | infrastructure that enhances information and resource exchange |
| 370 | and integration through researchers working in diverse |
| 371 | disciplines; facilitate the full spectrum of cancer |
| 372 | investigations; facilitate the technical coordination, business |
| 373 | development, and support of intellectual property as it relates |
| 374 | to the advancement of cancer research; and aid in other |
| 375 | multidisciplinary research-support activities as they inure to |
| 376 | the advancement of cancer research. |
| 377 | 2. Improve both research and treatment through greater |
| 378 | participation in clinical trial networks by: |
| 379 | a. Identifying ways to increase enrollment in cancer |
| 380 | clinical trials; |
| 381 | b. Supporting public and private professional education |
| 382 | programs designed to increase the awareness and knowledge about |
| 383 | cancer clinical trials; |
| 384 | c. Providing tools to cancer patients and community-based |
| 385 | oncologists to aid in the identification of cancer clinical |
| 386 | trials available in the state; and |
| 387 | d. Creating opportunities for the state's academic cancer |
| 388 | centers to collaborate with community-based oncologists in |
| 389 | cancer clinical trials networks. |
| 390 | 3. Reduce the impact of cancer on disparate groups by |
| 391 | identifying those cancers that disproportionately impact certain |
| 392 | demographic groups and building collaborations designed to |
| 393 | reduce health disparities as they relate to cancer. |
| 394 | (b) Preference may be given to grant proposals that foster |
| 395 | collaborations among institutions, researchers, and community |
| 396 | practitioners, as such proposals support the advancement of |
| 397 | cures through basic or applied research, including clinical |
| 398 | trials involving cancer patients and related networks and the |
| 399 | transfer of knowledge gained from research into the practice of |
| 400 | community practitioners. |
| 401 | (3)(a) Applications for funding for cancer research may be |
| 402 | submitted by any university or established research institute in |
| 403 | the state. All qualified investigators in the state, regardless |
| 404 | of institutional affiliation, shall have equal access and |
| 405 | opportunity to compete for the research funding. Collaborative |
| 406 | proposals, including those that advance the program's goals |
| 407 | enumerated in subsection (2), may be given preference. Grants |
| 408 | shall be awarded by the State Surgeon General, after |
| 409 | consultation with the Biomedical Research Advisory Council |
| 410 | established in s. 215.5602, on the basis of scientific merit, as |
| 411 | determined by an open, competitive peer review process that |
| 412 | ensures objectivity, consistency, and high quality. The |
| 413 | following types of applications shall be considered for funding: |
| 414 | 1. Investigator-initiated research grants. |
| 415 | 2. Institutional research and training grants. |
| 416 | 3. Predoctoral and postdoctoral research fellowships. |
| 417 | 4.3. Collaborative research grants, including those that |
| 418 | advance the finding of cures through basic or applied research. |
| 419 | 5. Clinical trial project grants, particularly those |
| 420 | projects such as matching services that identify prospective |
| 421 | clinical trials treatment options for cancer patients in this |
| 422 | state or those projects that otherwise foster greater rates of |
| 423 | participation in trials. At least one such grant shall be |
| 424 | awarded in any given year if a meritorious proposal or proposals |
| 425 | are received. Such project grant proposals are not required to |
| 426 | be posed as a research question in order to qualify for an |
| 427 | award. |
| 428 | (b) For any given year, the Biomedical Research Advisory |
| 429 | Council may recommend up to one-third of the allocation for the |
| 430 | William G. "Bill" Bankhead, Jr. and David Coley Cancer Research |
| 431 | Program for the recruitment of cancer researchers and research |
| 432 | teams to institutions in the state, for operational start-up |
| 433 | grants for newly recruited cancer researchers and research |
| 434 | teams, or for equipment expenditures related to the expansion of |
| 435 | cancer research and treatment capacity in the state. |
| 436 | (c)(b) In order to ensure that all proposals for research |
| 437 | funding are appropriate and are evaluated fairly on the basis of |
| 438 | scientific merit, the State Surgeon General, in consultation |
| 439 | with the council, shall appoint a peer review panel of |
| 440 | independent, scientifically qualified individuals to review the |
| 441 | scientific content of each proposal and establish its priority |
| 442 | score. The priority scores shall be forwarded to the council and |
| 443 | must be considered in determining which proposals shall be |
| 444 | recommended for funding. |
| 445 | (d)(c) The council and the peer review panel shall |
| 446 | establish and follow rigorous guidelines for ethical conduct and |
| 447 | adhere to a strict policy with regard to conflicts of interest. |
| 448 | A member of the council or panel may not participate in any |
| 449 | discussion or decision with respect to a research proposal by |
| 450 | any firm, entity, or agency with which the member is associated |
| 451 | as a member of the governing body or as an employee or with |
| 452 | which the member has entered into a contractual arrangement. |
| 453 | Meetings of the council and the peer review panels are subject |
| 454 | to chapter 119, s. 286.011, and s. 24, Art. I of the State |
| 455 | Constitution. |
| 456 | (4) By February 1 December 15 of each year, the Department |
| 457 | of Health shall submit to the Governor, the President of the |
| 458 | Senate, and the Speaker of the House of Representatives a report |
| 459 | indicating progress towards the program's mission and making |
| 460 | recommendations that further its purpose. |
| 461 | (5) The William G. "Bill" Bankhead, Jr. and David Coley |
| 462 | Cancer Research Program is funded pursuant to s. 215.5602(12) |
| 463 | and this section, with an annual allocation of $25 million. |
| 464 | Funds appropriated for the William G. "Bill" Bankhead, Jr., and |
| 465 | David Coley Cancer Research Program shall be distributed |
| 466 | pursuant to this section to provide grants to researchers |
| 467 | seeking cures for cancer and cancer-related illnesses, with |
| 468 | emphasis given to the goals enumerated in paragraph (2)(a) s. |
| 469 | 381.921. From the total funds appropriated, an amount of up to |
| 470 | 7.5 10 percent may be used for administrative expenses. In the |
| 471 | 2009-2010 fiscal year, 2.5 percent, not to exceed $25 million, |
| 472 | of the revenue deposited into the Health Care Trust Fund |
| 473 | pursuant to s. 215.5602(12)(a) shall be transferred to the |
| 474 | Biomedical Research Trust Fund within the Department of Health |
| 475 | for the William G. "Bill" Bankhead, Jr., and David Coley Cancer |
| 476 | Research Program. |
| 477 | (6) The Department of Health may accept gifts made |
| 478 | unconditionally by will or otherwise, deposit them into the |
| 479 | Biomedical Research Trust Fund, and use them for grant or |
| 480 | fellowship awards in the William G. "Bill" Bankhead, Jr. and |
| 481 | David Coley Cancer Research Program. Any gift made under |
| 482 | conditions that, in the judgment of the department, upon |
| 483 | consultation with the council, are proper and consistent with |
| 484 | this section, the laws of the United States, and state law, may |
| 485 | be accepted and shall be held, invested, reinvested, and used in |
| 486 | accordance with the conditions of the gift. By June 1, 2009, the |
| 487 | Division of Statutory Revision of the Office of Legislative |
| 488 | Services shall certify to the President of the Senate and the |
| 489 | Speaker of the House of Representatives the language and |
| 490 | statutory citation of this section, which is scheduled to expire |
| 491 | January 1, 2011. |
| 492 | (7) The Legislature shall review the performance, the |
| 493 | outcomes, and the financial management of the William G. "Bill" |
| 494 | Bankhead, Jr., and David Coley Cancer Research Program during |
| 495 | the 2010 Regular Session of the Legislature and shall determine |
| 496 | the most appropriate funding source and means of funding the |
| 497 | program based on its review. |
| 498 | (8) This section expires January 1, 2011, unless reviewed |
| 499 | and reenacted by the Legislature before that date. |
| 500 | Section 6. Section 381.923, Florida Statutes, is created |
| 501 | to read: |
| 502 | 381.923 Comprehensive cancer control.- |
| 503 | (1) SHORT TITLE.-This section may be cited as the "Florida |
| 504 | Comprehensive Cancer Control Act." |
| 505 | (2) LEGISLATIVE INTENT.-It is the finding of the |
| 506 | Legislature that: |
| 507 | (a) Advances in scientific knowledge have led to |
| 508 | prevention, early detection, and therapeutic capabilities in the |
| 509 | control of cancer. Such knowledge, screening technologies, and |
| 510 | therapies must be made available to all residents of this state. |
| 511 | (b) Research shows that certain lifestyles and exposures, |
| 512 | such as tobacco use, exposure to ultraviolet radiation from the |
| 513 | sun, and exposure to occupational and environmental carcinogens, |
| 514 | contribute to the risk for many types of cancer and that certain |
| 515 | screening tests are effective in finding cancer early when it is |
| 516 | more treatable. The role of diet, exercise, and other healthy |
| 517 | lifestyles are also important in cancer prevention and control. |
| 518 | Proven causes of cancer and methods for early detection should |
| 519 | be publicized and be the subject of linguistically and |
| 520 | culturally appropriate educational and awareness programs for |
| 521 | the prevention of cancer. |
| 522 | (c) An effective cancer control program would mobilize the |
| 523 | scientific, educational, and medical resources that presently |
| 524 | exist into an intense attack against this dreaded disease, with |
| 525 | the primary goal to reduce the cancer burden for the residents |
| 526 | of this state. |
| 527 | (3) DEFINITIONS.-As used in this section, the term: |
| 528 | (a) "Cancer" means all malignant neoplasms, regardless of |
| 529 | the tissue of origin, including lymphoma and leukemia. |
| 530 | (b) "Council" means the Florida Cancer Control and |
| 531 | Resource Advisory Council, which is an advisory body appointed |
| 532 | to function on a continuing basis to recommend solutions and |
| 533 | policy alternatives to the Governor, members of the Legislature, |
| 534 | the State Surgeon General, and other policymakers. |
| 535 | (c) "Department" means the Department of Health. |
| 536 | (d) "Plan" means the Florida Cancer Plan. |
| 537 | (e) "Program" means the Florida Cancer Control |
| 538 | Collaborative Program. |
| 539 | (f) "Qualified nonprofit association" means any |
| 540 | association, incorporated or unincorporated, which has received |
| 541 | tax-exempt status from the Internal Revenue Service. |
| 542 | (4) FLORIDA CANCER CONTROL AND RESOURCE ADVISORY COUNCIL; |
| 543 | CREATION; COMPOSITION.- |
| 544 | (a) There is created within the H. Lee Moffitt Cancer |
| 545 | Center and Research Institute, Inc., the Florida Cancer Control |
| 546 | and Resource Advisory Council. The council shall consist of |
| 547 | cancer organizational representation and cancer control |
| 548 | stakeholders, with an elected chairperson. Each member must be a |
| 549 | resident of this state. Three members representing the general |
| 550 | public shall be appointed by the Governor. The President of the |
| 551 | Senate and the Speaker of the House of Representatives shall |
| 552 | each appoint one member from his or her legislative body to the |
| 553 | council. Other members shall be selected to represent agencies |
| 554 | and organizations in this state which are involved with various |
| 555 | aspects of cancer control. These may include nonprofit |
| 556 | organizations, professional associations, governmental agencies, |
| 557 | medical schools, schools of public health, hospitals, cancer |
| 558 | centers, cancer survivor groups, and other relevant cancer |
| 559 | stakeholder organizations. Each of the following organizations |
| 560 | shall appoint a representative to serve on the council: |
| 561 | 1. H. Lee Moffitt Cancer Center and Research Institute, |
| 562 | Inc. |
| 563 | 2. University of Florida Shands Cancer Center. |
| 564 | 3. University of Miami Sylvester Comprehensive Cancer |
| 565 | Center. |
| 566 | 4. Mayo Clinic, Florida. |
| 567 | 5. M.D. Anderson Cancer Center, Florida. |
| 568 | 6. American Cancer Society, Florida Division. |
| 569 | 7. American Association for Retired Persons. |
| 570 | 8. Department of Health. |
| 571 | 9. Department of Education. |
| 572 | 10. Florida Tumor Registrars Association. |
| 573 | 11. Florida Cancer Data System. |
| 574 | 12. Florida Society of Oncology Social Workers. |
| 575 | 13. Florida Oncology Nurses Society. |
| 576 | 14. Florida Society of Clinical Oncology. |
| 577 | 15. Florida Association of Pediatric Tumor Programs, Inc. |
| 578 | 16. Cancer Information Service. |
| 579 | 17. Florida Medical Association. |
| 580 | 18. Florida Hospital Association. |
| 581 | 19. Florida Nursing Association. |
| 582 | 20. Florida Dental Association. |
| 583 | 21. Florida Osteopathic Association. |
| 584 | 22. University of Florida College of Medicine. |
| 585 | 23. University of Miami College of Medicine. |
| 586 | 24. University of South Florida College of Medicine. |
| 587 | 25. Florida State University College of Medicine. |
| 588 | 26. University of Central Florida College of Medicine. |
| 589 | 27. Nova Southeastern College of Osteopathic Medicine. |
| 590 | 28. University of Central Florida College of Medicine. |
| 591 | 29. Florida International University College of Medicine. |
| 592 | 30. Lake Erie School of Osteopathic Medicine. |
| 593 | 31. Biomedical Research Advisory Council. |
| 594 | 32. Center for Universal Research to Eradicate Disease. |
| 595 | 33. A representative from each of the regional Cancer |
| 596 | Control Collaboratives. |
| 597 | (b) An executive committee shall be comprised of the |
| 598 | council's elected chairman, one at-large member elected by the |
| 599 | full council, and the members representing the Department of |
| 600 | Health, the American Cancer Society, the H. Lee Moffitt Cancer |
| 601 | Center and Research Institute, Inc., the University of Florida |
| 602 | Shands Cancer Center, and the University of Miami Sylvester |
| 603 | Comprehensive Cancer Center, as well as the appointee of the |
| 604 | President of the Senate, the appointee of the Speaker of the |
| 605 | House of Representatives, and one of the gubernatorial |
| 606 | appointees, who shall be designated by the council's chairman. |
| 607 | Should the council chairman be a designee from one of the named |
| 608 | entities in this paragraph, the full council shall elect a |
| 609 | second at-large position to serve on the executive committee. |
| 610 | The elected positions on the executive committee shall be for |
| 611 | terms of 2 years. |
| 612 | (c) The council shall meet at least semiannually. A |
| 613 | majority of members participating shall constitute a quorum for |
| 614 | the purpose of exercising all of the powers of the council. |
| 615 | (d) The council members shall serve without compensation, |
| 616 | but are entitled to reimbursement for per diem and travel |
| 617 | expenses as provided in s. 112.061. |
| 618 | (e) A member of the council may not participate in any |
| 619 | discussion or decision to recommend any type of award or |
| 620 | contract to any qualified nonprofit association or to any agency |
| 621 | of this state or its political subdivisions with which the |
| 622 | member is associated as a member of the governing body or as an |
| 623 | employee or with which the member has entered into a contractual |
| 624 | arrangement. |
| 625 | (f) The council may prescribe, amend, and repeal bylaws |
| 626 | governing the manner in which the business of the council is |
| 627 | conducted. |
| 628 | (g) The council shall advise the Governor, the |
| 629 | Legislature, the State Surgeon General, or other state |
| 630 | policymakers with respect to cancer control and resources in |
| 631 | this state. |
| 632 | (h) The council shall approve a program for cancer control |
| 633 | to be known as the "Florida Cancer Plan," which shall be |
| 634 | consistent to the extent possible with other cancer or health- |
| 635 | related state plans and integrated and coordinated with existing |
| 636 | programs in this state. The council shall review and approve the |
| 637 | plan at least every 2 years. |
| 638 | (i) The council shall formulate and recommend to the |
| 639 | Governor, the Legislature, the State Surgeon General, and other |
| 640 | state policymakers a plan for the prevention and early detection |
| 641 | of cancer which is evidence-based and consistent with standards |
| 642 | of practice and supported by evidence-based medicine. The State |
| 643 | Surgeon General and other state policymakers shall consider the |
| 644 | plan in developing departmental priorities and funding |
| 645 | priorities and standards under chapter 395. |
| 646 | (j) The council shall provide expertise and input in the |
| 647 | content and development of the Florida Cancer Plan. |
| 648 | Recommendations shall include the coordination and integration |
| 649 | of other state plans concerned with cancer control. Committees |
| 650 | may be formed by the council so that the following areas will be |
| 651 | established as entities for actions: |
| 652 | 1. Cancer plan evaluation, including tumor registry, data |
| 653 | retrieval systems, and epidemiology of cancer in the state and |
| 654 | its relation to other areas. |
| 655 | 2. Cancer prevention. |
| 656 | 3. Cancer detection. |
| 657 | 4. Cancer treatments. |
| 658 | 5. Support services for cancer patients and caregivers. |
| 659 | 6. Cancer education for laypersons and professionals. |
| 660 | 7. Other cancer-control-related topics. |
| 661 | (k) The council shall advise the State Surgeon General on |
| 662 | methods of enforcing and implementing laws already enacted and |
| 663 | concerned with cancer control. |
| 664 | (l) The council may recommend to the State Surgeon General |
| 665 | rules not inconsistent with law as it may deem necessary for the |
| 666 | performance of its duties and the proper administration of this |
| 667 | section. |
| 668 | (m) The council shall be physically located at the H. Lee |
| 669 | Moffitt Cancer Center and Research Institute, Inc. |
| 670 | (n) By December 1 of each year, the council shall report |
| 671 | any findings and recommendations to the Governor, the President |
| 672 | of the Senate, the Speaker of the House of Representatives, and |
| 673 | the State Surgeon General. |
| 674 | (5) RESPONSIBILITIES OF THE H. LEE MOFFITT CANCER CENTER |
| 675 | AND RESEARCH INSTITUTE, INC., AND THE DEPARTMENT OF HEALTH.- |
| 676 | (a) The H. Lee Moffitt Cancer Center and Research |
| 677 | Institute, Inc., shall provide a full-time executive director to |
| 678 | coordinate, facilitate, and communicate the mission and |
| 679 | responsibilities of the council. Additional administrative |
| 680 | support, information, and other assistance shall also be |
| 681 | provided as reasonably necessary for the completion of the |
| 682 | responsibilities of the council. |
| 683 | (b) From the funds appropriated annually for the William |
| 684 | G. "Bill" Bankhead, Jr. and David Coley Cancer Research Program, |
| 685 | the sum of $150,000 shall be allocated to the H. Lee Moffitt |
| 686 | Cancer Center and Research Institute, Inc., for the |
| 687 | administrative costs and staff support to convene and facilitate |
| 688 | the responsibilities of the council. |
| 689 | (c) The Department of Health, after consultation with the |
| 690 | council, may adopt rules necessary to administer this section. |
| 691 | (d) The Florida Cancer Plan is established within the |
| 692 | Department of Health. The Department of Health shall consult |
| 693 | with the council in developing the plan, prioritizing goals, and |
| 694 | allocating resources. The plan shall be approved by the council. |
| 695 | The Cancer Control Collaborative Program shall prioritize |
| 696 | programs and resources to reduce the burden of cancer in this |
| 697 | state, consistent with the plan. |
| 698 | (6) FLORIDA CANCER CONTROL COLLABORATIVE PROGRAM; |
| 699 | CREATION; COMPOSITION.- |
| 700 | (a) The Cancer Control Collaborative Program is |
| 701 | established within the Department of Health and resides within |
| 702 | the cancer program. The program is responsible for overseeing |
| 703 | and providing infrastructure for the state cancer collaborative |
| 704 | network. The primary mission of the program is to implement the |
| 705 | plan's initiatives and identify and facilitate the local |
| 706 | development of solutions to cancer control needs of the |
| 707 | populations served by the regional cancer control |
| 708 | collaboratives. |
| 709 | (b) The Department of Health shall appoint a cancer |
| 710 | program director, who is responsible for supervising the |
| 711 | collaborative program. At a minimum, centralized organization, |
| 712 | communications, information technology, shared resources, and |
| 713 | cancer control expertise shall be provided to the regional |
| 714 | cancer control collaboratives by the Department of Health. |
| 715 | (c) Each regional cancer control collaborative shall bring |
| 716 | together local cancer stakeholders, develop bylaws, identify |
| 717 | priority cancer control needs of its region, and develop |
| 718 | solutions to solve problems, consistent with the plan and the |
| 719 | goal of reducing the burden of cancer in this state. Each |
| 720 | collaborative shall meet at least semiannually and send |
| 721 | representation to the council meetings. |
| 722 | (d) By October 15 of each year, the collaborative program |
| 723 | shall submit an annual report to the council. The council shall |
| 724 | have input into the prioritization of programs and proposed |
| 725 | allocation of resources in the program consistent with the plan. |
| 726 | (e) The Cancer Control Collaborative Program shall serve |
| 727 | as the infrastructure for expansion or adaptation as federal |
| 728 | programs or other opportunities arise for future cancer control |
| 729 | initiatives. The development of the infrastructure for local |
| 730 | cancer control collaboratives, to the extent possible, shall be |
| 731 | designed to leverage opportunities for funding from the United |
| 732 | States Centers for Disease Control or other federal sources. |
| 733 | Section 7. Paragraph (a) of subsection (5) of section |
| 734 | 381.855, Florida Statutes, is amended to read: |
| 735 | 381.855 Florida Center for Universal Research to Eradicate |
| 736 | Disease.- |
| 737 | (5) There is established within the center an advisory |
| 738 | council that shall meet at least annually. |
| 739 | (a) The council shall consist of one representative from a |
| 740 | Florida not-for-profit institution engaged in basic and clinical |
| 741 | biomedical research and education which receives more than $10 |
| 742 | million in annual grant funding from the National Institutes of |
| 743 | Health, to be appointed by the State Surgeon General from a |
| 744 | different institution each term, and one representative from and |
| 745 | appointed by each of the following entities: |
| 746 | 1. Enterprise Florida, Inc. |
| 747 | 2. BioFlorida. |
| 748 | 3. The Biomedical Research Advisory Council. |
| 749 | 4. The Florida Medical Foundation. |
| 750 | 5. Pharmaceutical Research and Manufacturers of America. |
| 751 | 6. The Florida Cancer Council. |
| 752 | 6.7. The American Cancer Society, Florida Division, Inc. |
| 753 | 7.8. The American Heart Association. |
| 754 | 8.9. The American Lung Association of Florida. |
| 755 | 9.10. The American Diabetes Association, South Coastal |
| 756 | Region. |
| 757 | 10.11. The Alzheimer's Association. |
| 758 | 11.12. The Epilepsy Foundation. |
| 759 | 12.13. The National Parkinson Foundation. |
| 760 | 13.14. The Florida Public Health Institute, Inc. |
| 761 | 14.15. The Florida Research Consortium. |
| 762 | Section 8. Subsection (1) and paragraph (a) of subsection |
| 763 | (2) of section 458.324, Florida Statutes, are amended to read: |
| 764 | 458.324 Breast cancer; information on treatment |
| 765 | alternatives.- |
| 766 | (1) DEFINITION.-As used in this section, the term |
| 767 | "medically viable," as applied to treatment alternatives, means |
| 768 | modes of treatment generally considered by the medical |
| 769 | profession to be within the scope of current, acceptable |
| 770 | standards, including treatment alternatives described in the |
| 771 | written summary prepared by the Florida Cancer Control and |
| 772 | Resource Research Advisory Council in accordance with s. |
| 773 | 1004.435(4)(m). |
| 774 | (2) COMMUNICATION OF TREATMENT ALTERNATIVES.-Each |
| 775 | physician treating a patient who is, or in the judgment of the |
| 776 | physician is at high risk of being, diagnosed as having breast |
| 777 | cancer shall inform such patient of the medically viable |
| 778 | treatment alternatives available to such patient; shall describe |
| 779 | such treatment alternatives; and shall explain the relative |
| 780 | advantages, disadvantages, and risks associated with the |
| 781 | treatment alternatives to the extent deemed necessary to allow |
| 782 | the patient to make a prudent decision regarding such treatment |
| 783 | options. In compliance with this subsection: |
| 784 | (a) The physician may, in his or her discretion: |
| 785 | 1. Orally communicate such information directly to the |
| 786 | patient or the patient's legal representative; |
| 787 | 2. Provide the patient or the patient's legal |
| 788 | representative with a copy of the written summary prepared in |
| 789 | accordance with s. 1004.435(4)(m) and express a willingness to |
| 790 | discuss the summary with the patient or the patient's legal |
| 791 | representative; or |
| 792 | 3. Both communicate such information directly and provide |
| 793 | a copy of the written summary to the patient or the patient's |
| 794 | legal representative for further consideration and possible |
| 795 | later discussion. |
| 796 |
|
| 797 | Nothing in this subsection shall reduce other provisions of law |
| 798 | regarding informed consent. |
| 799 | Section 9. Subsection (1) and paragraph (a) of subsection |
| 800 | (2) of section 459.0125, Florida Statutes, are amended to read: |
| 801 | 459.0125 Breast cancer; information on treatment |
| 802 | alternatives.- |
| 803 | (1) DEFINITION.-As used in this section, the term |
| 804 | "medically viable," as applied to treatment alternatives, means |
| 805 | modes of treatment generally considered by the medical |
| 806 | profession to be within the scope of current, acceptable |
| 807 | standards, including treatment alternatives described in the |
| 808 | written summary prepared by the Florida Cancer Control and |
| 809 | Resource Research Advisory Council in accordance with s. |
| 810 | 1004.435(4)(m). |
| 811 | (2) COMMUNICATION OF TREATMENT ALTERNATIVES.-It is the |
| 812 | obligation of every physician treating a patient who is, or in |
| 813 | the judgment of the physician is at high risk of being, |
| 814 | diagnosed as having breast cancer to inform such patient of the |
| 815 | medically viable treatment alternatives available to such |
| 816 | patient; to describe such treatment alternatives; and to explain |
| 817 | the relative advantages, disadvantages, and risks associated |
| 818 | with the treatment alternatives to the extent deemed necessary |
| 819 | to allow the patient to make a prudent decision regarding such |
| 820 | treatment options. In compliance with this subsection: |
| 821 | (a) The physician may, in her or his discretion: |
| 822 | 1. Orally communicate such information directly to the |
| 823 | patient or the patient's legal representative; |
| 824 | 2. Provide the patient or the patient's legal |
| 825 | representative with a copy of the written summary prepared in |
| 826 | accordance with s. 1004.435(4)(m) and express her or his |
| 827 | willingness to discuss the summary with the patient or the |
| 828 | patient's legal representative; or |
| 829 | 3. Both communicate such information directly and provide |
| 830 | a copy of the written summary to the patient or the patient's |
| 831 | legal representative for further consideration and possible |
| 832 | later discussion. |
| 833 |
|
| 834 | Nothing in This subsection does not shall reduce other |
| 835 | provisions of law regarding informed consent. |
| 836 | Section 10. Section 1004.435, Florida Statutes, is |
| 837 | repealed. |
| 838 | Section 11. This act shall take effect July 1, 2010. |