| 1 | Representative Bean offered the following: |
| 2 |
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| 3 | Amendment (with title amendment) |
| 4 | Remove everything after the enacting clause and insert: |
| 5 | Section 1. Subsection (6) of section 381.006, Florida |
| 6 | Statutes, is amended to read: |
| 7 | 381.006 Environmental health.--The department shall |
| 8 | conduct an environmental health program as part of fulfilling |
| 9 | the state's public health mission. The purpose of this program |
| 10 | is to detect and prevent disease caused by natural and manmade |
| 11 | factors in the environment. The environmental health program |
| 12 | shall include, but not be limited to: |
| 13 | (6) A public facilities function, including sanitary |
| 14 | practices relating to state, county, municipal, and private |
| 15 | institutions serving the public; jointly with the Department of |
| 16 | Education, publicly and privately owned schools; all places used |
| 17 | for the incarceration of prisoners and inmates of state |
| 18 | institutions for the mentally ill; toilets and washrooms in all |
| 19 | public places and places of employment; any other condition, |
| 20 | place, or establishment necessary for the control of disease or |
| 21 | the protection and safety of public health. |
| 22 |
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| 23 | The department may adopt rules to carry out the provisions of |
| 24 | this section. |
| 25 | Section 2. Subsection (1) of section 381.86, Florida |
| 26 | Statutes, is amended to read: |
| 27 | 381.86 Institutional Review Board.-- |
| 28 | (1) The Institutional Review Board is created within the |
| 29 | Department of Health in order to satisfy federal requirements |
| 30 | under 45 C.F.R. part 46 and 21 C.F.R. parts 50 and 56 that an |
| 31 | institutional review board review all biomedical and behavioral |
| 32 | research on human subjects which is funded or supported in any |
| 33 | manner by the department. |
| 34 | Section 3. Section 381.98, Florida Statutes, is amended to |
| 35 | read: |
| 36 | 381.98 The Florida Public Health Institute Foundation, |
| 37 | Inc.; establishment; purpose; mission; duties; board of |
| 38 | directors.-- |
| 39 | (1) The Florida Public Health Institute Foundation, Inc., |
| 40 | referred to in this section as "the corporation," is established |
| 41 | for the purpose of advancing the knowledge and practice of |
| 42 | public health, including disseminating breakthrough findings in |
| 43 | biomedical research and promoting health awareness in this state |
| 44 | and providing services to the Department of Health. |
| 45 | (2) The corporation's mission includes disseminating |
| 46 | information about innovative biomedical research and clinical |
| 47 | trials in this state as well as making Floridians and their |
| 48 | treatment providers aware of specified diseases and conditions |
| 49 | and available methods of preventing, diagnosing, treating, and |
| 50 | curing those diseases and conditions. |
| 51 | (2)(3) The purpose and objective of the corporation is |
| 52 | shall be to operate exclusively for charitable, scientific, and |
| 53 | educational purposes; to protect and improve the health and |
| 54 | well-being of Florida's people and environment through |
| 55 | partnerships committed to program innovation, education, applied |
| 56 | research, and policy development; and to engage in charitable |
| 57 | programs dedicated to improving the health of Floridians. |
| 58 | (3)(4) The corporation shall be established as a not-for- |
| 59 | profit entity qualifying under s. 501(c)(3) of the Internal |
| 60 | Revenue Code. The corporation may receive, hold, invest, and |
| 61 | administer property and any moneys acquired from private, local, |
| 62 | state, and federal sources, as well as technical and |
| 63 | professional income generated or derived from the mission- |
| 64 | related activities of the corporation. The corporation shall |
| 65 | have all of the powers conferred upon corporations organized |
| 66 | under chapter 617. |
| 67 | (4)(5) The corporation's duties include procuring funds |
| 68 | necessary for accomplishing the purpose and mission of the |
| 69 | corporation. The corporation shall strive to complement, |
| 70 | supplement, and enhance the missions of the various |
| 71 | organizations, entities, and departments represented on its |
| 72 | board by serving as the lead corporation in the state for |
| 73 | promoting public health awareness. |
| 74 | (5)(6) The affairs of the corporation shall be managed by |
| 75 | an executive director appointed by a board of directors. |
| 76 | consisting of: |
| 77 | (6) The board of directors shall be elected in accordance |
| 78 | with the bylaws of the corporation and must include, but need |
| 79 | not be limited to: |
| 80 | (a) The State Surgeon General or his or her designee. |
| 81 | (b) A representative of the Florida Public Health |
| 82 | Association former member of the Senate appointed by the |
| 83 | President of the Senate. |
| 84 | (c) Representatives of local health departments, with at |
| 85 | least one representative from the southern, central, and |
| 86 | northern areas of the state A former member of the House of |
| 87 | Representatives appointed by the Speaker of the House of |
| 88 | Representatives. |
| 89 | (d) Representatives from institutions of higher learning A |
| 90 | representative of the American Heart Association. |
| 91 | (e) Representatives from the private health care, |
| 92 | business, or foundation community A representative of the |
| 93 | American Cancer Society, Florida Division, Inc. |
| 94 | (f) A representative of the American Lung Association of |
| 95 | Florida. |
| 96 | (g) A representative of the American Diabetes Association, |
| 97 | South Coastal Region. |
| 98 | (h) A representative of the Alzheimer's Association. |
| 99 | (i) A representative of the Epilepsy Foundation. |
| 100 | (j) A representative of the National Parkinson Foundation. |
| 101 | (k) A representative of the March of Dimes, Florida |
| 102 | Chapter. |
| 103 | (l) A representative of the Arthritis Foundation, Florida |
| 104 | Chapter. |
| 105 | (m) A representative of the American Liver Foundation. |
| 106 | (n) A representative of the Florida Council for Behavioral |
| 107 | Healthcare, Inc. |
| 108 | (o) A representative of the Florida Alcohol and Drug Abuse |
| 109 | Association. |
| 110 | (p) A representative of Pharmaceutical Research and |
| 111 | Manufacturers of America. |
| 112 | (q) A representative of the Florida Public Health |
| 113 | Association. |
| 114 | (r) A representative of the Florida Association of County |
| 115 | Health Officers. |
| 116 | (s) A public health academician selected by the State |
| 117 | Health Officer. |
| 118 | (t) A representative of the Florida Academy of Family |
| 119 | Physicians. |
| 120 | (u) Three consumers who have demonstrated an interest in |
| 121 | protecting the public health appointed by the Florida Public |
| 122 | Health Association. |
| 123 | (v) A representative of the Florida Association of Health |
| 124 | Plans. |
| 125 | (7) The majority of board members must be nonstate |
| 126 | employees. |
| 127 | (7) Members of the board of directors shall serve for 2- |
| 128 | year terms and shall serve without compensation. Each |
| 129 | organization represented on the board of directors shall cover |
| 130 | the expenses of its representative. |
| 131 | (8) The corporation, in consultation with the Department |
| 132 | of Health and the Florida Center for Universal Research to |
| 133 | Eradicate Disease, shall facilitate communication between |
| 134 | biomedical researchers and health care providers each month |
| 135 | according to the health awareness schedule established by the |
| 136 | Florida Public Health Foundation, Inc., in order to ensure |
| 137 | ongoing dialogue between researchers, treatment providers, and |
| 138 | the department. |
| 139 | (8)(9) The corporation and the Department of Health shall |
| 140 | enter into partnerships with providers of continuing education |
| 141 | for health care practitioners, including, but not limited to, |
| 142 | hospitals and state and local medical organizations, to ensure |
| 143 | that practitioners are aware of the most recent and complete |
| 144 | diagnostic and treatment tools. |
| 145 | (9)(10) The corporation may provide personnel to the |
| 146 | Department of Health for the purpose of performing duties and |
| 147 | responsibilities outlined in private and public grants received |
| 148 | by the Department of Health. These personnel are not state |
| 149 | employees and are not entitled to retirement credit and other |
| 150 | benefits provided to state employees under chapters 110 and 112. |
| 151 | These personnel shall perform services under pursuant to an |
| 152 | agreement between the corporation and the Department of Health. |
| 153 | (10)(11) The corporation may purchase goods, services, and |
| 154 | property for use by the Department of Health. These purchases |
| 155 | are not subject to the provisions of chapters 253, 255, and 287, |
| 156 | nor to the control or direction of the Department of |
| 157 | Environmental Protection or the Department of Management |
| 158 | Services. |
| 159 | (11)(12) The corporation shall provide an annual report |
| 160 | concerning its activities and finances to the Florida Center for |
| 161 | Universal Research to Eradicate Disease and shall provide copies |
| 162 | of the annual report to the Governor, the President of the |
| 163 | Senate, and the Speaker of the House of Representatives. |
| 164 | Section 4. Paragraph (h) of subsection (1) of section |
| 165 | 20.435, Florida Statutes, is amended to read: |
| 166 | 20.435 Department of Health; trust funds.-- |
| 167 | (1) The following trust funds are hereby created, to be |
| 168 | administered by the Department of Health: |
| 169 | (h) Biomedical Research Trust Fund. |
| 170 | 1. Funds to be credited to the trust fund shall consist of |
| 171 | funds deposited pursuant to s. 215.5601 and any other funds |
| 172 | appropriated by the Legislature. Funds shall be used for the |
| 173 | purposes of the James and Esther King Biomedical Research |
| 174 | Program and the William G. "Bill" Bankhead, Jr., and David Coley |
| 175 | Cancer Research Program as specified in ss. 215.5602, 288.955, |
| 176 | and 381.922. The trust fund is exempt from the service charges |
| 177 | imposed by s. 215.20. |
| 178 | 2. Funds deposited into the trust fund pursuant to s. |
| 179 | 215.5601 and any other funds appropriated by the Legislature as |
| 180 | specified in s. 215.5602(12)(a) for research related to tobacco- |
| 181 | related diseases shall be used exclusively for the purpose of |
| 182 | awarding grants and fellowships for research regarding the |
| 183 | prevention, diagnosis, treatment, and cure of tobacco-related |
| 184 | diseases by the James and Esther King Biomedical Research |
| 185 | Program. |
| 186 | 3. Funds deposited into the trust fund pursuant to the |
| 187 | William G. "Bill" Bankhead, Jr., and David Coley Cancer Research |
| 188 | Program as specified in s. 381.922 shall be used for the purpose |
| 189 | of awarding grants for cancer research by the William G. "Bill" |
| 190 | Bankhead, Jr., and David Coley Cancer Research Program. |
| 191 | 4. All other funds deposited into the trust fund shall be |
| 192 | used for the purpose of awarding grants and fellowships for |
| 193 | biomedical research regarding the prevention, diagnosis, |
| 194 | treatment, and cure of the most deadly and widespread |
| 195 | nontobacco-related acute, chronic, and degenerative diseases by |
| 196 | the James and Esther King Biomedical Research Program as |
| 197 | specified in s. 215.5602(2)(b) and (12)(b). |
| 198 | 5.2. Notwithstanding the provisions of s. 216.301 and |
| 199 | pursuant to s. 216.351, any balance in the trust fund at the end |
| 200 | of any fiscal year shall remain in the trust fund at the end of |
| 201 | the year and shall be available for carrying out the purposes of |
| 202 | the trust fund. The department may invest these funds |
| 203 | independently through the Chief Financial Officer or may |
| 204 | negotiate a trust agreement with the State Board of |
| 205 | Administration for the investment management of any balance in |
| 206 | the trust fund. |
| 207 | 6.3. Notwithstanding s. 216.301 and pursuant to s. |
| 208 | 216.351, any balance of any appropriation from the Biomedical |
| 209 | Research Trust Fund which is not disbursed but which is |
| 210 | obligated pursuant to contract or committed to be expended may |
| 211 | be carried forward for up to 5 3 years following the effective |
| 212 | date of the original appropriation. |
| 213 | Section 5. Paragraph (e) of subsection (5) of section |
| 214 | 215.5601, Florida Statutes, is amended to read: |
| 215 | 215.5601 Lawton Chiles Endowment Fund.-- |
| 216 | (5) AVAILABILITY OF FUNDS; USES.-- |
| 217 | (e) Notwithstanding s. 216.301 and pursuant to s. 216.351, |
| 218 | all unencumbered balances of appropriations from each |
| 219 | department's respective Tobacco Settlement Trust Fund as of June |
| 220 | 30 or undisbursed balances as of December 31 shall revert to the |
| 221 | endowment's principal. Unencumbered balances in the Biomedical |
| 222 | Research Trust Fund shall be managed as provided in s. |
| 223 | 20.435(1)(h)5.2. |
| 224 | Section 6. Section 215.5602, Florida Statutes, is amended |
| 225 | to read: |
| 226 | 215.5602 James and Esther King Biomedical Research |
| 227 | Program.-- |
| 228 | (1) There is established within the Department of Health |
| 229 | the James and Esther King Biomedical Research Program funded by |
| 230 | the proceeds of the Lawton Chiles Endowment Fund pursuant to s. |
| 231 | 215.5601. The purpose of the James and Esther King Biomedical |
| 232 | Research Program is to provide an annual and perpetual source of |
| 233 | funding in order to support research initiatives that address |
| 234 | the health care problems of Floridians in the areas of tobacco- |
| 235 | related cancer, cardiovascular disease, stroke, and pulmonary |
| 236 | disease and nontobacco-related acute, chronic, and degenerative |
| 237 | diseases, including cancer, cardiovascular disease, stroke, |
| 238 | pulmonary disease, diabetes, autoimmune and genetic disorders, |
| 239 | and neurological disorders, including Alzheimer's disease, |
| 240 | epilepsy, and Parkinson's disease. The long-term goals of the |
| 241 | program are to: |
| 242 | (a) Improve the health of Floridians by researching better |
| 243 | prevention, diagnoses, treatments, and cures for the most deadly |
| 244 | and widespread acute, chronic, and degenerative diseases, |
| 245 | including, but not limited to, tobacco-related diseases, cancer, |
| 246 | cardiovascular disease, stroke, and pulmonary disease, diabetes, |
| 247 | autoimmune and genetic disorders, and neurological disorders, |
| 248 | including Alzheimer's disease, epilepsy, and Parkinson's |
| 249 | disease. |
| 250 | (b) Expand the foundation of biomedical knowledge relating |
| 251 | to the prevention, diagnosis, treatment, and cure of tobacco- |
| 252 | related diseases related to tobacco use, including cancer, |
| 253 | cardiovascular disease, stroke, and pulmonary disease. |
| 254 | (c) Expand the foundation of biomedical knowledge relating |
| 255 | to the prevention, diagnosis, treatment, and cure of the most |
| 256 | widespread acute, chronic, and degenerative diseases affecting |
| 257 | Floridians, including, but not limited to, cancer, |
| 258 | cardiovascular disease, stroke, pulmonary disease, diabetes, |
| 259 | autoimmune and genetic disorders, and neurological disorders, |
| 260 | including Alzheimer's disease, epilepsy, and Parkinson's |
| 261 | disease. |
| 262 | (d) Expand the foundation of biomedical knowledge relating |
| 263 | to the deadly and most widespread acute, chronic, and |
| 264 | degenerative diseases and identify biomedical solutions |
| 265 | regarding health disparities that exist in relation to these |
| 266 | diseases. |
| 267 | (e)(c) Improve the quality of the state's academic health |
| 268 | centers by bringing the advances of biomedical research into the |
| 269 | training of physicians and other health care providers. |
| 270 | (f)(d) Increase the state's per capita funding for |
| 271 | research by undertaking new initiatives in public health and |
| 272 | biomedical research that will attract additional funding from |
| 273 | outside the state. |
| 274 | (g)(e) Stimulate economic activity in the state in areas |
| 275 | related to biomedical research, such as the research and |
| 276 | production of pharmaceuticals, biotechnology, and medical |
| 277 | devices. |
| 278 | (2)(a) Funds appropriated for the James and Esther King |
| 279 | Biomedical Research Program pursuant to the Lawton Chiles |
| 280 | Endowment Fund created in s. 215.5601 and additional funding |
| 281 | provided under paragraph (12)(a) for research related to |
| 282 | tobacco-related diseases shall be credited to the Biomedical |
| 283 | Research Trust Fund pursuant to s. 20.435 and shall be used |
| 284 | exclusively for the award of grants and fellowships related to |
| 285 | the prevention, diagnosis, treatment, and cure of tobacco- |
| 286 | related diseases, including cancer, cardiovascular disease, |
| 287 | stroke, and pulmonary disease and for expenses incurred in the |
| 288 | administration of this section. Priority shall be granted to |
| 289 | research designed to prevent or cure tobacco-related diseases. |
| 290 | (b) Beginning in fiscal year 2009-2010, and each fiscal |
| 291 | year thereafter, all other funds appropriated for the James and |
| 292 | Esther King Biomedical Research Program shall be credited to the |
| 293 | Biomedical Research Trust Fund pursuant to s. 20.435 and shall |
| 294 | be used exclusively for the award of grants and fellowships as |
| 295 | established in this section; for research relating to the |
| 296 | prevention, diagnosis, treatment, and cure of the most deadly |
| 297 | and widespread acute, chronic, and degenerative nontobacco- |
| 298 | related diseases affecting Floridians related to tobacco use, |
| 299 | including cancer, cardiovascular disease, stroke, and pulmonary |
| 300 | disease, diabetes, autoimmune and genetic disorders, and |
| 301 | neurological disorders, including Alzheimer's disease, epilepsy, |
| 302 | and Parkinson's disease,; and for expenses incurred in the |
| 303 | administration of this section. Priority shall be granted to |
| 304 | research designed to prevent or cure disease. |
| 305 | (3) There is created within the Department of Health the |
| 306 | Biomedical Research Commission Advisory Council. |
| 307 | (a) The commission council shall consist of 15 11 members, |
| 308 | including: the chief executive officer of the Florida Division |
| 309 | of the American Cancer Society, or a designee; the chief |
| 310 | executive officer of the Greater Southeast Florida/Puerto Rico |
| 311 | Affiliate of the American Heart Association, or a designee; and |
| 312 | the chief executive officer of the American Lung Association of |
| 313 | Florida, or a designee; the chief executive officer of the South |
| 314 | Coastal Region of the American Diabetes Association, or a |
| 315 | designee; and the president of the Florida Medical Association, |
| 316 | or a designee. The remaining 10 8 members of the commission |
| 317 | council shall be appointed as follows: |
| 318 | 1. The Governor shall appoint four members, two members |
| 319 | with expertise in the field of biomedical research, one member |
| 320 | from a research university in the state, and one member |
| 321 | representing the general population of the state. |
| 322 | 2. The President of the Senate shall appoint three two |
| 323 | members, one member with expertise in the field of behavioral or |
| 324 | social research and two members representing volunteer health |
| 325 | organizations operating in the state that focus on Alzheimer's |
| 326 | disease, Parkinson's disease, epilepsy, stroke, or autoimmune |
| 327 | and genetic disorders one representative from a cancer program |
| 328 | approved by the American College of Surgeons. |
| 329 | 3. The Speaker of the House of Representatives shall |
| 330 | appoint three two members, two members representing volunteer |
| 331 | health organizations operating in the state that focus on |
| 332 | Alzheimer's disease, Parkinson's disease, epilepsy, stroke, or |
| 333 | autoimmune and genetic disorders one member from a professional |
| 334 | medical organization and one member representing representative |
| 335 | from a cancer program approved by the American College of |
| 336 | Surgeons. |
| 337 |
|
| 338 | In making these appointments, the Governor, the President of the |
| 339 | Senate, and the Speaker of the House of Representatives shall |
| 340 | select primarily, but not exclusively, Floridians with |
| 341 | biomedical and lay expertise in the general areas of cancer, |
| 342 | cardiovascular disease, stroke, and pulmonary disease, diabetes, |
| 343 | autoimmune and genetic disorders, and neurological disorders, |
| 344 | including Alzheimer's disease, epilepsy, and Parkinson's |
| 345 | disease. The appointments shall be for a 3-year term and shall |
| 346 | reflect the diversity of the state's population. An appointed |
| 347 | member may not serve more than two consecutive terms. |
| 348 | (b) Except for the William G. "Bill" Bankhead, Jr., and |
| 349 | David Coley Cancer Research Program that expires June 30, 2011, |
| 350 | pursuant to s. 381.922, beginning in fiscal year 2009-2010, and |
| 351 | each fiscal year thereafter, funds appropriated for the James |
| 352 | and Esther King Biomedical Research Program shall serve as the |
| 353 | exclusive source of awarding grants or fellowships for |
| 354 | biomedical research in the state using state funds. This |
| 355 | paragraph does not preclude another grant or fellowship program |
| 356 | created by state law from awarding grants from funds received |
| 357 | from private or federal sources if permitted by state law. |
| 358 | (c) The commission shall create committees to focus on |
| 359 | disease-specific areas, including, but not limited to, tobacco- |
| 360 | related diseases, cancer, stroke, cardiovascular disease, |
| 361 | pulmonary disease, diabetes, autoimmune and genetic disorders, |
| 362 | and neurological disorders, including Alzheimer's disease, |
| 363 | epilepsy, and Parkinson's disease. |
| 364 | (d)(b) The commission council shall adopt internal |
| 365 | organizational procedures as necessary for its efficient |
| 366 | organization, including policies and procedures regarding the |
| 367 | creation and composition of the committees, the submission of |
| 368 | reports and recommendations by committees regarding the awarding |
| 369 | of grants and fellowships, coordination between the commission |
| 370 | and committees, and the methods for receiving input from |
| 371 | individuals, organizations, or entities that are not members of |
| 372 | the commission or its committees regarding the prioritization of |
| 373 | research. |
| 374 | (e)(c) The department shall provide such staff, |
| 375 | information, and other assistance as is reasonably necessary to |
| 376 | assist the commission council in carrying out its |
| 377 | responsibilities, including those of its committees. |
| 378 | (f)(d) Members of the commission council shall serve |
| 379 | without compensation, but may receive reimbursement as provided |
| 380 | in s. 112.061 for travel and other necessary expenses incurred |
| 381 | in the performance of their official duties, including attending |
| 382 | committee meetings. |
| 383 | (4) The commission council shall, after considering the |
| 384 | recommendations of its committees, advise the State Surgeon |
| 385 | General as to the direction and scope of the biomedical research |
| 386 | program. The responsibilities of the commission council may |
| 387 | include, but are not limited to: |
| 388 | (a) Establishing Providing advice on program priorities |
| 389 | and emphases. |
| 390 | (b) Evaluating Providing advice on the overall program |
| 391 | budget and making recommendations to the State Surgeon General |
| 392 | and the Legislature regarding future appropriations. |
| 393 | (c) Participating in periodic program evaluation. |
| 394 | (d) Developing Assisting in the development of guidelines |
| 395 | to ensure fairness, neutrality, and adherence to the principles |
| 396 | of merit and quality in the conduct of the program. |
| 397 | (e) Developing Assisting in the development of appropriate |
| 398 | linkages to nonacademic entities, such as voluntary |
| 399 | organizations, health care delivery institutions, industry, |
| 400 | government agencies, and public officials. |
| 401 | (f) Developing criteria and standards for the award of |
| 402 | research grants. |
| 403 | (g) Developing administrative procedures relating to |
| 404 | solicitation, independent peer review, and award of research |
| 405 | grants and fellowships, to ensure an impartial, high-quality, |
| 406 | science-based peer review system. |
| 407 | (h) Developing and supervising research peer review |
| 408 | panels. |
| 409 | (i) Reviewing reports of peer review panels and making |
| 410 | recommendations for research grants and fellowships. |
| 411 | (j) Developing and providing oversight regarding |
| 412 | mechanisms for the dissemination of research results. |
| 413 | (5)(a) Applications for biomedical research funding under |
| 414 | the program may be submitted from any university or established |
| 415 | research institute in the state. All qualified investigators in |
| 416 | the state, regardless of institution affiliation, shall have |
| 417 | equal access and opportunity to compete for the research |
| 418 | funding. |
| 419 | (b) Beginning in fiscal year 2008-2009, grants and |
| 420 | fellowships shall be awarded by the State Surgeon General, after |
| 421 | consultation with the commission council, on the basis of |
| 422 | scientific merit, as determined by an open competitive peer |
| 423 | review process that ensures objectivity, consistency, and high |
| 424 | quality. |
| 425 | (c) Beginning in fiscal year 2009-2010, and each fiscal |
| 426 | year thereafter, the State Surgeon General shall submit to the |
| 427 | Legislature by February 1 priority lists for the funding of both |
| 428 | tobacco-related and nontobacco-related biomedical research by |
| 429 | the Legislature based on the recommendations made by the |
| 430 | commission after peer review and scoring of the applications |
| 431 | received. Recommendations to the Legislature shall be in the |
| 432 | form of lists submitted by the State Surgeon General of the |
| 433 | commission's rank order of priority from the proposal with the |
| 434 | highest priority through the proposal with the lowest priority, |
| 435 | including the recommended dollar amount and duration for each |
| 436 | proposal. The State Surgeon General may not reject or modify the |
| 437 | commission's recommendations. Successful applicants shall be |
| 438 | awarded grants or fellowships by the State Surgeon General based |
| 439 | upon the recommendations of the commission and the final funding |
| 440 | decision made by the Legislature. Funding for grant and |
| 441 | fellowship applications for tobacco-related research shall be |
| 442 | based upon funds available pursuant to paragraphs (2)(a) and |
| 443 | (12)(a) and s. 215.5601. |
| 444 | (d) Beginning in fiscal year 2009-2010, and each fiscal |
| 445 | year thereafter, the commission's overall ranking of grant and |
| 446 | fellowship applications shall be based on the score awarded to |
| 447 | the proposal by peer reviewers on the basis of scientific merit |
| 448 | through an open competitive peer review process that ensures |
| 449 | objectivity, consistency, and high quality and the commission's |
| 450 | determination of the following: |
| 451 | 1. The projected impact that the proposed research will |
| 452 | have on the most deadly and widespread diseases affecting |
| 453 | Floridians at the time the grant or fellowship is awarded; |
| 454 | 2. The likelihood or possibility that the proposed |
| 455 | research will result in new treatment modalities or technology |
| 456 | during the term of the grant or fellowship; and |
| 457 | 3. Whether the research proposed offers an efficient use |
| 458 | of state funds in order to prevent or cure disease. |
| 459 | (e) The following types of applications shall be |
| 460 | considered for funding: |
| 461 | 1. Investigator-initiated research grants. |
| 462 | 2. Institutional research grants. |
| 463 | 3. Predoctoral and postdoctoral research fellowships. |
| 464 | (f) The State Surgeon General shall award grants or |
| 465 | fellowships for terms of 1 to 5 years. State funds shall only be |
| 466 | provided for research that was applied for, reviewed, and |
| 467 | recommended in accordance with this section. |
| 468 | (g) Except for the William G. "Bill" Bankhead, Jr., and |
| 469 | David Coley Cancer Research Program that expires June 30, 2011, |
| 470 | pursuant to s. 381.922, beginning July 1, 2009, and each fiscal |
| 471 | year thereafter, any program, board, commission, council, |
| 472 | advisory group, agency, or entity created by state law that |
| 473 | awards or recommends the award of grants or fellowships for |
| 474 | biomedical research may not award grants or fellowships that |
| 475 | require the use of state funds and, instead, shall make any |
| 476 | recommendation to the commission and its committees for the |
| 477 | prioritization and award of grants and fellowships through the |
| 478 | James and Esther King Biomedical Research Program. |
| 479 | (6) To ensure that all proposals for research funding are |
| 480 | appropriate and are evaluated fairly on the basis of scientific |
| 481 | merit, the State Surgeon General, in consultation with the |
| 482 | commission council, shall appoint a peer review panel of |
| 483 | independent, scientifically qualified individuals to review the |
| 484 | scientific content of each proposal and establish its scientific |
| 485 | priority score. The priority scores shall be forwarded to the |
| 486 | commission and its committees council and must be considered in |
| 487 | determining which proposals shall be recommended for funding. |
| 488 | (7) The commission, the committees, council and the peer |
| 489 | review panel shall establish and follow rigorous guidelines for |
| 490 | ethical conduct and adhere to a strict policy with regard to |
| 491 | conflict of interest. A member of the commission, committee, |
| 492 | council or panel may not participate in any discussion or |
| 493 | decision with respect to a research proposal by any firm, |
| 494 | entity, or agency with which the member is associated as a |
| 495 | member of the governing body or as an employee, or with which |
| 496 | the member has entered into a contractual arrangement. Meetings |
| 497 | of the commission, committees, council and the peer review |
| 498 | panels shall be subject to the provisions of chapter 119, s. |
| 499 | 286.011, and s. 24, Art. I of the State Constitution. |
| 500 | (8) The department may contract on a competitive-bid basis |
| 501 | with an appropriate entity to administer the program. |
| 502 | Administrative expenses may not exceed 15 percent of the total |
| 503 | funds available to the program in any given year. Effective July |
| 504 | 1, 2009, administrative expenses may not exceed 10 percent of |
| 505 | the total funds available to the program in any given year. |
| 506 | Effective July 1, 2011, administrative expenses may not exceed 5 |
| 507 | percent of the total funds available to the program in any given |
| 508 | year. |
| 509 | (9) The department, after consultation with the commission |
| 510 | council, may adopt rules pursuant to ss. 120.536(1) and 120.54 |
| 511 | as necessary to implement this section. |
| 512 | (10) In addition to its recommendations regarding |
| 513 | appropriations for the award of grants and fellowships to the |
| 514 | State Surgeon General and the Legislature, the commission |
| 515 | council shall submit an annual progress report on the state of |
| 516 | biomedical research in this state to the Florida Center for |
| 517 | Universal Research to Eradicate Disease and to the Governor, the |
| 518 | State Surgeon General, the President of the Senate, and the |
| 519 | Speaker of the House of Representatives by February 1. The |
| 520 | report must include: |
| 521 | (a) A list of current research projects supported by |
| 522 | grants or fellowships awarded under the program. |
| 523 | (b) A list of recipients of program grants or fellowships. |
| 524 | (c) A list of publications in peer-reviewed peer reviewed |
| 525 | journals involving research supported by grants or fellowships |
| 526 | awarded under the program. |
| 527 | (d) The total amount of biomedical research funding |
| 528 | currently flowing into the state. |
| 529 | (e) New grants for biomedical research which were funded |
| 530 | based on research supported by grants or fellowships awarded |
| 531 | under the program. |
| 532 | (f) Progress in the prevention, diagnosis, treatment, and |
| 533 | cure of the most deadly and widespread acute, chronic, and |
| 534 | degenerative tobacco-related and nontobacco-related diseases |
| 535 | affecting Floridians diseases related to tobacco use, including |
| 536 | cancer, cardiovascular disease, stroke, and pulmonary disease, |
| 537 | diabetes, autoimmune and genetic disorders, and neurological |
| 538 | disorders, including Alzheimer's disease, epilepsy, and |
| 539 | Parkinson's disease. |
| 540 | (11) The commission council shall award grants for cancer |
| 541 | research through the William G. "Bill" Bankhead, Jr., and David |
| 542 | Coley Cancer Research Program created in s. 381.922. This |
| 543 | subsection expires June 30, 2011. |
| 544 | (12)(a) Beginning in fiscal year 2006-2007, the sum of $6 |
| 545 | million is appropriated annually from recurring funds in the |
| 546 | General Revenue Fund to the Biomedical Research Trust Fund |
| 547 | within the Department of Health for purposes of the award of |
| 548 | grants and fellowships by the James and Esther King Biomedical |
| 549 | Research Program for research relating to tobacco-related |
| 550 | diseases pursuant to this section. From these funds up to |
| 551 | $250,000 shall be available for the operating costs of the |
| 552 | Florida Center for Universal Research to Eradicate Disease. |
| 553 | (b) Beginning in fiscal year 2009-2010, and each fiscal |
| 554 | year thereafter, the Legislature may appropriate funds from |
| 555 | recurring funds in the General Revenue Fund to the Biomedical |
| 556 | Research Trust Fund within the Department of Health for purposes |
| 557 | of the award of grants and fellowships by the James and Esther |
| 558 | King Biomedical Research Program for research of the most deadly |
| 559 | and widespread nontobacco-related acute, chronic, and |
| 560 | degenerative diseases pursuant to this section. Any research |
| 561 | grant or fellowship awarded for Alzheimer's research pursuant to |
| 562 | this section shall be named a "Johnnie B. Byrd, Sr. Alzheimer's |
| 563 | Grant." Any research grant or fellowship awarded for cancer |
| 564 | research pursuant to this section shall be named a "Bankhead- |
| 565 | Coley Cancer Grant." |
| 566 | (13) This section does not apply to the 21st Century World |
| 567 | Class Scholars, Centers of Excellence, or State University |
| 568 | Research Commercialization Assistance Grant Programs established |
| 569 | under s. 1004.226; to the University Major Gifts Program |
| 570 | established under s. 1011.94; or to the use of general operating |
| 571 | funds appropriated to universities. |
| 572 | (14)(13) By June 1, 2014 2009, the Division of Statutory |
| 573 | Revision of the Office of Legislative Services shall certify to |
| 574 | the President of the Senate and the Speaker of the House of |
| 575 | Representatives the language and statutory citation of this |
| 576 | section, which is scheduled to expire January 1, 2016 2011. |
| 577 | (15)(14) The Legislature shall review the performance, the |
| 578 | outcomes, and the financial management of the James and Esther |
| 579 | King Biomedical Research Program during the 2015 2010 Regular |
| 580 | Session of the Legislature and shall determine the most |
| 581 | appropriate funding source and means of funding the program |
| 582 | based on its review. |
| 583 | (16)(15) This section expires January 1, 2016 2011, unless |
| 584 | reviewed and reenacted by the Legislature before that date. |
| 585 | Section 7. Subsection (3) of section 381.79, Florida |
| 586 | Statutes, is amended to read: |
| 587 | 381.79 Brain and Spinal Cord Injury Program Trust Fund.-- |
| 588 | (3) Annually, 5 percent of the revenues deposited monthly |
| 589 | in the fund pursuant to s. 318.21(2)(d) shall be appropriated to |
| 590 | the University of Florida and 5 percent to the University of |
| 591 | Miami for spinal cord injury and brain injury research. The |
| 592 | amount to be distributed to the universities shall be calculated |
| 593 | based on the deposits into the fund for each quarter in the |
| 594 | fiscal year, but may not exceed $500,000 per university per |
| 595 | year. Funds distributed under this subsection shall be made in |
| 596 | quarterly payments at the end of each quarter during the fiscal |
| 597 | year. This subsection expires June 30, 2009. |
| 598 | Section 8. Paragraph (h) is added to subsection (4) of |
| 599 | section 381.853, Florida Statutes, to read: |
| 600 | 381.853 Florida Center for Brain Tumor Research.-- |
| 601 | (4) The Florida Center for Brain Tumor Research is |
| 602 | established within the Evelyn F. and William L. McKnight Brain |
| 603 | Institute of the University of Florida. |
| 604 | (h) Beginning in fiscal year 2009-2010, and each fiscal |
| 605 | year thereafter, if the center seeks to conduct biomedical |
| 606 | research using state funds, the center shall apply for funding |
| 607 | through the James and Esther King Biomedical Research Program |
| 608 | pursuant to s. 215.5602. |
| 609 | Section 9. Paragraph (a) of subsection (5) of section |
| 610 | 381.855, Florida Statutes, is amended, and paragraphs (n), (o), |
| 611 | (p), and (q) are added to subsection (3) of that section, to |
| 612 | read: |
| 613 | 381.855 Florida Center for Universal Research to Eradicate |
| 614 | Disease.-- |
| 615 | (3) There is established within the Department of Health |
| 616 | the Florida Center for Universal Research to Eradicate Disease, |
| 617 | which shall be known as "CURED." |
| 618 | (n) The center shall identify ways to attract new research |
| 619 | talent and attendant national grant producing researchers to |
| 620 | research facilities in this state. |
| 621 | (o) If funds are specifically appropriated by the |
| 622 | Legislature, the center shall disseminate information to |
| 623 | Floridians and treatment providers about specified diseases and |
| 624 | conditions and available methods of preventing, diagnosing, |
| 625 | treating, and curing those diseases and conditions. |
| 626 | (p) The center shall provide information regarding |
| 627 | research needs in the state to the Biomedical Research |
| 628 | Commission located in the James and Esther King Biomedical |
| 629 | Research Program. |
| 630 | (q) The center shall identify ways to attract students |
| 631 | from underserved communities for roles as health professionals |
| 632 | and researchers. |
| 633 | (5) There is established within the center an advisory |
| 634 | council that shall meet at least annually. |
| 635 | (a) The council shall consist of one representative from a |
| 636 | Florida not-for-profit institution engaged in basic and clinical |
| 637 | biomedical research and education which receives more than $10 |
| 638 | million in annual grant funding from the National Institutes of |
| 639 | Health, to be appointed by the State Surgeon General from a |
| 640 | different institution each term, and one representative from and |
| 641 | appointed by each of the following entities: |
| 642 | 1. Enterprise Florida, Inc. |
| 643 | 2. BioFlorida. |
| 644 | 3. The Biomedical Research Commission Advisory Council. |
| 645 | 4. The Florida Medical Foundation. |
| 646 | 5. Pharmaceutical Research and Manufacturers of America. |
| 647 | 6. The Florida Cancer Council. |
| 648 | 6.7. The American Cancer Society, Florida Division, Inc. |
| 649 | 7.8. The American Heart Association. |
| 650 | 8.9. The American Lung Association of Florida. |
| 651 | 9.10. The American Diabetes Association, South Coastal |
| 652 | Region. |
| 653 | 10.11. The Alzheimer's Association. |
| 654 | 11.12. The Epilepsy Foundation. |
| 655 | 12.13. The National Parkinson Foundation. |
| 656 | 14. The Florida Public Health Foundation, Inc. |
| 657 | 13.15. The Florida Research Consortium. |
| 658 | Section 10. Subsections (2), (3), and (4) of section |
| 659 | 381.911, Florida Statutes, are amended to read: |
| 660 | 381.911 Prostate Cancer Awareness Program.-- |
| 661 | (2) For purposes of implementing the program, the |
| 662 | Department of Health and the Florida Public Health Foundation, |
| 663 | Inc., may: |
| 664 | (a) Conduct activities directly or enter into a contract |
| 665 | with a qualified nonprofit community education entity. |
| 666 | (b) Seek any available gifts, grants, or funds from the |
| 667 | state, the Federal Government, philanthropic foundations, and |
| 668 | industry or business groups. |
| 669 | (3) A prostate cancer advisory committee is created to |
| 670 | advise and assist the Department of Health and the Florida |
| 671 | Public Health Foundation, Inc., in implementing the program. |
| 672 | (a) The State Surgeon General shall appoint the advisory |
| 673 | committee members, who shall consist of: |
| 674 | 1. Three persons from prostate cancer survivor groups or |
| 675 | cancer-related advocacy groups. |
| 676 | 2. Three persons who are scientists or clinicians from |
| 677 | public universities or research organizations. |
| 678 | 3. Three persons who are engaged in the practice of a |
| 679 | cancer-related medical specialty from health organizations |
| 680 | committed to cancer research and control. |
| 681 | (b) Members shall serve without compensation but are |
| 682 | entitled to reimbursement, pursuant to s. 112.061, for per diem |
| 683 | and travel expenses incurred in the performance of their |
| 684 | official duties. |
| 685 | (4) The program shall coordinate its efforts with those of |
| 686 | the Florida Public Health Foundation, Inc. |
| 687 | Section 11. Section 381.922, Florida Statutes, is amended |
| 688 | to read: |
| 689 | 381.922 William G. "Bill" Bankhead, Jr., and David Coley |
| 690 | Cancer Research Program.-- |
| 691 | (1) The William G. "Bill" Bankhead, Jr., and David Coley |
| 692 | Cancer Research Program, which may be otherwise cited as the |
| 693 | "Bankhead-Coley Program," is created within the Department of |
| 694 | Health. The purpose of the program shall be to advance progress |
| 695 | towards cures for cancer through grants awarded through a peer- |
| 696 | reviewed, competitive process. |
| 697 | (2) The program shall provide grants for cancer research |
| 698 | to further the search for cures for cancer. |
| 699 | (a) Emphasis shall be given to the goals that enumerated |
| 700 | in s. 381.921, as those goals support the advancement of such |
| 701 | cures. |
| 702 | (b) Preference may be given to grant proposals that foster |
| 703 | collaborations among institutions, researchers, and community |
| 704 | practitioners, as such proposals support the advancement of |
| 705 | cures through basic or applied research, including clinical |
| 706 | trials involving cancer patients and related networks. |
| 707 | (3)(a) Applications for funding for cancer research may be |
| 708 | submitted by any university or established research institute in |
| 709 | the state. All qualified investigators in the state, regardless |
| 710 | of institutional affiliation, shall have equal access and |
| 711 | opportunity to compete for the research funding. Collaborative |
| 712 | proposals, including those that advance the program's goals |
| 713 | enumerated in subsection (2), may be given preference. |
| 714 | (b) For fiscal year 2008-2009, grants shall be awarded by |
| 715 | the State Surgeon General, after consultation with the |
| 716 | Biomedical Research Commission Advisory Council, on the basis of |
| 717 | scientific merit through, as determined by an open, competitive |
| 718 | peer review process that ensures objectivity, consistency, and |
| 719 | high quality. |
| 720 | (c) Beginning in fiscal year 2009-2010, and each fiscal |
| 721 | year thereafter, the State Surgeon General shall submit to the |
| 722 | Legislature by February 1 a priority list for cancer research |
| 723 | funding by the Legislature based on the recommendations of the |
| 724 | commission after peer review and scoring of the applications |
| 725 | received. Recommendations to the Legislature shall be in the |
| 726 | form of a list submitted by the State Surgeon General of the |
| 727 | commission's rank order of priority from the proposal with the |
| 728 | highest priority through the proposal with the lowest priority, |
| 729 | including the recommended dollar amount and duration for each |
| 730 | proposal. The State Surgeon General may not reject or modify the |
| 731 | commission's recommendations. Successful applicants shall be |
| 732 | awarded grants by the State Surgeon General based upon the |
| 733 | recommendations of the commission and the final funding decision |
| 734 | made by the Legislature. |
| 735 | (d) Beginning in fiscal year 2009-2010, and each fiscal |
| 736 | year thereafter, the commission's overall ranking of grant |
| 737 | applications shall be based on the score awarded to the proposal |
| 738 | by peer reviewers on the basis of scientific merit through an |
| 739 | open competitive peer review process that ensures objectivity, |
| 740 | consistency, and high quality and the commission's determination |
| 741 | of the following: |
| 742 | 1. The projected impact that the proposed research will |
| 743 | have on cancer research at the time the grant is awarded; |
| 744 | 2. The likelihood or possibility that the proposed |
| 745 | research will result in new treatment modalities or technology |
| 746 | during the term of the grant; and |
| 747 | 3. Whether the research proposed offers an efficient use |
| 748 | of state funds in order to prevent or cure cancer. |
| 749 | (e) The following types of applications shall be |
| 750 | considered for funding: |
| 751 | 1. Investigator-initiated research grants. |
| 752 | 2. Institutional research grants. |
| 753 | 3. Collaborative research grants, including those that |
| 754 | advance the finding of cures through basic or applied research. |
| 755 | (f) Beginning in fiscal year 2009-2010, and each fiscal |
| 756 | year thereafter, state funds shall only be provided for research |
| 757 | that was applied for, reviewed, and recommended in accordance |
| 758 | with this section. |
| 759 | (g)(b) In order to ensure that all proposals for research |
| 760 | funding are appropriate and are evaluated fairly on the basis of |
| 761 | scientific merit, the State Surgeon General, in consultation |
| 762 | with the commission council, shall appoint a peer review panel |
| 763 | of independent, scientifically qualified individuals to review |
| 764 | the scientific content of each proposal and establish its |
| 765 | priority score. The priority scores shall be forwarded to the |
| 766 | commission and its committees council and must be considered in |
| 767 | determining which proposals shall be recommended for funding. |
| 768 | (h)(c) The commission, the committees, council and the |
| 769 | peer review panel shall establish and follow rigorous guidelines |
| 770 | for ethical conduct and adhere to a strict policy with regard to |
| 771 | conflicts of interest. A member of the commission, a committee, |
| 772 | council or the panel may not participate in any discussion or |
| 773 | decision with respect to a research proposal by any firm, |
| 774 | entity, or agency with which the member is associated as a |
| 775 | member of the governing body or as an employee or with which the |
| 776 | member has entered into a contractual arrangement. Meetings of |
| 777 | the commission, the committees, council and the peer review |
| 778 | panels are subject to chapter 119, s. 286.011, and s. 24, Art. I |
| 779 | of the State Constitution. |
| 780 | (4) By December 15 of each year, the Department of Health |
| 781 | shall submit to the Governor, the President of the Senate, and |
| 782 | the Speaker of the House of Representatives a report indicating |
| 783 | progress towards the program's mission and making |
| 784 | recommendations that further its purpose. |
| 785 | (5) Beginning in fiscal year 2006-2007, the sum of $9 |
| 786 | million is appropriated annually from recurring funds in the |
| 787 | General Revenue Fund to the Biomedical Research Trust Fund |
| 788 | within the Department of Health for purposes of the William G. |
| 789 | "Bill" Bankhead, Jr., and David Coley Cancer Research Program |
| 790 | and shall be distributed pursuant to this section to provide |
| 791 | grants to researchers seeking cures for cancer, with emphasis |
| 792 | given to the goals enumerated in s. 381.921. From the total |
| 793 | funds appropriated, an amount of up to 10 percent may be used |
| 794 | for administrative expenses. |
| 795 | (6) By June 1, 2009, the Division of Statutory Revision of |
| 796 | the Office of Legislative Services shall certify to the |
| 797 | President of the Senate and the Speaker of the House of |
| 798 | Representatives the language and statutory citation of this |
| 799 | section, which is scheduled to expire January 1, 2011. |
| 800 | (7) The Legislature shall review the performance, the |
| 801 | outcomes, and the financial management of the William G. "Bill" |
| 802 | Bankhead, Jr., and David Coley Cancer Research Program during |
| 803 | the 2010 Regular Session of the Legislature and shall determine |
| 804 | the most appropriate funding source and means of funding the |
| 805 | program based on its review. |
| 806 | (6)(8) This section expires June 30 January 1, 2011, |
| 807 | unless reviewed and reenacted by the Legislature before that |
| 808 | date. |
| 809 | Section 12. Subsection (1) and paragraph (a) of subsection |
| 810 | (2) of section 458.324, Florida Statutes, are amended to read: |
| 811 | 458.324 Breast cancer; information on treatment |
| 812 | alternatives.-- |
| 813 | (1) DEFINITION.--As used in this section, the term |
| 814 | "medically viable," as applied to treatment alternatives, means |
| 815 | modes of treatment generally considered by the medical |
| 816 | profession to be within the scope of current, acceptable |
| 817 | standards, including treatment alternatives described in the |
| 818 | written summary prepared by the Florida Cancer Control and |
| 819 | Research Advisory Council in accordance with s. 1004.435(4)(m). |
| 820 | (2) COMMUNICATION OF TREATMENT ALTERNATIVES.--Each |
| 821 | physician treating a patient who is, or in the judgment of the |
| 822 | physician is at high risk of being, diagnosed as having breast |
| 823 | cancer shall inform such patient of the medically viable |
| 824 | treatment alternatives available to such patient; shall describe |
| 825 | such treatment alternatives; and shall explain the relative |
| 826 | advantages, disadvantages, and risks associated with the |
| 827 | treatment alternatives to the extent deemed necessary to allow |
| 828 | the patient to make a prudent decision regarding such treatment |
| 829 | options. In compliance with this subsection: |
| 830 | (a) The physician may, in his or her discretion: |
| 831 | 1. Orally communicate such information directly to the |
| 832 | patient or the patient's legal representative; |
| 833 | 2. Provide the patient or the patient's legal |
| 834 | representative with a copy of a the written summary prepared in |
| 835 | accordance with s. 1004.435(4)(m) and express a willingness to |
| 836 | discuss the summary with the patient or the patient's legal |
| 837 | representative; or |
| 838 | 3. Both communicate such information directly and provide |
| 839 | a copy of the written summary to the patient or the patient's |
| 840 | legal representative for further consideration and possible |
| 841 | later discussion. |
| 842 |
|
| 843 | Nothing in this subsection shall reduce other provisions of law |
| 844 | regarding informed consent. |
| 845 | Section 13. Subsection (1) and paragraph (a) of subsection |
| 846 | (2) of section 459.0125, Florida Statutes, are amended to read: |
| 847 | 459.0125 Breast cancer; information on treatment |
| 848 | alternatives.-- |
| 849 | (1) DEFINITION.--As used in this section, the term |
| 850 | "medically viable," as applied to treatment alternatives, means |
| 851 | modes of treatment generally considered by the medical |
| 852 | profession to be within the scope of current, acceptable |
| 853 | standards, including treatment alternatives described in the |
| 854 | written summary prepared by the Florida Cancer Control and |
| 855 | Research Advisory Council in accordance with s. 1004.435(4)(m). |
| 856 | (2) COMMUNICATION OF TREATMENT ALTERNATIVES.--It is the |
| 857 | obligation of every physician treating a patient who is, or in |
| 858 | the judgment of the physician is at high risk of being, |
| 859 | diagnosed as having breast cancer to inform such patient of the |
| 860 | medically viable treatment alternatives available to such |
| 861 | patient; to describe such treatment alternatives; and to explain |
| 862 | the relative advantages, disadvantages, and risks associated |
| 863 | with the treatment alternatives to the extent deemed necessary |
| 864 | to allow the patient to make a prudent decision regarding such |
| 865 | treatment options. In compliance with this subsection: |
| 866 | (a) The physician may, in her or his discretion: |
| 867 | 1. Orally communicate such information directly to the |
| 868 | patient or the patient's legal representative; |
| 869 | 2. Provide the patient or the patient's legal |
| 870 | representative with a copy of a the written summary prepared in |
| 871 | accordance with s. 1004.435(4)(m) and express her or his |
| 872 | willingness to discuss the summary with the patient or the |
| 873 | patient's legal representative; or |
| 874 | 3. Both communicate such information directly and provide |
| 875 | a copy of the written summary to the patient or the patient's |
| 876 | legal representative for further consideration and possible |
| 877 | later discussion. |
| 878 |
|
| 879 | Nothing in this subsection shall reduce other provisions of law |
| 880 | regarding informed consent. |
| 881 | Section 14. Subsections (7), (8), and (12) of section |
| 882 | 1004.445, Florida Statutes, as amended by chapter 2007-332, Laws |
| 883 | of Florida, are amended to read: |
| 884 | 1004.445 Johnnie B. Byrd, Sr., Alzheimer's Center and |
| 885 | Research Institute.-- |
| 886 | (7) The board of directors of the not-for-profit |
| 887 | corporation shall create a council of scientific advisers to the |
| 888 | chief executive officer comprised of leading researchers, |
| 889 | physicians, and scientists. The council shall review programs |
| 890 | and recommend research priorities and initiatives to maximize |
| 891 | the state's investment in the institute. The members of the |
| 892 | council shall be appointed by the board of directors of the not- |
| 893 | for-profit corporation. Each member of the council shall be |
| 894 | appointed to serve a 2-year term and may be reappointed to the |
| 895 | council. This subsection expires on June 30, 2009. |
| 896 | (8)(a) Applications for Alzheimer's disease research |
| 897 | funding may be submitted from any university or established |
| 898 | research institute in the state. All qualified investigators in |
| 899 | the state, regardless of institutional affiliation, shall have |
| 900 | equal access and opportunity to compete for the research |
| 901 | funding. Grants shall be awarded by the board of directors of |
| 902 | the not-for-profit corporation on the basis of scientific merit, |
| 903 | as determined by an open, competitive peer review process that |
| 904 | ensures objectivity, consistency, and high quality. The |
| 905 | following types of applications shall be considered for funding: |
| 906 | 1. Investigator-initiated research grants. |
| 907 | 2. Institutional research grants. |
| 908 | 3. Collaborative research grants, including those that |
| 909 | advance the finding of cures through basic or applied research. |
| 910 | (b) Preference may be given to grant proposals that foster |
| 911 | collaboration among institutions, researchers, and community |
| 912 | practitioners because these proposals support the advancement of |
| 913 | cures through basic or applied research, including clinical |
| 914 | trials involving Alzheimer's patients and related networks. |
| 915 | (c) To ensure that all proposals for research funding are |
| 916 | appropriate and are evaluated fairly on the basis of scientific |
| 917 | merit, the board of directors of the not-for-profit corporation, |
| 918 | in consultation with the council of scientific advisors, shall |
| 919 | appoint a peer review panel of independent, scientifically |
| 920 | qualified individuals to review the scientific content of each |
| 921 | proposal and establish its scientific priority score. The |
| 922 | priority scores shall be forwarded to the council and must be |
| 923 | considered by the board of directors of the not-for-profit |
| 924 | corporation in determining which proposals shall be recommended |
| 925 | for funding. |
| 926 | (d) The council of scientific advisors and the peer review |
| 927 | panel shall establish and follow rigorous guidelines for ethical |
| 928 | conduct and adhere to a strict policy with regard to conflict of |
| 929 | interest. All employees, members of the board of directors, and |
| 930 | affiliates of the not-for-profit corporation shall follow the |
| 931 | same rigorous guidelines for ethical conduct and shall adhere to |
| 932 | the same strict policy with regard to conflict of interest. A |
| 933 | member of the council or panel may not participate in any |
| 934 | discussion or decision with respect to a research proposal by |
| 935 | any firm, entity, or agency with which the member is associated |
| 936 | as a member of the governing body or as an employee or with |
| 937 | which the member has entered into a contractual arrangement. |
| 938 | Meetings of the council and the peer review panels are subject |
| 939 | to chapter 119, s. 286.011, and s. 24, Art. I of the State |
| 940 | Constitution. |
| 941 | (e) This subsection expires on June 30, 2009. |
| 942 | (12)(a) Beginning in fiscal year 2008-2009 2007-2008, the |
| 943 | sum of $3.75 $13.5 million is appropriated annually from |
| 944 | recurring funds in the General Revenue Fund to the Grants and |
| 945 | Donations Trust Fund within the Department of Elderly Affairs |
| 946 | for the Johnnie B. Byrd, Sr., Alzheimer's Center and Research |
| 947 | Institute at the University of South Florida for the purposes as |
| 948 | provided under paragraph (6)(a), conducting and supporting |
| 949 | research, providing institutional research grants and |
| 950 | investigator-initiated research grants, developing and operating |
| 951 | integrated data projects, and providing assistance to |
| 952 | statutorily designated memory disorder clinics as provided under |
| 953 | s. 430.502. Not less than 80 percent of the appropriated funds |
| 954 | shall be expended for these purposes, and not less than 20 |
| 955 | percent of the appropriated funds shall be expended for peer- |
| 956 | reviewed investigator-initiated research grants. |
| 957 | (b) Beginning in fiscal year 2009-2010, and each fiscal |
| 958 | year thereafter, the sum appropriated in paragraph (a) shall be |
| 959 | used for programs that fulfill the mission of the institute in |
| 960 | education, treatment, prevention, and early detection of |
| 961 | Alzheimer's disease, developing and operating integrated data |
| 962 | projects, and providing assistance to statutorily designated |
| 963 | memory disorder clinics. If the institute intends to conduct |
| 964 | research using state funds, it shall compete for funding through |
| 965 | the James and Esther King Biomedical Research Program pursuant |
| 966 | to s. 215.5602. |
| 967 | Section 15. Sections 381.0404, 381.85, 381.895, 381.912, |
| 968 | 381.92, 381.921, 381.98, 381.981, and 1004.435, Florida |
| 969 | Statutes, are repealed. |
| 970 | Section 16. If any provision of this act or the |
| 971 | application thereof to any person or circumstance is held |
| 972 | invalid, the invalidity does not affect other provisions or |
| 973 | applications of the act which can be given effect without the |
| 974 | invalid provision or application, and to this end the provisions |
| 975 | of this act are declared severable. |
| 976 | Section 17. This act shall take effect July 1, 2008. |
| 977 |
|
| 978 |
|
| 979 |
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| 980 |
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| 981 |
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| 982 | ----------------------------------------------------- |
| 983 | T I T L E A M E N D M E N T |
| 984 | Remove the entire title and insert: |
| 985 | A bill to be entitled |
| 986 | An act relating to public health; amending s. 381.006, F.S.; |
| 987 | limiting application of the environmental health program of the |
| 988 | Department of Health to state institutions for the mentally ill |
| 989 | rather than all institutions used for the incarceration of |
| 990 | prisoners and inmates; amending s. 381.86, F.S.; revising |
| 991 | responsibilities of the Institutional Review Board; amending s. |
| 992 | 381.98, F.S.; changing the name of the Florida Public Health |
| 993 | Foundation, Inc., to the Florida Public Health Institute, Inc.; |
| 994 | providing that the purpose of the institute is to advance the |
| 995 | knowledge and practice of public health, including promoting |
| 996 | health awareness in this state; providing for the objectives of |
| 997 | the institute; requiring that the institute be established as a |
| 998 | not-for-profit entity qualifying under s. 501(c)(3) of the |
| 999 | Internal Revenue Code; providing for the duties of the |
| 1000 | institute; providing that affairs of the institute be managed by |
| 1001 | an executive director appointed by a board of directors; |
| 1002 | providing for membership on the board of directors; requiring |
| 1003 | the institute to present an annual report concerning its |
| 1004 | activities and finances to the Governor, the President of the |
| 1005 | Senate, and the Speaker of the House of Representatives; |
| 1006 | amending s. 20.435, F.S.; specifying use of funds deposited in |
| 1007 | the Biomedical Research Trust Fund; revising a time limit |
| 1008 | relating to certain undisbursed balances of appropriations from |
| 1009 | the trust fund; amending s. 215.5601, F.S.; conforming a cross- |
| 1010 | reference; amending s. 215.5602, F.S.; revising the purposes and |
| 1011 | long-term goals of the James and Esther King Biomedical Research |
| 1012 | Program; providing for certain funds appropriated for the |
| 1013 | program to be deposited into the Biomedical Research Trust Fund; |
| 1014 | specifying use of such funds; renaming the Biomedical Research |
| 1015 | Advisory Council the Biomedical Research Commission; revising |
| 1016 | membership of the commission; providing that the commission |
| 1017 | serves as an exclusive source of biomedical research grant and |
| 1018 | fellowship awards; requiring the commission to create committees |
| 1019 | for specified purposes; requiring the commission to adopt |
| 1020 | policies and procedures regarding the committees and to receive |
| 1021 | input from outside sources; revising responsibilities of the |
| 1022 | commission; creating a future requirement for the commission to |
| 1023 | submit priorities for funding research relating to tobacco- |
| 1024 | related and nontobacco-related diseases to the State Surgeon |
| 1025 | General; requiring the State Surgeon General to provide |
| 1026 | commission funding priorities to the Legislature; providing |
| 1027 | restrictions on the State Surgeon General; providing criteria |
| 1028 | for ranking priorities; authorizing the State Surgeon General to |
| 1029 | award grants or fellowships; providing for the award of grants |
| 1030 | or fellowships upon a specific appropriation; prohibiting the |
| 1031 | funding of research projects not in compliance with the |
| 1032 | requirements of the section; providing restrictions on the |
| 1033 | recommendation or award of grants or fellowships by other |
| 1034 | programs and entities; providing for future reductions of limits |
| 1035 | on annual administrative expenses; revising requirements |
| 1036 | relating to the commission's annual progress report; providing a |
| 1037 | future expiration date for the commission to award grants for |
| 1038 | the Bankhead-Coley Program; revising provisions relating to |
| 1039 | appropriations; providing for nonapplicability of James and |
| 1040 | Esther King Biomedical Research Program requirements to |
| 1041 | specified programs and the use of certain operating funds |
| 1042 | appropriated to universities; extending the expiration date of |
| 1043 | the program; amending s. 381.79, F.S.; providing for the |
| 1044 | expiration of a provision relating to the distribution of funds |
| 1045 | from the Brain and Spinal Cord Injury Program Trust Fund; |
| 1046 | amending s. 381.853, F.S.; providing a requirement for the |
| 1047 | Florida Center for Brain Tumor Research relating to the use of |
| 1048 | state funds for biomedical research; amending s. 381.855, F.S.; |
| 1049 | providing additional program functions for the Florida Center |
| 1050 | for Universal Research to Eradicate Disease; requiring the |
| 1051 | center to disseminate certain information if an appropriation is |
| 1052 | made; requiring the center to identify ways to attract students |
| 1053 | from underserved communities for roles as health professionals |
| 1054 | and researchers; conforming references to changes made by the |
| 1055 | act; amending s. 381.911, F.S.; conforming references to changes |
| 1056 | made by the act; amending s. 381.922, F.S., relating to the |
| 1057 | William G. "Bill" Bankhead, Jr., and David Coley Cancer Research |
| 1058 | Program; creating a future requirement for the commission to |
| 1059 | submit priorities for funding cancer research to the State |
| 1060 | Surgeon General; requiring the State Surgeon General to provide |
| 1061 | commission funding priorities to the Legislature; providing |
| 1062 | restrictions on the State Surgeon General; providing criteria |
| 1063 | for ranking priorities; authorizing the State Surgeon General to |
| 1064 | award grants; providing for the award of grants upon a specific |
| 1065 | appropriation; prohibiting the funding of research projects not |
| 1066 | in compliance with the requirements of the section; conforming |
| 1067 | references to changes made by the act; revising process and |
| 1068 | provisions relating to future peer review of grant applications |
| 1069 | to conform to the changes to the biomedical research program |
| 1070 | made by the act; deleting a provision requiring the Division of |
| 1071 | Statutory Revision within the Office of Legislative Services to |
| 1072 | certify certain language and citations related to the program; |
| 1073 | deleting a provision requiring future legislative review of the |
| 1074 | program; revising the expiration date of the program; amending |
| 1075 | ss. 458.324 and 459.0125, F.S.; conforming references to changes |
| 1076 | made by the act; amending s. 1004.445, F.S.; providing for the |
| 1077 | future repeal of specified provisions to conform to changes made |
| 1078 | by the act; reducing appropriations for fiscal year 2008-2009; |
| 1079 | providing for and specifying use of future appropriations; |
| 1080 | repealing s. 381.0404, F.S., relating to the Center for Health |
| 1081 | Technologies; repealing s. 381.85, F.S., relating to biomedical |
| 1082 | and social research; repealing s. 381.895, F.S., relating to |
| 1083 | relating to standards for compressed air used for recreational |
| 1084 | diving; repealing s. 381.912, F.S., relating to the Cervical |
| 1085 | Cancer Elimination Task Force; repealing s. 381.92, F.S., |
| 1086 | relating to the Florida Cancer Council; repealing s. 381.921, |
| 1087 | F.S., relating to the Florida Cancer Council; repealing s. |
| 1088 | 381.98, F.S., relating to the Florida Public Health Foundation, |
| 1089 | Inc.; repealing s. 381.981, F.S., relating to health awareness |
| 1090 | campaigns; repealing s. 1004.435, F.S., relating to cancer |
| 1091 | control and research; providing for severability; providing an |
| 1092 | effective date. |
| 1093 |
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| 1094 |
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