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