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