HB 7061

1
A bill to be entitled
2An act relating to biomedical research; amending s.
320.435, F.S.; specifying use of funds deposited in the
4Biomedical Research Trust Fund; revising a time limit
5relating to certain undisbursed balances of appropriations
6from the trust fund; amending s. 215.5601, F.S.;
7conforming a cross-reference; amending s. 215.5602, F.S.;
8revising the purposes and long-term goals of the James and
9Esther King Biomedical Research Program; providing for
10certain funds appropriated for the program to be deposited
11into the Biomedical Research Trust Fund; specifying use of
12such funds; renaming the Biomedical Research Advisory
13Council the Biomedical Research Commission; revising
14membership of the commission; providing that the
15commission serves as an exclusive source of biomedical
16research grant and fellowship awards; requiring the
17commission to create committees for specified purposes;
18requiring the commission to adopt policies and procedures
19regarding the committees and to receive input from outside
20sources; revising responsibilities of the commission;
21creating a future requirement for the commission to submit
22priorities for funding research related to tobacco-related
23and nontobacco-related diseases to the State Surgeon
24General; requiring the State Surgeon General to provide
25commission funding priorities to the Legislature;
26providing restrictions on the State Surgeon General;
27providing criteria for ranking priorities; authorizing the
28State Surgeon General to award grants or fellowships;
29providing for the award of grants or fellowships upon a
30specific appropriation; prohibiting the funding of
31research projects not in compliance with the requirements
32of the section; providing restrictions on the
33recommendation or award of grants or fellowships by other
34programs and entities; providing for future reductions of
35limits on annual administrative expenses; revising
36requirements relating to the commission's annual progress
37report; providing a future expiration date for the
38commission to award grants for the Bankhead-Coley Program;
39revising provisions relating to appropriations; extending
40the expiration date of the program; amending s. 381.79,
41F.S.; providing for the expiration of a provision relating
42to the distribution of funds from the Brain and Spinal
43Cord Injury Program Trust Fund; amending s. 381.853, F.S.;
44providing a requirement for the Florida Center for Brain
45Tumor Research relating to the use of state funds for
46biomedical research; amending s. 381.855, F.S.; providing
47additional program functions for the Florida Center for
48Universal Research to Eradicate Disease; requiring the
49center to disseminate certain information if an
50appropriation is made; conforming references to changes
51made by the act; amending s. 381.911, F.S.; conforming
52references to changes made by the act; amending s.
53381.922, F.S., relating to the William G. "Bill" Bankhead,
54Jr., and David Coley Cancer Research Program; creating a
55future requirement for the commission to submit priorities
56for funding cancer research to the State Surgeon General;
57requiring the State Surgeon General to provide commission
58funding priorities to the Legislature; providing
59restrictions on the State Surgeon General; providing
60criteria for ranking priorities; authorizing the State
61Surgeon General to award grants; providing for the award
62of grants upon a specific appropriation; prohibiting the
63funding of research projects not in compliance with the
64requirements of the section; conforming references to
65changes made by the act; revising process and provisions
66relating to future peer review of grant applications to
67conform to the changes to the biomedical research program
68made by the act; deleting a provision requiring the
69Division of Statutory Revision within the Office of
70Legislative Services to certify certain language and
71citations related to the program; deleting a provision
72requiring future legislative review of the program;
73revising the expiration date of the program; amending s.
74430.502, F.S.; requiring the Department of Elderly
75Affairs, in consultation with the Alzheimer's Disease
76Brain Bank, to evaluate the need for additional memory
77disorder clinics in the state; conforming references to
78changes made by the act; deleting obsolete language;
79amending ss. 430.503, 430.504, 458.324, and 459.0125,
80F.S.; conforming references to changes made by the act;
81amending s. 1004.445, F.S.; providing for the future
82repeal of specified provisions to conform to changes made
83by the act; reducing appropriations for fiscal year 2008-
842009; providing for and specifying use of future
85appropriations; repealing s. 381.0404, F.S., relating to
86the Center for Health Technologies; repealing s. 381.85,
87F.S., relating to biomedical and social research;
88repealing s. 381.912, F.S., relating to the Cervical
89Cancer Elimination Task Force; repealing s. 381.92, F.S.,
90relating to the Florida Cancer Council; repealing s.
91381.921, F.S., relating to the Florida Cancer Council;
92repealing s. 381.98, F.S., relating to the Florida Public
93Health Foundation, Inc.; repealing s. 381.981, F.S.,
94relating to health awareness campaigns; repealing s.
95430.501, F.S., relating to the Alzheimer's Disease
96Advisory Committee; repealing s. 1004.435, F.S., relating
97to cancer control and research; providing for
98severability; providing an effective date.
99
100Be It Enacted by the Legislature of the State of Florida:
101
102     Section 1.  Paragraph (h) of subsection (1) of section
10320.435, Florida Statutes, is amended to read:
104     20.435  Department of Health; trust funds.--
105     (1)  The following trust funds are hereby created, to be
106administered by the Department of Health:
107     (h)  Biomedical Research Trust Fund.
108     1.  Funds to be credited to the trust fund shall consist of
109funds deposited pursuant to s. 215.5601 and any other funds
110appropriated by the Legislature. Funds shall be used for the
111purposes of the James and Esther King Biomedical Research
112Program and the William G. "Bill" Bankhead, Jr., and David Coley
113Cancer Research Program as specified in ss. 215.5602, 288.955,
114and 381.922. The trust fund is exempt from the service charges
115imposed by s. 215.20.
116     2.  Funds deposited into the trust fund pursuant to s.
117215.5601 and any other funds appropriated by the Legislature as
118specified in s. 215.5602(12)(a) or other provisions of law for
119research related to tobacco-related diseases shall be used
120exclusively for the purpose of awarding grants and fellowships
121for research regarding the prevention, diagnosis, treatment, and
122cure of tobacco-related diseases by the James and Esther King
123Biomedical Research Program.
124     3.  Funds deposited into the trust fund pursuant to the
125William G. "Bill" Bankhead, Jr., and David Coley Cancer Research
126Program as specified in s. 381.922 shall be used for the purpose
127of awarding grants for cancer research by the William G. "Bill"
128Bankhead, Jr., and David Coley Cancer Research Program.
129     4.  All other funds deposited into the trust fund shall be
130used for the purpose of awarding grants and fellowships for
131biomedical research regarding the prevention, diagnosis,
132treatment, and cure of the most deadly and widespread
133nontobacco-related acute, chronic, and degenerative diseases by
134the James and Esther King Biomedical Research Program as
135specified in s. 215.5602(2)(b) and (12)(b).
136     5.2.  Notwithstanding the provisions of s. 216.301 and
137pursuant to s. 216.351, any balance in the trust fund at the end
138of any fiscal year shall remain in the trust fund at the end of
139the year and shall be available for carrying out the purposes of
140the trust fund. The department may invest these funds
141independently through the Chief Financial Officer or may
142negotiate a trust agreement with the State Board of
143Administration for the investment management of any balance in
144the trust fund.
145     6.3.  Notwithstanding s. 216.301 and pursuant to s.
146216.351, any balance of any appropriation from the Biomedical
147Research Trust Fund which is not disbursed but which is
148obligated pursuant to contract or committed to be expended may
149be carried forward for up to 5 3 years following the effective
150date of the original appropriation.
151     Section 2.  Paragraph (e) of subsection (5) of section
152215.5601, Florida Statutes, is amended to read:
153     215.5601  Lawton Chiles Endowment Fund.--
154     (5)  AVAILABILITY OF FUNDS; USES.--
155     (e)  Notwithstanding s. 216.301 and pursuant to s. 216.351,
156all unencumbered balances of appropriations from each
157department's respective Tobacco Settlement Trust Fund as of June
15830 or undisbursed balances as of December 31 shall revert to the
159endowment's principal. Unencumbered balances in the Biomedical
160Research Trust Fund shall be managed as provided in s.
16120.435(1)(h)5.2.
162     Section 3.  Section 215.5602, Florida Statutes, is amended
163to read:
164     215.5602  James and Esther King Biomedical Research
165Program.--
166     (1)  There is established within the Department of Health
167the James and Esther King Biomedical Research Program funded by
168the proceeds of the Lawton Chiles Endowment Fund pursuant to s.
169215.5601. The purpose of the James and Esther King Biomedical
170Research Program is to provide an annual and perpetual source of
171funding in order to support research initiatives that address
172the health care problems of Floridians in the areas of tobacco-
173related cancer, cardiovascular disease, stroke, and pulmonary
174disease and nontobacco-related acute, chronic, and degenerative
175diseases, including cancer, cardiovascular disease, stroke,
176pulmonary disease, diabetes, autoimmune and genetic disorders,
177and neurological disorders, including Alzheimer's disease,
178epilepsy, and Parkinson's disease. The long-term goals of the
179program are to:
180     (a)  Improve the health of Floridians by researching better
181prevention, diagnoses, treatments, and cures for the most deadly
182and widespread acute, chronic, and degenerative diseases,
183including, but not limited to, tobacco-related diseases, cancer,
184cardiovascular disease, stroke, and pulmonary disease, diabetes,
185autoimmune and genetic disorders, and neurological disorders,
186including Alzheimer's disease, epilepsy, and Parkinson's
187disease.
188     (b)  Expand the foundation of biomedical knowledge relating
189to the prevention, diagnosis, treatment, and cure of tobacco-
190related diseases related to tobacco use, including cancer,
191cardiovascular disease, stroke, and pulmonary disease.
192     (c)  Expand the foundation of biomedical knowledge relating
193to the prevention, diagnosis, treatment, and cure of the most
194widespread acute, chronic, and degenerative diseases affecting
195Floridians, including, but not limited to, cancer,
196cardiovascular disease, stroke, pulmonary disease, diabetes,
197autoimmune and genetic disorders, and neurological disorders,
198including Alzheimer's disease, epilepsy, and Parkinson's
199disease.
200     (d)(c)  Improve the quality of the state's academic health
201centers by bringing the advances of biomedical research into the
202training of physicians and other health care providers.
203     (e)(d)  Increase the state's per capita funding for
204research by undertaking new initiatives in public health and
205biomedical research that will attract additional funding from
206outside the state.
207     (f)(e)  Stimulate economic activity in the state in areas
208related to biomedical research, such as the research and
209production of pharmaceuticals, biotechnology, and medical
210devices.
211     (2)(a)  Funds appropriated for the James and Esther King
212Biomedical Research Program pursuant to the Lawton Chiles
213Endowment Fund created in s. 215.5601 and additional funding
214provided under paragraph (12)(a) or other provisions of law for
215research related to tobacco-related diseases shall be credited
216to the Biomedical Research Trust Fund pursuant to s. 20.435 and
217shall be used exclusively for the award of grants and
218fellowships related to the prevention, diagnosis, treatment, and
219cure of tobacco-related diseases, including cancer,
220cardiovascular disease, stroke, and pulmonary disease and for
221expenses incurred in the administration of this section.
222Priority shall be granted to research designed to prevent or
223cure tobacco-related diseases.
224     (b)  Beginning in fiscal year 2009-2010, and each fiscal
225year thereafter, all other funds appropriated for the James and
226Esther King Biomedical Research Program shall be credited to the
227Biomedical Research Trust Fund pursuant to s. 20.435 and shall
228be used exclusively for the award of grants and fellowships as
229established in this section; for research relating to the
230prevention, diagnosis, treatment, and cure of the most deadly
231and widespread acute, chronic, and degenerative nontobacco-
232related diseases affecting Floridians related to tobacco use,
233including cancer, cardiovascular disease, stroke, and pulmonary
234disease, diabetes, autoimmune and genetic disorders, and
235neurological disorders, including Alzheimer's disease, epilepsy,
236and Parkinson's disease,; and for expenses incurred in the
237administration of this section. Priority shall be granted to
238research designed to prevent or cure disease.
239     (3)  There is created within the Department of Health the
240Biomedical Research Commission Advisory Council.
241     (a)  The commission council shall consist of 15 11 members,
242including: the chief executive officer of the Florida Division
243of the American Cancer Society, or a designee; the chief
244executive officer of the Greater Southeast Florida/Puerto Rico
245Affiliate of the American Heart Association, or a designee; and
246the chief executive officer of the American Lung Association of
247Florida, or a designee; the chief executive officer of the South
248Coastal Region of the American Diabetes Association, or a
249designee; and the president of the Florida Medical Association,
250or a designee. The remaining 10 8 members of the commission
251council shall be appointed as follows:
252     1.  The Governor shall appoint four members, two members
253with expertise in the field of biomedical research, one member
254from a research university in the state, and one member
255representing the general population of the state.
256     2.  The President of the Senate shall appoint three two
257members, one member with expertise in the field of behavioral or
258social research and two members representing volunteer health
259organizations operating in the state that focus on Alzheimer's
260disease, Parkinson's disease, epilepsy, stroke, or autoimmune
261and genetic disorders one representative from a cancer program
262approved by the American College of Surgeons.
263     3.  The Speaker of the House of Representatives shall
264appoint three two members, two members representing volunteer
265health organizations operating in the state that focus on
266Alzheimer's disease, Parkinson's disease, epilepsy, stroke, or
267autoimmune and genetic disorders one member from a professional
268medical organization and one member representing representative
269from a cancer program approved by the American College of
270Surgeons.
271
272In making these appointments, the Governor, the President of the
273Senate, and the Speaker of the House of Representatives shall
274select primarily, but not exclusively, Floridians with
275biomedical and lay expertise in the general areas of cancer,
276cardiovascular disease, stroke, and pulmonary disease, diabetes,
277autoimmune and genetic disorders, and neurological disorders,
278including Alzheimer's disease, epilepsy, and Parkinson's
279disease. The appointments shall be for a 3-year term and shall
280reflect the diversity of the state's population. An appointed
281member may not serve more than two consecutive terms.
282     (b)  Except for the William G. "Bill" Bankhead, Jr., and
283David Coley Cancer Research Program that expires June 30, 2011,
284pursuant to s. 381.922, beginning in fiscal year 2009-2010, and
285each fiscal year thereafter, funds appropriated for the James
286and Esther King Biomedical Research Program shall serve as the
287exclusive source of awarding grants or fellowships for
288biomedical research in the state using state funds. This
289paragraph does not preclude another grant or fellowship program
290created by state law from awarding grants from funds received
291from private or federal sources if permitted by state law.
292     (c)  The commission shall create committees to focus on
293disease-specific areas, including, but not limited to, tobacco-
294related diseases, cancer, stroke, cardiovascular disease,
295pulmonary disease, diabetes, autoimmune and genetic disorders,
296and neurological disorders, including Alzheimer's disease,
297epilepsy, and Parkinson's disease.
298     (d)(b)  The commission council shall adopt internal
299organizational procedures as necessary for its efficient
300organization, including policies and procedures regarding the
301creation and composition of the committees, the submission of
302reports and recommendations by committees regarding the awarding
303of grants and fellowships, coordination between the commission
304and committees, and the methods for receiving input from
305individuals, organizations, or entities that are not members of
306the commission or its committees regarding the prioritization of
307research.
308     (e)(c)  The department shall provide such staff,
309information, and other assistance as is reasonably necessary to
310assist the commission council in carrying out its
311responsibilities, including those of its committees.
312     (f)(d)  Members of the commission council shall serve
313without compensation, but may receive reimbursement as provided
314in s. 112.061 for travel and other necessary expenses incurred
315in the performance of their official duties, including attending
316committee meetings.
317     (4)  The commission council shall, after considering the
318recommendations of its committees, advise the State Surgeon
319General as to the direction and scope of the biomedical research
320program. The responsibilities of the commission council may
321include, but are not limited to:
322     (a)  Establishing Providing advice on program priorities
323and emphases.
324     (b)  Evaluating Providing advice on the overall program
325budget and making recommendations to the State Surgeon General
326and the Legislature regarding future appropriations.
327     (c)  Participating in periodic program evaluation.
328     (d)  Developing Assisting in the development of guidelines
329to ensure fairness, neutrality, and adherence to the principles
330of merit and quality in the conduct of the program.
331     (e)  Developing Assisting in the development of appropriate
332linkages to nonacademic entities, such as voluntary
333organizations, health care delivery institutions, industry,
334government agencies, and public officials.
335     (f)  Developing criteria and standards for the award of
336research grants.
337     (g)  Developing administrative procedures relating to
338solicitation, independent peer review, and award of research
339grants and fellowships, to ensure an impartial, high-quality,
340science-based peer review system.
341     (h)  Developing and supervising research peer review
342panels.
343     (i)  Reviewing reports of peer review panels and making
344recommendations for research grants and fellowships.
345     (j)  Developing and providing oversight regarding
346mechanisms for the dissemination of research results.
347     (5)(a)  Applications for biomedical research funding under
348the program may be submitted from any university or established
349research institute in the state. All qualified investigators in
350the state, regardless of institution affiliation, shall have
351equal access and opportunity to compete for the research
352funding.
353     (b)  Beginning in fiscal year 2008-2009, grants and
354fellowships shall be awarded by the State Surgeon General, after
355consultation with the commission council, on the basis of
356scientific merit, as determined by an open competitive peer
357review process that ensures objectivity, consistency, and high
358quality.
359     (c)  Beginning in fiscal year 2009-2010, and each fiscal
360year thereafter, the State Surgeon General shall submit to the
361Legislature by February 1 priority lists for the funding of both
362tobacco-related and nontobacco-related biomedical research by
363the Legislature based on the recommendations made by the
364commission after peer review and scoring of the applications
365received. Recommendations to the Legislature shall be in the
366form of lists submitted by the State Surgeon General of the
367commission's rank order of priority from the proposal with the
368highest priority through the proposal with the lowest priority,
369including the recommended dollar amount and duration for each
370proposal. The State Surgeon General may not reject or modify the
371commission's recommendations. Successful applicants shall be
372awarded grants or fellowships by the State Surgeon General based
373upon the recommendations of the commission and the final funding
374decision made by the Legislature. Funding for grant and
375fellowship applications for tobacco-related research shall be
376based upon funds available pursuant to paragraphs (2)(a) and
377(12)(a) and s. 215.5601.
378     (d)  Beginning in fiscal year 2009-2010, and each fiscal
379year thereafter, the commission's overall ranking of grant and
380fellowship applications shall be based on the score awarded to
381the proposal by peer reviewers on the basis of scientific merit
382through an open competitive peer review process that ensures
383objectivity, consistency, and high quality and the commission's
384determination of the following:
385     1.  The projected impact that the proposed research will
386have on the most deadly and widespread diseases affecting
387Floridians at the time the grant or fellowship is awarded;
388     2.  The likelihood or possibility that the proposed
389research will result in new treatment modalities or technology
390during the term of the grant or fellowship; and
391     3.  Whether the research proposed offers an efficient use
392of state funds in order to prevent or cure disease.
393     (e)  The following types of applications shall be
394considered for funding:
395     1.  Investigator-initiated research grants.
396     2.  Institutional research grants.
397     3.  Predoctoral and postdoctoral research fellowships.
398     (f)  The State Surgeon General shall award grants or
399fellowships for terms of 1 to 5 years. State funds shall only be
400provided for research that was applied for, reviewed, and
401recommended in accordance with this section.
402     (g)  Except for the William G. "Bill" Bankhead, Jr., and
403David Coley Cancer Research Program that expires June 30, 2011,
404pursuant to s. 381.922, beginning July 1, 2009, and each fiscal
405year thereafter, any program, board, commission, council,
406advisory group, agency, or entity created by state law that
407awards or recommends the award of grants or fellowships for
408biomedical research may not award grants or fellowships that
409require the use of state funds and, instead, shall make any
410recommendation to the commission and its committees for the
411prioritization and award of grants and fellowships through the
412James and Esther King Biomedical Research Program. This section
413does not apply to the 21st Century World Class Scholars, Centers
414of Excellence, or State University Research Commercialization
415Assistance Grant Programs established under s. 1004.226.
416     (6)  To ensure that all proposals for research funding are
417appropriate and are evaluated fairly on the basis of scientific
418merit, the State Surgeon General, in consultation with the
419commission council, shall appoint a peer review panel of
420independent, scientifically qualified individuals to review the
421scientific content of each proposal and establish its scientific
422priority score. The priority scores shall be forwarded to the
423commission and its committees council and must be considered in
424determining which proposals shall be recommended for funding.
425     (7)  The commission, the committees, council and the peer
426review panel shall establish and follow rigorous guidelines for
427ethical conduct and adhere to a strict policy with regard to
428conflict of interest. A member of the commission, committee,
429council or panel may not participate in any discussion or
430decision with respect to a research proposal by any firm,
431entity, or agency with which the member is associated as a
432member of the governing body or as an employee, or with which
433the member has entered into a contractual arrangement. Meetings
434of the commission, committees, council and the peer review
435panels shall be subject to the provisions of chapter 119, s.
436286.011, and s. 24, Art. I of the State Constitution.
437     (8)  The department may contract on a competitive-bid basis
438with an appropriate entity to administer the program.
439Administrative expenses may not exceed 15 percent of the total
440funds available to the program in any given year. Effective July
4411, 2009, administrative expenses may not exceed 10 percent of
442the total funds available to the program in any given year.
443Effective July 1, 2011, administrative expenses may not exceed 5
444percent of the total funds available to the program in any given
445year.
446     (9)  The department, after consultation with the commission
447council, may adopt rules pursuant to ss. 120.536(1) and 120.54
448as necessary to implement this section.
449     (10)  In addition to its recommendations regarding
450appropriations for the award of grants and fellowships to the
451State Surgeon General and the Legislature, the commission
452council shall submit an annual progress report on the state of
453biomedical research in this state to the Florida Center for
454Universal Research to Eradicate Disease and to the Governor, the
455State Surgeon General, the President of the Senate, and the
456Speaker of the House of Representatives by February 1. The
457report must include:
458     (a)  A list of current research projects supported by
459grants 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
462journals involving research supported by grants or fellowships
463awarded under the program.
464     (d)  The total amount of biomedical research funding
465currently flowing into the state.
466     (e)  New grants for biomedical research which were funded
467based on research supported by grants or fellowships awarded
468under the program.
469     (f)  Progress in the prevention, diagnosis, treatment, and
470cure of the most deadly and widespread acute, chronic, and
471degenerative tobacco-related diseases affecting Floridians
472diseases related to tobacco use, including cancer,
473cardiovascular disease, stroke, and pulmonary disease, diabetes,
474autoimmune and genetic disorders, and neurological disorders,
475including Alzheimer's disease, epilepsy, and Parkinson's
476disease.
477     (11)  The commission council shall award grants for cancer
478research through the William G. "Bill" Bankhead, Jr., and David
479Coley Cancer Research Program created in s. 381.922. This
480subsection expires June 30, 2011.
481     (12)(a)  Beginning in fiscal year 2006-2007, the sum of $6
482million is appropriated annually from recurring funds in the
483General Revenue Fund to the Biomedical Research Trust Fund
484within the Department of Health for purposes of the award of
485grants and fellowships by the James and Esther King Biomedical
486Research Program for research relating to tobacco-related
487diseases pursuant to this section. From these funds up to
488$250,000 shall be available for the operating costs of the
489Florida Center for Universal Research to Eradicate Disease.
490     (b)  Beginning in fiscal year 2009-2010, and each fiscal
491year thereafter, the Legislature may appropriate funds from
492recurring funds in the General Revenue Fund to the Biomedical
493Research Trust Fund within the Department of Health for purposes
494of the award of grants and fellowships by the James and Esther
495King Biomedical Research Program for research of the most deadly
496and widespread nontobacco-related acute, chronic, and
497degenerative diseases pursuant to this section. Any research
498grant or fellowship awarded for Alzheimer's research pursuant to
499this section shall be named a "Johnnie B. Byrd, Sr. Alzheimer's
500Grant." Any research grant or fellowship awarded for cancer
501research pursuant to this section shall be named a "Bankhead-
502Coley Cancer Grant."
503     (13)  By June 1, 2014 2009, the Division of Statutory
504Revision of the Office of Legislative Services shall certify to
505the President of the Senate and the Speaker of the House of
506Representatives the language and statutory citation of this
507section, which is scheduled to expire January 1, 2016 2011.
508     (14)  The Legislature shall review the performance, the
509outcomes, and the financial management of the James and Esther
510King Biomedical Research Program during the 2015 2010 Regular
511Session of the Legislature and shall determine the most
512appropriate funding source and means of funding the program
513based on its review.
514     (15)  This section expires January 1, 2016 2011, unless
515reviewed and reenacted by the Legislature before that date.
516     Section 4.  Subsection (3) of section 381.79, Florida
517Statutes, is amended to read:
518     381.79  Brain and Spinal Cord Injury Program Trust Fund.--
519     (3)  Annually, 5 percent of the revenues deposited monthly
520in the fund pursuant to s. 318.21(2)(d) shall be appropriated to
521the University of Florida and 5 percent to the University of
522Miami for spinal cord injury and brain injury research. The
523amount to be distributed to the universities shall be calculated
524based on the deposits into the fund for each quarter in the
525fiscal year, but may not exceed $500,000 per university per
526year. Funds distributed under this subsection shall be made in
527quarterly payments at the end of each quarter during the fiscal
528year. This subsection expires June 30, 2009.
529     Section 5.  Paragraph (h) is added to subsection (4) of
530section 381.853, Florida Statutes, to read:
531     381.853  Florida Center for Brain Tumor Research.--
532     (4)  The Florida Center for Brain Tumor Research is
533established within the Evelyn F. and William L. McKnight Brain
534Institute of the University of Florida.
535     (h)  Beginning in fiscal year 2009-2010, and each fiscal
536year thereafter, if the center seeks to conduct biomedical
537research using state funds, the center shall apply for funding
538through the James and Esther King Biomedical Research Program
539pursuant to s. 215.5602.
540     Section 6.  Paragraph (a) of subsection (5) of section
541381.855, Florida Statutes, is amended, and paragraphs (n), (o),
542and (p) are added to subsection (3) of that section, to read:
543     381.855  Florida Center for Universal Research to Eradicate
544Disease.--
545     (3)  There is established within the Department of Health
546the Florida Center for Universal Research to Eradicate Disease,
547which shall be known as "CURED."
548     (n)  The center shall identify ways to attract new research
549talent and attendant national grant producing researchers to
550research facilities in this state.
551     (o)  If funds are specifically appropriated by the
552Legislature, the center shall disseminate information to
553Floridians and treatment providers about specified diseases and
554conditions and available methods of preventing, diagnosing,
555treating, and curing those diseases and conditions.
556     (p)  The center shall provide information regarding
557research needs in the state to the Biomedical Research
558Commission located in the James and Esther King Biomedical
559Research Program.
560     (5)  There is established within the center an advisory
561council that shall meet at least annually.
562     (a)  The council shall consist of one representative from a
563Florida not-for-profit institution engaged in basic and clinical
564biomedical research and education which receives more than $10
565million in annual grant funding from the National Institutes of
566Health, to be appointed by the State Surgeon General from a
567different institution each term, and one representative from and
568appointed by each of the following entities:
569     1.  Enterprise Florida, Inc.
570     2.  BioFlorida.
571     3.  The Biomedical Research Commission Advisory Council.
572     4.  The Florida Medical Foundation.
573     5.  Pharmaceutical Research and Manufacturers of America.
574     6.  The Florida Cancer Council.
575     6.7.  The American Cancer Society, Florida Division, Inc.
576     7.8.  The American Heart Association.
577     8.9.  The American Lung Association of Florida.
578     9.10.  The American Diabetes Association, South Coastal
579Region.
580     10.11.  The Alzheimer's Association.
581     11.12.  The Epilepsy Foundation.
582     12.13.  The National Parkinson Foundation.
583     14.  The Florida Public Health Foundation, Inc.
584     13.15.  The Florida Research Consortium.
585     Section 7.  Subsections (2), (3), and (4) of section
586381.911, Florida Statutes, are amended to read:
587     381.911  Prostate Cancer Awareness Program.--
588     (2)  For purposes of implementing the program, the
589Department of Health and the Florida Public Health Foundation,
590Inc., may:
591     (a)  Conduct activities directly or enter into a contract
592with a qualified nonprofit community education entity.
593     (b)  Seek any available gifts, grants, or funds from the
594state, the Federal Government, philanthropic foundations, and
595industry or business groups.
596     (3)  A prostate cancer advisory committee is created to
597advise and assist the Department of Health and the Florida
598Public Health Foundation, Inc., in implementing the program.
599     (a)  The State Surgeon General shall appoint the advisory
600committee members, who shall consist of:
601     1.  Three persons from prostate cancer survivor groups or
602cancer-related advocacy groups.
603     2.  Three persons who are scientists or clinicians from
604public universities or research organizations.
605     3.  Three persons who are engaged in the practice of a
606cancer-related medical specialty from health organizations
607committed to cancer research and control.
608     (b)  Members shall serve without compensation but are
609entitled to reimbursement, pursuant to s. 112.061, for per diem
610and travel expenses incurred in the performance of their
611official duties.
612     (4)  The program shall coordinate its efforts with those of
613the Florida Public Health Foundation, Inc.
614     Section 8.  Section 381.922, Florida Statutes, is amended
615to read:
616     381.922  William G. "Bill" Bankhead, Jr., and David Coley
617Cancer Research Program.--
618     (1)  The William G. "Bill" Bankhead, Jr., and David Coley
619Cancer Research Program, which may be otherwise cited as the
620"Bankhead-Coley Program," is created within the Department of
621Health. The purpose of the program shall be to advance progress
622towards cures for cancer through grants awarded through a peer-
623reviewed, competitive process.
624     (2)  The program shall provide grants for cancer research
625to further the search for cures for cancer.
626     (a)  Emphasis shall be given to the goals that enumerated
627in s. 381.921, as those goals support the advancement of such
628cures.
629     (b)  Preference may be given to grant proposals that foster
630collaborations among institutions, researchers, and community
631practitioners, as such proposals support the advancement of
632cures through basic or applied research, including clinical
633trials involving cancer patients and related networks.
634     (3)(a)  Applications for funding for cancer research may be
635submitted by any university or established research institute in
636the state. All qualified investigators in the state, regardless
637of institutional affiliation, shall have equal access and
638opportunity to compete for the research funding. Collaborative
639proposals, including those that advance the program's goals
640enumerated in subsection (2), may be given preference.
641     (b)  For fiscal year 2008-2009, grants shall be awarded by
642the State Surgeon General, after consultation with the
643Biomedical Research Commission Advisory Council, on the basis of
644scientific merit through, as determined by an open, competitive
645peer review process that ensures objectivity, consistency, and
646high quality.
647     (c)  Beginning in fiscal year 2009-2010, and each fiscal
648year thereafter, the State Surgeon General shall submit to the
649Legislature by February 1 a priority list for cancer research
650funding by the Legislature based on the recommendations of the
651commission after peer review and scoring of the applications
652received. Recommendations to the Legislature shall be in the
653form of a list submitted by the State Surgeon General of the
654commission's rank order of priority from the proposal with the
655highest priority through the proposal with the lowest priority,
656including the recommended dollar amount and duration for each
657proposal. The State Surgeon General may not reject or modify the
658commission's recommendations. Successful applicants shall be
659awarded grants by the State Surgeon General based upon the
660recommendations of the commission and the final funding decision
661made by the Legislature.
662     (d)  Beginning in fiscal year 2009-2010, and each fiscal
663year thereafter, the commission's overall ranking of grant
664applications shall be based on the score awarded to the proposal
665by peer reviewers on the basis of scientific merit through an
666open competitive peer review process that ensures objectivity,
667consistency, and high quality and the commission's determination
668of the following:
669     1.  The projected impact that the proposed research will
670have on cancer research at the time the grant is awarded;
671     2.  The likelihood or possibility that the proposed
672research will result in new treatment modalities or technology
673during the term of the grant; and
674     3.  Whether the research proposed offers an efficient use
675of state funds in order to prevent or cure cancer.
676     (e)  The following types of applications shall be
677considered for funding:
678     1.  Investigator-initiated research grants.
679     2.  Institutional research grants.
680     3.  Collaborative research grants, including those that
681advance the finding of cures through basic or applied research.
682     (f)  Beginning in fiscal year 2009-2010, and each fiscal
683year thereafter, state funds shall only be provided for research
684that was applied for, reviewed, and recommended in accordance
685with this section.
686     (g)(b)  In order to ensure that all proposals for research
687funding are appropriate and are evaluated fairly on the basis of
688scientific merit, the State Surgeon General, in consultation
689with the commission council, shall appoint a peer review panel
690of independent, scientifically qualified individuals to review
691the scientific content of each proposal and establish its
692priority score. The priority scores shall be forwarded to the
693commission and its committees council and must be considered in
694determining which proposals shall be recommended for funding.
695     (h)(c)  The commission, the committees, council and the
696peer review panel shall establish and follow rigorous guidelines
697for ethical conduct and adhere to a strict policy with regard to
698conflicts of interest. A member of the commission, a committee,
699council or the panel may not participate in any discussion or
700decision with respect to a research proposal by any firm,
701entity, or agency with which the member is associated as a
702member of the governing body or as an employee or with which the
703member has entered into a contractual arrangement. Meetings of
704the commission, the committees, council and the peer review
705panels are subject to chapter 119, s. 286.011, and s. 24, Art. I
706of the State Constitution.
707     (4)  By December 15 of each year, the Department of Health
708shall submit to the Governor, the President of the Senate, and
709the Speaker of the House of Representatives a report indicating
710progress towards the program's mission and making
711recommendations that further its purpose.
712     (5)  Beginning in fiscal year 2006-2007, the sum of $9
713million is appropriated annually from recurring funds in the
714General Revenue Fund to the Biomedical Research Trust Fund
715within the Department of Health for purposes of the William G.
716"Bill" Bankhead, Jr., and David Coley Cancer Research Program
717and shall be distributed pursuant to this section to provide
718grants to researchers seeking cures for cancer, with emphasis
719given to the goals enumerated in s. 381.921. From the total
720funds appropriated, an amount of up to 10 percent may be used
721for administrative expenses.
722     (6)  By June 1, 2009, the Division of Statutory Revision of
723the Office of Legislative Services shall certify to the
724President of the Senate and the Speaker of the House of
725Representatives the language and statutory citation of this
726section, which is scheduled to expire January 1, 2011.
727     (7)  The Legislature shall review the performance, the
728outcomes, and the financial management of the William G. "Bill"
729Bankhead, Jr., and David Coley Cancer Research Program during
730the 2010 Regular Session of the Legislature and shall determine
731the most appropriate funding source and means of funding the
732program based on its review.
733     (6)(8)  This section expires June 30 January 1, 2011,
734unless reviewed and reenacted by the Legislature before that
735date.
736     Section 9.  Subsection (3) of section 430.502, Florida
737Statutes, is amended to read:
738     430.502  Alzheimer's disease; memory disorder clinics and
739day care and respite care programs.--
740     (3)  The Department of Elderly Affairs shall consult with
741the Alzheimer's Disease Brain Bank and model day care programs
742to Alzheimer's Disease Advisory Committee must evaluate the need
743for additional memory disorder clinics in the state. The first
744report will be due by December 31, 1995.
745     Section 10.  Section 430.503, Florida Statutes, is amended
746to read:
747     430.503  Alzheimer's Disease Initiative; fees and
748administrative expense.--
749     (1)  Sections 430.502-430.504 430.501-430.504 may be cited
750as the "Alzheimer's Disease Initiative."
751     (2)  Provider agencies are responsible for the collection
752of fees for services in accordance with rules adopted by the
753department. Provider agencies shall assess fees for services
754rendered in accordance with those rules. To help pay for
755services received pursuant to the Alzheimer's Disease
756Initiative, a functionally impaired elderly person shall be
757assessed a fee based on an overall ability to pay. The fee to be
758assessed shall be fixed according to a schedule to be
759established by the department. Services of specified value may
760be accepted in lieu of a fee. The fee schedule shall be
761developed in cooperation with the Alzheimer's Disease Advisory
762Committee, area agencies on aging, and service providers.
763     Section 11.  Section 430.504, Florida Statutes, is amended
764to read:
765     430.504  Confidentiality of information.--Information about
766clients of programs created or funded under s. 430.501 or s.
767430.503 which is received through files, reports, inspections,
768or otherwise, by the department or by authorized departmental
769employees, by persons who volunteer services, or by persons who
770provide services to clients of programs created or funded under
771s. 430.501 or s. 430.503 through contracts with the department
772is confidential and exempt from the provisions of s. 119.07(1).
773Such information may not be disclosed publicly in such a manner
774as to identify a person who receives services under s. 430.501
775or s. 430.503, unless that person or that person's legal
776guardian provides written consent.
777     Section 12.  Subsection (1) and paragraph (a) of subsection
778(2) of section 458.324, Florida Statutes, are amended to read:
779     458.324  Breast cancer; information on treatment
780alternatives.--
781     (1)  DEFINITION.--As used in this section, the term
782"medically viable," as applied to treatment alternatives, means
783modes of treatment generally considered by the medical
784profession to be within the scope of current, acceptable
785standards, including treatment alternatives described in the
786written summary prepared by the Florida Cancer Control and
787Research Advisory Council in accordance with s. 1004.435(4)(m).
788     (2)  COMMUNICATION OF TREATMENT ALTERNATIVES.--Each
789physician treating a patient who is, or in the judgment of the
790physician is at high risk of being, diagnosed as having breast
791cancer shall inform such patient of the medically viable
792treatment alternatives available to such patient; shall describe
793such treatment alternatives; and shall explain the relative
794advantages, disadvantages, and risks associated with the
795treatment alternatives to the extent deemed necessary to allow
796the patient to make a prudent decision regarding such treatment
797options. In compliance with this subsection:
798     (a)  The physician may, in his or her discretion:
799     1.  Orally communicate such information directly to the
800patient or the patient's legal representative;
801     2.  Provide the patient or the patient's legal
802representative with a copy of a the written summary prepared in
803accordance with s. 1004.435(4)(m) and express a willingness to
804discuss the summary with the patient or the patient's legal
805representative; or
806     3.  Both communicate such information directly and provide
807a copy of the written summary to the patient or the patient's
808legal representative for further consideration and possible
809later discussion.
810
811Nothing in this subsection shall reduce other provisions of law
812regarding informed consent.
813     Section 13.  Subsection (1) and paragraph (a) of subsection
814(2) of section 459.0125, Florida Statutes, are amended to read:
815     459.0125  Breast cancer; information on treatment
816alternatives.--
817     (1)  DEFINITION.--As used in this section, the term
818"medically viable," as applied to treatment alternatives, means
819modes of treatment generally considered by the medical
820profession to be within the scope of current, acceptable
821standards, including treatment alternatives described in the
822written summary prepared by the Florida Cancer Control and
823Research Advisory Council in accordance with s. 1004.435(4)(m).
824     (2)  COMMUNICATION OF TREATMENT ALTERNATIVES.--It is the
825obligation of every physician treating a patient who is, or in
826the judgment of the physician is at high risk of being,
827diagnosed as having breast cancer to inform such patient of the
828medically viable treatment alternatives available to such
829patient; to describe such treatment alternatives; and to explain
830the relative advantages, disadvantages, and risks associated
831with the treatment alternatives to the extent deemed necessary
832to allow the patient to make a prudent decision regarding such
833treatment options. In compliance with this subsection:
834     (a)  The physician may, in her or his discretion:
835     1.  Orally communicate such information directly to the
836patient or the patient's legal representative;
837     2.  Provide the patient or the patient's legal
838representative with a copy of a the written summary prepared in
839accordance with s. 1004.435(4)(m) and express her or his
840willingness to discuss the summary with the patient or the
841patient's legal representative; or
842     3.  Both communicate such information directly and provide
843a copy of the written summary to the patient or the patient's
844legal representative for further consideration and possible
845later discussion.
846
847Nothing in this subsection shall reduce other provisions of law
848regarding informed consent.
849     Section 14.  Subsections (7), (8), and (12) of section
8501004.445, Florida Statutes, as amended by chapter 2007-332, Laws
851of Florida, are amended to read:
852     1004.445  Johnnie B. Byrd, Sr., Alzheimer's Center and
853Research Institute.--
854     (7)  The board of directors of the not-for-profit
855corporation shall create a council of scientific advisers to the
856chief executive officer comprised of leading researchers,
857physicians, and scientists. The council shall review programs
858and recommend research priorities and initiatives to maximize
859the state's investment in the institute. The members of the
860council shall be appointed by the board of directors of the not-
861for-profit corporation. Each member of the council shall be
862appointed to serve a 2-year term and may be reappointed to the
863council. This subsection expires on June 30, 2009.
864     (8)(a)  Applications for Alzheimer's disease research
865funding may be submitted from any university or established
866research institute in the state. All qualified investigators in
867the state, regardless of institutional affiliation, shall have
868equal access and opportunity to compete for the research
869funding. Grants shall be awarded by the board of directors of
870the not-for-profit corporation on the basis of scientific merit,
871as determined by an open, competitive peer review process that
872ensures objectivity, consistency, and high quality. The
873following types of applications shall be considered for funding:
874     1.  Investigator-initiated research grants.
875     2.  Institutional research grants.
876     3.  Collaborative research grants, including those that
877advance the finding of cures through basic or applied research.
878     (b)  Preference may be given to grant proposals that foster
879collaboration among institutions, researchers, and community
880practitioners because these proposals support the advancement of
881cures through basic or applied research, including clinical
882trials involving Alzheimer's patients and related networks.
883     (c)  To ensure that all proposals for research funding are
884appropriate and are evaluated fairly on the basis of scientific
885merit, the board of directors of the not-for-profit corporation,
886in consultation with the council of scientific advisors, shall
887appoint a peer review panel of independent, scientifically
888qualified individuals to review the scientific content of each
889proposal and establish its scientific priority score. The
890priority scores shall be forwarded to the council and must be
891considered by the board of directors of the not-for-profit
892corporation in determining which proposals shall be recommended
893for funding.
894     (d)  The council of scientific advisors and the peer review
895panel shall establish and follow rigorous guidelines for ethical
896conduct and adhere to a strict policy with regard to conflict of
897interest. All employees, members of the board of directors, and
898affiliates of the not-for-profit corporation shall follow the
899same rigorous guidelines for ethical conduct and shall adhere to
900the same strict policy with regard to conflict of interest. A
901member of the council or panel may not participate in any
902discussion or decision with respect to a research proposal by
903any firm, entity, or agency with which the member is associated
904as a member of the governing body or as an employee or with
905which the member has entered into a contractual arrangement.
906Meetings of the council and the peer review panels are subject
907to chapter 119, s. 286.011, and s. 24, Art. I of the State
908Constitution.
909     (e)  This subsection expires on June 30, 2009.
910     (12)(a)  Beginning in fiscal year 2008-2009 2007-2008, the
911sum of $5 $13.5 million is appropriated annually from recurring
912funds in the General Revenue Fund to the Grants and Donations
913Trust Fund within the Department of Elderly Affairs for the
914Johnnie B. Byrd, Sr., Alzheimer's Center and Research Institute
915at the University of South Florida for the purposes as provided
916under paragraph (6)(a), conducting and supporting research,
917providing institutional research grants and investigator-
918initiated research grants, developing and operating integrated
919data projects, and providing assistance to statutorily
920designated memory disorder clinics as provided under s. 430.502.
921Not less than 80 percent of the appropriated funds shall be
922expended for these purposes, and not less than 20 percent of the
923appropriated funds shall be expended for peer-reviewed
924investigator-initiated research grants.
925     (b)  Beginning in fiscal year 2009-2010, and each fiscal
926year thereafter, the sum appropriated in paragraph (a) shall be
927used for programs that fulfill the mission of the institute in
928education, treatment, prevention, and early detection of
929Alzheimer's disease, developing and operating integrated data
930projects, and providing assistance to statutorily designated
931memory disorder clinics. If the institute intends to conduct
932research using state funds, it shall compete for funding through
933the James and Esther King Biomedical Research Program pursuant
934to s. 215.5602.
935     Section 15.  Sections 381.0404, 381.85, 381.912, 381.92,
936381.921, 381.98, 381.981, 430.501, and 1004.435, Florida
937Statutes, are repealed.
938     Section 16.  If any provision of this act or the
939application thereof to any person or circumstance is held
940invalid, the invalidity does not affect other provisions or
941applications of the act which can be given effect without the
942invalid provision or application, and to this end the provisions
943of this act are declared severable.
944     Section 17.  This act shall take effect July 1, 2008.


CODING: Words stricken are deletions; words underlined are additions.