Florida Senate - 2008 SB 2752

By Senator Peaden

2-03594A-08 20082752__

A bill to be entitled

An act relating to biomedical research; amending s.

20.435, F.S.; revising funding sources for the Biomedical

Research Trust Fund to conform to changes made by the act;

providing for segregation of trust funds based on the type

of research conducted; amending s. 215.5602, F.S.,

relating to the James and Esther King Biomedical Research

Program; providing for the prevention, diagnosis,

treatment, and cure of specified diseases as a long-term

goal of the research program; providing for the expansion

of the foundation of biomedical knowledge relating to the

prevention, diagnosis, treatment, and cure for specified

diseases; requiring that funds appropriated for the

research program be used for research relating to the

prevention, diagnosis, treatment, and cure of various

diseases; requiring that other funds appropriated for the

research program be credited to the Biomedical Research

Trust Fund; renaming the Biomedical Research Advisory

Council the Biomedical Research Commission; revising the

membership of the commission; requiring the biomedical

research program to serve as the exclusive source for

awarding grants and fellowships; requiring the commission

to create other committees; requiring the commission to

adopt procedures for assigning commission members to

committees; requiring the commission to advise the State

Surgeon General as to the direction and scope of the

research program; providing responsibilities of the

commission; requiring the State Surgeon General to award

grants and fellowships after consultation with the

commission; requiring the State Surgeon General to submit

to the Legislature lists of priorities for funding tobacco

and non-tobacco-related diseases based on recommendations

of the commission; providing restrictions on the State

Surgeon General; providing for the award of grants or

fellowships upon a specific appropriation; providing that

funding is only available to research projects that go

through a certain process; providing criteria for ranking

priorities; providing for the terms of the grants;

requiring other programs, boards, commissions, councils,

advisory groups, and committees to cease awarding

biomedical research grants or fellowships and to make

recommendations to the Biomedical Research Commission and

its committees; requiring the State Surgeon General, in

consultation with the commission, to appoint a peer review

panel; requiring that priority scores be forwarded to the

commission and the committees; requiring the commission,

the committees, and the peer review panel to establish

rigorous guidelines for ethical conduct with regard to

conflicts of interest; reducing the limits on

administrative expenses; requiring the commission to

submit its recommendations and annual progress report to

the Governor, the State Surgeon General, the Legislature,

and the Florida Center for Universal Research to Eradicate

Disease; requiring the commission to award grants for

cancer research through the William G. "Bill" Bankhead,

Jr., and David Coley Cancer Research Program; providing an

expiration date; providing appropriations; revising

provisions relating to sunset of the program; amending s.

381.79, F.S.; providing an expiration date for the

appropriation for spinal cord injury and brain injury

research; amending s. 381.853, F.S.; requiring the Florida

Center for Brain Tumor Research to apply through the James

and Esther King Biomedical Research Program if the center

seeks to conduct biomedical research using state funds;

amending s. 381.855, F.S.; providing additional program

functions for the Florida Center for Universal Research to

Eradicate Disease; requiring the center to disseminate

information about diseases and conditions to Floridians

and providers if an appropriation is made; deleting

references to conform to changes made by this act;

amending s. 381.911, F.S.; deleting references to conform

to changes made by this act; repealing s. 381.912, F.S.,

relating to the Cervical Cancer Elimination Task Force;

repealing s. 381.92, F.S., relating to the Florida Cancer

Council; repealing s. 381.921, F.S., relating to Florida

Cancer Council's mission and duties; amending s. 381.922,

F.S.; deleting cross-references to conform to changes of

this act; requiring the State Surgeon General to submit to

the Legislature a priority list for cancer research

funding by the Legislature; prohibiting the State Surgeon

General from rejecting or modifying the commission's

recommendations under certain circumstances; providing

ranking criteria for the commission; prohibiting the

provision of state funds for research that was not applied

for, reviewed, and recommended; requiring the commission,

the committees, and the peer review panel to establish

rigorous guidelines for ethical conduct with regard to

conflicts of interest; deleting a provision concerning

certification by the Division of Statutory Revision of the

Office of Legislative Services related to the program;

deleting a provision concerning future Legislative review

of the program; revising the sunset date for the program;

repealing s. 381.98, F.S., relating to the Florida Public

Health Foundation, Inc.; repealing s. 381.981, F.S.,

relating to Health awareness campaigns; amending s.

430.502, F.S.; requiring the Department of Elderly Affairs

to evaluate the need for more memory disorder clinics in

the state; deleting cross-references to conform to changes

made by this act; amending ss. 430.503, 430.504, and

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458.324, F.S.; deleting a reference and cross-references

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to conform to the changes made by this act; amending s.

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459.0125, F.S.; redefining the term "medically viable";

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deleting a cross-reference to conform to the changes made

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by this act; repealing s. 1004.435, F.S., relating to

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cancer control and research and the Cancer Control and

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Research Commission; amending s. 1004.445, F.S.; providing

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an expiration date for the appointment of a council by the

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not-for-profit corporation that governs the Johnnie B.

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Byrd, Sr., Alzheimer's Center and Research Institute;

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providing an expiration date for applying for funding for

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Alzheimer's disease research through the Johnnie B. Byrd,

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Sr., Alzheimer's Center and Research Institute; providing

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an expiration date for the appropriation of funds from the

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General Revenue Fund to the Grants and Donations Trust

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Fund within the Department of Elderly Affairs for the

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Johnnie B. Byrd, Sr., Alzheimer's Center and Research

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Institute; revising an appropriation of funds from the

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General Revenue Fund to the Grants and Donations Trust

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Fund within the Department of Elderly Affairs for the

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Johnnie B. Byrd, Sr., Alzheimer's Center and Research

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Institute; providing an appropriation of funds from the

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General Revenue Fund to the Grants and Donations Trust

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Fund within the Department of Elderly Affairs for the

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Johnnie B. Byrd, Sr., Alzheimer's Center and Research

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Institute for the purpose of providing assistance to

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memory disorder clinics; requiring the Johnnie B. Byrd,

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Sr., Alzheimer's Center and Research Institute to apply

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for funding through the James and Esther King Biomedical

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Research Program; providing for severability; providing an

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effective date.

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Be It Enacted by the Legislature of the State of Florida:

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Section 1. Paragraph (h) of subsection (1) of section

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20.435, Florida Statutes, is amended to read:

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20.435 Department of Health; trust funds.--

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(1) The following trust funds are hereby created, to be

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administered by the Department of Health:

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(h) Biomedical Research Trust Fund.

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1. Funds to be credited to the trust fund shall consist of

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funds deposited pursuant to s. 215.5601 and any other funds

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appropriated by the Legislature. Funds shall be used for the

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purposes of the James and Esther King Biomedical Research Program

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and the William G. "Bill" Bankhead, Jr., and David Coley Cancer

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Research Program as specified in ss. 215.5602, 288.955, and

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381.922. The trust fund is exempt from the service charges

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imposed by s. 215.20.

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2. Funds deposited to the trust fund pursuant to s.

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215.5601 and any other funds appropriated by the Legislature as

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specified in ss. 215.5602(12)(a) and 288.955 or elsewhere for

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research related to tobacco-related diseases shall be used

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exclusively for the purpose of awarding grants and fellowships

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for research regarding the prevention, diagnosis, treatment, and

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cure of tobacco-related diseases by the James and Esther King

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Biomedical Research Program.

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3. Funds deposited to the trust fund pursuant to the

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William G. "Bill" Bankhead, Jr., and David Coley Cancer Research

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Program as specified in s. 381.922 shall be used for the purpose

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of awarding grants for cancer research by the James and Esther

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King Biomedical Research Program.

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4. All other funds deposited to the trust fund shall be

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used for the purpose of awarding grants and fellowship for

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biomedical research regarding the prevention, diagnosis,

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treatment, and cure of the most deadly and widespread non-

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tobacco-related acute, chronic, and degenerative diseases by the

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James and Esther King Biomedical Research Program as specified in

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ss. 215.5602(2)(b) and 215.5602(12)(b).

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5.2. Notwithstanding the provisions of s. 216.301 and

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pursuant to s. 216.351, any balance in the trust fund at the end

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of any fiscal year shall remain in the trust fund at the end of

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the year and shall be available for carrying out the purposes of

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the trust fund. The department may invest these funds

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independently through the Chief Financial Officer or may

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negotiate a trust agreement with the State Board of

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Administration for the investment management of any balance in

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the trust fund.

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6.3. Notwithstanding s. 216.301 and pursuant to s. 216.351,

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any balance of any appropriation from the Biomedical Research

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Trust Fund which is not disbursed but which is obligated pursuant

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to contract or committed to be expended may be carried forward

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for up to 3 years following the effective date of the original

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appropriation.

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Section 2. Section 215.5602, Florida Statutes, is amended

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to read:

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215.5602 James and Esther King Biomedical Research

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Program.--

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(1) There is established within the Department of Health

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the James and Esther King Biomedical Research Program funded by

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the proceeds of the Lawton Chiles Endowment Fund pursuant to s.

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215.5601. The purpose of the James and Esther King Biomedical

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Research program is to provide an annual and perpetual source of

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funding in order to support research initiatives that address the

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health care problems of Floridians in the areas of tobacco-

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related cancer, cardiovascular disease, stroke, and pulmonary

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disease, and non-tobacco-related acute, chronic, and degenerative

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diseases, including cancer, cardiovascular disease, stroke,

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pulmonary disease, diabetes, autoimmune and genetic disorders,

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and neurological disorders, including Alzheimer's disease,

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epilepsy, and Parkinson's disease. The long-term goals of the

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program are to:

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(a) Improve the health of Floridians by researching better

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prevention, diagnoses, treatments, and cures for the most deadly

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and widespread acute, chronic, and degenerative diseases,

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including, but not limited to, tobacco-related diseases, cancer,

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cardiovascular disease, stroke, and pulmonary disease, diabetes,

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autoimmune and genetic disorders, and neurological disorders,

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including Alzheimer's disease, epilepsy, and Parkinson's disease.

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(b) Expand the foundation of biomedical knowledge relating

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to the prevention, diagnosis, treatment, and cure of diseases

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related to tobacco use, including cancer, cardiovascular disease,

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stroke, and pulmonary disease.

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to the prevention, diagnosis, treatment, and cure of the most

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widespread acute, chronic, and degenerative diseases affecting

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Floridians, including, but not limited to, cancer, cardiovascular

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disease, stroke, pulmonary disease, diabetes, autoimmune and

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genetic disorders, and neurological disorders, including

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Alzheimer's disease, epilepsy, and Parkinson's disease.

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(d)(c) Improve the quality of the state's academic health

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centers by bringing the advances of biomedical research into the

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training of physicians and other health care providers.

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(e)(d) Increase the state's per capita funding for research

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by undertaking new initiatives in public health and biomedical

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research that will attract additional funding from outside the

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state.

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(f)(e) Stimulate economic activity in the state in areas

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related to biomedical research, such as the research and

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production of pharmaceuticals, biotechnology, and medical

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devices.

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(2)(a) Funds appropriated for the James and Esther King

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Biomedical Research Program pursuant to the Lawton Chiles

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Endowment Fund in s. 215.5601 and additional funding provided in

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s. 215.5602(12)(a) or elsewhere in law for research related to

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tobacco-related diseases shall be credited to the Biomedical

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Research Trust Fund pursuant to s. 20.435 and shall be used

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exclusively for the award of grants and fellowships related to

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the prevention, diagnosis, treatment, and cure of diseases

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related to tobacco use, including cancer, cardiovascular disease,

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stroke, and pulmonary disease, and for expenses incurred in the

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administration of this section. Priority shall be granted to

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research designed to prevent or cure tobacco-related disease.

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(b) Beginning in the 2009-2019 fiscal year and each fiscal

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year thereafter, all other funds appropriated for the James and

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Esther King Biomedical Research Program shall be credited to the

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Biomedical Research Trust Fund pursuant to s. 20.435 and shall be

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used exclusively for the award of grants and fellowships as

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established in this section; for research relating to the

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prevention, diagnosis, treatment, and cure of the most deadly and

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widespread acute, chronic, and degenerative non-tobacco-related

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diseases affecting Floridians related to tobacco use, including

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cancer, cardiovascular disease, stroke, and pulmonary disease,

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diabetes, autoimmune and genetic disorders, and neurological

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disorders, including Alzheimer's disease, epilepsy, and

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Parkinson's disease,; and for expenses incurred in the

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administration of this section. Priority shall be granted to

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research designed to prevent or cure disease.

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(3) There is created within the Department of Health the

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Biomedical Research Commission Advisory Council.

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(a) The council shall consist of 15 11 members, including:

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the chief executive officer of the Florida Division of the

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American Cancer Society, or a designee; the chief executive

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officer of the Greater Southeast Florida/Puerto Rico Affiliate of

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the American Heart Association, or a designee; and the chief

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executive officer of the American Lung Association of Florida, or

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a designee; the chief executive officer of the South Coastal

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Region of the American Diabetes Association, or a designee; and

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the president of the Florida Medical Association, or a designee.

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The remaining 10 8 members of the commission council shall be

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appointed as follows:

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1. The Governor shall appoint 13 four members as follows:,

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two members having with expertise in the field of biomedical

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research, one member from a research university in the state, and

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one member representing the general population of the state.

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2. The President of the Senate shall appoint three two

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members, one member having with expertise in the field of

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behavioral or social research and two representatives from

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volunteer health organizations operating in this state which

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focus on Alzheimer's disease, Parkinson's disease, epilepsy,

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stroke, or autoimmune or genetic disorders one representative

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from a cancer program approved by the American College of

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Surgeons.

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3. The Speaker of the House of Representatives shall

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appoint three two members, two representatives from volunteer

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health organizations operating in this state which focus on

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Alzheimer's disease, Parkinson's disease, epilepsy, stroke, or

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autoimmune or genetic disorders, one member from a professional

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medical organization and one representative from a cancer program

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approved by the American College of Surgeons.

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In making these appointments, the Governor, the President of the

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Senate, and the Speaker of the House of Representatives shall

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select primarily, but not exclusively, Floridians with biomedical

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and lay expertise in the general areas of cancer, cardiovascular

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disease, stroke, and pulmonary disease, diabetes, autoimmune and

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genetic disorders, and neurological disorders, including

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Alzheimer's disease, epilepsy, and Parkinson's disease. The

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appointments shall be for a 3-year term and shall reflect the

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diversity of the state's population. An appointed member may not

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serve more than two consecutive terms.

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(b) Beginning July 1, 2009, and each year thereafter, the

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biomedical research program shall serve as the exclusive source

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of awarding grants or fellowships for biomedical research in the

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state using state funds. This paragraph does not preclude another

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grant or fellowship program in the state from awarding grants

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from funds received from private or federal sources where

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permitted by state law.

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disease specific areas, including, but not limited to, tobacco-

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related diseases, cancer, stroke, cardiovascular disease,

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pulmonary disease, diabetes, autoimmune or genetic disorders,

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Alzheimer's disease, epilepsy, and Parkinson's disease.

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(d)(b) The commission council shall adopt internal

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organizational procedures as necessary for its efficient

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organization, including policies and procedures regarding the

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creation and composition of the committees, reporting and

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recommendations by the committee to the commission regarding the

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award of grants and fellowships, coordination between the

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commission and committees, and the methods for receiving input

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from outside individuals, organizations, or entities regarding

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the prioritization of research..

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(e)(c) The department shall provide such staff,

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information, and other assistance as is reasonably necessary to

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assist the commission council in carrying out its

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responsibilities, including those of its committees.

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(f)(d) Members of the commission council shall serve

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without compensation, but may receive reimbursement as provided

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in s. 112.061 for travel and other necessary expenses incurred in

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the performance of their official duties, including committee

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meetings.

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(4) The commission council shall, after considering the

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recommendations of its committees, advise the State Surgeon

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General as to the direction and scope of the biomedical research

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program. The responsibilities of the commission council may

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include, but are not limited to:

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(a) Establishing Providing advice on program priorities and

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emphases.

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(b) Establishing Providing advice on the overall program

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budget and making recommendations to the State Surgeon General

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and the Legislature for future appropriations.

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(d) Developing Assisting in the development of guidelines

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to ensure fairness, neutrality, and adherence to the principles

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of merit and quality in the conduct of the program.

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(e) Developing Assisting in the development of appropriate

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linkages to nonacademic entities, such as voluntary

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organizations, health care delivery institutions, industry,

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government agencies, and public officials.

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(f) Developing criteria and standards for the award of

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research grants.

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(g) Developing administrative procedures relating to

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solicitation, independent peer review, and award of research

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grants and fellowships, to ensure an impartial, high-quality

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peer, science-based review system.

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(h) Developing and supervising research peer review panels.

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(i) Reviewing reports of peer review panels and making

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recommendations for research grants and fellowships.

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(j) Developing and providing oversight regarding mechanisms

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for the dissemination of research results.

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(5)(a) Applications for biomedical research funding under

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the program may be submitted from any university or established

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research institute in the state. All qualified investigators in

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the state, regardless of institution affiliation, shall have

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equal access and opportunity to compete for the research funding.

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(b) For the 2008-2009 fiscal year, grants and fellowships

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shall be awarded by the State Surgeon General, after consultation

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with the commission council, on the basis of scientific merit, as

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determined by an open competitive peer review process that

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ensures objectivity, consistency, and high quality.

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Surgeon General shall submit to the Legislature by February 1

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priority lists for both tobacco and non-tobacco-related

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biomedical research funding by the Legislature based on the

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recommendations made by the commission after peer-review and

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scoring of the applications received. Recommendations to the

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Legislature shall be in the form of a list from the State Surgeon

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General of the commission's ranking by order of priority from the

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proposal having the highest priority through the proposal having

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the lowest priority, including the recommended dollar amount and

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duration for each proposal. Unless the commission recommends

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funding for an entity that is ineligible to receive funding under

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the program, the State Surgeon General may not reject or modify

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the commission's recommendations. Successful grant and fellowship

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applications shall be awarded by the State Surgeon General based

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upon the recommendations of the commission and the final funding

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decision made by the Legislature. Funding for grant and

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fellowship applications for tobacco-related research shall be

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based upon funds available pursuant to ss. 215.5601,

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215.5602(2)(a), and 216.5602(12)(a).

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(d) Beginning in the 2009-2010 fiscal year and each fiscal

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year thereafter, the commission's overall rank for grant or

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fellowship applications shall be based on the score awarded to

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the proposal by peer reviewers on the basis of scientific merit

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through an open competitive peer review process that ensures

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objectivity, consistency, and high quality, and the commission's

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determination of the following:

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1. The projected impact that the proposed research will

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have on the most deadly and widespread diseases affecting

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Floridians at the time the grant or fellowship is awarded;

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2. The likelihood or possibility that the proposed research

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will result in new treatment modalities or technology during the

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term of the grant or fellowship; and

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3. Whether the research proposed offers an efficient use of

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state funds in order to prevent or cure disease.

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(e) The following types of applications shall be considered

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for funding:

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1. Investigator-initiated research grants.

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2. Institutional research grants.

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3. Predoctoral and postdoctoral research fellowships.

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(f) Upon a specific appropriation, the council shall award

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grants for terms of 1 to 5 years. State funds may not be provided

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for research that was not applied for, reviewed, and recommended

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in accordance with this section.

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(g) Except for the William G. "Bill" Bankhead, Jr., and

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David Coley Cancer Research Program that expires June 30, 2011,

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as set forth in s. 381.922, beginning July 1, 2009, and each year

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thereafter, any program, board, commission, council, advisory

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group, agency, or entity created by state law that awards or

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recommends the award of grants or fellowships for biomedical

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research shall cease awarding grants or fellowships using state

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funds and, instead, shall make recommendations to the commission

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and its committees for the prioritization and award of grants and

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fellowships through the James and Esther King Biomedical Research

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Program. This section does not apply to the World Class Scholars,

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Centers of Excellence, or State University Research

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Commercialization Assistance Grant Programs as set forth in s.

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1004.226.

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(6) To ensure that all proposals for research funding are

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appropriate and are evaluated fairly on the basis of scientific

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merit, the State Surgeon General, in consultation with the

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commission council, shall appoint a peer review panel of

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independent, scientifically qualified individuals to review the

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scientific content of each proposal and establish its scientific

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priority score. The priority scores shall be forwarded to the

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commission and its committees council and must be considered in

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determining which proposals shall be recommended for funding.

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(7) The commission, the committees, council and the peer

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review panel shall establish and follow rigorous guidelines for

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ethical conduct and adhere to a strict policy with regard to

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conflict of interest. A member of the commission, a committee,

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council or a panel may not participate in any discussion or

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decision with respect to a research proposal by any firm, entity,

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or agency with which the member is associated as a member of the

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governing body or as an employee, or with which the member has

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entered into a contractual arrangement. Meetings of the

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commission, the committees, council and the peer review panels

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shall be subject to the provisions of chapter 119, s. 286.011,

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and s. 24, Art. I of the State Constitution.

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(8) The department may contract on a competitive-bid basis

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with an appropriate entity to administer the program.

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Administrative expenses may not exceed 15 percent of the total

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funds available to the program in any given year. Effective July

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1, 2009, administrative expenses may not exceed 10 percent of the

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total funds available to the program in any given year.

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(9) The department, after consultation with the commission

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council, may adopt rules pursuant to ss. 120.536(1) and 120.54 as

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necessary to implement this section.

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(10) In addition to its recommendations to the State

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Surgeon General and the Legislature to appropriate funds for the

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award of grants and fellowships, the commission the council shall

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submit an annual progress report on the state of biomedical

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research in this state to the Florida Center for Universal

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Research to Eradicate Disease and to the Governor, the State

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Surgeon General, the President of the Senate, and the Speaker of

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the House of Representatives by February 1. The report must

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include:

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(a) A list of current research projects supported by grants

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or fellowships awarded under the program.

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(b) A list of recipients of program grants or fellowships.

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journals involving research supported by grants or fellowships

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awarded under the program.

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(d) The total amount of biomedical research funding

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currently flowing into the state.

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(e) New grants for biomedical research which were funded

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based on research supported by grants or fellowships awarded

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under the program.

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(f) Progress in the prevention, diagnosis, treatment, and

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cure of the most deadly and widespread acute, chronic, and

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degenerative diseases affecting Floridians, including diseases

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related to tobacco use, including cancer, cardiovascular disease,

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stroke, and pulmonary disease, diabetes, autoimmune and genetic

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disorders, and neurological disorders, including Alzheimer's

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disease, epilepsy, and Parkinson's disease.

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(11) The commission council shall award grants for cancer

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research through the William G. "Bill" Bankhead, Jr., and David

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Coley Cancer Research Program created in s. 381.922. This

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subsection expires June 30, 2011.

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(12)(a) Beginning in fiscal year 2006-2007, the sum of $6

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million is appropriated annually from recurring funds in the

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General Revenue Fund to the Biomedical Research Trust Fund within

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the Department of Health for purposes of the award of grants and

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fellowships by the James and Esther King Biomedical Research

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Program for research relating to tobacco-related diseases

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pursuant to this section. From these funds up to $250,000 shall

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be available for the operating costs of the Florida Center for

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Universal Research to Eradicate Disease.

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(b) Beginning in the 2009-2010 fiscal year and each fiscal

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year thereafter, the Legislature may appropriate funds from

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recurring funds in the General Revenue Fund to the Biomedical

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Research Trust Fund within the Department of Health for purposes

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of the award of grants and fellowships by the James and Esther

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King Biomedical Research Program for research concerning the most

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deadly and widespread non-tobacco-related acute, chronic, and

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degenerative diseases pursuant to this section. Any research

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grant or fellowship awarded for Alzheimer's research pursuant to

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this section shall be named a "Johnnie B. Byrd, Sr., Alzheimer's

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Grant." Any research grant or fellowship awarded for cancer

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research pursuant to this section shall be named a "Bankhead-

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Coley Cancer Grant."

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(13) By June 1, 2014 2009, the Division of Statutory

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Revision of the Office of Legislative Services shall certify to

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the President of the Senate and the Speaker of the House of

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Representatives the language and statutory citation of this

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section, which is scheduled to expire January 1, 2016 2011.

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(14) The Legislature shall review the performance, the

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outcomes, and the financial management of the James and Esther

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King Biomedical Research Program during the 2015 2010 Regular

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Session of the Legislature and shall determine the most

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appropriate funding source and means of funding the program based

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on its review.

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(15) This section expires January 1, 2016 2011, unless

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reviewed and reenacted by the Legislature before that date.

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Section 3. Subsection (3) of section 381.79, Florida

524

Statutes, is amended to read:

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381.79 Brain and Spinal Cord Injury Program Trust Fund.--

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(3) Annually, 5 percent of the revenues deposited monthly

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in the fund pursuant to s. 318.21(2)(d) shall be appropriated to

528

the University of Florida and 5 percent to the University of

529

Miami for spinal cord injury and brain injury research. The

530

amount to be distributed to the universities shall be calculated

531

based on the deposits into the fund for each quarter in the

532

fiscal year, but may not exceed $500,000 per university per year.

533

Funds distributed under this subsection shall be made in

534

quarterly payments at the end of each quarter during the fiscal

535

year. This subsection expires June 30, 2009.

536

Section 4. Paragraph (h) is added to subsection (4) of

537

section 381.853, Florida Statutes, to read:

538

381.853 Florida Center for Brain Tumor Research.--

539

(4) The Florida Center for Brain Tumor Research is

540

established within the Evelyn F. and William L. McKnight Brain

541

Institute of the University of Florida.

542

(h) Beginning in the 2009-2010 fiscal year and each fiscal

543

year thereafter, if the center seeks to conduct biomedical

544

research using state funds, the center shall apply for funding

545

through the James and Esther King Biomedical Research Program

546

pursuant to s. 215.5602.

547

Section 5. Paragraphs (n), (o), and (p) are added to

548

subsection (3) of section 381.855, Florida Statutes, and

549

paragraph (a) of subsection (5) of that section is amended, to

550

read:

551

381.855 Florida Center for Universal Research to Eradicate

552

Disease.--

553

(3) There is established within the Department of Health

554

the Florida Center for Universal Research to Eradicate Disease,

555

which shall be known as "CURED."

556

(n) The center shall identify ways to attract new research

557

talent and attendant national grant producing researchers to

558

research facilities in this state.

559

(o) If funds are specifically appropriated by the

560

Legislature, the center shall disseminate information to

561

Floridians and treatment providers about specified diseases and

562

conditions and available methods of preventing, diagnosing,

563

treating, and curing those diseases and conditions.

564

(p) The center shall provide information regarding research

565

needs in the state to the Biomedical Research Commission located

566

in the James and Esther King Biomedical Research Program.

567

(5) There is established within the center an advisory

568

council that shall meet at least annually.

569

(a) The council shall consist of one representative from a

570

Florida not-for-profit institution engaged in basic and clinical

571

biomedical research and education which receives more than $10

572

million in annual grant funding from the National Institutes of

573

Health, to be appointed by the State Surgeon General from a

574

different institution each term, and one representative from and

575

appointed by each of the following entities:

576

1. Enterprise Florida, Inc.

577

2. BioFlorida.

578

3. The Biomedical Research Commission Advisory Council.

579

4. The Florida Medical Foundation.

580

5. Pharmaceutical Research and Manufacturers of America.

581

6. The Florida Cancer Council.

582

6.7. The American Cancer Society, Florida Division, Inc.

583

7.8. The American Heart Association.

584

8.9. The American Lung Association of Florida.

585

9.10. The American Diabetes Association, South Coastal

586

Region.

587

10.11. The Alzheimer's Association.

588

11.12. The Epilepsy Foundation.

589

12.13. The National Parkinson Foundation.

590

14. The Florida Public Health Foundation, Inc.

591

13.15. The Florida Research Consortium.

592

Section 6. Subsections (2), (3), and (4) of section

593

381.911, Florida Statutes, are amended to read:

594

381.911 Prostate Cancer Awareness Program.--

595

(2) For purposes of implementing the program, the

596

Department of Health and the Florida Public Health Foundation,

597

Inc., may:

598

(a) Conduct activities directly or enter into a contract

599

with a qualified nonprofit community education entity.

600

(b) Seek any available gifts, grants, or funds from the

601

state, the Federal Government, philanthropic foundations, and

602

industry or business groups.

603

(3) A prostate cancer advisory committee is created to

604

advise and assist the Department of Health and the Florida Public

605

Health Foundation, Inc., in implementing the program.

606

(a) The State Surgeon General shall appoint the advisory

607

committee members, who shall consist of:

608

1. Three persons from prostate cancer survivor groups or

609

cancer-related advocacy groups.

610

2. Three persons who are scientists or clinicians from

611

public universities or research organizations.

612

3. Three persons who are engaged in the practice of a

613

cancer-related medical specialty from health organizations

614

committed to cancer research and control.

615

(b) Members shall serve without compensation but are

616

entitled to reimbursement, pursuant to s. 112.061, for per diem

617

and travel expenses incurred in the performance of their official

618

duties.

619

(4) The program shall coordinate its efforts with those of

620

the Florida Public Health Foundation, Inc.

621

Section 7. Section 381.912, Florida Statutes, is repealed.

622

Section 8. Section 381.92, Florida Statutes, is repealed.

623

Section 9. Section 381.921, Florida Statutes, is repealed.

624

Section 10. Subsections (2), (3), (5), (6), (7), and (8) of

625

section 381.922, Florida Statutes, are amended to read:

626

381.922 William G. "Bill" Bankhead, Jr., and David Coley

627

Cancer Research Program.--

628

(2) The program shall provide grants for cancer research to

629

further the search for cures for cancer.

630

(a) Emphasis shall be given to the goals enumerated in s.

631

381.921, as those goals that support the advancement of such

632

cures.

633

(b) Preference may be given to grant proposals that foster

634

collaborations among institutions, researchers, and community

635

practitioners, as such proposals support the advancement of cures

636

through basic or applied research, including clinical trials

637

involving cancer patients and related networks.

638

(3)(a) Applications for funding for cancer research may be

639

submitted by any university or established research institute in

640

the state. All qualified investigators in the state, regardless

641

of institutional affiliation, shall have equal access and

642

opportunity to compete for the research funding. Collaborative

643

proposals, including those that advance the program's goals

644

enumerated in subsection (2), may be given preference.

645

(b) For the 2008-2009 fiscal year, grants shall be awarded

646

by the State Surgeon General, after consultation with the

647

Biomedical Research Commission Advisory Council, on the basis of

648

scientific merit through, as determined by an open, competitive

649

peer review process that ensures objectivity, consistency, and

650

high quality.

651

652

year thereafter, the State Surgeon General shall submit to the

653

Legislature by February 1 a priority list for cancer research

654

funding by the Legislature based on the recommendations made by

655

the commission after peer review and scoring of the applications

656

received. Recommendations to the Legislature shall be in the form

657

of a list from the State Surgeon General of the commission's

658

ranking by order of priority from the proposal having the highest

659

priority through the proposal having the lowest priority,

660

including the recommended dollar amount and duration for each

661

proposal. Unless the commission recommends funding for an entity

662

that is ineligible to receive funding under the program, the

663

State Surgeon General may not reject or modify the commission's

664

recommendations. Successful grant and fellowship applications

665

shall be awarded by the State Surgeon General based upon the

666

recommendations of the commission and the final funding decision

667

made by the Legislature.

668

(d) Beginning in the 2009-2010 fiscal year and each fiscal

669

year thereafter, the commission's overall rank for grant or

670

fellowship applications shall be based on the score awarded to

671

the proposal by peer reviewers on the basis of scientific merit

672

through an open competitive peer review process that ensures

673

objectivity, consistency, and high quality, and the commission's

674

determination of the following:

675

1. The projected impact that the proposed research will

676

have on cancer research at the time the grant is awarded;

677

2. The likelihood or possibility that the proposed research

678

will result in new treatment modalities or technology during the

679

term of the grant; and

680

3. Whether the research proposed offers an efficient use of

681

state funds in order to prevent or cure cancer.

682

(e) The following types of applications shall be considered

683

for funding:

684

1. Investigator-initiated research grants.

685

2. Institutional research grants.

686

3. Collaborative research grants, including those that

687

advance the finding of cures through basic or applied research.

688

(f) Beginning in the 2009-2010 fiscal year and each fiscal

689

year thereafter, state funds may not be provided for research

690

that was not applied for, reviewed, and recommended in accordance

691

with this section.

692

(g)(b) In order to ensure that all proposals for research

693

funding are appropriate and are evaluated fairly on the basis of

694

scientific merit, the State Surgeon General, in consultation with

695

the commission council, shall appoint a peer review panel of

696

independent, scientifically qualified individuals to review the

697

scientific content of each proposal and establish its priority

698

score. The priority scores shall be forwarded to the commission

699

and its committees council and must be considered in determining

700

which proposals shall be recommended for funding.

701

(h)(c) The commission, the committees, council and the peer

702

review panel shall establish and follow rigorous guidelines for

703

ethical conduct and adhere to a strict policy with regard to

704

conflicts of interest. A member of the commission, a committee,

705

council or panel may not participate in any discussion or

706

decision with respect to a research proposal by any firm, entity,

707

or agency with which the member is associated as a member of the

708

governing body or as an employee or with which the member has

709

entered into a contractual arrangement. Meetings of the

710

commission, the committees, council and the peer review panels

711

are subject to chapter 119, s. 286.011, and s. 24, Art. I of the

712

State Constitution.

713

(5) Beginning in fiscal year 2006-2007, the sum of $9

714

million is appropriated annually from recurring funds in the

715

General Revenue Fund to the Biomedical Research Trust Fund within

716

the Department of Health for purposes of the William G. "Bill"

717

Bankhead, Jr., and David Coley Cancer Research Program and shall

718

be distributed pursuant to this section to provide grants to

719

researchers seeking cures for cancer, with emphasis given to the

720

goals enumerated in s. 381.921. From the total funds

721

appropriated, an amount of up to 10 percent may be used for

722

administrative expenses.

723

(6) By June 1, 2009, the Division of Statutory Revision of

724

the Office of Legislative Services shall certify to the President

725

of the Senate and the Speaker of the House of Representatives the

726

language and statutory citation of this section, which is

727

scheduled to expire January 1, 2011.

728

(7) The Legislature shall review the performance, the

729

outcomes, and the financial management of the William G. "Bill"

730

Bankhead, Jr., and David Coley Cancer Research Program during the

731

2010 Regular Session of the Legislature and shall determine the

732

most appropriate funding source and means of funding the program

733

based on its review.

734

(6)(8) This section expires June 30, 2011 January 1, 2011,

735

unless reviewed and reenacted by the Legislature before that

736

date.

737

Section 11. Section 381.98, Florida Statutes, is repealed.

738

Section 12. Section 381.981, Florida Statutes, is repealed.

739

Section 13. Subsection (3) of section 430.502, Florida

740

Statutes, is amended to read:

741

430.502 Alzheimer's disease; memory disorder clinics and

742

day care and respite care programs.--

743

(3) The Department of Elderly Affairs The Alzheimer's

744

Disease Advisory Committee must evaluate the need for additional

745

memory disorder clinics in the state. The first report will be

746

due by December 31, 1995.

747

Section 14. Subsection (2) of section 430.503, Florida

748

Statutes, is amended to read:

749

430.503 Alzheimer's Disease Initiative; fees and

750

administrative expense.--

751

(2) Provider agencies are responsible for the collection of

752

fees for services in accordance with rules adopted by the

753

department. Provider agencies shall assess fees for services

754

rendered in accordance with those rules. To help pay for services

755

received pursuant to the Alzheimer's Disease Initiative, a

756

functionally impaired elderly person shall be assessed a fee

757

based on an overall ability to pay. The fee to be assessed shall

758

be fixed according to a schedule to be established by the

759

department. Services of specified value may be accepted in lieu

760

of a fee. The fee schedule shall be developed in cooperation with

761

the Alzheimer's Disease Advisory Committee, area agencies on

762

aging, and service providers.

763

Section 15. Section 430.504, Florida Statutes, is amended

764

to read:

765

430.504 Confidentiality of information.--Information about

766

clients of programs created or funded under s. 430.501 or s.

767

430.503 which is received through files, reports, inspections, or

768

otherwise, by the department or by authorized departmental

769

employees, by persons who volunteer services, or by persons who

770

provide services to clients of programs created or funded under

771

s. 430.501 or s. 430.503 through contracts with the department is

772

confidential and exempt from the provisions of s. 119.07(1). Such

773

information may not be disclosed publicly in such a manner as to

774

identify a person who receives services under s. 430.501 or s.

775

430.503, unless that person or that person's legal guardian

776

provides written consent.

777

Section 16. 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

780

alternatives.--

781

(1) DEFINITION.--As used in this section, the term

782

"medically viable," as applied to treatment alternatives, means

783

modes of treatment generally considered by the medical profession

784

to be within the scope of current, acceptable standards,

785

including treatment alternatives described in the written summary

786

prepared by the Florida Cancer Control and Research Advisory

787

Council in accordance with s. 1004.435(4)(m).

788

(2) COMMUNICATION OF TREATMENT ALTERNATIVES.--Each

789

physician treating a patient who is, or in the judgment of the

790

physician is at high risk of being, diagnosed as having breast

791

cancer shall inform such patient of the medically viable

792

treatment alternatives available to such patient; shall describe

793

such treatment alternatives; and shall explain the relative

794

advantages, disadvantages, and risks associated with the

795

treatment alternatives to the extent deemed necessary to allow

796

the patient to make a prudent decision regarding such treatment

797

options. In compliance with this subsection:

798

(a) The physician may, in his or her discretion:

799

1. Orally communicate such information directly to the

800

patient or the patient's legal representative;

801

2. Provide the patient or the patient's legal

802

representative with a copy of the written summary prepared in

803

accordance with s. 1004.435(4)(m) and express a willingness to

804

discuss the summary with the patient or the patient's legal

805

representative; or

806

3. Both communicate such information directly and provide a

807

copy of the written summary to the patient or the patient's legal

808

representative for further consideration and possible later

809

discussion.

810

811

Nothing in this subsection shall reduce other provisions of law

812

regarding informed consent.

813

Section 17. 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

816

alternatives.--

817

(1) DEFINITION.--As used in this section, the term

818

"medically viable," as applied to treatment alternatives, means

819

modes of treatment generally considered by the medical profession

820

to be within the scope of current, acceptable standards,

821

including treatment alternatives described in the written summary

822

prepared by the Florida Cancer Control and Research Advisory

823

Council in accordance with s. 1004.435(4)(m).

824

(2) COMMUNICATION OF TREATMENT ALTERNATIVES.--It is the

825

obligation of every physician treating a patient who is, or in

826

the judgment of the physician is at high risk of being, diagnosed

827

as having breast cancer to inform such patient of the medically

828

viable treatment alternatives available to such patient; to

829

describe such treatment alternatives; and to explain the relative

830

advantages, disadvantages, and risks associated with the

831

treatment alternatives to the extent deemed necessary to allow

832

the patient to make a prudent decision regarding such treatment

833

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

836

patient or the patient's legal representative;

837

2. Provide the patient or the patient's legal

838

representative with a copy of the written summary prepared in

839

accordance with s. 1004.435(4)(m) and express her or his

840

willingness to discuss the summary with the patient or the

841

patient's legal representative; or

842

3. Both communicate such information directly and provide a

843

copy of the written summary to the patient or the patient's legal

844

representative for further consideration and possible later

845

discussion.

846

847

Nothing in this subsection shall reduce other provisions of law

848

regarding informed consent.

849

Section 18. Subsections (7), (8), and (12) of section

850

1004.445, Florida Statutes, are amended to read:

851

1004.445 Johnnie B. Byrd, Sr., Alzheimer's Center and

852

Research Institute.--

853

(7) The board of directors of the not-for-profit

854

corporation shall create a council of scientific advisers to the

855

chief executive officer comprised of leading researchers,

856

physicians, and scientists. The council shall review programs and

857

recommend research priorities and initiatives to maximize the

858

state's investment in the institute. The members of the council

859

shall be appointed by the board of directors of the not-for-

860

profit corporation. Each member of the council shall be appointed

861

to serve a 2-year term and may be reappointed to the council.

862

This subsection expires June 30, 2009.

863

(8)(a) Applications for Alzheimer's disease research

864

funding may be submitted from any university or established

865

research institute in the state. All qualified investigators in

866

the state, regardless of institutional affiliation, shall have

867

equal access and opportunity to compete for the research funding.

868

Grants shall be awarded by the board of directors of the not-for-

869

profit corporation on the basis of scientific merit, as

870

determined by an open, competitive peer review process that

871

ensures objectivity, consistency, and high quality. The following

872

types of applications shall be considered for funding:

873

1. Investigator-initiated research grants.

874

2. Institutional research grants.

875

3. Collaborative research grants, including those that

876

advance the finding of cures through basic or applied research.

877

(b) Preference may be given to grant proposals that foster

878

collaboration among institutions, researchers, and community

879

practitioners because these proposals support the advancement of

880

cures through basic or applied research, including clinical

881

trials involving Alzheimer's patients and related networks.

882

883

appropriate and are evaluated fairly on the basis of scientific

884

merit, the board of directors of the not-for-profit corporation,

885

in consultation with the council of scientific advisors, shall

886

appoint a peer review panel of independent, scientifically

887

qualified individuals to review the scientific content of each

888

proposal and establish its scientific priority score. The

889

priority scores shall be forwarded to the council and must be

890

considered by the board of directors of the not-for-profit

891

corporation in determining which proposals shall be recommended

892

for funding.

893

(d) The council of scientific advisors and the peer review

894

panel shall establish and follow rigorous guidelines for ethical

895

conduct and adhere to a strict policy with regard to conflict of

896

interest. All employees, members of the board of directors, and

897

affiliates of the not-for-profit corporation shall follow the

898

same rigorous guidelines for ethical conduct and shall adhere to

899

the same strict policy with regard to conflict of interest. A

900

member of the council or panel may not participate in any

901

discussion or decision with respect to a research proposal by any

902

firm, entity, or agency with which the member is associated as a

903

member of the governing body or as an employee or with which the

904

member has entered into a contractual arrangement. Meetings of

905

the council and the peer review panels are subject to chapter

906

119, s. 286.011, and s. 24, Art. I of the State Constitution.

907

(e) This subsection expires June 30, 2009.

908

(12)(a) For the 2008-2009 fiscal year, Beginning in fiscal

909

year 2007-2008, the sum of $7 million $13.5 million is

910

appropriated annually from recurring funds in the General Revenue

911

Fund to the Grants and Donations Trust Fund within the Department

912

of Elderly Affairs for the Johnnie B. Byrd, Sr., Alzheimer's

913

Center and Research Institute at the University of South Florida

914

for the purposes as provided under paragraph (6)(a), conducting

915

and supporting research, providing institutional research grants

916

and investigator-initiated research grants, developing and

917

operating integrated data projects, and providing assistance to

918

statutorily designated memory disorder clinics as provided under

919

s. 430.502. Not less than 80 percent of the appropriated funds

920

shall be expended for these purposes, and not less than 20

921

percent of the appropriated funds shall be expended for peer-

922

reviewed investigator-initiated research grants. This paragraph

923

expires June 30, 2009.

924

(b) Beginning July 1, 2009, and each year thereafter, the

925

sum of $5 million is appropriated annually from recurring funds

926

in the General Revenue Fund to the Grants and Donations Trust

927

Fund within the Department of Elderly Affairs for the Johnnie B.

928

Byrd, Sr., Alzheimer's Center and Research Institute at the

929

University of South Florida for the purposes of providing

930

assistance to statutorily designated memory disorder clinics as

931

provided under s. 430.502 and for the education, treatment,

932

prevention, and early detection of Alzheimer's disease. In order

933

to receive state funds for research, the Johnnie B. Byrd, Sr.,

934

Alzheimer's Center and Research Institute shall apply for funding

935

through the James and Esther King Biomedical Research Program

936

pursuant to s. 215.5602.

937

Section 19. If any provision of this act or the application

938

thereof to any person or circumstance is held invalid, the

939

invalidity does not affect other provisions or applications of

940

the act which can be given effect without the invalid provision

941

or application, and to this end the provisions of this act are

942

severable.

943

Section 20. This act shall take effect July 1, 2008.

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