Senate Bill sb2496
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Florida Senate - 2007 SB 2496
By Senator Haridopolos
26-1672A-07 See HB
1 A bill to be entitled
2 An act relating to stem cell research; creating
3 s. 381.99, F.S.; providing a short title;
4 providing definitions; creating the Stem Cell
5 Research Advisory Council and Biomedical Ethics
6 Advisory Council within the Department of
7 Health; providing for membership and terms;
8 providing duties and responsibilities;
9 requiring the Secretary of Health to make
10 grants-in-aid from the Biomedical Research
11 Trust Fund for stem cell research; providing
12 requirements relating to applications for and
13 awards of such grants-in-aid; providing
14 specifications for moneys to be made available
15 from the trust fund for stem cell research
16 grants-in-aid; providing restrictions and
17 requirements for uses of funds from such
18 grants-in-aid; providing prohibitions relating
19 to human cloning; providing for penalties;
20 providing an appropriation; amending s. 20.435,
21 F.S.; revising references; amending s. 381.86,
22 F.S.; providing an exception to the
23 Institutional Review Board for the Stem Cell
24 Research Advisory Council and Biomedical Ethics
25 Advisory Council; providing an effective date.
26
27 Be It Enacted by the Legislature of the State of Florida:
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29 Section 1. Section 381.99, Florida Statutes, is
30 created to read:
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Florida Senate - 2007 SB 2496
26-1672A-07 See HB
1 381.99 Florida Hope Offered through Principled,
2 Ethically Sound Stem Cell Research Act.--
3 (1) SHORT TITLE.--This section may be cited as the
4 "Florida Hope Offered through Principled, Ethically Sound Stem
5 Cell Research Act."
6 (2) DEFINITIONS.--As used in this section, the term:
7 (a) "Adult stem cell" means a cell found within
8 differentiated tissue or an organ that can renew itself and
9 give rise to the major cell types of the tissue or organ. This
10 includes cells from the fetal to adult stages of development.
11 (b) "Amniotic stem cell" means a cell extracted from
12 human amniotic fluid or a placenta.
13 (c) "Embryonic stem cell" means a cell obtained from
14 the undifferentiated inner mass of an early stage embryo.
15 (d) "Human cloning" means human asexual reproduction,
16 accomplished by introducing nuclear material from one or more
17 human somatic cells into a fertilized or unfertilized oocyte
18 the nuclear material of which has been removed or inactivated
19 so as to produce a living organism at any stage of development
20 that is genetically virtually identical to an existing or
21 previously existing human organism.
22 (e) "Stem cell" means a cell that retains the
23 potential to generate some or all other cell types.
24 (3) STEM CELL RESEARCH ADVISORY COUNCIL.--There is
25 created the Stem Cell Research Advisory Council within the
26 Department of Health.
27 (a)1. The advisory council shall consist of the
28 Secretary of Health or his or her designee, who shall act as
29 chair, and six additional members, who shall be appointed as
30 follows:
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Florida Senate - 2007 SB 2496
26-1672A-07 See HB
1 a. Two persons appointed by the Governor, one of whom
2 shall be an academic researcher in the field of stem cell
3 research and one of whom shall have a background in bioethics.
4 b. One person appointed by the President of the
5 Senate, who shall have a background in private-sector stem
6 cell funding and development or public-sector biomedical
7 research and funding.
8 c. One person appointed by the Speaker of the House of
9 Representatives, who shall have a background in private-sector
10 stem cell funding and development or public-sector biomedical
11 research and funding.
12 d. One person appointed by the President of the
13 Senate, who shall have a background and experience in either
14 public-sector or private-sector stem cell research and
15 development.
16 e. One person appointed by the Speaker of the House of
17 Representatives, who shall be an executive of a biotech
18 company, or his or her designee.
19 2. Each member shall serve a term of 2 years
20 commencing on October 1, 2007. No member shall serve for more
21 than two consecutive 2-year terms; however, for the purpose of
22 providing staggered terms, of the initial appointments, three
23 members shall be appointed to a 1-year term and three members
24 shall be appointed to a 2-year term. Any vacancy on the
25 advisory council shall be filled in the same manner as the
26 original appointment. All initial appointments shall be made
27 by October 1, 2007. The first meeting shall take place no
28 later than November 1, 2007. All meetings are subject to the
29 call of the chair. Members shall meet at least twice a year or
30 as often as necessary to discharge their duties but shall have
31 no more than four meetings during any 12-month period. Members
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Florida Senate - 2007 SB 2496
26-1672A-07 See HB
1 shall serve without compensation but may be reimbursed for per
2 diem and travel expenses in accordance with s. 112.061.
3 (b) The advisory council shall:
4 1. Develop a donated funds program for recommendation
5 to the Secretary of Health to encourage the development of
6 funds other than state appropriations for human adult stem
7 cell research in the state.
8 2. Examine and identify specific ways to improve and
9 promote for-profit and not-for-profit human adult stem cell
10 and related research in the state, including, but not limited
11 to, identifying both public and private funding sources for
12 such research, maintaining existing human adult stem
13 cell-related businesses, recruiting new human adult stem
14 cell-related businesses to the state, and recruiting
15 scientists and researchers in such fields to the state and
16 state universities.
17 3. Develop a biomedical research grant program for
18 recommendation to the Secretary of Health that shall provide
19 grants-in-aid to eligible state institutions for the
20 advancement of human adult stem cell research.
21 4. Develop, no later than December 1, 2007, an
22 application for grants-in-aid under this section for
23 recommendation to the Secretary of Health for the purpose of
24 conducting human adult stem cell research.
25 5. Review applications from eligible institutions for
26 grants-in-aid on and after December 1, 2007, and provide to
27 the Secretary of Health recommendations for grant awards.
28 6. Review the stem cell research conducted by eligible
29 institutions that receive such grants-in-aid.
30 (c) The advisory council shall submit an annual
31 progress report on the status of biomedical research in the
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Florida Senate - 2007 SB 2496
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1 state to the Florida Center for Universal Research to
2 Eradicate Disease and to the Governor, the Secretary of
3 Health, the President of the Senate, and the Speaker of the
4 House of Representatives by June 30. The report must include:
5 1. The amount of grants-in-aid awarded to eligible
6 institutions from the Biomedical Research Trust Fund.
7 2. The names of the recipients of such grants-in-aid.
8 3. The current status and progress of stem cell
9 research in the state.
10 4. A list of research projects supported by
11 grants-in-aid awarded under the program.
12 5. A list of publications in peer-reviewed journals
13 involving research supported by grants-in-aid awarded under
14 the program.
15 6. The total amount of biomedical research funding
16 currently flowing into the state.
17 7. New grants for biomedical research that were funded
18 based on research supported by grants-in-aid awarded under the
19 program.
20 8. All other materials the advisory council deems
21 advisable to include.
22 (d) Advisory council members shall disclose any
23 conflict of interest or potential conflict of interest to the
24 Secretary of Health.
25 (e) The Department of Health shall provide
26 administrative staff to assist the advisory council in
27 developing the application for the grants-in-aid, reviewing
28 the applications, preparing the written consent form described
29 in paragraph (6)(b), and performing other administrative
30 functions as the advisory council requires.
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Florida Senate - 2007 SB 2496
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1 (4) BIOMEDICAL ETHICS ADVISORY COUNCIL.--There is
2 created within the Department of Health the Biomedical Ethics
3 Advisory Council.
4 (a)1. The advisory council shall consist of the
5 Secretary of Health or his or her designee, who shall act as
6 chair, and six additional members, who shall be appointed as
7 follows:
8 a. Two persons appointed by the Governor.
9 b. One person appointed by the President of the
10 Senate.
11 c. One person appointed by the Speaker of the House of
12 Representatives.
13 d. One person appointed by the Minority Leader of the
14 Senate.
15 e. One person appointed by the Minority Leader of the
16 House of Representatives.
17 2. All members must demonstrate knowledge and
18 understanding of the ethical, medical, and scientific
19 implications of stem cell research and should also demonstrate
20 knowledge of related fields, including, but not limited to,
21 genetics, cellular biology, and embryology. Each member shall
22 serve a term of 4 years commencing on October 1, 2007;
23 however, for the purpose of providing staggered terms, of the
24 initial appointments, three members shall be appointed to a
25 2-year term and three members shall be appointed to a 4-year
26 term. No member shall serve for more than two consecutive
27 terms. Any vacancy on the advisory council shall be filled in
28 the same manner as the original appointment. All initial
29 appointments shall be made by October 1, 2007. The first
30 meeting shall take place no later than November 1, 2007. All
31 meetings are subject to the call of the chair. Members shall
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Florida Senate - 2007 SB 2496
26-1672A-07 See HB
1 meet at least twice a year or as often as necessary to
2 discharge their duties but shall have no more than one meeting
3 per month during any 12-month period. Members shall serve
4 without compensation but may be reimbursed for per diem and
5 travel expenses in accordance with s. 112.061.
6 (b) The advisory council shall review all stem cell
7 research that is funded or supported in any manner through the
8 Biomedical Research Trust Fund to ensure the adherence to
9 ethical and safety guidelines and procedures as set forth by
10 federal ethical standards established by the United States
11 Department of Health and Human Services.
12 (5) BIOMEDICAL RESEARCH TRUST FUND AND
13 GRANTS-IN-AID.--
14 (a) The Secretary of Health shall make grants-in-aid
15 from the Biomedical Research Trust Fund in accordance with the
16 provisions of this section.
17 (b) The Department of Health shall require any
18 applicant for a grant-in-aid under this section, for the
19 purpose of conducting stem cell research, to submit a complete
20 description of the applicant's organization, the applicant's
21 plans for stem cell research, the applicant's proposed funding
22 for such research from sources other than the state, and the
23 applicant's proposed arrangements concerning financial
24 benefits to the state as a result of any patent, royalty
25 payment, or similar right resulting from any stem cell
26 research made possible by the awarding of the grant-in-aid.
27 The Stem Cell Research Advisory Council shall provide
28 recommendations to the Secretary of Health with respect to
29 awarding such grants-in-aid after considering the
30 recommendations of the Biomedical Ethics Advisory Council.
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Florida Senate - 2007 SB 2496
26-1672A-07 See HB
1 (c) Beginning with the 2007-2008 fiscal year, and for
2 10 consecutive years thereafter, not less than $20 million
3 shall be made available annually from the Biomedical Research
4 Trust Fund within the Department of Health for grants-in-aid
5 to eligible institutions for the purpose of conducting adult
6 stem cell research pursuant to this section. Up to 15 percent
7 of the funds may be used for administrative costs. Any
8 unexpended funds not used for grants-in-aid during the current
9 fiscal year shall be carried forward for the following fiscal
10 year to fund the grants-in-aid.
11 (6) USE OF FUNDS; REQUIREMENTS AND RESTRICTIONS.--
12 (a) Funds provided under this section may only be used
13 for research involving:
14 1. Human adult stem cells, including, but not limited
15 to, adult stem cells derived from umbilical cord blood and
16 bone marrow. Funding for research may be given for human adult
17 stem cells derived from postmortem tissues, other than from
18 medically induced abortions. Funds may be used for studies of
19 human adult stem cells obtained from either normal or
20 transformed tissues.
21 2. Amniotic stem cells extracted from human amniotic
22 fluid or placentas that are otherwise discarded after birth.
23 (b) Amniotic and adult stem cell material may only be
24 donated for research purposes with the informed consent of the
25 donor.
26 (c) No funds shall be used for research with human
27 embryonic stem cells that are derived by a process entailing
28 the donor embryo's death or destruction.
29 (7) HUMAN CLONING; PROHIBITION; PENALTIES.--
30 (a) It is unlawful for any person to knowingly:
31 1. Perform or attempt to perform human cloning;
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Florida Senate - 2007 SB 2496
26-1672A-07 See HB
1 2. Participate or assist in an attempt to perform
2 human cloning; or
3 3. Ship or receive for any purpose an embryo produced
4 by human reproductive cloning or any product derived from such
5 embryo.
6 (b) A person who violates paragraph (a) commits a
7 felony of the second degree, punishable as provided in s.
8 775.082, s. 775.083, or s. 775.084.
9 (8) CONTINUING APPROPRIATION.--Beginning in fiscal
10 year 2007-2008, the sum of $20 million is appropriated
11 annually from recurring funds in the General Revenue Fund to
12 the Biomedical Research Trust Fund within the Department of
13 Health for the purpose of carrying out the provisions of this
14 section. The amount of funds appropriated shall not exceed
15 $200 million for the 10-year period beginning in fiscal year
16 2007-2008 and ending in fiscal year 2016-2017.
17 Section 2. Paragraph (h) of subsection (1) of section
18 20.435, Florida Statutes, is amended to read:
19 20.435 Department of Health; trust funds.--
20 (1) The following trust funds are hereby created, to
21 be administered by the Department of Health:
22 (h) Biomedical Research Trust Fund.
23 1. Funds to be credited to the trust fund shall
24 consist of funds deposited pursuant to ss. s. 215.5601,
25 288.955, and 381.99 and any other funds appropriated by the
26 Legislature. Funds shall be used for the purposes of the James
27 and Esther King Biomedical Research Program, and the William
28 G. "Bill" Bankhead, Jr., and David Coley Cancer Research
29 Program, and the Florida Hope Offered through Principled,
30 Ethically Sound Stem Cell Research Act as specified in ss.
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Florida Senate - 2007 SB 2496
26-1672A-07 See HB
1 215.5602, 288.955, and 381.922, and 381.99. The trust fund is
2 exempt from the service charges imposed by s. 215.20.
3 2. Notwithstanding the provisions of s. 216.301 and
4 pursuant to s. 216.351, any balance in the trust fund at the
5 end of any fiscal year shall remain in the trust fund at the
6 end of the year and shall be available for carrying out the
7 purposes of the trust fund. The department may invest these
8 funds independently through the Chief Financial Officer or may
9 negotiate a trust agreement with the State Board of
10 Administration for the investment management of any balance in
11 the trust fund.
12 3. Notwithstanding s. 216.301 and pursuant to s.
13 216.351, any balance of any appropriation from the Biomedical
14 Research Trust Fund which is not disbursed but which is
15 obligated pursuant to contract or committed to be expended may
16 be carried forward for up to 3 years following the effective
17 date of the original appropriation.
18 4. The trust fund shall, unless terminated sooner, be
19 terminated on July 1, 2008.
20 Section 3. Subsection (1) of section 381.86, Florida
21 Statutes, is amended to read:
22 381.86 Institutional Review Board.--
23 (1) The Institutional Review Board is created within
24 the Department of Health in order to satisfy federal
25 requirements under 45 C.F.R. part 46 and 21 C.F.R. parts 50
26 and 56 that an institutional review board review all
27 biomedical and behavioral research on human subjects which is
28 funded or supported in any manner by the department, except
29 that a separate Stem Cell Research Advisory Council and
30 Biomedical Ethics Advisory Council shall be appointed under s.
31 381.99.
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Florida Senate - 2007 SB 2496
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1 Section 4. This act shall take effect July 1, 2007.
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