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Senate Bill 2496

Senate Bill sb2496

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

28  

29         Section 1.  Section 381.99, Florida Statutes, is

30  created to read:

31  

                                  1

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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:

31  

                                  2

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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

                                  3

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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

                                  4

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    Florida Senate - 2007                                  SB 2496
    26-1672A-07                                             See HB




 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.

31  

                                  5

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    Florida Senate - 2007                                  SB 2496
    26-1672A-07                                             See HB




 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

                                  6

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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.

31  

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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;

                                  8

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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.

31  

                                  9

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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
    26-1672A-07                                             See HB




 1         Section 4.  This act shall take effect July 1, 2007.

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