Senate Bill sb0468
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2006 SB 468
By Senators Klein and Smith
30-339A-06
1 A bill to be entitled
2 An act relating to biomedical research;
3 amending s. 20.435, F.S.; revising uses for
4 funds credited to the Biomedical Research Trust
5 Fund; amending s. 381.86, F.S.; providing that
6 the Institutional Review Board within the
7 Department of Health may not review certain
8 research within the jurisdiction of the
9 Biomedical Research and Ethics Oversight
10 Council; creating s. 381.99, F.S., the Florida
11 Better Quality of Life and Biomedical Research
12 Act; providing definitions; providing
13 legislative findings; creating the Biomedical
14 Research Advisory Council; providing for
15 criteria, appointment, and terms of members;
16 authorizing reimbursement for per diem and
17 travel expenses; providing duties of the
18 advisory council, including a report to the
19 Governor, the President of the Senate, and the
20 Speaker of the House of Representatives;
21 requiring the Department of Health to provide
22 administrative support; creating the Biomedical
23 Research and Ethics Oversight Council to
24 regulate research procedures and enforce
25 ethical guidelines; providing for criteria,
26 appointment, and terms of members; authorizing
27 reimbursement for per diem and travel expenses;
28 providing duties of the oversight council;
29 providing for a grants-in-aid program for the
30 purpose of conducting embryonic or human adult
31 stem cell research; providing that
1
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2006 SB 468
30-339A-06
1 grants-in-aid shall be provided through funds
2 in the Biomedical Research Trust Fund;
3 restricting the use of such funds for research
4 on certain stem cells; providing requirements
5 with respect to the disposition of human
6 embryos following infertility treatment;
7 requiring the Department of Health to develop
8 and maintain on its Internet website a consent
9 form for the donation of certain embryos;
10 prohibiting the purchase or sale of embryonic
11 fetal tissue for research purposes; prohibiting
12 certain acts relating to human reproductive
13 cloning; providing penalties; providing an
14 effective date.
15
16 Be It Enacted by the Legislature of the State of Florida:
17
18 Section 1. Paragraph (h) of subsection (1) of section
19 20.435, Florida Statutes, is amended to read:
20 20.435 Department of Health; trust funds.--
21 (1) The following trust funds are hereby created, to
22 be administered by the Department of Health:
23 (h) Biomedical Research Trust Fund.
24 1. Funds to be credited to the trust fund shall
25 consist of funds deposited pursuant to ss. s. 215.5601,
26 288.955, and 381.99. Funds shall be used for the purposes of
27 the James and Esther King Biomedical Research Program as
28 specified in ss. 215.5602 and 288.955 and the purposes of the
29 Florida Better Quality of Life and Biomedical Research Act as
30 specified in s. 381.99. The trust fund is exempt from the
31 service charges imposed by s. 215.20.
2
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2006 SB 468
30-339A-06
1 2. Notwithstanding the provisions of s. 216.301 and
2 pursuant to s. 216.351, any balance in the trust fund at the
3 end of any fiscal year shall remain in the trust fund at the
4 end of the year and shall be available for carrying out the
5 purposes of the trust fund. The department may invest these
6 funds independently through the Chief Financial Officer or may
7 negotiate a trust agreement with the State Board of
8 Administration for the investment management of any balance in
9 the trust fund.
10 3. Notwithstanding s. 216.301 and pursuant to s.
11 216.351, any balance of any appropriation from the Biomedical
12 Research Trust Fund which is not disbursed but which is
13 obligated pursuant to contract or committed to be expended may
14 be certified by the Governor for up to 3 years following the
15 effective date of the original appropriation.
16 4. The trust fund shall, unless terminated sooner, be
17 terminated on July 1, 2008.
18 Section 2. Subsection (1) of section 381.86, Florida
19 Statutes, is amended to read:
20 381.86 Institutional Review Board.--
21 (1) The Institutional Review Board is created within
22 the Department of Health in order to satisfy federal
23 requirements under 45 C.F.R. part 46 and 21 C.F.R. parts 50
24 and 56 that an institutional review board review all
25 biomedical and behavioral research on human subjects which is
26 funded or supported in any manner by the department except for
27 research within the jurisdiction of the Biomedical Research
28 and Ethics Oversight Council, which shall be reviewed pursuant
29 to the provisions of s. 381.99.
30 Section 3. Section 381.99, Florida Statutes, is
31 created to read:
3
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2006 SB 468
30-339A-06
1 381.99 Florida Better Quality of Life and Biomedical
2 Research Act.--
3 (1) SHORT TITLE.--This section may be cited as the
4 "Florida Better Quality of Life and Biomedical Research Act."
5 (2) DEFINITIONS.--As used in this section, the term:
6 (a) "Adult stem cell" means an undifferentiated cell
7 found among differentiated cells in a tissue or an organ that
8 can renew itself and can differentiate to yield the major
9 specialized cell types of the tissue or organ.
10 (b) "Asexual reproduction" means reproduction not
11 initiated by the union of oocyte and sperm.
12 (c) "Embryonic stem cells" means cells obtained from
13 the undifferentiated inner mass of an early stage embryo.
14 (d) "Human reproductive cloning" means the practice of
15 creating or attempting to create a human being by transferring
16 the nucleus from a human cell into an egg cell from which the
17 nucleus has been removed for the purpose of implanting the
18 resulting product in a uterus or substitute for a uterus to
19 initiate a pregnancy.
20 (e) "In vitro fertilization" means a technique in
21 which oocytes are fertilized by sperm outside of a woman's
22 body resulting in organisms that are not genetically identical
23 to any one existing human.
24 (f) "Oocyte" means an immature egg cell of the human
25 ovary.
26 (g) "Stem cells" means undifferentiated cells which
27 retain the potential to differentiate into some or all other
28 cell types.
29 (3) LEGISLATIVE FINDINGS.--The Legislature finds that:
30 (a) An estimated 130 million Americans suffer from
31 acute, chronic, and degenerative diseases and that there is
4
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2006 SB 468
30-339A-06
1 enormous potential for lifesaving treatment and therapy as a
2 result of recent advances in biomedical research.
3 (b) Florida is unique among all states for its large
4 projected net population increase within the next 20 years.
5 This increase, in turn, raises significant health care
6 concerns as a new, larger generation of retirees moves to this
7 state, resulting in a corresponding rise in the number of
8 persons suffering from illnesses such as cancer, heart
9 disease, Alzheimer's Disease, Parkinson's Disease, cerebral
10 palsy, atherosclerosis, amyotrophic lateral sclerosis, AIDS,
11 spinal cord injuries, severe burns, osteoporosis,
12 osteoarthritis, cystic fibrosis, muscular dystrophy, multiple
13 sclerosis, macular degeneration, diabetic retinopathy,
14 retinitis pigmentosa, cirrhosis of the liver, motor neuron
15 disease, brain trauma, stroke, sickle cell anemia, and
16 intestinal diseases. Juvenile diabetes is becoming more
17 prevalent in children in this state.
18 (c) In order to maintain a high quality of life for
19 all Floridians, research into stem cell regenerative therapies
20 and treatment, among other therapies and treatments, should be
21 supported to give hope and relief to the millions of residents
22 who suffer in silence from degenerative and crippling
23 diseases.
24 (d) To reduce the burden on the health care
25 infrastructure, the state must shift its health care
26 objectives from costly long-term maintenance toward prevention
27 and cures.
28 (e) To bolster and advance Florida's burgeoning
29 biotechnology industry, the state should continue to provide
30 funds and incentives for private research companies to work in
31 the state.
5
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2006 SB 468
30-339A-06
1 (f) The state should advance the goal of scientific
2 and academic discourse in our colleges, universities, and
3 private research institutions and should continue to help
4 bring these institutions to the forefront in biomedical
5 research and technology.
6 (g) It will benefit the economy of the state to create
7 a wide array of new projects and high-paying jobs relating to
8 biomedical research.
9 (h) It will benefit the state to foster cooperation
10 between the state's colleges, universities, and private-sector
11 research in terms of jobs, resources, and academic discourse
12 relating to biomedical research.
13 (i) The public funds provided under this section are
14 intended to spur innovation and development in the state's
15 biomedical technology sector, which will be used to treat
16 debilitating chronic diseases.
17 (4) BIOMEDICAL RESEARCH ADVISORY COUNCIL.--There shall
18 be established a Biomedical Research Advisory Council.
19 (a) The advisory council shall consist of the
20 Secretary of Health, who shall act as chair, and six
21 additional members, who shall be appointed as follows:
22 1. Two persons appointed by the Governor, one of whom
23 shall be an academic researcher in the field of stem cell
24 research and one of whom shall have a background in bioethics.
25 2. One person appointed by the President of the
26 Senate, who shall have a background in private sector stem
27 cell funding and development and public sector biomedical
28 research and funding.
29 3. One person appointed by the Speaker of the House of
30 Representatives, who shall have a background in private-sector
31
6
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2006 SB 468
30-339A-06
1 stem cell funding and development and public-sector biomedical
2 research and funding.
3 4. One person appointed by the Minority Leader of the
4 Senate, who shall have a background and experience in
5 public-sector or private-sector stem cell research and
6 development.
7 5. One person appointed by the Minority Leader of the
8 House of Representatives, who shall have a background and
9 experience in business and financial investments.
10
11 Members shall be appointed to terms of 2 years each commencing
12 on October 1, 2006. A member may not serve for more than two
13 consecutive 2-year terms. All initial appointments must be
14 made by October 1, 2006. The first meeting shall take place no
15 later than November 1, 2006. Members shall meet at least twice
16 annually, but no more than four times annually. Members shall
17 serve without compensation but are entitled to reimbursement
18 for per diem and travel expenses in accordance with s.
19 112.061.
20 (b) The members of the advisory council shall work to
21 provide an environment fostering the advancement of embryonic
22 and human adult stem cell research. The advisory council
23 shall:
24 1. Develop a donated-funds program for recommendation
25 to the Secretary of Health, to encourage the development of
26 funds other than state appropriations for embryonic and human
27 adult stem cell research in the state.
28 2. Examine and identify specific ways to improve and
29 promote for-profit and not-for-profit embryonic and human
30 adult stem cell and related research in the state, including,
31 but not limited to, identifying both public and private
7
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2006 SB 468
30-339A-06
1 funding sources for such research, maintaining existing
2 activities related to embryonic and human adult stem cell
3 research, recruiting new activities to the state related to
4 embryonic and human adult stem cell research, and recruiting
5 scientists and researchers in such fields to the state and
6 state universities.
7 3. Develop a biomedical research grant program for
8 recommendation to the Secretary of Health, which shall provide
9 grants-in-aid to eligible institutions for the advancement of
10 embryonic or human adult stem cell research.
11 4. Develop, no later than December 1, 2006, an
12 application for grants-in-aid under this section for
13 recommendation to the Secretary of Health for the purpose of
14 conducting embryonic or human adult stem cell research.
15 5. Receive applications from eligible institutions for
16 grants-in-aid on and after December 1, 2006, and provide to
17 the Secretary of Health recommended grant awards.
18 6. Monitor the stem cell research conducted by
19 eligible institutions that receive such grants-in-aid.
20 (c) The advisory council shall submit an annual
21 progress report on the state of biomedical research in the
22 state to the Florida Center for Universal Research to
23 Eradicate Disease and to the Governor, the Secretary of
24 Health, the President of the Senate, and the Speaker of the
25 House of Representatives by June 30. The report must include:
26 1. The amount of grants-in-aid awarded to eligible
27 institutions from the Biomedical Research Trust Fund.
28 2. The recipients of such grants-in-aid.
29 3. The current status and progress of stem cell
30 research in the state.
31
8
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2006 SB 468
30-339A-06
1 4. A list of research projects supported by
2 grants-in-aid awarded under the program.
3 5. A list of publications in peer-reviewed journals
4 involving research supported by grants-in-aid awarded under
5 the program.
6 6. The total amount of biomedical research funding
7 currently flowing into the state.
8 7. New grants for biomedical research that were funded
9 based on research supported by grants-in-aid awarded under the
10 program.
11 8. All other materials the council deems advisable to
12 include.
13 (d) Advisory council members shall disclose any
14 conflict of interest or potential conflict of interest to the
15 Secretary of Health.
16 (e) The Department of Health shall provide
17 administrative staff to assist the advisory council in
18 developing the application for the grants-in-aid, reviewing
19 such applications, making recommendations to the advisory
20 council, preparing the written consent form described in
21 paragraph (7)(b), and performing other administrative
22 functions as the advisory council requires or as is deemed
23 necessary.
24 (5) BIOMEDICAL RESEARCH AND ETHICS OVERSIGHT
25 COUNCIL.--There shall be established a Biomedical Research and
26 Ethics Oversight Council.
27 (a) The oversight council shall consist of seven
28 members, of which the Secretary of Health shall act as chair.
29 The additional members shall be appointed as follows:
30 1. Two persons appointed by the Governor.
31
9
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2006 SB 468
30-339A-06
1 2. One person appointed by the President of the
2 Senate.
3 3. One person appointed by the Speaker of the House of
4 Representatives.
5 4. One person appointed by the Minority Leader of the
6 Senate.
7 5. One person appointed by the Minority Leader of the
8 House of Representatives.
9
10 All members must demonstrate knowledge and understanding of
11 the ethical, medical, and scientific implications of embryonic
12 and adult stem cell research and should also demonstrate
13 knowledge of related fields, including, but not limited to,
14 genetics, cellular biology, and embryology. At least three
15 members shall have practical research experience in stem cell
16 research or related fields. Members shall be appointed to
17 terms of 4 years each commencing on October 1, 2006. A member
18 may not serve for more than two consecutive 4-year terms. All
19 initial appointments must be made by October 1, 2006. The
20 first meeting shall take place no later than November 1, 2006.
21 Members shall meet at least twice annually, but no more than
22 four times annually. Members shall serve without compensation
23 but are entitled to reimbursement for per diem and travel
24 expenses in accordance with s. 112.061.
25 (b) The oversight council shall review all embryonic
26 or human adult stem cell research that is funded or supported
27 in any manner through the Biomedical Research Trust Fund to
28 ensure the adherence to ethical and safety guidelines and
29 procedures as laid out by federal ethical standards
30 established by the United States Department of Health and
31 Human Services.
10
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2006 SB 468
30-339A-06
1 (6) BIOMEDICAL RESEARCH TRUST FUND AND
2 GRANTS-IN-AID.--
3 (a) The Secretary of Health shall make grants-in-aid
4 from the Biomedical Research Trust Fund in accordance with the
5 provisions of this section.
6 (b) The Department of Health shall require any
7 applicant for a grant-in-aid under this section, for the
8 purpose of conducting stem cell research, to submit a complete
9 description of the applicant's organization, the applicant's
10 plans for stem cell research, the applicant's proposed funding
11 for such research from sources other than the state, and the
12 applicant's proposed arrangements concerning financial
13 benefits to the state as a result of any patent, royalty
14 payment, or similar rights resulting from any stem cell
15 research made possible by the awarding of such grant-in-aid.
16 The Biomedical Research Advisory Council shall provide
17 recommendations to the Secretary of Health with respect to
18 awarding such grants-in-aid after considering recommendations
19 from the Biomedical Research and Ethics Oversight Council.
20 (c) Beginning with the 2006-2007 fiscal year, and for
21 10 consecutive years thereafter, not less than $15 million
22 shall be made available annually from the Biomedical Research
23 Trust Fund for grants-in-aid to eligible institutions for the
24 purpose of conducting embryonic or human adult stem cell
25 research as directed by the Biomedical Research Advisory
26 Council. Any balance of such amount not used for such
27 grants-in-aid during a fiscal year shall be carried forward
28 for the fiscal year next succeeding for such grants-in-aid.
29 (7) FUNDING.--Funds provided under this section may be
30 used only for research involving:
31
11
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2006 SB 468
30-339A-06
1 (a) Human adult stem cells, including, but not limited
2 to, adult stem cells derived from umbilical cord blood and
3 bone marrow.
4 (b) Human embryonic stem cells taken from donated
5 leftover embryos from in vitro fertilization treatments which
6 would otherwise be thrown away or destroyed.
7 1. A physician or other health care provider who is
8 treating a patient for infertility shall provide the patient
9 with timely, relevant, and appropriate information sufficient
10 to allow the person to make an informed and voluntary choice
11 regarding the disposition of any human embryos that remain
12 following infertility treatment.
13 2. A person to whom information is provided pursuant
14 to subparagraph 1. shall be presented with the options of
15 storing any unused embryos, donating them to another person,
16 donating the remaining embryos for research purposes, or
17 selecting other means of disposition.
18 3. A person who elects to donate, for research
19 purposes, any embryos remaining after receiving infertility
20 treatment shall provide written consent for that donation in a
21 consent form provided by the Department of Health and made
22 available to the public on the department's Internet website.
23 4. A person may not knowingly, for material or
24 financial gain, purchase, sell, or otherwise transfer or
25 obtain, or promote the sale or transfer of, embryonic fetal
26 tissue for research purposes pursuant to this section.
27 Embryonic and adult stem cell material may be donated only for
28 research purposes with the informed consent of the donor. A
29 person who violates this subparagraph commits a felony of the
30 second degree, punishable as provided in s. 775.082, s.
31 775.083, or s. 775.084.
12
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2006 SB 468
30-339A-06
1 (8) HUMAN REPRODUCTIVE CLONING; PROHIBITION;
2 PENALTIES.--
3 (a) A person may not knowingly:
4 1. Perform or attempt to perform human reproductive
5 cloning.
6 2. Participate or assist in an attempt to perform
7 human reproductive cloning.
8 3. Ship or receive for any purpose an embryo produced
9 by human reproductive cloning or any product derived from such
10 embryo.
11 (b) A person who violates paragraph (a) commits a
12 felony of the second degree, punishable as provided in s.
13 775.082, s. 775.083, or s. 775.084.
14 Section 4. This act shall take effect July 1, 2006.
15
16 *****************************************
17 SENATE SUMMARY
18 Revises uses for funds credited to the Biomedical
Research Trust Fund. Provides that the Institutional
19 Review Board within the Department of Health may not
review certain research within the jurisdiction of the
20 Biomedical Research and Ethics Oversight Council. Creates
the Florida Better Quality of Life and Biomedical
21 Research Act. Creates the Biomedical Research Advisory
Council. Provides duties of the advisory council,
22 including a report to the Governor, the President of the
Senate, and the Speaker of the House of Representatives.
23 Requires the Department of Health to provide
administrative support. Creates the Biomedical Research
24 and Ethics Oversight Council. Provides duties of the
oversight council. Provides for a grants-in-aid program
25 for the purpose of conducting embryonic or human adult
stem cell research. Provides that grants-in-aid shall be
26 provided through funds in the Biomedical Research Trust
Fund. Restricts the use of such funds for research on
27 certain stem cells. Provides requirements with respect to
the disposition of human embryos following infertility
28 treatment. Requires the Department of Health to develop
and maintain on its Internet website a consent form for
29 the donation of certain embryos. Prohibits purchase or
sale of embryonic fetal tissue for research purposes.
30 Prohibits certain acts relating to human reproductive
cloning. Provides penalties.
31
13
CODING: Words stricken are deletions; words underlined are additions.