BILL ANALYSIS
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|SENATE RULES COMMITTEE | SB 322|
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THIRD READING
Bill No: SB 322
Author: Ortiz (D)
Amended: 6/3/03
Vote: 21
SENATE HEALTH & HUMAN SERV. COMMITTEE : 10-3, 4/23/03
AYES: Ortiz, Alarcon, Chesbro, Escutia, Figueroa, Florez,
Kuehl, Romero, Vasconcellos, Vincent
NOES: Aanestad, Ashburn, Battin
SENATE APPROPRIATIONS COMMITTEE : 8-5, 5/29/03
AYES: Alpert, Bowen, Burton, Escutia, Karnette, Machado,
Murray, Speier
NOES: Battin, Aanestad, Ashburn, Johnson, Poochigian
SUBJECT : Human Stem Cell Research Review Council
SOURCE : Author
DIGEST : This bill requires the State Department of
Health Services to develop guidelines for research in
California involving the derivation or use of human
embryonic stem cells and an institutional review board to
review and approve research projects involving human
embryonic stem cells. The bill requires the institutional
review board to ensure that all projects reviewed comply
with the guidelines established by the department.
ANALYSIS :
Existing State Law
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1.Declares the policy of the state of California that
research involving the derivation and use of human
embryonic stem cells, human embryonic germ cells, and
human adult stem cells from any source, including somatic
cell nuclear transplantation, shall be permitted and that
full consideration of the ethical and medical
implications of this research be given.
2.Prohibits the cloning of a human being or engaging in
human reproductive cloning.
Existing Federal Law, Regulations and Guidelines
1.Prohibits the use of federal funds for any research in
which human embryos are created for research purposes or
are destroyed, discarded, or subjected to greater than
minimal risk.
2.Requires all research involving human subjects conducted,
supported, or otherwise subject to regulation by any
Federal Department or Agency to comply with requirements
governing protection of human subjects, including review
by a federally-approved Institutional Review Board,
assurance that risks to subjects are minimized or that
risks to subjects are reasonable in relation to the
anticipated benefits of the research; and that standards
pertaining to informed consent are met.
3.Prohibits the use of federal funds for the derivation or
use of stem cell lines derived from embryos created after
August 9, 2001, research in which embryonic stem cells
are derived using somatic cell nuclear transfer, and
research in which human embryonic stem cells are used in
combination with somatic cell nuclear transfer for the
purposes of reproductive cloning of a human being.
4.Permits, specifically, federal funding of stem cell
research that is conducted using federally-approved
embryonic stem cell lines that were in existence as of
August 9, 2001 that were derived with the informed
consent of the donors of the embryos, from excess embryos
created solely for reproductive purposes, without any
financial inducements to the donors.
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This bill:
1.Requires the State Department of Health Services (DHS) to
develop guidelines for research involving the derivation
or use of human embryonic stem cells in California,
taking into consideration other applicable guidelines
developed or in use in the United States and other
countries. Sunsets June 30, 2006.
2.Requires all research projects involving the derivation
or use of human embryonic stem cells to be reviewed and
approved by an institutional review board (IRB) that is
established in accordance with federal regulations prior
to being undertaken.
3.Requires any such IRB, in its review of human embryonic
stem cell research projects, consider and apply the
guidelines developed by DHS.
4.Authorizes an IRB to require modification to the plan or
design of a proposed human embryonic stem cell research
project as a condition of approving the research project.
5.Requires, not less than once per year, an IRB to conduct
continuing review of research projects reviewed and
approved in order to ensure that the research continues
to meet the standards for approval. Allows an IRB to
revoke its prior approval and require modifications
before permitting the research to continue. Sunsets June
30, 2006.
6.Requires each IRB to report to DHS annually on the number
of research projects that have been reviewed and the
status and disposition of each project. Also requires
each IRB to report any unanticipated problems, unforeseen
issues or serious investigator noncompliance and actions
taken to respond to these situations. Sunsets June 30,
2006.
7.Requires DHS to at least annually review the reports and
revise the guidelines it deems necessary. Requires DHS
to report annually to the Legislature on research
activity. Sunsets June 30, 2006.
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Comments
There are currently no comprehensive federal guidelines or
oversight process that address the full array of ethical
and legal issues relevant to stem cell research, including
standardized procedures for informed consent and criteria
for use of embryos and human eggs for research. In
January, 2002 the California Advisory Committee on Human
Cloning recommended that California "reasonably" regulate
therapeutic cloning. According to the Committee, such
regulation would consist of a prohibition on the use of
preembryos after the development of the "primitive streak"
(which generally occurs after about 14 days of gestation);
assurance that persons providing cells for this purpose
provide informed consent; and a requirement that research
be approved by a federally-approved institutional review
board.
The provisions of this bill are consistent with the
recommendations of the Advisory Committee on Human Cloning
but extend the mandate for the development of guidelines to
all forms of embryonic stem cell research.
Related Legislation
The author is also carrying SB 771, which requires the DHS
to establish an anonymous registry of embryos that have
been made available for research purposes, and SB 778,
which authorizes the issuance of general obligation bonds
for biomedical and stem cell research.
Other Related Legislation
SB 133 (Battin) - Prohibits human reproductive cloning and
therapeutic cloning.
SB 765 (Ortiz) - Authorizes lease revenue bonds for
biomedical research.
Prior Legislation
In 2002, the author successfully carried SB 253, which
declares state policy that research involving the
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derivation and use of human embryonic stem cells, human
embryonic germ cells, and human adult stem cells from any
source, including somatic cell nuclear transplantation,
shall be permitted and that full consideration of the
ethical and medical implementation of this research be
given.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
According to the Senate Appropriations Committee, cost to
the General Fund of $25,000 in 2003-04, $50,000 in 2004-05
and $50,000 in 2005-06.
SUPPORT : (Verified 6/3/03)
The American College of Obstetricians and Gynecologists
American Lung Association
Californians for Cure
California Medical Association
Children's Neurobiological Solutions Foundation
Diabetes Coalition of California
Gray Panthers
Kirsch Foundation
Parkinson's Action Network
Numerous individuals
OPPOSITION : (Verified 6/3/03)
California Pro-Life Council, Inc.
California Catholic Conference
Campaign for California Families
Committee on Moral Concerns
Scholl Institute of Bioethics
ARGUMENTS IN SUPPORT : The author's office believes it is
necessary for California, in light of its position as a
world leader in stem cell research and in light of the fact
that private, and potentially state, funding is being
committed to stem cell research, to develop comprehensive
guidelines that address the ethical and legal issues
relevant to such research, to ensure that it is conducted
in an appropriate manner and pursuant to established
guidelines.
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The author's office notes that many issues related to stem
cell research are currently not addressed in National
Institutes of Heath (NIH) guidelines or oversight
mechanisms, including the conditions under which unused
embryos and eggs may be donated for research; specific
procedures for informed consent on the part of embryo, egg,
and somatic material donors; timetables for derivation of
stem cells from developing embryos; and assurances that
embryonic stem cell research projects do not venture into
the area of human cloning, as defined in California law.
ARGUMENTS IN OPPOSITION : Opponents state that while they
support the work being done with adult stem cell research,
they oppose research that involves destruction of human
embryos or cloning of human embryos for purposes of
deriving human stem cells and they oppose any efforts that
would facilitate embryonic stem cell research through
establishment of boards, programs, or bond financing.
CP:cm 6/3/03 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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