BILL ANALYSIS
SB 1260
Page 1
SENATE THIRD READING
SB 1260 (Ortiz)
As Amended August 21, 2006
Majority vote
SENATE VOTE :39-0
HEALTH 12-0 APPROPRIATIONS 18-0
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|Ayes:|Chan, Aghazarian, Berg, |Ayes:|Chu, Sharon Runner, Bass, |
| |Frommer, Jones, Lieu, | |Berg, |
| |Montanez, Nakanishi, | |Calderon, De La Torre, |
| |Negrete McLeod, Richman, | |Emmerson, |
| |Ridley-Thomas, Strickland | |Haynes, Karnette, Klehs, |
| | | |Leno, |
| | | |Nakanishi, Nation, Laird, |
| | | | |
| | | |Ridley-Thomas, Saldana, |
| | | |Walters, Yee |
|-----+--------------------------+-----+--------------------------|
| | | | |
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SUMMARY : Deletes sunset dates of certain provisions in existing
law relating to the derivation or use of human embryonic stem
(hES) cell research. Establishes guidelines relating to egg
donation for stem cell research funded outside of Proposition
71. Specifically, this bill :
1)Deletes the January 1, 2007 sunset date of the following
requirements for research projects involving the derivation or
use of hES cells in California:
a) The requirement that an institutional review board (IRB)
review and approve research projects;
b) The requirement for an IRB to annually report to the
Department of Health Services (DHS) the number of hES cell
research projects that the IRB has reviewed; and,
c) The requirement that DHS submit biennial reports to the
Legislature.
2)Requires DHS to consider the Guidelines for Human Embryonic
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Stem Cell Research issued by the National Research Council and
Institute of Medicine of the National Academies in 2005 in
developing the guidelines, as specified.
3)Deletes existing requirement for an IRB on research involving
hES cell and transfers IRBs current functions to a stem cell
research oversight committee (SCRO). Allows an SCRO to
provide scientific and ethical review of such research.
4)Requires an SCRO to be established, substantially in
accordance with the Guidelines for hES Cell Research issued by
the National Research Council and the Institute of Medicine of
the National Academies in 2005.
5)Requires an SCRO to be established in accordance with
standards issued by the California Institute for Regenerative
Medicine (CIRM), as specified. States that legislative intent
is to avoid inconsistencies on an SCRO established pursuant to
this bill and other existing standards for research conducted
in California.
6)Replaces existing annual requirement for DHS to report to the
Legislature on hES cell research activity with biennial
reviews.
7)Defines the following terms:
a) Assisted oocyte production (AOP) is the surgical
extraction of oocytes following pharmaceutically induced
manipulation of oocyte production through the use of
ovarian stimulation;
b) Oocyte is a female egg or egg cell of a human female;
and,
c) Alternate method of oocyte retrieval means a method of
oocyte retrieval that does not involve the pharmaceutically
induced manipulation of oocyte production.
8)Requires a physician and surgeon, prior to obtaining informed
consent from a subject for AOP or any alternative method of
ovarian retrieval for procuring oocytes for research or
development of medical therapies, to do the following:
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a) Provide to the subject a standardized medically accurate
written summary of health and consumer issues associated
with AOP and any alternative methods of oocyte retrieval;
and,
b) Obtain written and oral informed consent for the
procedure from the subject.
9)Makes any failure to provide the written summary and obtain a
written consent from the subject, unprofessional conduct, as
specified.
10)Requires the summary specified in # 8) a) to include
medically accurate disclosures concerning the potential risks
of AOP or any alternative method of oocyte retrieval, as
specified.
11)Defines "written summary of health and consumer issues" as
the guide published and updated by the American Society for
Reproductive Medicine entitled, "Assisted Reproductive
Technology: A Guide for Patients" or an alternative document.
Allows this alternative document to be one that has been
approved by DHS, as specified, and requires that it adhere to
the following:
a) Simplified reading standards, written in layperson's
language, and be made available in languages spoken by
subjects in the study if their proficiency is a language
other than English; and,
b) Include additional resources for, or list additional
sources of, medical information on health and safety issues
surrounding oocyte retrieval.
12)Requires the consent specified in # 8) b) above to comply
with the informed consent requirements of the Protection of
Human Subjects in Medical Experimentation Act.
13)States this bill does not affect the suitability or
availability of oocytes procured for research before January
1, 2006, if the oocytes were donated pursuant to protocols or
standards that are generally recognized and accepted by
national or international scientific bodies.
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14)Requires an IRB to require any research program that involves
AOP or any alternative method of oocyte retrieval to do all of
the following:
a) Include a written summary with information on the health
risks and potential adverse consequences of the procedure,
and describe the manner in which the subject will receive
and review this written summary;
b) Obtain informed consent, as specified;
c) Provide an objective and accurate statement about the
existing state of the research for which the subject is
providing oocytes;
d) Perform psychological and physical screening, in
accordance with the appropriate standard of care, for all
subjects prior to the oocyte retrieval procedure;
e) Ensure that after an AOP or any alternative method of
oocyte retrieval on a subject, a postprocedure medical
examination is conducted on the subject, as specified.
Require that the subject be informed of the right to a
second opinion if there are any medical concerns;
f) Ensure that the subject has access to and coverage for
medically appropriate medical care that is required as a
direct result of the procedure. Require the research
program or project to ensure that payment or coverage of
resulting medical expenses be provided at no cost to the
subject;
g) Provide a summary informing the subject that oocytes may
not be sold or transferred for valuable consideration
except as specified; and,
h) Disclose if the physician and surgeon and his or her
immediate family members has any professional interest in
the outcome of the research or of the oocyte retrieval
procedure, as specified.
15)Requires a research program or project that involves AOP or
any alternative method of oocyte retrieval to ensure that a
written record is established and maintained. Specifies the
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information that must be maintained in the written record.
Requires the information collected to protect personally
identifiable information and remain confidential. Requires
the information to be reported to the branch, which shall
aggregate the data and make it publicly available, while
protecting personally identifiable information.
16)Requires DHS to provide public access to information to which
it is required to release pursuant to the California Public
Records Act. Requires DHS to disseminate the information to
the general public, as specified.
17)Prohibits any employee or relative of an employee of a
research organization conducting stem cell research involving
human oocytes from being a subject in the research.
18)Prohibits a physician and surgeon performing the AOP or any
alternative method of oocyte retrieval from having any
financial interest in the outcome of the research.
19)Requires any procedures for procuring oocytes in this state
for research or the development of medical therapies to meet
all of the standards for subjects included in this bill.
Requires all eggs procured outside of this state for research
taking place in this state meet these same standards.
Requires all egg extractions for research to be approved by an
IRB.
20)Prohibits any human oocyte or embryo from being acquired,
sold, offered for sale, or transferred for valuable
consideration for the purposes of medical research or
development of medical therapies.
21)States that "valuable consideration" excludes reasonable
payment for the removal, processing, disposal, preservation,
quality control, and storage of oocytes or embryos.
22)Prohibits payment in excess of the amount of reimbursement of
direct expenses made to any research subject to encourage her
production of human oocytes for the purposes of medical
research.
23)Prohibits construing this bill to amend Proposition 71.
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24)Encourages the Independent Citizen's Oversight Committee
(ICOC), established pursuant to Proposition 71, to review
existing studies concerning the health risks and benefits of
ovarian stimulation drugs used for assisted oocyte production,
identify gaps in existing knowledge concerning health risks
and benefits, and undertake further research as the ICOC deems
necessary to characterize the risks and benefits of those
drugs.
FISCAL EFFECT : According to the Assembly Appropriations
Committee, on-going General Fund costs to DHS of approximately
$200,000. Minor and absorbable special fund costs (Medical
Board Contingent Fund) to the Medical Board of California.
COMMENTS : According to the author, the purpose of this bill is
to ensure adequate safeguards for research subjects who are
donating eggs for stem cell research, given that this is an area
not currently addressed specifically and thoroughly in state
law. The author state that these provisions will not impact
projects that are funded by Proposition 71, but projects that
occur outside of CIRM-funded research, where there are no
specified guidelines in law about the requirements for this type
of research. The author also point out that this bill ensures
that women considering undergoing AOP for the purposes of
donating eggs for medical research are fully informed of the
potential risks. Stem cell research is moving into the realm of
somatic cell transfer, also known as therapeutic cloning, a
field of research that will enable scientists to study the
progression of diseases and disorders. One source of the eggs
needed for this important line of research will be donations
from women who volunteer to take fertility drugs or ovarian
stimulation drugs to develop multiple eggs. According to
available research, there is a 1% risk of development of serious
ovarian hyperstimulation syndrome (OHSS) among women who take
ovarian stimulation drugs, which is associated with serious
health problems such as pulmonary complications, blood clotting,
and kidney impairment. In severe cases OHSS can require
hospitalization and lead to death. In addition, scientists have
not been able to rule out a link between fertility drugs and
ovarian cancer. For women considering in vitro fertilization
for reproductive purposes, the offsetting benefit is clear; in
contrast, for women considering donating eggs for research
purposes, the offsetting benefit is less clear. This bill
ensures that women considering undergoing AOP for the purposes
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of donating eggs for medical research are fully informed of the
potential risks before electing to do so.
The Center for Genetics and Society (Center) states that as a
supporter of embryonic stem cell research, it believes that the
research will be best served if it is conducted in a manner that
promotes the health and well-being of all research subjects. In
addition, the Center states that this bill will prevent the
emergence of a market that would unduly influence women's
decisions to provide their eggs for research and that
compensation beyond direct expenses would inappropriately create
financial incentives, especially by economically vulnerable
women, who may put themselves at risk in exchange for payment.
The Pro-Choice Alliance states that the bill demonstrates
respect and dignity for women for recognizing that in order to
give fully informed consent, women must be given accurate and
unbiased information, that the information must be
understandable and accessible to women of limited English
proficiency or literacy, and that women's wishes about the
research in which they are participating will be respected
In their opposition, the American College of Obstetricians and
Gynecologists and the American Society for Reproductive Medicine
state that while they support the intent of the bill, they
believe this bill in its current form is unfair to women and
will stall stem cell research. They specifically state that
oocyte donors, like other research subjects, must be compensated
for their time and trouble and that professional guidelines can
be used to determine the reasonable amounts to avoid
exploitation. In addition, they state that out-of-pocket
reimbursements should include lost wages.
DHS' Human Stem Cell Research Advisory Committee (committee),
created pursuant to SB 322 (Ortiz), Chapter 506, Statutes of
2003, writes that it has concerns with this bill. The committee
states that it is concerned with the designation of the IRBs as
regulatory bodies of stem cell research, the breadth of the
requirement for provision of medical care for adverse medical
consequences of donating oocytes for research purposes, and the
broad and ambiguous restrictions on who may be a research oocyte
donor.
Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916)
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319-2097
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