BILL ANALYSIS Ó
AB 2531
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CONCURRENCE IN SENATE AMENDMENTS
AB
2531 (Burke)
As Amended August 19, 2016
Majority vote
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|ASSEMBLY: |65-3 |(April 28, |SENATE: | |(August 29, |
| | |2016) | |26-11 |2016) |
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Original Committee Reference: HEALTH
SUMMARY: Repeals the ban on compensation for women providing
human oocytes (eggs) for research, and instead allows a woman
providing eggs for research to be compensated for her time,
discomfort, and inconvenience in the same manner as other
research subjects.
The Senate amendments require that a woman providing eggs for
research be provided with a summary of health and consumer
issues associated with assisted oocyte production (AOP) and
informed consent requirements, and to be informed that ongoing
studies will continue to assess the long-term health impacts of
ovarian stimulation and egg retrieval.
FISCAL EFFECT: None.
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COMMENTS: According to the author, this bill promotes medical
research in California while ensuring research participants are
fairly treated by removing the prohibition on compensation for
women participating in egg donation for medical research. The
author states that we all benefit from those willing to
participate in research, and the current processes in place are
designed to appropriately reward participants, while protecting
them from abusive or coercive practices. The author notes that
this bill ensures that women are treated equally to all other
research subjects - allowing them to actively evaluate their
participation in research studies and be paid for their time,
trouble, and inconvenience when they do participate. The author
concludes, given that compensation is allowed in 47 other
states, and there is no evidence of abuse, it's time to
reconsider our ban, just as New York did.
Research using donated eggs. Embryonic stem cells are a unique
discovery with the power to unlock causes of and treatments for
many human illnesses. Diseases and disabilities such as heart
disease, spinal cord injuries, juvenile diabetes (Type I
diabetes), amyotrophic lateral sclerosis (ALS or Lou Gehrig's
disease), Parkinson's disease, and Alzheimer's disease afflict
millions of Americans. These are some of the most debilitating
diseases known to modern medicine in that they often severely
limit the activity of the affected individual, cause painful
degeneration of normal bodily functions, bring on premature
death, and cause immense suffering for the individual and his or
her family.
Potential benefits of embryo research include an improved
understanding of fertilization, implantation, and early
pregnancy biology and, with this understanding, possibly fewer
undesired outcomes, such as miscarriage. For infertile couples,
embryo research offers the possibility of more effective
therapies: research efforts helped optimize conditions for
intracytoplasmic sperm injection, embryo culture, and
cryopreservation, for example. For others at risk for heritable
genetic disease who feel pregnancy termination is undesirable or
inappropriate, embryo research has led to the possibility of
early, accurate genetic diagnosis. Preimplantation genetic
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diagnosis provides diagnostic results at a point before
implantation, so pregnancy termination can be avoided. In
addition to these benefits of embryo research in general, stem
cell research promises additional potential benefits, for such
work may lead both to a better understanding of the processes
leading to tissue differentiation and function and to possible
therapies by creating lines that can replace diseased or
nonfunctioning tissues.
SUPPORT. The American Society for Reproductive Medicine (ASRM)
is the sponsor of this bill and states, in the United States and
California there is a fundamental principle that all research
participants deserve just compensation for their contribution to
research that entails some risk and much time, trouble, and
inconvenience. ASRM contends the lack of compensation deters
participants and stalls research. The sponsor notes, women
considering ovarian stimulation and oocyte retrieval are capable
of informed decision making as to the risks of compensated
participation in research, just as they do for now for
fertility. ASRM concludes that fairness requires research
participants receive the same compensation fertility donors
presently receive, and allowing compensation for fertility
purposes while banning it for research serves a false value,
subordinating research to fertility.
The American Congress of Obstetricians and Gynecologists,
District IX - California (ACOG) writes that all other research
subjects are compensated for their time, trouble, and
inconvenience related to participating in research, except for
this population. ACOG notes that this bill ensures that women
are treated equal to all other research subjects - allowing them
to actively evaluate their participation in research studies.
OPPOSITION. The Center for Genetics and Society (CGS) is
opposed to this bill stating, that women providing eggs are not
research subjects, and egg retrieval is very different from a
clinical trial. CGS notes that, in clinical trial,
investigators study the reactions and health outcomes of
subjects who take a drug, use a device, or undergo a procedure,
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however, in the case of egg harvesting, investigators are not
studying, or seeking to understand the effects of the procedures
on women. CGS also notes that many experts remain concerned
about the long-term risks of these drugs, especially their
potential impact on infertility and various cancers, and that
follow-up research on egg providers, which could establish the
frequency and severity of these adverse outcomes, and best
protocols for avoiding them, is widely recognized to be grossly
inadequate. CGS also references the Institute of Medicine
report, "Assessing the Medical Risks of Human Oocyte Donation
for Stem Cell Research (2006)," and that it concluded that one
of the striking facts about ovarian stimulation is just how
little is known about long-term health outcomes for women.
We Are Egg Donors indicates that with no provisions in this bill
to protect the health of women who would be providing these
oocytes, based on their collective experiences as egg providers,
they feel it would be imprudent to pass this bill because women
cannot give informed consent when there is a lack of information
about the risks.
Analysis Prepared by:
Lara Flynn / HEALTH / (916) 319-2097 FN:
0004769