BILL ANALYSIS Ó
AB 2531
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Date of Hearing: April 5, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
AB 2531
(Burke) - As Introduced February 19, 2016
SUBJECT: Reproductive health and research.
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. Specifically, this bill:
1)Prohibits payment received for providing eggs for research
from being for the eggs themselves, or predicated on the
number obtained, including if none are obtained.
2)Requires the proposed compensation amount to be determined by
a human subject research panel or institutional review board
(IRB).
3)Specifies, in the event that a human subject research panel or
IRB determines that a proposed compensation amount is
inappropriate, the panel or board to determine an appropriate
compensation amount.
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4)Requires the IRB, if a woman is compensated for providing eggs
for the purpose of infertility treatment, and any eggs or
embryos in excess of those needed for fertility are offered
for research, to disregard the amount of compensation if all
of the following conditions are met:
a) The clinic performing egg retrieval is a member of the
Society for Assisted Reproductive Technology;
b) The procurement and disposition for research purposes of
eggs initially provided for reproductive uses, either for
use by the donor or another woman, shall not knowingly
compromise the optimal reproductive success of the woman in
the infertility treatment;
c) The infertility treatment protocol is established prior
to requesting or obtaining consent for donation for
research purposes and the prospect of donation for research
does not alter the timing, method, or procedures selected
for clinical care;
d) The woman in infertility treatment makes the
determination that she does not want or need the eggs for
her own reproductive success; and,
e) The donation of eggs for research is done without
valuable consideration. Valuable consideration does not
include reasonable payment for the removal, processing,
disposal, preservation, quality control, and storage of
eggs or embryos.
5)Makes various legislative findings and declarations, stating
that concerns that women will be exploited if compensated for
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providing human eggs for research have not been borne out in
the states where compensation is allowed, and that sufficient
protections are in place to treat women providing human eggs
for research, similar to any other research subject, and that
women are competent and able to make decisions for themselves.
EXISTING LAW:
1)Defines "oocyte" as a female egg or egg cell of a human
female, and defines "assisted oocyte production" (AOP) as
surgical extraction of oocytes following pharmaceutically
induced manipulation of oocyte production through the use of
ovarian stimulation.
2)Prohibits any payment in excess of the amount of reimbursement
of direct expenses incurred as a result of the procedure to be
made to any subject to encourage her to produce human eggs for
purposes of medical research.
3)Prohibits any human egg or embryo from being acquired, sold,
offered for sale, received, or otherwise transferred for
valuable consideration for the purposes of medical research or
development of medical therapies.
4)Requires a physician, prior to providing AOP for the purposes
of medical research, to obtain written and oral informed
consent for the procedure from the subject, and requires this
informed consent to comply with the requirements of the
Protection of Human Subjects in Medical Experimentation Act
(Act), as specified.
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5)Requires a physician, prior to obtaining informed consent from
a subject for AOP for the purpose of procuring eggs for
research, to provide to the subject a standardized medically
accurate written summary of health and consumer issues
associated with AOP. Requires this summary to include
medically accurate disclosures concerning the potential risks
of AOP, including the risks associated with the surgical
procedure and with using the drugs, medications, and hormones
prescribed for ovarian stimulation during the AOP process.
6)Requires an IRB to require research programs or projects under
its review that involve AOP to comply with certain
requirements, including that the research program perform
psychological and physical screening for all subjects, and
that subjects be given a post-procedure medical examination.
7)Requires a research program that involves AOP to ensure that a
written record is maintained that includes specified
components, including the demographics of subjects,
information regarding every egg that has been donated or used,
and a record of all adverse health outcomes resulting from the
AOP.
8)Prohibits a physician performing the AOP from having a
financial interest in the outcome of the research.
9)Establishes the Act, which provides various statutory
protections for Californians involved in medical experiments,
including a detailed requirement for what constitutes
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voluntary informed consent, and includes penalties for
violations of this Act.
10)Establishes, in the California Constitution, via the passage
of Proposition 71 in 2004, the California Stem Cell Research
and Cures Act and the California Institute for Regenerative
Medicine (CIRM), to provide $3 billion in bond funding over a
period of 10 years to fund stem cell research. Requires the
Independent Citizens Oversight Committee of CIRM to establish
certain standards for the use of the funds provided by the
Act, including a prohibition against compensation to donors or
participants of the research, beyond reimbursement of
expenses.
FISCAL EFFECT: None.
COMMENTS:
1)PURPOSE OF THIS BILL. 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
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inconvenience when they do participate.
The author continues, 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. Lifting the ban
will allow women providing eggs, just as any other research
subject, to make an informed decision as to participation, and
justly compensate them for doing so. The author concludes we
should no longer deny a woman's fundamental ability to make
informed decisions or think for herself, or tell her if she
wants to participate, she can only participate on terms
different than for any other procedure.
2)BACKGROUND.
a) Egg production, retrieval, and donation. Over the past
two decades, millions of women have had eggs collected for
the purpose of assisted reproduction. Most of these were
women undergoing in vitro fertilization (IVF) with their
own eggs; however, a significant minority were donating
their eggs to help other women get pregnant. In the egg
donation process, hormones are used to basically trick the
body into producing many mature eggs, instead of the normal
single egg per menstrual cycle. The donation process
involves the woman self-injecting a mix of hormones over
the span of a month that stimulate the growth of ovarian
follicles, stop the normal ovulation cycle, and affect egg
maturation. When the eggs are ready, the woman is brought
into surgery, where she receives intravenous sedation, and
the eggs are harvested via needle aspiration. A woman who
has undergone the usual hormone treatment will have a dozen
or so eggs that can be collected.
b) Compensation of egg donors. Under California law, the
prohibition against compensation to egg donors applies only
to donors for research purposes, not to assist someone else
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in getting pregnant. According to a March 2010 report by
the Hastings Center, a research institution focusing on
bioethics, entitled "Self-Regulation, Compensation, and the
Ethical Recruitment of Oocyte Donors," the fertility
industry in the United States relies heavily on
self-regulation, which generally takes the form of
guidelines issued by the American Society for Reproductive
Medicine (ASRM, the sponsor of this bill) and its
affiliated organization, the Society for Assisted
Reproductive Technology. The report looked at egg donor
recruitment advertisements on college campuses, and found
that nearly half offered compensation that exceeded
recommended levels. The average compensation offered was
approximately $9,000, with a maximum offer of $50,000. The
oocyte donor compensation guidelines of the ASRM, adopted
in 2007, state that compensation should be structured to
acknowledge the time, inconvenience, and discomfort
associated with the process, and should not vary according
to the planned use of the eggs, the number or quality
retrieved, or the donor's ethnic or other personal
characteristics. The guidelines stated that total payments
to donors in excess of $5,000 require justification, and
sums above $10,000 are not appropriate.
According to the author, besides California, only
Massachusetts and South Dakota specifically prohibit
compensation for egg donors.
c) Institutional Review Boards. An IRB is a committee that
has been formally designated to approve, monitor, and
review biomedical and behavioral research involving humans
conducted under the auspices of the institution with which
it is affiliated. IRBs are regulated by the federal Office
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for Human Research Protection, and are required to have at
least five members, including at least one member who is
not otherwise affiliated with the institution. IRBs have
the authority to approve, require modifications in, or
disapprove all research activities under its review. Under
California law, regarding any research project involving
AOP, the IRB is required to ensure that the research
program comply with specified requirements, including the
following:
i) That the research program provide the subject with
an objective and accurate statement about the existing
state of the research for which the subject is providing
oocytes;
ii) That the research program performs psychological and
physical screening for all subjects prior to the oocyte
retrieval procedure;
iii) That the research program ensures, after conducting
AOP retrieval on a subject, that the subject be given a
post-procedure medical examination at a time within the
standard of care to determine if the subject has
experienced an adverse health effect that is a result of
the procedure, and to inform the subject of the right to
a second opinion if she has any medical concerns;
iv) That the research program ensures that the subject
has access to and coverage for medically appropriate
medical care that is required as a direct result of the
procedure, and to ensure that payment or coverage of
resulting expenses is provided at no cost to the subject;
and,
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v) That the research program provides disclosure if the
physician and his or her immediate family members have
any professional interest in the outcome of the research
or of the oocyte retrieval procedure.
d) Institute of Medicine Report. Following passage of
Proposition 71 in 2004, CIRM asked the Institute of
Medicine (IOM) and the National Research Council to convene
a committee of experts to ascertain the medical risks of
oocyte donation for stem cell research. A workshop was
convened in 2006, and issued a report in 2007 entitled
"Assessing the Medical Risks of Human Oocyte Donation for
Stem Cell Research" (IOM Report). According to the IOM
Report, years of experience with assisted reproduction have
identified a number of potential risks associated with egg
donation, falling into three main categories: i) the
potential risks arising from the hormone regimen that women
are given to stimulate egg production, including ovarian
hyper-stimulation syndrome (OHSS), problems with long-term
fertility, breast, ovarian, and endometrial cancers; ii)
the risks associated with the surgical procedure, including
the anesthesia, which involves many of the same issues that
anyone having surgery faces; and, iii), the potential risks
that are psychological in nature, including anxiety, mood
swings, and post-donation adjustment.
However, the IOM Report stated that there was a need for
more and better data. According to the report, one of the
most striking facts about IVF is just how little is known
for sure about the long-term health outcomes for the women
who undergo the procedures. The IOM Report notes that
there are no registries that track the health of the people
who have taken part, and without such registries to draw
from, most of the studies have focused on relatively small
groups of people. The IOM Report did acknowledge that the
available data come primarily from IVF patients and not
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from healthy subjects, yet it is healthy women and not
those coping with infertility who will be donating eggs for
research, which raises the possibility that the existing
data overstates the potential risks for healthy donors.
The bottom line, according to the IOM Report, is that there
is a great deal of uncertainty about the potential health
risks for egg donation.
e) National Academy of Sciences. The National Academy of
Sciences' (NAS) Guidelines for Human Embryonic Stem Cell
Research state that women who undergo hormonal induction to
generate eggs specifically for research purposes should be
reimbursed only for direct expenses incurred as a result of
the procedure, as determined by an IRB. The Guidelines go
on to state that "no payments beyond reimbursements, cash
or in-kind, should be provided for donating oocytes for
research purposes. Similarly, no payments beyond
reimbursements should be made for donations of sperm for
research purposes." When developing the 2010 amendments to
these guidelines (the most recent update), NAS noted that
since the prior update in 2008, the ethics committee of the
State of New York's Empire State Stem Cell Board adopted a
resolution allowing New York State-funded stem cell
researchers to compensate women who donate their eggs
directly and solely to research for the time, risk, and
burden involved in donating. Amounts of compensation are
to be comparable to those received by women in New York
State for similar donations for reproductive purposes. NAS
stated that while it "acknowledges that the circumstances
surrounding the issue of compensation to oocyte donors
continues to evolve, it chose not to change the National
Academies' Guidelines." NAS went on to state that while it
was leaving its guideline on no payments in place, it
recognized that "other states and entities may choose to
set their own policies, as New York has done."
f) Research using donated eggs. Embryonic stem cells are a
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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
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.
3)SUPPORT. 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
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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.
The National Center for Lesbian Rights (NCLR) asserts that only
through research - through translating science from the
laboratory to clinical practice - can treatment options and
patient outcomes be improved. NCLR states that without
compensation for oocyte donations, few women participate in
research, creating barriers to reproductive and other
biomedical research that could benefit all women. NCLR
concludes a lack of fertility research affect LGBT people in
particular because assisted reproduction is essential for many
LGBT people to become parents and build families.
4)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, however, in the case of egg harvesting,
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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 IOM 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.
The California Catholic Conference, Inc. opposes this bill
stating that it would put women's health in jeopardy by
creating and, in effect, result in a marketing dynamic
designed to exploit women who are most in need of resources -
including college students, immigrants, and women with
economic challenges.
5)PREVIOUS LEGISLATION.
a) AB 926 (Bonilla), vetoed by Governor Brown in 2013, was
substantially similar to this bill. AB 926 would have
lifted the prohibition on compensation for egg donations
for medical research, and would have established guidelines
for the use of IRBs relative to egg donations and
compensation. Governor Brown's veto message read:
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Not everything in life is for sale nor should it be.
This bill would legalize the payment of money in
exchange for a woman submitting to invasive
procedures to stimulate, extract and harvest her
eggs for scientific research.
The questions raised here are not simple; they touch
matters that are both personal and philosophical.
In medical procedures of this kind, genuinely
informed consent is difficult because the long-term
risks are not adequately known. Putting thousands of
dollars on the table only compounds the problem.
Six years ago the Legislature, by near unanimity,
enacted the prohibition that this bill now seeks to
reverse. After careful review of the materials which
both supporters and opponents submitted, I do not
find sufficient reason to change course.
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I am returning this bill without my signature.
b) AB 1317 (Block), Chapter 523, Statutes of 2009, required
that all advertisements for egg donations for fertility
(non-research) purposes to include a warning that there is
a screening process, that not all potential donors are
selected, and that not all selected donors receive the
compensation amount advertised. AB 1313also requires the
advertisement to include a warning that there may be risks
involved, and required egg donors for fertility purposes to
be provided with the same risk information required to be
provided to donors for research purposes, and to comply
with the same informed consent requirements.
c) SB 1260 (Ortiz), Chapter 483, Statutes of 2006,
establishes various requirements related to the donation of
eggs for research. The prohibition against compensating
donors beyond reimbursement of direct costs, which this
bill is seeking to repeal, was among the provisions
established by SB 1260.
6)POLICY COMMENT. In 2013 the Governor vetoed AB 926 which
included similar provisions to those contained in this bill.
The Committee may wish to ask the author her plans to address
the Governor's veto message.
REGISTERED SUPPORT / OPPOSITION:
Support
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American Society for Reproductive Medicine (sponsor)
American Congress of Obstetricians and Gynecologists, District
IX - California
California Chronic Care Coalition
California Cryobank
Equality California
Fertile Action
National Center for Lesbian Rights
RESOLVE: The National Infertility Association
Opposition
California Catholic Conference, Inc.
California Right to Life Committee, Inc.
Center for Genetics and Society
We Are Egg Donors
Several individuals
Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097
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