BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 926
AUTHOR: Bonilla
AMENDED: April 23, 2013
HEARING DATE: June 12, 2013
CONSULTANT: Marchand
SUBJECT : Reproductive health and research.
SUMMARY : Repeals the prohibition against payments to a woman to
encourage her to produce human oocytes, or eggs, for the
purposes of medical research.
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 oocytes
for purposes of medical research.
3.Prohibits any human oocyte 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,
as specified.
5.Requires a physician, prior to obtaining informed consent from
a subject for AOP for the purpose of procuring oocytes for
research, to provide to the subject a standardized medically
accurate written summary of health and consumer issues
associated with AOP, as specified. Requires this summary to
include medically accurate disclosures concerning the
potential risks of AOP, including the risks associated with
Continued---
AB 926 | Page 2
the surgical procedure and with using the drugs, medications,
and hormones prescribed for ovarian stimulation during the AOP
process.
6.Requires an institutional review board (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 oocyte 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 Protection of Human Subjects in Medical
Experimentation Act, which provides various statutory
protections for Californians involved in medical experiments,
including a detailed requirement for what constitutes
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 this
Act, including a prohibition against compensation to donors or
participants of the research, beyond reimbursement of
expenses.
This bill:
1.Repeals the prohibition against payments to a woman to
encourage her to produce human oocytes for the purposes of
medical research which are in excess of reimbursement for
direct expenses.
2.Requires a woman providing human oocytes for research to be
AB 926 | Page
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compensated for her time, discomfort, and inconvenience in the
same manner as other research subjects.
3.Prohibits payments made pursuant to this bill to be for the
human oocytes themselves or predicated on the number of
oocytes obtained, including if no oocytes are obtained.
4.Requires a human subject research panel or IRB to determine
whether a proposed compensation is appropriate, and if a
proposed compensation amount is determined to be
inappropriate, the panel or board is required to determine an
appropriate compensation amount.
5.Requires an IRB to disregard the amount of compensation paid
to a woman providing human oocytes for the purposes of
fertility who offers for research any oocytes or embryos in
excess of those needed for fertility, if all of the following
conditions are met:
a. The clinic performing oocyte retrieval is a
member of the Society for Assisted Reproductive
Technology;
b. The procurement and disposition for research
purposes of human oocytes initially provided for
reproductive uses, either for use by the donor or
another woman, does 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
oocytes for her own reproductive success; and,
e. The donation of oocytes for research is done
without valuable consideration provided for the
oocytes, as specified.
6.Makes various legislative findings and declarations, including
concerns that the women will be exploited if compensated for
providing human oocytes for research have not borne out in the
states where compensation is allowed, and that sufficient
protections are in place to treat women providing human
AB 926 | Page 4
oocytes for research, similar to any other research subject,
knowing women are competent and able to make decisions for
themselves.
FISCAL EFFECT : This bill has been keyed non-fiscal.
PRIOR VOTES :
Assembly Health: 14- 5
Assembly Floor: 54- 20
COMMENTS :
1.Author's statement. This bill seeks to create equity in the
field of medical research compensation by removing the
prohibition on compensation for women participating in oocyte
(egg) donation for medical research. All other research
subjects are compensated for their time, trouble, and
inconvenience involved in participating in research. AB 926
ensures that women are treated equally to all other research
subjects - allowing them to actively evaluate their
participation in research studies. Unfortunately, the ban on
compensation has had serious unintended consequences. It has
led to a de facto prohibition on women's reproductive research
in California, adversely impacting the same women that the ban
intended to protect. With few oocytes donated, fertility
research and fertility preservation research has been at a
standstill. This greatly affects women suffering from
fertility issues and women facing cancer who would like to
preserve their oocytes.
2.Background on Oocyte Production and Retrieval for Donation.
Over the past two decades, millions of women have had oocytes
collected for the purpose of assisted reproduction. Most of
these were women undergoing in vitro fertilization (IVF) with
their own eggs, but a significant minority were donating their
eggs to help other women get pregnant. During the normal
ovulation cycle, 10 or 20 egg follicles will begin to grow,
eventually leading to one "dominant follicle" producing a
single egg, and the other egg follicles dying off. In the
oocyte or egg donation process, hormones are used to basically
trick the body into keeping the other follicles alive and also
produce eggs. The donation process involves the woman
self-injecting hormones to stimulate the growth of ovarian
follicles, plus a gonadotropin-releasing hormone (GnRH)
agonist to block the normal surge of luteinizing hormone (LH),
which could cause the woman to ovulate before the physician
retrieves the eggs. Typically, GnRH agonists are administered
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a week before stimulation to control the stimulation cycle and
avoid a spontaneous LH surge. The woman subsequently
self-injects the hormone chorionic gonadotropin (hCG, similar
to LH) to 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.
3.Background on Compensation of Oocyte Donors. Under California
law, the prohibition against compensation to oocyte donors
applies only to donors for research purposes, not to assist
someone else get pregnant (fertility purposes). 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 (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 American Society
for Reproductive Medicine, 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 oocytes,
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 oocyte
donors.
4.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 for
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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:
a. 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;
b. That the research program performs psychological and
physical screening for all subjects prior to the oocyte
retrieval procedure;
c. That the research program ensure, 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;
d. That the research program ensure 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,
e. That the research program provide 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.
5.Institute of Medicine Report. Following passage of
Proposition 71 in 2004, CIRM asked the Institute of Medicine
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" (IMR report).
According to the IMR Report, years of experience with
assisted reproduction have identified a number of potential
risks associated with egg donation, falling into three main
categories: (1) the potential risks arising from the hormone
regimen that women are given to stimulate egg production,
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including ovarian hyperstimulation syndrome (OHSS), perhaps
problems with long-term fertility, and breast, ovarian, and
endometrial cancers; (2) the risks associated with the
surgical procedure, including the anesthesia, which involves
many of the same issues that anyone having surgery faces; and
(3), the potential risks that are psychological in nature,
including anxiety, mood swings, and post-donation adjustment.
These risks are summarized below. However, the IMR Report
stated that there was a need for more and better data.
According to the report, one of the most striking facts about
in vitro fertilization is just how little is known for sure
about the long term health outcomes for the women who undergo
the procedures. The IMR 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 IMR Report did acknowledge that the available data come
primarily from IVF patients and not 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
IMR Report, is that there is a great deal of uncertainty about
the potential risks for oocyte donation for research.
Risk of Ovarian Hyperstimulation Syndrome. OHSS is the most
common side effect of the use of fertility drugs, and is
described in the IMR Report as an "exaggeration of a desired
response" - which is to override the female body's natural
mechanism of getting a single egg during an ovulation cycle.
The administration of the ovulation-inducing hormone hCG is a
key factor in the development of OHSS. OHSS symptoms include
enlarged ovaries, an accumulation of fluid in the abdomen.
Moderate cases of OHSS are characterized by more than minimal
discomfort, a significant fluid buildup in the abdomen,
leading to shortness of breath, nausea and vomiting. These
cases can normally be handled on an outpatient basis. Serious
cases are rare - about 100 to 200 cases for every 100,000
stimulation cycles, but they can have serious complications,
including blood clots or kidney failure in the most severe
cases, requiring hospitalizations.
Risk of Cancer. The IMR Report noted that because women with
infertility itself are at higher risk for cancer, it is more
difficult to ascertain the extent to which egg donation
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increases cancer risk, because many of the women undergoing
egg harvesting are doing so because of infertility problems.
Taking this into consideration, the IMR Report stated that
there was no evidence that fertility drugs elevate the risk of
breast cancer, and that there was no systematic evidence at
this point that fertility drugs elevate the risk for invasive
ovarian cancer. But for uterine cancer, the IMR Report stated
that while the data are too sparse to lead to any conclusion,
there is greater concern. The IMR Report also noted a concern
that these effects may not be evident until a longer period of
time has elapsed between the exposure, the assisted
reproduction therapy, and the cancer. According to the
report, one study in particular found that as time elapsed
since the treatment, there did seem to be an increased risk
for breast, ovarian, and endometrial cancers, stating that
this study raised the possibility that many studies have
missed the increased cancer risk because they haven't followed
their subjects for enough years.
Risk of Long-Term Fertility Effects. The IMR Report stated that
one of the concerns that had been raised was that the
retrieval of up to 20 eggs instead of the normal ovulation of
one egg per cycle could hasten the onset of age-related
infertility. However, based on both ovarian physiology and
clinical experience, the report stated that is no reason to
think that repeated ovarian stimulation poses a risk to a
woman's long-term fertility. The IMR Report acknowledged,
however, that not everything is known on the subject, and
there are several important questions that have not yet been
answered. The IMR Report stated that it would be helpful, for
example, to have a longitudinal study that followed woman who
had ovarian stimulation all the way to menopause to find out
what their reproduction future holds.
Risk of Surgery. The potential risk of surgical complications
from oocyte retrieval is generally very small. A related
concern is whether the trauma applied to the ovary by the
needle during harvesting could increase the risk of
infertility. The IMR reports that several studies have found
that women who have undergone oocyte retrievals have a greater
prevalence of antibodies to ovarian tissue, and these
antibodies have been shown to be associated with IVF failures,
but it is difficult to know whether antibodies play any role
at all in infertility.
Psychological Risks. One form of psychological risk
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associated with donating eggs is that the screening process
may reveal some previously unknown psychological or medical
condition that disqualifies the woman from donating and that
is uncomfortable or psychologically threatening to the
patient. After the eggs have been donated, the main
psychological issues that donors experience are related to
worries about future fertility, about which the IMR Report
states that more and better research should be done on the
risks of oocyte donation so that these risks can be reported
to the donors and they can be clear about what they are
getting themselves into.
6.National Academy of Sciences. The National Academy of
Sciences' (NAS) Guidelines for Human Embryonic Stem Cell
Research states that women who undergo hormonal induction to
generate oocytes 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 oocytes 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."
7.Prior legislation. AB 1317 (Block), Chapter 523, Statutes of
2009, required that all advertisements for oocyte donations
for fertility (non-research) purposes to include a warning
that there was a screening process and that not all potential
donors are selected, and that not all selected donors receive
the compensation amount advertised. Also required the
advertisement to include a warning that there may be risks
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involved, and required oocyte 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.
SB 1260 (Ortiz), Chapter 483, Statutes of 2006, established
various requirements related to the donation of oocytes 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.
8.Support. This bill is sponsored by the American Society for
Reproductive Medicine (ASRM), which states that this bill will
permit women who wish to participate in research to be treated
as any other research participant when they undergo ovarian
stimulation and oocyte retrieval. ASRM states that society
benefits from people being willing to participate in research,
and that in order to encourage participation, it is understood
there should be some reward for doing something to which
people otherwise would not subject themselves. ASRM notes
that with financial reward comes the potential for persons to
participate in research purely for the financial benefit and
disregarding potential risks. In order to guard against this
potential, ASRM states that various protections were adopted
in state and federal law, including oversight by IRBs. ASRM
notes that these protections are in addition to the basic
protection of these subjects as patients of the involved
physician - participation in research does not alter the
underlying physician/patient relationship. ASRM states that
the result of the ban is that women are unwilling to
participate without compensation.
As an example of the types of research for which oocytes are
needed, ASRM points to oocyte cryopreservation (essentially,
the freezing of eggs for future use). ASRM notes that embryo
cryopreservation has evolved to where there is a high degree
of certainty that pregnancy can be achieved. Oocytes, due to
their more watery structure, have been more challenging. ASRM
states that while it declared oocyte cryopreservation as no
longer experimental, more research needs to be done to improve
the changes of a successful pregnancy using cryopreserved
oocytes. This increased likelihood is very important to a
woman weighing her options for cancer treatment, and concerned
about the effects of chemotherapy on their fertility.
Several companies in the scientific research field have written
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in support. Representative of these letters was Reprogenetics,
which states that the work it has done in the field of human
reproduction has resulted in fewer miscarriages for women over
the age of 35 who conceived via IVF, as well as better
implantation rates and healthier outcomes. According to
Reprogenetics, if you cannot compensate research participants,
you cannot recruit them, which is why every other type of
research involves compensation. Reprogenetics states it cannot
use its lab in California for research, and instead uses its
lab on the east coast.
The American Association of University Women and Planned
Parenthood Affiliates of California state in support that this
bill will remove barriers to women participating in research
that could result in improvement in care for reproductive
health, including infertility and cancer care. Equality
California (EC) writes in support that many of us are healthy
today thanks to treatment derived from clinical research,
which involved voluntary human participation. In order to
encourage participation, EC notes that a reward-based system
compensates people, who, out of their willingness to help
society, subject themselves to clinical exams, blood draws,
medicines, diets and therapies they would not otherwise
undergo. It is consider ethically sound to compensate human
research subjects commensurate with their clinical
participation.
9.Opposition. The Center for Genetics and Society (CGS), the
Alliance for Human Biotechnology (AHB), Forward Together, the
National Women's Health Network, Our Bodies Ourselves, the
Pro-Choice Alliance for Responsible Research, and We Are Egg
Donors all make similar arguments in opposition. These groups
state in that egg harvesting exposes healthy young women to
multiple synthetic hormones in order to produce many times the
normal number of eggs per cycle. One of the potential harms
is OHSS, which has resulted in hospitalizations and at least a
few documented deaths. These groups state that many experts
remain concerned about the long-term risks of these drugs,
especially their potential impact on infertility and various
cancers. Follow-up research on egg providers, which could
establish the frequency and severity of these adverse
outcomes, is widely recognized to be grossly inadequate.
These groups also assert that women who provide eggs for
research are in a different situation than research subjects
in clinical trials. In clinical trials, investigators are
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studying the reactions and health outcomes of the subjects who
take a drug, use a device, or undergo a procedure. In the case
of egg providers, the reactions and health outcomes of the
healthy young women who provide eggs are not part of their
study, and as a result, researchers may consciously or
subconsciously be less interested in the effects of retrieval
on women who supply the eggs, and more interested in obtaining
as many eggs as possible. These groups state that
unfortunately, the more eggs retrieved, the greater the risks
to women's health, which creates a built-in conflict of
interest between the responsibilities of the physician and
their goal of retrieving eggs. Finally, these groups note that
payment for eggs for research runs counter to the most recent
guidelines of the National Academy of Sciences, as well as the
language in the California constitution pertaining to research
funded by the California Institute for Regenerative Medicine.
Breast Cancer Action makes similar argument in opposition, and
also states that many researchers and leaders in the women's
health movement are concerned that the hormones used to
stimulate multiple egg maturation can cause breast and ovarian
cancer, though the possible correlation has not been
adequately studied.
Concerned Women for America of California (CWA) states that it
is concerned with the basic moral and ethical issue of what is
essentially creating a "commodity" in human eggs. CWA states
that college-aged women are the most sought-after donors and
also the most likely to be tempted by the money, given their
college bills and tough economic times. The lure of cash may
well outweigh their consideration of the danger to their
health and future fertility.
The California Catholic Conference states in opposition that
unlike sperm donation, egg donation is an onerous procedure,
requiring weeks of hormone injections, anesthesia, and a
surgical procedure to remove the eggs. The California
Catholic Conference suggests this is tantamount to trafficking
in human body parts, and that most countries of the world ban
this practice.
The California Right to Life Committee (CRLC) states in
opposition that this bill repeals provisions of law set in
place to prevent the exploitation of women and of unborn
children. CRLC states that all forms of research that involve
either the destruction of human life, (whether in embryonic
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stem cell research or in the process of in vitro
fertilization), or the degradation of a women's body are
reprehensible and no amount of potential good resulting from
these unethical practices can make it otherwise.
SUPPORT AND OPPOSITION :
Support: American Society for Reproductive Medicine (sponsor)
Acacio Fertility
American Association of University Women
American Congress of Obstetricians and Gynecologists,
District IX
California Chronic Care Coalition
California Cryobank
California National Organization for Women
Equality California
National Center for Lesbian Rights
Planned Parenthood Affiliates of California
Reprogenetics
RESOLVE: The National Infertility Association
Southern California Institute for Reproductive
Sciences
Oppose: Alliance for Humane Biotechnology
Breast Cancer Action
California Catholic Conference
California Right to Life Committee, Inc.
Center for Bioethics and Culture
Center for Genetics and Society
Concerned Women for America of California
Forward Together
National Women's Health Network
Our Bodies, Ourselves
Pro-Choice Alliance for Responsible Research
Traditional Values Coalition
We are Egg Donors
20 individuals
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