BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 2531
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|AUTHOR: |Burke |
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|VERSION: |February 19, 2016 |
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|HEARING DATE: |June 8, 2016 | | |
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|CONSULTANT: |Melanie Moreno |
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SUBJECT : Reproductive health and research
SUMMARY : Existing law prohibits human oocytes or embryos from being
acquired, sold, offered for sale, received, or otherwise
transferred for valuable consideration for medical research or
development of medical therapies, and prohibits payment in
excess of the amount of reimbursement of direct expenses to be
made to any research subject to encourage her to produce human
oocytes for the purposes of medical research.
This bill would instead require women providing human oocytes
for research to be compensated for their time, discomfort, and
inconvenience in the same manner as other research subjects, as
prescribed and determined by a human subject research panel or
institutional review board. The bill would require the
institutional review board to disregard the amount of
compensation if a woman providing human oocytes for fertility is
compensated, human oocytes or embryos in excess of those needed
for fertility are offered for research, and certain conditions
are met.
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.
AB 2531 (Burke) Page 2 of ?
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.
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 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 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
voluntary informed consent, and includes penalties for
violations of this Act.
AB 2531 (Burke) Page 3 of ?
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.
This bill:
1)Repeals the ban on compensation in excess of the amount of
reimbursement of direct expenses incurred as a result of the
procedure for women providing human oocytes for the purposes
of medical research. Compensation amounts will be determined
by human subject research panels and institutional review
boards.
2)Requires a woman providing human oocytes for research to be
compensated for her time, discomfort, and inconvenience in the
same manner as other research subjects. Prohibits this payment
from being for the human oocytes themselves or predicated on
the number of oocytes obtained, including if no human oocytes
are obtained.
3)Requires a human subject research panel or IRB to determine
whether a proposed compensation amount is appropriate.
Requires the panel or board, in the event that a proposed
compensation amount is determined to be inappropriate, to
determine an appropriate compensation amount.
4)Requires the IRB, if a woman providing human oocytes for the
purposes of fertility is compensated, and any human oocytes or
embryos in excess of those needed for fertility are offered
for research, to disregard the amount of compensation if:
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;
AB 2531 (Burke) Page 4 of ?
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, as specified.
5)Makes a number of findings and declarations.
FISCAL
EFFECT : This bill is keyed non-fiscal.
PRIOR
VOTES :
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|Assembly Floor: |65 - 3 |
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|Assembly Health Committee: |15 - 0 |
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COMMENTS :
1)Author's statement. According to the author, AB 2531 promotes
medical research in California while ensuring research
participants are fairly treated by removing the prohibition on
compensation for women participating in oocyte (egg) donation
for medical research. 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. AB 2531
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. 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
oocytes, just as any other research subject, to make an
AB 2531 (Burke) Page 5 of ?
informed decision as to participation, and justly compensate
them for doing so. 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 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
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
AB 2531 (Burke) Page 6 of ?
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
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
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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,
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
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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.
a) 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.
b) 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 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
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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.
c) 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.
d) 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.
e) Psychological risks. One form of psychological
risk 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
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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 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:
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
AB 2531 (Burke) Page 11 of ?
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.
I am returning this bill without my signature.
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 1317 also 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.
SB 1260 (Ortiz, Chapter 483, Statutes of 2006), established
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.
8)Support. The American Association of University Women and the
American Congress of Obstetricians and Gynecologists, District
IX (California) (AAUW/ACOG) state that all other research
subjects can be compensated for their time, trouble, and
inconvenience related to participating in research, except for
this population. AAUW/ACOG contend 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 that it will remove barriers to women
participating in research that could result in improvement in
care for reproductive health, including infertility and cancer
care. AAUW/ACOG state that this research could benefit untold
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numbers of women in the future. The California Life Sciences
Association states that California is one of three states
banning compensation for oocytes, which ultimately deters
participation among women who are willing donors and stalls
research excellence. California Cryobank states that to single
out egg donors is inherently discriminatory so few, if any
women, participate in oocyte research in California, creating
barriers to reproductive and other biomedical research that
could result in major medical advancements in cancer and
degenerative diseases. The National Association of Hepatitis
Task Forces, the California Hepatitis C Task Force, and the
Fair Allocation in Research Foundation state that the gender
inequality regarding women and research will be resolved by
having a requirement for women providing human oocytes for
research to be compensated. Equality California writes that
despite all of the protections to guard against the dangers of
exploitation in laws and informed consent procedures, women
are the only ones singled out and prohibited from being
compensated for research purposes in cases of oocyte donation
and that as a result of the prohibition, all research is
suffering due to lack of needed tissues. RESOLVE states that
while some fear potential exploitation of women for their
oocytes, in the 47 other states which permit compensation
there is no evidence of exploitation or abuse. The National
Center for Lesbian Rights states that if paying for oocyte
donors is an acceptable practice for infertility treatment, it
should also be acceptable to compensate donors who provide
their eggs for research. The California Chronic Care Coalition
writes that this bill will ensure 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.
9)Opposition. Former California State Senator Deborah Ortiz,
who authored the legislation that this bill seeks to repeal,
states that In 2006, she stood alongside women's health and
reproductive rights advocates to call for more studies on the
long-term health outcomes for women undergoing egg retrieval.
Senator Ortiz states that the health risks to women are not
only significant, but there is wide recognition that they are
understudied and that the many reports of harm to women who
provide eggs in the fertility context should not be ignored.
Senator Ortiz further states that the research has advanced
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very little in the last 10 years, reinforcing the need for
more data before expanding the market in eggs and that the
absence of data should urge caution, not serve as a rationale
to support inducements for medical procedures that carry
risks. A number of organizations, including Breast Cancer
Action, Black Women for Wellness, Friends of the Earth, and
National Women's Health Network write that while they support
reimbursing women for the reasonable expenses of egg donation,
they oppose paying women over and above those amounts because
women providing eggs are not research subjects, and egg
harvesting is very different from a clinical trial and the
health risks of egg harvesting are substantial, but there is
insufficient evidence about their extent and severity to be
able to provide true informed consent. These supporters
further state that this bill conflicts with recommendations by
the National Academy of Sciences, and with policies that apply
to CIRM-funded researchers and are part of the California
constitution. Black Women for Wellness also writes that they
are concerned about the lack of oversight to protect
vulnerable women from being preyed upon for research purposes,
especially with the lack of clarity around the longer term
health consequences of egg harvesting. We Are Egg Donors
states that they understand that research with human oocytes
can contribute to important knowledge that can be used for the
greater good, but with no provision in this bill to protect
the health of women who would be providing these oocytes,
based on their collective experiences as egg providers, feel
it would be imprudent to pass it. The Alliance for Humane
Biotechnology states that in clinical trials, investigators
study the reactions and health outcomes of subjects who take a
drug, use a device, or undergo a procedure and that in a case
of egg harvesting, investigators are not studying, or seeking
to understand, the effects of the procedures on women. The
Alliance for Humane Biotechnology states that egg providers
are thus quite different from research subjects. The
California Catholic Conference states that this bill puts
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.
SUPPORT AND OPPOSITION :
Support: Alliance for Fertility Preservation
American Association of University Women
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American Congress of Obstetricians and Gynecologists
American Society for Reproductive Medicine
California Chronic Care Coalition
California Cryobank
California Hepatitis C Task Force
California Life Sciences Association
Equality California
Fair Allocation in Research Foundation
Fertile Action
National Association of Hepatitis Task Force
National Center for Lesbian Rights
Resolve: The National Infertility Association
Oppose: Alliance for Humane Biotechnology
Black Women for Wellness
Black Women's Health Imperative
Breast Cancer Action
California Catholic Conference, Inc.
California Nurses for Ethical Standards
California Right to Life Committee, Inc.
Center for Genetics and Society
Friends of the Earth
Forward Together
National Women's Health Network
Our Bodies Ourselves
Pro-Choice Alliance for Responsible Research
We Are Egg Donors
Five Individuals
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