BILL ANALYSIS Ó
AB 926
Page 1
GOVERNOR'S VETO
AB 926 (Bonilla)
As Amended April 23, 2013
2/3 vote
HEALTH 14-5
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|Ayes:|Pan, Ammiano, Atkins, |
| |Bonilla, Bonta, Chesbro, |
| |Gomez, |
| |Roger Hernández, |
| |Bocanegra, Maienschein, |
| |Mitchell, Nazarian, |
| |V. Manuel Pérez, |
| |Wieckowski |
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|Nays:|Logue, Mansoor, Nestande, |
| |Wagner, Wilk |
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| |54-20|(May 2, 2013) |SENATE: |24-9 |(July 1, 2013) |
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|ASSEMBLY: | | | | | |
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SUMMARY : Requires women who provide human oocytes (eggs) for
research to be compensated for their time, trouble, and
inconvenience in the same manner as other research subjects.
Specifically, this bill :
1)Deletes existing law banning women from being compensated for
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donating eggs for medical research, and instead requires women
donating eggs for research to be compensated for their time,
discomfort, and inconvenience in the same manner as other
research subjects.
2)Clarifies that payment pursuant to this bill must not be for
the eggs themselves or predicated on the number of eggs
obtained, including if no eggs are obtained, and requires a
human subject research panel or institutional review board
(IRB) to determine whether a proposed compensation amount is
appropriate.
3)Requires an IRB, in instances when a woman is compensated for
providing eggs for fertility purposes, to disregard the
compensation the woman received if the woman offers any excess
eggs or embryos for research, provided 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, must 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 determines that she
does not want or need the eggs for her own reproductive
success; and,
e) The donation of excess eggs for research is done with
reasonable payment for the removal, processing, disposal,
preservation, quality control, and storage of eggs or
embryos.
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4)Makes a number of legislative findings and declarations
relating to reproductive health and research.
FISCAL EFFECT : None
COMMENTS : According to the author, current law's prohibition on
compensation for oocyte donation for research purposes unfairly
treats women as individuals who cannot evaluate health
information to make decisions about their participation in
medical research. The author points out that the prohibition
extends to all research, even though it was originally created
in response to concerns regarding the high volume of eggs needed
for embryonic stem cell research. The author notes that, while
modern stem cell research now has little need for donated
oocytes, researchers in reproductive health care have
significant need for these donations. Without compensation, the
author writes, few women participate in research that could
benefit all women.
For example, the author states that more research could be done
on embryo quality to enable women undergoing in vitro
fertilization (IVF) to confidently choose to have a single
embryo implanted with a high probability of achieving a
successful pregnancy, rather than multiple embryos. The author
maintains that this type of research could help to lower the
rate of multiple pregnancies in IVF, with benefits for women,
parents, the resulting children, and society. Lastly, the
author adds that the best source of available eggs or embryos
for research comes from those created for fertility using a
compensated donor because she is more likely to produce a higher
volume of viable excess eggs and embryos than an infertile
woman, but due to the ban on compensation, eggs and embryos not
needed for fertility but suitable for research have to be
discarded.
The egg donation process involves stimulation of the ovaries
with fertility medications and the subsequent retrieval of the
eggs from the donor's ovaries, usually in an operative procedure
under light anesthesia with needle aspiration. In California,
egg donations for research purposes require informed consent
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from the donor and require donors to be provided medically
accurate written and oral information on the potential risks of
the procedure. Regulation of research studies involving egg
donation is overseen by IRBs, administrative bodies within a
research institution tasked with protecting the rights and
welfare of human research subjects. Specific areas of concern
to IRBs are informed consent, measuring the risks and benefits
of the proposed research, and recruitment of subjects for
research. The IRB has the authority to approve, require
changes, or disapprove all research activities under its review.
IRBs are regulated by the federal Office for Human Research
Protection. Federal law requires IRBs to have at least five
members, with varying backgrounds, to promote complete and
adequate review of research activities commonly conducted by the
institution. The IRB must be sufficiently qualified through the
experience and expertise of its members and the diversity of
their backgrounds, including considerations of their racial and
cultural heritage and their sensitivity to issues, such as
community attitudes, to promote respect for its advice and
counsel in safeguarding the rights and welfare of human
subjects. Additionally, federal regulations require at least
one member of the IRB to have primary concerns in the scientific
area and at least one to have primary concerns in the
non-scientific area. Institutions may have their own IRB, use
the IRB of a cooperating agency, or use a commercial IRB.
In a 2007 review of the potential acute and chronic risks
associated with egg donation, the Institute of Medicine (IOM)
found the most prominent negative side effect of ovarian
stimulation is ovarian hyper-stimulation syndrome, which causes
nausea and vomiting, breathing difficulties, kidney and liver
problems, and, in the most severe cases, blood clots. However,
the IOM's research indicated only about 1.4 cases per 100,000
women experienced any of these symptoms. The IOM reported low
risks associated with the surgical procedures of egg donation
and did not find data suggesting that donation surgery posed a
risk to future fertility. The IOM did express concern that very
little is known about the long-term health outcomes of women who
undergo these procedures and strongly recommended additional
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research on the subject.
Supporters of this bill, representing reproductive groups and
women's advocacy organizations, such as Fertile Action,
California National Organization for Women, and Planned
Parenthood Affiliates of California, state that this bill will
provide for equal treatment for women who wish to participate in
research, allowing them to be treated as any other research
participant when they undergo ovarian stimulation and egg
retrieval. Supporters note that society benefits from people
being willing to participate in research, and in order to
encourage participation in research, there should be some reward
for doing something to which people otherwise would not subject
themselves. Supporters add that existing safeguards, such as
IRBs in research settings, will ensure fair compensation of
women for their time and inconvenience, without unduly inducing
or exploiting them.
Opponents, led by ethical and religious groups such as the
Center for Bioethics and Culture Network, the Center for
Genetics and Society, and the California Catholic Conference,
object to reversing the compensation ban because they contend it
could put women's health in jeopardy and exploit those women who
are most in need of resources. They believe that the lack of
long-term studies on the aftermath of egg donation precludes a
potential donor from giving proper informed consent.
GOVERNOR'S VETO MESSAGE :
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
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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.
Analysis Prepared by : Lara Flynn / HEALTH / (916) 319-2097
FN: 0001672