BILL ANALYSIS Ó
AB 926
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Date of Hearing: April 16, 2013
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
AB 926 (Bonilla) - As Introduced: February 22, 2013
SUBJECT : Reproductive health and research.
SUMMARY : Deletes existing law prohibiting women from being
compensated for donating oocytes (eggs) for medical research and
allows excess eggs or embryos from a compensated woman who
provides eggs or embryos for fertility treatment to be used for
medical research if specified conditions are met. Specifically,
this bill :
1)Makes a number of legislative findings and declarations
relating to reproductive health and research, including the
following:
a) The purpose of this bill is to create protections for
research subjects and it should not be construed to affect
any other form of medical care;
b) Scientific research can be most effectively achieved by
establishing protocols to protect, respect, and promote
human health, safety, dignity, autonomy, and rights in
conducting research;
c) This bill seeks to support the requirements in current
law upholding the principle of voluntary and informed
consent and to tailor them to this new area of pioneering
research that utilizes eggs;
d) Concerns that women will be exploited if compensated for
providing eggs for research have not borne out in the
states where compensation is allowed;
e) Sufficient protections are in place to treat women
providing eggs for research, similar to any other research
subject, knowing women are competent and able to make
decisions for themselves; and,
f) This bill will reverse the current ban on compensation
for women providing eggs for research. Compensation
amounts will be determined by human subject research panels
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and institutional review boards (IRBs).
2)Deletes existing law banning women from being compensated for
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.
3)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.
4)Requires an IRB, in instances when a woman who provides eggs
for fertility purposes is compensated 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, 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.
EXISTING LAW :
1)Establishes the Protection of Human Subjects in Medical
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Experimentation Act which prescribes various protections for
subjects of medical research relative to a bill of rights;
informed consent procedures and documentation; and, specified
disclosure requirements, including the right for a subject to
give or withdraw consent freely and without duress.
2)Requires a research investigator to provide subjects making
egg donations for research purposes a standardized, medically
accurate, written summary of health and consumer issues
associated with egg donation.
3)Specifies that the written summary must identify potential
risks associated with the surgical procedure and the use of
drugs, medications, and hormones prescribed for ovarian
stimulation and requires written and oral informed consent of
all donors prior to the procedures.
4)Requires all egg extractions for research to be approved by an
IRB and requires an IRB to impose the following requirements
on any research program or study involving egg donation:
a) The subject must be provided the summary specified in 3)
above and provide written and oral informed consent;
b) The subject must be provided with a statement on the
existing state of research for which the subject is
providing eggs;
c) The subject must undergo psychological screening,
physical screening, and a post procedure medical exam;
d) The subject must be informed of the right to obtain a
second opinion if the subject has any medical concerns
about the procedure;
e) The subject must have free access to and coverage for
medical care related to the procedure and be given a
summary of medical coverage arrangements made relative to
the procedure before the procedure is performed; and,
f) The investigator must disclose if he or she has any
professional interest in the outcome of the research or the
egg retrieval.
FISCAL EFFECT : This bill has not yet been analyzed by a fiscal
committee.
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COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, the
compensation prohibition in current law has adversely affected
women's health and discriminately targets 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 asserts that, without compensation, few
women participate in research and this creates barriers to
reproductive 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, which is a high
priority goal that benefits 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.
2)BACKGROUND . 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. According to the American Congress of
Obstetricians and Gynecologists, District IX, California, the
potential of stem cell treatments and recent advances in
fertility treatments have significantly increased the demand
for human egg cells, scientifically known as "oocytes"
(pronounced "oh-sites"). In California, egg donations for
research purposes require informed consent 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
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overseen by IRBs.
3)IRBs . IRBs are regulated by the federal Office for Human
Research Protection (OHRP). According to the OHRP's IRB
Guidebook, an IRB is an administrative body established to
protect the rights and welfare of human research subjects
recruited to participate in research activities conducted
under the auspices of the institution with which it is
affiliated. 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. Officials at an
institution may disapprove a project that has been approved by
an IRB; however, they may not approve research that has been
disapproved by the IRB.
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.
Institutional policy, not federal regulations, determines
whether compensation and medical treatment will be offered and
the conditions that might be placed on subject eligibility for
compensation or treatment. However, for research involving
more than minimal risk, the subject must be told whether any
compensation and any medical treatment is available if injury
occurs and, if so, what they are, or where further information
may be obtained.
4)COMPENSATION GUIDELINES . In August 2007, the sponsor of this
bill, the American Society for Reproductive Medicine developed
the following guidelines for financial compensation of egg
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donors:
a) Financial compensation of women donating eggs for
infertility therapy or research is justified on ethical
grounds;
b) Compensation should be structured to acknowledge the
time, inconvenience, and discomfort associated with
screening, ovarian stimulation, and egg retrieval;
c) Compensation should not vary according to the planned
use of the eggs, the number or quality of eggs retrieved,
the number or outcome of prior donation cycles, or the
donor's ethnic or other personal characteristics;
d) Total payments to donors in excess of $5,000 require
justification and sums above $10,000 are not appropriate;
e) Programs should adopt effective information disclosure
and counseling processes to discourage inappropriate
decisions to donate eggs;
f) Egg-sharing programs should formulate and disclose clear
policies on the eligibility criteria for participants and
on how eggs will be allocated, especially if a low number
of eggs or eggs of varying quality are produced;
g) Programs should ensure equitable and fair provision of
services to donors; and,
h) Programs should adopt and disclose policies regarding
coverage of an egg donor's medical costs should she
experience complications from the procedure.
5)INSTITUTE OF MEDICINE REPORT . The Institute of Medicine (IOM)
organized a comprehensive review of the potential acute and
chronic risks associated with egg donation and published their
findings in "Assessing the Medical Risks of Human Oocyte
Donation for Stem Cell Research (2007)." In this assessment,
the IOM noted that in order to increase the number of eggs
retrieved from a single donor, the donor normally takes a
regimen of hormone shots. The most prominent negative side
effect of this ovarian stimulation is ovarian
hyper-stimulation syndrome which causes nausea and vomiting,
breathing difficulties, kidney and liver problems, and in the
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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 research
on the subject.
6)SUPPORT . 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
whether it is clinical trials for new drugs, testing new
models of cancer treatment or providing tissue such as lung
and intestinal biopsies, and in order to encourage
participation in research, it is understood there should be
some reward for doing something to which people otherwise
would not subject themselves. They add that there are
existing safeguards in place, such as IRBs in research
settings, to find a balance between fairly compensating women
for the time and inconvenience to undergo the procedure,
without unduly inducing or exploiting them, and this bill will
ensure financial incentives are available to increase the
possibility of more women coming forward to participate in
potentially life-saving fertility and fertility preservation
research.
7)OPPOSITION . 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
are concerned that the lack of long-term studies on the
aftermath of egg donation precludes a potential donor from
giving proper informed consent and that informed consent
becomes even more meaningless when someone is being paid.
Lastly, opponents contend that lifting the compensation ban
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could result in researchers being less interested in the
effects of retrieval on women who supply the eggs and more
interested in obtaining as many eggs as possible.
8)PRIOR LEGISLATION .
a) AB 1317 (Block), Chapter 523, Statutes of 2009, requires
a specified warning in all advertisements for egg donations
associated with the delivery of fertility treatment.
b) SB 1260 (Ortiz), Chapter 483, Statutes of 2006, requires
investigators, prior to obtaining informed consent from
subjects for egg donations used in research, to provide
potential donors with standardized written summaries of
health and consumer issues resulting from the donation and
bans compensating women for donating eggs.
REGISTERED SUPPORT / OPPOSITION :
Support
American Society for Reproductive Medicine (sponsor)
American Association of University Women - California
American Congress of Obstetricians and Gynecologists, District
IX, California
California Cryobank
California National Organization for Women
Equality California
Fertile Action
National Center for Lesbian Rights
Planned Parenthood Affiliates of California
Reprogenetics
RESOLVE: The National Infertility Association
Opposition
California Catholic Conference
California ProLife Council
Center for Bioethics and Culture Network
Center for Genetics and Society
Analysis Prepared by : Cassie Royce / HEALTH / (916) 319-2097
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