Berkeley Journal of Gender, Law & Justice
Volume 22 | Issue 1
Article 6
September 2013
The Value of the Human Egg: An Analysis of Risk
and Reward in Stem Cell Research
Sarah B. Angel
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Recommended Citation
Sarah B. Angel, The Value of the Human Egg: An Analysis of Risk and Reward in Stem Cell Research, 22 Berkeley J. Gender L. & Just.
183 (2007).
Available at: http://scholarship.law.berkeley.edu/bglj/vol22/iss1/6
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http://dx.doi.org/https://doi.org/10.15779/Z38R20RW0S
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The Value of the Human Egg:
An Analysis of Risk and Reward in Stem Cell
Research
Sarah B. Angelt
I. INTRODUCTION TO CALIFORNIA SENATE BILL 1260
On September 26, 2006, California Governor Arnold Schwarzenegger
signed into law Senate Bill 1260 ("SB 1260"), authored by Democratic State
Senator Deborah Ortiz and Republican Senator George Runner.' The touted
purpose of the law is to protect the women who become research subjects from
undue enticement by prohibiting compensation for their oocytes. 2 However, at
the heart of this law is a concern about the cloning research that requires these
oocytes, research which is peerless in its potential to study and treat genetic
diseases. While it is beyond the scope of this article to discuss the moral status of
the embryo or the debate regarding when life begins, these ethical issues are at
the core of the call to prohibit both cloning research and compensation for
oocyte donation.
This article will consider whether compensation should be banned for
human oocytes donated for research purposes. A primary concern is the risk of
harm women may face in the oocyte donation process. SB 1260 ostensibly seeks
to prevent this harm, and it must be determined whether proponents' concerns
are real or overstated. How should society address any real risks of harm? Is
informed consent sufficient in this context? Is an effective ban on compensation
f
1.
2.
J.D. candidate, 2007, Boalt Hall School of Law, University of California, Berkeley; B.A.,
2000, University of California, Los Angeles. I would like to thank my professor R. Alta
Charo, who encouraged me to attend the conference that sparked my interest in research egg
donation and who nurtured earlier drafts. I am indebted to Aubra Fletcher, for her invaluable
editorial assistance, and Daniel Redman, Katherine Kasameyer, and Sarah Steinheimer for
their work on this piece. All mistakes, however, are my own. This piece would not have been
published without the support and friendship of Audrey Mink. Finally, my deepest thanks
goes to my parents, Stephen and Ellen Angel, for teaching me to appreciate science and
medicine, and to my sisters, Joni and Rebecca Angel, for encouraging me to question.
Act of Sept. 26, 2006, ch. 483, 2006 Cal. Stat. 90 (codified at CAL. HEALTH & SAFETY CODE
§§ 125118, 125119, 125119.3, 125119.5, 125300, 125330-123853 (Deering 2006)).
Id. An oocyte is defined as the reproductive cell in the human female; it is also called an
ovum. CAL. HEALTH & SAFETY CODE § 125330(b) (Deering 2006).
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
for research donations the answer? This article posits that such a ban is
inappropriate and that SB 1260's prohibition on compensation will hamper
promising research by unjustifiably exceptionalizing research oocyte donors
from reproductive oocyte donors and other human research subjects.
The first section of this article reviews the legislative intent underlying SB
1260 by briefly surveying the text of the bill, preexisting guidelines, supporters'
motivations, and critics' concerns. Section II illustrates the significant potential
of somatic cell nuclear transfer ("SCNT") and the lack of substitutes for this
procedure. The next section examines egg donation for SCNT by considering the
lack of alternatives to human oocytes, the demographics of research donors, the
medical protocol involved in oocyte stimulation and retrieval, the attendant risks,
and the ability of informed consent to protect donors in this context. Section IV
identifies the theoretical arguments on each side of the compensation debate,
speculates that there would be shortages in oocytes when SB 1260's prohibition
on compensation takes effect, and estimates that an appropriate level of
compensation for research oocytes would be near that for reproductive oocytes.
The final section concludes that the SB 1260 ban is inappropriate because
arguments for prohibiting compensation for research donors overstate potential
risks and do not justify making research donors an exception to compensation
schemes for egg donors for reproductive purposes or typical human research
subject protections.
A. The Legislative Intent Underlying SB 1260
Financial remuneration for women who donate their eggs in a research
setting was the most contentious issue in the passage of SB 1260. In enacting the
bill into law, the California Legislature found that "[t]he potential for
exploitation of the reproductive capabilities of women for commercial gain
raises health and ethical concerns that justify the prohibition of payment for
human oocytes" in the research context. 3 The law strictly limits financial
remuneration to reimbursement of direct expenses resulting
from the procedure;
4
the law bans any form of compensation above this amount.
Existing national guidelines and state regulations 5 already provide clear
3.
4.
5.
Ch. 483, 2006 Cal. Stat. 90.
CAL. HEALTH & SAFETY CODE § 125355 (Deering 2006). Specifically, this law prohibits the
exchange of something valuable for the acquisition, sale, offer for sale, receipt, or other
method of transfer of human oocytes or embryos for the purpose of medical research. "For
the purposes of this section, 'valuable consideration' does not include reasonable payment
for the removal, processing, disposal, preservation, quality control, and storage of oocytes or
embryos." § 125350 (Deering 2006). While these provisions will not be applicable to the
stem cell research funded by the $3 billion in grants from the new California Institute for
Regenerative Medicine ("CIRM"), they will apply to all acquisitions of human oocytes both
inside and outside of California that will be used in research within the state. § 125346.
A regulation is "a rule or order, having legal force, issued by an administrative agency or a
local government." BLACK'S LAW DICTIONARY 1289 (7th ed. 1999). The legal force behind
a regulation contrasts with that of a guideline. A guideline is "a statement or other indication
of policy or procedure by which to determine a course of action." American Heritage
THE VALUE OF THE HUMAN EGG
and sufficient protection to donors, 6 rendering SB 1260's provisions related to
financial remuneration unnecessary and therefore a statutory barrier to research.
The National Academies of Science ("NAS") adopted guidelines in 2005 which
state that women who undergo oocyte donation for research purposes, such as
for SCNT, should be reimbursed only for direct expenses arising from their
participation. 7 Moreover, the California Institute for Regenerative Medicine's
("CIRM") regulations allow for reimbursement of only the "necessary and
reasonable costs directly incurred as a result of donation or participation in
research activities. ' 8 These guidelines currently prohibit any compensation
beyond the allowable reimbursement.
While SB 1260 as enacted is consistent with the current NAS Guidelines, it
is more restrictive than the California regulations promulgated by CIRM. The
NAS elected to prohibit compensation to promote national public confidence in
stem cell research. 9 Californians, on the other hand, have been on the cutting
edge of support for stem cell research, 0 as reflected in the broader allowance for
reimbursement in CIRM's regulations. SB 1260 appears to contradict the intent
of California voters in passing Proposition 71, making California the first state
publicly to commit taxpayer money to stem cell research.
SB 1260 penalizes women for contributing to SCNT research without
6.
7.
8.
9.
10.
Dictionary
of
the
English
Language, (4th
ed.
2000),
available at
http://www.dictionary.reference.com/browse/guideline.
See generally COMM. ON GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH &
NATIONAL RESEARCH COUNCIL, GUIDELINES FOR HUMAN EMBRYONIC STEM CELL
RESEARCH (National Academy of Sciences 2005) [hereinafter NAS GUIDELINES], available
at http://www.nap.edu/catalog/11278.html; CAL. CODE REGS. tit. 17, §§ 100010-100130
(2006) [hereinafter CIRM Regulations]; see also Hearing on SB 1260 before the Assembly
Comm. on Health, 2006 Leg. 5-6 (Cal. June 27, 2006) [hereinafter SB 1260 Health Comm.
Analysis] (discussing the lack of prior-existing statutory law on the subject of compensation
for research oocyte donors).
SB 1260 Health Comm. Analysis, supra note 6, at 7. Direct expenses will be determined by
the Institutional Review Board overseeing the research project for which reimbursement is
an issue. Id.
Id. at 8. These regulations were developed by the Scientific and Medical Accountability
Standards Working Group of CIRM and relied on various sources, including the National
Academies of Science. The expenses CIRM allows include but are not limited to: travel,
housing, child care, medical care, health insurance, and actual lost wages. Id.
Letter from Shannon Smith-Crowley, Legislative Advocate, American College of
Obstetricians and Gynecologists, to Arnold Schwarzenegger, Governor, State of California
(Sept. 3, 2006) (on file with author) [hereinafter ACOG Veto Letter]. Moreover, the NAS
Guidelines did not find that compensation for oocyte donors is unethical. The Guidelines
acknowledged that most research subjects are compensated for their time and trouble. See
NAS GUIDELINES, supra note 6, at 3; Letter from Shannon Smith-Crowley, Legislative
Advocate, American Society for Reproductive Medicine, to Arnold Schwarzenegger,
Governor, State of California (Sept. 3, 2006) (on file with author) [hereinafter ASRM Veto
Letter].
California voters passed Proposition 71 in 2004, which established CIRM to fund $3 billion
in stem cell research. This was the largest grant of state funded support for stem cell
research. David E. Winickoff, Governing Stem Cell Research in California and the USA:
Towards a Social Infrastructure, 24:9 TRENDS IN BIOTECHNOLOGY 390 (July 14, 2006);
Smart Voter, League of Women Voters, Proposition71, http://www.smartvoter.org/2004/l 1/
02/ca/state/prop/7 1/ (last visited March 5, 2007).
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
providing them any new protections. While most of the law's intent language
refers to donor protection, its payment provisions do not reflect this rationale.
The law limits reimbursement to direct expenses and prohibits any additional
form of compensation. Supporters reason that the law's ban on compensation
and caps on reimbursement protect women from undue financial enticement to
donate eggs. This reasoning is unsatisfying both because it represents an
exception to other human research compensation schemes and because it fails to
provide egg donors with financial protection." Instead, the law financially
punishes women who have chosen to donate their oocytes for research. Without
reimbursement for lost wages, these women lose money by donating. As a result,
few women are likely to participate, which will restrict the resources available to
scientists to conduct this genetic research.
B. Concerns about SB 1260
SB 1260 supporters spanned the political spectrum and made a variety of
public acknowledgements as to the intent and purpose of the legislation. The
California Family Council ("CFC") was among the bill's supporters. 2 CFC is
affiliated with the conservative Christian group Focus on the Family. 3 CFC
stated that "SB 1260 will actually reduce the number of women who are willing
to submit their bodies to chemicals and drugs for the sole purpose of producing
more embryos for such research."' 14 This public statement acknowledged the
philosophical opposition to any kind of stem cell research undergirding support
for SB 1260's prohibition on compensation, as well as the chilling effect the law
will have on stem cell research.
Other supporters included the Center for Genetics and Society, the ProChoice Alliance for Responsible Research, Planned Parenthood Affiliates of
California, and the Women's Foundation of California, all self-described
feminist organizations that support embryonic stem cell research.1 5 These groups
supported SB 1260 in order to prevent undue influence on women to undergo the
11.
12.
13.
14.
15.
This argument is reflective of the libertarian argument regarding the compensation paid to
egg donors in the reproductive context: "Keeping prices low might seem to be a compromise
between banning sales and embracing them, but half measures defy the logic of both
extremes. The same people who complain ova are too valuable to be sold complain that the
market price is obscenely high." Kerry Howley, Ova For Sale, REASON ONLINE, Oct. 2006,
availableat http://www.reason.com/news/printer/36867.html.
California Family Council, http://www.californiafamily.org/Site/leg-billdetails.asp?BilllD
=346 (last visited Feb. 9, 2007).
See id. at http://www.califomiafamily.org/Site/cfc-about.asp (last visited December 20,
2006). This portion of the website describes the purpose of the organization. CFC "strongly
opposes" embryonic stem cell research because it violates one of the group's foundational
pillars of protecting the "pre-bom."
Id. at http://www.californiafamily.org/Site/leg-billdetails.asp?BilIID=346.
SB 1260 Health Comm. Analysis, supra note 6, at 10 (listing the supporters and opponents of
the legislation); see generally Center for Genetics and Society, http://www.genetics-andsociety.org (last visited Feb. 9, 2007); Planned Parenthood Affiliates of California,
http://www.ppacca.org (last visited Feb. 9, 2007); Women's Foundation of California,
http://www.womensfoundca.org (last visited Feb. 9, 2007).
THE VALUE OF THE HUMAN EGG
process of oocyte retrieval
for research
purposes.1 6 They argued
that
compensation beyond direct expenses would likely create a tempting financial
incentive, "especially [for] economically vulnerable women, who may put
themselves at risk in exchange for payment." 17 In contrast to egg donors for
reproductive purposes who tend to be white, well-educated, and well-paid,
supporters of the bill argue that stem cell researchers would turn to poor women
who may disregard medical risks because of their need for money. 18 In this way,
proponents are also concerned about protecting women from a procedure that
carries unknown long-term consequences. 19 The rationale claimed by these
groups can be said to reflect a paternalistic desire to protect those whom they
consider unable to protect themselves.
Opponents countered that the prohibition on compensation would unduly
burden embryonic stem cell research, specifically SCNT, and would render these
oocyte donors an exception to traditional regulations of human research subjects.
Among others, the American College of Obstetricians and Gynecologists
("ACOG") and the American Society for Reproductive Medicine ("ASRM")
argued that the compensation ban was unnecessary and would stall important
These concerns point to the singling out of this
scientific discoveries.
procedure for unwarranted reasons.
II.
SOMATIC CELL NUCLEAR TRANSFER RESEARCH
Oocytes are needed for controversial cloning research, which appears to be
the reason interest groups and legislators have enacted a special compensation
rule for oocyte donation for research. To understand the issues actually at play in
SB 1260's restriction on compensation, we first must understand both the
potential and the controversy surrounding the science that the supporters of the
law fear. The following section describes the immense potential of SCNT
research to understand and treat human disease, the scientific process that
constitutes SCNT, and possible alternatives to SCNT research.
16.
17.
18.
19.
20.
See SB 1260 Health Comm. Analysis, supra note 6, at 8 (this point was specifically
articulated by the Center for Genetics and Society).
Hearing on SB 1260 before the Assembly Comm. on Appropriations,2006 Leg. 2 (Cal.
2006).
Lee Romney, New Battle Lines Are Drawn Over Egg Donation, L.A. TIMES, Sept. 13, 2006,
at A27. This hypothesis that there may be a socio-economic difference between reproductive
and research donors will be explored infra. Briefly, it is grounded in the science of the two
procedures. Unlike in reproductive egg donation where the DNA of the egg donor will be
expressed by a potential offspring, research using donated eggs does not use the nuclear
DNA of the donor. NAS GUIDELINES, supra note 6, at 34.
See SB 1260 Health Comm. Analysis, supra note 6, at 6. Yet, in other contexts, such as Phase
I clinical trials, research participants are subjected to unknowable levels of risk because the
drugs have never been tested in humans before. For a discussion of informed consent, refer
to Section II.E, infra.
ACOG Veto Letter, supra note 9; ASRM Veto Letter, supra note 9.
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
A. The potential of SCNT research
Many consider human embryonic
stem ("hES") cells the "most
fundamental and extraordinary of the stem cells." 21 They differ from adult stem
cells 22 and other cell types because they are pluripotent 23 and have the ability in a
laboratory to proliferate without differentiating 24 for a year or more. 25 As a
result, hES cells present "unprecedented access" to the most fundamental
components of the human body: the cells and tissues. 26 These embryonic stem
cells give scientists information about how humans grow from a single cell into a
healthy adult and how healthy cells have the potential to supplant an adult's
diseased or damaged cells. 27 This prospect suggests the possible development of
regenerative
medicine, the use of cell-based therapies as treatments for human
28
diseases.
Embryonic stem cells are a unique discovery with the power to unlock
causes of and treatments for many human illnesses. 29 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. 30 These are some
of the most debilitating diseases known to modem 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
31
suffering for the individual and his or her family.
21.
NAS GUIDELINES, supra note 6, at 15.
22.
Adult stem cells are housed in tissues ranging from brain to muscle to bone marrow and can
regenerate cells that are destroyed through disease or normal biological processes of life.
23.
24.
25.
26.
27.
28.
29.
30.
31.
NATIONAL INSTITUTES OF HEALTH, STEM CELL BASICS, § IV, available at
http://stemcells.nih.gov/info/ basic (last visited Feb. 10, 2007) [hereinafter STEM CELL
BASICS].
Id. at § III, 6. Pluripotent refers to the ability to develop into any type of cell in the human
body. Stedman's Medical Dictionary Online, http://www.stedmans.com [hereinafter
Stedman's].
Differentiation is the "process whereby an unspecialized cell acquires specialized features,
such as those of a heart, liver, or muscle cell." NAS GUIDELINES, supra note 6, at 29.
STEM CELL BASICS, supra note 22, at § II. hES cells have been described as "immortal" and
having "almost unlimited developmental potential." DEPARTMENT OF HEALTH AND HUMAN
SERVICES, REGENERATIVE MEDICINE I (August 2006), http://stemcells.nih.gov/info/
scireport/2006report.htm [hereinafter REGENERATIVE MEDICINE].
REGENERATIVE MEDICINE, supra note 25, at 4.
NAS GUIDELINES, supra note 6, at 29.
Id. at 30.
PRESIDENT'S COUNCIL ON BIOETHICS, HUMAN CLONING AND HUMAN DIGNITY: AN
ETHICAL INQUIRY 130 (2002), http://www.bioethics.gov/reports/cloningreport/index.html
[hereinafter PCBE CLONING].
Id. at 129.
Id. One opinion in the Presidential Commission on Bioethics concluded that "[t]he inspiring
example of exceptional persons who bear bravely the great burdens of illness or injury
should not blind us to the powerful warrants for research and therapy that might lift these
burdens." Id. While many of these afflicted individuals carry on nobly, it is also noble, and
imperative, to utilize every resource and method available to researchers to find treatments
and cures for these diseases and injuries. Id. at 130.
THE VALUE OF THE HUMAN EGG
SCNT is a novel and unique research method used to investigate and
potentially to treat these genetic diseases. 32 To understand a disease fully,
scientists must investigate its molecular and cellular processes and analyze its
development. 33 In vitro modeling at a cellular level would assist the study of
disease, 34 and this methodology represents SCNT's "most valuable and unique
benefits." 35 Because SCNT enables researchers to target specific diseases, it is
more useful than typical stem cell research, which uses fertilized eggs.
Several main avenues of research may be conducted using SCNT
procedures. These include increasing knowledge of human disease, developing
new treatments for diseases, creating cell-based therapies, and growing immunocompatible transplant tissues. 36 Most significantly, human diseases can be
investigated at a genetic level in a way never possible before SCNT.37 A primary
goal of all types of stem cell research is to understand the process through which
unspecialized cells become specialized and to understand when and how genes
control this process. 38 Currently, it is thought that somatic cells donated by
individuals with certain diseases, or those with a genetic predisposition for
39
certain diseases, could be used for SCNT research to enable these discoveries.
Some experts believe that SCNT in vitro research so improves traditional genetic
and neurodegenerative disease modeling that it could substantially reduce the
time necessary to devise new treatments for diseases for which there is currently
no cure.
32.
33.
34.
35.
36.
37.
38.
39.
40.
4
0
Id. at 130. This commission used the term "cloning-for-biomedical-research." Id. Others use
the term "nuclear transfer" ("NT"). NAS GUIDELINES, supra note 6, at 2, 119. This paper
will use "SCNT" and "NT" interchangeably.
PCBE CLONING, supra note 29, at 130.
Id.
Id. This type of research has been shown to be promising. Several groups of researchers have
used NT blastocysts to derive pluripotent embryonic stem cells from mice. NAS
GUIDELINES, supra note 6, at 34 (citing Kawase et al., 2000; Munsie et al., 2000; Wakayama
et al., 2001). Other scientists have proved the principle of ameliorating conditions of a
genetic disease by transplanting mouse NT embryonic stem cells that had been genetically
repaired into an immuno-deficient mouse. Id. at 34-35 (citing Rideout et al., 2002). It has
also been shown that NT embryonic stem cells have differentiated normally in laboratory
mice and contributed extensively in chimera adult tissues. Id. at 35 (citing Wakayama et al.,
2001).
See, e.g., PCBE CLONING, supra note 29, at 130-33; NAS GUIDELINES, supra note 6, at 2;
STEM CELL BASICS, supra note 22, at § VI.
See PCBE CLONING, supra note 29, at 130.
STEM CELL BASICS, supra note 22, at § VI. Pathological cell division and differentiation is
the cause of some of the gravest medical conditions, such as cancer and birth defects. Id.
See PCBE CLONING, supra note 29, at 130-31. The traditional method of modeling involved
the injection of the human disease-causing gene into either a human or animal cell, in order
to observe a cell system with the genetic abnormality. Id. at 130. Human cellular components
and tissues are generally more useful than animal cells when working with human diseases.
Id. Rather than injecting abnormal genes into normal cells, research benefits from a process
that begins with abnormal cells. Id. For example, to study Parkinson's disease most
effectively, it is preferable to investigate cells with genes that have a predisposition to the
disease. Id.
Id. at 130-31. Parkinson's disease is illustrative of how SCNT research functions for this
purpose. Scientists already know that individuals who suffer from early-onset Parkinson's
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
B. The methodology of SCNT
Somatic cell nuclear transfer is the process of combining two cells for the
purpose of growing one cell with particular genetic characteristics. 41 First,
scientists remove the nuclear genome (the chromosomes) of an oocyte, which is
the female gamete. 42 Without chromosomes, which contain genes, the result is
not a cell, but what may be termed an "ovaplast" or "ooplast. 'A3 Researchers then
take the nucleus of a specialized somatic cell, containing its own DNA, and
transfer it into the ovaplast. 44 This nuclear transplantation creates a genetically
reconstructed oocyte, 5 formed with the intent of creating somatic cells and not
offspring.46 The result is an "ovasome. 47 Researchers can then activate the
disease carry two genetic mutations that cause increased aggregation of alpha-synuclein. Id.
at 130. In order to understand disease progression, appropriate laboratory modeling is
required. Id. SCNT provides a significantly improved way to accomplish this. Id. at 131. It
may then be possible for scientists to derive hES cells from SCNT blastocysts produced from
donations of somatic cells from individuals who have mutant genes. Id. Once this occurs,
researchers could potentially differentiate these hES cells in vitro into dopamine-producing
nerve cells. Id. At this stage, researchers would have a vastly superior model of the metabolic
process of alpha-synuclein and its impact on the progression of Parkinson's disease. Id.
41. Ethics Committee of the American Society for Reproductive Medicine, Human Somatic Cell
Nuclear Transfer (Cloning), 74 FERTILITY & STERILITY 873, 873 (Nov. 2000) [hereinafter
Human SCNT]; NAS GUIDELINES, supra note 6, at 34. Since the birth of Dolly the sheep
there has been intense debate about the ethics of reproductive cloning. Human SCNT, supra
note 41, at 873. This debate spans the spectrum, including those who find it morally
reprehensible in all circumstances, those who reason that certain situations may call for the
use of reproductive SCNT, and others who refrain from deciding the ethical status of the
procedure for reproductive purposes. Id. However, some experts in the field argue that the
ethical quandary regarding reproductive SCNT should not prohibit research into genetic and
therapeutic uses of SCNT, which do not involve growth of embryos in utero, provided that
the research is conducted in an ethical manner. Id. at 875. This distinction between
reproductive and therapeutic cloning has been made to educate the public that SCNT can be
utilized for different purposes. It is not intended to imply that these are scientifically
accepted terminology. J.B. Guordon & A. Colman, The Future of Cloning, 402 SCIENCE
743, 743-6 (1999).
42. NAS GUIDELINES, supra note 6, at 34; see also Ann A. Kiessling, What is an Embryo, 36
CoNN. L. REv. 1051, 1090 (2004) [hereinafter Kiessling, Embryo]. This leaves a sphere of
organelles, structural proteins, enzymes, and nutrients, scientifically referred to as
"ooplasm." Kiessling, Embryo, supra note 42, at 1091.
43. Kiessling, Embryo, supra note 42, at 1091. Kiessling argues that to call the structure by
another name would incorrectly suggest that it is capable of developing into an embryo. Id.
44. NAS GUIDELINES, supra note 6, at 34; see also Kiessling, Embryo, supra note 42, at 1091.
45. Kiessling, Embryo, supra note 42, at 1091.
46. Id. at 1092.
47. Id. Kiessling argues that "[s]ince a single nucleus is transplanted into the egg, cloning is an
accurate term for the process, but the word 'clone' has come to mean the creation of an
offspring genetically identical to an adult. The term is also loaded with the specter of
eugenics and genetically engineered individuals. Several lines of reasoning argue against
calling such a somatic-cell-ovaplast-construct an 'embryo.' First, by definition, they do not
go through a zygote stage because they are not fertilized by sperm and the transplanted
nucleus undergoes remodeling to a single, large pronucleus, reminiscent of the parthenote.
Second, they would only become embryos in the classical sense if they are transferred to the
uterus and initiate implantation. At this stage they could rightfully be termed 'embryos.'
Since the derivation of pluripotent stem cells will be the goal for human somatic-cellovaplast-constructs, they will never achieve 'embryo' status." Id. at 1091-92. Kiessling
THE VALUE OF THE HUMAN EGG
ovasome to begin the cellular division necessary to form a blastocyst. 48 It grows
comprising between
to a blastocyst, a primitive and undifferentiated structure
49
organs.
or
tissues
specialized
no
with
cells
100 and 200
This SCNT blastocyst is distinct from blastocysts generated by the
reproductive process wherein a sperm fertilizes an oocyte. In contrast, the
blastocyst created by SCNT is genetically identical to the donor of the somatic
cell. 51 Notably, this SCNT blastocyst retains no chromosomes from the oocyte
donor. 52 However, the oocyte provides the internal cellular structures,53including
the mitochondria, which contribute only minimal genetic information.
Overall, the genes from the somatic cell's nucleus provide the overridingly
important genetic makeup of the new cell, since the somatic cell's genes are
responsible for the vast majority of the developing cell's characteristics. 54 It is
also important to note that the result is not the creation of a unique human being
with a novel combination of genes from two parents. 55 This distinction between
SCNT and in vitro fertilization ("IVF") may be significant for some people; it
may therefore be more politically acceptable to create blastocysts for research
56
purposes.
The result of the process is not an "embryo.
57
What is created grows from
a single cell product of SCNT, a "somatic-cell-ovaplast construct. ' 58 It
completes only the earliest stages of development, until the blastocyst stage. 59 At
"proposed a totally new term, 'ovasome' to be applied to the creation of somatic-cellovaplast-constructs solely for the purpose of deriving pluripotent stem cells. Other terms may
be preferred. Unless they are transferred to a uterus, they will not, in any event, become
human embryos." Id. at 1093. However, commentators have criticized this proposed name
because they argue it ignores the possibility that the ovasome could develop into a cloned
human. Id. at 1091. Kiessling acknowledges that while the term is not ideal, there is a need
for better terminology to accurately describe and distinguish the science from reproduction.
Id. at 1092.
48. NAS GUIDELINES, supra note 6, at 34.
49. PCBE CLONING, supra note 29, at 135.
50. See id.
51. Id.
52. See id.
53. Id.
54. Id. "If such a blastocyst were transferred to a uterus, the transferred blastocyst could
potentially develop into a live-born offspring-a clone of the nuclear donor." Id.
55. Id. at 16.
56. Id. (citing NATIONAL INSTITUTES OF HEALTH, HUMAN EMBRYO RESEARCH PANEL, 1994).
57. Kiessling, Embryo, supra note 42, at 1064 ("no other word involved in the debates about
harnessing the power of the human egg to remodel chromosomes calls up such an emotional
response as 'embryo."'), 1069-71 ("The wide range of definitions and descriptions of early
human conception presented here reveal the failure of science to provide clear meanings for
these developmental stages. As judicial rulings point out, the need for clear descriptions and
terminology have been dealt with on a case-by'case basis and have yielded a variety of
definitions, and led to somewhat confused terms in new state laws."), 1067 (the new
definition "must incorporate both the wonder and respect deserved by the process that unites
sperm and egg, with the recent advances in harnessing the power of the egg to create
replacement cells with the potential to alleviate multiple human sufferings.").
58. Kiessling, Embryo, supra note 42, at 1092.
59. PCBE CLONING, supra note 29, at 135.
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
60
this point development is halted for research use.
C. Are there alternatives to SCNT research?
Opponents of egg donation for SCNT have pointed to alternative research
methods to avoid the use of human oocytes. However, there exists scant
evidence that the suggested alternatives are equal or superior to SCNT. Possible
alternatives to SCNT methodology include research procedures that use adult
stem cells, human embryonic germ cells, or embryos that cannot produce a live
birth. These alternatives to SCNT invite their own ethical objections.
1. Adult Stem Cells
There has been some promising research and use of adult stem cells for
therapeutic purposes, but overall many barriers exist to the widespread use of
adult stem cells in place of embryonic stem cells. 61 Various tissues in the body
contain adult stem cells, 62 but many are resistant to characterization and
isolation.63 Some scientists hypothesize that certain tissues64 in the adult body do
not maintain their own cohorts of unspecialized stem cells.
Significant differences between adult and embryonic stem cells illustrate
that adult stem cells are not a perfect replacement for research on embryonic
stem cells. Whereas hES cells are pluripotent, have a large propensity for self-
renewal, and can undergo plentiful cell division, adult stem cells are not
65
pluripotent, have slower self-renewal, and have lower proliferation capabilities.
As a result, adult stem cells cannot differentiate into any cell type in the body,
but can create only a limited variety of specialized cells. 66 Thus, most experts
conclude that adult stem cell research should continue as a complement to hES
67
cell research but should not be considered a valid alternative to it.
60.
61.
62.
63.
64.
65.
66.
67.
Id. Not unexpectedly, this complex and novel procedure has yielded low early success rates
of NT-derived embryonic stem cells at less than five percent. NAS GUIDELINES, supra note
6, at 35. This may be expected because of the novelty of the procedure. Just two years ago,
researchers first reported the derivation of hES cell lines using SCNT. Id. (citing W.S.
Hwang et al., Evidence of a PluripotentHuman Embryonic Stem Cell Line Derived From a
Cloned Blastocyst, 303 Science 1669 (2004)). It is expected that this research will become
more efficient, however, since during the procedure improvements were made and resulted
in higher yields of blastocysts. Id. at 36. This research demonstrates the practical
achievement of the theory of generating NT hES cells and encourages scientists that it is
possible to culture genetically specific hES lines. Id.
Id. (citing HANDBOOK OF STEM CELLS: EMBRYONIC STEM CELLS (Robert Lanza et al. eds.,
2004); Wagers and Weissman, Plasticity ofAdult Stem Cells, 116(5) CELL 639 (2004)).
For example, those hematopoietic (blood-forming) adult stem cells can be derived from both
bone marrow and umbilical cord blood. The heart, brain, and skin also have adult stem cells.
Id.
Id. For example, the heart and brain adult stem cells make access difficult. Id.
Id.
Id.
Id. (citing Wagers and Weissman, supra note 61).
Id.
THE VALUE OF THE HUMAN EGG
2. Human embryonic germ cells
Human embryonic germ ("hEG") cells are even more controversial than
hES cells. These hEG cells have been isolated from the primordial gonadal cells
in a fetal cadaver's tissue. 68Human embryonic germ cells possess traits
analogous to those of hES cells, although little research regarding their
capabilities has been conducted.69 While some researchers have ventured into
this territory, hEG cell research is politically controversial in a country in which
the abortion debate continues in the courts and ballot boxes.
3. Embryos that cannot produce a live birth
Lastly, several methods have been proposed to derive hES cells from
embryos that have stopped dividing. One method is extraction of viable
blastomeres, cells that have the potential to give rise to any cell in the body,70
from blastocysts that would not develop on their own because cell division has
stopped. 7 1 However, this method
has not been tested in the laboratory and
72
presents technical challenges.
Another method involves parthenogenesis or androgenesis, in which a
technician activates unfertilized oocytes or sperm cells, respectively. 73 The
resulting ovaplast possesses only female or only male genes and cannot develop
into a human being.74 There is interest in this procedure for two reasons. It might
68.
69.
70.
71.
72.
73.
74.
NAS GUIDELINES, supra note 6, at 16. There are important and unresolved issues as to the
acquisition, distribution, and use of fetal cadavers, especially in the context of the effects of
the use of fetal cadavers on the procedures for and incidence of abortion.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&listuids=8012
729&dopt=Abstract; but see 42 U.S.C. § 289(g) et seq. (forbidding change of abortion
procedure to facilitate fetal donation and mandating that decision to abort be made before
decision to donate fetal remains).
NAS GUIDELINES, supra note 6, at 16.
Kiessling, Embryo, supranote 42, at 1060.
NAS GUIDELINES, supra note 6, at 36 (citing Landry & Zucker, Embryonic Death and the
Creation of Human Embryonic Stem Cells, 114 J. CLINICAL INVESTIGATION 1184 (2004)).
The purpose of the distinction in the Landry-Zucker proposal was to avoid the problem of
researchers causing the death of the blastocysts. This was an attempt to side-step some of the
ethical arguments against using embryos for research. To be clear, blastocysts or morulae
would die as a result of cleavage arrest, which is the failure of the cells in the blastocyst (the
blastomeres) to continue to go through cell division.
Id. The likelihood that scientists would also be able accurately to identify those blastocysts
with no chance of further development, isolate a viable blastomere, and culture hES cells is
very small. Only Delhaise et al. reported isolation and derivation from 8-cell blastomeres to
produce mouse embryonic stem cell lines. Delhaise et al., Establishment of an Embryonic
Stem Cell Line from 8-cell State Mouse Embryos, 34 EUR. J. MORPHOLOGY 237 (1996). In
addition, "one cell line was obtained from 52 fully viable, dissociated 8-cell stage morulae."
NAS GUIDELINES, supra note 6, at 36.
NAS GUIDELINES, supra note 6, at 36.
Id. There have been scientific reports of this procedure being accomplished successfully in
mice and non-human primates to generate ES cell lines (citing M.H. Kaufman et al.,
Establishment of pluripotentcell lines from haploidmouse embryos, 73 J. EMBRYOLOGY &
EXPERIMENTAL MORPHOLOGY 249 (1983); Cielli et al., Establishment of Pluripotent Cell
Lines from Haploid Mouse Embryos AND Parthenogenetic Stem Cells in Nonhuman
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
reduce or eliminate the need to create and destroy blastocysts. Also,
parthenogenetic or androgenetic ES cells might provide another source for
autologous cell therapy. However, serious side-effects accompany this technique
because some genes may malfunction. 75 Moreover, no stem cell lines have yet
been derived in this way; further scientific exploration is required to assess
whether this method of stem cell production is feasible in humans.76
A more promising alternative may be genetic engineering of the nucleus
involved in SCNT to prevent its development into an offspring. 77 This measure
would address concerns about attempts to clone human beings. To ensure that
SCNT would be used to derive pluripotent stem cells for research and treatment,
the nucleus of the somatic cell could be modified to favor the differentiation of
the specialized cell type on which the research is focused.78 This hypothesis has
not been tested with human cells and would nevertheless require manipulation of
viable human oocytes.
D. Conclusion
The use of SCNT to derive hES cells for genetic research is a scientific
procedure filled with incredible promise. Neither current nor proposed
alternatives appear able to replicate what it offers. However, SB 1260 will
significantly curb SCNT's unique promise, based on fears regarding health risks
and economic exploitation. The following sections demonstrate the exaggerated
nature of these concerns.
III. EGG DONATION FOR SCNT RESEARCH
Proponents of SB 1260 maintain that its limits are necessary to regulate
risks inherent in oocyte retrieval and to prevent exploitation of donors. These
contentions raise several questions regarding oocyte donation for genetic
research. Are there feasible alternatives to using donated human oocytes for
SCNT? It appears that all alternative sources of oocytes pose significant
scientific or ethical problems. Who are the potential donors? While it is not
known for certain, it appears that they are not among the most vulnerable ranks
of women. What is the medical protocol for oocyte donation? It does not differ
75.
76.
77.
78.
Primates,295 SCIENCE 819 (2002)).
Id. (citing Allen et al., A FunctionalAnalysis of Imprinting in ParthenogeneticEmbryonic
Stem Cells, 120 DEVELOPMENT 1473 (1994)). Mouse embryonic stem cells derived in this
way show that some of the genes do not work correctly because they are not turned on,
which is correlated with the lack of contribution of genes from a paternal genome. Id. at 36.
Id. at 37.
Kiessling, Embryo, supra note 42, at 1092.
Id. Genetic manipulation of animals has generated a large literature which has provided
invaluable information about the physiological function of specific genes. However, there
have been no experiments with human cells of this favored differentiation. Id. Nevertheless,
these animal studies have offered invaluable information about the physiological function of
specific genes. Id.
THE VALUE OF THE HUMAN EGG
much from the protocol for oocyte extraction for reproductive purposes, which
we tolerate women undergoing repeatedly. How risky is the procedure used to
procure human oocytes? It appears that the risks can be controlled and are less
severe for donors to research than for donors for reproductive purposes. Is
informed consent possible in this context? Especially in comparison to clinical
trials, oocyte donors are able to make an informed decision as to whether to
participate in this research. Responses to these inquiries will inform this article's
look at whether a compensation ban is justified and appropriate in the context of
oocyte donation for SCNT research.
A. Is there an alternative to donated human oocytes for SCNT?
In light of ethical and safety concerns, alternative sources of oocytes for
SCNT research should be investigated and seriously considered as a replacement
for donated human oocytes. The fact that none have yet been identified weakens
the arguments of some SB 1260 proponents that oocyte donation to research is
not necessary. If the law discourages human oocyte donation by prohibiting
compensation for female research participants, it will slow SCNT research.
Oocytes are a basic and necessary resource for the expansion of SCNT.79
Several current and hypothesized sources of oocytes for SCNT merit discussion,
including oocytes from other animals, oocytes from women undergoing IVF,
stem cell lines manipulated to yield oocytes, and oocytes derived from cadaveric
fetal remains. First, while it is relatively easy to derive large quantities of
oocytes from other mammals, there is some concern about deriving stem cells
lines using non-human oocytes. Problems of interspecies mixing within cells
remain unresolved. 8° Second, despite the frequency of IVF treatment, excess
oocytes may not be of high quality, and relying on IVF-produced oocytes creates
the moral hazard of encouraging additional ovarian stimulation to feed
reproductive and research needs. 81 Third, the use of non-reproductive tissue,
such as existing embryonic stem cells, to create cells that resemble oocytes
79.
80.
81.
NAS GUIDELINES, supra note 6, at 37. However, the number of oocytes required will likely
decrease as the expertise of SCNT researchers increases. Moreover, the scale of demand for
oocytes will likely be limited since researchers studying prevention and treatment of genetic
disease do not require an hES cell line unique to each patient.
Id. at 38. Mixing would occur because there would be non-human mitochondria in the
oocytes while the nuclear genome would be completely human. Having human and nonhuman material in the same cells might cause growth and safety problems. These risks would
need to be evaluated prior to using non-human oocytes. Id. (citing Chen et al., Embryonic
Stem Cells Generatedby Nuclear Transfer ofHuman Somatic Nuclei into Rabbit Oocytes, 13
CELL RESEARCH 251 (2003) (creation of alleged embryonic stem cells produced from SCNT
using human nuclear genomes and oocytes from rabbits) However, these findings must be
rigorously studied before this approach could be feasible. Id.).
Id. at 37. While increased hormones during IVF may lead to some excess oocytes available
for donation to research, there are concerns that the oocytes that did not successfully become
fertilized may be of a lesser quality, and not appropriate for the derivation of hES cell lines.
Id. There are further ethical concerns regarding possible changes to the IVF clinical protocol
to purposefully induce higher yields of oocytes than are necessary for reproductive purposes,
even if it were done with the consent of the IVF patients. Id.
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
remains a hypothetical source. 8 2 However, if recent studies can be replicated in
humans, 83 human stem cells could provide "an extensive source" of material for
SCNT.84 Fourth, in vitro maturation of immature oocytes appears promising but
requires further research and policy consensus. 85 Lastly, the current and
foreseeable reality is that SCNT's most reliable source is the direct donation of
oocytes from adult female donors. 86 Yet, as will be discussed infra, this source of
human oocytes sparks concern about health risks, informed consent, and unduly
enticing compensation. 87 On balance, because of the dearth of alternative oocyte
sources, SCNT will be unable to achieve its potential if compensation bans like
SB 1260's restrict the supply of donated oocytes. While this supply argument
provides a compelling rationale against the law, SB 1260 might be valid for
other reasons, such as the vulnerability of the potential donors.
B. Who will donate oocytes for research purposes?
SB 1260 proponents cite the vulnerability of potential donors as a rationale
for a ban on compensation. To evaluate this concern, we must identify these
potential oocyte donors. 8 We must further inquire whether they differ
significantly from the women who donate for IVF purposes and whether these
differences support the restrictions imposed by SB 1260. As the following
discussion demonstrates, because extant evidence regarding oocyte donors
suggests that they are not among the most vulnerable in society, the SB 1260
restrictions reach too far.
1. Altruism and financial reward may motivate research and
reproductive donors
There is little research examining why women donate their oocytes,
82.
83.
Id. at 38.
Id. (citing Hubner et al., Derivation of Oocytes From Mouse Embryonic Stem Cells, 300
SCIENCE 1251(2003)). These reports describe mouse embryonic stem cells that have been
coaxed in culture to develop into cells that resemble oocytes.
84. Id.
85. Id. at 37. These immature oocytes could theoretically be harvested from two sources: ovaries
removed from adult women for therapeutic reasons and ovaries removed from fetal cadavers.
Id. at 37. There has been only limited success in human experiments, which have required
transplantation of the ovarian tissue into an animal in order to stimulate maturation of the
oocytes within the immature ovaries. Id. (citing O'Brien et al., 2003). Extracting ovaries
from aborted fetuses for SCNT would likely pose a significant political hurdle to public
funding for this research.
86. Id. This type of third party donation also exists in some IVF programs for reproductive
purposes. Id. at 37-38.
87. Id. at 38.
88. Currently, there is very little demographic data on oocyte donors for research. The first
documented derivation of hES cell lines using SCNT took place only three years ago. NAS
GUIDELINES, supra note 6, at 35 (citing Hwang et al., 2004). Because this procedure is new
in humans, there have been few experiments using human donors and few, if any, studies of
the characteristics of these women.
THE VALUE OF THE HUMAN EGG
whether for reproduction or research. Existing evidence suggests that the groups
are distinct; women who have donated for general research purposes are not
inclined to participate as donors for IVF programs, and vice versa. 89 Both groups
appear to donate out of altruism, but some who donate for reproductive purposes
may also receive significant financial incentives.
It is likely that research donors provide oocytes because they want to
support treatment and cures for dreaded human diseases. 90 These donors may
suffer from some of the diseases that show the most promise of benefit from
SCNT research, such as Parkinson's disease and Type I (juvenile) diabetes;
donors may also be close to individuals with these diseases. 9 1 This personal
connection may exert a strong influence on the donor's decision to participate in
SCNT research. In addition, research donors not subject to California's laws may
also be motivated by the offer of compensation.
By way of comparison, reproductive donors may also harbor altruistic
sentiments; they may want to help someone who is infertile. Reproductive
donors may also be lured by advertisements offering tens of thousands of dollars
for eggs from a donor who meets preferred criteria. 92 In this way, donors of both
types may be motivated by altruism as well as financial remuneration.
89.
90.
91.
92.
Likewise, in one study, 25% of IVF oocyte donors indicated that they did not want the
embryos created for reproductive purposes to be used for research. Bernard Lo, et al.,
Consentfrom Donors for Embryo and Stem Cell Research, 301 SCIENCE 921 (Aug. 15,
2003) (citing A. Kalfoglou & G. Gellar, A Follow-up Study with Oocyte Donors Exploring
their Experiences,Knowledge, and Attitudes about the Use of their Oocytes and the Outcome
of the Donation, 74 FERTILITY & STERILITY 660 (2000)). Moreover, Kiessling found the
same response in discussions with donors in her program for oocyte donation for research.
Ann A. Kiessling, Remarks at the final session of the Institute of Medicine Public Workshop
on Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research (Sept.
28, 2006) (webcast availableat http://www.iom.edu/CMS/3740/36353.aspx).
Ellen Goodman, Op-Ed., Egg Donationand Morality, BOSTON GLOBE, Apr. 7, 2005, at A23.
Id. (citing the belief of the Bedford Stem Cell Research Center and its director, Dr. Ann
Kiessling, that donors will be those individuals with a family or friend with a serious illness.
Kiessling is quoted as saying, "[w]e are contacted regularly by people who have a serious
illness in their family and would like to help.").
Carl T. Hall, Stem Cell Panel Ponders Hazards of Egg Donation, S. F. CHRON., Sept. 29,
2006, at BI (explaining that egg donors to IVF programs are paid between $5000 - $10,000
for each donation, but that egg donors for research will not be compensated except in the
form of reimbursement of limited expenses); PRESIDENT'S COUNCIL ON BIOETHICS
(President George W. Bush), REPRODUCTION AND RESPONSIBILITY: THE REGULATION OF
NEW BIOTECHNOLOGIES, Ch. 6 (2004), available at http://www.bioethics.gov/reports/
reproductionandresponsibility/chapter6.html (citing various advertisements for potential
reproductive donors, including an offer of between $3,500 and $12,000 from Egg Donation,
Inc., an offer of between $8,000 and $20,000 to Ivy League donors from Tiny Treasures, and
a $50,000 offer in the Stanford Daily); Ada Tso, Despite Risks, Students Profit Selling Eggs
to FertilityClinics, DAILY CALIFORNIAN, Nov. 22, 2005 (reporting that a Berkeley alumna
was paid $65,000 for her eggs). Yet there is "scant documentation that such prices [as
$50,000] are actually being paid." Rick Weiss, Limited Payfor Egg Donors Advised; Report
Proposes a Variety of Other Ethical Standardsfor Infertility Treatments, WASH. POST, Aug.
4, 2000, at A5.
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
2. Scientists and prospective parents may select research and
reproductive donors based on different criteria
Scientists are much less selective than IVF patients. Recipients of donated
oocytes for IVF often attempt to find phenotypic matches so that the donor has a
similar look and background as the female recipient of the oocyte. 93 Recipients
tend to choose a donor based on her physical, genetic, psychological, familial,
and intellectual traits. 94 It is also speculated that some recipients seek oocytes
from donors with what the recipients consider "better" phenotypic and
behavioral characteristics. 95 IVF patients typically find potential donors through
brokerages 96 or individual advertisements. 97 These methods have often targeted
college women at prestigious universities offering tens of thousands of dollars,
seeking to capitalize
on students' youth, presumed well-roundedness, and
98
financial needs.
In contrast to the demands made by IVF recipients, SCNT researchers only
require that the oocytes contain healthy cytoplasm. 99 Like reproductive donors,
research donors must be healthy women capable of undergoing several weeks of
medically invasive procedures. However, research donors' genetic makeup is
irrelevant. A research donor will contribute oocytes from which the nuclei will0
0
be removed, which means her genes will not be a part of the SCNT research.'
93.
94.
95.
96.
97.
98.
99.
100.
Kenneth Baum, Golden Eggs: Toward the Rational Regulation of Oocyte Donation, 2001
B.Y.U. L. REv. 107, 119 (2001). The theory behind this matching is that if potential donors
shared these characteristics, it would be more likely that the offspring would as well, and
hence better "fit the family mold." Id.
Id. at 107-09, 117. Some of the most common characteristics solicited by recipients are: age,
height, intellect (in the form of SAT scores), athleticism, education, and family medical
history.
Although recipients put much emphasis on these characteristics, science does not show a
clear link between these traits and those of the resulting offspring. Matching donors and
recipients springs from a confusion of genotype and phenotype, a "fail[ure] to appreciate the
limitations of genetic determinism, and [ignorance of] the implications of multi-factorial
inheritance." Id. at 119-20. Moreover, it is believed that one of the best indicators of success
in IVF is previous fertility of the donor.
Marsha J. Gorrill et al., Qocyte Donor Screening: The Selection Process and Cost Analysis,
75 FERTILITY & STERILITY 400, 401 (Feb. 2001). There are many for-profit organizations
that recruit oocyte donors and provide them to IVF clinics on an as-needed basis. Id.
Baum, supra note 93, at 116. There are also guidelines established by the American Society
for Reproductive Medicine. See Ethics Committee of the American Society for Reproductive
Medicine, Financial Incentives in Recruitment of Oocyte Donors, 82 FERTILITY &
STERILITY (SUPPL.) S240 (Sept. 2004), available at http://www.asrm.org/Media/Ethics/
fmancial-incentives.pdf [hereinafter ASRM, Financial Incentives].
Baum, supra note 93, at 108-09. One such ad ran in student newspapers in 1999 at Harvard,
Yale, Princeton, Columbia, Stanford, MIT, Cal Tech, and the University of Pennsylvania.
Irene Sege, A $50,000 Dilemma On Campus: Top Students Wrestle With Egg Donor Lure,
BOSTON GLOBE, Mar. 6, 1999, at Al.
See NAS GUIDELINES, supra note 6, at 34.
See id.
THE VALUE OF THE HUMAN EGG
In fact, because SCNT research focuses on deriving embryonic stem cell lines
with a genetic predisposition to a specific disease, it is the specialized somatic
cell donor who must be screened for the targeted genotype. 1° 1 Because research
donors need only provide healthy cytoplasm, there are no preferences for certain
genotypes or phenotypes. Consequently, the potential pool of donors is large.
3. Little data is available on the education and socioeconomic status of
reproductive or research donors
There is little evidence about the demographic characteristics of either
group. More research is necessary before the harsh limitations of SB 1260 are
warranted. For reproductive purposes, donors tend to be: 1) women who are
currently undergoing IVF themselves and are willing to share some of the
oocytes they produce, 102 2) women undergoing unrelated gynecological surgery
who are willing to have eggs removed at the same time, 10 3 or 3) women
presumed to be fertile who volunteer or are recruited solely to become egg
donors. 1°4 The most common donor type for IVF is the third category. 10 5 These
reproductive donors are often "college-educated, working mothers who are
frequently married with children."' 0 6 That these women are typically collegeeducated may provide some information as to their socio-economic status, but
education is not a definitive indicator. A college education could signify that the
woman is at least middle class, but taken alone requires generalization and
stereotyping, as well as disregard of scholarship and loan programs which
provide access to higher education for individuals from lower socio-economic
classes. Moreover, because oocyte donors for reproductive purposes may be paid
upwards of $10,000,107 extra income may be a significant motivating factor.
101.
102.
103.
104.
105.
106.
107.
See id.
This procedure is commonly called "egg sharing." Two infertile women share the costs so
that one of them may go through oocyte stimulation and retrieval. A preplanned portion of
the harvested oocytes, selected at random, are given to the non-donor, while the donor keeps
the rest for her own in vitro fertilization. There are concerns about this procedure because
the infertile donor's probability of pregnancy will be decreased because she will have access
to fewer oocytes. Gorrill, supra note 96, at 400.
This form of donation has proved to be impractical since studies have shown that most
women undergoing these surgeries were not eligible to donate, largely because of advanced
age. Id.
Id.; Katheryn D. Katz, Ghost Mothers: Human Egg Donation and the Legacy of the Past, 57
ALB. L. REV. 733, 772 (1994).
Katz, supra note 104, at 772.
Gorrill, supra note 96, at 401 (citing Mark V. Sauer & R.J. Paulson, Oocyte Donors: A
Demographic Analysis Of Women At The University of Southern California, 7 HUMAN
REPRODUCTION 726 (1992) and R. Lessor et al., An Analysis Of Social And Psychological
Ccharacteristics Of Women Volunteering To Become Oocyte Donors, 59 FERTILITY &
STERILITY 65 (1993)); see also Andrea L. Kalfoglou & Joel Gittelsohn, A qualitative
Follow-Up Study Of Wwomen's Experiences With Oocyte Donation, 15:4 HUMAN
REPRODUCTION 798 (2000) (providing additional demographic data on reproductive oocyte
donors).
Hall, supra note 92.
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
Financial need suggests that reproductive donors might come from lower socioeconomic classes. While reproductive donors are typically college-educated,
their typical socio-economic status is difficult to determine.
There is even less data relating to the demographic characteristics of
women who become research donors.108 The SB 1260 restrictions therefore seem
to be a solution in search of a problem. It may be inferred, however, that research
donors as a group are less educated than reproductive donors. This hypothesis is
based on the tendency of SCNT researchers to advertise in wide-circulation
newspapers to gain access to a larger audience of potential donors, whereas
much recruitment for IVF programs takes place on elite college campuses and in
university newspapers. Thus those who seek to obtain oocytes for IVF target
individuals with highly desired characteristics. As mentioned supra many
recipients of oocytes donated for reproductive purposes require specific traits,
such as high SAT scores, to qualify. 10 9 As a result, it may be important to design
informed consent procedures based on the fact that research donors may have
less education than reproductive donors.
In sum, it is unclear to what socio-economic status most research donors
belong. Currently, solicitations for reproductive donors offer tens of thousands of
dollars for their participation. Without data as to whether compensation has
proven unduly enticing to reproductive donors, commentators are left to
speculate. It seems unlikely that compensation would be found to be unduly
enticing. Similarly, it is improbable that compensation to research donors would
be unduly enticing. In light of this uncertainty, prohibition on compensation to
research donors creates an exception to the standard practice for reproductive
donors and typical research subjects without factual justification. It is
consequently premature to cap compensation to research donors for fear of
undue economic enticement.
4. More information about how research and reproductive donors
differ is needed to design appropriate research protocols
Any identified socio-economic differences between oocyte donors for
research and reproductive purposes must be considered because they may affect
the reasonability of proposed public policy. Some observers believe that poor
women may be disproportionately enticed into donation, but others argue that
informed consent procedures sufficiently protect potential donors from undue
enticement. 110 The effect of this potential difference will be considered more
fully infra, in discussing whether women should be allowed to participate in
oocyte donation for research purposes, what types of protections should be
afforded to women considering this procedure, and whether there should be any
form of compensation. Moreover, other factors such as respect for women's
108.
109.
110.
See NAS GUIDELINES, supra note 6, at 35 (citing Hwang et al., 2004).
Baum, supra note 93, at 107.
See PCBE CLONING, supra note 29.
THE VALUE OF THE HUMAN EGG
autonomy to make their own decisions, the power of the informed consent
processes to equip subjects with sufficient understanding to make knowing
decisions, and the severity and prevalence of negative health consequences from
the donation process weigh on policy choices as to whom, if anyone, should be
allowed to donate for research purposes.
C. The medical protocol for oocyte donation for research
Oocyte donation is an arduous process. Women undergo basically the same
procedures whether they donate to reproduction or research. Women can be
handsomely compensated for this time and trouble if they donate their oocytes to
IVF patients. Under SB 1260, they cannot be paid if they donate to SCNT
research. Because oocyte donation is difficult, SB 1260's prohibition on
compensation for women who donate their eggs for research is unjustified.
To begin with, the protocols medical professionals follow when a woman
donates oocytes for either reproductive or research purposes are almost the
same."' However, certain reproductive procedures are often unnecessary in the
research context. 12 Also, the donor screening procedures in the reproductive
setting relate to the safety of the donor, recipient, and
child, whereas donor
3
safety is the main consideration in research screening.''
Generally, both types of donors undergo medical, physical, and
psychological evaluations. 14 Both kinds of donors also receive daily
subcutaneous hormone injections for a period of seven to ten days to stimulate
111.
112.
113.
114.
See generally American Society for Reproductive Medicine, Guidelines For Oocyte
Donation, 82 FERTILITY & STERILITY S13-15 (Sept. 2004) (procedures for extracting
oocytes do not differentiate between those destined for research and those intended for
reproduction) [hereinafter ASRM, Guidelines For Oocyte Donation]; see generally Zev
Rosenwaks, Similarities and Differences in the Process of Oocyte Donation: Clinical v.
Research, Address at the Institute of Medicine Public Workshop on Assessing the Medical
Risks of Human Oocyte Donation for Stem Cell Research (Sept. 28, 2006) (webcast
available at http://www.iom.edu/CMS/3740/36353.aspx) (Power Point slides on file with
author), at slides 15-17. The most recent data regarding the number of assisted reproductive
technology cycles using donor oocytes show that 9,261 cycles used fresh donor eggs and
3,922 cycles used frozen donor eggs.The total number of ART cycles in the U.S. by 2003
was 115,392. Linda Guidice, Overview and Historical Perspectives of Oocyte Donation:
Medical Therapy and Biomedical Research, Address at the Institute of Medicine Public
Workshop on Assessing the Medical Risks of Human Oocyte Donation for Stem Cell
Research (Sept. 28, 2006) (webcast available at http://www.iom.edu/CMS/3740/36353.aspx)
(Power Point slides on file with author), at slide 20.
For instance, for IVF with donated oocytes, the recipient and the donor must have their
menstrual cycles synchronized. Rosenwaks, supra note 11, at slides 15-17. This requires
additional hormonal manipulation, in the form often to fourteen days of injections to supress
ovulation, in addition to the chemicals needed to stimulate oocyte production. Baum, supra
note 93, at 117-18.
See Rosenwaks, supra note 111, at slide 16. However, in the research setting it may be
necessary to consider the potential stem cell therapy recipient's safety. This concern will be
present whenever there will be a direct therapeutic application at any point in the future. Id.
at slide 11.
See ASRM, Guidelines ForOocyte Donation, supra note 111, at S 13.
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
multiple ovarian follicles. 115 These ovarian stimulants cause production of an
"abnormally large" amount of oocytes during the stimulated menstrual cycle. 116
The progress of both kinds of donors is monitored through ultrasound." 7 Once
the donor's oocytes have fully matured, a final injection of human chorionic
gonadotropin ("HCG") prepares the matured oocytes for removal.' A physician
removes the oocytes from the donor during an out-patient surgical procedure for
which anesthesia is required. 19 The physician inserts a long needle guided by
ultrasound through the vagina and into the donor's ovaries.
The doctor
suctions the oocytes into the needle and deposits them into test tubes. 121 It is
estimated that women who undergo oocyte donation spend "56 hours in the
medical setting, undergoing interviews, counseling, and medical procedures
related to the process. ' 22 Thus both reproductive and research donors undergo a
similar series of medical interventions.
The arduousness of the process argues strongly against SB 1260's
reimbursement limit and compensation prohibition. Egg donors for research are
no different from participants in any other kind of human subject research, who
are routinely compensated for time and trouble. 23 The oocyte donors'
commitment and the procedure's intensiveness justify reimbursement of direct
expenses and lost wages, at a minimum, but also justify fuller compensation for
undergoing a procedure that affords the donor no direct benefit.' 24 SB 1260's
exceptionalization of research egg donors from the traditional human subject
compensation scheme raises a question left unanswered by SB 1260 proponents:
what justifications exist for treating these women differently? Neither donor
demographic characteristics nor the medical procedures they undergo justify
disparate treatment of oocyte donors for research. In addition, the same egg
donation is compensated generously in the reproductive context but not at all in
the research context. It is illogical to prohibit compensation to research donors in
the name of donor protection, especially in light of their contribution to a larger
societal goal of curing serious diseases.
In sum, the medical procedures that the donor undergoes are virtually the
same whether her oocytes go to IVF patients or to SCNT research. In the case of
115.
116.
117.
118.
119.
120.
121.
122.
123.
Robert Steinbrook, Egg Donation and Human Embryonic Stem-Cell Research, 354:4 NEW
ENG. J. MEDICINE 324 (Jan. 26, 2006).
Baum, supra note 93, at 118.
Id.
Id.
Steinbrook, supra note 115, at 324; Baum, supra note 93, at 118.
Steinbrook, supra note 115, at 324; Baum, supra note 93, at 118.
Baum, supra note 93, at 118.
ASRM, FinancialIncentives, supra note 97, at S243.
See, e.g., Neal Dicker & Christine Grady, What's the Price of a Research Subject?
Approaches to Paymentfor Research Participation,341 NEW ENG. J. MED. 198-203 (1999)
(discussing different compensation models for human research subjects).
124.
See generally Hall, supra note 92 (stating that there is no direct benefit to research oocyte
donors, either through personal medical benefit or the satisfaction of helping an infertile
couple have a baby).
THE VALUE OF THE HUMAN EGG
research, she may jump through fewer hoops because it is not necessary to
establish a match between her characteristics and that of a donor. Because the
procedures that any donor goes through are long and arduous, proponents of SB
1260 are misguided in trying to limit payment to donors to research.
D. The risks of oocyte donation
An analysis of the risks associated with oocyte donation is crucial to a
consideration of whether SB 1260's prohibition on compensation is justified.
The discussion must evaluate whether the risks described by the proponents are
real, exaggerated, or based on outdated or faulty analysis.' 25 Medical risks must
be weighed against the promise of SCNT for understanding and treating disease
in light of scant alternatives to SCNT and human oocyte donation. Because the
medical benefits possible through SCNT are unique and potentially life-saving
on a large scale, and because there are few viable alternatives to human oocyte
donation, we must consider whether the medical risks to donors are acceptable.
The current lack of alternatives to human oocyte donation may influence this
balancing of benefits and risks. Based on this analysis, the banning of
compensation for oocyte donation for research purposes may not be prudent
public policy.
The question becomes: what level of risk is acceptable? 126 First, it is
necessary to examine the risks involved in donation for research. There are
several different types of risk that women may be exposed to as part of the
process of human oocyte donation. These include risks of Ovarian
Hyperstimulation Syndrome ("OHSS"), future infertility, and cancer.
1. Ovarian Hyperstimulation Syndrome
27
OHSS has been called the principal risk involved in oocyte donation.
OHSS may be mild, moderate, or severe. Physicians report that even moderately
128
severe OHSS can be a "devastating, frightening experience for a donor."'
Women with particular characteristics are at risk. However, researchers can
125.
126.
127.
128.
Most of the studies to date have focused on oocyte donation in a clinical, reproductive
context and not for research purposes. However, the procedural risks appear to be about the
same in the two settings. Rosenwaks, supra note 111, at slides 19-21 (less risk of OHSS for
research donation), 35, 38. In both settings, it is important to select oocyte donors carefully,
with special attention paid to the characteristics that will influence a donor's mental and
physical well-being. Id.
As to the level of risk we are willing to tolerate it must be recognized that thus far society has
tolerated risk for women who want to become pregnant. For example, infertile women who
contribute their own oocytes for IVF procedures often undergo repeated stimulations in order
to have a child. In the research context, it is unlikely that women will repeat the procedure.
And it is repetition of hormone cycles that carries the possibility of substantially increasing
the occurrence of side effects in reproductive donors.
Rosen, supra note 111, at slide 27.
Rosenwaks, supra note 111, at slide 27. Treatment of moderate to severe OHSS involves
hospitalization, IV fluids, and removal of fluid from the abdominal cavity. Id.
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
employ certain techniques to make the process safer.
Generally, OHSS is characterized by increased size of the ovaries,
increased vascular permeability, and gastrointestinal symptoms. 129 One study of
the prevalence of OHSS amongst reproductive donors found that 4.5 percent of
the donor cycles surveyed had mild to moderate OHSS, requiring one office visit
for treatment. 130 Moderate OHSS classified as requiring two to four office visits
occurred in only 2.1 percent of those assessed.131 Only two donors (0.26 percent)
32
exhibited moderate OHSS requiring hospital admission for observation.'
Moderate OHSS which included torsion 133 and required hospital admission and
surgery occurred in only one donor, or 0.13 percent of cases. 134 In this study,
there were no incidences of severe OHSS. 135 While OHSS is decidedly
undesirable, severe cases are rare.
It is important to understand the factors that may lead to increased risk and
what measures can be taken to reduce risk. 13 6 Factors which may increase risk of
OHSS include young age, ovary abnormalities, 137 low body weight, a history of
allergies, and underlying thrombophilia, a condition which can cause excessive
blood clotting.' 38 Experts conclude that with appropriate individualization of the
process for each donor-patient, monitoring,
and use of preventative measures,
39
the risk of OHSS can be minimized.1
129.
Id.; Marcelle Cedars, Oocyte Donation for Research: the Risk of Ovarian Hyperstimulation
Syndrome (OHSS), Address at the Institute of Medicine Public Workshop on Assessing the
Medical Risks of Human Oocyte Donation for Stem Cell Research (Sept. 28, 2006) (webcast
available at http://www.iom.edu/CMS/3740/36353.aspx) (Power Point slides on file with
author), at slide 3. Mild OHSS is classified by elevated sex steroids and ovarian enlargement
of less than 5 centimeters. Rosenwaks, supra note 111, at slide 25 (citing NAVOT ET AL.,
REPRODUCTIVE ENDOCRINOLOGY, SURGERY, AND TECH. 2216 (1996)). Moderate OHSS
includes the symptoms of mild OHSS plus ovarian enlargement between 5 and 12 cm,
abdominal distension, "nausea, vomiting, diarrhea," id., as well as normal blood counts and a
minimal amount of abdominal fluid. Cedars, supra note 129, at 4 (citing Botros Rizk &
Mohamed Aboulghar, Modern Management Of Ovarian Hyperstimulation Syndrome, 6
HUMAN REPRODUCTION 1082 (1999)). Severe OHSS is characterized by excessive weight
gain, fluid accumulation in the abdomen and chest, respiratory difficulty, over-concentration
of red blood cells in the blood, and in rare cases the development of blood clots and kidney
failure. See Rosenwaks, supra note 111, at slides 25-26.
130. One study by the Comell Institute for Reproductive Medicine observed 764 donor cycles and
analyzed the prevalence of OHSS at different classifications. Rosenwaks, supra note 111, at
slide 28.
131. Id.
132. Id.
133. Torsion is "[a] twisting or rotation of a part upon its long axis or on its mesentery; often
associated with compromise of the blood supply." Stedman's, supra note 23.
134. Rosenwaks, supra note 111, at slide 29.
135. Id.
136. See generally id. at slide 29.
137. Id. at slide 33. Ovary abnormalities include polycystic ovary syndrome, polycystic-like
ovaries, and oligomenorrhea (infrequent or very light menstruation in a woman with
previously normal periods). See id. at slide 30; Cedars, supra note 129, at slide 11.
138. Cedars, supra note 129, at slide 10. Thrombophilia refers to a group of conditions involving
an increased tendency for excessive blood clotting. Rosenwaks, supra note 111, at slide 33.
139. Rosenwaks, supra note 111, at slide 39.
THE VALUE OF THE HUMAN EGG
Experts argue that the use of prevention strategies can significantly reduce
the risk of OHSS. 4 These include identifying donor-patients who are at risk,' a '
excluding women with irregular menstrual cycles or poly-cystic ovaries, 42 and
administering gentle stimulation, that tailors the dosages of fertility drugs to the
individual donor-patient. 143 Experts advise that careful monitoring of donors
should accompany all of these protocols. 144
45
OHSS prevention strategies may differ in clinical and research settings.
Because there is no direct benefit to the research donor either in terms of health
or pregnancy outcomes, physicians have greater latitude in modifying
stimulation procedures to avoid harm to the research donor. 146 If OHSS
symptoms do appear, treatment strategies are possible. 147 Moreover, upon
diagnosis of OHSS, cancellation of the stimulation cycle will eliminate the risk
of severe OHSS. 14 8 Experts believe that severe and life-threatening OHSS is
avoidable. 149 Physicians experienced in research and reproductive oocyte
donation conclude that where there is careful donor selection, particularized
stimulation protocols for each individual donor, attentive monitoring, and
utilization of appropriate prevention techniques, "OHSS can be virtually
eliminated."' 50
2. Future fertility
There are two main sources of risk to the future fertility of donors: oocyte
retrieval and oocyte stimulation. 151 Studies show no increased impairment of
fertility as a result of either oocyte retrieval or stimulation. 152 Yet, researchers
140.
141.
142.
143.
144.
145.
146.
147.
148.
149.
150.
151.
152.
Id. at 30, 32; Cedars, supra note 129, at slides 10-14.
Rosenwaks, supra note 111, at slide 30.
Cedars, supra note 129, at slide 14.
Rosenwaks, supra note 111, at slides 21, 32; Cedars, supra note 129, at slide 14.
Cedars, supra note 129, at slide 12-14; Rosenwaks, supra note 111, at slide 40.
In the IVF context, the goal is to retrieve multiple oocytes, anywhere between 5 and 15
oocytes, to increase the possibilities of a successful pregnancy. Rosenwaks, supra note 111,
at slide 21. In contrast, research protocols entail a gentler hormone stimulation aimed at
obtaining fewer oocytes. Id.
See id.
These include: 1) monitoring urine output, vital signs, weight, and abdominal girth; 2)
following CBC, electrolytes, liver function, 3) "potential prophylaxis for DVT with severe
hemoconcentration;" and 4) maintaining fluid with NS; 5) paracentesis for pain or renal
impairment; 6) oxygen support as needed; and 7) colloid replacement for severe
hypoalbuminemia. Cedars, supra note 129, at slides 6-7.
Rosenwaks, supra note 111, at slide 32.
See id. at slide 41. At the Institute of Medicine Workshop, Rosenwaks stated that severe
OHSS was unacceptable. See also Cedars, supra note 129, at slide 14.
Rosenwaks, supra note 111, at slide 41.
Nicholas Cataldo, Future Fertility in Oocyte Donors, Address at the Institute of Medicine
Public Workshop on Assessing the Medical Risks of Human Oocyte Donation for Stem Cell
Research (Sept. 28, 2006) (webcast available at http://www.iom.edu/CMS/3740/36353.aspx)
(Power Point slides on file with author), at slide 3.
Id. at slides 8, 21.
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
the ASRM 2003 Practice
expect that the risk may be cumulative. 153 As a result,
54
Guidelines suggest a limit of six stimulated cycles.'
Based on the biology of follicle development and the knowledge gained
from experience in the IVF context, ovarian stimulation does not increase
infertility over the medium term. 155 First, there is strong biological evidence that
there is no risk that ovarian stimulation would decrease the supply of oocytes
available for future ovulation or that it would hasten menopause.' 56 Second,
researchers experienced in IVF have observed that ovarian response
and oocyte
57
cycles.
stimulation
repeated
in
diminish
not
does
production
There is no significant link between oocyte retrieval and impairment of
future fertility.' 58 Researchers have found that the risk of future infertility is
lower in fertile women as compared with infertile women. 159 One set of studies
has found that infection which may lead to future infertility is rare. A second
set of studies has examined whether trauma to the ovaries during oocyte retrieval
could cause impaired fertility.' 6 1 These studies found that antibodies are more
common in women who have undergone retrievals for IVF-embryo-transfer,
153.
American Society for Reproductive Medicine, Practice Guidelines, 82
STERILITY (SUPPL.)
FERTILITY &
S158 (2004).
154.
Id.
155.
156.
Cataldo, supra note 15 1, at slide 21.
Id. at slide 10. First, in each month between first menses and menopause, about 1000
primordial follicles and between ten and twenty small antral follicles interact to cause the
ovulation of one oocyte in an ordinary cycle. Id. at slides 16, 18. The remaining
approximately 999 eggs die each month. Id. at slides 16. In IVF, the ovarian stimulation
drugs provide a follicle-stimulating hormone ("FSH"), which allows more of the small antral
follicles to mature to oocytes during the cycle. Id. at slides 17-19. This process captures more
oocytes than a normal ovulatory cycle, but does not exhaust the supply of oocytes. Id. at
slides 19-20.
Id. at slide 1 (citing Evelien J. de Boer et al., The Number OfRetrieved Oocytes Does Not
Decrease During Consecutive Gonadotrophin-Stimulated IVF Cycles, 19 HUMAN
REPRODUCTION 899 (2004)). A similar study and found that the number of retrieved oocytes
does not decrease after up to nine cycles. Id. at slide 12 (citing Cinthia Caligara et al., The
Effect Of Repeated Controlled Ovarian Stimulation In Donors, 16 HUMAN REPRODUCTION
2320 (2001)).
Id. at slide 8.
Cataldo, supra note 151.
Id. at slide 8. This is due to the fact that complications from the oocyte retrieval process,
such as infection or bleeding, are rare and rarely lead to surgery adhesions, which may lead
to infertility. Id. at slide 5. The rate of infection in IVF cycles has been found to be 0.5
percent. Id. at slide 6 (citing Reija. Klemetti et al., Complications of IVF and ovulation
induction, 20 HUMAN REPRODUCTION 3293 (2005)). The risk in oocyte donors should be
even lower. Id. (citing Dov Dicker et al., Severe Abdominal Complications After
Transvaginal UltrasonographicallyGuided Retrieval Of Oocytes For Invitro Fertilization
And Embryo Transfer, 59 FERTILITY & STERILITY 1313 (1993)). While hemorrhaging was
found in 0.2 percent of donors, no adhesions were seen. Id. (citing Mark V. Sauer, Defining
the incidence of serious complications experienced by Oocyte Donors: A Review Of 1000
cases, 184 AM. J. OBSTETRICS & GYNECOLOGY 277 (2001); Mark V. Sauer, Laparoscopy
After Multiple Follicle AspirationsFails To DemonstratePathology In Oocyte Donors, 13 J.
ASSISTED REPRODUCTION & GENETICS 450, 452 (1996)).
Id. at slide 7. The causal chain these studies explore is whether ovarian trauma may lead to
anti-ovarian antibodies, which may lead to future infertility.
157.
158.
159.
160.
161.
THE VALUE OF THE HUMAN EGG
162
which is a procedure used by women who have difficulty becoming pregnant.
However, researchers have not found anti-ovarian antibodies to be a cause of
infertility,63 and the role of anti-ovarian antibodies in causing fertility failure is
unclear.'
Because future fertility is such an immediate concern of potential research
donors, experts emphasize that there is a need for longitudinal studies of the
donor cohort. 164 At this point, however, there is no indication that future fertility
is affected by oocyte donation.
3. Cancer risks generally
There is no evidence to suggest that fertility drugs used in oocyte donation
elevate the risk of breast cancer or invasive ovarian cancer. 165 Evidence as to the
risk posed by these drugs on the incidence of uterine cancer is too sparse to lead
to an accurate scientific conclusion.' 66 However, all of these findings must be
qualified, since the effects67of the fertility drugs on the rates of cancer over a
longer period are unclear.'
a. Breast cancer
Breast cancer studies show that in vitro fertilization does not lead to an
increased risk of breast cancer. In one large review of 15 other studies,' only
one study found an increased risk of breast cancer from the use of fertility
drugs. 169 This outlier found that all subjects have an increased risk of breast
cancer. 170 Overall however, there was no evidence that breast cancer risks were
162.
163.
164.
165.
166.
167.
168.
169.
170.
Id. (citing P. Barbarino-Monnier, Antiovary Antibodies, Repeated Attempts, And Outcome Of
In Vitro Fertilization,56 FERTILITY & STERILITY 928 (1991)).
Id. at slide 8.
Id. at slide 22.
Roberta Ness, Assisted Reproductive Technology and Cancer, Address at the Institute of
Medicine Public Workshop on Assessing the Medical Risks of Human Oocyte Donation for
Stem Cell Research (Sept. 28, 2006) (webcast available at http://www.iom.edu/CMS/3740/
36353.aspx) (Power Point slides on file with author), at slide 37.
Id.
Id. at slide 37. On a slightly separate note, there is still an open question about the impact
that assisted reproductive technologies ("ART") has on women's cancer risk. Because
having been pregnant is a factor that protects women against certain cancers and women
using ART are more likely to conceive, it is unknown whether the resulting pregnancy
reduces the risk of cancer or whether the ART risk is masked by pregnancy. It remains
unknown which is protective. Id. at slide 10.
Id. at slides 26-30 (citing Salhab et al., In Vitro Fertilization and Breast Cancer Risk: A
Review, 50 INT'L J. FERTILITY 259 (2005)). All studies had a confidence interval of 95
percent. Id.
Id.
Id. at slide 31 (citing Louise Brinton et al., Breast CancerRisks Associated With OvulationStimulating Drugs, 19 HUMAN REPRODUCTION 2005 (2004)). Brinton et al. standardized the
incidence ratios to compare breast cancer risk among infertile patients and the general
population overall, and stratified by infertility drug usage. Id.
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
elevated due to fertility drugs. 7 '
b. Ovarian cancer
It appears that infertility plays a role in the likelihood of developing
ovarian cancer, but there is no evidence to show that fertility drugs increase the
risk of invasive ovarian cancer. 17 2 One published study analyzed the occurrence
of ovarian cancer by disaggregating the data according to the type of fertility
drugs used by women and found that whether a woman was fertile or infertile
was statistically significant in relation to ovarian cancer risk.173 A meta-analysis
compared assisted reproductive technology ("ART") treated infertile women
against untreated infertile women, and showed that there was not much
among infertile women, whether or
difference in the incidence of ovarian cancer 174
not they had been treated with fertility drugs.
In 2004, a study by the National Cancer Institute of 12,000 women treated
for infertility found no associations between the use of ovarian stimulation drugs
and ovarian cancer. 175 However, there was a slightly elevated risk among those
176
women who had been followed for the longest period of time, for 15 years.
This finding could be of concern because most participants in the study were
is required, as
relatively young.' 77 It also suggests that continuing follow-up
78
age.
advanced
more
a
at
diagnosed
typically
is
ovarian cancer
c. Uterine cancer
Very few studies have examined the risk of uterine cancer posed by
infertility drugs, largely due to the low incidence of this type of cancer. The
small number of studies precludes any legitimate conclusions. However, one
study found that in comparing infertile women to the general population, there
171.
172.
173.
174.
Id. at 37.
Id. at slide 37. There may be other confounding factors as well, including, but not limited to
age, socio-economic status, oral contraceptive use, parity (having a born child), type of
infertility, latency period, and dose and duration of the fertility drugs. Id. at slides 8-9.
Id. at slides 16-18 (citing Roberta Ness et al., Infertility, Fertility Drugs, and Ovarian
Cancer: A PooledAnalysis of Case-ControlStudies, 155 AM. J. EPIDEMIOLOGY 217 (2002)).
The odds ratios used here were adjusted for age, the number of times a woman has been
pregnant (gravidity), race, education, history of ovarian cancer, tubal ligation, duration of
oral contraceptive use, and research site; the study included 5,207 cases and 7,705 controls.
Id. at slide 12.
Id. at slides 19-20, 23-25 (citing Sonya Kashyap et al., Assisted Reproductive Technology
and the Incidence of Ovarian Cancer: A Meta-Analysis, 103 OBSTETRICS & GYNECOLOGY
785 (2004)).
175.
INSTITUTE OF MEDICINE AND NATIONAL RESEARCH COUNCIL OF THE NATIONAL
ACADEMIES, ASSESSING THE MEDICAL RISKS OF HUMAN OOCYTE DONATION FOR STEM
176.
conference materials, Public Workshop on Assessing the Medical Risks of
Human Oocyte Donation for Stem Cell Research 1 (Sept. 28, 2006) (on file with author).
Id.
177.
Id.
178.
Ness, supra note 173. Ovarian cancer is usually diagnosed in a woman's sixties. Id.
CELL RESEARCH,
THE VALUE OF THE HUMAN EGG
was an increased risk of uterine cancer among infertile women. 79 It is important
to understand the confounding effect that infertility may play on the risk of
cancer, independent of the administration of fertility drugs. As a result, these
findings do not necessarily indicate a correlation between infertility drugs and
uterine cancer, but may show that infertility itself may increase the risk of
uterine cancer. However, a study of fertility drug use and risk of uterine cancer
compared only infertile women over a 23-year period and found a higher relative
risk.180 These findings prompt greater concern among
researchers regarding the
I s1
cancers.
other
of
risk
the
than
cancer
risk of uterine
4. Other risks
Additional factors to be considered in oocyte donation include surgical
risks, anesthetic risks, and psychological risks. First, similar to any type of
surgery, oocyte retrieval can on rare instances cause vascular injury, injury to
adjacent organs, infection, and twisting of the ovaries. 182 However, while there is
no available data on surgical risk to oocyte donors specifically, it is likely that
infertile women face a higher risk than others in oocyte retrieval. 183 Second,
there are very rare risks related to the anesthesia necessary during oocyte
retrieval. 184 Mortality risks associated with anesthesia are low and amount to less
than one per 300,000.185 Lastly, small samples in post-donation studies of
psychological consequences of oocyte donation for IVF indicate that: 1) a
minority of donors either regretted their donation or had an unfavorable
emotional reaction to the donation; 2) the oocyte donors were curious about the
outcome of their donation; and 3) the donors expressed concerns related to the
179.
Id. at slide 33 (citing Michelle Althius et al., Uterine Cancerafter Use of Clomiphene Citrate
to Induce Ovulation, 161 AM. J. EPIDEMIOLOGY 607 (2005)).
180. Id. at slides 34-35 (citing Michelle Althius et al., Uterine CancerAfter Use Of Clomiphene
Citrate To Induce Ovulation, 161 AM. J. EPIDEMIOLOGY 607 (2005); Alison Verm et al., Risk
Of CancerAfter Use Of FertilityDrugs With In-Vvitro Fertilization, 354 LANCET 1586-90
(1999)).
181. Ness, supranote 173 (explaining the conclusions on slide 37).
182. Ana Alvarez Murphy, Surgical Risks of Oocyte Retrieval, Address at the Institute of
Medicine Public Workshop on Assessing the Medical Risks of Human Oocyte Donation for
Stem Cell Research (Sept. 28, 2006) (webcast available at http://www.iom.eduICMS/3740/
36353.aspx) (Power Point slides on file with author), at slide 2. Between 2000 and 2004,
there were reports of 379,563 vaginal aspirations by ultrasound. Id. at slide 11. While 28.23
percent did not report any information about complications, the following are the totals of
surgical risks: vaginal bleeding: 0.07%; intra-abdominal bleeding: 0.05%; intestinal injuries:
0.001%; peritonitis: 0.005%; complication requiring surgery: 0.002%; complication
requiring hospitalization: 0.002%. Id.
183. Id. at slide 28. Infertile women will typically undergo both oocyte retrieval and embryo
transfer, whereas oocyte donors will only have oocyte retrieval. Id.
184. Lawrence Tsen, Assessing Medical Risks of Human Oocyte Donation: Anesthesia, Address
at the Institute of Medicine Public Workshop on Assessing the Medical Risks of Human
Oocyte Donation for Stem Cell Research (Sept. 28, 2006) (webcast available at http://
www.iom.edu/CMS/3740/36353.aspx) (Power Point slides on file with author), at slide 26.
185. Id. There is low major morbidity risk and low minor morbidity risk. Id.
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
health and fertility consequences of their donation. 86 However, it is unknown
whether oocyte donors in the reproductive 87
context can appropriately predict the
psychological response of research donors.1
5. Summary
The best data currently available suggests that there is no known increased
risk of future infertility or breast cancer as a result of the procedure of human
oocyte donation. However, there may be a slightly elevated risk of uterine cancer
in the near-term and ovarian cancer in the medium-term. There is also a known
risk of OHSS, which can be significantly reduced with proper management.
Uncertainty accompanies all of the data because there are few long-term follow
up studies, largely due to the novelty of the procedure. Long-term follow-up of
three or four decades is needed to reduce this uncertainty, 188 yet some irreducible
level of uncertainty may always persist. 89 Moreover, it does not appear that
compensation will lead to undue enticement since information is available as to
the medium-term risks of being an oocyte donor. As the following section will
discuss, research oocyte donors may be protected from undue enticement by
informed consent procedures. Medical findings and informed consent safeguards
illustrate that the medical risks are not sufficient to justify banning compensation
for research oocyte donors to deter participation in critical research.
E. Is informed consent possible when some risk is unknown?
This absence of long-term data regarding the medical effects of oocyte
donation raises the question: how are researchers and donors to treat
uncertainties surrounding potential risks to oocyte donors? Are research
participants able to give informed consent in this context? Can informed consent
protect human research participants when there is a lack of long-term
information? How can donors give consent with uncertain information?19 ° Some
9
argue that incomplete information undermines the informed consent process.
186.
187.
188.
189.
190.
191.
1
Susan Klock, Psychological Aspects of Oocyte Donation, Address at the Institute of
Medicine Public Workshop on Assessing the Medical Risks of Human Oocyte Donation for
Stem Cell Research (Sept. 28, 2006) (webcast available at http://www.iom.edu/CMS/3740/
36353.aspx) (Power Point slides on file with author), at slides 31-32.
Id. at 32.
See id.
How to handle this uncertainty will be discussed in the following section related to informed
consent.
The traditional concern regarding informed consent is focused on those human research
subjects who have particular illnesses and are recruited to participate in clinical trials by their
physicians. In contrast, oocyte donation for research requires healthy volunteers. The patients
with specific illnesses may be more vulnerable to abuses of the informed consent process
than those donors for SCNT. See Sharona Hoffman, Thinking about Biomedical Advances:
The Role of Ethics & Law: Regulating Clinical Research: Informed Consent, Privacy, and
IRBs, 31 CAP. U. L. REV. 71, 78 (2003).
Oversight Hearing on the Implementation of Proposition 71, Joint Hearing Before the S.
Subcomm. on Stem Cell Research Oversight, S. Health Comm., and Assembly Health Comm.
THE VALUE OF THE HUMAN EGG
In this regard, it is helpful to compare oocyte donation to Phase I clinical trials to
understand and assess how informed consent is and should be treated where
there is incomplete information as to the risk of exposure for research subjects.
The Center for Genetics and Society and the Pro-Choice Alliance for
Responsible Research argue that oocyte donors cannot give "truly informed
consent" because donors do not have full, complete, and accurate information as
to the short and long term risks to which they may be exposed in the donation
process.192 These organizations recommend that before women undergo oocyte
93
stimulation for research purposes, "better quality data" should be assembled.,
They do not provide any detail about what "better quality data" would entail.
The organizations further believe that each potential donor should utilize her
own physician, who would be independent of the research, to assess whether the
woman should participate.' 94 These measures, it is argued, would begin to meet
the challenges inherent in creating guidelines for informed consent.' 95 This
argument fails to consider to what extent uncertainty is permissible for an
individual's consent to be sufficiently informed. The offered recommendations
do not address research which involves somewhat uncertain risks but which also
holds great potential for medical progress. The effect of these recommendations
is to freeze potential research without providing sufficient benchmarks to
demarcate acceptable levels of uncertainty.
Clinical trials commonly balance risks and benefits as well as obtain
informed consent in the face of incomplete information. 96 In Phase I human
clinical trials, between 20 and 100 healthy volunteers subject themselves to a
new drug, not to gain information about the efficacy of the drug, but solely to
determine whether it is safe. 19 7 Prior to the Phase I trial, animal and laboratory
tests help to assess the safety of the new drug, though some effects can be
discovered only through experimental human trials.' 98 The answer most coveted
by a potential research volunteer is what will happen to her as a result of her
participation, and that answer is unknown at the time of her participation. Yet,
the federal government has allowed individuals to participate in this type of
research, despite the lack of information
as to the drug's effects on humans,
199
provided there is informed consent.
When Phase I clinical trials occur, there exists no information as to short2005-2006 Sess. (Cal. 2005) (statement of Francine Coeytaux, Pro-Choice Alliance for
Responsible Research) (transcript availableat http://www.genetics-and-society.org/resources
/items/20050309_senatecoeytaux.html).
192. Id.
Id.
Id.
Id.
Dana Ziker, Reviving Informed Consent: Using Risk Perception in Clinical Trials, 2003
DUKE L. & TECH. REv. 15 (2003).
197. Id.
198. Id.
199. Id. (citing 21 C.F.R. § 50.02 (2003)).
193.
194.
195.
196.
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
or long-term risks of the drug in humans. The uncertainty involved in this
research is maximum and irreducible, since the medicines have theretofore never
been administered to humans. The process of informed consent requires the
200
disclosure of known risks and the potential for unknown consequences.
Despite this deficiency of information about risks in humans, there is general
consensus that it is acceptable to allow individuals to participate in these trials,
and to make their own decisions as to whether the potential benefits to
themselves or society in general outweigh the possible, unknown risks. The trials
are allowed to proceed because society believes that the informed consent
process sufficiently protects volunteers from exploitation. Hence, the absence of
information does not function to prohibit informed consent.
These same principles should apply to oocyte donation. In contrast to
Phase I trials, information is available as to the short-term risks of the process
based on years of experience with IVF. This is a significant improvement upon
the amount and quality of risk information available in Phase I trials. Because
informed consent is possible, women are not at risk of exploitation if offered
compensation for egg donation. They receive adequate information as to the
known and unknown risks involved. Therefore, SB 1260's prohibition on
compensation unjustifiably constrains oocyte donation for research by
discouraging donation that could lead to significant medical breakthroughs.
F. Conclusion
There are several reasons why SB 1260's cap on payment to research
donors is unjustified. First, there are no currently available alternatives to human
donated oocytes. Second, donors for research may be less educated and may
come from lower socio-economic strata than reproductive donors, but there is no
indication that established safeguards would fail to protect them or would make
them more vulnerable to harm. Third, the medical protocol underscores the
arduousness of the donation process and the justification for compensation.
Fourth, in most areas, the short-term data does not suggest an increased risk of
harm from the stimulation drugs. And although there is a need for clarification in
uterine cancer studies and long-term assessments for all risks, informed consent
requirements adequately protect SCNT research participants. This is especially
so when compared to Phase I clinical trials, as oocyte donors have access to
some data regarding their potential risks.
V.
THE COMPENSATION REGIME FOR HUMAN
OOCYTE DONATION FOR RESEARCH
Limiting reimbursement and prohibiting compensation for research oocyte
donors, as was done with SB 1260, is very likely to decrease the scale of SCNT
research. An analysis of the philosophical underpinnings of perspectives on the
200.
Hoffman, supra note 190, at 78.
THE VALUE OF THE HUMAN EGG
consequences of compensating women for egg donation yields this conclusion. It
is necessary therefore to determine the appropriate level of compensation for
research donors to motivate donations without unduly enticing women to
participate.
A. The theoretical arguments regarding compensation for egg donation
Some feminists argue that compensation for human oocytes translates
women's bodies and their physiological processes into a product. 20 This
commodifies and alienates the individual woman-donor. The result is to diminish
the inherent value of all individuals. Other feminists urge that compensation
reflects the value that women contribute in the market, and2 refusal
to provide
2
compensation for donors' contributions subordinates women. 0
1. Objections to commodification
The argument against providing compensation for certain activities related
to human reproduction is that the commodification of body parts inherently
belittles human existence. 203 There are goods that are acceptable for
commodification and others that are not.20 4 Some are unacceptable for
commodification because they derive from our bodies, and are therefore interconnected with our concept of personhood.2 °5 Commodifying these "goods"
would transform our own existence into that of chattel.20 6 This strain of thought
believes that commodification of human bodies impedes human development
and flourishing by supplanting personal relationships with economic market
transactions. 207 It is argued that it is morally suspect to treat reproductive
services, such as surrogacy, or biological matter similarly to any other
commercial item.20 8
In this way, putting a price on the services or derivatives of women's
bodies unacceptably creates marketable products. Because the market is
propelled by efficiency, it is irreconcilable with those areas related to human
201.
202.
203.
204.
205.
206.
207.
208.
This argument against the commodification of reproductive capacity springs from Margaret
Radin's seminal article on market-inalienability. See Margaret Jane Radin, MarketInalienability, 100 HARV. L. REv. 1849, 1884-85 (1987) [hereinafter Radin, MarketInalienability].
John A. Robertson, Technology and Motherhood: Legal and Ethical Issues in Human Egg
Donation, 39 CASE W. RES. L. REv. 1, 31 (1989) [hereinafter Robertson, Egg Donation]
(citing M. MAUss, THE GIFT (1967); Murray, Gifts of the Body and the Needs of Strangers,
HASTINGS CENTER REP. (1987)).
Baum, supra note 93, at 134.
See Radin, Market-Inalienability,supra note 201, at 1851.
Id. at 1920-28.
Id. Radin further states her opinion that "the characteristic rhetoric of economic analysis is
morally wrong when it is put forward as the sole discourse of human life." Id. at 1851.
Id. at 1884-85.
Baum, supra note 93, at 134.
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
existence that are not based on efficiency. 2 0 9 As Margaret Jane Radin, an
opponent of universal commodification, theorizes:
Universal market rhetoric transforms our world of concrete persons, whose
uniqueness and individuality is expressed in specific personal attributes, into a
world of disembodied, fungible, attribute-less entities possessing a wealth of
alienable, severable "objects." This rhetoric reduces the conception
of a person
2
to an abstract, fungible unit with no individuating characteristics. 1
Commodification treats women like "anonymous fungible breeders,"
which objectifies them and creates and reinforces gender subordination. 211 In this
way, placing a monetary equivalent on any contribution from a person's body
would violate Radin's conception of personhood.
These objections to commodification are largely based on theories of
personhood and a "religious or moral view of human dignity that is not
universally shared., 21 2 In fact, even some feminists who follow this conception
of personhood agree that while compensation may be appropriate to make
donors whole, additional compensation would be unacceptable. 2 13 If
remuneration exceeded the amount necessary to make a donor whole, the
resulting financial incentive would obscure the division between altruism2 and
14
profit-maximization, which would blur the line between person and property.
There are other feminist arguments against market-driven compensation for
women's gametic products.2 15 Since oocyte donation requires surgical retrieval
of oocytes, it is thought by some that compensation for the donation amounts to
paying someone for bodily intrusion, which treats the donor and her body as a
commodity.21 6 Other common criticisms of compensation for oocyte donation
derive from a sense of disgust at trading genetic material like any other market
commodity. 217 Both strains of argument about bodily intrusion and genetic
material posit that the resulting compensation commodifies women generally
218
and is an example of exploitation of women.
When these philosophical arguments combine with hypotheses about the
socio-economic dimensions of oocyte donation, they lead to an argument that
209.
210.
211.
212.
213.
214.
215.
216.
217.
218.
Id. at 135.
Radin, Market-Inalienability,supra note 201, at 1885.
See Lynn M. Squillace, Too Much of a Good Thing: Toward a Regulated Market in Human
Eggs, 1 J. HEALTH & BIOMED. L. 135, 143 (2005). Radin argues that it is intuitively wrong
to discuss personal attributes sinilarly to fungible objects, which can be solicited, bought,
and sold. Radin, Market-Inalienability,supra note 201, at 1880.
Robertson, Egg Donation, supra note 202, at 30.
Baum, supra note 93, at 134.
Id. at 134-35.
Id. at 161.
Robertson, Egg Donation,supra note 202, at 30.
See id. at 30 (citing Radin, Market-Inalienability,supra note 201, at 1921-25).
See Baum, supra note 93, at 161.
THE VALUE OF THE HUMAN EGG
poor women may be coerced into participating in SCNT research.2 19 One written
opinion in the report by President Bush's Commission on Bioethics states that
"financially vulnerable populations" will be disproportionately represented
among oocyte donors for research. 220 This belief is based on the economic
argument that the same compensation will be more valuable to women with less
economic resources, which may entice them into donating. Proponents of this
argument say that it follows then that the enticement of the financial reward
would persuade these women to undergo burdens and risks that they would not
otherwise choose. 221 If such a scenario were realized, it would create a caste
system in which the poor become suppliers of the biological resources that are
necessary for SCNT research. 222 This line of reasoning implies that low income
women need protection from the temptation of incurring bodily risk for profit.
No evidence supports this hypothesis or explains why oocyte donation for
stem cell research should be an exception to the compensation scheme applied to
other types of research activities, which carry their own risks. Such
exceptionalism is unfounded especially if Radin's inalienability argument is
focused on a personhood theory that is only relevant to the salability of genetic
characteristics and reproductive capacity. Compensation for oocyte donation for
research would not seem at odds with this argument, since an oocyte donor's
contribution is only used for her cytoplasm in SCNT, rather than her nuclear
DNA, without the possibility of developing an embryo or child.
2. Feminist arguments in favor of compensation
Compelling feminist arguments in favor of compensation for oocyte
donation are premised on practical realities of society, women's autonomy,
equity, and the impact of socio-economic differences. They are grounded in the
fact that we live in a non-ideal society, characterized by a capitalist market
system in which liberation derives from power, which largely derives from the
marketplace. 223 According to this line of reasoning, women should be allowed to
leave their traditional, protected environment and sell what they wish.224 Such
arguments consider a ban on compensation to be paternalistic and a method of
219.
221.
See Robertson, Egg Donation, supra note 202, at 30; Winickoff, supra note 10, at 392
(explaining that providing compensation to oocyte donors could result in "possible economic
coercion").
PCBE CLONING, supra note 29. This is the opinion of those members of the Commission
who signed on to "The Moral Case against Cloning-for-Biomedical-Research" section of the
report.
Robertson, Egg Donation,supra note 202, at 30.
222.
This argument is similar to Radin's discussion of the "worst case" in which poor women
223.
would serve the reproductive interests of wealthier members of society. See Radin, MarketInalienability,supra note 201, at 1930.
Baum, supra note 93, at 161 (citing MARGARET JANE RADIN, CONTESTED COMMODITIES
149 (1996) [hereinafter RADIN, CONTESTED COMMODITIES]).
RADIN, CONTESTED COMMODITIES, supra note 223, at 149.
220.
224.
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
225
infantilizing women and perpetuating power imbalances based on gender.
Female autonomy is a significant reason to allow compensation for oocyte
donation. Many commentators find that the entire argument against the
commodification of oocyte donation, along with a corresponding absence of
focus on the commodification of sperm donation, devalues women as
autonomous equals. 226 They do not find that paying donors diminishes their
human dignity. 227 Instead, women should be allowed to determine, to a large
extent, what they do with their bodies. In this view of autonomy, women
gain
228
full personhood by taking full responsibility for their moral decisions.
The concept of equity offers additional support for reimbursement and
compensation for donation. Many would find that compensation for the time and
trouble incurred by research donors is not only "morally unobjectionable and
appropriate" but also obligatory.2 2 9 In fact, refusing to pay donors for their
efforts may itself be "unfair and exploitative. ' 23° This reasoning acknowledges
the burdens donors undertake during the process of stimulation, a process that
requires multiple sonograms,
blood tests, travel, and scheduling
inconveniences. 23 1 Furthermore, bioethicists consider it ethically appropriate to
compensate research donors if reproductive donors are compensated.232 The
rationale rests on the idea that fairness requires adequate compensation when an
individual undertakes considerable burdens and some risk for another's gain.233
Nevertheless, it is important to acknowledge the predominant view that it may be
morally improper to offer levels of compensation that could unduly influence
donors' judgment. 234 Compensation must therefore be reasonable and sufficient
235
to acknowledge the donor's critical contribution to the research enterprise.
Equity requires that donors be treated similarly to others involved in the
research. No part of a scientific research endeavor exists outside of the market.
No one asks scientists, research assistants, lawyers, or doctors to participate
225. Baum, supra note 93, at 161.
226. See id.
227. See Robertson, Egg Donation, supra note 202, at 30. Robertson compares the effects on
human dignity as created by oocyte donation and prostitution. He concludes that the question
remains open as to whether oocyte donation is demeaning in the same way prostitution
demeans the sex act. Id.
228. RADIN, CONTESTED COMMODITIES, supra note 223, at 149; Squillace, supra note 211, at
143.
229. Steinbrook, supra note 115, at 326; Robertson, Egg Donation, supra note 202, at 31 (citing
Lori Andrews, My Body, My Property, 16:5 HASTINGS CENTER REP. 28, 29-38 (1986));
Squillace, supra note 211, at 137.
230. Robertson, Egg Donation, supra note 202, at 31.
231. Even Radin, who opposes universal commodification, supports payment in cases that
demand it as a matter ofjustice. See Radin, Market-Inalienability,supra note 201, at 191518.
232. Steinbrook, supra note 115, at 326 (citing Bonnie Steinbock, Payment For Egg Donation
And Surrogacy, 71 MT. SINAI J. MED. 255-65 (2004)).
233. Id. at 326 (quoting Steinbock).
234. See id. at 326.
235. See Robertson, Egg Donation, supra note 202, at 31.
THE VALUE OF THE HUMAN EGG
without some form of compensation or to have purely altruistic reasons for
providing their services. No one faults them for being paid for using a product of
their being-their intelligence. 236 Even the regime proposed by NAS and largely
enacted in the CIRM regulations presents this "major ethical problem." 237 The
altruistic precondition is "deployed asymmetrically," requiring altruism without
compensation of the donors, but not of the researchers' institutions or
corporations. 238 And, although this imbalance between researchers and research
subjects is not uncommon in the biomedical research industry, this situation is of
more concern where
there are substantial time commitments by and potential
239
risks to the donor.
Equity is also a concern in terms of the different treatment between men
and women who donate their gametic material. Critics posit that at its most basic
level, the proponents' ban on compensation for oocyte donation is ill-founded
because the same proponents do not object to compensation for sperm
donation. 24 Paying men who donate sperm for reproductive purposes while
refusing payment to women who undergo a much more difficult process, to say
nothing of risk, "would unfairly discriminate against women." 24 1 Dr. Kiessling,
the director of the Bedford Stem Cell Research Foundation, has argued for equal
pay for equal time, assessing the appropriate level of compensation for egg
donors by analogizing the hourly rate paid to sperm
donors for the time,
242
inconvenience, and travel involved in their donation.
Arguments against compensation based on socio-economic grounds
unjustifiably exclude an important source of oocytes and fail to establish that the
risks and payment involved create an unacceptable enticement. John Robertson,
an ethicist from the University of Virginia, has written extensively about
reproductive technologies and believes that fears regarding class bias and
speculation about the exploitation of the least well-off are insufficient to prevent
infertile couples from accessing an important source of oocytes for IVF
procedures. 243 Similarly, these fears should not be the grounds upon which we
force scientists to forgo the only viable source of biological materials currently
available for SCNT, which is a promising area of scientific exploration.
Robertson further argues that "neither the risks nor the payments are so great that
236.
237.
238.
239.
240.
241.
242.
243.
See Squillace, supra note 211, at 137; Howley, supra note 11, at 8 (using a similar argument
in the realm of reproductive oocyte donation).
Winickoff, supra note 10, at 392.
Id.
Id.
See, e.g., Ann Kiessling and Machelle M. Seibel, CompensatingEgg Donors: Equal Pay for
Equal Time?, 328 NEW ENG. J. MED. 737 (1993), available at http://content.nejm.org/
cgilcontent/full/328/10/737 [hereinafter Kiessling, Equal Pay]; Robertson, Egg Donation,
supra note 202, at 31; Squillace, supra note 211, at 143.
Robertson, Egg Donation, supra note 202, at 31.
Kiessling, Equal Pay,supra note 240.
Robertson, Egg Donation, supra note 202, at 31.
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
an unacceptable exploitation of poorer persons would occur." 244 The most recent
research shows that there are few elevated risks associated with oocyte
stimulation and retrieval. Moreover, numerous occupations entail more serious
physical risks than those involved in egg donation, and society permits workers
to choose these occupations for financial reasons.245 Society generally allows its
members to assume risks that they individually determine are proportionate to
the compensation offered. Often such risks are higher and more severe than
those related to oocyte donation. 246 The market system commodifies people's
ability to work. Professionals are paid for their intelligence and skills, while
research subjects are compensated for their time and effort. 247 Given the
uncontested commodification of so many aspects of human productivity, it
seems arbitrary
to draw the line at human oocyte retrieval for research
8
24
purposes.
B. Projected effects of SB 1260's ban on compensation
SB 1260 took effect on January 1, 2007, and it is likely that a sufficient
stream of donors for SCNT research will be unobtainable as a result. Many have
questioned whether women will participate if their only compensation is
reimbursement for direct expenses. 249 Donors may ultimately lose necessary
income because they will not be reimbursed for wages lost due to participation in
the research. Analogizing from the reproductive context, Robertson has
hypothesized that banning payment would lead to shortages in meeting the
demand for oocytes. 250 While acknowledging that not only fiscal motivations
influence a woman's decision to donate oocytes, it is nevertheless reasonable to
assume that many women would probably need a financial incentive to dedicate
the substantial amounts of time and effort required.25 ' This has been shown to be
true in the reproductive context. 252 Experiences in other jurisdictions that have
244.
245.
Id.
Id. Many jobs involve even higher risks but are not judged by society to be exploitative:
"Markets for the sale of gestational services are no more exploitative than the sale of other
kinds of physical labor. If people are free to sell their labor as petro-chemical workers,
cleaning persons, or construction workers in the hot Texas sun, why should the sale of
gestational services be treated any differently? Much paid labor is equally or even more risky
to health." JOHN A. ROBERTSON, CHILDREN OF CHOICE: FREEDOM AND THE NEW
REPRODUCTIVE TECHNOLOGIES 141 (1994).
246.
247.
248.
249.
250.
251.
252.
Baum, supra note 93, at 151.
See id. at 135.
Seeid. at 136.
Steinbrook, supra note 115, at 326; Robertson, Egg Donation, supra note 202, at 31-32;
Baum, supra note 93, at 158-59.
Robertson, Egg Donation,supra note 202, at 31-32 (arguing that in this context, it is unlikely
that women who are not related to a needy recipient would be disinclined to donate,
especially if they were not already undergoing IVF).
Id.
Baum, supra note 93, at 158-59; see, e.g., Nicole Veash, Internet Donors Offer Perfect
Babies to Order, THE OBSERVER (London), Aug. 15, 1999, at 3 (noting that the restrictions
on compensation to British egg donors correlate with diminished supply of oocytes to
THE VALUE OF THE HUMAN EGG
severely limited compensation for reproductive purposes have shown that such
restrictions correlate with a decreased supply of oocytes. 153 These findings
portend what could happen if compensation is never allowed in the research
context.
In an environment in which compensation is banned and there is only
reimbursement for expenses of the donation for research, there remain concerns
that women may be coerced into donating for non-monetary reasons. If
reimbursement is the only form of incentive to donate for research purposes, it
may be that the only donors are the friends and relatives of individuals who are
afflicted with the diseases that are most likely to yield benefits from SCNT
research. 254 The result could become a situation in which the donors and their
friends and relatives have unrealistic expectations for the donation and are overly
optimistic about the possibilities of converting early research into therapeutic
treatments. 255 It is possible that banning compensation would not prevent the
coercion of donors that some fear would occur if compensation were permitted.
In fact, it is possible that a system of altruistic donation would create coercion of
256
those family and friends who may be pressured to fill the donation shortages.
C. What is the appropriate level of compensation?
At a minimum, it appears reasonable to reimburse a donor's expenses
incurred as a direct result of her participation in the oocyte stimulation and
retrieval process. Such reimbursement would conform to the current CIRM
regulations and should be the model for all California stem cell research. Yet, SB
1260 strictly limits reimbursement to a donor's "direct expenses incurred as a
result of the procedure. 257 For example, this excludes reimbursement for
expenses that do not come out of the donor's pocket, such as lost wages resulting
from her participation. 8 CIRM's regulations, by contrast, would reimburse the
"necessary and reasonable costs directly incurred as a result of donation or
infertile couples).
Baum, supra note 93, at 159; Kathleen Morgan, Babiesfor Sale, DAILY RECORD (Glasgow),
Aug. 17, 1999, at 8 (noting that British egg donors are paid 15 pounds plus expenses, while
American clinics offer donors around $5000, and noting that there are more American
donors than British donors). The U.K. and Israel have both substantially restricted
compensation to reproductive oocyte donors. Both countries face severe shortages in supply
of oocytes for infertility treatment. This indicates that, in the reproductive context at least,
the supply of oocytes from donors who are motivated by altruism does not meet the need of
infertile couples in those countries.
254. Steinbrook, supra note 115, at 326.
255. Id. (citing David Magnus et al., Issues In Oocyte Donation For Sem Cell Research, 308
SCIENCE 1747 (2005)). This scenario would place even greater pressure on the novel
research at a time when its potential and support are not fully realized.
256. Magnus, supranote 255, at 1748.
257. CAL. HEALTH & SAFETY CODE § 125355 (Deering 2006): "No payment in excess of the
amount of reimbursement of direct expenses incurred as a result of the procedure shall be
made to any subject to encourage her to produce human oocytes for the purposes of medical
research."
258. Id.
253.
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
participation in research activities." 259 Reimbursement under the CIRM would
cover transportation, housing, child care, medical care, health insurance, and
actual lost wages. This level of reimbursement is preferable because it makes the
donor whole, and at the very least, would not financially penalize women who
participate in the research.
Beyond reimbursement for directly related expenses, an appropriate level
of compensation encourages women to donate without unfairly enticing them.
Striking this balance may entail a distinction between compensation levels for
reproductive and research purposes. To begin with, the ASRM guidelines
suggest that the compensation for an oocyte donor who contributes to the IVF
process should be paid no more than $5000.260 If this amount brings in a
sufficient number of donors to meet the demand of infertile couples, it would
appear to be appropriate compensation. Others may argue that a lower cap could
still meet the demand for reproductive egg donors. Regardless, it has not been
found that poor women make up a disproportionate amount of reproductive
donors or that they have been unduly enticed into donating their oocytes for this
purpose. Other factors, such as recipient couples' biases against poor women as
egg donors, might explain why the cohort of reproductive egg donors are not
disproportionately poor women. Yet, on the whole, this amount currently seems
an appropriate level of compensation.
The amount recommended for reproductive purposes may not be sufficient
to motivate women to donate for research because it may be more difficult to
motivate donations for research purposes. First, the occurrence in the population
of genetic diseases is rarer than the occurrence of pregnancy, so fewer women
may feel an emotional draw to participate for altruistic reasons. It is highly likely
that most women know someone who has struggled with infertility, but they may
not know anyone affected by those diseases which are the subject of SCNT
research. Second, the novelty of the science and the chance that potential donors
may mistake SCNT for reproductive cloning may discourage some women from
donating for research purposes. Third, the cost-benefit analysis may lead some to
reject the idea of donating. While many potential donors may consider the
process of oocyte donation arduous and the long-term risks uncertain, they may
also view the research's uncertain outcome as unworthy of their participation.
On the other hand, researchers may have a larger pool of potential donors
from which to choose. Where infertile couples undergoing IVF may require
certain traits of their donors, the fact that researchers are not genetically selective
may increase the pool of potential donors and thus decrease the amount
necessary to pay donors. Moreover, with increased publicity and awareness
about the potential benefits of SCNT research, a large number of altruistic
259.
260.
SB 1260 Health Comm. Analysis, supra note 6, at 8. These regulations were developed by
CIRM's Scientific and Medical Accountability Standards Working Group and relied on
various sources, including the National Academies of Science.
American Society for Reproductive Medicine, Guidelines For Gamete And Embryo
Donation, 86 FERTITY & STERILITY (SUPPL. 4) S38 (Nov. 2006).
THE VALUE OF THE HUMAN EGG
donors may step forward to donate. These individuals may be motivated by the
assistance that they could provide to others who are afflicted by debilitating
diseases or by the desire to participate in the cutting edge of research. Lastly,
others may be willing to donate for research purposes but not for IVF based on
an objection to having offspring in this manner.
On balance, one may conclude that in the near future fewer donors will be
available for SCNT research. This is because at this beginning stage of SCNT
research, there is little public awareness of the procedures, the potential benefits,
and the need for donors. In addition, the media's chosen focus, whether the
potential research discoveries or the health risks to donors, will likely have a
great influence on women's willingness to participate.
As a result, researchers may need to offer more compensation than what is
being provided to reproductive donors. It is difficult to assess how much
compensation would encourage potential donors to participate and how much
would foster undue enticement. The most practical course of action would be
first to reimburse related expenses, including actual lost wages. If this level of
compensation does not bring in the requisite number of donors to drive SCNT
research, the next step may be to offer a few thousand dollars as compensation.
An additional assessment of donor response should follow after compensation
has been raised to that level. This process may be repeated as needed. By
increasing the level of compensation by a small margin at each step, researchers
may be able to avoid the undue enticement that may result from offering $10,000
or more at the outset. Although the offer-and-assessment process may slow
research, it may be prudent to begin with a lower figure and work upward as
necessary, in order to prevent undue enticement and exploitation.
VI. CONCLUSION
While SB 1260's purported policy goal to protect oocyte donors for
research is worthy, its methods for meeting this goal are severely flawed and
seriously risk hampering stem cell research discoveries. The prohibition on
compensation exceptionalizes oocyte donors from standard human research
subject guidelines without justification based on increased medical risk or
unduly enticing financial rewards.
A. Where does SB 1260 accomplish its goals and
where are its objectives misplaced?
Most proponents of SB 1260 laudably intend to protect vulnerable women.
Accordingly, the law's informed consent provisions are important, even though
they are not novel. On balance, the legislation attempts to solve a problem that
may never exist. The law anticipates a world in which women are coerced by
large monetary rewards to subject themselves to dangerous medical procedures.
In reality, oocyte donation has been shown to have few elevated risks. Moreover,
any compensation offered to research donors may be close to the amounts
BERKELEY JOURNAL OF GENDER, LAW & JUSTICE
currently offered to reproductive donors. And, at worst, SB 1260 severely
hampers efforts to research, prevent, and treat human disease.
SB 1260 is misplaced in several respects. First, oocyte donors for research
should not be exceptionalized in the field of research on human subjects. ACOG
and ASRM argue that like any other research participant, egg donors should be
compensated for the time and trouble of undergoing the oocyte retrieval
process.261 During the month-long process of preparation for oocyte retrieval,
donors undergo fifty to sixty hours of activities associated with the donation,
including: blood tests, hormone injections, and ultrasounds, followed by an
invasive procedure to retrieve the matured oocytes. 262 This is similar to research
263
done on other human subjects and should be compensated similarly.
Additionally, compensation "values a woman's contribution." 264 Professional
guidelines, such as those promulgated by ASRM, provide a useful source of
guidance in avoiding undue enticement to participate in research. 265 Excessive
disincentives to oocyte donation seem to arise from a desire to stymie embryonic
stem cell research in which oocytes are used.
Second, because it is important to obtain a diverse group of research
participants, SB 1260 opponents argue that lost wages should be included in
reimbursement for direct expenses associated with egg donation. 266 By making
research donors whole, it is possible for women of lesser economic means to
participate in oocyte donation. 267 Again, the legislation restricts compensation to
donors in an effort to protect lower income women from potential coercion, yet it
prevents these women from being indemnified once they do participate in the
research.
Third, SB 1260 creates standards which conflict with those commonly
applied NAS and CIRM. While NAS and CIRM standards complement each
other, the new legislation's provisions conflict with them 268 and do not provide
261. Letter from Shannon Smith-Crowley, Legislative Advocate, American College of
Obstetricians and Gynecologists, to Assembly member Wilma Chan, Chair, California State
Assembly Health Comm. (June 21, 2006) (on file with author) [hereinafter ACOG Health
Comm. Letter].
262. ACOG Veto Letter, supra note 9, at 1.
263. Id. If they can be said to benefit at all, oocyte donors do not benefit directly in any way from
their research participation, unlike typical research subjects undergoing clinical trials for
treatments for diseases that afflict them. The lack of direct material benefit in exchange for
services raises an additional reason to compensate oocyte donors for their participation in
research.
264. Id.
265. ACOG Health Comm. Letter, supra note 261, at 1.
266. Letter from Shannon Smith-Crowley, Legislative Advocate, American College of
Obstetricians and Gynecologists, to Senator Deborah Ortiz, Author, S.B. 1260 2 (May 2,
2006) (on file with author) [hereinafter ASRM Letter to Senator Deborah Ortiz]. The
Independent Citizens' Oversight Committee ("ICOC") did not register their support or
opposition to SB 1260 but did hear from members of the public that lost wages should be
included as out of pocket expenses that qualify for reimbursement. ICOC Regular Meeting
223 (June 2, 2006).
267. ASRM Letter to Senator Deborah Ortiz, supra note 266, at 2.
268. ICOC, supra note 266, at 223 (noting that SB 1260 differs from CIRM medical and ethical
THE VALUE OF THE HUMAN EGG
269
significant protections beyond those guidelines.
Finally, while the intent of the authors of SB 1260 appears to be the
protection of women from medical risk, prohibitions on compensation do not
ensure their proper treatment. 270 The supporters of the bill conflate the issues of
informed consent and compensation. Dr. Ann Kiessling remarked that women
are "only going to be protected by good medical care and fully informed
consent.... How well1 they're cared for is independent of whether they're going
27
to be compensated.",
B. Summary analysis of SB 1260
If SCNT research is at the core of SB 1260's regulation of oocyte donation,
then why draw the line at compensation? If it is cloning research that concerns
SB 1260 proponents, why tolerate either compensated or uncompensated oocyte
donation at all? 272 Rather than following either of these frameworks, SB 1260
leaves California with a half measure that may cripple cutting-edge stem cell
research without providing new informed consent protections to women who
participate in oocyte donation for research.
Any substantial restriction on oocyte donation for research purposes must
address donors' actual harm to justify the interference with significant stem cell
research.273 So far, arguments to limit compensation misconstrue and overstate
the potential risks and harm to donors, especially in light of existing informed
consent protections. 274 These arguments and risk studies fail to demonstrate that
oocyte stimulation's attendant risks are sufficiently prevalent to warrant SB
1260's harsh restrictions. Because proponents of SB 1260 fail to explain the
275
reason for differing treatment of oocyte donors and other research subjects,
they also fail to justify paternalistic statutes that severely restrict potential
scientific progress.
If SCNT is to change the lives of existing and future victims of genetic
diseases, the statutory system must create appropriate incentives for oocyte
donor participationn coupled with meaningful informed consent requirements. In
the end, there must be a reason to impose limits. Neither existing risk data nor
regulations).
ACOG Veto Letter, supra note 9.
See Romney, supra note 18.
Id.
See Baum, supra note 93, at 154 (using a similar line of reasoning in discussing arguments
related to restricting compensation for oocyte donation because of fear of eugenics).
273. See Robertson, Egg Donation,supra note 202, at 32.
274. See, e.g., Diane Beeson and Abby Lippman, Egg Harvesting For Stem Cell Research:
Medical Risks And Ethical Problems, 13 RBM ONLINE 14 (2006), http://www.rbmonline.
com/4DCGI/Article/Article?38%091%09=%202503%09.
275. See Magnus, supra note 255, at 1747. Oocyte donors may be viewed as human research
subjects because their participation contributes to scientific investigations. Research typically
requires exposure of participants to risk for the benefit of others, although often the
participant stands to benefit from a research procedure. In this case, there is no such possible
direct benefit.
269.
270.
271.
272.
224
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arguments against compensation reveal sufficient cause to impose restrictions
that discourage women from donating their oocytes for research purposes,
particularly considering the compelling promise of somatic cell nuclear transfer
research.