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PERSPECTIVES
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ENCYCLOPEDIA OF LIFE SCIENCES Plant
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Advances in Agronomy 46, 245–298 (1991).
Duvick, D. N. Genetic contributions to advances in yield of
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Biotechnology’s Bitter Harvest —Herbicide Tolerant Crops
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SCIENCE AND SOCIETY
Human embryonic stem cell research:
ethical and legal issues
John A. Robertson
The use of human embryonic stem
cells to replace damaged cells and
tissues promises future hope for the
treatment of many diseases. However,
many countries now face complex
ethical and legal questions as a result
of the research needed to develop
these cell-replacement therapies.
The challenge that must be met is how
to permit research on human embryonic
tissue to occur while maintaining respect
for human life generally.
Embryonic stem (ES) cell research offers the
hope of cell-replacement therapy for diseases such as Parkinson disease, diabetes
and cardiac myopathy, but formidable scientific and clinical challenges must be over-
74
come before such therapies could become
available1,2. For example, scientists need to
learn how to direct pluripotent ES cells to
differentiate into the required cell or tissue
type3. Clinicians must then determine the
transplanted cells’ immune compatibility
with the host, and where, and in what
amounts, to replace cells in diseased organs
to achieve a therapeutic effect. These scientific efforts are also complicated by ethical
concerns about obtaining human ES cells
from aborted fetuses or from the destruction of early human embryos. The resulting
controversy has delayed or stopped human
ES cell research in some countries, and
could affect the extent to which human EScell derived therapies are developed and
used. This article will survey the main ethi-
| JANUARY 2001 | VOLUME 2
cal and legal issues that arise from human
ES cell research, and how public policy
should accommodate them.
Legality of human embryo research
Legal treatment of the use of human fetal
tissue or the destruction of human embryos
to obtain ES cells for research varies widely
throughout the world. The United States,
the United Kingdom and many other countries permit the use of human fetal tissue
for research when a woman’s decision to
donate fetal tissue is clearly separate from
the decision to abort. Although most
American states permit ES cell research that
requires the destruction of human embryos,
federal law prohibits the direct funding of
embryo destruction to obtain such cells4,5.
However, federal law permits the funding of
research on human embryonic tissue that
has been derived with private funds, provided that guidelines for how these cells should
be derived have been followed6. Although
the United Kingdom at present only permits human embryos to be used to study
infertility, contraception and birth defects,
an expert group at the Department of
Health has recommended that embryo
research involving cell-based treatments be
added to the list of acceptable purposes 7.
Germany and France prohibit destructive
embryo research, whereas other European
Union members are split on the question8,9.
Australia also has a mixture of positions,
with the state of Victoria specifically banning “destructive embryo research” that
produces ES cells for research10, whereas the
states of New South Wales and Queensland
permit it according to the guidelines of the
Australian Medical Research Council11.
A legal ban on destroying human
embryos to produce ES cells, however, does
not mean that research on ES cells legally
derived in another jurisdiction is also prohibited. The United States Congress’ ban on federal funding of human embryo research
restricts only federal support for the derivation of human ES cells. The ban does not
affect research on human ES cells that have
been derived by using private funds, provided that National Institutes of Health (NIH)
regulations for how those cells were derived
have been observed6. Similarly, human ES cell
research is now occurring in Victoria, despite
its ban on embryo destruction, with cells
derived in Singapore where their destructive
derivation is legal.
Some countries or states, including
Michigan in the United States12 and Victoria
in Australia, now ban human cloning without drawing a distinction between cloning
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PERSPECTIVES
a
b
Nuclear
transfer
Adult cell
c
Oocyte activation
and development
Enucleated
oocyte
Nucleus of
adult cell
Inner cell
mass
d
Culture and differentiate
cells in vitro
Trophoblast
Blastocoel
Figure 1 | Somatic-cell nuclear cloning for therapeutic purposes. a | A nucleus from an adult cell is removed and dedifferentiated in vitro. b | It is then
transferred to an enucleated oocyte, which is activated so that it grows in vitro to the blastocyst stage. c | At this stage, cells from the inner cell mass would
be harvested and cultured in vitro to select embryonic stem (ES) cells. d | ES cells would then be differentiated in vitro to form a cell type or tissue that the
patient needs.
for reproductive or for therapeutic purposes.
If clinical research shows that immunologically competent ES cells could aid the treatment of certain diseases, such as diabetes or
Alzheimer disease, these legal bans could
prevent the use of nuclear-transfer cloning
(FIG. 1) to produce such cells. However, both
the Council of Europe’s Convention on
Human Rights and Biomedicine, and
UNESCO’s Universal Declaration on the
Human Genome and Human Rights have
been careful to recommend the banning of
only reproductive cloning, thereby avoiding
this problem.
Ethical status of human embryos
If pluripotent stem cells could be obtained
from adult tissues, as some research suggests,
an important source of ethical conflict
would vanish13. However, when stem cells
are obtained from preimplantation human
embryos, ethical objections arise from the
need to destroy embryos to obtain those
cells. Those who believe that preimplantation human embryos are themselves persons
or subjects with rights are against the
destruction of embryos for research, whereas
those who view the embryo as too rudimentary in development to have an inherent
moral status generally permit this research.
Although the conflict between these positions might ultimately be unresolvable, two
sets of distinctions are helpful to negotiate
the terrain between them.
Symbolic versus rights issues. An important
distinction in this ethical and legal debate is
whether objections to human ES cell research
rest on rights-based or symbolic grounds.
Those who view the human preimplantation
embryo as a person or subject with rights and
interests believe that the intentional destruction of an embryo is equivalent to murder. If
that position is correct then the beneficial goal
of saving or prolonging life would not matter,
for no life may be taken to preserve the life of
one or even many persons (except in cases of
self-defence, war and dire necessity).
Although some religions, and many people, take this position, it conflicts with widely
held philosophical and moral views that hold
that status as a person or as an entity with
interests requires, at the very least, a nervous
system capable of sentience, if not also of cognition and consciousness14–16. The neural
development that is essential to have inherent
moral status and interests in one’s own right is
not present in the undifferentiated cells of
preimplantation embryos. The earliest differentiation in the embryo is towards TROPHOBLASTIC tissue, after which the INNER CELL MASS forms
— it is from these cells that the embryo proper
develops and from which ES cells are
derived17. Only after implantation in the
uterus does the embryo proper begin to establish its body plan, events that are later followed
by the development of the nervous system.
Because of the preimplantation embryo’s
rudimentary state of development, removing
ES cells from the inner cell mass of human
BLASTOCYSTS does not wrong them, and so
should be permitted.
Denial of the early embryo’s inherent
moral status and of the correlative moral duty
not to destroy embryos does not, however,
mean that the human embryo is perceived as
being without value, or that it may then be
treated like any other excised human tissue.
An object or thing can be invested with
meaning, even if it lacks rights or interests in
itself, as occurs with religious objects, monuments, works of art or even parts of nature.
Many people, for example, reject the view that
the embryo is a person but believe that the
embryo is different from ordinary human tissue because of the unique potential it has to
develop into a new human being. Sometimes
described as ‘special respect,’ this attitude
towards human embryos shows or symbolizes our respect for human life generally14,18–20.
NATURE REVIEWS | GENETICS
The desire to make a symbolic commitment to non-rights-bearing entities, such as
human embryos, depends on the entity and
context involved. In the context of in vitro
“Those who view the
human preimplantation
embryo as a person or
subject with rights and
interests believe that the
intentional destruction
of an embryo is equivalent
to murder.”
fertilization (IVF) treatment, for example,
the generation of more embryos than can
be safely transferred to the uterus is widely
accepted as not being unduly disrespectful
of human life, because it enables children to
be born to infertile couples. Similarly,
destroying embryos that are left over from
IVF procedures to develop cell-replacement
therapies should also be ethically acceptable, for the goal of treating disease and saving life justifies the symbolic loss that arises
from destroying embryos in the process. By
contrast, selling human embryos or using
them in cosmetic-toxicology testing seems
to be disrespectful of the symbolic meaning
that many people attach to embryos
because those uses fulfil no life-affirming,
or other important, purpose.
The distinction between rights/duties
and symbols explains many of the laws and
regulations that exist in countries that permit embryo research. In the United
Kingdom, for example, embryos may be
used in research but only for specified purposes. Many countries, such as the United
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© 2001 Macmillan Magazines Ltd
PERSPECTIVES
States, permit unlimited research in the private sector but ban or strictly limit human
embryo research that is funded by the government. Both the 1994 report of the NIH
Human Embryo Research Panel and the
1999 report of the United States National
Bioethics Advisory Commission rejected
the idea that the embryo is a person or
moral subject in its own right but, at the
same time, restricted certain kinds of
human embryo research. They put in place
special consent and review procedures that
can be interpreted as a form of symbolic or
‘special respect’ for human embryos21,22.
Two kinds of complicity. A second important
ethical distinction is the difference between
causative and beneficial complicity. A legal
ban on destroying human embryos to obtain
ES cells need not constitute a ban on conducting human ES cell research with ES cells
derived elsewhere, if that derivation would
have occurred regardless of a particular later
use. Recognition of the use versus derivation
distinction now informs federal research
funding law in the United States6. In other
countries, it distinguishes whether embryo
research activities are permitted or made
criminal, as in Victoria, Australia. As long as
some jurisdictions permit destructive embryo
research to occur, ES cell lines might be
derived that could be used for research in
countries that themselves ban the derivation
of human ES cells by embryo destruction.
This is because the cells lines would have been
derived independently of the later decision to
use them for research.
The distinction between use and derivation is neither cynical nor disingenuous for it
reflects the basic distinction in the ethics of
complicity between causing an immoral or
wrongful act to occur and benefiting from it
once it has occurred. One who intends or
Glossary
TROPHOBLAST CELLS
Cells that contribute to the placenta but not to the
embryo itself and that are required for an embryo to
implant into the uterine wall.
INNER CELL MASS
Cells that give rise to the embryo proper and that arise
from the inner cells of an early preimplantation
embryo.
BLASTOCYST
A preimplantation embryo that contains a fluid-filled
cavity called a blastocoel.
CLEAVAGE
The mitotic divisions of the early embryo that occur
in the absence of growth to divide the embryo into
many smaller nucleated cells.
76
causes an immoral act to occur is responsible
or has complicity in a causative sense, and
may be held responsible for the event.
Conversely, one who does not proximately
cause a wrongful event is not morally responsible for its occurrence, even if he or she later
benefits from it.
“Because of the
preimplantation embryo’s
rudimentary state of
development, removing
ES cells from the inner cell
mass of human blastocysts
does not wrong them, and
so should be permitted.”
This distinction explains the general willingness to transplant organs from murder
(or suicide) victims, despite the fact that a
benefit is being reaped from what is clearly a
wrongful act. It also explains national policy
in the United States and the United Kingdom
for the use of fetal tissue, when procedures
were put in place to ensure that the prospect
of research use of fetal tissue did not cause
the abortion to occur23. The distinction
between causing and benefiting from a
wrong also explains the United States government’s position that a Congressional ban on
federally funded ‘embryo research’ does not
ban funding of ‘ES cell research’, because ES
cells are not ‘embryos’22. Because researchers
at many institutions will produce lines of
human ES cells for their own purposes, other
researchers can use them without being
causatively complicit in their production.
Those who reject the line between
causative and beneficial complicity often do
so for symbolic reasons; for example, they do
not want to be associated with what they
regard as a prior immoral act. The acceptability of this distinction will affect the willingness of governments that ban human embryo
research to allow research with human ES
cells derived elsewhere to occur, as will the
adoption of procedures to discourage the
generation of IVF embryos to meet the
demand for human ES cells6. It will also affect
the willingness of people to use human ES cell
therapies once they are developed.
Beyond embryo destruction
A different set of ethical issues arises once
researchers have learnt safe and effective
| JANUARY 2001 | VOLUME 2
ways to direct human ES cells to differentiate into specified cell or tissue types, and to
transplant them for therapeutic effect in
patients. An important clinical issue at this
point will be whether ES cells not derived
from the patient will be rejected by the
patient’s immune system. If so, one strategy
for dealing with this problem would be to
use a patient’s nuclear DNA to create an
embryo from which ES cells compatible
with that patient could then be
derived21,22,24 (FIG. 1).
If nuclear-transfer cloning were necessary for safe and effective use of ES-cellderived replacement therapies, three additional ethical issues beyond the destruction
of left-over embryos to obtain human ES
cells would arise. One issue would be ethical concerns about creating human
embryos for the sole purpose of destroying
them to obtain replacement cells for the
patient who provided the nuclear DNA.
However, the problem of creating embryos
to be destroyed is an ethical problem primarily for those who accept that embryos
left over from IVF procedures may be
destroyed. People who believe that embryos
are persons to whom moral duties are owed
would also object to such a practice, but on
the grounds that any destruction of an
embryo is wrong, not merely the destruction of embryos created to be destroyed for
their ES cells.
Ethical debates about creating human
embryos solely for research have existed
since the inception of debates over embryo
research 25. One can question, however,
whether those concerns are even relevant to
generating human ES cells by somatic cell
nuclear transfer, for the haplogenomes of
gametes are not combined through sexual
fertilization to form the blastocyst that provides the ES cells. In addition, there is no
intention of culturing the embryo beyond
the blastocyst stage, nor of implanting that
blastocyst in a uterus for reproduction.
Given the asexual means of creating the
embryo and the lack of intent of implanting
it in the uterus, the embryonic entity produced in these circumstances lacks the
reproductive significance that some have
argued is the moral basis for valuing early
embryos21,26.
In any event, the question of the ethical
acceptability of creating embryos solely for
research or for therapeutic purposes clearly
implicates symbolic rather than substantive
moral concerns. If one rejects the view that
embryos have interests or are the subjects of
moral duties, then creating them for
research or for therapeutic purposes does
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© 2001 Macmillan Magazines Ltd
PERSPECTIVES
“Sometimes described as
‘special respect,’ this
attitude towards human
embryos shows or
symbolizes our respect
for human life generally.”
no further substantive harm to them.
Objections to the practice might then be
viewed as the symbolic expression of a more
generalized commitment to respect for
human life14,18,20.
Many people, however, would fail to see
symbolic harm beyond that already occurring
by the destruction for research of left-over
IVF embryos. If they accept that embryos lack
rights or interests, it becomes difficult to
argue that any further significant symbolic
harm is caused by creating embryos from a
person’s own cells for that person’s therapeutic use. The additional symbolic harm of creating embryos only to destroy them will matter to some people but is not in itself a
sufficiently strong ethical argument to justify
a legal ban on or to morally condemn
nuclear-transfer cloning with the patient’s
own cells. Nor should it support a ban on the
public funding of this research, because the
practice of generating ES cells with a patient’s
own DNA to prolong or improve the quality
of their life does not imply disrespect for
human life generally.
A second ethical issue presented by the
generation of ES cells from adult somatic
cell nuclear DNA is that such a practice
could lead to reproductive cloning or to the
eventual engineering of an offspring’s characteristics. This objection assumes that all
forms of reproductive cloning and genetic
alteration would be so antithetical to
human values, and would be so likely to
occur once ES cell cloning for therapeutic
uses was established, that society should
give up the considerable benefits of histocompatible, cell-replacement therapy to
prevent any such potential uses from occurring. A more reasonable position, reflected
in both the Council of Europe’s Convention
on Human Rights and Biomedicine and
UNESCO’s Universal Declaration on the
Human Genome and Human Rights, is that
the line between therapeutic cloning and
reproductive cloning is so clear that it is not
necessary to prevent cloning for therapeutic
purposes to prevent reproductive cloning.
A third ethical issue that would arise if
therapeutic cloning became necessary for
effective cell-replacement therapy is the
access and cost demands that would then be
placed on a health-care system. Such costs
might be manageable if cell-replacement
therapies turned out to be more cost effective and more efficient than existing therapies and systems of care. An equally serious
problem in meeting that demand, however,
would be the scarcity of human oocytes
needed to receive the patient’s nuclear DNA
for this cloning.
The cloning of non-human mammals so
far has been highly inefficient, often requiring in excess of 100 oocytes to obtain one
viable clone24,27. If cell-reprogramming factors could not be extracted from oocytes
with which to dedifferentiate a patient’s
somatic cells to stem-cell types (which could
then be multiplied for therapeutic purposes), the ability to meet the therapeutic
demand for oocytes would present an
important problem.
The ability of live, unrelated donors to
meet such a demand is highly unlikely for
several reasons: the hormone treatments
that stimulate the production of many
oocytes imposes a considerable burden on
women; surgery is required to retrieve the
oocytes; oocyte donations are costly; and
ethical problems now surround such donations28. Indeed, even if it became ethically
and socially acceptable to pay thousands of
unrelated women to undergo repeated cycles
of oocyte retrieval for therapeutic uses, the
demand for oocytes for therapeutic cloning
might still outstrip that supply, leaving many
patients dependent on the generosity of
their female relations to donate the needed
oocytes. A system of safely retrieving and
storing ES cells from young, healthy women
for their own later use would still leave males
in need of live donors.
Alternative sources of human eggs might
be cadavers or aborted fetuses. Techniques to
mature oocytes in vitro so that they could
receive transferred nuclei would have to be
developed, but little research to perfect such
techniques is occurring. If it became possible
to mature oocytes in vitro, other ethical issues
concerning the use of cadaveric or fetal ovary
donations would then have to be faced, such as
the risk of non-consensual posthumous reproduction by the cadaveric or fetal donor. A clear
legal ban on the use of oocytes from cadaveric
or fetal ovaries for reproduction would meet
that concern. If the use of oocytes from these
sources did not lead to reproduction, their use
in cloning for therapeutic purposes should be
as acceptable as is the use of other cadaveric or
fetal transplants to save or prolong lives.
NATURE REVIEWS | GENETICS
A third alternative to meet the demand
for oocytes would be to use bovine eggs,
which are in plentiful supply from slaughterhouses. As reported in the press 29
(although as yet unpublished in the scientific literature), one company has already
experimented with transferring human
nuclear DNA to enucleated bovine oocytes,
and found that development to early CLEAVAGE stages does occur. They hypothesize
that proteins in the bovine cytoplasm that
activate the human DNA would soon be
overwhelmed by human proteins, and
therefore would not create a true hybrid,
even at the embryonic level. Viewed solely
as a way to get the nucleus to express itself
to the blastocyst stage, with no transfer to
the uterus permitted, bovine eggs might be
an ethically acceptable way to supply
the oocytes needed to provide many
patients with immunologically competent
replacement cells.
Future prospects
Biomedical research and therapy based on
human embryonic material present complex
ethical, legal and social issues that require
careful attention if society is to reap the benefits that these techniques potentially offer to
many patients. Those who believe that
preimplantation human embryos are already
persons or moral subjects with rights have
profound and probably insurmountable
objections to their destruction to obtain ES
cells for research or therapy. However, such a
person might not object to all uses of human
ES cells if those cells had already been
derived for other research or therapeutic
purposes and if procedures were in place to
discourage the creation of embryos just to
produce ES cells.
“The goal of treating
disease and saving life
justifies the symbolic loss
that arises from destroying
embryos in the process.
By contrast, selling human
embryos or using them in
cosmetic-toxicology testing
seems to be disrespectful …
because those uses fulfil no
life-affirming, or other
important, purpose.”
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© 2001 Macmillan Magazines Ltd
PERSPECTIVES
Those who do not view embryos as having inherent moral status, however, should
see no significant ethical barrier to the
derivation of human ES cells from early
preimplantation embryos for their use in
research or therapy. Those people might
still value embryos as important symbols of
human life generally but the strength of the
desire to use embryos to show respect for
human life will vary depending on the therapeutic context or research use. Just as discarding surplus embryos generated in the
course of treating infertility is generally
acceptable, so deriving ES cells from those
embryos before their being discarded
should be acceptable as well, for in each
case an important human purpose — initiating pregnancy or developing new therapies — is fulfilled.
Given the prevalence of such views and
the strength of the reasoning underlying
them, public policies that permit human ES
cell research and therapy to occur should be
both ethically acceptable and legally available
in many countries. In some countries, however, views against abortion, or politics,
might continue to block human ES cell
research conducted with private or public
funds. Once the science progresses to the
point that ES cell-derived replacement therapies are safe and effective, ethical concerns
will shift from issues of embryo status and
protection to issues of cloning for therapeutic purposes, oocyte supply and access to
treatment for all who could benefit from
these potentially revolutionary therapies.
78
John A. Robertson, J.D. Law School,
727 East Dean Keeton Street,
University of Texas, Austin 78705, Texas, USA.
email: [email protected]
Links
FURTHER INFORMATION Parliament advisory
group’s recommendations on therapeutic
cloning | The United States Congress’ ban on
federal funding of human embryo research |
Council of Europe’s Convention on Human
Rights and Biomedicine | UNESCO’s
Universal Declaration on the Human Genome
and Human Rights | United States National
Bioethics Advisory Commission
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Thomson, J. A. et al. Embryonic stem cell lines derived
from human blastocysts. Science 282, 1145–1147
(1998).
Shamblott, M. J. et al. Derivation of pluripotent stem
cells from cultured human primoridial germ cell. Proc.
Natl Acad. Sci. USA 95, 13726–13731 (1998).
Reubinoff, B. E., Pera, M. F., Fong, C. -Y., Trounson,
A. & Bongso, A. Embryonic stem cell lines from human
blastocysts: somatic differentiation in vitro. Nature
Biotechnol. 18, 399–404 (2000).
Andrews, L. State regulation of embryo research,
(National Institutes of Health, Papers Commissioned
for the Human Embryo Research Panel, Vol. II 1994).
Public Law No. 105–277, 112 Stat. 2681 (1998).
National Institutes of Health. National Institute of
Health Guidelines for Research using Human
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Department of Health. Stem Cell Research: Medical
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France: Law No. 94-654 No. 175. 11060–11068
(Journal officiel de la République française, Lois et
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