Embryonic Stem Cell Technology: Ethical and Legal Considerations

This essay explores the complex ethical and legal landscape of embryonic stem cell (ES cell) technology. It begins by outlining the potential of ES cells for treating various diseases but quickly pivots to address the controversies that arise from their use, particularly the destruction of human embryos. The essay delves into legal considerations, noting the varying regulations across countries like the UK, US, and Australia, including funding restrictions and permitted research scenarios. It then examines ethical complications, such as the debate over the moral status of embryos, informed consent for embryo donation, and the importance of maintaining donor confidentiality. The essay also addresses ethical issues in gene cloning and the potential for reproductive cloning, highlighting the arguments for and against therapeutic cloning. The essay concludes by emphasizing the interplay between ethical and legal debates, and the varying perspectives on the moral status of the embryo and the implications for ES cell research. Overall, the essay provides a comprehensive overview of the ethical and legal complexities associated with ES cell technology.

Running head: EMBRYONIC STEM CELLS TECHNOLOGY
Regulatory Issues of Embryonic Stem Cells Technology
Name of the Student
Name of the University
Author Note

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EMBRYONIC STEM CELLS TECHNOLOGY
The research in the domain of stem cell offers significant evidence for analyzing the
standard process of human development and cell differentiation along with hope for new
improved treatments for common disease like diabetes and injury in the spinal cord,
myocardial infarction and other neurological complications like Parkinson’s disease.
Embryonic stem cell is multipotent or pluripotent in nature and thus can differentiate into
different group of specialised cells. Thus, the haematologists are planning to use this
pluripotent cell lines in the process of transplantation towards the treatment of the debilitating
diseases1. However, human stem cells or the embryonic stem cells from the human cell line
raise distinct ethical and legal controversies. The extraction of the pluripotent stem cell lines
from oocytes or fertilized embryos is fraught with discrepancies in the domain of onset of
human reproduction and human personhood. Numerous other techniques of extracting stem
cell raise comparatively less ethical concerns. The somatic cells reprogramming to generate
induced pluripotent stem cells (iPS) dodges the ethical stigma distinct to embryonic stem
cells. With any form of human haematopoietic stem cells (HSC) research there are however
complex ethical and legal dilemmas like approval to donate HSC to research, early stage
clinical trials for HSC therapies and further oversight of the HSC research2.
Furthermore, in the domain of embryonic stem cell, it can be stated that pluripotent
stem cells can be extracted from the inner mass of 7 to 5 days old blastocyst. Nevertheless,
research in embryonic stem (ES) cell research is full of controversy in the legal and ethical
grounds because it centres on the destruction of the live human embryos. The alarming
question of when the life initiates is extremely controversial and is inherently associated with
debates over the subsequent controversy of abortion. It is never neglected that human
embryos have full potential to generate into a complete human beings if gets properly
1Lo, Bernard, and Lindsay Parham."Ethical issues in stem cell research." (2009): 204-213 Endocrine
reviews 30.3.
2Ishii, Tetsuya, Renee A. ReijoPera, and Henry T. Greely. "Ethical and legal issues arising in research on
inducing human germ cells from pluripotent stem cells." (2013): 145-148. Cell Stem Cell13.2.

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transplanted into women womb during right hormonal cycle. Thus controversy of destruction
of life is always associated with the research centring embryonic stem cell. The following
essay aims to highlight the ethical and legal issues associated with the recent development of
embryonic stem cell technology and other ethical and legal aspects of gene cloning and
subsequent treatment3.
Legal consideration of the ES cell research
The legal association behind the use of human fetal tissue of subsequent destruction
of human embryo to extract ES cells for research differs vastly throughout the world. For
example, the United Kingdom and Unites States and other countries allow the application of
human fetal tissue for the use of research when the decision of the ES donor (the woman) to
donate the fetal tissue is distinctly different from her decision to abort. Although the majority
of the states in America and United Kingdom permits ES cell research that demands the
destruction of human embryos, the law in the federal ground prevents the direct funding of
the embryo destruction to extract such cells. However, the laws of the federal bodies permit
the finding of research undertaken over the human embryonic tissues which has been derived
under the influence of private funding, provided that the guidelines regarding how these cells
lines must be used derived is strictly followed. Although under the legislation published by
the Australian Law Reform Commission, human embryo research is allowed only under
certain restricted circumstances. The research may incorporate only embryos that are
allocated under the category of the excess assisted reproductive technology (ART) embryo4.
According to the Australian Parliament, Prohibition of cloning Act (2002), it is an offense to
employ embryos that are not an excess of ART. Furthermore, the law has also opined that
excess ART embryo must either be conducted pursuant against a granted licence in
3King, Nancy MP, and Jacob Perrin."Ethical issues in stem cell research and therapy." (2014): 85. Stem cell
research & therapy 5.4.
4Robertson, John A. "Human embryonic stem cell research: ethical and legal issues." (2001): 74. Nature
Reviews Genetics 2.1.

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EMBRYONIC STEM CELLS TECHNOLOGY
accordance with the stated procedures highlighted under the Research Involving Human
Embryos Act or a subject of a statutory exemption under which a license is not mandatory. In
spite of the legislations passed by the Australian Parliament of Prohibition of cloning Act
(2002), the Australian Department of Health has opined that research of embryo centering
cell-based treatments must be added under the list of the acceptable purposes5. However, the
Victorian state specifically bans "destructive embryo research" that leads to the generation of
ES cells for research. However, human ES cell research is at present happening in Victoria in
spite of its ban on the process of embryo destruction. On the other hand, the states of New
South Wales and Queensland allow use of ES as per the guidelines highlighted by the
Australian Medical Research Council. A legal ban over the destruction of human embryos to
generate ES cells does not necessarily highlights that the research undertaken over ES cells is
legally extracted in another domain of jurisdiction is also strictly prohibited. In Victoria,
Australia, there is also a ban in the domain of cloning done via ES cells for reproductive and
therapeutic reasons. If subsequent clinical research highlights that the immunologically
competent ES cells is suitable for aiding the treatment of certain diseases like diabetes or
neuro-degenerative disease, these legal bands could restrict the application of nuclear-transfer
cloning to generate such cells6.
Ethical complicationsof the ES cell research
Some researchers are of the opinion that if the pluripotent stem cells could be
extracted from adults’ tissues then the prevailing ethical conflict might have been vanished.
However, extraction of stem cells from pre-implantation human embryos generate ethical
objects especially for those who believes that pre-implantation of human embryos are
5Key Ethical Issues in Embryonic Stem Cell Research.Parliament of Australia. 2002. Retrieved from:
https://www.aph.gov.au/About_Parliament/Parliamentary_Departments/Parliamentary_Library/
Publications_Archive/CIB/cib0203/03cib05
6Robertson, John A. "Human embryonic stem cell research: ethical and legal issues." (2001): 74. Nature
Reviews Genetics 2.1

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EMBRYONIC STEM CELLS TECHNOLOGY
themselves persons or subjects. However, those who believe that embryos are too
rudimentary in development to have their own moral status, generally have no objection for
this research. However, the conflict between these two positions is difficult to resolve but this
two distinct sets of differences are useful to negotiate the subsequent terrain in between
them7.
(Source: Lo, Bernard, and Lindsay 2009)
Informed consent for the donation of embryos for stem cell research
As per the Nuremburg code, informed consent is denoted as the most basic
requirement for research while centring the human subject. Since embryonic stem cell
research involves the human subject, the consent is of prime importance. Members of public
7Barker, Roger A., and Inez de Beaufort. "Scientific and ethical issues related to stem cell research
and interventions in neurodegenerative disorders of the brain." (2013): 63-73. Progress in
neurobiology 110.

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EMBRYONIC STEM CELLS TECHNOLOGY
and the others potential embryos donors for embryonic stem cell research hold diverse and
strong view-points on the matter8. Some are of the opinion that all form of embryonic
researches is acceptable while others support only few specific form of research. For
example, a person might regard research in the domain of infertility acceptable but at the
same time can object research use to extract stem cell lines or other forms of research that
might lead to the generation of commercial patents or products which have commercial use9.
Gaining informed consent for the promising future uses of the embryos which are being
donated try to respect this diversity of views. Any neglect in respecting this diversity in
deviating views can causes serious ethical complications. Moreover, individuals generally
place certain inherent emotional and other moral significance in their reproductive tissues
other than other physiological tissues and thereby further increasing the sensitivity of the
informed consent a complications of ethical domain of the research10.
Waiver of consent
Waiver of consent is applicable to research used for de-identified biological materials
that cannot directly be linked with the donors. For example, during the procedure of in-vitro
fertilization, oocytes that fail to fertilize or the fertilized embryos that fail to generate in 8-cell
stage in an adequate manner are mainly discarded. These materials thus could be de-
identified and then can be used by the researchers for ES research. Furthermore, if the
patients who are enrolled under infertility clinic and have frozen embryos left after the
successful treatment can also be used for ES research. However, under this criteria, the
couples must be contacted by the administrative personnel of IVF organisation to state their
consent over whether they want tp continue to store their fertilized embryos for future use or
8Carroll, Katherine, and Catherine Waldby."Informed consent and fresh egg donation for stem cell
research." (2012): 29-39. Journal of bioethical inquiry 9.1.
9Lowenthal, Justin, et al. "Specimen collection for induced pluripotent stem cell research: harmonizing the
approach to informed consent. (2012): 409-421. " Stem cells translational medicine 1.5.
10Brezina, Paul R., and Yulian Zhao. "The ethical, legal, and social issues impacted by modern assisted
reproductive technologies." (2012). Obstetrics and gynecology international 2012.

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EMBRYONIC STEM CELLS TECHNOLOGY
like to donate them to an infertile women or want to discard them. If the couples vouch for
discard then it can be used for ES research without bridging any complex ethical challenges11.
On the other hand, of the couple cannot be reached to stated their decision, their embryos can
also be used. However, ethical justifications for enabling de-identified biological materials to
be employed for research without the consent do not necessarily holds for true for ES
research in all grounds. For example, one rationale for enabling the application of de-
identified materials is that in this grounds, the ethical complications are low and thus there
can be no breach of significant confidentiality12.
Confidentiality of the information of the donor
Confidentiality must be strictly preserved in ES research. This is because any breach
of confidentiality may provoke donors towards unwanted publicity stunts or even
harassments. However, identification of the information about the donors must be
documented during audits done by the Food and Drug Administration (FDA). It is a routine
part of the approval program for new therapies and concerns might deter few donors from
vouching to be re-contacted. At present, confidentiality of donor’s data has been violated via
deliberate breaches by computer hackers and through loss laptops. So in order to protect the
confidentiality of the donors, the files containing the information of the donors whose
embryos or gametes are used should be protected via heightened security measures13.
Ethics in gene cloning and ES research
In this domain, the main ethical issue presented by the formation of ES cells from
adult somatic cell nuclear DNA is that this kind of research practice could generate threats
towards reproductive cloning or towards eventual engineering of the characteristics of the
11Gefenas, Eugenijus, et al. "Turning residual human biological materials into research collections: playing with
consent." (2012): 351-355. Journal of medical ethics 38.6.
12Lanphier, Edward, et al. "Don’t edit the human germ line." (2015): 410. Nature News 519.7544.
13Isasi, Rosario, et al. "Identifiability and privacy in pluripotent stem cell research." (2014): 427-430. Cell Stem
Cell 14.4.

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EMBRYONIC STEM CELLS TECHNOLOGY
off-spring. This kind of specific objection assumes that nearly all forms of reproductive
cloning and other genetic alteration would be so unethical towards human values. This would
be so likely to happen once ES cell cloning and alteration in genetic level would be so likely
to occurs once the ES cell cloning for therapeutic use was firmly established, that members of
the orthodox society must give up the significant benefits of cell-replacement therapy towards
prevent any such potential application from happening. Further strong position is reflected on
UNESCO’s Universal Declaration on Human Genome and Human Rights. This position
states that the line in between reproductive cloning and therapeutic cloning is so distinct that
it is not necessary to prevent cloning for therapeutic purposes for preventing reproductive
cloning14.
Amalgamation of ethical and legal complication
At last it can be said that an important difference between this ethical and legal debate
is, whether the significant objections towards human ES cell research is based on the rights or
over the symbolic grounds. People who visualize the human pre-implantation embryo as a
subject or a person with interests and rights believe that the overall intentional damage of
embryos in proportional to homicide. If this position is considered to be correct then,
important goal of protecting or prolonging life will not matter, for no life may be snatched to
secure the life of one. However, few religions, take this stand, it contradicts with famously
held moral and philosophical views that conserved that position as an individual with
interests requires, at very least, a nervous system suitable for sentience, if not also for
consciousness and cognition15.
14Lo, Bernard, and Lindsay Parham."Ethical issues in stem cell research." (2009): 204-213 Endocrine
reviews 30.3.
15Carvalho, Ana Sofia, and Joao Ramalho-Santos. "How can ethics relate to science? (2013): 591. The case of
stem cell research." European Journal of Human Genetics 21.6.

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EMBRYONIC STEM CELLS TECHNOLOGY
Conclusion
Thus from the above discussion it can be said that ES cell research tough have put
forward a promising potential to be an effective alternative of many fatal disease treatments,
it is associated with sudden form of legal or ethical consideration. The essay highlighted that
use of ES cells in research is associated with ethical challenges of informed consent and
maintenance of confidentiality. Moreover, the observance of ES cell research also had certain
pitfall like whether it is actually killing any life or is providing benefit to the global
communities. From the legal grounds, it can be said that different federal laws in different
portion of Australia have different views regarding use of ES cells in gene cloning or disease
treatment. This different in approach in the domain of funding or ethical or non-ethical
grounds further creates problems towards a comprehensive application of ES cell technology
into research. Thus, biomedical or biotechnology research and therapy based on human ES
cells lays out a complication legal and ethical issue that demands strict attention if the society
is willing to reap of the maximum benefits of these techniques.

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EMBRYONIC STEM CELLS TECHNOLOGY
References
Barker, Roger A., and Inez de Beaufort. "Scientific and ethical issues related to stem cell
research and interventions in neurodegenerative disorders of the brain." (2013): 63-73.
Progress in neurobiology 110.
Brezina, Paul R., and Yulian Zhao. "The ethical, legal, and social issues impacted by modern
assisted reproductive technologies." (2012). Obstetrics and gynecology international 2012.
Carroll, Katherine, and Catherine Waldby."Informed consent and fresh egg donation for stem
cell research." (2012): 29-39. Journal of bioethical inquiry 9.1.
Carvalho, Ana Sofia, and Joao Ramalho-Santos. "How can ethics relate to science? (2013):
591. The case of stem cell research." European Journal of Human Genetics 21.6.
Gefenas, Eugenijus, et al. "Turning residual human biological materials into research
collections: playing with consent." (2012): 351-355. Journal of medical ethics 38.6.
Isasi, Rosario, et al. "Identifiability and privacy in pluripotent stem cell research." (2014):
427-430. Cell Stem Cell 14.4.
Ishii, Tetsuya, Renee A. ReijoPera, and Henry T. Greely. "Ethical and legal issues arising in
research on inducing human germ cells from pluripotent stem cells." (2013): 145-148. Cell
Stem Cell13.2.
Key Ethical Issues in Embryonic Stem Cell Research.Parliament of Australia. 2002.
Retrieved from: https://www.aph.gov.au/About_Parliament/Parliamentary_Departments/
Parliamentary_Library/Publications_Archive/CIB/cib0203/03cib05
King, Nancy MP, and Jacob Perrin."Ethical issues in stem cell research and therapy." (2014):
85. Stem cell research & therapy 5.4.

10
EMBRYONIC STEM CELLS TECHNOLOGY
Lanphier, Edward, et al. "Don’t edit the human germ line." (2015): 410. Nature
News 519.7544.
Lo, Bernard, and Lindsay Parham."Ethical issues in stem cell research." (2009): 204-213
Endocrine reviews 30.3.
Lowenthal, Justin, et al. "Specimen collection for induced pluripotent stem cell research:
harmonizing the approach to informed consent. (2012): 409-421. " Stem cells translational
medicine 1.5.
Robertson, John A. "Human embryonic stem cell research: ethical and legal issues." (2001):
74. Nature Reviews Genetics 2.1.

11
EMBRYONIC STEM CELLS TECHNOLOGY
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