Discuss about the Regulatory Issues of 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 diseases[1]. 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 research[2].
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 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 treatment[3].
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) embryo[4]. 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 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 purposes[5]. 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 cells[6].
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 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 them[7].
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 and the others potential embryos donors for embryonic stem cell research hold diverse and strong view-points on the matter[8]. 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 use[9]. 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 research[10].
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 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 challenges[11]. 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 confidentiality[12].
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 measures[13].
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 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 cloning[14].
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 cognition[15].
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.
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.
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.
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.
Ethics Committee of the American Society for Reproductive Medicine.”Donating embryos for human embryonic stem cell (hESC) research: a committee opinion.” (2013): 935-939. Fertility and Sterility100.4.
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.
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.
Karch, Andrew. “Vertical diffusion and the policy-making process: The politics of embryonic stem cell research.” (2012): 48-61. Political Research Quarterly 65.1(2012): 48-61.
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.
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.
Thompson, Charis. Good science: the ethical choreography of stem cell research.2013. MIT Press.
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