Stem Cells Research (1)

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1828805977007Date: 5/10/2016

941009200Date: 5/10/2016

center1760717Ethical and Legal Concerns of Embryonic Stem Cell ResearchStudent’s Name:- Sandeep Kaur Grewal

Usq id: 0061082740

9410036300Ethical and Legal Concerns of Embryonic Stem Cell ResearchStudent’s Name:- Sandeep Kaur Grewal

Usq id: 0061082740

Letter of Transmittal

September 30, 2016

Dear Sir/ Madam,

Kindly find enclosed the report on the preliminary research you commissioned on the type of stem cells to use in formulating novel therapies to aid in the reduction of microcephaly development in the unborn babies whose mothers have become infected with the Zika virus. This report has sought to address the legal and ethical issues related to the use of embryonic stem cells. The report presents the ethical and legal validations and downsides of using embryonic stem cells research for therapeutic cloning. Further, alternatives that could minimize ethical conflicts has been presented as part of the recommendations.

Trusting you find this report satisfactory.

Sincerely yours,

(Sandeep Kaur Grewal)

Table of Contents

TOC o “1-3” h z u Executive Summary PAGEREF _Toc462440791 h 3Introduction PAGEREF _Toc462440792 h 4Stem Cell Research: Ethical Steps and Components in Research Design PAGEREF _Toc462440793 h 6A Review of Literature PAGEREF _Toc462440794 h 6Ethical Concerns PAGEREF _Toc462440795 h 6Legal Concerns PAGEREF _Toc462440796 h 7Ethical Steps and Modules in Research Design PAGEREF _Toc462440797 h 8Conclusions PAGEREF _Toc462440798 h 12Recommendations PAGEREF _Toc462440799 h 13References PAGEREF _Toc462440800 h 15

Executive SummaryStem cell research is a crucial new sphere for biomedical research which offers considerable therapeutic potential for incapacitating diseases as well as injury. The stem cells have the proficiency to spawn various tissue cells which are instrumental in therapeutic approaches to debilitating and incurable diseases. Consequently, stem cell research offers an inordinate capacity for comprehending the essential mechanisms of human development as well as differentiation, moreover the anticipation for new treatments for diseases such as diabetes, spinal cord injury, and Zika Virus. Nonetheless, the stem cell technology advancement from lab to healthcare facilities raises innumerable ethical, moral, social and legal concerns. While a majority of people are currently aware of the wide spectrum of health advantages presented by stem cell research, they are less aware of the various ethical and legal issues significant to the stem cell research. The major ethical conversation revolves around the morality of terminating human embryos for the purposes of benefiting others. It is pertinent to note therefore, that the shift in the focus of stem cell research from basic science to the formulation of therapies brings about the fundamental question of justice. It is crucial hence to measure the nascent therapeutic benefits of stem cell research against the possible downsides and harms. This report presents the considered consensus on a wide spectrum of ethical and legal questions revolving around the complex field of stem cell research. It further focuses on the ethical concerns involved in applications embryonic stem cells in research.

IntroductionThe human body comprises of an elaborate mass of cells, with each cell having a defined role and are organized into tissues as well as organs. Pluripotent stem cells perpetuate themselves in culture and can differentiate into all types of specialized cells. Scientists have intended to differentiate pluripotent cells into specialized cells that could be employed for transplantation. Pluripotent stem cell lines from oocytes and embryos is fraught with disputes concerning the onset of human personhood and human reproduction. Several other techniques of deriving stem cells raise fewer ethical questions. It is important to highlight that the reprogramming of somatic cells in a bid to produce induced pluripotent stem cells (iPS cells) avoids the ethical problems that are specific to embryonic stem cells. Nonetheless, there are difficult ethical dilemmas with any human stem cell (hSC) including the consent to donate materials for hSC research, early clinical trials for hSC therapies, as well as oversight of hSC research (The Irish Council for Bioethics 2008).

The discovery of human embryonic stem cells have been one of the most notable developments in the biological sciences in the recent past. There is a considerable interest in the potential applications of hSC in regenerative medicine (TICFB 2008). The potential uses may include tissue engineering, genetic engineering, and other methods of repairing, replacing, or regenerating failing tissues and organs. While there is little controversy revolving around the use of human adult stem cells, the human embryonic stem cells have raised a range of ethical controversies (Lisker 2003). The extent of these ethical concerns is partly subject to the source of the embryonic stem cells. Currently, there are three used sources of embryonic stem cells:

Embryonic stem cell lines that are already existing;

Embryos that are left unused after in vitro fertilization procedures, otherwise known as “spare” embryos

Embryos developed through somatic cell nuclear transfer method.

Besides the sources of the embryonic stem cells, other ethical concerns revolve around the moral status of the human embryo, the slippery inclination toward commercialization of human life, safety concerns, proportionality challenge, and germ line intervention. The point at which the human life commences is a pivotal challenge. There are several stages, which include conception, primitive streak development, implantation, ensoulment, and birth, which different groups of commentators claim dignity begins in the course of human development (Koch et al. 2013).

Being cognizant that the embryonic stem research is inevitably expected to yield benefits for tissue and organ repair as well as replacement, the only ethical concerns it precipitates are those concerning supply and regulation. In the actual use of stem cell tissue in this manner there is no major ethical objection and the concern of obtaining embryo stem cells is ethically resolvable. It is paramount to note that when active non-therapeutic methods, including use of stem cells, are considered, there is need to recommend a conservative position (Mollar 2008). This follows from the fact that there is a number of reasons for caution, particularly ignorance of the consequences and questions as to the implications for individual integrity.

Stem Cell Research: Ethical Steps and Components in Research DesignA Review of LiteratureEthical ConcernsAutonomous decision-making regarding biological materials donation for stem cell research calls for the provision of fully informed, voluntary agreement or authorization. According to Koch et al. 2013, institutions and researchers are obligated to disclose the nature as well as the intent of the research. In addition, they are required to disclose the potential benefits and risks of participation, in a way that seeks to promote true understanding of the information provided. Being aware that fully informed, voluntary consent can generally be difficult to all forms of stem cell research and human participants, it may be more challenging in hSC research scenario subject to the complexity of the research, the potentially large distribution of stem cell lines from donated biological materials, the compensation provision for human subjects taking part in the research through donation, and the downstream potential of the research (Pandey 2016). Similar to all other areas of biomedical science, stem cell research precipitates debate revolving around ethics and legal regulation of the research as well as resulting therapies (Tiwari 2013). Conventionally, these controversies focus majorly on the moral status of the embryo (International Society for Stem Cell Research 2009). Besides the moral status of the embryo, wider ethical concerns are related to donor risk, affordability, accessibility, and informed consent issue among others (Tiwari 2013).

Pandey (2016) reports that some studies have carried out analysis of the complexities surrounding the proliferation of embryonic stem cell research and therapy including various cultural and social factors as well as the links between stem cell research and IVF clinics. Most of the studies have maintained focus on the development of embryonic stem cell therapy and the associated ethical and legal concerns regarding its proliferation (Gupta 2011). Very few previous studies have focused on the proliferation of therapies subject to adult stem cells (Lo & Parham, 2009). The research by Koch et al. (2013) demonstrates the short and long-term medical risks, exploitation of donor women, and other ethical issues related to egg harvesting for stem cell research. Mollar (2008) has showed the problem of unequal biological access in stem cell research. Besides the philosophical debates about the use of embryos in stem cell research, there are apprehensions that embryos will be used as commodities similar to human organs and tissues (Tolich 2010).

Legal ConcernsThe legal concerns around the use of embryonic stem cells are fundamentally related to the destruction of human embryos for purposes of conducting research. It is largely associated with the ethical consensus in different countries and consequently regulations and legislations are formulated. Due to the lack of ethical consensus, there has been rise in varying regulations across the globe (Zahedi-Anaraki & Larijani 2011). In the U.S, for instance, majority of states have allowed embryonic stem cell research that calls for the destruction of human embryos, but the federal law prohibits such forms of research. However, it was until 2009 that the federal government permitted embryonic stem research through the use of public funds (Tiwari 2013). Through the Human Fertilization and Embryology Act of 1990, the UK legalized the use of human embryos up to 14 days after fertilization for conduct of research (Mollar 2008). Australia allow the use of embryonic stem cells through surplus IVF embryos but however prohibits therapeutic cloning.

On the other hand, China is places more emphasis on the clinical application of embryonic stem cells as opposed to basic research. Gottweis et al. 2009 notes that different countries have different regulations. In the U.S, the federal law on research allow a waiver of informed consent for research use of deidentified biological materials that cannot be linked to donors (Lo & Parham 2009). Subsequently, it would be possible to conduct embryo and stem cell research on deidentified materials with no need for consent. In illustration, in the course of IVF procedures, the oocytes that fail to fertilize as well as embryos that fail to develop sufficiently for purposes of implantation are normally discarded. Such materials could be deidentified and then later used for research (Lo & Parham 2009). Nevertheless, the ethical validations for permitting deidentified biological materials to be utilized for research devoid of consent do not permanently hold for embryo research (Pandey 2016). For instance, one justification for sanctioning the use of deidentified materials is that the ethical jeopardies are very low, implying there can be no breach of confidentiality, which happens to be the major apprehension in this type of research. A second validation is that people would not be opposed to having their materials utilized in such a way if they were inquired. Conversely, this supposition does not inevitably hold in the perspective of embryo research (Lo & Parham 2009). 

Ethical Steps and Modules in Research DesignThe rapid spread of Zika virus (ZIKV) and its link to abnormal brain development make up a worldwide health emergency. Congenital ZIKV infection gives rise to a wide spectrum of mild to severe pathologies that include placental damage as well as microcephaly. Nonetheless, the placenta’s role in viral transmission and the mechanisms of microcephaly have not been sufficiently addressed in primary human tissues. Furthermore, there is an urgent need for therapy to be formulated that can curb developmental defects after infection. The use of embryonic stem cell can be a good starting point in developing therapy that can be instrumental in preventing microcephaly due to Zika virus infection of pregnant women. Employing a well-established ethical frameworks to the design as well as the conduct of stem cell research will involve appreciation of different ways individuals can take part or contribute to stem cell research, as donors of gametes, cells, or embryos for human embryonic stem cells, as subjects to clinical trials, or as the recipients of the consequent stem-cell based therapies (Pandey 2016). It is paramount that the acquisition of biological materials meant for embryonic stem cell research abide by the ethics and norms that appreciate and respect the donor’s rights. Moreover, the biological nature of embryonic stem cells make it challenging for ABC as a research entity to adhere to the three main principles that govern human subjects research in testing innovative stem cell therapies. These ethical principles are: beneficence, respect for persons, and justice.

Further, ethics and legal guidelines in embryonic stem cell research aid in ensuring that researchers can be held accountable to the public as regards issues of conflict of interest, protection of human participants, and accountability of funding from public money. Research ethics is also an important tool in building support for research from the public (Tolich 2010). The public tends to allow more funds for research subject to the integrity and quality of research. A variety of significant social and moral values such as compliance with law, human rights and social responsibility will need to be promoted by way of adhering to research ethics. This means that a tumble in research ethical norms can radically cause damage to human subjects, and the general public (Abdulgafoor et al. 2009).

Any scientific and clinical research is founded on six primary ethical values namely; fairness, honesty, openness, objectivity, respect for others, and trustworthiness. Any violation of these ethical norms during the process of conducting embryonic stem cell research will make up falsification, fabrication, as well as other doubtful research practices. Indisputably, ethical issues in the embryonic stem cell research will involve informed consent, risk assessment, data handling and reporting, confidentiality and privacy, mistakes and negligence.

Informed consent is considered to be the major ethical concern in the conduct of clinical research. It is defined as the means by which an individual gives consent knowingly, voluntarily, in clear and manifest way, and intelligently. It implies thus that it is up to the decree of a embryonic stem cell research participant to assess the risk as well as the benefits that accompany the research and subsequently come to a decision whether to take part in the research or not. The Helsinki Declaration (1975) accentuates that each potential subject to any research involving human beings ought to be sufficiently informed of the methods, aims, possible conflicts of interest, funding sources, organizational affiliation of the researcher, potential risks and expected benefits of the research as well as the disquiet that may be involved (Shahnazarian et al., 2013).

It is an ethical requirement for researcher conducting stem cell as well as any other clinical research to respect research subjects and participants, justice and inclusiveness, privacy and confidentiality, and respect for informed and free consent. Informed consent requires that researchers respect the autonomy of individuals taking part in the research as participants. Autonomy involves the capability of an individual to deliberate and make a personal choice and thus the responsibility of making the decision of participating in the research must be given the individual (Shahnazarian et al. 2013). The principle of informed consent dictates that the research subjects should be adequately informed on the details of the research study regarding the potential benefits and risks that come with their participation.

Dissemination of information is vital in aiding the participant to voluntarily make a decision whether to take part or not and it should involve a dialogue encapsulating the purpose of the research, empirical procedures, risks and benefits, duration, and alternatives. It should be noted that the consenting process should be ongoing in that the subject has a right to withdraw their participation at any given time (Shahnazarian et al. 2013). The core of ethical norms and standards are rooted in the protection of confidentiality and privacy of the subjects of research following the fact that such norms and standards are directly linked to the judgment and choice of the individual.

Closely related to informed consent is confidentiality and privacy, which are overlapping issues in dealing with research participants. Wet (2010), highlights that confidentiality is established in a bid to safeguard the privacy of the research subjects. Additionally, it is generally assumed that a research study is deemed ethical if standard statements of informed consent, anonymity, respect and confidentiality are considered by researchers. It becomes crucial therefore that a researcher should make sufficient provisions to observe the maintenance confidentiality of data as well as the privacy of the research subjects (Tolich 2010). The following measures are considered mandatory in enhancing confidentiality and privacy of participants; security of all documents containing data, safeguarding personally identifiable information, destruction of unutilized data after the analysis, database security, excluding the involvement of any third party in the course of data collection and analysis. As posited by Abdulgafoor et al. (2009), an individual’s privacy holds an inherent value binding it to human security as well as dignity and it is considered as the only ethical principle that is attached to ones sense of personhood.

ConclusionsThe ABC experiments studying the clinical application of embryonic stem cells ought not to shadow the distinction between research and medical treatment. The three approaches to the introduction of stem-cell based therapies in humans, which are: the clinical research paradigm, the clinical use of unproven interventions, and the medical intervention model, should be adequately protective of human subjects and should be compatible. Despite the unending need to address the ethical concerns, it is evident that embryonic stem research will continue to advance.

Adhering to ethical principles that govern clinical research will be very instrumental in ensuring the Company ABC will serve the aims and goals of embryonic stem cell research. Adhering to clinical research ethics will promote the aims of embryonic stem cell research which ought to include knowledge, avoidance of errors, and truth. It is paramount to remember that ethics serves to prohibit against falsification, fabrication, or misrepresentation of research data and in so doing promote truth and the avoidance of error. The stem cell research will bring together considerable coordination and cooperation among various people from various institutions and disciplines (Arpey et al. 2011). In this view, research ethics and standards play a vital role in the promotion of essential values in collaborative work which include fairness, mutual respect, accountability and trust. Consequently, ethical standards in this research will inform the authorship guidelines, patent and intellectual property policies, confidentiality rules relating to peer review, and policies on data sharing which are all established with the aim of cushioning the interest of intellectual property while encouraging collaboration (Abdulgafoor et al. 2009).

RecommendationsWhether embryonic stem cell research is justifiable or not is partly subject to what the available alternatives are, and how their specific paybacks and downsides balance out. Stem cells have been identified in adult tissues such as liver, skin, intestine, bone marrow and brain. However, according to current clinical research, it cannot be presumed that adult stem cells are universally productive in the same manner as the embryonic stem cells. This follows from the fact that it is difficult to isolate stem cells form tissues of adult humans. In addition, the cells are in few quantities, and it is difficult to keep them proliferating in culture. Another alternative that would ensure the avoidance of viable human embryos destruction in the course of conducting embryonic stem cell research is to produce non-viable human embryos through taking human cell and performing a nuclear transfer into a de-nucleated egg of other suitable species (Hug 2005). Obtaining stem cells from blastocysts developed by trans-species somatic cell nuclear transfer is a permitted procedure if there no slight possibility of creating viable hybrid creatures and provided such research is done for therapeutic purposes. The delinquency with this procedure, nonetheless, is that it is unfamiliar yet whether the utilization of ova from other species is in principle conceivable and whether the stem cells produced in this way would be functionally and immunologically comparable to those created using human ova (Hug 2005).

Exploring other alternatives, we are aware that embryonic stem cells employed in transplantation may be immunologically discordant with the recipient if they are not acquired through therapeutic cloning. To address this problem of immunological incompatibility a tissue bank with a appropriately huge quantity of diverse embryonic stem cell types could be developed. Such would be instrumental in generating tissues that can be immunologically harmonized with different recipients. Conversely, to create such a tissue bank would call for an enormous number of human embryonic stem cell lines. The shortcoming of such an embryonic stem cell bank is the fact that it would be technically challenging and costly to create (Lo & Parham 2009).

References this is not Harvard reference styleAbdulgafoor, B. M., Dawson, L., Hyder, A. A., & Lavery, J. V. (2009). Moving From Research Ethics Review to Research Ethics Systems in Low-Income and Middle-Income Countries. The Lancet, 373, 862–865.

Arpey, J. W., Marcuccio, E. A., & Stokes, L. E. (2011).Ethical Intervention During The College Years: Increasing The Moral Awareness Of Future Business Leaders. Mustang Journal of business & Ethics.152-161.

Gupta, B.D. (2011): An Introduction to Stem Cell and Debate Surrounding Them. J Indian Acad Forensic Med, 31(3):267-273.

Hug, K. (2005), Sources of Human Embryos for Stem Cell Research: Ethical Problems and their Possible Solutions, Medicina (Kaunas) 2005: 41 (12).

International Society for Stem Cell Research (2009), Guidelines for the Conduct of Human Embryonic Stem Cell Research, Version 1, December, 2016, Retrieved from < https://www.forth.gr/_gfx/pdf/ISSCRhESCguidelines2006.pdf>

Koch, V. G; Roxland, B. E; Pohl, Barbara, P. & Keech, S. K. (2013), Contemporary Ethical Issues in Stem Cell Research, S. Sell (ed.), Stem Cells Handbook, DOI 10.1007/978-1-4614-7696-2_2,

Larijani, B., Zahedi, F. (2008): Policy, Equity and Priority: Ethical Issues of Stem Cell in Developing Countries. Iranian J Publ Health, 37(1):1-11.

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Lo, B. and Parham, L. (2009), Ethical Issues in Stem Cell Research, Endocrine Reviews, 2009 May: 30 (3): 204-213

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Pandey, A (2016), Stem Cell Research in India: Socio-Ethical Concerns, Research Article, International Journal of Advanced Research, 2016, Vol. 4, Issue 1, 282-289, ISSN 2320-5407

Shahnazarian D., Hagemann J., Aburto M., and Rose S. (2013). Informed Consent in Human Subjects Research. Office for the Protection of Research Subjects. University of Southern California. Retrieved from http://oprs.usc.edu/files/2013/04/Informed-Consent-Booklet-4.4.13.pdf

The Irish Council for Bioethics (2008), Ethical, Scientific and Legal Issues Concerning Stem Cell Research, Opinion. The Irish Council for Bioethics, Dublin ISBN 978–1-904890–49–2

Tiwari, S. S. (2013), The Ethics and Governance of Stem Cell Clinical Research in India, PhD Thesis, The University of Nottingham. Retrieved from http://eprints.nottingham.ac.uk/14585/1/602957.pdf

Tolich, M. (2010).A Critique of Current Practice: Ten Foundational Guidelines for Autoethnographers. Qualitative Health Research, 20, 1599-1610. Doi: 10.1177/1049732310376076

Wet, K. D. (2010). The Importance of Ethical Appraisal in Social Science Research: Reviewing A Faculty Of Humanities‟ Research Ethics Committee.Journal of Academic Ethics, 8, 301-314. doi: 10.1007/s10805-010-9118-8.

Zahedi-Anaraki, F. and Larijani, B. (2011). Stem Cells: Ethical and Religious Issues, Bioethics in the 21st Century, Prof. Abraham Rudnick (Ed.), ISBN: 978-953-307-270-8, InTech, Available from: http://www.intechopen.com/books/bioethics-in-the-21st-century/stem-cells-ethical-and-religious-issues