Applied Business Research & Ethics For Structures Of Human Body

Selection of a Particular Research Type and Rationale

Discuss about the Applied Business Research & Ethics for Structures of Human Body.

The fundamental structures of human body are cells. It is considered to be an elaborate mass of various types of cells with definite function and organization into tissues to further form organs. The concept of the stem cells emerged in the 19^th century, but the proper experimental procedure were not available at that time. The re-emergence of the term occurred after the nuclear bombings of 1945, when researches on the survivors of the incident began (Bonneuil and Brandt 2016). Stem cells are referred to as the cells that have the potentiality to develop into various different types of cells within the body. They are considered as repairing system of the body. The stem cells undergo infinite divisions and form various kinds of cells, this continues as long as the host body is alive. A stem cell after division either results in a stem cell or some other form of cell like brain cell, muscle cell or red cell. Stem cells can be categorized into pluripotent or multipotent stem cells. The former produces all kind of specialized cells but cannot produce an entire organism of their own .The later produce a specialized subset of cells but in smaller quantity. A stem cell line once is established remains immortal irrespective of the way it had been derived (Hou et al. 2013). In the present assignment, the pluripotent stem cells are considered as the selected research type for obtaining the stem cells as they have the ability to produce many cells and ensure quality and length of life. The various ethical and legal issues related to the use of the selected type of stem cells, unborn babies, pregnant women and the potential for further international spread of the Zika Virus will be addressed adequately.

The type of research to obtain stem cells should be such that the stem cell lines can produce multiple tissues of human body which helps in improvement of the quality of life and longevity. Stem cell therapies can prove to be a promising technique to devastate certain serious diseases. According to NIH, it is very crucial to carry out all types of research to come up with the best kind of stem cells (Ding et al. 2013).  The chosen type of stem cell research is the embryonic pluripotent stem cell. This is so because choosing this type of research methodology will facilitate improvement in the quality of life and longevity as it has the potentiality to revolutionize the medical practices.

Ethical and Legal Issues Related to Use of Stem Cells

There are certain ethical and legal considerations in embryonic stem cell research. In the research studies, the embryos used for the purposes of conducting the experiments must meet the essential requirements in accordance with the laid guidelines of the Institutional Review Boards (IRBs) or such equivalent bodies (Li, Atkins and Bubela 2014).The regulatory guidelines must be followed especially when the parental donors have given prior consent for perusing the research. Hence, these are the important ethical components for stem cell research. The Human Embryonic Stem Cell (hESC) lines are derives from the cells that were either existing embryos or surplus embryos created for Artificial Reproductive Technique (ART), hence no longer required for reproductive purpose. Research that makes use of surplus embryos must meet guidelines of institutional review boards (IRBs) or equivalent bodies, especially in terms of prior informed consent of parental donors (Wagner et al. 2013). The International Regulatory Landscape Regarding national policy of human embryo creation for the purposes of research investigated that, seventeen countries permitted derivation of hESC from surplus embryos. Among them, fifteen countries allowed the hESC creation for research purposes. They include Australia, Canada, Japan, China, and India and so on. These countries by their guidelines restricted the period for culturing of the created embryos to fourteenth day or at the time when the primitive streak is formed (Ishii, Pera and Greely 2013).The restrictions were quite justifiable as the formation of the primitive creature indicates the significance of life or initial stage of becoming a human being (Kass 2002).  In some countries, proper justification regarding the necessity to create embryo for the study is mandatory for getting the permission for conducting the research work. In countries like Australia, India, Belgium, Israel, Singapore, South Korea, Japan, South Africa, Spain and the UK, a public consultation and authorization is required for creation of human embryo as per the law laid in these countries (de Miguel-Beriain 2015). It is also required in those countries to explain that the embryos used in studies are not surplus embryos that are ideally used for the techniques of invitro fertilization and hence undergo the review processes. In the countries where the creation of embryo is permissible for research studies, the method of therapeutic gene cloning by the use of somatic cell gene transfer is generally considered as a permitted technique for the research purposes. The other permitted techniques in various countries comprise of hESC derivations and parthenogenesis. In addition to them, in Australia a special kind of embryo called hybrid embryo is permitted to be used for the studies, in the UK and Singapore, cytoplasmic hybrids are used for the stated purpose. The countries like the UK, Belgium, Denmark, Canada and Japan, the research studies are permitted that lead to the creation of human embryos for improving the Artificial Reproductive Technology (ART) or provide a newer set of helpful informations regarding the technique. According to the Australian Act, by the use of precursor cells present in the human embryos, there is a huge possibility for creation of the human embryos. The precursor cells can be considered as germ cells that are induced rather from human embryonic stem cells and not from human induced pluripotent stem cells (hiPCs). The guidelines of Japan permitted the creation of germ cells from human induced pluripotent stem cells, embryonic stem cells. However, the fertilization technique involving induced germ cells are prohibited now. In Australia, Canada, Belgium, Denmark and the UK, the researchers might be allowed for creation of the human embryo after necessary prior consultation and permission from appropriate regulatory bodies. The embryos are allowed for growth and development, kept under strict observation for 14 days to the potential creating embryonic stem cells from induced germ cells. The federal funding is prohibited in the United States in cases where the research study results in destruction of the human embryonic cells or has the risk of being damaged. The researches that do not obtain federal funding, such laws and regulations are not applicable to them in the United States. The researches that do not obtain federal funding, such laws and regulations are not applicable to them in the United States. The individual statutes of the states influence the research studies. In California, Connecticut, Illinois, Iowa, Maryland, Massachusetts, New Jersey and New York, the statutes have good influence and encourage the researches with the embryonic cells of human, whereas the states like Michigan and Louisiana, the researches with human embryo is banned (Levine 2008).The researches that are not funded by the federals are allowed for using induced germ cells to create human embryos but in doing so prior approval is required both from the local concerned authority as well as the Institutional review Board (IRB). The Judiciary system of Japan has special guidelines that permit the use of stem cells for human embryo creation. However a policy came into being in 2004 that banned the research works involving such stem cells as it was believed that the moral status of the fetus and human dignity is harmed by such actions (Walters 2004). There were certain exceptions in the laid policy that are already discussed. The utilization of germ cells that are derived from pluripotent hESC or iPSC are considered legal for research studies in some other countries while the others have strict inhibition for such actions. However, the countries need to reconsider their policies and guidelines regarding the use of such cells in research activities as they are believed to be a promising tool for combating various diseases. Irrespective of all the similarities and dissimilarities in the derivation method of the stem cells, all human embryos should e given the equal respect in terms of morality and ethics.

The Legal and Ethical Issues Related to the Unborn Babies and the Pregnant Women

Embryonic stem cell researches give rise to critical and major ethical issues as it requires use of human embryo for derivation of the stem cells upon destruction of the embryo. Hence, the moral status of an embryo is the main point of consideration in this regard. It had been argued that an embryo is actually a human being that is presently at its embryonic stage. Personhood, potentiality and human dignity are the important considerations in this context (Jaworska and Tannenbaum 2013).

Personhood is the necessary condition for getting a status of being a person. It is often argued that at the early stage of pre-implantation, it does not contain any intellectual, physiological, psychological or emotional properties hence cannot be associated with personhood (Rudy 2015)

Potentiality is yet another consideration in moral status of the fetus. It is agreeable that the embryo will grow and develop into an individual human being in normal course of time. It is also true that they have high attrition rate, many of them die and cannot develop into an individual human being. Hence, the moral argument is not decisive in this backdrop.

Human dignity is another important part of moral status determination. The dignity should be maintained for all sorts of embryonic cells and considered as a living being that have the potential to grow into a human being. Hence, the research works must be done taking into such considerations that do not harm the morality issues (Rudy 2015).

 The use of supernumerary invitro fertilization embryos for the purpose of stem cell research is allowed in case the family has separated or all of them are or required for achieving pregnancy. The embryos that are not used immediately are stored in frozen conditions. They sometimes lead to their destruction which is considered unethical. There it necessitates an act for ensuring the proper utilization of the stored embryos. This initiated the “Nothing is lost” principle. It states that the supernumerary IVF embryos should not be allowed to simply get destroyed if not used for reproductive procedures; rather they should be used in research study to carry out necessary procedures (Hursthouse 2013). The principle of proportionality is another important consideration for the research purposes. It states that the embryos are not given the moral status of a complete human being but are considered to have moral values. These moral values must be respected and treated with regards to the high levels of morality (Andersson 2016).

The non-invasive method for prenatal diagnosis is a newer technology that allows the testing of fetal genes during the first trimester by isolation of cell free fetal DNA from the mother’s blood. This results in emergence of numerous ethical and legal issues. This is a non-invasive technique, hence is reliable and safe as compared to techniques like amniocentesis which is associated with high risk factor. The ethical issues become critical further in case the testing involves the whole genome sequencing (Dickens 2014).

Zika virus is spread by Aedes mosquitoes that are active during the day time. Zika fever is the infection caused by the virus (Malone et al. 2016). They are spread by the vector mosquitoes belonging to A.aegypti and A. albopictus. It was discovered 70 years age in the Uganda forest and isolated for the first time in the year 1947 (Sikka et al. 2016). It has been found that the Zika virus may spread from a pregnant mother to her fetus resulting in microcephaly, birth defects and malformations of brain. Series of experimental procedures involving cell lines from human and animals demonstrated that the virus has the capability to infect the nerve cells and hence called neurotropic. The ability to cross the placental membrane was further examined through a serious of tests involving amniotic fluids, placental membrane and fetal tissues. The Center for disease Control and Prevention (CDC) clearly stated that the Zika virus is the primary cause of microcephaly as per the current evidence (Fiorentino and Montero 2016).However, the rate at which the transmission occurs from mother to fetal body is still not clear and thus requires further studies and experimentations. It is also associated with congenital and neurological impairments and is an international public concern (Madhukar et al. 2016). The 2015-2016 epidemic caused by Zika virus was prevalent over Southern America and Caribbean areas due to deficiency of knowledge regarding the underlying pathophysiological mechanism of the virus that were discovered in Uganda 70 years ago (Simonin et al. 2016). The evidences from the recent outbreak of Zika indicated that the infection has the capability to spread internationally and they establish new vectors for transmission. The emergency committee focused on the potential risk factors that are associated with the Olympic and Paralympic Games. It took close review of the informations and data that were provided by Brazil and Advisors that are specialized in arbovirus. The spreading of the disease was worldwide, travelling through the medicines, gatherings of masses and bioethics. Eventually, the committee came to the conclusion that there was a low risk of the international spread of the infection further. This was so because the Olympics and Paralympics would be hosted by Brazil. The games would be held during winters. In winter seasons the intensity of the transmission would be low. Moreover, the control measures for the vectors infectious transmission could be intensified near and around the locations where the events would be organized. This would ensure further reduction of the risk level (Lewnard, Gonsalves and Ko 2016).

It is recommended that the research methodology to obtain the stem cells must be such that they produce cells I larger number. It should also be taken into account that they are used for improving the ART or newer techniques. This would ensure quality life and increase the life span of human beings (Mizuno 2016). It is recommended that it should have ethical acceptability and eligibility for federal funding irrespective of the source of derivation of the cells; it should be taken care of that the prior consent of the concerned mothers and individuals donating the research materials are obtained and formally recorded. Moreover, it is recommended that there should be restriction in the sale of the embryos taking into account its ethical and moral aspects. The needs, benefits of use and demerits must be addressed well and the review of the entire procedure by the Institutional Review Board and local committees must be carried out subsequently.

Conclusion

It is concluded that stem cells have greater potentials to eliminate fatal diseases. They are the cells that have the capability to develop into various different types of cells within the body. They are considered as repairing system of the body. In this assignment the pluripotent stem cells are considered as the selected research type for obtaining the stem cells as they have the ability to produce many cells and ensure quality and length of life. The ethical and legal issues are important considerations for such types of research study. The moral status of the fetus is also taken into considerations. Some countries have lenient legislative guidelines, while others have strict prohibitions on use of embryonic cells. However, the policies need to be amended and reconsidered for the betterment of humans and eliminate devastating ailments. Irrespective of all the similarities and dissimilarities in the derivation method of the stem cells, all human embryos should be given the equal respect in terms of morality and ethics. Hence the research should be carried out taking into account all the important considerations of ethical acceptability. 

References:

Andersson, A.K.M., 2016. Challenging the principle of proportionality. Journal of medical ethics, 42(4).

Bonneuil, C. and Brandt, C., 2016. Heredity Explored: Between Public Domain and Experimental Science.

de Miguel-Beriain, I., 2015. The ethics of stem cells revisited. Advanced drug delivery reviews, 82.

Dickens, B.M., 2014. Ethical and legal aspects of noninvasive prenatal genetic diagnosis. International Journal of Gynecology & Obstetrics, 124(2).

Ding, Q., Regan, S.N., Xia, Y., Oostrom, L.A., Cowan, C.A. and Musunuru, K., 2013. Enhanced efficiency of human pluripotent stem cell genome editing through replacing TALENs with CRISPRs. Cell stem cell, 12(4).

Fiorentino, D.G. and Montero, F.J., 2016. The Zika Virus and Pregnancy.Current Obstetrics and Gynecology Reports, 5(3).

Hou, P., Li, Y., Zhang, X., Liu, C., Guan, J., Li, H., Zhao, T., Ye, J., Yang, W., Liu, K. and Ge, J., 2013. Pluripotent stem cells induced from mouse somatic cells by small-molecule compounds. Science, 341(6146).

Hursthouse, R., 2013. Moral Status. The International Encyclopedia of Ethics.

Ishii, T., Pera, R.A.R. and Greely, H.T., 2013. Ethical and legal issues arising in research on inducing human germ cells from pluripotent stem cells.Cell Stem Cell, 13(2).

Jaworska, A. and Tannenbaum, J., 2013. The grounds of moral status.

Kass, L.R., 2002. Human cloning and human dignity: The report of the President’s Council on Bioethics. PublicAffairs.

Levine, A.D., 2008. Policy considerations for states supporting stem cell research: evidence from a survey of stem cell scientists. Public Administration Review, 68(4).

Lewnard, J.A., Gonsalves, G. and Ko, A.I., 2016. Low risk for international Zika virus spread due to the 2016 Olympics in Brazil. Annals of internal medicine.

Li, M.D., Atkins, H. and Bubela, T., 2014. The global landscape of stem cell clinical trials. Regenerative medicine, 9(1).

Madhukar, G.V., Bhausaheb, D.K., Babasaheb, K.K., Tukaram, D.R. and Balkrishna, S.S., 2016. ZIKA VIRUS INFECTION: AN OVERVIEW.

Malone, R.W., Homan, J., Callahan, M.V., Glasspool-Malone, J., Damodaran, L., Schneider, A.D.B., Zimler, R., Talton, J., Cobb, R.R., Ruzic, I. and Smith-Gagen, J., 2016. Zika virus: medical countermeasure development challenges. PLoS Negl Trop Dis, 10(3).

Mizuno, H., 2016. Recommended Ethical Safeguards on Fertilization of Human Germ Cells Derived from Pluripotent Stem Cells Solely for Research Purposes. Stem Cell Reviews and Reports.

Rudy, B., 2015. Embryonic Stem Cell Research, the Ethics, and the Alternatives.

Sikka, V., Chattu, V.K., Popli, R.K., Galwankar, S.C., Kelkar, D., Sawicki, S.G., Stawicki, S.P. and Papadimos, T.J., 2016. The emergence of zika virus as a global health security threat: A review and a consensus statement of the INDUSEM Joint working Group (JWG). Journal of global infectious diseases, 8(1).

Simonin, Y., Loustalot, F., Desmetz, C., Foulongne, V., Constant, O., Fournier-Wirth, C., Leon, F., Molès, J.P., Goubaud, A., Lemaitre, J.M. and Maquart, M., 2016. Zika Virus Strains Potentially Display Different Infectious Profiles in Human Neural Cells. EBioMedicine.

Wagner, A.M., Krenger, W., Holzgreve, W., Bürkli, P. and Surbek, D.V., 2013. Use of human embryonic stem cells and umbilical cord blood stem cells for research and therapy: a prospective survey among health care professionals and patients in Switzerland. Transfusion, 53(11).

Walters, L., 2004. Human embryonic stem cell research: an intercultural perspective. Kennedy Institute of Ethics Journal, 14(1).