Research Report: Ethical and Legal Issues of Zika Virus Treatment

This report addresses the ethical and legal issues associated with research on the treatment of the Zika virus, focusing on the use of stem cells and the development of gene therapy techniques to reduce microcephaly in unborn babies. The report analyzes the types of stem cells (embryonic, adult, and induced pluripotent) and their ethical implications, particularly concerning the destruction of embryos and donor consent. It recommends the use of induced pluripotent stem cells for their potential in creating customized genetic matches and avoiding tissue rejection. Furthermore, the report emphasizes the importance of experimental/laboratory research design for Company ABC, highlighting the need for ethical considerations and approval from the Ethics Committee to ensure responsible and ethical research practices. The report concludes with recommendations for ethical research design and the use of specific stem cell types.

The ethical and
legal issues
related to the
research on the
treatment of Zika
virus.

Letter of transmittal
Date
Alber, President
Institute of Research
400 Baywater Blvd.
Corpus Christi, Texas
Dear Mr. Albert:
As agreed in our September 21 contract, we are submitting the attached report entitled The
ethical and legal issues related to the research on the treatment of Zika virus.
The report aims to decide what type of stem cells to use by conducting some preliminary
research on the types of stem cells. The legal and ethical issues related to the use of stem cells,
the unborn babies, the pregnant women and the potential for further international spread of the
Zika virus has been discussed. Based on this report, company ABC will carry out some further
research to acquire the stem cells. Before they can do that research they will need to get approval
from the Ethics Committee. So, they need to be aware of the ethical issues when they are
designing their research. So, this report has outlined the steps that they should undertake to
ensure that their research is ethical. Along with this, the report has addressed essential ethical
components in the research.
I hope you find this report satisfactory.
Sincerely yours,
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XYZ, President
Company ABC
1212 Trace Dr., Suite 3
Austin, Texas 78741
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Executive summary
Zika virus is that harmful virus which enters into the body of pregnant women and hit the fetus
due to which it develops microcephaly. The report aims to decide what type of stem cells to use
by conducting some preliminary research on the types of stem cells. The legal and ethical issues
related to the use of stem cells, the unborn babies, the pregnant women and the potential for
further international spread of the Zika virus has been discussed. Based on this report, company
ABC will carry out some further research to acquire the stem cells. Before they can do that
research they will need to get approval from the Ethics Committee. So, they need to be aware of
the ethical issues when they are designing their research. So, this report has outlined the steps
that they should undertake to ensure that their research is ethical. Along with this, the report has
addressed essential ethical components in the research. It has been concluded that the scientists,
doctors and researchers should use the Induced Pluripotent Stem Cells and ABC should go for
experimental/laboratory research.
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Contents
Introduction......................................................................................................................................5
Types of stem cells..........................................................................................................................7
The legal and ethical issues related to the use of stem cells, the unborn babies, the pregnant
women and the potential for further international spread of the Zika virus....................................8
Recommendations on the type of stem cells to be used..................................................................9
Ethical issues related to the design of the research carried out by Company ABC.......................10
Steps that they should undertake to ensure that their research is ethical.......................................11
Conclusion and recommendations.................................................................................................12
References......................................................................................................................................14
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Introduction
Zika virus is caused by Aedes mosquito, the same mosquito that causes dengue and
chikungunya. When the unborn babies are hit by this virus during the phase of pregnancy, they
are born with serious birth defects and other problems also arise with the pregnancy (Evidence
shows Zika virus crosses placental barrier, 2016). The adults are found to be hit by the Guillain-
Barré syndrome (GBS) in which the nervous system of the people gets damaged and they suffer
from muscular weakness and get paralyzed. When the pregnant ladies are hit by this virus, the
fetus develops microcephaly which is a defect in the head due to which the head of the baby
becomes abnormally small and the brain does not develops in an appropriate manner (Torjesen,
2016).
Company ABC has produced a gene therapy technique that will reduce the development of
microcephaly in the unborn babies of pregnant woman who have become infected with the Zika
virus. The therapy requires the use of stem cells and company ABC will need a large supply of
them to treat the wider community. Clinical trials have shown that when adult stem cells are used
there is a 15% reduction in microcephaly. When embryo stem cells under 14 days old are used
there is a reduction in microcephaly of 50%. When embryo stem cells over 14 days old are used
there is a reduction in microcephaly of 100%.
Company ABC needs a large supply of stem cells for their gene therapy technique but they are
unsure of what type of stem cells to use. All they know at this stage is that they want to acquire
the stem cells legally and ethically. Company ABC is a huge multinational company and can set
up their laboratory anywhere in the world.
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Therefore, the purpose of this report is to decide what type of stem cells to use by conducting
some preliminary research on the types of stem cells. The legal and ethical issues related to the
use of stem cells, the unborn babies, the pregnant women and the potential for further
international spread of the Zika virus will also be discussed. Based on this report, Company ABC
will be carrying out some further research to acquire the stem cells. Before they can do that
research they will need to get approval from the Ethics Committee. So, they need to be aware of
the ethical issues when they are designing their research. So, this report will also outline the steps
that they should undertake to ensure that their research is ethical. Along with this, the report will
address essential ethical components in the research.
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Types of stem cells
The characteristic of the stem cell is that they renew themselves which means that they are able
to maintain their undifferentiated state during the process of cell division. Also, they are
characterized by potency which means that they have the ability to differentiate themselves in the
cells of special types.
Basically, there are three kinds of the stem cells. They are:
1. Embryonic Stem Cells: These are those cells that are separated from the interior mass of
the cell of the blastocysts during the pre-implantation stage of the embryo. Particular
signals are needed for differentiating the cell type that is desired. If it is to be directly
injected, then the cell will get differentiated into various cells and thus, a tumor will be
generated from the abnormal pluripotent development of the cell. These cells pose
specific challenges related to the directed differentiation of these cells and the rejection if
the transplantation. These cells have the potential to expand in an unlimited amount and
these are also the source of the regenerative medicine and the replacement of the tissue
after any kind of disease or injury (Krämer et al., 2012).
2. The adult stem cells: When these cells are produced, there is no harm to the embryo and
it is not destructed. These are obtained from the auto graft i.e. the intended recipient and
there is no risk of the rejection of the immune. Some disease like leukemia has been
treated with these methods and other bone related or the blood related diseases. This is
also used for the transplantation of the bone marrow (Baker, 2009).
3. Induced Pluripotent Stem Cells: These cells are the somatic cells which are
reprogrammed genetically to the state of an embryonic stem. These stem cells maintain
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the defining properties of the embryonic cells. These are useful when the drug needs to
be developed and the diseases are needed to be modeled. The main use of these cells is
seen in the transplantation of the medicines. The tissues that are obtained from these cells
are identical to the donor of the cells and therefore the possibility of the rejection by the
immune system is very less. These cells give the knowledge about the reprogramming of
the cells and the repair of the tissues that get damaged inside the body of the human’s
injury (Krämer et al., 2012).
The legal and ethical issues related to the use of stem cells, the unborn
babies, the pregnant women and the potential for further international
spread of the Zika virus
The stem cells generate hope for the success of the therapies but their use is debated in the world.
The use of these cells in the countries across the world is very different because there are various
ethical and legal issues related to their use. Some of them are as follows:
 There is a moral dilemma in the use of the embryonic stem cell. The researchers and
scientists feel that they should prevent the suffering or alleviate the suffering. Also, it is
the duty of the people that they respect the value of the life of the humans. But, when the
use of stem cells is made, these moral principles are not respected. For example, if the
Embryonic stem cell is to be used, there is need to destroy the early embryo which is
nothing but the destruction of the potential human life (Dhai, 2015). So, in this case a
major ethical issue is aroused.
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 When the embryo gets fertilized, it obtains a moral status and it seen as a person. So, it is
unethical to destroy a person while using the stem cells.
 As far as legal requirements are concerned, the consent is to be obtained for the donation
of the materials if the use of stem cells is to be made (Gracia and Woodruff, 2016). It is
required by the law that the informed consent is required to be obtained for the potential
future users of the donated embryo.
 Sometimes, the donors of the gamete helps in the creation of frozen embryos but these
donors do not participate in the further process of reproduction (Ishii, Pera and Greely,
2013). But when the stem cells of that embryo is to be used, the consent of the donors is
to be taken because the embryo id developed form their sperms and oocyte.
Recommendations on the type of stem cells to be used
The scientists, doctors and researchers should use the Induced Pluripotent Stem Cells. This is
because these cells are used for creating the cells or the tissues that are required by the body of
the humans for countering and fighting with the many diseases like the diabetes, the injury in the
cord, the leukemia , heart disease etc. Also, these cells are customized and they give a genetic
match which is almost perfect for the patients. Thus, the patients can be treated with ease, the
transplants can be done without matching the cells and the tissues and the problems of the tissue
rejection can be avoided (CHEN and SHI, 2012). Also, the patients do not have to take the
powerful immune-suppressing drugs after their treatment throughout their lives. Not only in the
treatments, but this cell are very useful in the study of the unfolding of the diseases that can be
done in the labs. So, the scientists and pinpoint and keep track of the diseases at the early stages
by observing the development of harmful cells. Finally, it is recommended that these types of
cells should be used because they make many new discoveries about the human body including
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the premature aging, the risk of the heart disease and cancer etc. (High-yield induced pluripotent
stem (iPS) cells, 2010). They have the characteristic of getting manipulated because they are
made from the cells of humans so, they have the ability to fix the diseases and thus the healthy
cells can be made for the transplantation.
Ethical issues related to the design of the research carried out by
Company ABC
The design of the research that the company ABC should adopt is the experimental/laboratory
research design. This is because in their research design, the researcher will have maintained the
control over the factors that affect the result of an experiment. This design is important for this
company because it will help the company in predicting the outcome. Here, the priority is given
to the time and the causal relation is determined. The causal relationship should be consistent
because then only the researcher will be able to predict the effect of something on the other. The
study that the company ABC is searching is the one that is very technical and important for the
welfare of the people. So, the level of evidence required for this should be highest.
The ethical issues related to this are:
 The scientists who conduct this study have to take care of the community and society at
large. Their experiments must contribute to the welfare of the people. The study on stem
cells is very crucial study and is related to the health of the people (McGee, 2005). So, it
must be conducted with an objective to help the society and not for any personal use.
 The planning, conduct and the design of the report should be in accordance with the
standards of the scientific competence that is recognized and is ethical too. The standards
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specify all the acceptable practices so if they are followed, that means that ethics are
followed.
 The possibility of the errors in this kind of research should be minimized. The scientists
cannot afford to waste the things that will be used here for the experiments like the stem
cells etc.
 The research should be conducted with the approval of the host institution that will be
made a part of the study (Wells, 2009). Also, the researcher has to provide the exact and
accurate information about the institution. If they are hiding some important information,
then that would be considered as unethical.
 The researcher has some responsibilities while conducting the research. Like, he has to
conduct the survey in an authentic manner; he has to obtain the consent of the
respondents’ before making them a part of the research.
 There are some federal and state law and regulations that have to be followed by the
researchers. If they do not follow them, then it is regarded as unethical.
Steps that they should undertake to ensure that their research is ethical
 The things for the experiments should be obtained in an ethical manner. The variables
should be picked in a proper way and ethical way by doing proper research. Also, the
variables should relate to the research rather than picking the variables randomly.
 When the embryo gets fertilized, it obtains a moral status and it seen as a person. So, it is
unethical to destroy a person while using the stem cells. Therefore, the researcher should
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