DEFINING GUIDELINES ON THE RESEARCH AND APPLICATION

Defining Guidelines on the Research and Application

of Human Gene Engineering
Jessica Halder
College of DuPage

Abstract
This paper discuss human genetic engineering, presenting both extreme viewpoints in the debate
regarding this topic. It explains why full pursuit, as well as complete banning of gene
modification will not only be a chaotic and fruitless option for society, but it will also be
impossible, considering how far humanity has come in both its research and application. In lieu
of any extreme, this paper analyzes the reasons a moderated approach to both the research and
application of human gene engineering would be the best global decision. Regarding the research
aspect of human biogenetics, I am highlighting the benefits derived from a solely medicinal
approach. The application of this technology should be narrowed down further to use only in the
case of illnesses that leave no survivors. This paper continues to analyze current laws regarding
gene therapy and research, and acknowledges the inconsistencies displayed by various nations.
The scientific community, as well as worldwide governments are thus, encouraged to consider
how far gene research has come, and how far it will go in the future. Considering the potential
this technology presents in the field of science, it is necessary that international regulations are
created based on detailed criteria about genetic research and application.

DEFINING GUIDELINES ON THE RESEARCH AND APPLICATION

Defining Guidelines on the Research and Application

of Human Gene Engineering
Background
The twenty-first century has been dubbed the technological age, as humanity has, and
continues to make tremendous breakthroughs in digital media and science. In the field of science,
the scope of the advancements can be demonstrated by everything from the creation of CRISPRCas9 technology, to the recent discovery of a new asteroid orbiting the Earth. However, as
scientists continue their research in many diverse topics, vague preexisting ethical guidelines in
science are being brought into question. Today, with the release of futuristic books and movies,
one of the most controversial topics in science is the research and application of human gene
engineering. After in vitro fertilization became common practice and the first successful threeparent baby became a reality, further advancements in this area are raising hopes of destroying
Alzheimers and Huntingtons disease from the human genome.
While numerous researchers and proponents of science encourage full pursuit of human
modification, fearful ethicists are concerned about the risks association with uninhibited pursuit
of genetic modification. Opponents of human gene research emphasize the fact that selective
gene editing essentially redirects evolution, and can bring the worst dystopian stories into
fruition. Despite the strong viewpoints presented by both extremes in this debate, the general
consensus is that that human modification should be pursued with firm regulations. I conducted
an online survey of 90 random people of all ages, genders, and ethnicities, asking about their
knowledge and beliefs about both research and application of human genetic engineering. In the
survey, 67% percent of the sample agree that research in human gene engineering should be
continued in moderation, with strict guidelines. It is necessary that these guidelines are

DEFINING GUIDELINES ON THE RESEARCH AND APPLICATION

constructed with detailed outlines acknowledging the medicinal, as well as practical application
of the research on an international level. In this paper, I will discuss both extreme viewpoints in
the debate about human genetic engineering, and outline the extent to which I believe research
and application in this field should be pursued.
Problems with Extreme Viewpoints in Human Genetic Engineering
Uninhibited pursuit.
Proponents of unrestrained pursuit of genetic engineering view transmogrification as
sign of human progress, and believe humanity would be limiting itself by introducing regulations
specific to genetic research. Jennifer Doudna (2015) from Stanford University co-developed
CRISPR-Cas9 in 2012a new technology that allows scientists to quickly and efficiently edit
DNA. Although it has only been used to edit the DNA of mice and monkeys thus far, this
technology holds the possibility of giving humans stronger bones, different height, eye color, and
a variety of other types of enhancement (Doudna, 2015). Humans would have the capacity to be
faster, stronger, smarter, and virtually a better version of themselves. Bioengineering research
branches out into the even more controversial topic of germ-line engineering. Germ-line
engineering is the modification of human DNA at the egg and sperm level; altering chromosomes
at such a basic level would yield results that affect gene expression on all of the embryos
successive descendants. That means that aside from the enhancements CRISPR-Cas9 can offer,
this technology has the potential to eliminate diseases such as Huntingtons, Alzheimers, and the
HIV virus from the human genome. Antonio Regalado (2015) from the MIT Technology Journal
mentions that scientists like Jonathon Tilly from Northwestern University are already working on
using CRISPR to edit egg stem cells to destroy an unnamed genetic disease (Regalado, 2015).

DEFINING GUIDELINES ON THE RESEARCH AND APPLICATION

Aside from usage of the CRISPR technology, human modification research is being
applied to the medical field to fight cancer. Naoum, Tawadros, Farooqi, Quereshi, Tabassum, and
Arafat (2016) believe in using gene editing technology and a new method called TRAIL in order
to induce apoptosis among cancer cells. It takes a gene therapy approach, using nanotechnology
or other gene delivery systems to insert an apoptosis-inducing ligand among cancerous cells
(Naoum, 2016). Gene engineering can, thus, overpower traditional methods of chemotherapy and
radiation to avoid the sickness and risk of recurrence that is associated with those methods.
Although the medical benefits of human gene engineering paint the topic in a haloed
light, it would be a reckless to allow DNA editing of all forms, because it can easily become a
subject of hate and fear. When application of gene engineering is limited to solely medical
purposes, the use of this research becomes a matter of necessitya matter of survivalrather
than trivial choice. If genetic modification grows to be a trivial matter like plastic surgery is now
considered, the construct of our society will be irrevocably transformed. Today, the majority of
the population are cautious about full use of genetic alternation. This was illustrated by the
results of my survey; when individuals were asked how much they would allow themselves to be
modified, only 13% of the sample of 90 claimed that they would agree to be enhanced in every
way possible. Meanwhile, 68% agreed to enhancement for medical purposes. If scientists are
allowed to research with no restrictions, everyone would eventually have the opportunity to alter
every trait from their intelligence to their height. As a result, a number of problems would arise,
such as issues regarding identity, life span, and economic status (Regalado, 2015).
The anxiety surrounding the topics societal problems was also reflected in my survey,
where the two most commonly acknowledged consequences from genetic engineering were
unequal opportunities for human modification based on income and wealth, and social

DEFINING GUIDELINES ON THE RESEARCH AND APPLICATION

stereotyping of people based on how individuals were genetically modified. Modified individuals
could become another matter of inequality, following inequality of race, gender, and income.
Alternatively, some believe that research of genetic modification should be pursued without
restraint, and society would not be negatively affected if the research is not applied to the level of
trait enhancement. But that scenario is impossible. Michael Bess (2015) considers the possibility
that transmogrification gets developed and perfected, but its application becomes banned by the
government. In that case, human modification technology would likely get reproduced and
distributed as a black market product. Those who truly wanted themselves altered would have the
means to attain it (Bess, 2015). Therefore, despite the benefits offered by genetic engineering
research, it should only be researched and applied in moderation, because its unrestricted
application would inevitably cause social issues.
Global prohibition.
On the other extreme, critics of gene engineering fear the repercussions of these
advancements and encourage bringing genetic research to a complete stop. Maxwell J. Mehlman
(2013) offers insight into all the ways gene engineering research canand willgo wrong.
Science can only be verified and perfected through experimentation, and experiments, especially
in the early stages, fail more than they succeed. In the case of cloning Dolly the Sheep, although
there eventually was a successful experiment, it took 277 tries to get there. That means 277 sheep
embryos were destroyed for an attempt at cloning an animal (Mehlman, 2013). Similarly, MIT
biologist Guoping Feng (2015) reveals that in the case of CRISPR, the likelihood that it will be
able to activate or disable a gene in a zygote is about 40%. More specific edits will work about
20% of the time, and only half the modified embryos will likely lead to live births. In the end,
each modification will be displayed through gene expression in about 20% of the embryos (as

DEFINING GUIDELINES ON THE RESEARCH AND APPLICATION

cited in Regalado, 2015). The mere possibility of genetic engineering research provides
staggering statistics, but its application also records tragic results. In 2000, the use of gene
therapy seemingly cured ten babies of Severe Combined Immune Deficiency (SCID), a disease
in newborns that cause them to be born without functioning immune systems. Although the gene
edits initially appeared safe and successful, three years later, nine of the ten children had gotten
diagnosed with leukemia. Evidently, the altered gene was too close to an oncogene, which was
unintentionally triggered, and became a cancer in 90% of the newborns (Mehlman, 2013).
That infamous experiment represents the high concern about the morals of evolutionary
engineering, because it suggests unraveling our fundamental concept of human biology. In the
case involving SCID, one disorder was cured, only to generate a new disease. When pursuing
any form of genetic engineering, whether it be in plants, or animals, mishandling DNA has the
potential to result in horrifying mutations. Regardless of how far humanity has come in
understanding our own biology and chemistry, there is still much left undiscovered. Genetic
modification broaches the realm of the undiscovered and it can easily yield terrible results.
Despite the public apprehension stemming from the fear of undiscovered territory,
complete prohibition of genetic engineering is unwise, because it would be a lost opportunity for
all of humanity. The previously discussed medical advancements would be all be dismissed, and
that in itself poses new ethical questions. Can it be considered morally ethical to prevent further
cancer research and destroy gene-editing technology? Are scientists not responsible for doing all
they can to eliminate fatalities? Scientists such as Clive Svendson (2015) are combining induced
pluripotent stem cells (iPSCs) with gene editing to improve the development of treatment and
increase precision of predicting future ailments. iPSCs transform donated cells to an embryo-like
state, which can be examined to dissect the initial structure of a genetically transferred disease.

DEFINING GUIDELINES ON THE RESEARCH AND APPLICATION

Combining iPSCs and gene editing can be used to screen drugs, and more significantly, it is
already being used to generate stem cell libraries that identify phenotypes associated with iPSCs
variants in certain diseases or disorders (Marx, 2015). Historically, scientists always did all they
could to eliminate the worst causes of fatalities. Everything from small pox to the bubonic plague
was researched enough to uncover a cure to aid future generations. Many agree that the tragedy
of failed experiments are worth the possibility of progress.
Nevertheless, even if the majority of the population wanted to, it would be impossible to
ban all forms of human gene modification research. Such comprehensive, detailed international
restriction would never be implemented in all countries. Prior to the creation of CRISPR-Cas9,
the European Union identified gene pool revision as a crime against human dignity and basic
human right. Although over a dozen countries have completely banned germ-line engineering,
there are at least three centers in the United States alone that are working on it. OvaScience is
one of those companies, and Editas is a new corporation that plans to use CRISPR for gene
therapy research. I attempted to contact both those companies, but neither of my attempts were
successful. Besides the research in America, scientists in China, who edited the first monkeys
with CRISPR, as well as researchers in the United Kingdom are pursing germ-line engineering
(Regalado, 2015). Complete prohibition of human gene modification would be a waste of
resources and technology, and it would be impossible to do. Conversely, full pursuit of the topic
would collapse the structure of our society and breed new problems in science and equality. The
best solution is to allow research and application of human gene engineering only to an extent. It
needs to be moderated by governments at an international level, and carried out with strict
guidelines.
Solution

DEFINING GUIDELINES ON THE RESEARCH AND APPLICATION

In regards to the research, governments should ensure that all organizations getting
funded for genetic engineering research should continue with the goal of only medical progress.
Mehlman (2015) and Regalado (2015) make very strong arguments about the loss of life that will
inevitably result from germ-line engineering research. Regardless of the goal with which
research is pursued, there will be failed cases. It is certain that there will be many more destroyed
embryos than successful cases before this technology becomes widely adapted and put to use.
The loss is tragic, but this is true for all cases of progressive research. If perfected, the
subsequent medical advancements will have the ability to save millions of lives. As much as I
wish research could be limited to only a medical scope, the reality is that research for genetic
enhancement and for medical advancements largely overlap. Although intention may not be
towards finding ways to alter the height, intelligence, or strength of any individual, all types of
gene modificationmedical or notattempt to modify individuals at their most basic level.
Most discoveries in gene engineering would be interchangeable between different fields of
genetic usage.
Therefore, it is imperative that the terms for future application of all genetic discoveries
are defined and strictly regulated. R. Alto Charo (2016) states that worldwide laws set by the
Council for International Organizations of Medical Sciences (CIOMS) are more restrictive than
scientific guidelines any nation sets on themselves. In the United States, the regulatory system
handling gene therapy is similar to the system of handling biological drugs or technology. It has
multiple laws concerning its impact on infection, control, efficacy, and safety. South Korea has a
similar approach, but the United Kingdom has more restrictive regulations concerning embryos
or human fertilization (R. Alto Charo, 2016). Broadly, the worlds views on the extent to which
gene engineering should be applied is predictably scattered and vague. Global standards created

DEFINING GUIDELINES ON THE RESEARCH AND APPLICATION

by the CIOMS hint at a request for uniformity that goes unacknowledged by individual nations.
But, it is careless to remain so ignorant of the scientific laws and regulations followed by other
nations. As a result, problems in foreign policy may arise and alliances can be disrupted among
nations. This is already a public fear, which was demonstrated by my survey; it records the third
biggest fear of uninhibited pursuit of human modification to be political controversy. It is not
hyperbolic to offer the possibility that disregard for internationally uniform scientific guidelines
could lead to a similar type of arms race that had previously existed between the United States
and Russia.
In order to avoid repeating past mistakes, there is a global need for more parallel
international pre-market regulations about biotechnology, genetic research, and the application of
new types of science. The guidelines should differentiate between what will be allowed versus
not allowed on the basis of two categories: medical purposes and non-medical purposes. All
application, requests, organizations, and funds devoted to genetic engineering for non-medical
purposes needs to be discarded and prohibited, barring no exceptions. The gray area exists in
application of human modification for medical purposes. Considering the medical, as well as
societal risks associated with gene modification, the application of extensive gene therapy must
always be considered a last resort. A multitude of ailments plague humanity, but human genetic
engineering should only be used to fight against diseases or disorders that will leave no
survivors. I am defining diseases or disorders that leave no survivors as ailments that will
result in death or loss of identity. The former can be exemplified by inoperable and untreatable
cancers, as well the HIV virus. Meanwhile, illnesses that result in the loss of identity are diseases
such as Huntingtons or Alzheimers, whichalthough not immediately fatalwill cause the
body or the mind to deteriorate beyond the capacity for regular function. These diseases most

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often decrease life expectancy, because they make the victim susceptible to other severe
complications. With discovery of new technology and the rise of new diseases, these guidelines
for application should have room to be modified.
Ultimately, the research and application of human genetic engineering should be
moderated, and then regulated carefully by the consent of all nations. In order to implement these
changes internationally, we need to emphasize the need for uniform standards in research and
therapy, so regardless of the guidelines implemented, nations can reduce conflicts among
themselves in the field of science. Several researchers in the field insist on holding an
international moratorium on all bio enhancements, and although people like Michael Bess (2015)
argue that it may be difficult to enact, this may be a good solution if full-body enhancement
becomes an option in the future. Any proposed regulations should involve treaties and active use
of federal government agencies, as well as the police force to stop genetic technology from
spilling into the black market. If it does, the exchange and production of this technology should
be accentuated as highly illegal, and monitored carefully as governments do for the trafficking of
drugs and other products. We are a progressive world, therefore, genetic engineering cannot be
stopped. However, we need to limit our pursuit to reasonable standards to ensure the
continuation of humanity with the least turmoil.

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References
Arafat, W., Buchsbaum, D. J.,Farooqi A. A., Naoum G. E., Qureshi, M. Z., Tabassum, S.,
Tawadros, F., (2013). Role of nanotechnology and gene delivery systems in TRAIL-based
therapies. ecancermedicalsciene, 10 (660), 1-17. Retrieved from
http://ecancer.org/journal/10/full/660-role-of-nanotechnology-and-gene-delivery-systemsin-trail-based-therapies.php
Bess, M. (2015). Our grandchildren redesigned: life in the bioengineered society of the near
future. Boston, MA: Beacon Press.
Charo, R. A. (2016). The legal and regulatory context for human gene editing. Issues in Science
and Technology, Spring 2016, 39-44.
Doudna, J. (2015). How CRISPR lets us edit our DNA. Retrieved from
https://www.ted.com/talks/jennifer_doudna_we_can_now_edit_our_dna_but_let_s_do_it
_wisely
Marx, V. (2015). Stem cells: disease models that show and tell. Nature Methods, 12(2), 111-114.
Mehlman, M. J. (2013). Extinction by design (Speech). Oklahoma City University Law Review,
38 (2), 233-248.
Regalado, A. (2015). Engineering the perfect baby (Cover Story). MIT Technology Review, 118
(3), 26-33.

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Appendix A
Survey: Public Knowledge and Beliefs about Human Genetic Engineering
*1. How do you rate your knowledge of past and current advancements in human genetic
engineering?
I know nothing about this topic.
I only know about this from science fiction novels and movies.
I know a little about this topic from reading science and technology magazines or
documentaries.
I did research on this topic, and it is something I feel strongly about.
I am an expert in this topic.

*2. What is your general opinion about human genetic modification?

The idea of human genetic modification is purely wrong and unethical
We have come very far with gene research and it is enough. We should stop where we are
now.
This research can help many people. We should further this research, but in moderation, and
with strict ethical guidelines.
We are a progressive world; we need to continue all gene research to further the scope of
human knowledge.
I have no opinion; I do not know about prior or current research on gene modification.

*3. How far would you allow yourself to be genetically modified if the resources and technology
were easily available to you?
I would let it make me smarter, stronger, healthier, more beautiful, and change me in any way
that may benefit me.
I would let it cure me of all possible diseases and health issues I could ever have, but go no
further than that.
I would only myself be modified if I was dying and it could save my life.

DEFINING GUIDELINES ON THE RESEARCH AND APPLICATION

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I would never let myself be genetically altered.

I do not know enough about genetic modification to answer this question.

*4. Do you think your children and your grandchildren should have the opportunity to be
genetically modified?
Absolutely,
No, this technology is not right to bring into the world.
I don't know, I am skeptical about its risks and benefits.
5. What risks do you think are associated with human genetic engineering? (Select all that apply)
Mutation of cells
Immune diseases
Different types of cancers
Social stereotyping of genetically modified people
Questioning of religious beliefs
Political controversy
A society of more modified people than unmodified
Less diversity
Eugenics
Unfair distribution of opportunities based on income and wealth
Overpopulation
Death
War
I don't think there are any risks associated with genetic modification on humans

DEFINING GUIDELINES ON THE RESEARCH AND APPLICATION

6. What benefits do you think are associated with human genetic engineering? (Select all that
apply)
Saves lives
Eliminates genetically transferred diseases like Alzheimer's and Huntington's
Increases diversity
Takes science and technology to a new level
Elimination of stereotyping
Elimination of mental deficiencies
Elimination of disabilities
Elimination of obesity and bias based on appearance
Allows for the continuation of the human race
Allows future generations to have better opportunities
Will bridge the wide gap between income and wealth
Eliminates overpopulation problem, because the world will be able to sustain all humanity
Elimination of racial and ethical prejudice
I don't think there are any benefits associated with genetic modification on humans

*7. Do you think scientific and technological advancements can ever stop?
No, it can't
If the government tries hard enough, advancements may slow down, but never stop.
If there are strict enough guidelines. advancements will can eventually stop.
Yes, scientific and technological advancements can easily end.
We shouldn't try to stop progress.

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