Less than three decades ago, the germline genetic modification that scientists take part in today was viewed as a wildly unethical atrocity. Germline genetic modification is a form of genetic engineering involving changing the genes of eggs, sperm, or very early embryos. This type of engineering is inheritable, meaning it can be passed down to future generations.  It is only recently that this expansive field of bioengineering has become more widely accepted and understood. As time progresses and technology advances, American’s face ethical quandaries they did not previously have to consider. Based on the rapid growth of the field of bioengineering as a whole and the nearly universal desire to achieve perfection, it can be said that designer babies are an inevitable part of our near future. A line must be drawn to focus on prevention and elimination of disease to improve human health and avoid unethical applications of this technology that could consequently harm the human population. The capabilities of germline engineering technology to manipulate human embryos in the United States are too far expansive to allow without strict limitations.  

In 1978 the first “test tube baby” was successfully produced. Despite numerous ethical controversies among the scientific community and the general public, people rejoiced over the birth of Louise Brown, a happy and healthy baby girl. Since the birth of Brown, in vitro fertilization, commonly referred to as IVF, has aided the pregnancies of over five million women struggling with fertility issues (Knoepfler). IVF is defined as surgical removal of eggs from the ovary to be combined with sperm, followed by by uterine implantation of one or more of the resulting fertilized eggs (Merriam-Webster). IVF technology has grown to be extremely popular in recent years, with numbers skyrocketing nearly 50 percent in the past decade (Diamandis). The successful birth of Louise Brown paved the way for scientists to utilize IVF technology, explore all of its capabilities, and further research human genetic manipulation. 

The technology that allows for IVF and more advanced procedures to take place requires a general understanding of the structure and function of human genes. The genetic code responsible for our identities as humans is found within the DNA located inside the nuclei of each of our cells. This genetic coding is responsible for our growth, development, and characteristics. Using the principles of IVF technology, it has been made possible for scientists to go beyond just implanting embryos and producing babies. By extracting and examining the cells of embryos before implantation, scientists can determine whether or not embryos carry the genes linked to known diseases. This is called Preimplantation Genetic Diagnosis (PGD) or Preimplantation Genetic Selection (PGS). Instead of implanting all of the embryos fertilized through IVF, scientists use PGD to choose the most viable embryos, those who do not carry any diseases. PGD is useful in detecting a wide variety of diseases including, “Down's Syndrome, Tay-Sachs Disease, Sickle Cell Anemia, Cystic Fibrosis, and Huntington's disease” (Baird). Aside from detecting disease, PGD can also be used to distinguish and select gender, which has raised additional ethical issues. Although this process does deal with genetic disorders, PGD is “a process of selection, not creation,” and therefore does not involve manipulating specific genes (Venosa).

After experimenting with the same technology used with PGD, scientists have been able to perform tissue matching tests on embryos for the production of donor babies. A donor baby is one produced to be able to donate tissues, such as blood or organs, for a preexisting individual with a life threatening illness. The concept of birthing children with the intent of subjecting them to procedures, some lengthy and often painful, to save the life of another individual is very controversial in itself. Some people argue that having two healthy children is more preferable than having one sick one, while others attest that it is unfair to birth a child for use of their “spare parts” (Baird). In saying this, Baird implies that some believe birthing a child with the intention of using its blood and tissues to maintain the life of another child is objectifying them as disposable. By acquiring their “spare parts,” parents use things their donor baby does not necessarily need to give to their sick child.

The combination of advancements in technology, increase in population, greater accessibility, and growing desire to achieve perfection, scientists are taking the concepts from IVF, PGD, and the production of donor babies to manipulate genes in different ways than before. 

Although there are some forms of genetic modification that are already widely used in America, the propositions scientists are making and the research being gathered regarding the future of this field raises many ethical red flags. Many of the standard procedures being done now pose little threat from an ethical standpoint. For instance, PGD being used to detect genetic diseases before the embryo has the opportunity to fully develop with said disease is rarely criticized and continues to grow in popularity. On the other hand, the capabilities of PGD and similar technologies increase power significantly, allowing parents to choose the child they want, not simply reject the ones they do not want and override the purpose of IVF, from a treatment for fertility to being able to pick and choose embryos like consumer goods—producing many, discarding most, and desiring only the chosen few (Baird). Individuals produced with a preemptively selected genetic makeup, ensuring the presence of, or eradication of, certain genes, are commonly referred to as a designer babies (dictionary.com). As explained by Gregory Stock, a world renowned biophysicist and bioethicist, “‘as effective somatic therapies become common...[there will be] a move from screening and selecting embryos to actually manipulating them’” (Mehlman). 

That being said, the problem lies more so in the future of bioengineering. It becomes important to question-- where exactly science is leading us, and what kinds of possibilities are being suggested? Stock describes his belief that, in the future, genetic manipulation technologies will first tackle eliminating disease that impedes upon one's quality of life followed by less severe diseases, and eventually transcending into manipulation of traits such as appearance and athletic ability (Mehlman). It is crucial to initiate a discussion among the public, emphasizing that potential problems regarding the manipulation of genes should be discussed now rather than later. While some individuals may not view PGD as a direct part of the problem, PGD technology can be seen as a vehicle to be used to surpass the desire to eliminate disease and cross into the designer baby trend.

As previously stated, PGD does not involve the actual manipulation of any genes, rather the examination, implantation, and sometimes destruction of embryonic cells. However, more advanced, disputatious technologies that do interfere with genetic coding are being studied. This controversial manipulation of genes is called germline genetic modification. In manipulating the chemical makeup of chromosomes in cells, germline engineering allows specific traits to be manipulated and changed. What separates germline genetic modification from PGD is the alteration of specific genes in the gametic cells (PBS). While PGD does not result in the passing down of any altered genetic information, all changes made through germline genetic modification are inheritable; the center of controversy for many scientists. 

Again, there are two sides to be considered here. While germline engineering does hold the potential to eliminate certain genetic disease from immediate offspring and following generations, it also holds the potential to be used in a more “cosmetic” fashion. Venturing into the manipulation of designer babies can be viewed as scientists taking over the roles natural selection has served for all of time. With that being said, scientists fear that manipulation of genes linked to disease could eventually evolve into the manipulation of genes influencing other traits, such as athletic ability, intelligence, appearance, and longevity. It is observable that this technology allows humanity to move further from evolution by natural selection, towards evolution by intelligent direction (Diamandis).

In situations where germline engineering is used to target specific cells attributed to a certain disease, there can be great success in preventing the inheritance of said disease in the future. Unlike in manipulating genetic diseases like tay sachs and sickle cell anemia, most human traits are controlled by multiple different genes. For instance, expression of height is speculated to be controlled by four genes, while hair color is thought to be dictated by three. Because the complete function of each gene and its relation to expressed traits are not entirely known, it is reasonable to consider that manipulating these traits using germline engineering could result in an array of unwanted effects. The long-term effects of genetically modified embryos are widely unknown and because of the uniqueness of human DNA, animal testing cannot suffice to research these speculations further. 

If scientists were to develop a method of manipulating human genes without resulting in negative future effects, a social issue would still remain. There would need to be a concrete model designed by a group of experts to reflect a universally agreed upon set of ideals for which scientists would adhere while manipulating genes; which is impossible. Because of economic, social, cultural, and religious differences, among other things, it is difficult to envision a model that would be sufficient to everyone within the population. In this instance, attempting to determine a model representing an ideal human would likely drive a greater divide between social classes. Individuals with social and economic advantages would likely influence the model more greatly than individuals with lower social or economic standing. Typically having greater access to resources and education that contribute to understanding these types of technology relates greatly to economic standing. Additionally, as time passes and populations redefine values, societal standards tend to change. Because germline engineering is inheritable and mutations are passed on to following generations, a consideration for how the progression of time would influence this model is necessary as well. In The United States alone, there could not be a truly agreeable model after considering both the magnitude of the population in consideration and the ever-changing societal standards to which that population adheres. 

Around the world, doctors, bioengineers, and geneticists are making breakthroughs using germline engineering to produce genetically modified humans. In recent news, Dr. Valery Zukin of the Nadiya Clinic for Reproductive Medicine in Ukraine produced a baby girl using a controversial procedure called pronuclear transfer (Scutti). In the past, procedures of this nature had been done in Ukraine for the production of male babies with mothers diagnosed with mitochondrial disease. This procedure has gained such a large amount of attention because the mother of the child did not have mitochondrial disease, rather, was infertile for unknown reasons. In the past, this procedure has only been used to treat women with mitochondrial disease. The process of pronuclear transfer replaces the faulty mitochondrial DNA of the mother with the normal mitochondrial DNA of another woman, technically resulting in offspring containing three sets of DNA. Doctors have previously considered male embryos most viable for this procedure because the risk of passing on mutated mitochondrial DNA is eliminated (Scutti). However the same cannot be confirmed for females. Because the procedure did not produce any viable male embryos, Zukin implanted a female embryo. Although the baby girl appears unaffected at this time, no one can be sure that the manipulation of her mitochondrial DNA will not lead to issues with her own health in the future, or the health of her potential children. While this procedure cannot legally be performed in The United States, Dr. Zukin has set a precedent for what germline engineering id currently is capable of.

There are numerous reasons why germline engineering could result in problems for future generations. Understanding the facts and identifying the risks at hand is crucial in developing an effective solution for the problem at hand. Government policy needs to be developed and enforced defining the bounds within which scientists can manipulate human genes. I think there is a need for the establishment of a board or committee, consisting of leading experts with an extensive educational background in genetic engineering and biomedical sciences. These board members would be expected to evaluate individual cases which involve the scientific mutation of human genes. 

While there are some policies currently in place that prevent specific procedures such as pronuclear transfer from being performed, it is important to further define what specific elements of genetic manipulation are allowed. While scientists in the United States do not quite have the capability to manipulate embryos to express a specific hair color, eye color, or height, it would not be considered completely illegal if they did. There needs to be a non-ambiguous set of guidelines by which scientists can determine whether or not their intended end result is be deemed ethical or unethical. Cases where success for desired result can be determined with near certainty without the possibility of adverse effects on other genes or their expression should be permitted after evaluation. For instance, a procedure done to eliminate a cancer causing gene that is, with near certainty, associated with only a specific gene or set of genes and can be manipulated without affecting the expression of any other traits or characteristics. 

In addition to a predetermined set of genetic manipulation guidelines, evaluation of procedures and research regarding germline engineering by a trusted and knowledgeable group of experts on an individual case-by-case basis would best ensure the safety of genetically manipulated offspring, both directly and in the future. 

Due to the strong media presence in the United States, many Americans are under the impression that the idea of designer babies is merely science fiction. In reality, the technology to recreate what we see in sci fi movies already exists. Aside from establishing and enforcing policies, public information is crucial. The designer humans in movies may not have detrimental effects from modification, but humans in real life could. Data collected by Pew Research in August 2015 shows American adults tending to agree that human genetic modification must be regulated and monitored. Pew Research found that 46 percent of adults approve of genetic modification to reduce the risk of serious diseases, while 86 percent believed genetically modifying intelligence was taking it too far (Diamandis).  It is important for the public to understand the very real risks and capabilities of these technologies in order to best protect the public. 

Through a TED Talk in January 2017, leader in stem cell research and renowned American biologist Paul Knoepfler, explained the discrepancies he has with human genetic modification. Clustered regularly interspaced short palindromic repeats, or CRISPR for short, is a tool scientists use to magnify our DNA, so we can hone in on a certain spot, scissors that cut the DNA right in that spot, and a pen to rewrite the genetic code in that location (Knoepfler). This three year old technology, said to be the “start of a new era of genetics,” is responsible for the recent advancements made in germline engineering around the world (Gallagher). Dr. Tony Perry, a pioneer in cloning at the University of Bath claims, “[CRIPSR] is approaching 100% efficiency already, it's a case of 'you shoot you score’,” (Gallagher). Although Knoepfler agrees that CRISPR technology contributes tremendously to research for genetic disease by saving time, money, and resources; he is insistent on his belief that the misuse of this technology could be detrimental in the future. The neverending “chase for profit” among individuals as well as the government has the potential to encourage the use of CRISPR technologies in ways that would ideally produce humans designed with the intention of reducing healthcare costs or alter abilities linked to being more successful (Knoepfler). 

While the benefits of CRISPR technology seem endless, it is important to consider the significant chance that modifications made with intentions of improving human health could do exactly the opposite. With CRISPR technologies, a door is opened to manipulate genes in ways that could have unknown effects on future generations of humans. For this and other reasons, Knoepfler believes that educating the public and banning human genetic modification all together is the best way to ensure the problem does not have an opportunity to get out of hand. As explained by Dr. David King of Human Genetics Alert, a campaign group in the UK opposing many elements of genetic manipulation, CRISPR is still relatively new technology and “there is a huge amount of research - particularly on unwanted mutations, efficiency and safety - ... before any attempt of humans would even be considered,” (Gallagher). While Dr. Perry supports CRISPR technology, much like Knopfler and King, he fears it could eventually evolve far past eliminating disease and ulterior motives could come into play

The germline engineering technologies being developed and researched by scientists today do have clear benefits. Existing technologies, such as IVF and PGD, were extremely controversial when made available to the public. Despite this, both technologies have made major impacts in fertility, pregnancy, and the birth of healthy babies. Although relatively new and controversial, germline engineering has the potential to make major positive impacts if used within boundaries. The potential to eliminate genetically linked diseases not only in immediate offspring, but also in the generations following presents a solution that PGD has been unable to offer. Beyond eliminating genetic diseases, germline engineering has the potential to eliminate congenital disabilities, improve abilities such as strength and agility, and increase longevity. While these ideas have associated possible risks and detriments, continued research regarding the way human genes operate individually and with one another could allow for germline engineering to be performed with reduced risk in the future. 

After weighing the risks and benefits of genetic modifications of humans, it is evident that governmental policy needs to be enacted to regulate the limitations of the ways in which scientists can manipulate the human genetic code. Across the globe, policy and regulations have been changing to adjust to the expansive nature of the field of bioengineering. As of 2015, 29 countries had enacted total bans regarding editing the genes of human embryos (Gould). In many countries, including China, there are limitations on human gene modification but policy is rarely enforced (Gould). Comparatively, the United States has restrictive rules in place, however, many countries have neglected to discuss or establish policies regarding genetic manipulation of human embryos all together. It is imperative for the United States to be proactive with these issues to best ensure the safety of Americans. The ambiguous policies and unenforced regulations in place throughout countries around the globe sets a precedent that we are obligated to rise above, acknowledging that these scientific advancements are serious and action must be taken. 
