Imagine you are about to embark on the exciting journey of having your first child with your partner. You schedule an appointment with a fertility specialist, and when the day comes, you enter the waiting room in the doctor's office.  You are directed to a room named the "selection room" where you are immediately given a questionnaire to complete.  You and your husband have been planning for this, taking weeks to prepare for how you will fill out this form.  It begins with the question of gender, and since both of you have always wanted a little girl, you select the "female" option.  You go on, selecting for brown hair, blue eyes, a height of 5'4", thin build, high athletic ability, and high intelligence.  Once you have finished, you hand in the form and wait to be seen by the doctor who will pick the appropriate donor to make your dreams become a reality.  This scenario might seem futuristic and far-fetched, but the ability to alter an embryo's genetic makeup is fast approaching, and has already begun in some research laboratories.  But what happens when not everyone can afford to pay for these selections?  And what if altering these genes in a child leads to a greater risk of cancer or abnormal developments as an adult? These are all questions that must be explored and considered before making any decisions about the use of these assisted reproductive technologies.  Although human genetic engineering -- the creation of "designer babies" through parental selection and removal of certain traits -- has several advantages, including the elimination of potential genetic diseases, there is still a need for stronger control measures in order to prevent possible negative consequences.  Without stronger regulation, the chances are high that we will begin to see a rise in mutations and developmental abnormalities, the violation of ethical principles, and a widening social and economic divide between families able to engineer their children and those who cannot afford to do so.

  In this essay, I will begin by explaining what human genetic engineering is from a scientific perspective and how it works.  I will then discuss the possible advantages of this scientific procedure and explain why it should not be banned altogether.  After this, I will discuss the disadvantages of genetic modification.  Finally, I will explain my proposal for the type of regulations that should be put in place and offer an example of regulation that could be used as a guide.  

I. Defining Human Genetic Engineering

The term, genetic engineering, at its most basic level, is the science of altering an organism's DNA.  More specifically, small sections of DNA are called genes, and these genes can be taken from another organism and added or they can be completely deactivated ("What is genetic engineering and how does it work?").  Currently, there are several techniques for modifying these genes, but the newest and most accurate method, according to Tanya Lewis, who has a bachelor of science in biomedical engineering from Brown University, is the CRISPR/Cas9, which is short for "clustered regularly interspaced short palindromic repeats."  CRISPRs are naturally occurring elements found in bacteria, while Cas9 is an enzyme that can be used to cut strands of DNA. Once the CRISPR/Cas9 complex finds its target DNA match, the Cas9 enzyme binds to the DNA and cuts it so that a new gene can be put in its place (Lewis).  In doing this, scientists can insert the gene for blue eyes or genes that are resistant to certain genetic illnesses, such as heart disease. Today, various genetically modified organisms can be found on the market, many of which appear in the form of food.  For example, "Almost 85 percent of corn grown in the U.S. is genetically modified ... so they are resistant to the herbicide glyphosate, which is used to kill weeds" (Young).  As research quickly advances, the time is soon coming where these genetic technologies are not only used to enhance food, but also to attempt to enhance children, which would impact the human race as a whole.

II. Ability to Eliminate Genetic Diseases 

Although this essay focuses on several concerning aspects of human genetic engineering which will be discussed below, some advantages, like the possibility to eliminate certain genetic diseases, must be considered.  For couples with serious genetic diseases in their family histories, having a child becomes a complex decision.  By bringing a baby into the world, they are also taking the chance that this baby will possibly inherit this genetic disorder, but reproductive technologies can help prevent this.  By editing the DNA of the embryo itself, this modification would almost act as a vaccine that creates a type of immunity to the certain disease found in the child's DNA sequence (Regalado).  It is also becoming possible for scientists to alter the human germline, the series of germ cells being passed on to consecutive generations of organisms.  This means that once the DNA sequence has been altered to become resistant to a specific disease in one mother's embryo, all future generations would naturally possess the same resistance (Regalado).  According to the Centers for Disease Control and Prevention, "About 610,000 people die of heart disease in the United States every year -- that's 1 in every 4 deaths" ("Heart Disease Facts").  As many types of heart disease are genetically inherited, the medical screening and modification of human embryos has the power to significantly reduce these numbers. 

Opening up the opportunity for a couple with a history of genetic disease to have a child that is born without this disorder would give countless couples new hope in starting a family.   Because of the possibilities for such health benefits, I do not propose that human genetic modification be banned altogether.  Instead, I am arguing that the medical screening and editing of human embryos should be allowed. In other words, medical professionals should be allowed to examine an embryo in search of chromosomal abnormalities before the embryo is transferred to the uterus ("Preimplantation Genetic Diagnosis").  Moreover, it is also important to watch out for safety and ethical issues, such as the possibility of mutations and excessive embryo discarding. If safety and ethicality can be proven, the use of gene editing only to prevent genetic diseases and disorders should be allowed.  

III. Status of Current Regulations

Even though these reproductive technologies have the potential for drastic improvements in human health, the fact of the matter is that the extent of the consequences of these modifications is still largely unknown.  So it is important that specific regulations be put in place because the full effects of these procedures are not fully realized until the end of the child's life.  Regulating assisted reproductive technologies has indeed begun, but currently, only the experimentation stages are regulated, and there are many gaps in the regulations, particularly in the area of unethical testing. Although certain regulations do currently exist in other areas of the world, according to Pete Shanks, consulting researcher with the Center for Genetics and Society, "The U.S., unlike most other countries with an active biotech sector, has no formal, legal prohibition of human heritable genetic modification" (24).  So even though regulations for Pre-implantation embryo Genetic Modification (PGM) exist, many scientists and researchers hold that they are incomplete and in need of more extensive coverage. For example, according to Rebecca Dresser of Washington University's School of Law, "At this point, only one federal law explicitly addresses experimental interventions on embryos expected to become children. This is the provision that prohibits the NIH from funding research that involves the destruction of human embryos." These gaps leave patients and human test subjects without adequate protection.  Medical journalist Shannon Brownlee explains how currently, embryologists are not allowed to work on embryos using federal dollars, so tens of thousands of embryos are discarded each year.  With the emergence of such life changing technologies, current regulations must be reconsidered and reanalyzed.  In order for human genetic engineering to continue safely, tightly controlled medical restrictions must be put in place and enforced.  There are three main issues that support the argument for strong restrictions, which can be classified as biological, ethical and socioeconomic concerns.  The following three sections outline these concerns and explain why heavy regulations are needed.  

IV. Genetic Mutations and Developmental Abnormalities 

First, scientists are concerned with the amount of abnormalities and mutations that may result from human genetic engineering.  Before genetic modification can be made available to the public, extensive experimentation must be conducted safely.  With these technologies being so new, many scientists, such as Stuart Newman, professor of Cell Biology and Anatomy and research program director at New York Medical College, worry about the possibility of dangerous, unforeseen mutations and the effects that these procedures will have on a person throughout one's lifespan.  Studies on animals have linked the use of assisted reproductive technologies to later mutations.  For example, in one experiment done on mice, Newman reports, "germline introduction of an improperly regulated normal gene into mice resulted in progeny with no obvious effects on development, but enhanced tumor incidence during adult life. Such effects may not be recognized for a generation or more." As Newman explains, it is very possible that these types of abnormalities could occur in humans, and in the same way that germline editing could eliminate diseases for future generations, it could also pass down any mutations that develop.  Pete Shanks of the Center for Genetics and Society describes the irregularity of these mutations, "genetic mutations, in many cases, do not function predictably. The same genetic variants may or may not be associated with a particular expression in any individual. This may be due to varying interactions among genes, interactions between genes and the environment and/or the different ways genes can be expressed."  In other words, even if one patient responds well to the modification of a certain gene, another patient receiving the exact same modification might develop a mutation.  

Another concern involves the effects that gene editing may have on diversity.  Law student Samuel Berger discusses the fact that mutations could become increasingly more frequent with the narrowing of the gene pool.  A gene pool is a diverse collection of all genes in a certain population or species ("Gene Pool").  When parents begin selecting similar traits to create the "perfect child," less desirable traits will begin to disappear, decreasing diversity of the human gene pool.  Berger explains this, saying, "These choices could dangerously narrow the gene pool -- with attendant risks of increased susceptibility to disease or unintended amplification of debilitating genes."  This decrease in diversity would make it much harder for the human species to adapt and survive and make it much more susceptible to mutations (Brain).  Because of this, great caution should be taken not only in human genetic engineering experimentation, but also in the decisions regarding regulations.           

V. Violation of Ethical Principles

A second disadvantage to human genetic engineering, and often the most cited, is the violation of ethical principles.  As the strongest argument against assisted reproductive technologies, the ethical side of the issue carries a great deal of weight in the matter.  This is primarily due to the fact that the only way to find out if these technologies can successfully work for humans is to use them on humans.  While some might argue that this is true of all medical advances in history, reproductive procedures are particularly different because the effects of treatment cannot be reversed, and possible consequences could be found throughout the entire duration of the patient's life ("The Call for Ban on 'Designer Babies'").  No one can fully predict the long-term consequences of these technologies, so even the initial experimentation is considered to be highly unethical.  A second concern is that there will be an increase in discarded embryos (Dresser).  According to Oxford Dictionary, an embryo is defined as "An unborn or unhatched offspring in the process of development" ("Embryo").  In order for traits to be selected or eliminated, a sample of several embryos must be taken.  This is done as a precautionary measure, as it is likely that one could be damaged or mutated throughout the procedure (Dresser).  These damaged embryos will be discarded. Many equate this with discarding human lives.  In a study of eighty-six genetically engineered embryos, "Only 28 embryos were spliced successfully, meaning the faulty gene was removed, and just a few of those incorporated the healthy gene in its place" (Lewis).  For many people, these experiments and procedures decrease the value of human life, and because of this, are considered highly unethical.     

A more religious ethical concern brings up the question of whether or not it is okay to "play God."  Until now, a child's phenotype, one's physical makeup, and genotype, one's genetic makeup, have been out of human control.  David King, former biologist and the director of Human Genetics Alert, a United Kingdom organization, explains, "The advocates of genetic engineering point out that humans constantly 'play God', in a sense, by interfering with nature. Yet the environmental crisis has forced us to [realize] that many of the ways we already do this are not wise, destroy the environment and cannot be sustained." To them, it is not humanity's responsibility, and therefore should not be done.  Although this argument is void of scientific evidence against practices, it must be acknowledged due to its prevalence in society.  Another common argument is known as the "slippery slope" argument, which contends that if the door to human genetic engineering is opened, then there is no stopping its advancements, and it could lead to some unforeseen consequences (Macer).  This argument is largely due to the simplicity of CRISPR/Cas9 and the free market forces. Pete Shanks quotes Jennifer Doudna, one of the discoverers of CRISPR/Cas9, saying, "Once the discovery is made, it's out there. Anybody with basic molecular biology training can use it for genome editing. That's a bit scary."  Imagine what would happen if this discovery fell into the hands of the wrong people.  As for the free market forces, David King argues that cosmetic enhancement is inevitable, saying, "Although the arguments for the first uses of HGE will be medical, in fact the main market for the technology will be 'enhancement'. Once it was available, how would it be possible to ensure that HGE was used for purely medical purposes?"  In order to prevent nonmedical genetic engineering from happening, strict laws and regulations must be enforced.

VI. Widening of the Social and Economic Gap

Lastly, if assisted reproductive technologies are made available without heavy restrictions, there is a high chance that we will see a widening of the social and economic divide.  The price of these procedures would make them only available to the wealthy upper class.  According to Antonio Regalado, senior editor for biomedicine for MIT Technology Review,

 "An in vitro fertility procedure costs about $20,000 in the United States. Add genetic testing and egg donation ... and the price soars toward $100,000" (Regalado).  Once those who are able to afford these costs begin to increase intelligence, select physical attributes, and even choose personality tendencies, a privileged elite would start to develop.  Instead of school programs for "gifted children," programs for "enhanced children" might be seen, and with enhanced intelligence, these people may very well become businesses' most desirable employees.  The highest paying jobs would go to the genetically enhanced, and while the rich get richer, the poor might very well get poorer. 

Supporters of designer baby technology often argue that although the procedure would initially be very expensive, as is the case with many new medical discoveries, over time the price would go down until it's within everyone's reach.  Unfortunately, by the time that happens, the genetically enhanced will be so far ahead that it would be virtually impossible for the lower classes to catch up.  Princeton biologist Lee Silver, an advocate of human genetic engineering, "acknowledges that the costs of these technologies will limit their full use to only a small 'elite', so that over time society will segregate into the 'GenRich' and the 'Naturals"' (King).  At what point have children been turned into objects and gadgets designed by parents?  Heather Long, writer for the US edition of The Guardian, draws a similar mental picture of the future, saying, "Imagine a scenario at a future Olympics: is it legitimate to have a genetically designed person competing against those who are not? At the moment, it's a bit of luck who has the right body for certain sports. But in the future, those traits could be selected for and groomed from the womb."  In a world where we are constantly fighting for equality, introducing designer baby technology would likely counteract all of the progress that has been made.  If designer baby technology is not restricted to medical purposes, this type of society may very easily become a reality.

VII.  Moving Forward

After weighing the benefits and risks of human genetic engineering, it is clear that although gene editing should not be banned altogether, it must be highly regulated.  It is my proposal that human gene editing be practiced only by certified individuals who are doing it for strictly medical purposes.  This will lessen the likelihood of societal consequences and new inequalities.  Medicine is designed to take away the pain and suffering of disease and illnesses, so doctors and scientists should be able to use these technologies in a controlled way to help lessen the likelihood of genetic disorders.  Though human experimentation can never truly be considered ethical, it is imperative to the advancement of these technologies and is, therefore, inevitable.  That being said, strict protocols must be enforced to prevent malpractice and irresponsible experimentation.  The FDA, Food and Drug Administration, must also update their charter.  "The FDA, along with the U.S. Department of Health and Human Services (HHS), jointly oversee the protection of human subjects in clinical trials, which are required to demonstrate safety and efficacy before new drugs or medical devices can be licensed for market" (Brownlee).  A thorough discussion of all possible consequences must take place with patients, as effects cannot be reversed. Experts in the field of assisted reproductive technologies and human genetic engineering that have been certified should also be the only ones conducting these clinical trials.  Since the CRISPR/Cas9 complex is so easy to use, it is very important that only these specialists be allowed to use it.  

England acts as a superior example for limiting human genetic engineering.  A licensing board, the Human Fertilization and Embryology Authority (HFEA), was created to ensure that gene editing be limited to solely medical purposes.  They even denied the request of a family of four boys that had lost their young sister in a fire the chance to choose a female embryo for In Vitro Fertilization (Brownlee).  The decision was made because there was no medical reasoning for choosing a certain sex.  It would be beneficial to the United States to treat England's example as a guide for creating similar mechanisms of regulation and restriction.  Above all, these technologies have the power to change the world, for the better or for the worse.  As such, these practices must be restricted to medical purposes, and they must be highly regulated or the effects could be catastrophic. Although there are many exciting scientific advancements that may come with the introduction of human genetic engineering, we must recognize that we have a responsibility to limit its negative consequences and ensure its ethical use by way of regulation. 

      

