Governing with Morality: Whether the Medical Benefits of CRISPR-Cas9 Outweigh the Potential Moral and Bioethical Consequences the Technology Could Bring if Used to Create “Designer Babies”

I. Introduction

Massive milestones in the medical field include the discovery of DNA’s double helix shape, the creation of penicillin, developing a treatment for HIV/AIDS, and the recent creation of Covid-19 vaccines. Today, scientists have discovered a technology called CRISPR-Cas9 that can edit tiny sections of one’s DNA and replacing it with a corrected or preferred segment. In the future, it might be possible to eliminate embryonic genes that carry predisposition to develop diseases like Alzheimer’s or even cancer. But the ability to prevent disease by altering DNA then begs the question: what else can be changed?

In recent years, medical advances have made it possible for parents to enter a fertility clinic and choose their baby’s sex and eye color using genetic screening. In the last decade, CRISPR-Cas9 has opened the door to seemingly endless possibilities regarding gene editing, however, Congress has created restrictive laws that prevent meaningful research into the technology. Because of this, CRISPR is still in its infancy and the government has not regulated its use. This paper examines the possible legal and legislative avenues that a government could take, while considering what fundamental rights such decisions could implicate and how any form of legislation will have ethical consequences.

CRISPR technology has shown potential to cure blood diseases and cancer in adults, and if actually viable, should be used for that purpose to create a healthier future for humanity. Any legislation regarding its potential medical use should keep in mind that the right to bodily autonomy can only be superseded in times where public health is a concern. Furthermore, when legislating the cosmetic usage of CRISPR-Cas9 to create designer babies, legislators should take great care to consider the eugenic, socioeconomic, and evolutionary implications that CRISPR has the potential to contribute to. and do their best to prevent any further aggravations between groups.

II. A Brief Overview of Genetic Testing and Modification

Thanks to computer and video games, people have been designing their own avatars and living out their fantasy lives for decades. When playing The Sims, for instance, users can customize their Sim’s age, facial features, body type, hair color, skin tone, and even design their Sim’s house and choose their career. Newer editions of the game not only offer a vast range of skin tones, hair colors, and eye colors, but include incredibly detailed customization options that essentially allow players to utilize photoshop-like technology to precisely mold their Sims’s facial and body features to ensure they looks as realistic as possible.[1] Many other computer and video games also allow users to play as specific characters or offer the option to design a custom avatar using pre-set features. The idea of artificially creating the ideal image of oneself is further exemplified in the young adult fiction series The Uglies by Scott Westerfeld. The series invents a world in which the government forces teenagers to get plastic surgery on their sixteenth birthdays to ensure they satisfy societal beauty standards.[2] Defining characteristics like skin color and IQ are not altered during this surgery, but rather the

body [is] opened up, the bones ground down to the right shape, some of them stretched or padded…nose cartilage and cheekbones stripped out and replaced with programmable plastic…eyes [are] laser-cut for a lifetime of perfect vision…muscles all trimmed up and…baby fat sucked out.[3]

The surgeries depicted in the series perpetuate the unrealistic expectations that adhering to societal standards of beauty is not only preferrable, but only attainable through surgical enhancement. However, the surgeries are biologically more than just skin-deep. The foundations of the features that the doctors correct—like impaired vision, muscle function, and bone structure—are coded in our DNA strands and expressed through physical traits; any modifications to the genes would ultimately change a person’s physical appearance. The technological advancements in games and works of fiction mirror the technological advancements that biologists and geneticists are making in real life but until now, the ability to create the ideal image of oneself has existed only in fantasy. Scientists have been researching genetic testing and genetic modification for decades, and in the 1990’s, they had a breakthrough that revolutionized genomic sequencing.

a. Cloning paved the way to simplify genomic sequencing, thus opening the door to other genetic technologies

Though she was not the first of her kind, perhaps the most famous example of science’s impressive advances in genetic modification came in 1996 when Scottish scientists successfully cloned a sheep.[4] Scientists created Dolly by replacing the nucleus of one sheep’s egg cell with the nucleus of another sheep’s mammary gland cell, and then implanted in the surrogate sheep’s uterus.[5] Dolly and her predecessors were part of an experiment to “develop a better method for producing genetically modified livestock”, and after 277 failed attempts, Dolly was the first lamb to survive.[6] The experiment also proved that adult cells could be used in cloning and genetic modification; a feat that was previously thought to be accomplishable only with embryonic stem cells.[7] Although geneticists involved in her creation said it is unlikely that the technology utilized to create Dolly would be viable in human research, her survival opened the door for more advanced genetic research.[8]

Fast forward 25 years and advances in technology have simplified genomic sequencing, thereby making genetic testing cheaper and more attainable to consumers. In recent years, home testing kits from companies like Ancestry and 23andMe that trace one’s ancestral lineage have become popular due to their low cost (particularly around the holidays), high accuracy, and sometimes surprising results. They’re even available for pets. In the 1990’s, new genetic technology enabled scientists to develop a paternity test with 99% accuracy that examined sixteen fragments of the child’s DNA and matched them with the supposed parents’ DNA.[9] Today, paternity tests have solved innumerable legal disputes over custody and child support, and are even the focal point of several daytime TV shows like Jerry Springer and The Maury Povich Show. Though commercial DNA tests are getting cheaper every year, private genetic screening for pregnancies remain costly, and not just financially.

b. Genetic testing during pregnancy has many uses and its technology continues to develop

Historically, genetic testing has been used to identify variants and mutations in one’s DNA to help explain or predict a condition or disease.[10] Doctors can test singular genes to diagnose a specific disease, or test a panel of genes to obtain a bigger picture of the patient’s medical profile.[11] Many women undergo genetic testing during pregnancy for health-related reasons, both for themselves and for their baby. Currently, fertility clinics can test for hundreds of diseases in utero including congenital heart/brain defects, Down Syndrome, Huntington’s Disease, and muscular dystrophy.[12] Some genetic diseases are sex-linked and can only be passed down via the X or Y chromosomes, such as red-green color blindness, which is passed via the X chromosome and more likely to be found in males.[13] If test results determine there is a high likelihood that their baby will be born with a defect or disease, a woman might elect to terminate the pregnancy. Some prenatal genetic tests can determine sex, but the vast majority of women who do find out their baby’s sex typically wait until an ultrasound can detect it—typically between fourteen and 21 weeks—while some blood tests can determine the sex as early as seven weeks.[14] A woman might also elect to terminate her pregnancy if she finds out she is pregnant with a boy and wants a girl, or vice versa. This is a drastic form of sex selection, but the Court’s decision in Roe v. Wade ruled that a woman’s [limited] right to an abortion is constitutionally protected.[15] However, there are eleven states that restrict abortions on the basis of sex selection, including Arizona, North Carolina, and Pennsylvania.[16] Moreover, genetic testing can be done pre-implantation to aid in family planning, a viable option for couples who want to ensure their child is their preferred sex.

Statistically speaking, since the 1970’s the “ideal family” has been described as two parents having 2.5 kids.[17] Many couples often do want to have one boy and one girl to “balance” their family, but it really is a crapshoot.[18] To enhance their odds, some fertility clinics currently offer Preimplantation Genetic Diagnosis (“PGD”) to parents who want to screen their embryos for chromosomal abnormalities and/or determine or choose their baby’s sex before implantation.[19] Some couples take advantage of this option solely to choose their baby’s sex, citing reasons like personal preference or a desire to avoid passing on sex-linked genetic diseases.[20] Currently, PGD screenings are only possible through in-vitro fertilization (“IVF”) and work by removing a single cell from an embryo and examining it. Scientists can screen it to see whether it is carrying any disease, or examine its chromosomes to determine if the embryo is XX (female) or XY (male).[21] Once the preferred embryos are identified, the IVF process continues normally.

Precise statistics regarding the number of parents who utilize PGD are not available, but it can be assumed that the process does not constitute a huge percentage of babies born every year. One study published in 2019 suggested that in 2015, of the roughly 4 million babies born annually in the US, only 55,700 were born using IVF technologies.[22] A 2004 study estimated that since its inception, only a thousand babies had been born using this method.[23],[24] Therefore, when taking into account the additional costs, the number of babies implanted after undergoing PGD in the last decade and a half is likely considerably lower than that—probably only several thousand.

With the advent of this technology, some have raised concerns that couples’ sex preferences might skew towards one gender over the other. These fears presumably exist because sex preference is prevalent and well-documented in countries like China and India, where sons are infamously preferred over daughters.[25] However, multiple doctors from reputable fertility clinics in the United States who perform the process state that they have seen a 50/50 balance between couples who want males and those who want females.[26] Others, especially mothers who had difficulty conceiving naturally, are concerned that sex selection is an unnecessary and vain process. One mother described IVF as “such a hard and long and laboring process to even get to the point of being pregnant” that she cannot imagine someone voluntarily undergoing the process just to be able to pick their child’s sex.[27] Health information technology has undergone major advances in recent history, and in the future, genetic advances might lead to IVF becoming a more common route for conceiving a child regardless of a woman’s ability to reproduce naturally.

III. What is CRISPR-Cas9, and is it the Future of Healthcare?

a. CRISPR has the ability to modify organisms’ genomes

Scientists have spent decades studying DNA and working on technology that possesses the ability to alter one’s embryonic genomes. In the early 2010’s, scientists built upon discoveries made in the 80’s and learned that bacteria adapt to create an immune system by storing clustered fragments of defeated viruses in their DNA.[28] The clusters of foreign DNA enable the bacteria to remember the invading virus and create RNA strands and enzymes built to destroy the virus if it comes back.[29] The scientists called these fragments “Clustered Regularly Interspaced Short Palindromic Repeats”, “CRISPR” for short.[30] In 2012, two biochemists named Jennifer Doudna and Emmanuelle Charpentier—who would later share the 2020 Nobel Prize in Chemistry for their work—made one of the most significant scientific breakthroughs in history with their continued research into CRISPR’s capabilities in human embryos.[31] CRISPR was discovered as a bacterial immune system so naturally, initial research has been focused on fighting viruses, with scientists making immense and successful progress on that front.[32]

The CRISPR associated protein 9, or “Cas-9”, is the specific enzyme that physically edits genes. It essentially works the same way that a film editor might splice a frame of a movie and either delete the a selection of the frame, or insert another scene into the spot where he made the cut.[33] In order to determine precisely where to make the cut in an embryo’s DNA, scientists program artificial RNA that leads the Cas-9 protein to the targeted or “matching” DNA segment in the strand. [34] There, depending on the instructions, Cas-9 will either sever the segment and remove the unwanted or harmful trait entirely, or it will sever, remove, and insert new genes in its place.[35] If executed properly, the process does not harm embryos, but rather enhances them.

Doudna has described CRISPR-Cas9 as a “molecular scalpel” that could theoretically cure any disease that stems from a genetic basis.[36] Diseases like Alzheimer’s, cystic fibrosis, HIV, and even cancers could be eradicated, while another researcher stated that CRISPR can create cartilage and will likely be able to cure or prevent arthritis and even alter muscles to treat muscular dystrophy.[37] Additionally, in California, immune biologists are currently using CRISPR to experiment with limb and organ regeneration using chicken fetuses.[38] They hope to be able to introduce this technology to human subjects in the near future, thus eliminating the need for post-mortem organ donation.[39] The vast majority of CRISPR-Cas9 research has been geared towards editing embryos to ensure that a child is born without predispositions to develop diseases like cancer and Alzheimer’s, but more recent experiments have been focused on altering the cells of both agricultural products and adults, too.[40]

b. CRISPR has applications in agricultural technology, too…

The global population is expected to reach 10 billion by the year 2050, and in order to meet increasing demands for food, scientists have turned to CRISPR.[41] Humans have been eating genetically modified food for years, but the future of CRISPR-Cas9-altered food might prove to be revolutionary. Not only will CRISPR-Cas9 be able to edit a crop’s DNA to make it pest-resistant and climate-resistant, it could even insert and remove genes to create varied food options without the typical chemical processing involved.[42] For example, the U.S. Department of Agriculture has already approved browning-resistant mushrooms, apples, and potatoes for cultivation and selling “without passing through the agency's regulatory process” because thanks to CRISPR-Cas9, they do not include any added genes.[43] In the future, CRISPR-Cas9 might be able to add genes to crops that can control the traits of the food. For instance, modifications could “make tomatoes spicy, or remove other [traits, creating] gluten-free wheat or decaf coffee beans.”[44] Utilizing CRISPR to edit plant genomes could even one day lead to eradicating hunger in food-insecure countries.[45] And if CRISPR is able to eradicate disease in humans, therefore increasing their life spans, humanity might not have a choice but to genetically engineer “super foods.”[46]

c. …but its most consequential uses might be used to cure disease in adults.

CRISPR research has not been limited to crops and embryos, though. Scientists have recently begun to experiment using adult cells in order to pursue a CRISPR process that is less invasive than undergoing IVF to ensure an embryo is protected. Currently, there are two methods being utilized to modify an adult’s genome. The first method is ex vivo gene editing, which involves “extracting human cells, engineering them in a lab, and reinjecting them into the patient.”[47] In in vivo gene editing, scientists insert CRISPR-Cas9 directly into a patient’s body without first extracting any cells and letting the protein edit DNA on its own, using engineered RNA to direct it.[48] Human trials using in vivo gene editing only began in 2020, so there is far more available and reliable research using ex vivo techniques.[49] For example, scientists are currently utilizing ex vivo gene editing to eradicate many blood diseases in adults. [50]

One ex vivo technique has successfully been used to battle diseases like hemophilia sickle-cell disease. It requires scientists to harvest bone marrow stem cells, CRISPR-engineer them to create fetal hemoglobin, which “binds oxygen much better than the conventional adult form”, and then infuse the new blood cells into the patient.[51] Moreover, Chinese scientists have also began studying ways to edit non-small cell lung cancer cells in adults using similar methods. Studies involve removing T-cells from cancer patients and using CRISPR to remove a gene/protein called PD-1 that some tumor cells “bind to … to block the immune response against cancer.”[52] These CRISPR experiments on adult cells have successfully “provided the eagerly awaited first pieces of evidence supporting the safety and feasibility of CRISPR-based cell therapy in human patients.”[53] Furthermore, the University of Pennsylvania recently funded and conducted similar experiments that proved to be safe in patients with late-stage cancer diagnoses. These trials involved removing three genes that allow cancer cells to invade the immune system and introduced a different gene that would allow the immune cells to recognize and fight against tumor cells.[54] If these methods prove to be successful in altering adult genomes to fight off life-threatening diseases, there is a chance that the government might make them mandatory in order to preserve human life.

IV. Could the Police Powers Enshrined by the 10th Amendment Allow States to Enforce Mandatory CRISPR Procedures in the Name of Public Health?

a. The 10th Amendment gave states the right to pass laws to preserve public health

Because CRISPR researchers hope to one day be able to utilize in vivo gene editing in human embryos, fundamental rights related to body autonomy and parenting will certainly come into play when considering the legislative implications this science can bring. Some fear that enhanced designer babies might become the norm, while others believe the government will enforce the procedure, like the plot to a science fiction novel.[55] First and foremost, the 10th Amendment gave states police powers that allow it to “govern, establish, adopt as well as enforce laws that are designed for the protection as well as preservation of the public health.”[56] Justice Harlan further asserted these states’ rights by stating in Jacobson v. Massachusetts that the Court has “distinctly recognized the authority of a State to enact … ‘health laws of every description’” if concern for public health is at stake.[57] Moreover, Cruzan v. Dir., Missouri Dep't of Health held that states may “properly … assert an unqualified interest in the preservation of human life” when enacting health-related policies.[58], [59] For instance, public schools currently require its students to get many mandatory vaccines in the interest of public health, and there are ongoing debates regarding the legality of requiring “Covid passports” when attempting to travel in the near future.[60]

These cases demonstrate that a state government could enact public health laws if deemed reasonable. Therefore, if scientists were to develop a method to safely and reliably cure almost any disease or ailment, and these diseases were issues of public health, state and federal governments might successfully enact mandates to promote public health. However, there will likely be two methods of employing CRISPR-Cas9 to fight disease in the future. Scientists might utilize in vivo editing and inject the Cas-9 protein into an adult to disable a gene, or they could conduct embryonic CRISPR procedures, which are much more invasive. Concerning the latter, it is highly improbable that the government will ever have the power to mandate any such procedures.

b. The rights to privacy and bodily autonomy are fundamental and any legislation infringing those rights would have to withstand a strict scrutiny analysis

It is safe to assume that there exists a general consensus that preventing and eliminating disease would be good for humankind, and any applicable technology would likely be implemented in healthcare. However, the Court has long upheld bodily autonomy as a constitutional right. In Griswold v. Connecticut, the Court held that although not explicitly defined, “specific guarantees in the Bill of Rights have penumbras, formed by emanations,” and one of those specific guarantees is a right to privacy.[61] The right to privacy, or “the right to be let alone” has been upheld in numerous decisions.[62] For example, Roe v. Wade used the right to privacy to constitutionally protect a “woman’s decision whether or not to terminate her pregnancy”,[63] and Eisenstadt v. Baird held that the right to privacy implies a right “to be free from unwarranted government intrusion.”[64] The Court in Cruzan held that “a competent person has a constitutionally protected liberty interest in refusing unwanted medical treatment,”[65] while the New York Court of Appeals in Schloendorff v. Society of New York Hospital held that “every human being of adult years and sound mind has a right to determine what shall be done with [her] own body.”[66]

These rulings emphasize that there exists a fundamental right for a person to decide what happens to their bodies, bar unreasonable government interference. If a government were to pass a law saying that women must undergo a CRISPR process to protect her embryos from disease in the future, it would likely be struck down as unconstitutional under the Due Process Clause of the 14th Amendment. First and foremost, embryonic CRISPR procedures require women to undergo IVF—an invasive and expensive process—so the right to bodily autonomy ought to extend to decisions a woman makes regarding her eggs.[67] Many official bodies consider embryos to be property, which further asserts a mother’s right to decide its outcome. For instance, in 2008, the Oregon Court of Appeals deemed embryos marital property[68] while the Missouri District Court in Mansaw v. Midwest Organ Bank held that the parents had a property interest in their son’s body.[69] In addition to rights surrounding bodily autonomy, the rights to procreate and raise that child will also be implicated if a government enforces embryonic gene editing.

The Court has also decided numerous cases in which it upheld the right to procreate as fundamental. When faced with the issue of whether forced sterilization after two felony convictions was constitutional, the Court in Skinner v. Oklahoma held that it was not, and that “marriage and procreation are fundamental to the very existence and survival of the race.”[70] Additionally, the full holding from Eisenstadt states that there is a fundamental right “to be free from unwarranted governmental intrusion into matters so fundamentally affecting a person as the decision whether to bear or beget a child.”[71] Furthermore, Cruzan guaranteed a right to refuse unwanted medical treatment, so forcing a person to undergo an invasive procedure for gene editing would almost certainly violate that right. [72]

Based on these decisions from the Court, the fundamental rights to bodily autonomy and procreation are well-established. Any fundamental right that has been infringed upon by government intervention must undergo a strict scrutiny analysis before it can be upheld.[73] The first prong of strict scrutiny analysis states that the government must have a compelling interest in the matter. Passing legislation designed to protect people from potentially fatal diseases beginning before birth could be viewed as a compelling interest in public health. Secondly, the legislation must be narrowly tailored. There are innumerable health and safety laws that would need to be implemented to ensure a mandate is narrowly tailored to the extent a person’s reproductive freedom could be abridged. One example might be that a government would likely have to set guidelines for scientists to examine embryos on a case-by-case basis to determine which ones express a predisposition for certain genes in order to satisfy this requirement, but it could be done. Finally, the legislation must be the least restrictive means to achieve that interest. Although a mandate could possibly satisfy the first two prongs, an in vivo embryonic CRISPR procedure would not be the least restrictive means of achieving the interest; in fact, there are very few more invasive procedures than going through the process of in-vitro fertilization. Due to the invasive nature of embryonic CRISPR procedures, it is almost certain that the any legislation mandating such procedures would be struck down as unconstitutional.[74]

c. Mandating an injection-like procedure in adults to cure and/or prevent disease might withstand a strict scrutiny analysis.

As previously stated, however, scientists are currently working on CRISPR-Cas9 techniques that could alter DNA in adults. Although the same rights to bodily autonomy as described above also apply here, when compared to in-vitro fertilization, undergoing a series of injections is generally far less invasive. Almost all of the diseases that CRISPR-Cas9 might have the ability to cure have a genetic basis and are rarely contagious through person-to-person contact. However, the government might deem some of them—like HIV, cancer, and blood diseases— as large enough threats to public health that in the future it might mandate CRISPR-Cas9 procedures if they are proven to be safe and infallible.[75] If so, and science has advanced enough to the point where ex vivo CRISPR procedures are viable, a challenge to a mandate’s constitutionality might fail.

The only difference between the aforementioned strict scrutiny analysis and an analysis in which the government seeks to mandate injections in adults is the third prong, the “least restrictive means” prong. In this analysis, a court might find that injecting sick adults with a CRISPR-Cas9 protein designed to target and disable the gene causing the illness to be the least restrictive means of curing their disease. Though current long-term effects are unknown, considering current treatments like chemo and dialysis that can cause nausea, hair loss, severe weight loss, and pain, an injection is far less invasive and restrictive. If that is the case, then a mandate in the interest in preserving public health might withstand strict scrutiny. Regardless, CRISPR technology allows scientists to modify an organism’s DNA with seeming ease, and they hope that one day it will be used to prevent and eradicate disease with genetic bases, mandated or not.

d. Speculating on potential government mandates regarding CRISPR

Because CRISPR procedures are neither absolutely feasible nor FDA-approved yet there are very few regulations in this area, and it will be interesting to see how the laws develop. For instance, though it will likely remain a state matter, the Federal government could ban genetic modification as a whole. There are many hazards when it comes to gene editing, and the government could cite those when justifying its ban. It could also enact a limited ban in human genetic modification. One route could entail permitting modifications in the name of preventing and eliminating disease, but banning “cosmetic” modifications that would change an embryo’s physical appearance and attributes. Another option regarding cosmetic modification could see the government making edits to certain traits (like IQ and athleticism) off-limits, or even setting a limit of the number of modifications that can be made per embryo or per family as a whole. If the government were to enact a total ban on modification, it might cite public health concerns, as there are evolutionary ramifications associated with editing a genome, while a ban on cosmetic edits could be justified using the governments interest in preventing racism, eugenics, and widening socioeconomic gaps. Furthermore, the Court in Moore v. East Cleveland stated: “of course, the family is not beyond regulation”, while the Court in Parham v. J.R. ruled that “a state is not without constitutional control over parental discretion in dealing with children when their physical or mental health is jeopardized”, so the government would likely be able to impose some regulations on how genetic modification can be used. [76], [77]

e. The fundamental right to parent could also be used as an argument in support of genetic modification.

Though the focus of this paper has so far centered around the government’s ability to mandate CRISPR procedures, a government’s decision to limit and restrict availability could also lead to litigation. If the government were to pursue some form of ban on embryonic genetic modification, there is a chance that some parents will see it as a violation, not only of an opportunity to enhance their children’s genes to make them more successful in life, but of their right to raise their children how they want. Not only does a parent have a right to procreate, but they have a fundamental right to raise that child as they see fit. The Court in Pierce v. Society of Sisters held that a government statute regarding schooling methods “unreasonably interfered” with parents’ liberty to direct the upbringing of their children, while the decision in Meyer v. Nebraska recognized that establishing a home and bringing up children is a fundamental right, and any opposition must survive strict scrutiny.[78] If CRISPR proves to be effective and can edit out predisposition for disease and “enhance” a child’s attributes, some parents might claim that they have a right genetically modify their children and any government limitations infringe upon that right.

Although the fundamental right to parent is applicable when the government tries to intervene in the upbringing of a child, it is unlikely that a court would agree a parent has a fundamental right to genetically modify their child. In Washington v. Glucksburg, the Court not only decided that a right to assisted suicide is not constitutionally protected, but it also created a two-prong standard used to identify what rights deserve the protection of the Due Process Clause of the 14th Amendment. First, the Court has “regularly observed” that only fundamental rights that are “objectively, deeply rooted in this Nation's history and tradition” are given the protections enumerated in the Due Process Clause.[79] Genetic modification is a new facet of technology and has not been available in the past; the government would not necessarily be depriving anyone of anything that they were previously allowed to do, therefore it is not liberty deeply rooted in this country’s history and tradition. Secondly, it also requires a “‘careful description" of the asserted fundamental liberty interest.’”[80] To do this, parents would have to explain why genetically modifying their child should constitute a fundamental liberty.

For instance, there is an obvious economic interest in utilizing CRISPR to prevent disease in people of all ages. According to one study, “early diagnosis of genetic disease in newborns has considerable potential to affect the cost of care. The average hospital charge for an initial level II NICU stay was $76,164…Preterm birth results in $26 billion annual economic costs.”[81] Furthermore, the same study stated that in 1997, “parental divorce occurred in 50% of families with a child with a genetic disease.”[82] Courts operate under the best interest of the child standard, and it is hard to argue that preventing potentially fatal illness would be in a child’s best interest, even if that disease would not present itself until late stages of life. Furthermore, ensuring a child is born healthy and remains in a stable home would also be in a child’s best interest. However, it might not be enough to convince a court that genetic modification is a fundamental right. Additionally, it is hard to imagine a world in which a court agrees that a parent reserves the right to conceive a child who is predisposed to be a good basketball player due to cosmetic genetic modification, regardless of reasoning.

Regardless of where the government chooses to go in terms of legislation, it is safe to say we are likely decades away from any type of regulation. There is just not enough research being done in this field of genetics, which is due largely in part to current restrictions on allocation of federal funds.

V. Current Restrictions on Using Human Embryos in Genetic Testing and Research

a. CRISPR has been used in Covid vaccines.

CRISPR’s capabilities have been manipulated in many different experiments since its discovery. In addition to its ability to engineer better foods with few inorganic additives and potentially eradicate cancer and blood diseases, scientists have also successfully utilized CRISPR technology to develop rapid Covid-19 tests and its current vaccines.[83] Rather than using the Cas-9 enzyme, however, scientists employed Cas-13d and a synthetic copy of Covid’s RNA to detect and destroy the virus in test samples.[84] This technology was known in March 2020 thanks to federal grants that the Department of Defense provided to Stanford University and Georgia Tech in 2019 for the purpose of creating a “CRISPR-based means of fighting influenza.”[85] By funding research into whether CRISPR could one day eradicate influenza in humans—thereby preventing death in tens of thousands of lives per year—the government has expressed an interest in preserving life.[86] The government has also expended trillions of dollars since March 2020 by passing Covid relief bills and further funding research, at the forefront of which is CRISPR technology.

b. The Dickey-Wicker Amendment Limits Research into CRISPR’s Capabilities

Unfortunately, little is known about the long-term effects of CRISPR in human gene editing because the government has limited and restricted research on the subject. In 1996, Congress passed the Dickey-Wicker Amendment which prohibits the use of federal (taxpayer) funds in “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research under applicable Federal regulations.”[87] The amendment is still in place today.[88] Although successful CRISPR modifications themselves do not harm embryos, scientists have not done sufficient research into the process in humans. They therefore need to experiment on embryos, all of which will likely be destroyed in the process, which is why the Dickey-Wicker Amendment causes difficulties in furthering scientific research.

In 2007, President Bush issued an executive order that slightly relaxed the restrictions enacted by the Dickey-Wicker Amendment. It permitted scientists to conduct research on human embryos that existed before the issuance of the order on June 20, 2007, however, it continued to bar federal scientists from using federal funds to create embryos for stem cell research.[89] Shortly after entering office in 2009, President Obama issued an executive order that asserted his administration’s intent to support embryonic stem cell research.[90] It not only revoked Bush’s executive order, but also permitted federal researchers to utilize embryos that already existed and those which were otherwise going to be discarded, typically from fertility clinics.[91] A statement issued with Obama’s executive order said Bush’s order imposed an arbitrary date that had “no basis in science.”[92] Finally, in 2019, President Trump placed restrictions on federal grants to the National Institute of Health that provided funding to researchers who use fetal tissue in experiments.[93] Fetal tissue research differs from stem cell research in that fetal tissues typically came from fetuses after elective abortions, federal researchers did not create the embryos. It is also worth mentioning because as one stem cell biologist who is studying organ regeneration stated, “it’s a decision that’s going to set back research.”[94]

When Obama eased revoked restrictions in 2009, CRISPR was not yet refined the way it is today, and it is unlikely that the administration could not have predicted how quickly technology would advance in three short years. Three years after Doudna and Charpentier’s breakthrough, the Obama Administration issued a 2015 statement saying “[it] believes that altering the human germline for clinical purposes is a line that should not be crossed at this time.”[95] This statement also included discourse on the ethical implications of genome editing, with the Administration taking the stance that it “fully supports a robust review of the ethical issues associated with using gene-editing technology to alter the human germline.”[96] The Obama Administration also seemed apprehensive of the possible discoveries that the CRISPR technology could bring, as the statement called recent Chinese experiments on human embryos an ethical risk.[97]

In November 2018, just three years after China began its experiments, one scientist reportedly used CRISPR to edit human embryos. He Jiankui claimed to have successfully edited the genome of a set of twins whose father was HIV-positive.[98] Although the chance of him passing the disease to his children was low, Jiankui utilized CRISPR to disable CCR5, a gene “which encodes a protein that allows HIV to enter cells.”[99] Scientists around the world had mixed reactions; one researcher called Jiankui’s experiments “unconscionable”, while another said this kind of human experimentation is “far too premature.”[100] However, a Harvard University geneticist said Jiankui’s actions were “justifiable” because HIV is a “major and growing public health threat”, while most scientists condemned Jiankui’s experiments as “not morally or ethically defensible.”[101] In May 2020, China revised its civil code to include regulations on gene editing, stipulating that experiments “shall not endanger human health, offend ethics and morals, or harm public interests” and would hold anyone who manipulated human genes responsible for adverse outcomes.[102],[103] Because research on the long-term ramifications of gene editing is virtually nonexistent, any human experimentation would therefore endanger human health because the edits might result in other mutations or increased susceptibility to other diseases.[104] Research on gene editing is necessary to ensure that scientists have every opportunity to make advancements that will benefit the human race, but at the same time, governments make it difficult to conduct the research because they seem to be more concerned with maintaining the integrity of embryos than ensuring a healthier future for humanity.

Today, the only U.S. law in place governing human embryonic stem cell research continues to be the Dickey-Wicker Amendment. Preventing government researchers from creating their own stem cell lines and instead forcing them to rely on embryos obtained elsewhere slows the rate at which technology-advancing discoveries—both negative and positive—can be made. Of course, private clinics can create their own embryos, but funding is harder to come by. The Dickey-Wicker Amendment, as the previously mentioned stem cell biologist stated, is “a decision that’s going to set back research.”[105] Congress, which is now controlled by Democrats who recognize the importance of science and its advancements, should refuse to include the amendment in future NIH spending bills to ensure that scientists are given freedom to conduct potentially lifesaving research.

VI. The Government Should Consider the Ethical Ramifications of Allowing Parents to Utilize CRISPR to Cosmetically Enhance Their Children When Drafting Relevant Regulatory Legislation.

Though the long-term effects of gene editing are not yet fully realized, the proposed technology has incredible potential to save millions of lives. In 2018, one geneticist acknowledged the strides yet to be made in CRISPR technology, but of its progress thus far, he said “what we have able to do in the last four or five years is unbelievable…it’s science fiction.”[106] What used to be considered fantasy is possible now that science can eliminate and/or alter anything with a genetic basis, thus changing their physical appearance. For instance, CRISPR poses the ability to alter one’s physical appearance, which could include traits like height, body type, hair color, facial features, vision, personality traits, IQ, and perhaps even talents, including athletic and music ability.[107] However, this is easier said than done. As one geneticist said, “it might be possible to predict certain behaviors, although with far less accuracy than gender, as thousands of genes are involved in things like intelligence or athletic ability.”[108] Although the medical advances will be groundbreaking, critics still wonder when and where will scientists draw the line; when does too much change actually become too much, and cross ethical lines that cannot be un-crossed?[109]

a. Some are concerned that CRISPR-Cas9 usage could lead to a form of eugenics

As previously stated, mothers have had the ability to undergo genetic testing while pregnant to get a better understanding of their child’s likelihood to develop certain diseases for years. Using CRISPR technology, however, many have raised concerns that it could bring “market-based eugenics that would exacerbate already existing discrimination, inequality, and conflict.”[110] For instance, two physically disabled women collaborated on an article cautioning against the use of CRISPR because of the negative attitudes surrounding people with disabilities. They write that there exists “the subtle, yet insidious, idea that some genes are inherently bad and contaminate the human gene pool [and] people who carry them should not propagate and pass those genes on to their progeny so as to make those children either carriers or affected.”[111] They also praise its capabilities in that CRISPR is “a powerful, scientific technology that can reshape medical treatments and people’s lives” but at its worst, it can delete “unwanted” traits from a genome, thereby “harmfully reduce human diversity and increase social inequality.”[112] Additionally, one scientist argues against using CRISPR to delete genes associated with neuropsychiatric diseases. He stated that willfully eliminating these genes could affect things like creativity and the quality of entertainment, citing authors, actors, and other celebrities with noted mental illnesses like autism, schizophrenia, and depression.[113]

However, despite concern for potential eugenics movements perpetuated by CRISPR-Cas9, it should not go unmentioned that the United States itself enacted pro-eugenics laws. Buck v. Bell was a case in which the Court affirmed the constitutionality of a Virginia law that sought to “promote the health of the patient and the welfare of society” by sterilizing “feeble-minded women” who were confined to mental institutions.[114] The Court has never expressly overturned Buck, but its holding in Skinner weakened it, stating that forced sterilizations after two felony convictions were unconstitutional.[115]

Furthermore, the mere existence of egg and sperm banks could be argued as being a current method of eugenics. Some clinics are extremely selective regarding their donors. For example, the California Cryobank excludes 99% of its applicants based on characteristics like height, weight, education, genetic history, and psychological test results.[116] Prospective parents are then allowed to filter out donors based on preferred traits until they find a subjectively perfect match. The difference between selecting from an already (subjectively) high-quality group of traits and CRISPR technology is that CRISPR can be “used to select for desirable traits, not just against markers for [unwanted traits].” (emphasis added)[117] Physical eugenics is not the only form of eugenics that scientists and legislators should worry about, though. Genetically modifying embryos is extremely expensive, so it follows that CRISPR will likely perpetuate issues of socioeconomic inequality.

b. Designer babies could widen socioeconomic disparities in healthcare

There is an indisputable history of racial, gender, and socioeconomic discrimination in healthcare, whether purposeful or not. On its surface, the advent of CRISPR technology sounds promising—eradicating disease and enhancing one’s genetic features. However, it soon becomes clear that due to the price and history of inequality in healthcare, a select few will actually have access to it. Based on current technology and information, the lowest price for genetically modifying an embryo might begin at $24,000. If not covered by insurance, IVF procedures can cost more than $20,000 out-of-pocket, even before any Preimplantation Genetic Diagnosis costs are added. At the San Diego Fertility Center for example, PGD costs an additional $4,250[118] while PGD at several fertility clinics in Chicago begins at $6,000.[119] There is also no guarantee that the fertilized embryos will successfully implant, meaning a mother might have to go through several rounds of IVF before a viable pregnancy occurs, turning this into a potential hundred-thousand-dollar process, not to mention the physical toll on the body.

CRISPR technology will further the divide between the upper and lower classes because only the wealthy will have access to the procedures. Historically speaking, those who suffer from healthcare inequality include people of color, immigrants, LGBTQ members, and those below the poverty line with little education. These groups are essentially barred from allowing their children to benefit from the opportunities CRISPR offers.

As one molecular biologist stated, “once you start creating a society in which rich people’s children get biological advantages over other children, basic notions of human equality go out the window. Instead, what you get is social inequality written into DNA.[120] It does not seem morally or ethically fair to restrict access to a procedure that will have lifelong implications to only those who have the means to afford it. [121] Doing so might lead to members of the upper class creating “superior” children who pass their edited genes onto their offspring. This consequence would not only exacerbate existing societal problems of racism and ableism, but it could also potentially alter evolution because any modifications made to a genome using CRISPR-Cas9 will become inheritable in future generations.[122]

c. Human evolution will likely be affected

Furthermore, because this science has the potential to eliminate disease as we know it, it suggests that new unknowable genetic mutations might develop as a result. A continuing theme in the film Interstellar is Murphy’s Law: the idea that anything that can go wrong, will go wrong.[123] In one scene, Matthew McConaughey’s character says that “accident is the first building block of evolution.”[124] By removing accidents (mutations) in genes, science is all but guaranteeing that its human experiments are likely lead to the rise of new, unknowable mutations and diseases, which will likely affect evolution in drastic and unpredictable ways.

There are several drawbacks to using CRISPR-Cas9 to edit the human genome. Due to CRISPR’s precision, however, the skepticism does not stem from the fear that Cas9 will miss its target and edit other genes; rather, the fear is that editing specific genes might lead to unintended evolutionary consequences.[125] For instance, one geneticist believes that editing a set of genes might not only “alter how other genes are going to function … [but might] alter the overall behavior of the cell and the phenotype of [the] organism.”[126] Furthermore, a researcher against CRISPR-enhanced genetic modifications asserted that both the social and physical consequences are unknowable at this point in time, “scientists simply do not know whether knocking out any particular gene will have other, unintended health consequences down the road [because] the genetic code is complicated and interconnected, and even a small, well-intentioned modification could have large ramifications.”[127] Further, China condemned and imprisoned He Jiankui, the scientist who edited the genome of a set of twins to become HIV-resistant, because the long-term effects of his experiments were completely unknown.[128]

VII. Conclusion

First and foremost, CRISPR-Cas9 is an incredible technology with the potential to impact life as we know it. Therefore, it requires careful consideration when any governmental bodies sit down and draft legislation to regulate it. However, before any legislation can be drafted, science needs to learn more about the consequences it presents and the future it has in medicine. Therefore, Congress should repeal the Dickey-Wicker Amendment which limits federal funds when conducting embryonic research. This restriction is setting back potentially groundbreaking research into whether CRISPR has viable potential to cure and eradicate genetic diseases. If CRISPR can replace treatments like chemotherapy and dialysis, it should be made available to the public. Emerging technologies will dictate the methods by which it is made available, but any legislation drafted to encourage and mandate such procedures would have to withstand a court’s strict scrutiny analysis to be considered a constitutional use of police power due to the fundamental rights implicated.

Potentially more consequential than its legal implications are CRISPR-Cas9’s ethical ramifications. Some are concerned that it will only be available to upper-class (typically white) patients, and lower-class citizens will be unable to genetically edit their children, and not giving them the same advantages in life. This type of exclusion could give rise to a eugenics movement and play a role in perpetuating racism and sexism in healthcare. Furthermore, many scientists and researchers assert that this type of gene editing could affect surrounding genes and even evolution in unknowable ways. Due to congressional restrictions, research is limited and will likely stay this way until change is enacted. Restrictions like this could pave the way for more illicit experiments, like the one conducted on twins in China.

So far, the Supreme Court has not yet decided a case regarding parents’ constitutional rights to genetically modify their embryos. Due to rapid advances in technology though, it might not be long until courts hear attorneys argue the merits of a mother’s right to ensure her future child will be six-foot-seven and good at basketball. As one scientist who opposes all CRISPR procedures said, “humans must govern technology, not the reverse…new biotechnologies hold the potential to cure and prevent disease, to promote human flourishing—but only if the deployment of technology is governed by morality.” [129] Courts and legislators alike will have to grapple with the issue of whether the medical benefits outweigh the potential ethical consequences and how a person’s fundamental rights will come to be interpreted in the face of new technology.

[1] Neecxle, Making a Realistic Sim in The Sims 4 + CC List, YouTube (August 4, 2020) https://youtu.be/Ub_3gI___l0

[2] Scott Westerfeld, The Uglies (Editors, 2005).

[3] Id., at 43.

[4] The University of Edinburgh, The Life of Dolly: Why Was Dolly So Important? (May 2020) https://www.ed.ac.uk/roslin/about/dolly/facts/life-of-dolly

[5] Gina Kolata, Scientist Reports First Cloning Ever of Adult Mammal, New York Times (Feb 23, 1997), http://news.bbc.co.uk/onthisday/hi/dates/stories/february/22/newsid_4245000/4245877.stm

[6] Yedetipe University, Father of Dolly the Cloned Sheep showed as a speaker at Yeditepe University for the first time in Turkey! (2009) https://yeditepe.edu.tr/en/news/father-dolly-cloned-sheep-showed-speaker-yeditepe-university-first-time-turkey

[7] The University of Edinburgh, supra.

[8] Roger Highfield, Dolly Creator Prof. Ian Wilmut Shuns Cloning (November 16, 2007) https://web.archive.org/web/20071202064534/http://www.telegraph.co.uk/earth/main.jhtml?xml=%2Fearth%2F2007%2F11%2F16%2Fscidolly116.xml

[9] GeneSys Biotech, History of Paternity Testing (2004) https://web.archive.org/web/20041119070715/ http://www.paternity-answers.com/history-paternity-test.html#1990

[10] CDC, Genetic Testing, https://www.cdc.gov/genomics/gtesting/genetic_testing.htm

[11] Id.

[12] The Fertility Institutes, PGD Testable Diseases, (2001-2021) https://www.fertility-docs.com/programs-and-services/pgd-screening/genetic-diseases-tested-for-with-pgd.php

[13] Carla Easter, Sex Linked, National Human Genome Research Institute https://www.genome.gov/genetics-glossary/Sex-Linked

[14] Ashley Marcin, How Soon Can You Find Out the Sex of Your Baby? Healthline (January 22, 2020) https://www.healthline.com/health/pregnancy/when-can-you-find-out-sex-of-baby

[15] Roe v. Wade, 410 U.S. 13, 153 (1973)

[16] Guttmacher Institute, Abortion Bans in Cases of Sex or Race Selection or Genetic Anomaly (April 1, 2021) https://www.guttmacher.org/state-policy/explore/abortion-bans-cases-sex-or-race-selection-or-genetic-anomaly

[17] Frank Newport and Joy Wilke, Desire for Children Still Norm in US, Gallup (September 25, 2013) https://news.gallup.com/poll/164618/desire-children-norm.aspx

[18] Dulce Zamora, Choosing the Sex of Your Child, WebMD (May 5, 2003) https://www.webmd.com/baby/features/choosing-sex-of-your-child#1

[19] San Diego Fertility Center, Gender Selection https://www.sdfertility.com/fertility-treatments/genetic-testing/gender-selection#

[20] Zamora, supra.

[21] San Diego Fertility Center, PGS https://www.sdfertility.com/fertility-treatments/genetic-testing/pgs

[22] Bart CJM Fauser, Towards the global coverage of a unified registry of IVF outcomes, 133 38 Reproductive Biomedicine Online J 3 (2019) http://dx.doi.org/10.1016/j.rbmo.2018.11.001.

[23] The President's Council on Bioethics, Reproduction and Responsibility: The Regulation of New Biotechnologies (2003-04) http://hdl.handle.net/10822/559381 I could not find more recent statistics.

[24] Christina Farr, Some families are paying thousands of dollars to choose their baby’s sex, CNBC (August 4, 2018) https://www.cnbc.com/2018/08/04/fertility-clinics-advertise-gender-selection-ethical-wuandary.html

[25] Tamara Kayali Browne, The Problem with Sex Selection, 18 O&G Magazine 2 (Winter 2016) https://www.ogmagazine.org.au/18/2-18/problem-sex-selection/

[26] Jane Ridley, We spent $100k to guarantee a baby girl, New York Post (July 6, 2015) https://nypost.com/2015/07/06/we-spent-100000-to-guarantee-a-baby-girl/

[27] Farr, supra.

[28] MedlinePlus, What are genome editing and CRISPR-Cas9? (September 18, 2020) https://medlineplus.gov/genetics/understanding/genomicresearch/genomeediting/

[29] Id.

[30] Id.

[31] Andew Pollack, Jennifer Doudna, a Pioneer Who Helped Simplify Genome Editing, New York Times (May 11, 2015) https://www.nytimes.com/2015/05/12/science/jennifer-doudna-crispr-cas9-genetic-engineering.html

[32] Id.

[33] Id.

[34] Id.

[35] Id.

[36] Unnatural Selection: Cut, Paste, Life (Netflix streaming, 2019).

[37] Id.

[38] Id.

[39] Id.

[40] Clara Rodriguez Fernandez, Eight Diseases CRISPR Technology Could Cure, Labiotech (April 13, 2021) https://www.labiotech.eu/best-biotech/crispr-technology-cure-disease/

[41] Syed Shan-e-Ali Zaidi, et al. Engineering crops of the future: CRISPR approaches to develop climate-resilient and disease-resistant plants. Genome Biol 21, 1 (2020). https://doi.org/10.1186/s13059-020-02204-y

[42] Id. Climate-resistant meaning unaffected by temperature, droughts, and floods.

[43] Emily Waltz, Gene-edited CRISPR mushroom escapes US regulation, Nature 532, 293 (April 14, 2016) https://www.nature.com/news/gene-edited-crispr-mushroom-escapes-us-regulation-1.19754. See also, Emily Waltz, USDA Approves next-generation GM potato, Nature Biotechnology 33, 12 (January 2015) https://www.nature.com/articles/nbt0115-12

[44] Clara Rodriguez Fernandez, CRISPR-Cas9: The Gene Editing Tool Changing the World, Labiotech (July 9, 2020) https://www.labiotech.eu/in-depth/crispr-cas9-review-gene-editing-tool/

[45] Utibe Effiong & Ramadhani Abdallah Noor, Can gene editing provide a solution to global hunger? Alliance for Science at Cornell University (April 24, 2019) https://allianceforscience.cornell.edu/blog/2019/04/can-gene-editing-provide-solution-global-hunger/

[46] Linda Zeldovich, Scientists are Gene Editing These Berries to Be the Next Superfood, JSTOR (October 23, 2018) https://daily.jstor.org/scientists-are-gene-editing-these-berries-to-be-the-next-superfood/

[47] Rodriguez Fernandez, Eight Diseases CRISPR Technology Could Cure

[48] Id.

[49] Id.

[50] Id.

[51] Id.

[52] Id.

[53] Shenghui He, The first human trial of CRISPR-based celltherapy clears safety concerns as new treatment for late-stage lung cancer, Sig Transduct Target Ther 5, 168 (2020). https://doi.org/10.1038/s41392-020-00283-8

[54] Penn Medicine, CRISPR-Edited Immune Cells Can Survive and Thrive After Infusion into Cancer Patients (February 6, 2020) https://www.pennmedicine.org/news/news-releases/2020/february/crispr-edited-immune-cells-can-survive-and-thrive-after-infusion-into-cancer-patients

[55] Ryan T. Anderson, Just Because We Can Create Genetically Modified Babies Doesn’t Mean We Should, Forbes (December 17, 2018) https://www.heritage.org/marriage-and-family/commentary/just-because-we-can-create-genetically-modified-babies-doesnt-mean

[56] Police Power, Black’s Law Dictionary (2nd ed. 1910).

[57] Jacobson v Massachusetts, 197 US 11, at 26 [1905]

[58] Cruzan by Cruzan v. Dir., Missouri Dep't of Health, 497 U.S. 261, 262 (1990)

[59] P.G. Peters, The state’s interest in the preservation of life: from Quinlan to Cruzan, Ohio State Law J, 50(4):891 (1989) https://pubmed.ncbi.nlm.nih.gov/16044607/

[60] New York State Department of Health, School Vaccination Requirements (2020) https://www.health.ny.gov/prevention/immunization/schools/school_vaccines/

[61] Griswold v Connecticut, 381 US 479, at 484 [1965]

[62] Samuel Warren and Louis Brandeis, The Right to Privacy, 4 Harvard L.R. 193 (Dec. 15, 1890) http://faculty.uml.edu/sgallagher/Brandeisprivacy.htm

[63] Roe v. Wade, 410 U.S. 13, at 63 (1973)

[64] Eisenstadt v Baird, 405 US 438, at 453 [1972]

[65] Cruzan by Cruzan v. Dir., Missouri Dep't of Health, 497 U.S. 261, 262 (1990)

[66] Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 92 (1914)

[67] Allyn Benintendi, Bodily Integrity in the Age of Dislocated Human Eggs, Center for Technology, Society, and Politics (August 17, 2017) https://ctsp.berkeley.edu/bodily-integrity-in-the-age-of-dislocated-human-eggs/

[68] Dahl v. Angle, 222 Ore. App. 572 (2008)

[69] Mansaw v. Midwest Organ Bank (1998 WL 386327)

[70] Skinner v. State of Okl. ex rel. Williamson, 316 U.S. 535, 541, 62 S. Ct. 1110, 1113, 86 L. Ed. 1655 (1942)

[71] Eisenstadt, 405 US 438, 453

[72] Cruzan, 497 US 261, 265

[73] United States v. Carolene Products Company, 304 U.S. 144 (1938)

[74] I could probably make a plausible Equal Protection argument at this point too because only people with the ability to bear children would be subjected to this procedure, but in the sake of saving time and space, hopefully a footnote shall suffice.

[75] Rodriguez Fernandez, Eight Diseases CRISPR Technology Could Cure, supra.

[76] Moore v E. Cleveland, 431 US 494, 499 [1977]

[77] Parham v. J.R., 442 U.S. 584, 603 (1979)

[78] Meyer v. Nebraska, 262 US 390 (1923)

[79] Washington v. Glucksberg, 521 U.S. 702, 723 (1997)

[80] Id., at 724.

[81] Laurie D. Smith, et al., Whole-Exome Sequencing and Whole-Genome Sequencing in Critically Ill Neonates Suspected to Have Single-Gene Disorders, Cold Spring Harb Perspect Med, 10-11 (2016).

[82] Id., at 4-5.

[83] Walter Isaacson, mRNA Technology Gave Us the First COVID-19 Vaccines. It Could Also Upend the Drug Industry Time (January 11, 2021) https://time.com/5927342/mrna-covid-vaccine/

[84] Steven Levy, Could Crispr be Humanity’s Latest Virus Killer? Wired (March 18, 2020) https://www.wired.com/story/could-crispr-be-the-next-virus-killer/

[85] Id.

[86] CDC, Past Seasons Estimated Influenza Disease Burden, https://www.cdc.gov/flu/about/burden/past-seasons.html

[87] H.R. 2880, 104th Cong. (1996)

[88] Sheryl Gay Stohlberg, Obama is Leaving Some Stem Cell Issues to Congress, The New York Times (March 8, 2009) https://www.nytimes.com/2009/03/09/us/politics/09stem.html?_r=2

[89] Exec. Order No. 13435, 72 Fed. Reg. 34591 (2007)

[90] Exec. Order No. 13505, 74 Fed. Reg. 10667 (2009)

[91] Stohlberg, supra.

[92] NPR, Obama Lifts Limit on Funding Stem Cell Research (March 9, 2009) https://www.npr.org/templates/story/story.php?storyId=101653356

[93] NIH, Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research (July 26, 2019) https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-128.html

[94] Nature, Trump administration halts fetal-tissue research by government scientists (June 5, 2019) https://www.nature.com/articles/d41586-019-01783-6

[95] The White House, A Note on Genome Editing (May 26, 2015), https://obamawhitehouse.archives.gov/blog/2015/05/26/note-genome-editing

[96] The White House, Fact Sheet on Presidential Executive Order: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells (May 2009), https://obamawhitehouse.archives.gov/realitycheck/the-press-office/fact-sheet-presidential-executive-order

[97] White House, A Note on Gene Editing, supra.

[98] Marilynn Marchione, Chinese researcher claims first gene-edited babies, The Associated Press (November 28, 2018) https://apnews.com/article/4997bb7aa36c45449b488e19ac83e86d Jiankui reportedly genetically modified embryos for seven couples with HIV-positive fathers, but only one pregnancy was carried to term.

[99] David Cyranoski, The CRISPR-baby scandal: what’s next for human gene editing, Nature (February 26, 2019) https://www.nature.com/articles/d41586-019-00673-1

[100] Marchione, supra.

[101] Id.

[102] China.org.cn, China’s Civil Code introduces regulations on human gene editing, (February 18, 2021) http://www.china.org.cn/china/2021-02/18/content_77223470.htm

[103] David Cyranoski, China set to introduce gene-editing regulation following CRISPR-baby furore, Nature (May 20, 2019) https://www.nature.com/articles/d41586-019-01580-1

[104] Id.

[105] Nature, Trump administration halts fetal-tissue research by government scientists (June 5, 2019) https://www.nature.com/articles/d41586-019-01783-6

[106] National Geographic, Why Gene Editing is the Next Food Revolution (August 10, 2018) https://www.nationalgeographic.com/environment/article/food-technology-gene-editing

[107] William Reville, Are “designer babies” something we really want? The Irish Times (July 2, 2020) https://www.irishtimes.com/news/science/are-designer-babies-something-we-really-want-1.4287235

[108] Farr, supra.

[109] Unnatural Selection, supra.

[110] Center for Genetics and Society, New Human Gene Editing Report is “Unsettling and Disappointing” (February 14, 2017)

[111] Sandy Sufian and Rosemary Garland-Thompson, The Dark Side of CRISPR, Scientific American (February 16, 2021) https://www.scientificamerican.com/article/the-dark-side-of-crispr/

[112] Id.

[113] Jim Kozubek, How Gene Editing Could Ruin Human Evolution, Time (January 9, 2017) https://time.com/4626571/crispr-gene-modification-evolution/

[114] Buck v. Bell, 274 U.S. 200 (1927)

[115] Skinner, 316 U.S. 535

[116] California Cryobank, Sperm Donor Qualification Process (2018) https://d3hwulnyp980el.cloudfront.net/files/cryobankcom/_forms/pdf/brochures/donorpyramid.pdf

[117] The President's Council on Bioethics, supra.

[118] San Diego Fertility Center, supra.

[119] Laurence A. Jacobs, What is the Cost of Family Planning Using Gender Selection Technology? IVF Chicago (February 18, 2019) http://www.ivfchicago.com/blog/cost-of-family-planning-using-gender-selection-technology

[120] David King, Editing the human genome brings us one step closer to consumer eugenics, The Guardian (August 4, 2017) https://www.theguardian.com/commentisfree/2017/aug/04/editing-human-genome-consumer-eugenics-designer-babies

[121] The President's Council on Bioethics, supra.

[122] Unnatural Selection, supra.

[123] Interstellar (Paramount Pictures 2014)

[124] Id.

[125] Caroline Brokowski, et al., Cutting Eugenics Out of CRISPR-Cas9, Ethics in Biology, Engineering & Medicine - An Int’l J 6, 264 (2015) http://www.columbia.edu/cu/biology/pdf-files/faculty/pollack/2015%20CUTTING%20EUGENICS%20OUR%20OF%20CRISPR.pdf

[126] Yasemin Saplakoglu, Gene-Edited Babies Reportedly Born in China. What Could Go Wrong? Live Science (November 26, 2018) https://www.livescience.com/64166-first-genetically-modified-babies-risks.html

[127] Ryan T. Anderson, Just Because We Can Create Genetically Modified Babies Doesn’t Mean We Should, Forbes (December 17, 2018) https://www.heritage.org/marriage-and-family/commentary/just-because-we-can-create-genetically-modified-babies-doesnt-mean

[128] Marchione, supra.

[129] Anderson, supra.