Intergenerational Control: Why Genetic Modification of Embryos via CRISPR-Cas9 Is Not a Fundamental Parental Right

69 Am. U. L. Rev. 1015 (2020).

* Junior Staff Member, American University Law Review, Volume 69; J.D. Candidate, May 2021, American University Washington College of Law; B.S., Political Science and History, 2014, Illinois State University. I would like to thank Professor Robert Dinerstein for his invaluable feedback and the Law Review staff for their diligent work in editing this piece for publication. I would also like to thank Erin Downey, Connie Potter, and Nora Clifford for their extensive contributions during the editorial process. Finally, I am eternally grateful to my friends, family, and the Murphys for their constant support and encouragement throughout my law school career.

In 2012, a momentous scientific breakthrough occurred in the field of genetic editing: the discovery of CRISPR-Cas9. This new technique allows scientists to edit the human genome more rapidly, cheaply, and precisely than ever before. Researchers now have the potential to cure illnesses like cancer, ALS, and Alzheimer’s disease. CRISPR not only provides a mechanism for curing people currently suffering from a disease, but it establishes a manner in which an embryo’s DNA can be modified to prevent any future generation from inheriting that disease. Because using CRISPR to alter the human genome presents irreversible intergenerational consequences for the human gene pool—and given the appealing nature of the technology to change a child’s future from the womb—this Comment considers whether parents have a fundamental constitutional right to use CRISPR to edit their child’s DNA.

This Comment argues that the right to permanently modify an embryo’s DNA, and consequently alter future generations’ genetic make-up, via CRISPR significantly deviates from Supreme Court precedent. Because the right to use CRISPR modifications is not engrained in the minds of people or traditions of society, it does not qualify as a fundamental right and is not subject to a strict scrutiny standard. Moreover, the Court has also held that a “special weight” should be given to parents in regard to visitation and child-rearing decisions, effectively ruling out the application of a rational basis standard. Therefore, intermediate scrutiny is a more appropriate test for courts to apply in cases regarding parents’ constitutional rights of CRISPR’s use to genetically modify embryos. An intermediate scrutiny standard allows for the most flexible standard when making decisions that will have enduring repercussion on our species.

History repeats, but science reverberates.

—Siddhartha Mukherjee¹

Introduction

Imagine having the ability to manipulate your child’s genetic make-up to change her eye color, raise her intelligence, or permanently rid her of a disease to which she was predisposed—all before she was born. While genetic modification of this kind historically seemed implausible, it recently gained monumental traction and “marked the beginning of a new era for biology.”² For the first time in human history, in 2018, a scientist used a genetic modification technique called Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR-Cas9)³ to create two young and healthy girls, Lulu and Nana.⁴ The twin girls’ father was HIV-positive; however, while Lulu and Nana were a single cell, scientists were able to remove “the doorway through which HIV enter[s] to infect people.”⁵

These relatively nascent⁶ genetic modification technologies allow scientists to permanently and precisely add, remove, or alter an organism’s DNA.⁷ At first, editing techniques were tested and used on somatic cells—any cells that are neither egg nor sperm cells—and only resulted in genetic changes that did not carry any intergenerational implications.⁸ However, as scientific methods for editing techniques progressed, scientists were eventually able to make changes to human DNA that could be passed to future generations.⁹ Among those new technologies was the revolutionary CRISPR,¹⁰ with which scientists could make all desired DNA changes “faster, cheaper, more accurate, and more efficient” than ever before.¹¹

The significance of CRISPR’s achievements cannot be overstated. CRISPR was named “Breakthrough of the Year” in 2015 and has the potential to permanently cure diseases such as, inter alia, human immunodeficiency virus (HIV) and some cancers.¹² In fact, CRISPR allowed scientists to create Lulu and Nana by changing “[n]o gene . . . except the one to prevent HIV infection.”¹³ However, because of the serious intergenerational implications that come with editing viable embryos through CRISPR, many, including those under the Obama Administration, have been wary of accepting widespread, unregulated use of the technology.¹⁴

While no Supreme Court precedent discusses parents’ rights to genetically modify an embryo’s DNA, the question is likely to come before the Court in the near future. When the Court addresses this issue, it will look to its precedents addressing parental rights and caselaw closely related to those rights.

This Comment argues that human germline genome modification through CRISPR technology is not a traditionally protected right under the test that Justice Scalia established in Michael H. v. Gerald D.¹⁵ The right to permanently modify an embryo’s DNA, and consequently future generations’ genetic make-up, is not a fundamental right subject to strict scrutiny because it differs remarkably from the fundamental rights to “bear and beget” a child and to raise a child as one wishes. This Comment goes on to explain why Troxel v. Granville¹⁶ effectively overcomes Michael H.’s application of a rational-basis standard, making intermediate scrutiny the appropriate standard for courts to apply in cases concerning parents’ constitutional rights to use CRISPR to genetically modify embryos.

Part I of this Comment provides a scientific background of how DNA functions and discusses how CRISPR fundamentally changed the field of genetic editing. Additionally, this Part provides the relevant history and jurisprudence of caselaw directly related to parental rights and closely related interests created by the Court.¹⁷ Next, Part II of this Comment analyzes existing Fourteenth Amendment Due Process rights and shows how CRISPR modification is drastically different from the current interests that Supreme Court jurisprudence protects. This Part also shows how Michael H. establishes that germline editing through CRISPR is likely not a fundamentally protected interest. Part II also explains how the most recent parental rights case, Troxel, casts doubt on what standard of review courts should apply to these types of cases.¹⁸ Finally, in Part II, this Comment argues that CRISPR technology is not a fundamental right protected under the Due Process Clause of the Fourteenth Amendment, but, because courts will give some deference to parental decisions under Troxel’s precedent, intermediate scrutiny is the applicable standard of review.¹⁹

I. Background

Before exploring Supreme Court caselaw concerning parental rights, it is essential to comprehend the enormous leap that CRISPR made in the field of genetic modification. This Part first explains the basics of DNA function and discusses how the flow of genetic information dictates how the human body ultimately expresses genes. Next, this Part briefly discusses the science behind CRISPR technology and explains the numerous scientific benefits that CRISPR provides researchers. Finally, this Part explores the promising applications that CRISPR has on infectious and inherited diseases, heritable and nonheritable genome modifications, and DNA edits that result in artificial human enhancement.

A. The Road to CRISPR

A general understanding of DNA functionality provides a useful base for the science of genetic modification and, in turn, the constitutional implications that CRISPR would compel the Supreme Court to consider when weighing in on the breadth of parental rights.

1. The “Central Dogma”

DNA serves as the instructional code or “blueprint” that tells every part of a human body how to work properly.²⁰ All the instructional code contained in a single human body is referred to as a person’s genome.²¹ Additionally, DNA serves as the initial step in the flow of information that helps make ribonucleic acid (RNA),²² which aids in directing when and how many proteins are created.²³ Proteins play an integral role in the “structure, function, and regulation of the body’s tissues and organs.”²⁴ This flow of information is “essential for all known forms of life” and is so integral in the field of molecular biology that it is often referred to as the “central dogma.”²⁵ Two significant steps comprise the process of protein creation: transcription and translation.²⁶ Together, these two steps dictate how a gene is expressed.²⁷

More recently, scientists have discovered new techniques for modifying the human genome.²⁸ By cutting targeted areas of a DNA’s code, researchers now have the ability to add, remove, or replace that DNA sequence with different, more desirable code.²⁹ Consequently, the slightest modification in a DNA sequence can result in significant effects on the information flow described above, causing permanent changes to the overall genome. This extraordinary capability is fairly new to the biotechnological community, and its development—while swift—has gone through many different iterations, ultimately leading to the discovery of the CRISPR system.³⁰

2. The Discovery of CRISPR

In 2012, biochemist Jennifer Doudna and her bacteriologist colleague Emmanuelle Charpentier published their landmark study on a new genetic modification system called CRISPR.³¹ The publication immediately sparked the biology community’s interest.³² George Church, a professor at Harvard University, has gone so far as to state that CRISPR “trumps just about anything” with respect to the effectiveness and usability of gene editing tools.³³ With such high praise, it is no wonder that CRISPR’s use and presence in scientific research has exploded since its discovery.³⁴ Before discussing the endless scientific opportunities that CRISPR presents, it is important to understand why the technology is so groundbreaking that it was described as potentially triggering “Sputnik 2.0.”³⁵

CRISPR’s operation is best understood by breaking it into two components. “CRISPR” is a short DNA sequence that provides a code to, and then works in tandem with, RNA to guide and detect specific sequences in the genome.³⁶ Essentially, CRISPR provides a roadmap that instructs a molecule on how to get to its ultimate destination. “Cas9” refers to the protein that cuts the desired DNA site.³⁷ These Cas9 proteins virtually function like a pair of molecular scissors that cleave the targeted locations in the genome.³⁸ Although seemingly similar to some of its more recent predecessors, CRISPR is superior in numerous ways.

To begin with, CRISPR has proven to be more precise, efficient, and reliable than previous genome editing methods.³⁹ Some researchers found that CRISPR can be up to six times more efficient in successfully making targeted genomic edits than its ZFN counterparts.⁴⁰ Specifically, using CRISPR presents only a one–in–one–trillion chance of making an off-target edit.⁴¹ This achievement in reliability is monumental considering that only forty years prior, the success rate of making an on-target edit was as low as one–in–one–million.⁴² In fact, CRISPR is so precise that scientists analogize it to “a copyediting device that scans sixty–six volumes of the Encyclopedia Britannica and finds, erases, and changes one word, leaving all other words untouched.”⁴³ This spectacular accuracy is especially important considering that, as stated before, the human genome is comprised of three billion base pairs and even a single error can result in serious diseases or death.⁴⁴ The lowered probability of making off-target edits with CRISPR results in a technology that scientists can use more safely and confidently.

Furthermore, because CRISPR can use numerous guide RNA in tandem, it can target multiple sites at once.⁴⁵ This adaptability to more sites is a stark shift from using a single ZFN to target a single gene.⁴⁶ Apart from improving efficiency by targeting multiple genes at once, this new approach saves researchers a tremendous amount of money.⁴⁷ Before the discovery of CRISPR, creating a single protein with previous technologies could cost a research facility upwards of $1000.⁴⁸ With this new invention, scientists can produce guide RNA templates in a few days with free software and a $65 DNA starter kit.⁴⁹ CRISPR’s beneficial components show that the technology is ultimately far easier to use, faster to create and deploy, more reliable, and much less expensive.⁵⁰ That CRISPR provides immense clinical possibilities for future development bolsters these current achievements.

3. CRISPR’s Revolutionary Applications to the Human Genome

The potential applications of CRISPR technology range from therapeutics to diagnostics and, as previously discussed, to gene editing.⁵¹ Through these applications, many scientists believe that CRISPR could help “prevent, treat, or cure medical conditions or disease[s],”⁵² like diabetes,⁵³ malaria,⁵⁴ and HIV.⁵⁵ However, CRISPR also possesses the potential to help those affected by inherited diseases like Duchenne Muscular Dystrophy⁵⁶ and certain neurogenerative disorders.⁵⁷ Furthermore, this new technology demonstrates the potential to combat the growing problem of antibiotic resistance.⁵⁸ While some of these feats may be out of reach for now, the therapeutic possibilities have piqued the pharmaceutical industry’s interest, “show[ing] a promising futuristic approach for treatment of human diseases and inherited anomalies.”⁵⁹ Even more groundbreaking, the capabilities of CRISPR can affect future generations, extending far beyond assisting or potentially curing only those who are alive today.

The Congressional Research Service found that many studies are being conducted around the world using both nonheritable and heritable modifications.⁶⁰ Nonheritable modifications are changes made to a somatic cell—any cell other than an egg or sperm cell—that do not result in genetic alterations to the modified individual’s progeny.⁶¹ Significantly, researchers also used CRISPR to edit reproductive cells in viable and non-viable embryos.⁶² These types of edits do not only change the modified individual but also ensure that his or her germline retains those changes and passes them to offspring and future generations.⁶³ This type of germline modification allows scientists to alter the human embryo or gamete to remove or repair any deleterious genes while making certain that future generations do not inherit those diseases.⁶⁴ CRISPR’s powerful capabilities, and its premature use, make genetic watchdog groups leery of creating a potentially unfair “society of genetic haves and have-nots.”⁶⁵

Beyond prevention, treatment, and curing of diseases, CRISPR enables scientists to enhance the human genome.⁶⁶ That enhancement could come in the form of changing someone’s eye or hair color, making someone taller, or even raising someone’s IQ.⁶⁷ Other enhancements come in the form of selecting naturally occurring mutations that could result in a heightened resistance to disease, bones that become so hard “they’ll break a surgical drill,” and modifications that will help people “remain [mentally] sharp into old age.”⁶⁸

However, if germline editing becomes commonplace, it could have repercussions beyond one person’s well-being or that of their offspring.⁶⁹ Editing could result in long-term effects on people’s “life span, identity, and economic output.”⁷⁰ Additionally, gene modification using CRISPR could raise serious societal issues if it is only available to the richest people around the world or if it results in certain people’s genes becoming “obsolete.”⁷¹ According to Stephen Hawking, when “superhumans” appear, there will be significant political problems because unedited humans will be unable to compete and could either “die out or become unimportant.”⁷²

Unsurprisingly, the public has expressed general concern with human germline editing because of the “slippery slope from disease-curing applications toward uses with less compelling or even troubling implications.”⁷³ Under the Obama Administration, the Director of the Office of Science and Technology Policy cautioned about CRISPR’s unrestricted use,⁷⁴ and its Director of National Intelligence warned of CRISPR’s potential use to create weaponized biological agents.⁷⁵ Furthermore, a large international consensus has stated that, at this time, germline modification on humans would be “irresponsible.”⁷⁶ Because of this global concern, scientists who have used CRISPR on humans have been widely criticized and reprimanded. The Chinese doctor who used CRISPR to create Lulu and Nana received a three-year jail sentence and a $400,000 fine for violating his country’s ethical principles and regulations.⁷⁷

All of these uncertainties associated with CRISPR’s use led Pulitzer Prize-winning author Siddhartha Mukherjee to opine on one of the central questions that humans will have to answer when creating a framework for genetic modification.⁷⁸ He stated: “[t]he crux then is not genetic emancipation (freedom from the bounds of hereditary illnesses), but genetic enhancement (freedom from the current boundaries of form and fate encoded by the human genome).”⁷⁹

B. Caselaw Establishing Rights Related to CRISPR

The Fourteenth Amendment declares that “[n]o State shall . . . deprive any person of life, liberty, or property, without due process of law.”⁸⁰ From this Amendment, the Supreme Court extrapolated substantive due process, equal protection, and procedural due process rights.⁸¹ Substantive due process rights have historically protected citizens from state intervention through two major avenues.

The first avenue of protection derives from the Bill of Rights, which the Court has incorporated almost in its entirety.⁸² Some of those rights include the First Amendment’s free exercise of religion;⁸³ the Fourth Amendment’s protection against unreasonable searches and seizures;⁸⁴ and, most recently, the Second Amendment’s right to bear arms.⁸⁵

The second avenue has developed through the Court’s creation of “general protection[s] against certain arbitrary, wrongful government actions.”⁸⁶ These protections include the right to personal privacy,⁸⁷ the right to marriage,⁸⁸ and the right for a woman to decide whether to obtain an abortion.⁸⁹ Through this second avenue, the Supreme Court established a line of caselaw protecting parental and family-related rights.⁹⁰ This use of the latter branch was necessary because parental rights are not specifically enumerated in the Bill of Rights and instead needed to be “found somewhere between the lines” of the First Amendment’s “Freedoms of Speech, Religion, and the Press.”⁹¹

Despite the fact that the Court has protected unenumerated rights in the past, it has demonstrated a “hesit[ance] to extend the sphere of fundamental rights.”⁹² Whether protecting enumerated rights or extending protection beyond them, the Fourteenth Amendment is typically subject to three standards of review. Strict scrutiny—the highest standard—is applied to fundamental rights and requires a state government to demonstrate a compelling state interest to which the state’s ends are sufficiently narrowly tailored.⁹³ Intermediate scrutiny requires that government action be substantially related to furthering an important governmental interest.⁹⁴ Lastly, rational basis—the most deferential standard—simply inquires whether government action “pursues a legitimate end by rational means.”⁹⁵ Most commonly, the Court does not apply intermediate scrutiny to substantive due process rights and instead applies rational basis review if it finds that a right is not fundamental.⁹⁶

While the parental and familial rights cases help provide some insight into how the Court might view genetic modification, none of the cases explicitly tackles the issue of a parent’s right to use germline genome modification on a human embryo.⁹⁷ One reason may be because CRISPR, and genetic modification in general, are relatively recent technologies.⁹⁸ However, the advancement and innovation of these techniques has been rapid and the issue is likely to end up before the Court sooner rather than later.⁹⁹

Due to the lack of legal precedents on point, and because current parental rights jurisprudence leaves many unanswered questions,¹⁰⁰ a background of closely related substantive due process rights is necessary. This Section begins by examining caselaw directly related to parental and family rights. It then looks to other closely related or analogous substantive due process rights created and protected by the Court. Examining established rights from both of these perspectives presents a more complete framework, shedding light on how the Supreme Court and lower courts are likely to view the parental rights to genetically modify embryos via CRISPR.

1. Supreme Court jurisprudence of parental rights

In 1923, the Supreme Court decided its first case directly concerning parental rights. In Meyer v. Nebraska,¹⁰¹ the Court held a Nebraska law that prohibited teaching children in any language other than English unconstitutional under the Fourteenth Amendment.¹⁰² Justice McReynolds reasoned that parents had a “natural duty” to provide their children with an education and that seeking out an instructor of their choosing was well “within the liberty of the [Fourteenth] Amendment.”¹⁰³ Therefore, because Nebraska’s legislature attempted to materially interfere with parents’ power to dictate their own children’s education, the Court deemed the statute unconstitutional.¹⁰⁴

Two years later, the Court relied on its Meyer precedent in Pierce v. Society of Sisters¹⁰⁵ to reaffirm constitutional parental rights while striking down an Oregon statute requiring parents and guardians to send their children to public school during the academic year.¹⁰⁶ Pierce affirmed Meyer’s central holding that a state could not “unreasonably interfere[] with the liberty of parents and guardians to direct the upbringing and education of children under their control.”¹⁰⁷ Together, Meyer and Pierce established that parents had a broad constitutional right under the Fourteenth Amendment to raise and educate their children as they saw fit, without undue interference from the state.¹⁰⁸

However, after the Court established far-reaching parental rights to raise a child as one wished, these rights eventually faced opposition. In Michael H. v. Gerald D.,¹⁰⁹ Justice Scalia’s plurality opinion narrowed the Court’s prior decisions in Meyer and Pierce.¹¹⁰ The Court held that a biological father, whom Justice Scalia referred to as an “adulterous natural father,” was not denied any constitutional rights when the state refused to legally declare him the father of his child.¹¹¹ To warrant protection, the “adulterous natural father[‘s]” right had to meet two specific requirements.¹¹² First, the right at issue had to be fundamental.¹¹³ Second, the right had to be “traditionally protected by our society.”¹¹⁴ In other words, the right had to be “so rooted in the traditions and conscience of our people as to be ranked as fundamental.”¹¹⁵

The Court also expressed its openness to allow an exception if “on any other basis [the right] ha[d] been accorded special protection.”¹¹⁶ Ultimately, the plurality found no special exception and concluded that an “adulterous natural father[‘s]” relationship with his daughter was not traditionally protected and, in fact, was one that “our traditions have protected . . . against.”¹¹⁷ Consequently, the right contested in Michael H. was not fundamental and the Court used rational basis analysis to review the law infringing on it.¹¹⁸

The Court’s decision was not without criticism, as Justice Brennan asserted that the addition of the traditionally protected interest requirement turned the Due Process Clause into a “redundancy.”¹¹⁹ Justice Scalia rebutted that the Due Process Clause’s “purpose [was] to prevent future generations from lightly casting aside important traditional values—not to enable this Court to invent new ones.”¹²⁰ By holding that only traditionally protected societal rights would be upheld, Justice Scalia sought to limit new rights from being created simply due to a uniform societal or state consensus.¹²¹

After Michael H., more than a decade passed before the Supreme Court heard another landmark case regarding parental rights.¹²² In 2000, the Supreme Court decided Troxel, the most recent case in the parental rights lineage.¹²³ In Troxel, the Court considered a Washington statute that allowed courts to grant visitation privileges to grandparents even if the child’s parents did not want the grandparents visiting the child.¹²⁴ Justice O’Connor began by reciting a detailed history of precedent and concluded that caselaw made it clear that “it [could not] now be doubted” that the Fourteenth Amendment’s Due Process Clause protected a fundamental right of parents to make decisions regarding the “care, custody, and control of their children.”¹²⁵ The court found a fundamental right for parents to make decisions regarding their children and held that the Washington statute at issue infringed upon a mother’s constitutional parental rights.¹²⁶

For Justice O’Connor, the crux of the case was that the Washington statute allowed “any person” to petition for visitation at “any time,” while not allowing any deference to the parents’ “determination of [their child’s] best interests.”¹²⁷ She stated that a court “must accord at least some special weight” to a fit parent’s decisions when reviewing that parent’s decision making.¹²⁸ Because the lower courts had interfered with the parents’ fundamental rights while giving them “no special weight at all,” the courts had gone a step too far.¹²⁹ Additionally, the Court explained that “special factors” could have adequately justified the state’s interference but found that the lower courts had failed to provide any such factors in their reasoning.¹³⁰ However, Justice O’Connor’s opinion did not expand on what constitutes an adequate factor.¹³¹ Similar to Michael H., the Troxel opinion was subject to a wide range of criticism from the other Justices.¹³² In his very brief concurrence, Justice Thomas pointed out that neither the plurality, Justice Souter’s concurring opinion, nor Justice Kennedy’s dissent “articulate[d] the appropriate standard of review” even though they all agreed that the interest at issue was indeed a fundamental right.¹³³

Troxel has spurred a range of scholarly commentary on its impact on parental rights. Professor Stephen Gilles, an accomplished constitutional law scholar, agreed with Justice Thomas’s observation that Justice O’Connor’s opinion never stated the level of scrutiny to which the specific case should be subjected.¹³⁴ The vagueness left from the Troxel decision—deciding between giving adequate “special weight” to parental decisions and protecting parents’ fundamental due process rights—led Gilles to argue that future courts and Justices could argue for “any level of scrutiny.”¹³⁵ In the end, he argued that the most persuasive interpretation of Troxel calls for the use of intermediate scrutiny,¹³⁶ not rational basis review¹³⁷ or strict scrutiny.¹³⁸ Additionally, he argued that Troxel can, and should, be used in a manner that “extends beyond the context of visitation.”¹³⁹ Notably, others have pointed out that while the Court repeatedly recognized parental rights in Meyer, Pierce, and Troxel, those rights are not absolute.¹⁴⁰ Even though there exists a “private realm of family life which the state cannot enter,”¹⁴¹ a state is within its authority to regulate and infringe upon parental rights “to protect the health and/or well-being of children.”¹⁴²

Ultimately, the Supreme Court’s case-by-case approach to developing fundamental parental rights resulted in “a patchwork of decisions that leave[s] many questions unanswered.”¹⁴³ A brief discussion of closely related substantive due process rights established by the Supreme Court will provide a more robust framework.

2. Substantive due process rights closely related to parental interests

While many rights closely related to parental rights could affect the constitutionality of CRISPR’s use, this Comment focuses solely on those rights that might generate the strongest arguments to allow genetic modification via CRISPR. Those rights include the general right to personal privacy and the right to procreation and bodily autonomy. While these rights do not encompass all possible rights that could arguably protect the technique’s use, the protections afforded under these rights are most closely analogous to genetic modification.

One of the seminal cases that built the foundation for the rights mentioned above resulted from a coalescence of Amendments. In Griswold v. Connecticut,¹⁴⁴ Justice Douglas established an implied right to personal privacy through a “penumbra” of guarantees derived from the Bill of Rights.¹⁴⁵ This “zone[] of privacy” extended its protections to marital relationships because they were seen as “a bilateral loyalty, not commercial or social projects.”¹⁴⁶ Eventually, the Court’s protection of privacy interests split into two distinct branches: a right to “avoid[] disclosure of personal matters” and a right to “independence in making certain kinds of important decisions.”¹⁴⁷ The second branch of privacy, and the potential basis for a fundamental right to parental use of gene editing, was established in Roe v. Wade¹⁴⁸ and will be discussed later in this Section.¹⁴⁹

Courts have used Justice Douglas’s “penumbral” privacy analysis to expand privacy rights beyond the traditional marital relationship. In Eisenstadt v. Baird,¹⁵⁰ the Court heavily relied on Griswold’s penumbral privacy right to strike down a Massachusetts statute that prohibited the distribution of contraceptives to anyone other than married couples.¹⁵¹ More importantly, Justice Brennan clarified in dicta that, while Griswold protected marital privacy rights, those rights extended beyond that relationship alone.¹⁵² He stated that “[i]f the right of privacy means anything, it is the right of the individual, married or single, to be free from unwarranted governmental intrusion into matters so fundamentally affecting a person as the decision whether to bear or beget a child.”¹⁵³ Justice Brennan’s expansion of Griswold’s penumbral privacy rights from a marital relationship to the individual, including the declaration that the decision of whether to “bear or beget a child” was a personal decision, extended the realm of substantive due process rights even further.¹⁵⁴

Despite the previous cases’ focus on individual rights to privacy from government intrusion, Eisenstadt’s dicta spurred a line of cases debating a woman’s right to terminate her pregnancy. The Supreme Court dealt with the issue of terminating a pregnancy for the first time in Roe v. Wade.¹⁵⁵ The majority explained the history of abortion, societal and organizational views on the issue, and substantive due process rights, concluding that the idea of personal liberty was founded in the Fourteenth Amendment and was “broad enough to encompass a woman’s decision whether or not to terminate her pregnancy.”¹⁵⁶ However, the Court stated that this right was not absolute and that states maintained an important interest “in safeguarding health, in maintaining medical standards, and in protecting potential life.”¹⁵⁷ Therefore, not all pregnancy-related decisions fell squarely within the “protected sphere of liberty,”¹⁵⁸ and a number of courts had already upheld state laws that protected a mother’s “health or prenatal life.”¹⁵⁹ Furthermore, in response to the claim that a fetus was a “person” in the context of the Fourteenth Amendment, the Court found that no amendment to the Constitution had “any possible pre-natal application.”¹⁶⁰

After Roe established this broad right to terminate a pregnancy, states took it upon themselves to narrow its holding.¹⁶¹ In Planned Parenthood of Southeastern Pennsylvania v. Casey,¹⁶² the Court ruled on another landmark abortion case.¹⁶³ Justice O’Connor unequivocally affirmed Roe’s central holding that a woman was within her constitutional rights when determining whether to terminate her own pregnancy.¹⁶⁴ This determination was more than just a right to make one’s own procreative choices, but also encompassed the rights to “personal autonomy and bodily integrity.”¹⁶⁵ Nonetheless, the Court declared that a state could regulate that right so long as the state did not impose an “undue burden” on a woman’s ability to obtain an abortion.¹⁶⁶ Additionally, a woman’s right was not unlimited, and a state could have an interest in protecting the “life of the unborn” from the outset.¹⁶⁷

Collectively, these cases demonstrate that parents have an established right to decide how their child is cared for, who cares for their child, and most other decisions regarding that child’s upbringing. That right remains protected so long as the defined right is engrained in the minds of people and traditions of society, making it fundamental.¹⁶⁸ Because parents are often found to have the best interest of their children in mind, reviewing courts should give parents’ decisions special weight.¹⁶⁹ The cases concerning personal privacy add to this sphere of rights by creating a zone of privacy that protects married couples’ relationships from government intrusion.¹⁷⁰ Courts further expanded this idea by establishing a level of individual autonomy people have when making certain types of important decisions, including whether or not to terminate a pregnancy.¹⁷¹ The right to terminate a pregnancy, while broad, includes exceptions for a state’s interest in protecting the health of the mother, maintaining current medical standards, and protecting prenatal life.¹⁷² However, courts will strike down any statutory intrusion as unconstitutional if the state places an undue burden on a woman’s right to obtain an abortion.¹⁷³

Taken together, all of these rights still leave one question unanswered: do parents have a constitutional right to use CRISPR technology or other genetic modification techniques to permanently modify embryos and, consequently, future generations? Part II of this Comment addresses the substantive due process doctrine discussed above in the context of parents asserting their constitutional right to genetically modify an embryo, either to fix an ailment or to enhance their future child, via the use of CRISPR technology.

II. Analysis

As discussed above, germline genome modification through CRISPR enables parents to make child-rearing decisions, the effects of which reach far beyond the child they contemplate raising. Because germline genome modification via CRISPR is not a fundamental right under substantive due process doctrine, it should not be subject to strict scrutiny. This Section first explores both broadly and narrowly defined rights that parents could assert when attempting to make genetic modifications, showing that a narrow definition would be more appropriate in this context.¹⁷⁴ Next, this Section describes how CRISPR technology exceeds the scope of both Meyer’s and Pierce’s holdings.¹⁷⁵ Using the Supreme Court’s analysis in Michael H., this Section shows courts are not likely to protect germline editing using CRISPR as a fundamentally protected right.¹⁷⁶ Additionally, this Section explains that the most recent parental rights case, Troxel, calls for courts to give parental decisions special consideration and apply intermediate scrutiny when considering laws restricting the right to genetically modify embryos.¹⁷⁷ Moreover, this Section explains and responds to arguments calling for either strict scrutiny or rational-basis review standards, concluding that intermediate scrutiny is the most applicable standard.¹⁷⁸ Finally, this Section considers the potential application of intermediate scrutiny and contemplates states’ interests in barring CRISPR’s use along with parental interests in choosing to use the technique.¹⁷⁹

A. CRISPR Genome Editing as a Narrowly Defined Right

Before analogizing CRISPR to previously established rights or analyzing what standard of review a court may apply, it is crucial to define the explicit right a parent would attempt to assert under these circumstances. Some of the precedential parental rights cases could lead to arguments that a broader reading should be used. Together, Meyer and Pierce created a broad right that parents could “direct the upbringing and education of children under their control.”¹⁸⁰ Later, Troxel summarized the right and stated that “the care, custody, and control of their children” were well within the purview of parental interests.¹⁸¹ However, as previously addressed, that is not exactly what would occur if parents attempted to genetically modify an embryo.¹⁸² If a parent successfully modified an embryo’s germline, the edit would not only affect their soon-to-be child but all of the child’s descendants as well.¹⁸³ Therefore, using CRISPR to edit an embryo’s DNA has intergenerational repercussions and is much more expansive than only having “control of their children.”¹⁸⁴ Moreover, closely related rights could also be used to argue for a broader reading.

Taken as a whole, Griswold, Eisenstadt, Roe, and Casey created a personal privacy right that extends to decisions regarding reproductive matters like whether to terminate a pregnancy.¹⁸⁵ However, asserting the “right to make decisions regarding reproduction” has been deemed a “somewhat disingenuous classification” because genetic modification of an embryo is “radically different from traditional reproduction.”¹⁸⁶ In addition, precluding a parent from genetically modifying an embryo through CRISPR would not intrude or impose an undue burden upon a woman’s right to terminate her pregnancy. A constitutional right to “bear or beget a child” is vastly different from “being able to use genetic manipulation to create a child according to one’s own preferences.”¹⁸⁷ Thus, because neither established parental rights nor established related rights provide properly framed interests, a narrower reading of the parental right being asserted is more appropriate.

When defining the right to modify an embryo’s genes, the inclusion of its generational effects is a much more accurate way to portray the interests that parents would be asserting. When contemplating human germline genome modification (HGGM), one writer succinctly stated that the right could be described as “the right to choose the genetic or physical characteristics of one’s child using alternate reproductive technology.”¹⁸⁸ However, at the time that article was written, CRISPR had not been invented and the possibility of actually making permanent, targeted changes to DNA was not a reality. Since the publication of that article, CRISPR has enabled parents to change the DNA of their children and future generations.¹⁸⁹ Therefore, for the purposes of this analysis, the asserted right will be defined as the right to make permanent, heritable alterations to the genetic makeup of one’s child.

B. CRISPR Modification in Light of Established Parental Rights

To gain a better understanding of what level of scrutiny the Supreme Court and lower courts should apply when dealing with parental attempts to use CRISPR modification, the following Section will analogize the asserted right described above to established caselaw. Ultimately, because CRISPR genome editing does not fit neatly into any of the historically protected rights, a different standard from that applied in the following cases is required.

1. Genetic modification is broader than Meyer’s & Pierce’s Rulings

The first parental rights cases, Meyer and Pierce, were decided in 1923 and 1925, respectively, and did not cover the topic of genetic editing.¹⁹⁰ Together, Meyer and Pierce created precedent that a state cannot “unreasonably interfere[] with the liberty of parents and guardians to direct the upbringing and education of children under their control.”¹⁹¹ These cases affirmatively created rights to raise children, but, as mentioned previously, permanently editing the DNA of a child is certainly much broader than the Meyer and Pierce Courts even fathomed.¹⁹² Arguing that a parent could modify the genetics of a future embryo when the Court spoke directly to the “upbringing and education” of a child would be quite a stretch.¹⁹³ Additionally, parents would not only be modifying their future child’s DNA but they would effectively be permanently changing future generations’ DNA.¹⁹⁴ Consequently, the ability to affect the way in which future generations of one’s lineage are created or brought up must fall outside the purview of the rights that the Meyer and Pierce Courts considered.¹⁹⁵

2. CRISPR embryo modification cannot be “ranked as fundamental”

Under Michael H.’s more recent ruling, modifying embryos through CRISPR would likely not fall within the recognized, constitutionally protected fundamental rights of parents. Michael H. established that an asserted right must be both fundamental and one that is “traditionally protected” to be upheld.¹⁹⁶ CRISPR technology, and genetic modification generally, have only existed for approximately forty years.¹⁹⁷ As a result, it is unlikely that this technology is old enough to be “so rooted in the traditions and conscience of our people as to be ranked as fundamental.”¹⁹⁸ In fact, multiple Pew Research surveys have found that most people are currently against the use of CRISPR in embryos.¹⁹⁹ Additionally, due to the current lack of caselaw even mentioning genetic modification, it would be extreme difficulty to argue that the technology is traditionally protected.²⁰⁰

Furthermore, the Court is unlikely to make an exception for CRISPR because, much like the interest of the adulterous father in Michael H., there is no evidence that CRISPR “has been accorded special protection” under any other circumstances.²⁰¹ Justice Scalia even stated that the right in Michael H. was one that “our traditions have protected . . . against.”²⁰² Because the scientific community is still largely unaware of CRISPR’s long-term repercussions, its use on human DNA has “long been considered off-limits,” and many have been quite critical of those who have used it.²⁰³ Moreover, Justice Scalia stated that the “purpose [of the Due Process Clause] is to prevent future generations from lightly casting aside important traditional values—not to enable this Court to invent new ones.”²⁰⁴ CRISPR is a new technology that enables parents to edit the genome of embryos, and, consequently, it may impact future generations and their lineage, which is exactly what Justice Scalia cautioned against.²⁰⁵ Because of its potentially far-reaching, intergenerational implications, courts should be wary of extending special protection to this nascent technique. As a result, CRISPR’s use would likely not be a fundamental right and would only be subject to rational basis review, if not for Troxel.

3. Parental rights uncertainty after Troxel

After assuming that the genetic modification of an embryo is not a fundamental right under Michael H., one still needs to consider the significance of Troxel.²⁰⁶ Justice O’Connor stated that parents have an unequivocal right to make decisions regarding the “care, custody, and control of their children.”²⁰⁷ Similar to the Meyer and Pierce rights discussed above, applying Troxel’s determination to CRISPR would extend far beyond the “care, custody, and control of their children” because CRISPR has permanent intergenerational implications.²⁰⁸ Additionally, Troxel’s special weight could result in courts finding that parents get deferential treatment in decisions regarding whether to genetically modify embryos, so long as they have their child’s best interest in mind.²⁰⁹ According to Troxel, parents get the benefit of the doubt because, taken as a whole, they tend to have in mind their child’s best interest when making decisions.²¹⁰

However, granting parents a special weight in decision making without first considering whether the asserted right is fundamental would disregard Michael H.’s precedent. Justice O’Connor did briefly mention that any “special factors” given by a state could provide adequate justification for infringing on parental rights.²¹¹ While the Court never specifically enumerated exactly what some of those “special factors” could be, CRISPR, given its relative newness and potentially serious repercussions, arguably constitutes one such limiting factor.²¹² The Troxel Court’s finding that the state should accord special weight to parental decisions creates tension with Michael H. because it pushes back on Michael H.’s “traditionally protected” rights analysis. While the Court traditionally selects between strict scrutiny and rational basis standards of review when deciding substantive due process cases, another option remains available: intermediate scrutiny.

C. A Call for Intermediate Scrutiny

Troxel’s decision resulted in uncertainty for the parental rights analysis. Should courts automatically decide in the parents’ favor because of a special weight? How should the Michael H. analysis factor into a court’s decision making? Most importantly, among strict scrutiny, rational basis, and intermediate scrutiny, what standard should courts apply? The following analysis will consider the potential application of all three standards of review in turn.

1. Michael H. invalidates the application of strict scrutiny

As discussed above, the Supreme Court is not likely to find that parents have a fundamental right to use CRISPR to modify a human embryo. If the Court found such a fundamental right, the Court would apply strict scrutiny during judicial review of laws infringing on that right, and a state government would need to prove a compelling state interest to which the state’s ends were narrowly tailored.²¹³ However, the Supreme Court has historically “been hesitant to extend the sphere of fundamental rights.”²¹⁴ Considering that reluctance, the Court is even less likely to extend heightened protection to an advanced, nascent technology that has tremendous social and legal repercussions. Furthermore, fundamental protection is unfounded because Troxel’s “parental presumption” preserves an opportunity for a court to override a parent’s decision without actually finding any harm to a child.²¹⁵ Accordingly, this line of reasoning is inconsistent with strict scrutiny because a state claiming a compelling interest without any actual harm to the child seems implausible.²¹⁶ Lastly, while Justice Thomas advocated for strict scrutiny in Troxel, three Justices essentially rejected its use.²¹⁷

On the other hand, others have argued that procreative, parental, and privacy rights all suggest the use of strict scrutiny.²¹⁸ They state that allowing genetic modification will “enhance procreative liberty” and that “part of the fundamental good of having a child is getting to raise a healthy, happy child.”²¹⁹ This line of reasoning is problematic for two reasons. First, it fails to contemplate that genetic manipulation affects more than just the birth of one child.²²⁰ Second, the analysis fails to consider recent parental rights cases when it makes these judgments on parental rights. One note arguing for strict scrutiny only briefly mentions Michael H.’s precedent in a footnote and ignores mention of Troxel altogether.²²¹ As stated earlier, both of these cases significantly affect how courts view parents’ constitutional rights and must be taken into consideration.²²² Accordingly, a court’s application of strict scrutiny in this context would be inappropriate.

2. Rational basis standard of review is improper after Troxel

Traditionally, a court would proceed to apply rational basis review if it found that a substantive due process right was not fundamental.²²³ Under rational basis review, a court would ask whether a state’s legislation “pursues a legitimate end by rational means.”²²⁴ While analysis under Michael H. would result in applying a rational basis test, a reading of Troxel shows that the Court cannot apply this test when considering CRISPR’s use. Giving a “special weight” to parents was controlling in Troxel even when the state provided rational reasons for enacting the statute at issue.²²⁵

Professor Gilles posits that this rationale argues for intermediate scrutiny and refutes the application of rational basis for two reasons.²²⁶ First, a court using rational basis review usually defers to the government, unless the court finds that a specific decision “as a whole is not irrational.”²²⁷ This was not the case in Troxel, as the government had identified multiple benefits that children had derived from the statute.²²⁸ Second, the “special weight” that Justice O’Connor gave the parental decisions intruded on the discretion of the court “far more than rational-basis scrutiny would.”²²⁹ As a result, Troxel’s “special weight” consideration determined that rational basis review is not the proper standard of review for parental rights.

3. Intermediate scrutiny: A proper standard of review

Due to the confusion caused by these conflicting precedents and the Troxel plurality’s failure to explicitly mention a standard of review, the most persuasive interpretation of Troxel calls for courts to apply an intermediate scrutiny standard when considering laws infringing on parental rights to use CRISPR to genetically modify embryos.²³⁰ For a law to withstand intermediate scrutiny, it must be substantially related to furthering an important governmental interest.²³¹ As previously mentioned, some may argue that the Court does not use intermediate scrutiny in cases regarding substantive due process.”²³² However, Troxel’s inability to explicitly provide a standard of review left the door open for future courts to argue for “any level of scrutiny.”²³³ Additionally, as some scholars have identified, it has “become increasingly clear that intermediate scrutiny is also an appropriate option in substantive due process cases.”²³⁴ In fact, the Court seems to favor intermediate scrutiny with cases concerning “parental childrearing rights in particular.”²³⁵

Furthermore, expansion from visitation rights and child rearing to genetic modification is proper. Scholars have argued that Troxel’s precedent could “extend[] beyond the context of visitation.”²³⁶ Intermediate scrutiny could account for the uncertainty between Michael H.’s and Troxel’s precedents. By applying intermediate scrutiny to parents’ rights to use CRISPR modifications, a court would be able to account for both Michael H.’s “traditionally protected” analysis and Troxel’s “special weight” consideration.²³⁷

4. Potential application of intermediate scrutiny

When applying intermediate scrutiny, a court would first look to a state’s regulation on CRISPR and determine whether the state was acting in furtherance of an important governmental interest.²³⁸ In the case of CRISPR modification, state governments are likely to assert a few different interests to justify its regulation. For example, the government could establish valid interests in “maintaining medical standards” or “protecting potential life” outlined in Roe.²³⁹ As stated earlier, the medical field came to a consensus long ago that genetic editing resulting in intergenerational genetic manipulations is “considered off-limits.”²⁴⁰ This consensus could serve as an argument that the government is simply attempting to “maintain[] medical standards.”²⁴¹ Additionally, the government could argue that regulating CRISPR’s use was a method by which it could “protect[] potential life” given the unknown, and potentially dangerous, repercussions of using the technology.²⁴²

The government may also argue a need to expand its interest to encompass the general welfare of society altogether.²⁴³ Because CRISPR can be used to modify an embryo to make a child smarter, taller, or stronger for nonmedical purposes, scientists have worried about opening the floodgates to the creation of “designer babies.”²⁴⁴ The proliferation of genetic modification could lead to what the executive director of the Center for Genetics and Society called “a society of genetic haves and have-nots,” where only those that can afford genetic modification can reap its benefits, potentially rendering others’ genetics obsolete.²⁴⁵ Additionally, the government has an important interest in preventing the potential long term effects that CRISPR modification could have on society’s “identity[] and economic output.”²⁴⁶ Lastly, the government would need to prove that the legislation passed was substantially related to its goal of preventing CRISPR’s use, while not being over- or under-inclusive.²⁴⁷ To do this effectively, a state could explicitly mention CRISPR in the statute or identify heritable genetic modifications as the scope of the legislation, ensuring that no reproductive, parental, or personal privacy rights are violated when regulating CRISPR’s use.

If parents attempted to challenge the legitimacy of the state’s interest in regulating their rights to modify an embryo or argued that parental rights outweighed the government’s interests, a court could look to established exceptions available to states. For example, the Supreme Court found that states are within their authority to regulate and infringe upon parental rights “to protect the health and/or well-being of children.”²⁴⁸ Because the potentially dangerous repercussions of germline editing are unknown, the government would have a strong argument for protecting the health of a potential life.

Furthermore, when CRISPR technology is more advanced and widely accepted, intermediate scrutiny would be flexible enough to allow for parents or state governments to argue for its use to help prevent diseases and potentially save lives. The adaptability of this standard is significant because “[s]omeday we may consider it unethical not to use germline editing to alleviate human suffering.”²⁴⁹ Another established exception a reviewing court could use comes from Troxel’s “special factors” that a state could use to justify its interference upon parents’ rights.²⁵⁰ While the Court did not enumerate exactly what those factors could be, a reviewing court could—and should—determine that CRISPR is the exact type of factor the Court had in mind.²⁵¹ CRISPR is new and exciting, revolutionary, and provides endless opportunities for human evolution, but it also comes with many uncertainties that cannot be granted fundamental protection.

Conclusion

CRISPR technology developed rapidly and gave scientists the remarkable ability to make targeted, effective, and permanent edits to the human genome’s germline.²⁵² Given the technology’s superiority and success compared to previous techniques, it will not be long before parents are making the decision of whether they want to modify the DNA of a potential child. While the parental desire to make a child as fit for the world as possible is understandable, CRISPR’s immense powers must be used with caution and need to be reined in by the law.

While Meyer and Pierce first established a substantive parental right “to direct the upbringing and education of children under their control,”²⁵³ CRISPR germline modifications extend beyond the Court’s holdings because germline edits carry with them intergenerational consequences.²⁵⁴ The uncertainty of these ramifications led the Obama Administration to warn the scientific community about germline editing’s unrestricted use and its possible long-term dangers.²⁵⁵ Additionally, those that have used the science on embryos have been subjected to serious backlash.²⁵⁶

If a parent’s right to use CRISPR technology on embryos is found to be a fundamental right, it will be protected under the highest scrutiny available for substantive due process rights. However, under Michael H.’s precedent, CRISPR modifications cannot constitute fundamental parental rights because genetic modification of embryos has not been a traditionally-protected right.²⁵⁷ The decision to grant CRISPR a fundamental classification would run contrary to most of the scientific community’s call for limited use of CRISPR.²⁵⁸ Even one of the pioneers of the technique, Jennifer Doudna, essentially called for a moratorium on its clinical use in humans because the technology, while an extreme improvement over its predecessors, “occasionally cuts the genome at unintended sites.”²⁵⁹

To make matters more complicated, Troxel’s decision at the turn of the century called the status of parental rights into question. Troxel held that a “special weight” needed to be given to parental decisions, which competed against Michael H.’s traditionally protected test.²⁶⁰ This confusion left the door open for judges, courts, and parents to fight for “any level of scrutiny” when arguing the extent of parental rights.²⁶¹ Ultimately, when considering the narrow yet powerful right to make permanent, heritable alterations to the genetic makeup of one’s child, intermediate scrutiny is the most appropriate standard of review because it accommodates both Michael H.’s and Troxel’s precedents while giving courts flexibility in governing decisions that have the power to “direct the evolution of our own species.”²⁶²

Intergenerational Control: Why Genetic Modification of Embryos via CRISPR-Cas9 Is Not a Fundamental Parental Right

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