People have been striving for human “perfection” for as long as human civilization has existed, sometimes with questionable and even catastrophic results.1 The idea of perfecting the human population led to eugenics, the nineteenth and early twentieth-century philosophical movement to “breed better people.”2 Eugenics ultimately laid the framework for forced sterilization laws in a number of countries, including the United States, where lawmakers prohibited certain people from procreating.3 As appalling as forced sterilization was, eugenics took an even darker turn leading up to and during World War II when Nazi Germany murdered millions in the name of creating a superior Aryan race.4 Adolf Hitler did not come up with the concept of genetic purity on his own.5 “In fact, [Hitler] referred to American eugenics in his 1934 book, Mein Kampf.”6 Although eugenics lost momentum after these atrocities,7 the idea of human enhancement has continued. Today, scientific advancements in gene-editing technology offer a new take on human modification.
Gene editing is a group of technologies that enable scientists to change an individual’s DNA.8 Genetic material can be added, removed, or altered at particular locations in the genome.9 One such gene-editing technique is the revolutionary technology called CRISPR-Cas9, short for “clustered regularly interspaced short palindromic repeats” and CRISPR-associated protein 9,10 which was discovered in 2012.11 In 2013, groups of scientists led by Feng Zhang and George Church used CRISPR to edit human cell cultures for the first time.12 By 2015, Chinese scientist Puping Liang used CRISPR to edit the genes in human tripronuclear zygotes.13 CRISPR has generated much excitement in the scientific community because it is faster and cheaper, as well as more accurate and more efficient than any other existing method to genetically alter DNA.14 This is of particular interest in the prevention and treatment of diseases, because CRISPR has the potential to correct mutations associated with single-gene diseases such as cystic fibrosis, sickle-cell anemia, and hemophilia, as well as complex diseases such as cancer, heart disease, and HIV infection.15
However, CRISPR has rekindled debates about the numerous social, ethical, and policy concerns of genetic manipulation.16 These concerns become even more complicated with germline gene editing, which results in changes in sperm, eggs, or embryos that will be passed on to the next generation.17 Critics of germline editing worry about the potential for “designer babies,” children whose traits, including eye color, height, and even athletic ability, are modified by gene editors at the request of their parent-consumers.18 Genetically modified babies remained speculative until November 2018, when Chinese scientist Dr. He Jankui announced that he had created the world’s first “CRISPR babies,” twin girls named Lulu and Nana.19
To conduct his experiment, Dr. He recruited couples in which the men had HIV infection and the women did not.20 After creating embryos by fertilizing the eggs with the sperm, Dr. He used CRISPR to edit the embryos and disable a gene that helps HIV enter healthy cells, for the purpose of giving the twin girls resistance to HIV.21 Notably, however, “Dr. He admitted that the edit was not successful in one of the embryos, and it is unclear whether it was completely or even partially successful in the other.”22 Dr. He’s experiment generated an outpouring of criticism and hand-wringing from scientists and bioethicists around the world, who labeled him a “rogue” scientist23 whose unethical experiment was “amateurish” and “unconscionable.”24 The safety risks and long-term effects of Dr. He’s experiment will remain a mystery for years to come, meaning the twins will likely be studied for the rest of their lives.25 Although Lulu and Nana brought bioethical considerations of gene editing to the forefront, researchers are still striving to advance CRISPR technology, with one of the most recent developments occurring right now in New York City.26
Currently, reproductive biologists at Weill Cornell Medicine are making the first attempt at genetically editing the DNA in human sperm using CRISPR.27 The controversial research is aimed at preventing genetic disorders that are passed down from men, including certain forms of male infertility.28 The researchers are beginning with a gene that increases the risk of breast, ovarian, prostate and other cancers.29 Because DNA is packed very tightly inside the head of each sperm, it is difficult to insert the microscopic CRISPR tool.30 To overcome this challenge, the Cornell scientists electrically shock the sperm with the goal that the shock will cause the cells to loosen up for a moment so that CRISPR can get inside.31 June Wang, a lab technician conducting the experiments at Cornell, admits that “[i]t’s kind of a weird concept” but states that “it works pretty well.”32
Although the experiments are still underway and are not yet successful, the research raises many of the same hopes—and fears—as editing the genes in human embryos.33 Nevertheless, the researchers defend their work.34 Gianpiero Palermo, who runs the lab where the experiment is being conducted, states, “I think it’s important from the scientific point of view to investigate in an ethical manner to be able to learn if it’s possible.”35 Palermo went on to say, “If we can wipe out a particular gene, it would be incredible.”36 However, Françoise Baylis, a bioethicist at Dalhousie University in Canada who is advising the World Health Organization, expresses the view that editing DNA in sperm raises the same troubling questions as editing DNA in embryos.37 In addition to safety concerns for resulting babies and future generations in the event that the genetically edited sperm is used, there are profound ethical and social concerns about conducting the research in the first place.38 As bioethicist Ben Hurlbut put it,
There’s reason to worry about undertaking the research before we’ve asked the question properly whether we would ever actually want to use those techniques . . . . Once those techniques are developed, it becomes much harder to govern them. If you’ve done the hard work of developing the recipe, someone else can bake the cake.39
The willingness of researchers to develop human uses of CRISPR demonstrates the pressing need to regulate such advancements and, in particular, its possible use to genetically edit human sperm. Part I of this Note will provide a scientific background necessary to understand genetically edited sperm, including a brief history of relevant scientific advancements, a discussion of CRISPR-Cas9 technology, and an explanation of somatic cells and germline cells. Part II will analyze various ethical considerations regarding editing human sperm, including safety concerns, informed consent issues, the debate between treatment and enhancement, and the potential for new forms of social inequality. Part III will discuss the most applicable regulations in the United States under the Food and Drug Administration and National Institutes of Health, and ultimately conclude that as it stands, the law is unprepared for the development of genetically edited sperm. Part IV will propose a resolution to address these concerns, including a federal licensing regime, a call for public engagement, and regulations to mitigate equality and accessibility concerns if sperm editing is commercialized.
* Senior Editor, Southern California Law Review, Volume 94; J.D. Candidate 2021, University of Southern California Gould School of Law; B.S. Finance 2017, University of Florida. I thank my family, friends, and the fantastic editors of the Southern California Law Review for their support and guidance throughout the publication process.
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