By: Sabrina Hayes
Edited by: Alanna Liu and Olivia Paik
Chances are, you may have heard conversations or read about the relatively new CRISPR Cas-9 technology that allows for gene editing inside our cells. Scientists have found a precise way to take or remove genes in our sequences of DNA, which is incredibly exciting and could cure genetically inherited diseases like sickle cell anemia, and open doors for treatments that were never before imagined. Cancer, a disease caused by genetic or epigenetic mutations in the genome, may finally get a cure with the use of CRISPR [1]. As much as this seems to be optimistic news, there are difficulties with the new technology. This article is going to examine some of the legal and ethical implications of CRISPR, regarding both laws that do exist and those that have yet to be written. Research ethics, domestic regulation concerns, embryonic rights, and international law are prevalent to CRISPR Cas-9 technology, despite being handled outside of the lab.
When looking at the pillars of proper and ethical experimentation, informed consent, justice, and equity are all non-negotiables for an approved scientific experiment. With there being little known about CRISPR technology, it could be difficult to conduct the necessary further experimentation without infringing on those ethical values. The US has numerous laws to protect human subjects used in experiments, and the Environmental Protection Agency has a branch that approves projects done at scientific labs across the nation [2]. The first problem that CRISPR technology faces is breaching the obligation of informed consent. With technology that could edit embryonic DNA, certain mutations or complications that occur could be heritable, and impact an entirely new generation without scientists’ knowledge. If a mutation lay dormant for multiple generations of reproduction, only to occur in a child who never agreed to any experimentation, that would breach the child’s right to informed consent [3]. However, some argue that humans make decisions every day that could possibly alter the health and wellness of their offspring, and so the creation of a cure for thousands of people with thousands of diseases outweighs the risks for future generations. Secondly, considering equity and justice, CRISPR technology may not be accessible to lower-class civilians, and especially in the US, a country without universal healthcare, the discrepancies could grow to disproportionate magnitudes. There have been people who hypothesize a future with genomic quality creating class divides: a potential for genetically engineered ‘superior DNA’ [3]. Despite that not being the case currently, that is one example of legislation that would need to be written and enacted to prevent a comparable situation.
Following the overturn of Roe v. Wade, the right for states to define an embryo’s personhood has become a topic of debate. As much as it is worth diving into the complexities of each state’s legislation, the rights of women, and the implications of the Supreme Court’s decision, this section will examine embryonic rights from a CRISPR and genetic editing perspective. If a state defines personhood as beginning at conception, any genetic editing of the embryo would become illegal, because the embryo cannot give informed consent. Therefore, embryos that are tested and diagnosed with life-altering diseases could not be treated before birth. On an international level, the regulation of embryonic genetic editing differs from nation to nation. Albania, Bahrain, Belarus, and Croatia all have legislation that prohibits all human embryo research [1]. In addition to the legal rights of embryos, the ethical concerns of what are now called ‘designer babies’ can be considered when determining the powers and accessibility of CRISPR technology [1]. Should parents be allowed to genetically alter their children before birth? Given the dark, immoral history of eugenics across the globe, the possibility of trait selecting for aesthetics is terrifying. Something as simple as a child with blonde curly hair could be decided by the parent, and with the vast database of gene sequencing, it would be simple for scientists to pinpoint which segment of DNA contributes to hair color, and execute that switch using CRISPR Cas-9. The concerns of treating this technology without the wariness required is evident.
Third, and potentially the most frightening legal concern of CRISPR Cas-9 technology is its use for warfare. Along with the previous discussion of ‘designer babies’ and embryonic editing, leaders of different nations could create their own warrior ‘race’, children genetically modified to possess desirable traits: higher pain tolerance, easier ability to build muscle, etc.. As much as this seems like fear-mongering speculation, Vladimir Putin himself has publicly made comments about how genetically engineered soldiers who cannot feel pain would be “scarier than a nuclear bomb” [4]. The implications of these comments are not to be ignored. Yet with the novelty of CRISPR technology, our international laws have not caught up to the rate of scientific progress. On top of the fear of ‘perfect’ soldiers, CRISPR technology is not only for use in humans. Following the devastation COVID-19 pandemic, scientists and international legal bodies must consider the possibility of genetically adapted bioweapons: viruses with “unusual virulence” without a cure could be released by terrorist organizations, or countries at times of war [1]. Is there a need to adopt the United Nations Convention on Biological and Toxin Weapons? To some extent, it does cover creating or stockpiling biological weapons, but how can that be enforced, especially given the increasing accessibility of CRISPR Cas-9 technology [5].
In conclusion, there may be more lingering questions than definite answers. Domestic legislation moves at a slower pace than technological advancements and international legislation can feel completely stagnant in comparison. At the UNESCO General Conference in 1997, Article 10 established that “No research or research application concerning the human genome …should prevail over respect for the human rights” [6]. For the past 25 years, there has been a basis for the ethics of genetic engineering: that they must value basic human rights. However, as embryonic rights are introduced, we are left questioning when exactly those human rights begin to apply? When we consider times of war, the enforcement of basic human rights can feel uncertain. The ramifications of breaching ethical guidelines are minimal compared to breaking laws, and so accountability on all levels may feel unattainable. As much as this article may seem to be full of cynicism and fear, there is also promise in CRISPR Cas-9 technology. The ability to help people’s suffering, cure previously incurable diseases, and drastically improve the quality of life for people with genetic disorders is something to celebrate. Science is complicated, and so is the law. Nonetheless, both provide structure to be grateful for and should inspire more optimism than hopelessness.
Notes:
Tahir ul Mir et al., “CRISPR/Cas9: Regulations and Challenges for Law Enforcement to Combat Its Dual-Use,” Forensic Science International 334 (2022): https://doi.org/10.1016/j.forsciint.2022.111274.
“Basic Information About Human Subject Research,” EPA, accessed December 4, 2022, https://www.epa.gov/osa/basic-information-about-human-subjects-research-0
“What are the Ethical Concerns of Genome Editing?” NIH, last modified August 3, 2017, https://www.genome.gov/about-genomics/policy-issues/Genome-Editing/ethica l-concerns.
Regalado, Antonio. “The next trick for CRISPR is gene-editing pain away,” MIT Technology Review, August 22, 2019, https://www.technologyreview.com/2019/08/22/133291/the-next-trick-for-crispr -is-gene-editing-pain-away/
“Biological Weapons Convention,” United Nations, accessed December 4, 2022, https://www.un.org/disarmament/biological-weapons/
“Records of the General Conference, 29th session, Paris, 21 October to 12 November 1997, v. 1: Resolutions,” UNESCO, 1998, https://unesdoc.unesco.org/ark:/48223/pf0000110220.page=47
Bibliography:
Brokowski, Carolyn, and Adli, Mahzar. “CRISPR Ethics: Moral Considerations for Applications of a Powerful Tool”, Journal of Molecular Biology, 431, no.1 (2019): 88-101. https://doi.org/10.1016/j.jmb.2018.05.044
EPA. “Basic Information about Human Subjects Research.” Accessed December 4, 2022. https://www.epa.gov/osa/basic-information-about-human-subjects-research-0
HHS. “Federal Policy for the Protection of Human Subjects ('Common Rule').” Last Modified November 8, 2022. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html
Mir, Tahir ul, Atif Khurshid Wani, Nahid Akhtar, and Saurabh Shukla. “CRISPR/Cas9: Regulations and Challenges for Law Enforcement to Combat Its Dual-Use.” Forensic Science International 334 (2022): 111274. https://doi.org/10.1016/j.forsciint.2022.111274.
NIH. “What are the Ethical Concerns of Genome Editing?” Last Modified August 3, 2017. https://www.genome.gov/about-genomics/policy-issues/Genome-Editing/ethical-concerns Polo, Michelle J. “Infertility patients fear abortion bans could affect access to IVF treatment.” NPR, July 21, 2022, https://www.npr.org/sections/health-shots/2022/07/21/1112127457/infertility-patients-fear-aborti on-bans-could-affect-access-to-ivf-treatment
Regalado, Antonio. “The next trick for CRISPR is gene-editing pain away,” MIT Technology Review, August 22, 2019, https://www.technologyreview.com/2019/08/22/133291/the-next-trick-for-crispr-is-gene-editingpain-away/ Regalado, Antonio. “Putin could decide for the world on CRISPR babies.” MIT Technology Journal, September 30, 2019, https://www.technologyreview.com/2019/09/30/132822/putin-could-decide-for-the-world-on-cris pr-babies/
United Nations. “Biological Weapons Convention.” Accessed December 4, 2022, https://www.un.org/disarmament/biological-weapons/ UNESCO. “Records of the General Conference, 29th session, Paris, 21 October to 12 November 1997, v. 1: Resolutions.” 1998, https://unesdoc.unesco.org/ark:/48223/pf0000110220.page=47
