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Genome Editing 2020: Ethics and Human Rights in Germline Editing in Humans and Gene Drives in Mosquitoes

Published online by Cambridge University Press:  01 January 2021

George J. Annas*
Affiliation:
Boston University, and Director, Center for Health Law, Ethics & Human Rights, Boston University School of Public Health

Abstract

The moon landing, now more than a half century in the past, has turned out to be the culmination of human space travel, rather than its beginning. Genetic engineering, especially applications of CRISPR, now presents the most publicly-discussed engineering challenges—and not just technical, but ethical as well. In this article, I will use the two most controversial genomic engineering applications to help identify the ethics and human rights implications of these research projects. Each of these techniques directly modifies the mechanisms of evolution, threatens to alter our views of ourselves as humans and our planet as our home, and presents novel informed consent and dual use challenges: human genome editing and gene drives in insects.

I begin with a discussion of so far disastrously unsuccessful attempts to regulate germline editing in humans, including a summary of the first application of germline genome editing in humans and its aftermath. I then turn to a discussion of setting ethical standards for a genomic technology that has not yet been deployed in nature—gene drives. Finally, I end by suggesting that human rights can and should be directly applicable to defining the ethics of genomic research.

Type
Articles
Copyright
Copyright © 2020 American Society of Law, Medicine & Ethics Boston University School of Law

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References

1 George J. Annas, POV: How Did Claims of CRISPR Babies Hijack an International Gene-Editing Summit?, BU Today (Dec. 4, 2018), http://www.bu.edu/articles/2018/he-jiankui-gene-edited-babies/ [https://perma.cc/5YW7-NTG6].

2 Sui-Lee Wee, Man Who Claimed to Edit Baby Genes Gets Term in Prison, N.Y. Times, Dec. 31, 2019, at B3; see also David Cyranoski, What CRISPR-Baby Prison Sentences Mean for Research, 577 Nature 154-155 (2020). Celebrity researcher Paolo Macchiarini was also recently sent to prison for a variety of charges, including fraud. Michael Day, Disgraced tracheal transplant surgeon is handed 16 month prison sentence in Italy, BMJ 367:I6676 (Nov. 25, 2019), https://www.bmj.com/content/367/bmj.l6676.

3 Francoise Baylis, Scientific ethics and gene edited babies, Bos. Globe (Jan. 6, 2020), https://www.bostonglobe.com/2020/01/05/opinion/scientific-ethics-gene-edited-babies/.

4 Antonio Regalado, China's CRISPR babies: Read exclusive excerpts from the unseen original research, MIT Tech. Rev. (Dec. 3, 2019) https://www.technologyreview.com/s/614764/chinas-crispr-babies-read-exclusive-excerpts-he-jiankui-paper/ [https://perma.cc/WBJ6-CCSZ].

5 Kiran Musunuru, The CRISPR Generation: The Story of the World's First Gene Edited Babies 174-76 (2019).

6 Regalado, supra note 4.

7 Henry T. Greely, Human Germline Genome Editing: An Assessment, 2 CRISPR J. 253-65 (2019).

8 Marilynn Marchione, 1 year later, mystery surrounds fate of China's gene-edited babies, Associated Press (Nov. 26, 2019), https://apnews.com/86e4e98f7db64d0a9448e621a298ca58.

9 Id.

10 Id.

11 Sheryl Gay Stolberg, Researchers Debate Human Cloning, N.Y. Times (Aug. 7, 2001), https://www.nytimes.com/2001/08/07/science/researchers-debate-human-cloning.html?auth=login-google.

12 Ian Wilmut & Roger Highfield, After Dolly: The Uses and Misuses of Human Cloning 24-25 (2006) (explaining the involvement of these three scientists in cloning a sheep).

13 Annas, supra note 1.

14 National Academy of Sciences, Human Genome Editing: Science, Ethics, and Governance 7-8 (2017).

15 See David Shaw, The Consent Form in the Chinese CRISPR Study: In Search of Ethical Gene Editing. J. Bioethical Inquiry app. 1, (Jan. 3, 2020), https://www.sciencemag.org/sites/default/files/crispr_informed-consent.pdf.

16 See id. at 21-22.

17 See supra note 14 at 47.

18 See id. at 109-10 (showing the recommendations of NAS for clinical trials which omitted any requirement of a physician and created no fiduciary relationship).

19 See Jon Cohen, The untold story of the ‘circle of trust’ behind the world's first gene-edited babies, Sci. Mag. (Aug. 1, 2019), https://www.sciencemag.org/news/2019/08/untold-story-circle-trust-behind-world-s-first-gene-edited-babies.

20 Annas, George J., Beyond Nazi War Crimes Experiments: The Voluntary Consent Requirement of the Nuremberg Code at 70, 108 Am. J Pub. Health 42, 42 (2018)CrossRefGoogle ScholarPubMed.

21 An English language version of the consent form was posted online and all quotations from it are as they appear in that translation. See Shaw, supra note 15 (Shaw's online article includes the consent forms as attachments, emphasis is in the original document as posted).

22 Id. at 1.

23 Id.

24 Id. at 10.

25 Id. at 6.

26 Id. at 1.

27 Id.

28 Id. at 2.

29 Id. at 4.

30 Id. at 4-5.

31 Id. at 5-6.

32 Id. at 5.

33 Id. at 7.

34 Id. at 8.

35 Id.

36 Id.

37 Id. at 8-9.

38 Id. (failing to mention the possibility of twins).

39 Mancuso, Abigail C. et al., Elective Single Embryo Transfer in Women Less Than Age 38 Years Reduces Multiple Birth Rates, But Not Live Birth Rates, in United States Fertility Clinics, 106 Fertility & Sterility 1107, 1107 (2016)CrossRefGoogle Scholar.

40 Deciding how many embryos to transfer in a therapeutic setting with no experimental aspects can itself be challenging. Robert Klitzman, Deciding How Many Embryos to Transfer: Ongoing Challenges and Dilemmas, 3 Reprod. BioMedicine & Soc'y Online 1-15 (2016).

41 Musunuru supra note 5.

42 Musunuru supra note 5, at 166-167. Musunuru also reports that both embryos were mosaic, which, he believes, should have disqualified them from use in this experiment. Id. at 158-163.

43 International Commission on the Clinical Use of Human Germline Genome Editing, https://royalsociety.org/topics-policy/projects/genetic-technologies/international-commission/ [https://perma.cc/SJ2C-WKBP] (last visited Apr. 8, 2020).

44 George J. Annas, Some Choice: Law, Medicine, and the Market 16-17 (1998). (The actions of the ethics committee of the American Society for Reproductive Medicine [then the American Fertility Society] support the following four major descriptions of their ethics: “(1) The ethical acceptability of new reproductive technologies is assumed, and the burden of proof is n anyone who would question a new technology to show how its use is unethical; (2) A use of a new technology cannot be declared unethical if there is any possible ethical application of the technology, no matter how hypothetical; (3) It is assumed that imagined new technologies will ultimately work and will produce benefit, and that any imagined harms from the technology are speculative or can be controlled unless proven otherwise; (4) The major values to be taken into account in evaluating new reproductive technologies are economic (efficiency, supply, and cost) not ethical.”)

45 See supra note 15.

46 See Mancuso, supra note 39; Klitzman, supra note 40.

47 The Chinese court that sentenced JK to three years in prison for his role in the experiment found that the review committee's approval form had been forged. See Sui-Lee Wee, supra note 2.

48 Cohen, Jon, Inside the Circle of Trust, 365 Sci. 430, 431 (2019)Google ScholarPubMed. It also seems unlikely that the couple had any idea of what kind of monitoring their children (and grandchildren) would be expected to endure throughout their life time.

49 The separate agreement and letter regarding control of the baby's first photograph is just bizarre.

50 Aldous Huxley, A Brave New World (1st Perennial Classics ed., New York: Perennial Classics 1998) (1932).

51 Derek So, The Use and Misuse of Brave New World in the CRISPR Debate, 2 Crispr J. 316 (2019).

52 Id.

53 Mary Wollstonecraft Shelley, Frankenstein, or the Modern Prometheus (United Kingdom, Lackington, Hughes, Harding, Mavor, & Jones 1818).

54 A Modern Monster, 359 Sci. 129 (2018). See also Shelley, supra note 53; Jon Turney, Frankenstein's Footsteps: Science, Genetics And Popular Culture (1998); Audrey Shafer, Why Frankenstein Matters, Stan. Med., Winter 2018, at 6.

55 Cohen supra note 48.

56 Henk van den Belt, Frankenstein Lives On, 359 Sci. 137 (2018).

57 Id.

58 Id. See also, Willard Gaylin, The Frankenstein Factor, 297 N. Engl. J. Med. 665 (1977).

59 Kai Kupferschmidt, The Long Shadow of Frankenstein, 359 Sci. 147 (2018).

60 Annas, supra note 44, at 10.

61 Wilmut, I. et al., Viable Offspring Derived from Fetal and Adult Mammalian Cells, 385 Nature 810, 811 (1997)CrossRefGoogle ScholarPubMed.

62 See Shelley, supra note 53.

63 See supra note 15.

64 Of course this also raises the issue of her right to withdraw from the experiment at any time. See, e.g., Cwik, Bryan, Intergenerational Monitoring in Clinical Trials of Germline Gene Editing, 46 J. Med. Ethics 183, 185 (2020)CrossRefGoogle ScholarPubMed.

65 Berg, Paul, Asilomar 1975: DNA Modification Secured, 455 Nature 290, 290 (2008)CrossRefGoogle ScholarPubMed.

66 But see id.

67 Id. at 291.

68 Donald A. Henderson, The Eradication of Smallpox – An Overview of the Past, Present, and Future, 29 Vaccine D7, D7 (2011).

69 Craig, Anne L. & Desai, Sukumar P., Human Medical Experimentation with Extreme Prejudice: Lessons from the Doctors' Trial at Nuremberg, 1 J. Anesthesia Hist. 64, 64 (2015)CrossRefGoogle Scholar.

70 E.g., National Academy of Sciences, Biodefense in the Age of Synthetic Biology 1 (2018). A well-known example is the inadvertent use of the IL-4 gene into a mouse pox virus which instead of rendering the mice sterile, killed them. Finkel, Elizabeth, Engineered Mouse Virus Spurs Bioweapon Fears, 291 Sci. 585, 585 (2001)CrossRefGoogle ScholarPubMed (“This is the public's worst fears about GMOs [genetically modified organism] come true.”); see also Lawrence Wright, The End of October (2020).

71 E.g., National Academies, Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values, 1-2 (2016) (“Gene drives are systems of biased inheritance in which the ability of a genetic element to pass from a parent to its offspring through sexual reproduction is enhanced [to produce] the preferential increase of a specific genotype…from one generation to the next, and potentially throughout the population.”) [hereinafter Gene Drives]; see also Michael Specter, Rewriting the Code of Life, New Yorker, (Dec. 25, 2016) (“My greatest fear,” Kevin Esvelt told me one day “is that something terrible will happen before something wonderful happens. It keeps me up at night more than I would like to admit.”) See generally, Jennifer Kahn, The Gene Drive Dilemma: We Can Alter Entire Species, but Should We?, N.Y. Times (Jan. 8, 2020) https://www.nytimes.com/2020/01/08/magazine/gene-drive-mosquitoes.html (“activist groups are more likely to tap into unconscious values and emotions – like using the term ‘Frankenfoods’ to describe G.M.O.s ‘It's really a brilliant bit of framing…The message is: ‘Science is putting together two things that don't belong together. And that stuff gets out of control and out of the lab, and it's all because of scientific hubris.”).

72 See Hoeyer, Klaus & Hogle, Linda F., Informed Consent: The Politics of Intent and Practice in Medical Research Ethics, 43 Ann. R. Anthropology 327, 350 (2014)Google Scholar.

73 Holm, Soren, Not Just Autonomy, The Principles of American Biomedical Ethics, 21 J. of Med. Ethics 332, 332 (1995)CrossRefGoogle ScholarPubMed.

74 Robert Veatch, How Many Principles for Bioethics?, in 2 Principles of Health Care Ethics 43, 45 (Richard E. Ashcroft et al., eds., 2007).

75 Id. at 45.

76 In 2019 the National Academies released a report that adopted a similar approach to identifying a core set of values adopted by prior reports. National Academies of Sciences, Engineering, and Medicine, Framework for Addressing Ethical Dimensions of Emerging and Innovative Biomedical Technologies: A Synthesis of Relevant National Academies Reports 3 (National Academies Press 2019).

77 Presidential Commission for the Study of Bioethical Issues, New Directions: The Ethics of Synthetic Biology and Emerging Technologies (2010).

78 Id. at 3.

79 Id. at 4.

80 Id.

81 Id.

82 Id. at 5.

83 Id.

84 Id.

85 Human Genome Editing, supra note 14, at 11.

86 Id.

87 Id.

88 Id.

89 Id.

90 Id. at 12.

91 See Gene Drives, supra note 71, at 10, 21.

92 Id. at 5.

93 Id.

94 Id. at 9.

95 Id.

96 Id.

97 Id.

98 See The Cartagena Protocol on Biosafety, art. 23, Sept. 11, 2003, 2 U.N.T.S. 27 (stating that the parties to the treaty have a responsibility to promote and facilitate public awareness and participation).

99 See Peter Tyson, The Hippocratic Oath Today, PBS: NOVA (Mar. 27, 2001), https://www.pbs.org/wgbh/nova/article/hippocratic-oath-today/ [https://perma.cc/CGR9-KTWP] (stating the origins and evolution of the Hippocratic oath and highlighting the do no harm components of the ethical code).

100 See Innovation Action Council, U.S. Envtl. Prot. Agency, Everyday Choices: Opportunities for Environmental Stewardship 2 (2005), https://archive.epa.gov/stewardship/web/pdf/rpt2admin.pdf.

101 Cf. Human Genome Editing, supra note 85, at 165-69, 173-76 (discussing the concept of public engagement and how it is employed in the US and internationally).

102 See Françoise Baylis, Altered Inheritance: CRISPR and the Ethics of Genome Editing 19-35 (2019) (discussing the implications and consequences of somatic cell genome editing).

103 Cartagena Protocol on Biosafety to the Convention on Biological Diversity, Jan. 29, 2000, 2226 U.N.T.S. 208 [hereinafter Cartagena Protocol]; Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity, Oct. 29, 2010, U.N. Doc. UNEP/CBD/COP/DEC/X/1. The release of organisms, including mosquitoes, that have been genetically modified to include a gene drive, of course also raises critical questions of community consultation and approval, that are not easy to deal with. See, e.g., Kolopack, Pamela A. & Lavery, James V., Informed Consent in Field Trials of Gene-Drive Mosquitoes, 1 Gates Open Res. 1, 3-4 (2017)CrossRefGoogle ScholarPubMed.

104 Cf. U.S. Dep't of State, Fact Sheet: The Cartagena Protocol on Biosafety, 8 Econ. Persp., Sept. 2003, at 17-18 (describing the Cartagena Protocol and what it does not cover).

105 Gene Drives, supra note 71 at 164 (quoting Convention on Biological Diversity, Guidance on Risk Assessment of Living Modified Organisms: Risk Assessment of Living Modified Mosquitoes (2012), http://bch.cbd.int/onlineconferences/guidancedoc_ra_mosquitoes.shtml). Gene drive research has raised many issues that provoke debate (and more research) thankfully taking place before any modified organisms are released, including: will gene drives work? Can gene drives be controlled? How should gene drives be field tested? Who decides whether to use gene drives? See Scudellair, Megan, Hijacking Evolution, 571 Nature 160, 162 (2019)Google Scholar. See also, Benjamin R. Evans et al., Transgenic Aedes aegypti Mosquitoes Transfer Genes into a Natural Population, 9 Sci. Reps., no. 13047, 2019, at 4-5 (describing the results of an experiment involving the release of 450,000 trans genetically modified Aedes aegypti mosquitoes having a dominant lethal gene each week for 27 months in Jacobina, Bahia, Brazil). The result was a genetic mixture of three populations and a conclusion that “It is unclear how this may affect disease transmission or affect other efforts to control these dangerous vectors.” Id. at 1. The authors also concluded, in an understatement, “The results demonstrate the importance of having in place a genetic monitoring program during releases of transgenic organisms to detect un-anticipated consequences.” Id. at 5. See generally, Timothy C. Winegard, The Mosquito: A Human History of Our Deadliest Predator (2019).

106 Gene Drives, supra note 71 at 169.

107 World Health Org., Report of the WHO Informal Consultation on Dual Use Research of Concern 3 (2013). Although the term “dual use” is still widely used, with the decreasing costs of new technologies, putting them within the reach of small organizations, including terrorist groups, and individuals, including lone wolf terrorists, the current preferred term is “multi-use.” See Audrey Kurth Cronin, Power to the People: How Open Technological Innovation is Arming Tomorrow's Terrorists 55 (2019).

108 Callahan, Daniel & Jennings, Bruce, Ethics and Public Health: Forging a Strong Relationship, 92 Am J. Pub. Health 169, 172-73 (2002)CrossRefGoogle ScholarPubMed.

109 See generally, Baylis supra note 102; Musunuru supra note 5.

110 See Callahan & Jennings supra note 108, at 172-73; see also WMA Declaration of Geneva, World Med. Assoc. (July 9, 2018), https://www.wma.net/policies-post/wma-declaration-of-geneva (ethical code utilized by the international medical profession as adopted in Oct. 2017).

111 See Somerville, Margaret A. & Atlas, Ronald M., Ethics: A Weapon to Counter Bioterrorism, 307 Science 1881, 1881-82 (2005)CrossRefGoogle ScholarPubMed.

112 Id. at 1882.

113 Id.

114 WMA Declaration of Geneva, supra note 110.

115 Jarvis, Michaela, AAAS Adopts Scientific Freedom and Responsibility Statement, 358 Science 462, 462 (2017)CrossRefGoogle Scholar.

116 This code was written by a group of scientists working on safety issues in the use of gene drives in the period of June 2017 to the beginning of 2020. The work on developing the code was partially funded by DARPA through a contract awarded to the Massachusetts General Hospital, Contract No. HR0011-17-1-0042, Controlling and Countering Gene Drives in Mosquitoes, Keith Joung, PI. The team was known as the C2-GEM team, and includes scientists from the US, UK, and Italy. I was the ethics consultant to this team, and led the conference calls and in person meetings on ethics that led to the development of this code of ethics. Phase 1 involved jointly determining the primary values that should be supported by a code, phase 2 involved identifying and discussing all relevant professional codes we could find, and phase 3 involved drafting the specific language for our own code. I presented this code for comment at the May 2019 meeting of the “Safe Genes” researchers. The major change resulting from the discussion at the meeting was agreement to change “worst case scenarios” to “likely scenarios.”

117 This code is designed to be used for gene-drive research, but with slight adjustments can be adopted for other types of genetic research as well, including research with humans.

118 See Cohen, Jon, Crossing the Line, 366 Science 562, 562-65 (2019)CrossRefGoogle Scholar; see also Cyranoski, David, Russian Biologist Plans More CRISPR-edited Babies, 570 Nature 145, 145-46 (2019)CrossRefGoogle ScholarPubMed.

119 See Rick Berke, Alarmed by new ‘CRISPR babies’ plan, top science figures say they're powerless to stop it, STAT News (June 24, 2019), https://www.statnews.com/2019/06/24/outraged-by-newcrispr-babies-plan-top-science-figures-say-theyre-powerless-to-stop-it (WHO's Margaret Hamburg said, “Our committee is not in a position to provide direct oversight.”); see also Act Now on CRISPR Babies, 570 Nature 137, 137 (2019)CrossRefGoogle Scholar (“Plenty has been said about the need for debate, consensus and regulation on human germline gene editing, but that process has to keep up with the speed at which researchers can actually do the work.”).

120 The Russian molecular biologist Denis Rebrikov seems to be in the category of scientists who, like the would-be cloners, is primarily after publicity, and in this he has already succeeded. See Olga Dobrovidova, Calling embryo editing ‘premature,’ Russian authorities seek to ease fears of a scientist going rogue, STAT News (Oct. 16, 2019) (describing Rebrikov's relationship with Russian government and the portrayal of his work in the media). Russia has also announced that it has prohibited him from doing his proposal experiment. See id. The current law in the US is well summarized by this statement from the US Food and Drug Administration (FDA): “Since December 2015, Congress has included provisions in annual federal appropriations laws that prohibit FDA from accepting applications for clinical research [that would result in inherited germ line modification]. Therefore, the clinical use of these techniques in humans cannot legally proceed in the United States.” U.S. Food & Drug Admin., Advisory on Legal Restrictions on the Use of Mitochondria Replacement Techniques to Introduce Donor Mitochondria into Reproductive Cells Intended for Transfer into a Human Recipient (Mar. 16, 2018), https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/advisory-legal-restrictions-use-mitochondrial-replacement-techniques-introduce-donor-mitochondria. The FDA interpreted this to include gamete and embryo modification by gene modification, and mitochondrial replacement therapy. See Josephine Johnston, Budget Versus Bans: How U.S. Law Restricts Germline Gene Editing, Hastings Ctr. Rep., Mar.–Apr. 2020, at 4, 4-5.

121 See, e.g., Lander, Eric et al., Adopt a Moratorium on Heritable Genome Editing, 567 Nature 165, 168 (2019)CrossRefGoogle ScholarPubMed (call for a five year global moratorium). The American Society of Gene & Cell Therapy proposed a “binding global moratorium” in an April 24, 2019 letter to the Secretary of the Department of Health and Human Services, Alex Azar. See Scientific Leaders Call for Global Moratorium on Germline Gene Editing, Am. Soc'y Gene & Cell Therapy (Apr. 24, 2019), https://www.asgct.org/research/news/april-2019/scientific-leaders-call-for-global-moratorium-on-g.

122 See, e.g., Lanphier, Edward et al., Don't Edit the Human Germ Line, 519 Nature 410, 411 (2015)CrossRefGoogle ScholarPubMed (“A voluntary moratorium in the scientific community could be an effective way to discourage human germline modification.”).

123 See R. Isasi et al., Editing Policy to Fit the Genome?, 351 Science 337, 337-38 (2016).

124 See George J. Annas, The ABCs of Global Governance of Embryonic Stem Cell Research: Arbitrage, Bioethics and Cloning, 39 New Eng. L. Rev. 489, 492-93 n.8 (2005).

125 See id.

126 See Isasi, Rosario M. & Annas, George J., Arbitrage, Bioethics, and Cloning: The ABCs of Gestating a United National Cloning Convention, 35 Case W. Res. J. Int'l L. 397, 402-03 (2003)Google Scholar.

127 See George J. Annas et al., Protecting the Endangered Human: Toward an International Treaty Prohibiting Cloning and Inheritable Alterations, 28 Am. J.L. & Med. 151 (2002).

128 See, e.g., Health and Human Rights in a Changing World (Michael Grodin et al. eds., 3d ed. 2013) (examining health and human rights in various contexts and discussing human rights frameworks).

129 Although it has evolved as a regulatory mechanism in human experimentation (i.e., IRB review), ethics is more generally distinguished from law in that it is aspirational rather than mandatory, and its penalties are primarily reputational rather than involving jail time and/or fines.

130 See Expert Advisory Comm. on Developing Global Standards for Governance and Oversight of Human Genome Editing, Membership, World Health Org., https://www.who.int/ethics/topics/human-genome-editing/committee-members/en [https://perma.cc/94Z2-NGSX].

131 Countries, World Health Org., https://www.who.int/countries/en (last visited Apr. 4, 2020).

132 See Human rights and health, World Health Org. (Dec. 29, 2017), https://www.who.int/news-room/fact-sheets/detail/human-rights-and-health.

133 See Margaret Hamburg & Edwin Cameron, WHO plan for gene-edited embryos, 575 Nature 287 (2019). Hamburg and Cameron are the co-chairs of the Committee and also underline the anti-discrimination core of human rights: “We reject all forms of discrimination based on personal or group characteristics, including gender, race, ethnicity, sexuality, age and disability.” Id. It is unfortunate that in the midst of the Covid-19 pandemic the US has decided to cut funding for WHO on the pretext that it was soft on China at the outset of the pandemic, and then went further by accusing China of a failure to prevent the SARS virus that causes Covid-19 from escaping from a high-security state lab in Wuhan. International cooperation requires both a strong WHO to prevent and respond to future pandemics as well as U.S.–China scientific cooperation not just on oversight of human genome editing research, but on deterring the creation of new bioweapons. See, e.g., Mark Mazzetti, Julian E. Barnes, Edward Wong & Adam Goldman, U.S. Asks Spies to Trace Virus to Wuhan Lab, N.Y. Times, May 1, 2020, at Al; Richard Horton, Offline: Why President Trump Is Wrong About WHO, 395 Lancet 1330 (2020).

134 See Johannes Morsink, Inherent Human Rights: Philosophical Roots of the Universal Declaration 4-5 (2009). I'm not the only one to suggest that human rights are the proper international framework to work out the rules of experimenting with human inheritable gene experimentation. See Jodi Halpern et al., Societal and Ethical Impacts of Germline Genome Editing: How Can We Secure Human Rights?, 2 CRISPR J. 293, 293 (suggesting the development of a human rights impact assessment—a suggestion first made in 1994); Nuffield Council on Bioethics, Genome editing and human reproduction: social and ethical issues (2018), https://www.nuffieldbioethics.org/assets/pdfs/Genome-editing-and-human-reproduction-report.pdf.

135 See Convention on the Rights of the Child, Nov. 20, 1989, 1577 U.N.T.S. 3 (entered into force Sept. 2, 1990).

136 See Ctr. for Reprod. Rights, Whose Right to Life? Women's Rights and Prenatal Protections under Human Rights and Comparative Law 7-9, https://www.reproductiverights.org/sites/crr.civicactions.net/files/documents/RTL_3%2014%2012.pdf.

137 Women do not lose their human rights by becoming pregnant, and in no way “waive” their human rights by becoming pregnant.

138 See generally Gina Kolata et al., Chinese Scientist Claims to Use Crispr to Make First Genetically Edited Babies, N.Y. Times (Nov. 26, 2018), https://www.nytimes.com/2018/11/26/health/gene-editing-babies-china.html (describing the experiment).

139 See Rulli, Tina, Reproductive CRISPR Does not Cure Disease, 33 Bioethics 1072, 1080-81 (2019)CrossRefGoogle Scholar. See also Andorno, Roberto et al., Geneva Statement on Heritable Human Genome Editing: The Need for Course Correction, 38 Trends in Biotechnology 351, 352 (2020)CrossRefGoogle ScholarPubMed, which I signed, stating, “Heritable human genome editing would not treat, cure, or prevent diseases in any existing person. Instead it would modify the genes of future generation through the intentional creation of embryos with altered genomes.” (emphasis added).

140 For a discussion of the safety risks of germline gene editing, see Christopher Gyngell et al., The Ethics of Germline Gene Editing, 34 J. Applied Phil. 498 (2017) (concluding that the moral case in favor of pursuing germline gene editing is stronger than the case against it).

141 One “theory of souls” assumes that children come into existence at “ensoulment” at “animation” meaning when the embryo is infused with a “soul”; “Christian theology and the canon law came to fix the point of animation at 40 days for a male and 80 days for a female, a view that persisted until the 19th century.” Roe v. Wade, 410 U.S. 113, 134 (1973). Although out of favor, we can still use the concept of ensoulment to discuss the identity of any particular child. For example, we could assume further that we accept what I will term theory one: there is a line of souls waiting to be assigned to an embryo, and once an embryo is assigned, the soul goes to it and its fate is thereby determined—it will live, or die (and wind up in what used to be termed limbo, or heaven), based solely on the embryo's future. Alternatively, theory two, less draconian to the soul, posits that if the embryo dies, the embryo's soul could either get back at the end of the line of souls waiting for an embryo, or be re-assigned immediately to the next available newly conceived embryo. Even if you don't believe in souls, the parental perspective provides a different argument to separate the identity of the child from its DNA. When a child is born, the parents do not have its DNA analyzed to see which of all possible children this one is. Instead, the parents typically identify the child by the order in which it enters the family, as in “this is our first (or whichever) child.” Although arguably more complicated, the same is true of twins—the parents distinguish among the children as to which was born first and which second.

142 Cf. Ingo Brigandt & Alan Love, Notes to Reductionism in Biology, Stan. Encyclopedia of Phil. (May 27, 2008), https://plato.stanford.edu/entries/reduction-biology/notes.html; J. C. Polkinghorne, The Person, the Soul, and Genetic Engineering, 30 J. Med. Ethics 593 (2004).

143 Consistent with parental obligations, the Nuffield Council on Bioethics adopts the following language as principle one in their report on genome editing and human reproduction: “Principle 1: The welfare of the future person: Gametes or embryos that have been subject to genome editing procedures … should be used only where the procedure is carried out in a manner and for a purpose that is intended to secure the welfare of and is consistent with the welfare of a person who may be born as a consequence of treatment using those cells.” Nuffield Council on Bioethics, supra note 134, at xvii. The Council bases its analysis on “concepts of human rights” which it properly concludes is not dependent on the possession of a particular “human genome.” Its Principle 2: ‘Social justice and solidarity’, is straightforward: “The use of gametes or embryos that have been subject to genome editing procedures … should be permitted only in circumstances in which it cannot reasonably be expected to produce or exacerbate social division or the unmitigated marginalisation or disadvantage of groups within society.” Id. See also Bartha Maria Knoppers & Erika Kleiderman, Heritable Genome Editing: Who Speaks for ‘Future’ Children?, 2 CRISPR J. 285 (2019).

144 See e.g., David G. Marwell, Mengele: Unmasking the “Angel of Death” (2020).

145 See id.

146 Cf. Patrick Skerrett, Experts debate: Are we playing with fire when we edit human genes?, STAT News (Nov. 17, 2015), https://www.statnews.com/2015/11/17/gene-editing-embryo-crispr (explaining how the technique is generally used to repair defective genes and offers promise in improving quality of life).

147 George J. Annas, Crimes against the human species (‘type II crimes against humanity’ explained), in Humanity Across International Law and Biolaw 115, 115-32 (Britta van Beers et al. eds. 2014).

148 See, e.g., John A. Robertson, Children of Choice: Freedom and the New Reproductive Technologies (1994).

149 For a discussion on the desire for genetically related children and the use of other reproductive technologies, see Danielle Griffiths, The (Re)Production of the Genetically Related Body in Law, Technology and Culture: Mitochondria Replacement Therapy, 24 Health Care Analysis 196 (2016).

150 See G.A. Res. 217 (III) A, Universal Declaration of Human Rights (Dec. 10, 1948).

151 See Shelia Jasanoff & J. Benjamin Hurlbut, A Global Observatory for Gene Editing, 555 Nature 435 (2018); see also Eric T. Juengst, Crowdsourcing the Moral Limits of Human Gene Editing?, Hastings Ctr. Rep., May-June 2017, at 15-23; Pamela L. Sankar & Mildred K. Cho, Engineering Values into Genetic Engineering: A Proposed Analytic Framework for Scientific Social Responsibility, 15 Am. J. Bioethics 18 (2015).

152 George J. Annas, Law and the Life Sciences: Life Forms: The Law and the Profits, 8 Hastings Ctr. Rep., Oct. 1978, at 22; see also Int'l Union for Conservation of Nature, Genetic Frontiers for Conservation: An Assessment of Synthetic Biology and Biodiversity Conservation (Kent Redford et al. eds., 2019) (discussing the potential impacts of synthetic biology and how engineered gene drive systems can be a transformative tool in sectors like public health).