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Transcending Borders in the Ethical Oversight of Human Genome Editing

Published on: January 8, 2020
Published in: Clinical Trials and Human Subjects Research, Gene Editing, Genetic Testing & Screening, Hastings Bioethics Forum

Genomic Prediction, a two-year old company in the United States, offers prospective parents who use IVF a “cost-effective means to evaluate genetic risk” of embryos. In this regard, it is just another IVF clinic giving parents choice. But what makes the company unusual is its claim that it will allow parents to  deselect for traits such as intellectual disability and short stature, which are polygenic (caused by many genes, each with small effect sizes). Notably, the reliability of screening for polygenic traits, let alone selecting or deselecting for them, remains in question.

Genomic Prediction is only one example of a growing interest in both research and the private sector in human genetic testing technologies that extend beyond identifying disorders caused by a single gene. These technologies could support further attempts at human genome editing. In late 2018, Chinese scientist He Jiankui created the world’s first human gene-edited babies; the gene editing of the embryos was intended to make the babies immune to HIV. A Russian scientist recently announced that he had edited genes in human eggs to repair a gene linked with deafness. Across the world, researchers are beginning to take what was once a theoretical possibility and translate it into practical research efforts, some, such as Genomic Prediction, with profit in mind.  

The speed with which this movement is advancing is partly due to open borders in the scientific research community. Understanding how a company such as Genomic Prediction could come into existence means looking further back in the pipeline–to the systems and developments upstream that gave researchers access to the necessary data and technology to perform genome editing. Three factors are foundational to the status of human genome editing today.

First, researcher networks have expanded and strengthened. For instance, Genomic Prediction was cofounded by physicist Stephen Hsu and bioinformatic researcher Laurent Tellier, who met at the BGI Cognitive Genomics Lab. The BGI Cognitive Genomics Lab was founded in 2011 and with the goal of “investigating the genetics of human cognition. Second, the growing consumer genetics market and appetite for services provided by companies like 23andMe have generated new research opportunities. Third, international research consortiums, such as the Social Science Genetic Association Consortium, allow researchers to pool data and financial and human resources to run larger and more robust genome-wide association studies and polygenic risk scores. 

The bioethics and legal communities must come together to find ways to move with the same ease and proliferation of the scientific research community–to transcend the geopolitical borders and jurisdictional concerns that make international regulation so difficult. 

There is currently no binding, universally applicable legal framework preventing heritable modification of the human genome. Nine nations restrict or prohibit it, but each country imposes a different sanction and targets slightly different acts. In addition, the limitations established do not extend to other forms of genetic modification, such as gene therapies. The United States has no such restrictions. Instead, American research is curtailed only because the National Institutes of Health is legally prohibited from funding research into human embryo manipulation, and clinics that do engage in such activities must obtain approval from the Food and Drug Administration before any clinical trials. Though indirect, the FDA approval requirement serves as a de facto ban on germline editing, because in a catch-22 that has existed since 2016, federal law bars the FDA from considering any clinical trials “in which a human embryo is intentionally created or modified to include a heritable genetic modification.”  

International treaties and guidelines are also unhelpful for constructing new cross-border regulations. For example, the Declaration of Helsinki, the cornerstone document incorporated into many countries’ legal codes outlawing certain kinds of experimentation on human subjects, does not mention genetic experimentation.  It is likewise unclear whether data privacy protections in the European Union’s General Data Protection Regulation (2018) could protect against irresponsible genome editing. While GDPR considers genetic data “personal information,” the data protections attached to that designation are yet undefined and likely do not extend to the biological samples or cells from which genetic insights are mined. Thus, because extant regulations are outdated, nonbinding, and piecemeal, bad actors in the gene editing space can easily slip through the gaps.  He Jiankui, for instance, though sentenced last month to three years in prison and a lifetime ban on conducting reproductive medicine research by a Chinese court for violating “relevant national regulations,” may yet be able to participate in research given that the “black list” he is now on has no official status outside of China, and it remains to be seen how well the ban will be monitored and enforced within China.

As a critical first step, there must be something close to global consensus on what a “proper” set of ethical rules would be. But downstream applications of genetic technologies, such as germline editing and treatment of specific diseases, tend to get bogged down by differing cultural attitudes towards things like personal autonomy, economic competition, and the like. The National Academies Sciences, Engineering, and Medicine organized the International Summit on Human Gene Editing. First held in 2015 and convened again in 2018, the summit is an example of a well-intended, albeit largely ineffective, effort to build global consensus and oversight. The failure to achieve these outcomes manifested in He Jiankui’s decision to edit human embryos in 2018: the researcher stated he was following the guidelines established by the National Academies in 2017. This announcement prompted the National Academies and U.K.’s Royal Society to seek clearer guidelines for human genome editing, but raise an important issue facing the field: facilitating a dialogue is an worthwhile first step, but much more is needed to craft and implement constructive ethical oversight.

Given that most, if not all, downstream genetic uses rely upon large shared data sets and papers produced via initiatives like the Human Genome Project, legal solutions may be most effective if tied to those upstream building blocks. This parallels American regulation generally: premarket stages of drug, device, and biologic technologies are closely watched by government entities like the FDA, but once on the market, both the items and their users are far less scrutinized. 

Perhaps a legal framework that conceptually borrows from copyright law, which attaches protection to authorship, might be useful. Moreover, upstream regulation of the uses of genetic databases could acknowledge that scientific innovation does not happen in a vacuum. In fact, it is increasingly harder to publish in career-crowning prestigious scientific journals without having been “chaperoned into it” by more senior scientists. Placing greater onus on research communities to formalize existing ethical norms through prestige-limiting mechanisms, such as banning publications in top journals for both offenders and knowing enablers of unethical genetic research, or otherwise finding ways to slow the access pipeline to shared datasets, could provide a more robust enforcement. In short, ethical and legal protections and guidelines should attach more closely to data sets and basic research if oversight is to track scientific innovation’s cross-border movements. 

Most importantly, ethical and legal protections and guidelines should not be thought of as innovation-stifling, nor do they have to be. The bioethics and legal communities in partnership with researchers who are doing human genome editing will have to ensure that new technologies are, at their best, used in service of the common good and, at their worst, having a neutral impact on existing socioeconomic and racial disparities and divisions.

Daphne Martschenko is a research specialist at the University of Chicago Center for RISC and recently completed a PhD at the University of Cambridge Faculty of Education. Her work advocates for and facilitates cross-disciplinary research efforts that promote socially responsible communication of social science genomics research findings. Twitter: @daphmarts. Ayesha Rasheed is a law student at the University of California, Berkeley, specializing in privacy and bioscience issues. She graduated with honors in biology from Stanford University and uses her close connections to the scientific community to inform her advocacy for responsible technology regulations. Twitter: @akrasheed92.


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