In 2016, then-U.S. Director of National Intelligence James Clapper warned Congress that “Research in gene editing conducted by countries with different regulatory or ethical standards than those of western countries probably increases the risk of the creation of potentially harmful biological agents or products.” Two years later, a Chinese scientist named He Jiankui demonstrated the foreshadowing of those words when he gained international notoriety for using CRISPR-Cas9 technology to edit two human embryos’ genomes to prevent transmission of HIV. Not only was this type of genome editing of embryos against international norms of research conduct, but the unproven application of the technique may have created serious medical risks, demonstrating the very need for shared ethical principles of use of this type of research.
Last week, two women — Jennifer Doudna and Emmanuelle Charpentier — were awarded the Nobel Prize for their groundbreaking discovery of an enzyme system (CRISPR-Cas9) that can edit an organism’s genetic code with extreme precision of gene editing. As the Nobel committee recognized, this discovery has had a revolutionary impact on the life sciences. There are arguably fewer discoveries in recent years that have been met with as much excitement about the possibilities — from treating cancer patients to developing new crops to rapidly developing diagnostic tools in pandemics such as COVID-19 — coupled with as much concern of its use and application.
As the case of He indicates, China holds the key to seizing the potential of CRISPR-Cas9 and biotechnology research to improve the human condition while addressing the massive risks that it poses. The United States remains the dominant player in the global biotechnology sector. Still, public and private investment in the sector has boomed in China in recent years. Chinese biotech companies are at the forefront of producing important innovations in areas like cancer therapeutics. China’s biomedical research complex’s sheer size means that its scientists and research institutions play an outsized role in transformative research, such as creating transgenic organisms that combine genetic material from different species for gene editing. The same transformative research that can push the boundaries of the imagination also can push the boundaries of ethics.
As the two global leaders in biotechnology, the U.S. and Chinese scientists should also find ways to lead in dialogue about how path-breaking research should be conducted. There are at least a few signs that Chinese researchers and policymakers would be receptive to greater dialogue on biotechnology and bioethics issues. Concern over genetically modified organisms is arguably more public in China than in the West. In August 2019, the Chinese Communist Party announced creating a new committee to advise top leaders on biomedical research ethics, a move that appears triggered by He’s work on synthetic biology. Simultaneously, the tense bilateral relations between the United States and China have been further complicated during the COVID-19 pandemic, including politized claims over the origin and spread of the coronavirus, which damper prospects of cooperation, especially in areas of biomedical research. Disturbing reports suggest that China is leveraging biotechnology tools to further its repression of groups like Xinjiang’s Uighur minority. These ongoing tensions point to the need for engagement on bioethics to focus, initially at least, on “Track II” dialogues led by non-governmental actors in place of traditional government-to-government diplomacy.
One area where such engagement between the U.S. and Chinese counterparts could be mutually beneficial is to put forward a common set of standards to guide researchers in human subjects research. As the He Jiankui incident underscored, the application of such guidelines is not universal, yet further developments in synthetic biology are likely to continually challenge the prevailing framework, prioritizing principles like personal autonomy, which can vary between countries’ cultures. Second, building on ongoing work by bodies like the World Health Organization and the U.S. National Academy of Sciences (NAS)s, U.S. and Chinese researchers can discuss considerations for the NAS’s recent national-level implementation report on guidance on human genome editing. Third, the COVID-19 pandemic has demonstrated the tension between individual medical data protection and rapid action to control the spread of diseases. A new shared understanding of medical data protections that mitigates this tension would do much to inform efforts to prevent future pandemics. Indeed, a common understanding of such matters among the U.S. and Chinese biotechnology researchers and bioethics practitioners would provide a solid foundation for broadening global frameworks on a range of bioethics issues.
At a time when the world sometimes seems to lurch from one crisis to another, the risks and opportunities presented by biotechnology might seem far-off. But as the still-recent discovery of CRISPR-Cas9 has shown, the next transformative advance in biotechnology may be just around the corner — and the U.S., China, and other nations must seek new and expanded ways to identify shared principles to navigate the scientific, regulatory, and ethical dimensions of this brave new world.
Originally published by The Hill