By Adam Navara
Graduate Student, Department of Bioengineering, Rice University
In 2018, human embryos were genetically edited, implanted in women and brought to term. These were the world’s first genetically engineered human beings, a scientific achievement that is one of the most significant and controversial landmarks in recent history. This work and the man leading it, He Jiankui, have been widely condemned as unethical. Many believe He pushed this powerful new technology, which permanently alters the human gene pool, onto patients long before it was verified as safe, effective or ethically appropriate.
The news of these experiments, and the subsequent outrage, have hit particularly close to home. He Jiankui sat about where I am today, only eight short years ago as a doctoral student in the bioengineering department at Rice University. Within our department here at Rice, the response has been much the same as the international scientific community: surprise, anger and frustration. We, like most scientists, prioritize patient safety in our work, so it is upsetting to learn that one of our alumni pushed research forward so recklessly. This concerning reality demands that the scientific community reflect on how this happened and what we can do to prevent it from happening again.
Because the pace of scientific advancement is often more rapid than its regulation, the exploration of new scientific frontiers has historically been self-regulated. The 1975 Asilomar Conference, which addressed the hazards of recombining DNA in the lab, is the most famous example of scientists recognizing the potential dangers of their work and establishing their own guidelines for how to proceed. However, He’s case demonstrated the shortcomings of self-regulation. Prior to his studies, He received both collaborative support and tacit approval from his doctoral and postdoctoral advisors, respectively. Even when other confidants directly told He that they did not approve of his work, they ultimately felt powerless to stop it, with some simply asking to not receive any further updates. While He was carrying out his experiments in China, nearly all of his confidants were scientists working at U.S. institutions. Who were they supposed to call to raise the alarm?
In truth, there were many opportunities for this work to be stopped before it took place. However, there is currently no existing international infrastructure through which action could have been taken. As we enter an age in which biomedical technology is becoming increasingly powerful and globalized, the scientific community needs to push for a regulatory system that not only has the infrastructure and capability to enforce guidelines set by international conventions, but also has avenues to preemptively respond to dangerous or unethical studies. These ideas are supported by the presidents of the Chinese Academy of Sciences and the U.S. National Academies of Sciences and Medicine alike.
The World Health Organization (WHO) would be a suitable foundation to build such a regulatory system. It is an organization already structured to ensure global health and safety, has international legitimacy as an agency of the United Nations, and has precedent organizing international treaties and convention. In fact, the WHO has already assembled a scientific advisory board to advise on human germline editing. A system in which the WHO can organize conventions between national academies to establish ethical guidelines, and then remain in communication with the relevant domestic regulatory bodies where research is taking place, could provide a transparent, collaborative system for international regulation. In addition, this would create a reporting mechanism for scientists across international borders, a mechanism geneticists wish had existed when He disclosed his work to them. Universities can also play a critical role in ensuring the success of this system by mandating that faculty and staff report potentially dangerous or harmful studies.
As gene editing and other biotechnology advances, governments will inevitably reach different conclusions about when the technology is safe to use on humans, and what it should be used for, if at all. Having an international body to influence bioethics discussions and policy development will be important for ensuring that new technologies can be used safely for the benefit of humanity. The scientific community can develop better regulations than those currently being used, and we owe it to the public to do so.
This blog post is part of the Baker Institute Science and Technology Policy Program’s Developing Civic Scientist Leaders project.