I recently attended the Second International Summit on Human Genome Editing in Hong Kong, where the breaking news of the alleged world’s first birth of genetically edited babies loomed large.
The surprising news both reinforced and undercut the summit’s goal to “assess the evolving scientific landscape, possible clinical applications, and attendant societal reactions to human genome editing.”
In a video introducing the summit, its chairman, the Nobel Prize-winning scientist David Baltimore, said the summit would provide an opportunity “to come together to agree on what we want to do and how we want to do it, and what we consider to be right and wrong on a voluntary basis.”
On the one hand, reports of a rogue Chinese scientist, He Jiankui, who contravened the scientific and ethical norms that should guide the development of human genome editing, reinforce the need for clarity about those norms and international monitoring of advances in the field. On the other hand, it shows the weaknesses and limitations of voluntary efforts to guide scientists’ practices.
The 2018 summit came three years after the First Summit on Human Gene Editing in Washington. After the 2015 summit, the organizing committee released a statement saying that it would be “irresponsible to proceed with any clinical use of germline editing unless and until (1) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (2) there is broad societal consensus about the appropriateness of the proposed application.”
The 2018 summit assessed whether these scientific and ethical conditions are being met. The organizing committee said no.
What intrigued me most about the summit was the continued emphasis on consensus — or something approaching it — as a condition of moving forward with clinical applications of germline editing. Alongside calls for consensus, summit organizers seemed to embrace the inevitability of germline editing trials.
Several scientists shared research that would have clear clinical applications involving editing embryos or gametes. The organizing committee’s 2018 statement says that “it is time to define a rigorous, responsible translational pathway” toward clinical trials of germline editing. And yet, there is not consensus, even among summit panelists, that editing the human germline would ever be responsible.
I was grateful that several panelists and participants problematized the notion of consensus, raising a litany of questions, including: Who are the “we” that need to agree? On what issues is consensus needed? How will we know when we’ve reached consensus? What stories, metaphors, arguments, or moral frameworks are being used to facilitate, if not force, consensus?
I’m not so sure consensus is a laudable goal, much less an ethically necessary one. I think what these summits have aimed at is more akin to compromise, a provisional agreement among the scientific community to follow certain rules on good faith. Compromise is important: the world needs clarity on whether, when and how scientists, biohackers or clinicians are going to proceed with germline genome editing. But this does not require that “we” reach consensus on their moral basis or what ought to come next for the human race.
There’s much scientific work to be done to determine whether human germline genome editing can be made safe, feasible and accessible. There is a wide range of questions for bioethicists to work out. Aside from the very important question of whether we should ever edit the human germline, some questions include:
—Where is the line between research and clinical innovation?
Juxtaposing the biomedical research establishment and biohacker community, panelists noted that some uses of gene editing explicitly aim to treat patients or help prospective parents, rather than produce generalizable knowledge. It is an open question whether these primarily therapeutic practices count as research or clinical innovation. Either way, there was agreement among panelists that carrying out these practices would still require fully informed consent and transparency.
—What sorts of structures, norms or expectations are barriers to transparency?
If there was widespread agreement on anything, it’s the importance of transparency. In his condemnation of He Jiankui’s actions, David Baltimore lamented the “failure of self-regulation by the scientific community because of a lack of transparency.” We need more understanding about barriers to transparency, and efforts to lower them, in order to foster a culture among especially young scientists that rewards raising questions, whistleblowing, and sharing works in progress.
—What is the relationship between governance and public engagement?
Speakers on the panel titled “Identifying Basic Principles for Moving Forward” called for robust governance, including national regulations, international treaties, and a global observatory for gene editing.
Then, during the panel “Public Engagement Efforts,” speakers shared examples of local events at museums and high schools, and with patient groups that aimed to foster critical thinking and discussion about the use of medical and reproductive technologies, like stem cell therapies and gene editing. These two panels called for very different types of activities going forward. Their calls are not mutually exclusive.
Within these two paths forward, we encounter a series of questions:
—What kind of governance structures should be put in place?
The task ahead includes creating oversight structures at a variety of levels: institutional, local, national, international, professional organizations, etc. Creating this infrastructure and coordinating across these levels will be challenging, and probably frustratingly slow for some scientists. The 2018 summit statement specifically calls for continued meetings to “speed the development of regulatory science.”
—What kinds of public engagement efforts will facilitate meaningful education, dialogue and deliberation about human genome editing?
I was impressed with the examples of public engagement activities that were shared by panelists because they seemed to have fostered critical thinking and achieved dialogue about the topic at hand. Examples included a workshop for high school students to learn about gene editing. The events described were not meant to provide international guidance or achieve consensus on an issue, but rather to raise awareness and create informed publics.
When public engagement is put toward the end of achieving “widespread consensus about” or “widespread acceptance of” the inevitability of germline editing, it is no longer engagement but advertising. Those leading engagement efforts, creating curricula for high school students, or hosting public events might even stoke dissent in order to facilitate inclusive and expansive conversations not only about genome editing, but also about the kind of worlds we want to live in.
—How much risk to future persons will we tolerate?
Assuming scientists agree upon best scientific practices, for example, for identifying negative consequences of genome editing in embryos, what level of risk will research ethics allow parents to assume on behalf of their future children?
The risks to future children from editing embryos, sperm or eggs will never be zero. Risks are always relative, however.
How should we weigh lowering the risk of sickle cell anemia with possibly increasing the risk of cancer, which can result from off-target genetic mutations? More important, who should have the authority to decide these questions?
As I left Hong Kong, my thoughts were with the twins said to have come from gene-edited embryos. I hope they are happy, safe, and, for their parents’ sake, eating and sleeping well. We would do well to remember that the people most affected by germline genome editing are these babies. How will their health be affected? Their reproductive potential? If they choose to have children, will they face extra hurdles? Will their lives be dominated by hospital visits, check-ups and media frenzy? Will they be viewed differently by their parents, friends or society? How will that affect their family life, friendships, jobs and relationships?
Most of the defenses of germline gene editing have to do with parents’ strong desire to have a genetically related child with or without particular traits. That’s an important and in many cases a laudable goal. So is making sure that any child brought into the world has the love, support, freedom, environment and educational opportunities to flourish, whatever their genotype.
