With the advent of new technologies like the genome editing tool CRISPR, the manipulation of cells and genes is becoming more powerful, easy and affordable than ever before. Many scientists, bioethicists and members of the public are concerned about the potential consequences—both intentional and inadvertent—and feel that the technology is outpacing progress toward a much-needed regulatory and ethical framework.
Most worrisome is the unprecedented prospect of introducing lasting DNA changes into human embryos, with far-reaching and perhaps unintentional effects that could be passed down to future generations. This fear was recently reignited after a team of Chinese scientists reported using CRISPR (which stands for clustered regularly interspaced short palindromic repeats) to modify nonviable human embryos for the first time. The report prompted several groups of scientists to call for a moratorium on this technology.
More than talk
Recognizing the importance of staying ahead of or at least keeping pace with the new technology, nearly 200 scientists, bioethicists and thought leaders in policy, sociology, industry, religion and law from 30 top biotechnology-producing countries convened May 17–20 in Atlanta for an inaugural discussion on the ethics of cellular biotechnology called BEINGS 2015 (Biotechnology and the Ethical Imagination: A Global Summit).
“When we’re talking about such powerful genetic technologies, we have a moral imperative to ask the deeper questions, of what values those manipulations are in service of and whether those [values] are the right ones,” said Paul Root Wolpe, director of the Center for Ethics at Emory University and founder of BEINGS, in his opening remarks.
The goal of BEINGS 2015 extended far beyond simply starting a conversation: It sought to create the world’s first set of consensus guidelines about how to ethically navigate the changing landscape of cellular biotechnology. Attendees included 16 distinguished faculty members, who provided brief presentations and participated in panel discussions about five main topics: the goals of the Summit; alien organisms and new entities and identities; bioterror and bioerror; ownership; and donorship. In addition, 80 drafting delegates, divided among the topic areas, were then tasked with creating the consensus document over the subsequent months. Also present were “nondrafting” delegates, to serve as reviewers and editors of the final document.
The moral dimension
The summit focused on the use of cellular biotechnologies in research, stopping short of discussing human experimentation, animal rights or the use of genetically modified crops. In the first session, discussion centered on the need to define the aspirations and goals of biotechnology, though few specifics were proposed. Attendees discussed the importance of public trust in science and the need for careful consideration of the precise language used to describe new technologies, specifically the use of metaphors that can take hold in the media. Conversation also touched on how much and what kind of evidence is needed in order to deem a technology reasonably “safe” and free of unintended consequences.
The second session, “Alien Organisms and New (Id)entities,” centered on the creation of new organisms. Specifically, the panel discussed ways to create a bridge between the new technologies and the broader social context in which they’re emerging, and how to preserve equality amid innovation. Here the need for specific rather than sweeping statements in the consensus document became especially apparent. “The process will fail if it ends up making incredibly broad general statements that are difficult to apply,” cautioned Wolpe, admitting that more granular thinking will be challenging.
Regulation, ownership, donorship
Session three concentrated on bioterror and bioerror, and focused on some of the more practical logistics, like regulatory oversight to prevent malicious or accidental misuse of cellular biotechnology. Participants called for explicit definitions of both who should have oversight and when to intervene. Oversight will need to occur at multiple levels: within universities, regionally, nationally and internationally. Other practical suggestions included the use of branding to establish a technology’s specific origin and the introduction of lethality to prevent new organisms from thriving outside of designated environments.
A session on ownership asked who would own custom-designed genes and organisms, and whether they should be patentable or subject to open access. Also up for debate was whether the human germline should be considered “sacred” and, as such, not subject to modification by tools like CRISPR—and whether such a concept is even meaningful in the face of Mother Nature’s constant mutational onslaught. In the final session of the day, the Summit turned to the related idea of donorship, exploring the differences between group and individual donations, and the identities associated with each. Panelists discussed protecting the wishes and identities of donors and the specific role of the embryo in research.
Perhaps not surprisingly, the Summit raised more questions than it answered. Opinions on how to proceed varied widely among distinguished faculty members and delegates alike. At one end of the spectrum, Harvard cognitive scientist Steven Pinker cautioned against regulation, charging delegates to stay out of innovation’s way, while McGill University law professor Margaret Somerville argued that modification of the human germ line should be off limits.
After a summary panel discussion on the morning of May 19, it was time for the real work to start. That afternoon, drafting delegates began the difficult task of constructing and revising the consensus guidelines, a process set to continue into 2016.
“We knew from the beginning that [there would be] some areas where there are fundamental disagreements that are irreconcilable,” said Wolpe. But consensus won’t be forced. “The purpose of this document is not to come out with binary decisions,” he explained. In cases where discussion is ongoing, the goal will be to reflect those discussions and continue further dialogue.
The success of BEINGS 2015 and the consensus document will be revealed in the years to come as individual countries begin to set their own guidelines. “This is a pivotal moment,” said Canadian author, critic and environmental activist Margaret Atwood, whose fiction includes depictions of dystopian societies. She offered sound advice to delegates, and indeed everyone involved with gene editing: “Deliberate well. Keep the bar high. Take precautions.”