Gene Edited Babies: One Giant, Precarious Leap for Mankind

The realm of science fiction has often been unkind to the field of genetic engineering and its latest evolution synthetic biology. Generally speaking, genetic engineers operate within some of the strictest oversight and safety requirements imaginable — triple-checking laboratory best practice requirements and thoroughly exploring moral and ethical considerations for even the most minute laboratory experiments. Hollywood often paints a very different and very fictional environment, complete with rogue scientists and uncontrollable experiments gone awry. It is fleetingly rare for any individual scientist, let alone a complex laboratory, to move outside of a circle of safety that is informed by humanity’s understanding of risk.

A recent announcement that a scientist had edited viable human embryos without any rigorous oversight or defense of his methods plays right into the stereotype of a shadowy genetic engineer gone rogue. Scientist He Jiankui, without any direct support from his host institution, announced not only that he had edited the genome of viable human embryos, but that the twin girls resulting from such editing were born just months prior. What makes the recent announcement of living, gene-edited babies so shocking is that it bucks a decades-long tradition in the field of genetic engineering to thoroughly and transparently consider the consequences of one’s actions. Later, rather than seeking peer-review or oversight assistance, Jiankui instead worked with the media to tell the story of his incredible yet deeply concerning scientific breakthrough.

Perhaps one of the most alarming and dangerous components yet disclosed of this case is that the researcher’s actions were broadly inconsistent with traditional requirements of risk analysis. For the fields of genetic engineering in particular and biotechnology in general, these norms and best practices were inspired by a February 1975 meeting known as the Asilomar Conference on Recombinant DNA. Within this meeting, approximately 140 biologists, lawyers, and physicians developed a set of guidelines and principles that determined what types of genetic research are safe and appropriate for specific classes of organism. Differing forms of biological experimentation were categorized based upon their overall degree of complexity and risk to humans, animals, and the broader environment, where riskier or more uncertain forms of research required greater oversight and safe containment.

Some forms of experimentation, such as with the cloning of recombinant DNA from pathogenic organisms or the engineering and refinement of organisms that fostered bioweapons or toxins. Many core principles developed at Asilomar eventually informed national and international laws and agreements such as the Cartagena Protocol on Biosafety, which stated that new biotechnologies such as with genetically modified organisms (GMOs) must be based on the precautionary principle. That principle forms the backbone of many international institutions with extensive biotechnology research, and states that there exists a prevailing social responsibility to protect the public from harm when a plausible risk of a new technology exists. In such cases, rigorous controlled and limited experimentation has been a rigid requirement to identify conditions when such risks are unfounded or preventable.

While broadly successful in their effort to align the field’s governing and best practice requirements, the Asilomar Conference occurred at a moment in history where most institutions and scientists came from cultural and regulatory traditions that were generally aligned. Over forty years later, the genetic engineering and synthetic biology landscape is scattered across dozens of countries — many of which possess diverging or inconsistent cultural norms or practices to identify, measure, and manage emerging risk concerns. Further, the discipline has evolved so substantially since 1975 that the principles of Asilomar, while broadly helpful, may no longer address the rising concerns that many hold for the near-future of gene editing. Most critically includes a need for reflection regarding how nations with a longstanding biotechnology industry, such as with the United States or the United Kingdom, can identify shared norms and risk requirements with emerging scientific players, such as the People’s Republic of China.

Gene-edited babies represent just a small yet important portion of prospective research in the fields of biotechnology and synthetic biology. While the fields remain relatively nascent, it will be only a matter of years until this research yields commercial products as diverse as food, fuel, textiles, and even cleaning agents. The increasingly global research environment and commercial development of biotechnologies mean that many of the products sold to companies and households might be produced within a safety environment far different than one’s own, and may not be held to stringent standards that uphold the best available science.

The looming challenge of gene editing and other emerging biotechnologies is one of international accord and compliance. While the international community frequently gathers to share breakthroughs and best practices for specific organisms or experiments, it largely has not had a cultural alignment of risk-based values in a manner similar to Asilomar in 1975. Given the extensive developments in the field since then, such as the generation of the first genetically engineered human babies, the time is ripe to craft updated safety requirements and to established shared standards and norms that the global scientific community will respect and abide by. At a minimum, this must include a suborn insistence upon transparency, oversight, and a regular reflection upon whether prospective research might yield unacceptable risks to the world.

There is no question that editing along the human genome is a technology of incredible promise. That future-thinking technology is one that might greatly improve many elements of the human condition, from the elimination of debilitating and life-threatening conditions such as Tay-Sachs disease to the prevention of many forms of cancer. However, without a clear alignment of safety norms and best practices at an international level, that future is not yet consistent with our present needs. To get there, the international scientific and governing community needs to begin with a spirited dialogue to determine general principles of safe, secure, and transparent experimentation for our near future. Most likely, the world needs an Asilomar 2.0.

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News and ideas worthy of discourse. Fundamentally informative and intelligently analytical.

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Benjamin D. Trump, PhD

Benjamin D. Trump, PhD

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