The emergence of CRISPR genomic engineering technology has amplified the need for ongoing transparency and open discussion between scientists and the public. Careful consideration of this technology’s potential risks and benefits requires us to tackle fascinating and challenging questions as a society.
We can now edit our DNA, but let’s do it wisely. In her TED Talk, IGI Executive Director Jennifer Doudna gives a great introduction to how the CRISPR-Cas9 system lets scientists rewrite DNA sequences in any cell. She explains that this revolutionary genetic engineering tool has granted a monumental opportunity to cure genetic disease and simultaneously forces us to grapple with difficult moral dilemmas.
"...all of us [have] a huge responsibility, to consider carefully both the unintended consequences as well as the intended impacts of a scientific breakthrough."
In January 2015, the IGI assembled leaders in the fields of genomic engineering, law, and ethics to consider the possible ramifications of CRISPR gene editing. Scientific progress was rapidly expanding the capabilities of genetic engineering, but public understanding of the technology and its potential was falling behind. With this in mind, the "IGI Forum on Bioethics" participants penned a perspective piece outlining areas of concern and key steps to the broader community.
The group concluded that the prospect of making deliberate, heritable changes to the human germline called for the most immediate attention and extensive consideration. Their recommendations are summarized as follows:
Heeding the call of fellow researchers, top scientific societies from several countries convened the International Summit on Human Gene Editing in December 2015. Organized in part by Dr. Doudna, the event was co-hosted by the US National Academies of Sciences and Medicine, the Chinese Academy of Science, and the UK Royal Society. The global discussion included presentations on the science of genetic engineering, applications, governance strategies, international perspectives, societal implications, and more.
The Summit Organizing Committee concluded that basic, pre-clinical research into human gene editing applications and clinical somatic cell therapy should continue. Clinical gene editing of the human germline should not occur until safety and efficacy issues have been addressed, there is a broad societal consensus on its use, and regulations ensure its safe and ethical application. Finally, the discussion should be ongoing and individual countries should establish harmonious regulatory standards.
The Nuffield Council on Bioethics is an independent body that identifies and debates ethical questions that arise from biotechnology advances. In September 2016, the group released a comprehensive report that lays out many of the key issues associated with genome editing, including applications in human health, food, wildlife, ecosystems, industry, military, and amateur use.
The Council concluded that there is a "need for urgent ethical review" in genome editing for preventing genetic disease in humans and genetically engineering livestock to improve animal husbandry and food production. As a result, they have established a new working party on genome editing and human reproduction that will further address ethical concerns and make appropriate recommendations.
In February 2017, an expert committee assembled by the U.S. National Academies of Science and Medicine released a comprehensive set of recommendations on the ethical use of genomic editing technology.
Their key conclusion? “Heritable germline genome editing trials must be approached with caution, but caution does not mean they must be prohibited.” In their report entitled, “Human Genome Editing: Science, Ethics, and Governance,” the committee makes it clear that safe and effective germline intervention is currently unrealistic. Furthermore, in the United States, the FDA is prohibited from reviewing any “research in which a human embryo is intentionally created or modified to include a heritable genetic modification.” However, technical barriers are being overcome and the permissibility of germline editing clinical trials differs between countries. Thus, the committee provides a strict set of criteria that should eventually be met in order for germline editing to be considered justifiable. They recommend that germline modification should only be used to prevent serious diseases when the harmful mutations are well understood, reversing the mutations is not likely to have an adverse effect, and no reasonable alternative is available. Additionally, genomic editing should not be used for enhancement of any kind, heritable or otherwise.