Following a three-day summit in Washington, D.C. to discuss the use of human gene editing, scientists and bioethicists from around the world urged basic research using these technologies to continue, but strongly cautioned that embryos and other types of reproductive cells that have undergone gene editing not be used to establish pregnancy, according to a statement released shortly after the talk ended this afternoon.
Scientists as well as bioethicists, government officials, and various patient advocacy representatives gathered to discuss how research should proceed on the novel gene-editing tool, CRISPR-Cas9 (known commonly as CRISPR), which allows scientists to easily edit the human genome.
While other editing tools exist, CRISPR has sparked the interest of researchers worldwide as it is arguably the easiest and most efficient method to date and has the potential to be used in both research and clinical applications to treat and prevent disease in humans as well as other animals and even bacteria.
The statement contains no official regulations or laws, but it represents the conclusions of the committee members as a whole in the hopes that as research on CRISPR continues, researchers will use these as a guideline. They came to the following conclusions:
1. Basic research must continue.
Basic and preclinical research using gene-editing tools like CRISPR is “clearly needed and should proceed.” This means that scientists endorse the use of CRISPR on human embryos and germline cells (egg and sperm, also known as sex cells, and are used to pass on genes to the next generation) as it could help us better understand the biology and development of human embryos.
However, they caution that embryos or cells that have undergone gene editing and are still viable—that is, ones capable of contributing to a successful pregnancy—should not be used for those purposes.
2. Clinical applications should be limited to somatic cells.
The use of gene editing in clinical applications should be limited to somatic cells, which are cells whose DNA would not be transmitted to the next generation. Editing somatic cells would only help the affected individual who receives the treatment and would not have an effect on his or her future children. For example, researchers could edit the genes for sickle-cell anemia in the blood cells of affected individuals and essentially cure that person of the disease without having an effect on his or her offspring.
There are already rules and regulations that exist for gene therapy and the summit committee members suggest those should be used as a basis and new regulations established as research continues.
On the other hand, the committee strongly urges scientists against using gene-editing on germline cells. Unlike editing somatic cells, editing germline cells would ensure that those genetic alterations would be passed down to all future generations. While this could be useful as a way to avoid inheriting debilitating and life-threatening genetic diseases, the committee writes that it could also be used to enhance human capabilities, and could theoretically allow parents to design their future baby as they see fit.
The committee writes that, “It would be irresponsible to proceed with any clinical use of germline editing unless and until the relevant safety and efficacy issues have been resolved…and there is broad societal consensus about the appropriateness of the proposed application.”
Still, the go-ahead to use CRISPR on somatic, non-heritable cells, goes against the current stand that Francis Collins, the director of the National Institutes of Health (NIH), has taken. Earlier this year, he stated that the NIH would not fund studies that involved the editing of human embryos.
3. Ongoing Forum.
Lastly the committee hopes there to be ongoing discussions as well as future summits in order to keep up with how research evolves and to allow for continued consensus across the world; as the committee members write: “While each nation ultimately has the authority to regulate activities under its jurisdiction, the human genome is shared among all nations.”
While most saw the summit successful as a whole, some emphasized that minority groups were extremely underrepresented and one attendee strongly urged the committee to include religious leaders in future summits.
As research presses on, one thing to remember is that these statements are guidelines, and whether researchers around the world will follow them remains to be seen.