EXECUTIVE SUMMARY
Ethical debate needs to occur on new human gene-editing technologies, according to a statement released jointly by international organizations. Some recommendations from the statement include the following:
- Relevant safety and efficacy issues must be resolved.
- There needs to be broad societal consensus.
- Clinical use should proceed only under appropriate regulatory oversight.
International organizations are urging the scientific community to allow time for ethical debate on new human gene-editing technologies.
According to a recent statement from the Organizing Committee for the International Summit on Human Gene Editing, it would be irresponsible to proceed with any clinical use of germline editing “unless and until” these conditions have been met:
- relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives,
- there is broad societal consensus about the appropriateness of the proposed application, and
- there is appropriate regulatory oversight. (The complete statement can be viewed at http://bit.ly/1QWLlS8.)
“There is a consensus, or very close to one, that the technique should not be used now to make human babies and that it can be used, with appropriate regulation, to try to treat genetic diseases in living people,” says Henry T. Greely, JD, director of the Stanford (CA) Center for Law and the Biosciences and chair of the steering committee at Stanford Center for Biomedical Ethics.
Beyond those areas of agreement, there is no consensus about research use in humans and a variety of uses in non-humans, according to Greely.
In May 2015, Chinese scientists reported editing the genomes of human embryos, re-igniting an ethical debate.1 Some people strongly opposed to any possible use of human germline or embryo genome editing saw this as one step that could make that possible, notes Greely.
“Many people, including me, viewed it as an ethical experiment, as the embryos that were edited were triploid and thus non-viable,” he says. Greely notes that there is already widespread use of gene editing technology in non-human animals, for basic research and also for particular applications, such as goats with more meat and longer hair and malaria-immune mosquitos.
“These are likely to continue, and quite possibly without sufficient oversight,” says Greely. “In humans, we have already seen one case of gene therapy.”
The case involved an infant with acute lymphocytic leukemia who received gene-edited blood-forming stem cells. “That kind of somatic cell research will, and should, continue and accelerate, as [the gene-editing technique known as] CRISPR/Cas9 makes the editing easier,” says Greely. He expects to see limited research use of gene editing in human embryos and possibly human germ cells. However, he doesn’t expect to see efforts at clinical use of embryonic gene editing for several — perhaps many — years.
Greely says the top priority is to have a regulatory apparatus in place to weigh the consequences of the release of gene editing organisms into the environment. “I do not believe our current regulatory scheme is adequate,” he adds.
REFERENCE
- Liang, P, Xu Y, Zhang X, et al. CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes. Protein Cell 2015; 6(5):363-372.
SOURCE
- Henry T. Greely, JD, Director, Stanford (CA) Center for Law and the Biosciences. Phone: (650) 723-2517. Fax: (650) 725-0253. Email: hgreely@stanford.edu.