Faculty Author Says Human Genome Editing Policy Requires Setting Thresholds of Acceptability

Human genome editing for research has made great strides in recent years, yet a new University of Miami Miller School of Medicine faculty member says modification of the human germline raises socio-ethical and policy questions.

Rosario Isasi, J.D., M.P.H., associate professor, joined the Miller School this month with appointments in the Dr. John T. Macdonald Foundation Department of Human Genetics, the Bioethics Institute, the John P. Hussman Institute for Human Genomics and the Interdisciplinary Stem Cell Institute.

Writing in a recent article in Science magazine, Isasi, its first author, and two former research colleagues at the Centre of Genomics and Policy at McGill University in Montreal suggest that policy makers could be guided by the model that has served to develop policies regulating pre-implantation genetic diagnosis after in vitro fertilization.

Countries around the world are exploring the need for policies to manage gene editing, with the United Kingdom filing the first national research application for licensing genome editing in human embryos. Although the research offers great scientific and therapeutic potential, many researchers disagree with this approach and argue that germline editing should be banned.

Pre-implantation genetic diagnosis, used to identify genetic conditions in embryos and prevent certain diseases from being passed on to the child, “was first regarded as highly controversial and now is mainly governed within the general biomedical research context,” the researchers write. Many countries allow genetic testing in pre-implantation embryos, subject to medically determined requirements such as the gravity of the genetic condition and a substantial risk of occurrence.

“We should be careful of the language used when drafting policy,” said Isasi. “Terms are not just abstract concepts. They are what patients afflicted by, or at risk for, disease are hearing in reality. They have deep personal implications.”

In addition, she said, policy should reflect the values of each country.

The researchers write that many questions remain to be addressed. Two examples: Are there potential defensible uses for genome editing to select or deselect certain human traits? Are there any limits for non-medical interventions?

Public acceptance may change, they note, as genome editing’s benefits for disease prevention emerge.

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