11 Guidelines For Responsible Clinical Use Of Human Genome Editing

A common refrain in science fiction movies is the cautionary statement, “Just because we can doesn’t mean we should.” As new technologies such as CRISPR/Cas9 have made gene editing at precise locations in DNA possible, that sentiment has plagued ethicists and scientists alike regarding heritable human genomes.

The need for guidelines became apparent when Dr. Jiankui He, a researcher who worked in a lab in Shenzhen, China, announced the birth of two genome-edited infants in 2018. Dr. He used the CRISPR/Cas9 on the twin embryos to disable the gene that encodes a protein whose expression allows HIV to enter a cell — the implications of which may not be known for years or generations to come. In the aftermath of Dr. He’s announcement, the International Commission on the Clinical Use of Human Germline Genome Editing was established. The Commission, made up of experts in genetics and gene editing from around the world, recently published 11 guidelines citing scientific criteria for responsible clinical use of heritable human genome editing.

From the start, the Commission stated that heritable genome editing is not ready to be tried safely and effectively in humans, any initial clinical use should be limited to serious single-gene diseases, and only when it is permissible according to local regulations. Given the lack of evidence of potential long-term impact of editing heritable genes, members of the scientific community wonder if even laying out these strict parameters is wise.