An international commission has been assembled to provide guidance on the development of therapies using human germline genome editing.
The commission is a collaboration between the US National Academy of Medicine (NAM), the US National Academy of Sciences, and the UK's Royal Society, and aims to develop a precedent-setting framework for assessing the development of clinical uses of this emerging technology. The need for such a framework was highlighted by Dr He Jiankui's November 2018 announcement at the Second International Summit on Human Genome Editing in Hong Kong that twin girls had been born from genome-edited embryos (see BioNews 977).
'These revelations at the summit in Hong Kong underscore the urgent need for an internationally accepted framework to help scientists, medical experts, and regulators address the complex scientific and medical issues surrounding clinical use of germline genome editing,' said co-chairs of the commission's international oversight board, NAM President Victor J Dzau and Royal Society Vice-President John Skehel.
The framework will consider ethical, medical and social factors, and aims to develop a pathway to responsibly derive clinical benefit from the technology. The commission plans to deliver a report in 2020 detailing protocols to evaluate off-target effects and side effects of germline editing, appropriate consents for patients and an evaluation of the balance of benefits and harms to future children.
The co-chairs also welcomed the formation of the recently announced World Health Organisation's Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing (see BioNews 987)
Dr He's research was strongly condemned by the scientific community for breaching ethical norms. Genome-editing has been included as a last-minute addition to China's new draft civil code to dissuade other scientists from pursuing similar lines of research unregulated. Experiments on human genes or embryos will be regulated under the part of the code which upholds rights to dignity and physical wellbeing, meaning that dangerous or unethical research on human embryonic or adult genomes could constitute a fundamental rights violation. It is the first time that any regulation relating to the genome has been included in the code.
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