WHO issues new ethics recommendations for human genome editing

The World Health Organization (WHO) has released two new companion reports that provide the first global recommendations for using human genome editing as a tool for public health.

 Currently, countries can choose their own laws and regulations about human genome-editing, and these reports aim to give guidance to these policies. Human Genome Editing: a framework for governance and Human Genome Editing: recommendations emphasise safety, effectiveness and ethics.

“Human genome editing has the potential to advance our ability to treat and cure disease, but the full impact will only be realised if we deploy it for the benefit of all people, instead of fuelling more health inequity between and within countries,” says Tedros Adhanom Ghebreyesus, WHO Director-General.

The reports followed a global consultation on the use of genome editing techniques in humans, and included a diverse participant pool of scientists, researchers, patients, and indigenous peoples. The full consultation took two years to complete.

The benefits of human genome editing are vast; they may provide treatments for genetic disease, and have great potential in cancer treatment.

However, there are also risks, as the introduced mutations can sometimes be inherited by offspring or have off-target mutations that may be harmful. There is also concern that embryos cannot consent to editing.

The ability to edit the DNA in human somatic (like skin or liver) and germline (such as egg and sperm) cells is relatively new, and the first International Summit on Human Gene Editing took place in 2015 following the release of a research paper about the editing by CRISPR of a human embryo.

But the issue was entered the spotlight again in 2018 when He Jiankui controversially announced that two babies had been born following editing with CRISPR – the first humans to be born following such genome editing.

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Read more: Editing human embryos with CRISPR

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Many researchers and regulatory bodies saw this as ethically inappropriate and potentially dangerous, due to the risk of off-target mutations. The Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, which led these new reports, was established just a few months later.

The global consultation sought to address these issues and provide a more robust framework for the ethics and safety guidelines of human genome editing research and therapies.

The nine areas explored include recommendations for a framework to regulate human genome editing across:

1. Leadership by the WHO and its Director-General
2. International collaboration for effective governance and oversight
3. Human genome editing registries
4. International research and medical travel
5. Illegal, unregistered, unethical or unsafe research and other activities
6. Intellectual property
7. Education, engagement and empowerment
8. Ethical values and principles for use by WHO
9. Review of the recommendations.

One of the emphasised calls to action was to encourage other countries to build upon WHO’s existing Human Genome Editing Registry, which documents studies of this type, and can be accessed easily and equitably to promote transparency.

The second guideline that was emphasised was a framework for confidential reporting that won’t compromise the privacy and safety of subjects.

“The report is the first to consider a wide breadth of realistic applications for human genome editing and to address appropriate measures for governance from an institutional, national, regional and international level,” says Helen O’Neill, an expert in molecular genetics at the University College London.

“There is an acknowledgement that good governance (much like good science), is an ongoing and interactive process and the report seeks to identify methods of strengthening oversight for those working in human genome editing.

“Context is the most critical aspect of setting frameworks within scientific policy and this report identifies that not only are there different uses for human genome editing, but different groups and therefore different challenges that must be accommodated at each level of regulation and advocacy.

“The need for consistent, regular and revised meetings is essential and will give strength to the practical application of the intentions of this committee and report.”

“These new reports from WHO’s Expert Advisory Committee represent a leap forward for this area of rapidly emerging science,” says WHO’s Chief Scientist, Soumya Swaminathan. “As global research delves deeper into the human genome, we must minimise risks and leverage ways that science can drive better health for everyone, everywhere.”