The WHO took ethical, safety, and effectiveness considerations into account.
CRISPR-Cas9 gene editing opened a raft of possibilities for medical and scientific development, but it also opened an ethical debate on manipulation of the human genome that has received its first guidelines.
The World Health Organization has issued the first recommendations on genetic manipulation after discovery of the CRISPR-Cas9 gene editing “scissors”.
The WHO based its guidelines on two reports that recommend human genome editing be used as a tool for public health.
The international organization placed emphasis on safety, effectiveness, and ethics regarding the CRISPR-Cas9 gene editing method.
These first recommendations come after two years of analysis, thanks to a consultation in which scientists, patients, faith leaders, and indigenous peoples participated.
Their discussion was hastened after discovery of the CRISPR-Cas9 tool.
“Human genome editing has the potential to advance our ability to treat and cure disease, but the full impact will only be realized if we deploy it for the benefit of all people, instead of fueling more health inequity between and within countries,” said WHO Director-General, Tedros Adhanom Ghebreyesus.
The group was comprised of the Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing.
Their goal was to examine the scientific, ethical, social, and legal challenges associated with human genome editing (somatic, germline, and heritable).
The Committee produced a series of recommendations in nine areas:
Although the WHO recognizes that human genome editing, which involves altering human DNA, “can benefit faster and more accurate diagnosis, more targeted treatments, and prevention of genetic disorders,” it also admits that “some risks exist.”
According to Soumya Swaminathan, WHO’s Chief Scientist, “These new reports from WHO’s Expert Advisory Committee represent a leap forward for this area of rapidly emerging science.”
The governance framework recommended by the WHO offers concrete recommendations for dealing with specific scenarios such as:
Faced with these types of scenarios and according to the Committee’s analysis, the WHO recommends that clinical human genome editing trials be reviewed and approved by research ethics committees, and that the manipulation of the heritable genome only be carried out in places with this type of supervisory body.
WHO will convene a small expert committee to create a registry, including how to better monitor clinical trials using human genome editing technologies of concern.
It also plans to convene multi-sector stakeholders to develop an accessible mechanism for confidential reporting of concerns about possibly illegal, unregistered, unethical, and unsafe human genome editing research and other activities.
One of the first uses of human genome editing is for the treatment and prevention of disease.
However, its use raises ethical questions that require the existence of solid compliance guidelines.
The technology that opened the global debate won researcher Emmanuelle Charpentier, from the Max Planck Institute for Infection Biology in Berlin, and Jennifer Doudna, a scientist from The Howard Hughes Medical Institute and main researcher at Gladstone Institutes, the 2020 Nobel Prize in Chemistry.
The need for recommendations coordinated by the WHO came about in 2018.
In that year, Chinese biologist He Jiankui edited the genes of two human embryos to prevent them from contracting the Human Immunodeficiency Virus (HIV).
In December of the same year, the WHO established a multidisciplinary advisory committee of global experts.