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Regulating human germline genome editing

Researchers have recently published a paper describing how the development of an ‘informed adaptive consensus’ approach to regulating human germline genome editing could provide a practical solution to this controversial area of science.

Methods that make changes to DNA in human germline cells (eggs, sperm or embryos) are referred to as ‘human germline genome editing’, or HGGE. Such techniques have been made increasingly possible with the advent of CRISPR-Cas9. In fact, just two years after the molecular biological tool was described, scientists had applied it to human embryos. This tool immediately provided novel opportunities for studying gene function and cell fate in early human development.

In 2018, a genome-editing researcher at the Southern University of Science and Technology of China in Shenzhen, called He Jiankui, claimed that he had created the first genetically engineered babies. He specifically edited embryos to disable a gene (CCR5) that allows HIV to infect cells. As a result of this event and the rapid advancements of the practical applications of HGGE, there have been calls for stricter regulations and oversight over these interventions.

A genome editing ‘informed adaptive consensus’

The controversial leap in the use of genome editing made by Jiankui highlighted the pressing need to understand difficult ethical, legal and social questions surrounding how such tools should be appropriately regulated.

Recently, a group of researchers published a paper in PLOS Genetics suggesting that ‘traditional’ mechanisms, such as international and municipal laws, may be ineffective at achieving their intended purposes. The US National Academy of Medicine, the US National Academy of Sciences and the UK’s Royal Society established the International Commission on the Clinical Use of Human Germline Genome Editing, and WHO created a separate Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing. Nevertheless, some believe that these protocols may not be practical in the real-world due and a more inclusive, flexible approach being required.

Throughout the paper, it was argued that an ‘informed adaptive consensus’ approach is the best way to develop scientific and ethical guidelines on what may be acceptable in terms of the evolving gene editing technology. This approach would involve engaging an international community of stakeholders, researchers, scientists, clinicians and other workers in the field, who would collectively consider the fine balance between encouraging ethical scientific endeavours that may benefit mankind, and restricting research that poses unacceptable or unknown dangers to humanity.

A particular emphasis is put on the involvement of gene-editing scientists and making sure that they are well informed of the regulatory environment. The authors noted that it is critical for researchers to take responsibility for considering how the power available to them could be used responsibly and ethically.

One of the benefits of this approach is that it is not fixed. Instead, it would be expected to develop and change over time in response to new technological advances and knowledge.

The prospect of adaptive human genome editing regulations

In most cases, a decision to halt all involvement in HGGE is not feasible. This action would delay the hard work of scientists and ultimately pause research that could benefit future generations.

In this context, the concept of an informed adaptive consensus to regulate HGGE comes with many advantages. For example, adopting such an approach would encourage the participation of many stakeholders. The collaboration between international communities of scientists could lead to them having greater credibility, compared to working with national politicians alone. Furthermore, draft HGGE guidelines could be formulated in much less time due to the efficient gathering of reliable information from all parties involved. The constant re-moulding of regulations would allow them to be refined to address scientific developments as they appeared. The product would be a flexible international consensus that has been gradually built up over time, shaped by various stakeholders along the way.

To find out more about gene editing, watch our ‘A Spotlight On: Gene Therapy’ interview with Carolyn Chapman, a Bioethicist and Faculty Affiliate with the Division of Medical Ethics at NYU Grossman School of Medicine.

Image credit: American Academy of Ophthalmology

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CRISPR / Genome Editing / Genome Engineering