Pressure mounts to keep tabs on powerful biotechnologies

Pressure is mounting for enhanced governance of two powerful biotechnologies — genome editing and pathogen-enhancing research.

The big picture: Gene editing for the treatment of diseases is rapidly advancing, while the controversy over the origin of the COVID-19 virus is increasing scrutiny on how to manage the risks and benefits of dual-use research that can be used for scientific discoveries and misused by bad actors.

Driving the news: A World Health Organization advisory panel this week released two reports calling for international standards and oversight around the use of genome editing.

• CRISPR and other technologies are showing promise in treating diseases, but they also introduce ethical questions about who has access to treatments, concerns about unproven or unsafe claims by clinics offering them, and the possibility of making genetic modifications in the human germline that can be inherited by later generations, which the WHO currently opposes.
• The WHO report on governance for human genome editing calls for establishing an international registry for tracking and examining basic and preclinical research using human genome editing on embryos or germline cells that could be used to create embryos not used for pregnancy. (The WHO recently launched a registry for clinical trials involving human gene editing.)
• It also calls for a whistleblower mechanism to report unsafe and unethical research.

Background: The committee was formed after He Jiankui, a scientist working in China, announced he had used CRISPR gene editing to modify embryos from which twin babies were later born.

• He was sentenced to three years in prison and fined for conducting the research, which drew international condemnation.

The WHO is simultaneously developing a global framework for dual-use biological research "to protect against the potential risks caused by accidents and misuse."

• A major topic in dual-use research is pathogen-enhancing experiments in which scientists enhance viruses to make them more transmissible or more lethal.
• Some researchers argue such research can provide insights into the pandemic potential of a pathogen, but others say it should be banned.
• Unlike gene editing, there isn't commercial demand for pathogen-enhancing research, but if something goes wrong, the implications are global and therefore the work requires international-level oversight, says Gregory Koblentz, director of the Biodefense Graduate Program at George Mason University.

Where it stands: There is currently no registry of pathogen-enhancing research, and labs in different countries assess those experiments and conduct them under varying safety and security standards.

• But an international standard for biosafety and biosecurity was established in late 2019 and "provides a ready-made tool that labs can use to make sure the research they are doing is conducted safely and securely," says Koblentz.
• He and his colleagues propose the International Experts Group of Biosafety and Biosecurity Regulators (IEGBBR) or the WHO could help to implement those standards.

Yes, but: They don't have the ability to enforce standards for emerging technologies in the life sciences.

• But by creating internationally recognized standards of behavior, they can become the "goal of scientists to do the enforcement of those standards," says Koblentz.
• The WHO reports on genome editing also lay out institutional ways to establish ethical norms: Journals could require research to be registered in order to be published, and governmental and philanthropic funders could make grants contingent on complying with a registry.
• Guidelines can form a baseline for national policies and create norms and rules for scientists, but they're just as much about providing ways to responsibly bring health technologies to underserved and under-represented populations, says Ubaka Ogbogu, a professor of law at the University of Alberta who focuses on the regulation of emerging biotechnology.

The bottom line: Better governance of genome editing and pathogen-enhancing research could help to maximize their benefits and minimize their risks.