Heritable human genome editing: Who decides? Science or society?

By Françoise Baylis

Many describe the move from bench to bedside (from basic science to therapeutic or preventive applications) as a sprint – a short quick race. Others suggest that the race (such as it is) is more like hurdles given the many obstacles that must be overcome. Still others prefer to think of the scientific endeavour as a shuttle hurdles relay – a race that requires a team effort. There is competition, but also collaborative ambition. And finally, there are some for whom science is more like a marathon (perhaps, a marathon with hurdles and teammates).

In my book Altered Inheritance: CRISPR and the ethics of human genome editing I suggest that science is like orienteering. It is an endurance sport; it can be an individual competition, a team relay or a marathon event:

[T]he runners have to maneuver around obstacles while navigating difficult and unmarked terrain. Along the way, choices have to be made—take the shorter distance with hills, streams, marshes, boulders, ditches, fences, and wildebeests, or take the longer winding road with fewer obstacles—all the while keeping in mind the overarching goal of winning the race.

The challenge with orienteering, which involves moving through a series of checkpoints, is determining the best route between checkpoints and to the finish line. The challenge with translational science is determining (in incremental steps) the safest, most effective, ethical pathway to new and useful clinical interventions. But what counts as an ethical pathway, and who decides?

In my view, ethics is the compass the scientific community needs to navigate the terrain. It is thus for civil society – not the scientific community – to set the research parameters using various governance mechanisms that take into consideration a range of societal values and priorities.

This perspective informs my ongoing commitment to broad societal consensus as a necessary, but not sufficient, condition for proceeding with heritable human genome editing research. As stipulated by the 2015 organizing committee of the First International Summit on Human Gene Editing (of which I was a member):

It would be irresponsible to proceed with any clinical use of germline editing unless and until (i) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application. (emphasis added)

Notwithstanding this clear directive, in October 2018, Jiankui He – a researcher at the Southern University of Science and Technology of China in Shenzhen – self-reported that he had won the race to “make the world’s first genetically edited babies.” This announcement was made on the eve of the Second International Summit on Human Genome Editing. At the close of the 2018 summit, the organizing committee issued a formal statement in which it eschewed broad societal consensus and instead called for a translational pathway:

…proceeding with any clinical use of germline editing remains irresponsible at this time…

…Nevertheless, germline genome editing could become acceptable in the future if these risks are addressed and if a number of additional criteria are met.  These criteria include strict independent oversight, a compelling medical need, an absence of reasonable alternatives, a plan for long-term follow-up, and attention to societal effects…

…Such a pathway will require establishing standards for preclinical evidence and accuracy of gene modification, assessment of competency for practitioners of clinical trials, enforceable standards of professional behavior, and strong partnerships with patients and patient advocacy groups…

Together, the 2018 birth announcement and the 2018 closing statement from the summit organizing committee have significantly accelerated efforts to facilitate the reproductive use of human genome editing technology. This can be seen with two recent international documents: the 2020 Heritable Human Genome Editing report of the International Commission on the Clinical Use of Human Germline Genome Editing (a Commission of several national scientific Academies); and the 2021 ISSCR Guidelines for Stem Cell Research and Clinical Translation.

The 2020 International Commission report explicitly contributes to the project of developing a translational pathway for heritable human genome editing. The report lists criteria for defining responsible translational pathways for initial uses of heritable human genome editing (pp. 97-99) and for possible initial uses in humans (pp. 99-108).

The 2021 ISSCR Guidelines’ contribution to the project of advancing heritable human genome editing is less evident, but no less important. The updated Guidelines bridge the chasm between ‘prohibited’ and ‘permitted’ research activities by introducing a new intermediate category. The translational pathway is no longer from ‘prohibited’ to ‘permitted’, but is now from ‘prohibited’, to ‘currently not permitted’, to ‘permitted’. Heritable human genome editing is, by fiat, moved from the ‘prohibited’ category to the ‘currently not permitted’ category.  In this way, though still ‘not allowed’, heritable human genome editing is one step closer to being ‘permitted’ subject to specialized scientific and ethics review and approval.

My JME article “Heritable human genome editing is ‘currently not permitted’, but it is no longer ‘prohibited’: So says the ISSCR” carefully explains how this all works and why this maneuver matters.

Paper title: Heritable human genome editing is “currently not permitted”, but it is no longer “prohibited”: So says the ISSCR

Author: Françoise Baylis

Affiliations: Dalhousie University

Competing interests: Françoise Baylis is a member of the Planning Committee for the Third International Summit on Human Genome Editing (March 2022) and a member of the WHO Working Group on Principles of the Global Guidance Framework for the Responsible Use of the Life Sciences. She is the author of Altered Inheritance: CRISPR and the Ethics of Human Genome Editing. She was a member of the Planning Committee for the First International Summit on Gene Editing in 2015 and a member of the WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing (2019-2021).

Social media accounts of post author: @FrancoiseBaylis

 

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