Scientists set a path for field trials of gene drive organisms

December 17, 2020

The modern rise of gene drive research, accelerated by CRISPR-Cas9 gene editing technology, has led to transformational waves rippling across science.

Gene drive organisms (GDOs), developed with select traits that are genetically engineered to spread through a population, have the power to dramatically alter the way society develops solutions to a range of daunting health and environmental challenges, from controlling dengue fever and malaria to protecting crops against plant pests.

But before these gene drive organisms move from the laboratory to testing in the field, scientists are proposing a course for responsible testing of this powerful technology. These issues are addressed in a new Policy Forum article on biotechnology governance, "Core commitments for field trials of gene drive organisms," published Dec. 18, 2020 in Science by more than 40 researchers, including several University of California San Diego scientists.

"The research has progressed so rapidly with gene drive that we are now at a point when we really need to take a step back and think about the application of it and how it will impact humanity," said Akbari, the senior author of the article and an associate professor in the UC San Diego Division of Biological Sciences. "The new commitments that address field trials are to ensure that the trials are safely implemented, transparent, publicly accountable and scientifically, politically and socially robust."

A multidisciplinary group of gene drive organism developers, ecologists and con¬servation biologists joined experts in social science, ethics and policy to outline several commitments that they deem "critical for responsible conduct of a field trial and to ensure that these technologies, if they are introduced, serve the public interest." Twelve core commitments were developed under the following broad categories: fair partnership and transparency; product efficacy and safety; regulatory evaluation and risk/benefit assessment; and monitoring and mitigation.

"Our intent is to contribute to public policy decisions on whether and how to proceed with GDOs, based on evaluations conducted in fair and effective partnerships with relevant authori-ties and other stakeholders," the authors write in the article. A signatory page for those supporting this effort will be available here.

"This will be an influential piece for the field given the number and diversity of co-authors and will help set a course toward open and transparent research," said article co-author Cinnamon Bloss, an associate professor at UC San Diego's Herbert Wertheim School of Public Health and Human Longevity Science. In a recently funded R01 grant from the National Institutes of Health, Bloss will lead a team of researchers at UC San Diego in a project that will help ensure these core commitments are woven into community and stakeholder engagement work all the way from early proof of concept to field trials and deployment.

"As the authors point out, more needs to be done," Bloss said. "In particular, my co-authors and I represent a largely North American viewpoint, and thus, stakeholders in other countries that might be more likely to serve as trial sites need to be brought into this conversation."

Article co-author Robert Friedman, vice president for policy and university relations at the J. Craig Venter Institute, said a defining factor behind the effort was to merge disparate GDO viewpoints into a cohesive voice.

"The diversity of perspectives, background and engagement on the issue is really very impressive," said Friedman. "This paper includes a multidisciplinary group of developers, ecologists, ethicists and policy experts, and thus includes a broader set of commitments than might have otherwise been developed. This is, of course, appropriate and necessary for the significant next step, moving from the laboratory to a confined field trial."

Other coauthors from UC San Diego's Division of Biological Sciences include Associate Professor Kimberly Cooper and Assistant Research Scientist Valentino Gantz.

"I believe the process of working together over the past few months itself has been valuable and hope that this effort to define our shared commitments will lead to even more cross-disciplinary collaboration in the gene drive field," said first-author Kanya Long, assistant adjunct professor at UC San Diego's Herbert Wertheim School of Public Health and Human Longevity Science.

What exactly is a gene drive?

Relatedly, on Dec. 8, Akbari and several co-authors published an opinion article in the Proceedings of the National Academy of Sciences (PNAS) on the need to standardize the core definition of gene drive and related terms.

Surprising to those outside of science, the accelerated rise of gene drive technologies in recent years has emerged without a broadly accepted set of definitions. Without common agreement on gene drive-related terms, confusion and disagreement can emerge as gene drive policies and regulations are being developed. For example, the authors note, "gene drive" has been used both to describe a process (the biological activity of gene drive spreading in a population) and to describe an object (the development of a "gene drive" engineering tool).

"There are multiple flavors of gene drives so it's really hard for a non-specialist to understand what we are talking about," said Akbari, who joined with world gene drive leaders Luke Alphey (PirBright) and Andrea Crisanti (Imperial College London), alongside Filippo (Fil) Randazzo (Leverage Science), to develop the definitions. "The point of the PNAS article was to bring leading experts together to define gene drive to provide a consistent and common language that can be used for communication."

Working through the Foundation for the National Institutes of Health (FNIH), Akbari noted that individuals and organizations that agree with the new standard of definitions are becoming signatories in support of these definitions.
-end-
Coauthors of the Science paper are: Kanya Long, Luke Alphey, George Annas, Cinnamon Bloss, Karl Campbell, Jackson Champer, Chun-Hong Chen, Amit Choudhary, George Church, James Collins, Kimberly Cooper, Jason Delborne, Owain Edwards, Claudia Emerson, Kevin Esvelt, Sam Weiss Evans, Robert Friedman, Valentino Gantz, Fred Gould, Sarah Hartley, Elizabeth Heitman, Janet Hemingway, Hirotaka Kanuka, Jennifer Kuzma, James Lavery, Yoosook Lee, Marce Lorenzen, Jeantine Lunshof, John Marshall, Philipp Messer, Craig Montell, Kenneth Oye, Megan Palmer, Philippos Aris Papathanos, Prasad Paradkar, Antoinette Piaggio, Jason Rasgon, Gordana Raši?, Larisa Rudenko, J. Royden Saah, Maxwell Scott, Jolene Sutton, Adam Vorsino and Omar Akbari.

University of California - San Diego

Related Public Health Articles from Brightsurf:

COVID-19 and the decolonization of Indigenous public health
Indigenous self-determination, leadership and knowledge have helped protect Indigenous communities in Canada during the coronavirus disease 2019 (COVID-19) pandemic, and these principles should be incorporated into public health in future, argue the authors of a commentary in CMAJ (Canadian Medical Association Journal) http://www.cmaj.ca/lookup/doi/10.1503/cmaj.200852.

Public health consequences of policing homelessness
In a new study examining homelessness, researchers find that policy such a lifestyle has massive public health implications, making sleeping on the street even MORE unhealthy.

Electronic health information exchange improves public health disease reporting
Disease tracking is an important area of focus for health departments in the midst of the COVID-19 pandemic.

Pandemic likely to cause long-term health problems, Yale School of Public Health finds
The coronavirus pandemic's life-altering effects are likely to result in lasting physical and mental health consequences for many people--particularly those from vulnerable populations--a new study led by the Yale School of Public Health finds.

The Lancet Public Health: US modelling study estimates impact of school closures for COVID-19 on US health-care workforce and associated mortality
US policymakers considering physical distancing measures to slow the spread of COVID-19 face a difficult trade-off between closing schools to reduce transmission and new cases, and potential health-care worker absenteeism due to additional childcare needs that could ultimately increase mortality from COVID-19, according to new modelling research published in The Lancet Public Health journal.

The Lancet Public Health: Access to identification documents reflecting gender identity may improve trans mental health
Results from a survey of over 20,000 American trans adults suggest that having access to identification documents which reflect their identified gender helps to improve their mental health and may reduce suicidal thoughts, according to a study published in The Lancet Public Health journal.

The Lancet Public Health: Study estimates mental health impact of welfare reform, Universal Credit, in Great Britain
The 2013 Universal Credit welfare reform appears to have led to an increase in the prevalence of psychological distress among unemployed recipients, according to a nationally representative study following more than 52,000 working-age individuals from England, Wales, and Scotland over nine years between 2009-2018, published as part of an issue of The Lancet Public Health journal on income and health.

BU researchers: Pornography is not a 'public health crisis'
Researchers from the Boston University School of Public Health (BUSPH) have written an editorial in the American Journal of Public Health special February issue arguing against the claim that pornography is a public health crisis, and explaining why such a claim actually endangers the health of the public.

The Lancet Public Health: Ageism linked to poorer health in older people in England
Ageism may be linked with poorer health in older people in England, according to an observational study of over 7,500 people aged over 50 published in The Lancet Public Health journal.

Study: Public transportation use linked to better public health
Promoting robust public transportation systems may come with a bonus for public health -- lower obesity rates.

Read More: Public Health News and Public Health Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.