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January 26, 2018 | Patti Mulligan

The Genetic Engineering and Society Center at hosted a workshop in February of 2016, supported in part by the National Science Foundation, entitled ‘A Roadmap to Gene Drives: A Deliberative Workshop to Develop Frameworks for Research and Governance.’ (see workshop site)

In order to examine core governance issues and research needs in an anticipatory way, this 3-day workshop brought together over 70 subject matter experts from academia, business, government, and non-profit organizations from 10 different countries in Europe, Australia, and North and South America.

Those experts were invited to submit papers for this special issue of the Journal of Responsible Innovation. In total, 13 peer reviewed papers are included in the special Gene Drive issue of the Journal. The editorial team included three NC State faculty and two GES PhD students.

See all papers 

Adapted from the Introduction: “Mapping research and governance needs for gene drives

What is a gene drive?

A gene drive is a mechanism that biases inheritance of a trait in a sexually reproducing species of organisms. In this context, “bias” means to increase the odds of a parent passing on a portion of their DNA to above 50%, or what is historically understood as Mendelian inheritance (remember the wrinkled pea experiments?). In fact, under laboratory conditions, some gene drives have been shown to function at 95% efficiency or higher, meaning that a parent carrying a genetic sequence associated with a gene drive will pass on that sequence nearly every time that they reproduce. The key takeaway is that designed gene drives could theoretically allow humans to “drive” a desired trait into a population of organisms. Importantly, this population could be wild – neither its habitat nor its breeding behavior need be under human control – and the desired trait might reduce the fitness of the organism even while increasing in frequency throughout the population.

Why all the attention to gene drives?

While it has not quite become a household term, there has been significant attention to this emerging field of research in the popular and scientific media. On one hand, this should come as no surprise given the anticipated potential for gene drives to address intractable problems in public health, agriculture, and conservation. The close association between recent advances in gene editing (e.g., CRISPR) and gene drives likely also contributes to its newsworthiness. And perhaps there is some additional excitement seeing biotechnology cautiously embraced by public health advocates and biodiversity conservation NGOs. Of equal importance, while laboratory proofs of concept are accumulating slowly – increasing confidence that humans can construct gene drives with a purpose – no one yet knows if they really work. As of the close of 2017, no gene drive modified organism has been released outside of the laboratory.

What is behind this special issue?

In January 2015, faculty from North Carolina State University’s Genetic Engineering and Society Center submitted a workshop proposal to the National Science Foundation’s Science, Technology, and Society (STS) program entitled, “Gene Drives: A Deliberative Workshop to Develop Frameworks for Research and Governance.” The proposal noted that “[r]ecent legal and policy scholarship has focused on the need for governance to ‘keep pace’ with technological innovation in multiple domains, including biotechnology. However, we currently lack a broad evaluation of the potential ecological, political economy, ethical, and other issues to guide research and development of gene drives.” The workshop was envisioned to contribute to filling this gap, and its February 2016 agenda included presentations from diverse experts, ranging from molecular biologists to public policy scholars. Those experts and other attendees were invited to submit papers to this special issue, which were peer reviewed by a mixture of workshop attendees and other scholars.

What is inside this special issue?

This special issue represents both deep and broad thinking about gene drives. It is not a roadmap in a typical sense, such as a Google map, whose utility is marked by comprehensive integration of ground-truthed facts and perfect clarity in departure points and destinations. Instead, the articles provide signposts that encourage attention to diverse issues, remind readers of helpful frameworks and analogies, and foster interdisciplinary conversations about the pursuit of responsible innovation in gene drive research and development.

Acknowledgements

The editors would first like to thank the contributors to this special issue, who offered their expertise, creativity, time, and energy to create a truly interdisciplinary analysis of the emerging field of gene drive research. We also thank all those who attended the gene drive workshop at North Carolina State University in 2016, whose ideas helped inspire the papers that follow. Erik Fisher, Editor-in-Chief of the Journal of Responsible Innovation, provided thoughtful guidance and support at every step of the publication process. We also acknowledge the many scholars who offered their expert judgments and constructive criticisms of manuscript drafts as part of the invisible labor of peer-review. Finally, support from the staff at the Genetic Engineering and Society Center, including Sharon Stauffer and Patti Mulligan, make projects like this possible, impactful, and more enjoyable.

Papers

Journal of Responsible Innovation | Roadmap to Gene Drives: Research and Governance Needs in Social, Political, and Ecological Context

Gene drives and the expanding horizon of governance

  • Editorial
Erik Fisher. 2018. Gene drives and the expanding horizon of governance. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 1-3. doi: 10.1080/23299460.2017.1422378. Download

Mapping research and governance needs for gene drives

  • Introduction
Jason Delborne, Jennifer Kuzma, Fred Gould
, Emma Frow, Caroline Leitschuh and Jayce Sudweeks. 2018. Mapping research and governance needs for gene drives. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1419413. Download

A roadmap for gene drives: using institutional analysis and development to frame research needs and governance in a systems context

  • The deployment of gene drives is emerging as an alternative for protecting endangered species, controlling agricultural pests, and reducing vector-borne diseases. This paper reports on a 2016 workshop exploring the complex intersection of political, economic, ethical, and ecological risk issues associated with gene drives.
J. Kuzma, F. Gould, Z. Brown, J. Collins, J. Delborne, E. Frow, K. Esvelt, D. Guston, C. Leitschuh, K. Oye and S. Stauffer. 2017. A roadmap for gene drives: using institutional analysis and development to frame research needs and governance in a systems context. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1410344. Download

Harnessing gene drive

  • Determining whether, when, and how to develop gene drive interventions responsibly will be a defining challenge of our time. Here we describe capabilities, safeguards, applications, and opportunities relevant to gene drive technologies.
John Min, Andrea L. Smidler, Devora Najjar, and Kevin M. Esvelt. 2017. Harnessing gene drive. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1415586. Download

Gene drive to reduce malaria transmission in sub-Saharan Africa

  • Despite impressive progress, malaria continues to impose a substantial burden of mortality and morbidity, particularly in sub-Saharan Africa. A wide array of synthetic gene drive systems have been proposed to control the mosquitoes that transmit malaria.
Austin Burt, Mamadou Coulibaly, Andrea Crisanti, Abdoulaye Diabate, and Jonathan K. Kayondo. 2018. Gene drive to reduce malaria transmission in sub-Saharan Africa. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1419410. Download

Anticipating complexity in the deployment of gene drive insects in agriculture

  • Drawing on lessons from the deployment of other pest control technologies, we consider how insects containing gene drives could intersect with some of the complexities characterizing agricultural systems.
Jennifer Baltzegar, Jessica Cavin Barnes, Johanna E. Elsensohn, Nicole Gutzmann, Michael S. Jones, Sheron King, and Jayce Sudweeks. 2017. Anticipating complexity in the deployment of gene drive insects in agriculture. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1407910. Download

Agricultural production: assessment of the potential use of Cas9-mediated gene drive systems for agricultural pest control

  • We provide examples of gene drives that target specific genes, including female-essential genes. Further, we discuss issues related to containment in the laboratory & eventual field testing of strains harboring a Cas9-mediated gene drive system.
Maxwell J. Scott, Fred Gould, Marcé Lorenzen, Nathaniel Grubbs, Owain Edwards and David O’Brochta. 2017. Agricultural production: assessment of the potential use of Cas9-mediated gene drive systems for agricultural pest control. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1410343. Download

Developing gene drive technologies to eradicate invasive rodents from islands

  • Gene drive methods of rodent eradication offer an alternative to killing that has the potential to be more species-specific, more humane, and more biologically safe for use around humans. Technologies in development aim to apply gene drives to influence offspring, eventually creating a population that is not reproductively viable.
Caroline M. Leitschuh, Dona Kanavy, Gregory A. Backus, Rene X. Valdez, Megan Serr, Elizabeth A. Pitts, David Threadgill and John Godwin. 2017. Developing gene drive technologies to eradicate invasive rodents from islands. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1365232. Download

Identifying and detecting potentially adverse ecological outcomes associated with the release of gene-drive modified organisms

  • We outline methods to identify hazards and detect potentially adverse ecological outcomes at the individual, population, community and ecosystem level, when progressing Gene Drive Modified Organisms through a phased test and release pathway.
K.R. Hayes, G.R. Hosack, G.V. Dana, S.D. Foster, J.H. Ford, R. Thresher, A. Ickowicz, D. Peel, M. Tizard, P. De Barro, T. Strive and J. M. Dambacher. 2018. Identifying and detecting potentially adverse ecological outcomes associated with the release of gene-drive modified organisms. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1415585. Download

The roles of ethics in gene-drive research and governance

  • Ethics research queries the norms and values that shape the goals and justification for gene drive projects, and that might lead to issue or opposition to such projects. A framework for organizing ethics research is offered.
Paul B. Thompson. 2018. The roles of ethics in gene-drive research and governance. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1415587. Download

Economic issues to consider for gene drives

  • We examine four economic issues regarding gene drive applications. The potentially substantial benefits, coupled with the technical, social, and economic uncertainties, suggest that a responsible course of action is to move forward while maintaining regulatory flexibility and conducting research to resolve key uncertainties.
Paul D. Mitchell, Zachary Brown and Neil McRoberts. 2017. Economic issues to consider for gene drives. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1407914. Download

Regulating animals with gene drive systems: Lessons from the regulatory assessment of a genetically engineered mosquito

  • Given the profound impact that gene drives could have on species and ecosystems, their use is a highly contentious issue. In this paper, we consider the question of whether the United States Food and Drug Administration is prepared to effectively regulate insects and other animals with gene drives.
Zahra Meghani and Jennifer Kuzma. 2017. Regulating animals with gene drive systems: Lessons from the regulatory assessment of a genetically engineered mosquito. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1407912. Download

Anomaly handling and the politics of gene drives

  • Decisions about the development and use of gene drives are framing broader debates about the need for fundamental changes to biotechnology regulatory systems. We summarize this debate and describe how gene drives are being constructed as potential anomalies within the regulatory landscape
Sam Weiss Evans and Megan J. Palmer. 2017. Anomaly handling and the politics of gene drives. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1407911. Download

Gene drives and the management of agricultural pests

  • Difficulties involved in the containment of gene drives may restrict their use and require international agreements before release of approved types. The present commentary provides some thoughts on some of the issues one should consider when contemplating using gene drives in the management of agricultural pests.
Raul F. Medina. 2017. Gene drives and the management of agricultural pests. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1407913. Download

Committee on Gene Drive Research in Non-Human Organisms: Recommendations for Responsible Conduct

Summary of Consensus Report, Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values (2016). Washington, DC: The National Academies Press. doi: 10.17226/23405. Download
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