Ethical lessons from a tale of two genetically modified insects

Neuhaus, Carolyn P.; Caplan, Arthur L.

doi:10.1038/nbt.3927

Cited by 21 publications

(21 citation statements)

References 12 publications

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“…The risk assessment must be reexamined and updated before moving forward along the testing pathway, to take into account any changes in human or environmental exposure, additional data, and any further public concerns. 56 Although researchers are encouraged to make such external assessments available to regulators and the public, it should be understood that these would not supersede the risk assessments performed by the regulators in connection with evaluating applications, in compliance with national regulatory requirements and guidelines.…”

Section: General Considerations For Developing Gene Drive Mosquitoesmentioning

confidence: 99%

“…15 , 62 Researchers are responsible for obtaining fair and legitimate authorization for field-testing gene drive mosquitoes. 56 At the highest level, safety is a paramount public interest that is addressed through the regulatory mechanisms put in place by governments. Moreover, it is a standard requirement to obtain ethical clearance for any research involving human participation.…”

Section: General Considerations For Developing Gene Drive Mosquitoesmentioning

confidence: 99%

“…As discussed in the following text under community engagement, this requires practices undertaken to inform such persons about the project, and to understand, respond to, and learn from their perceptions and reactions in a way that makes it clear their opinions have influence. 15 , 56 , 62 …”

Section: General Considerations For Developing Gene Drive Mosquitoesmentioning

confidence: 99%

See 2 more Smart Citations

Pathway to Deployment of Gene Drive Mosquitoes as a Potential Biocontrol Tool for Elimination of Malaria in Sub-Saharan Africa: Recommendations of a Scientific Working Group †

James

Collins

Welkhoff

et al. 2018

The American Journal of Tropical Medicine and Hygiene

189

239

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Abstract.Gene drive technology offers the promise for a high-impact, cost-effective, and durable method to control malaria transmission that would make a significant contribution to elimination. Gene drive systems, such as those based on clustered regularly interspaced short palindromic repeats (CRISPR)/CRISPR associated protein, have the potential to spread beneficial traits through interbreeding populations of malaria mosquitoes. However, the characteristics of this technology have raised concerns that necessitate careful consideration of the product development pathway. A multidisciplinary working group considered the implications of low-threshold gene drive systems on the development pathway described in the World Health Organization Guidance Framework for testing genetically modified (GM) mosquitoes, focusing on reduction of malaria transmission by Anopheles gambiae s.l. mosquitoes in Africa as a case study. The group developed recommendations for the safe and ethical testing of gene drive mosquitoes, drawing on prior experience with other vector control tools, GM organisms, and biocontrol agents. These recommendations are organized according to a testing plan that seeks to maximize safety by incrementally increasing the degree of human and environmental exposure to the investigational product. As with biocontrol agents, emphasis is placed on safety evaluation at the end of physically confined laboratory testing as a major decision point for whether to enter field testing. Progression through the testing pathway is based on fulfillment of safety and efficacy criteria, and is subject to regulatory and ethical approvals, as well as social acceptance. The working group identified several resources that were considered important to support responsible field testing of gene drive mosquitoes.

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Section: General Considerations For Developing Gene Drive Mosquitoesmentioning

confidence: 99%

Section: General Considerations For Developing Gene Drive Mosquitoesmentioning

confidence: 99%

See 1 more Smart Citation

Pathway to Deployment of Gene Drive Mosquitoes as a Potential Biocontrol Tool for Elimination of Malaria in Sub-Saharan Africa: Recommendations of a Scientific Working Group †

James

Collins

Welkhoff

et al. 2018

The American Journal of Tropical Medicine and Hygiene

189

239

View full text Add to dashboard Cite

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“…Community advisory boards (CABs) have been proposed as a means for local community engagement [ 10 ]. In the context of international collaborative research in poorer nations, community engagement is praised as an indicator of sound ethical and research practice.…”

Section: Communities and Informed Decision-makingmentioning

confidence: 99%

Genetically engineered mosquitoes, Zika and other arboviruses, community engagement, costs, and patents: Ethical issues

Meghani

Boëte

2018

PLoS Negl Trop Dis

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“…This presumption has been reinforced in some early experiences with the testing of biologically-modified mosquitoes, in which regulators insisted on household level informed consent as a condition of approval for open-release trials 12 . Other commentators have argued that “(t)here are, strictly speaking, no human subjects of field trials, so the regulations governing human subjects research, which require informed consent from every participant, do not apply.” ( 13 , p. 716) It is both ethically and practically important that these presumptions are properly scrutinized to ensure that any appeals to apply informed consent in future trials of genetically modified mosquitoes constitute an appropriate response to the ethical stakes involved, and not simply a reflexive appeal to the most familiar tool in the research ethics toolbox.…”

Section: Conflicting Presumptions About the Role Of Informed Consentmentioning

confidence: 99%

Informed consent in field trials of gene-drive mosquitoes

Kolopack

Lavery

2017

Gates Open Res

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The US National Academies’ (NAS) recent report ‘Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values’ examines the requirements of responsible conduct in research involving gene drives in non-human organisms. Many of the complex ethical issues raised by the introduction of gene drive technologies for mosquito population control have been anticipated during the development and field-testing of earlier-generation genetic engineering approaches with mosquitoes. One issue—the requirement for informed consent in field trials—is not addressed explicitly in the NAS’ report. Some commentators have presumed that informed consent should play a role as a protection for research participants in studies of genetically modified mosquitoes. Others have argued that there are no human subjects of field trials, so the informed consent requirement does not apply. It is both ethically and practically important that these presumptions are adequately scrutinized to ensure that any applications of informed consent in these trials are properly justified. We argue that informed consent from individual research participants in gene drive trials may be required: (1) when blood and other forms of clinical data are collected from them, as will likely be the case in some studies involving epidemiological endpoints, such as the incidence of new infections with dengue and malaria; (2) when they participate in social science and/or behavioral research involving the completion of surveys and questionnaires; or (3) when their home or property is accessed and the location recorded as a spatial variable for the release or collection of mosquitoes because the precise location of the household is important for entomological reasons and these data constitute identifiable private information at the household level. Importantly, most regulations and guidelines allow these requirements to be waived or modified, to various degrees, according to the judgment of Institutional Review Boards.

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Ethical lessons from a tale of two genetically modified insects

Cited by 21 publications

References 12 publications

Pathway to Deployment of Gene Drive Mosquitoes as a Potential Biocontrol Tool for Elimination of Malaria in Sub-Saharan Africa: Recommendations of a Scientific Working Group †

Pathway to Deployment of Gene Drive Mosquitoes as a Potential Biocontrol Tool for Elimination of Malaria in Sub-Saharan Africa: Recommendations of a Scientific Working Group †

Genetically engineered mosquitoes, Zika and other arboviruses, community engagement, costs, and patents: Ethical issues

Informed consent in field trials of gene-drive mosquitoes

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