Fostering responsible research with genome editing technologies: a European perspective

Chneiweiss, Hervé; Hirsch, François; Montoliu, Lluı́s; Müller, Albrecht; Fenet, Solveig; Abecassis, Marion; Merchant, Jennifer; Baertschi, Bernard; Botbol-Baum, Mylène; Houghton, J. A.; Kritikos, Mihalis; Mifsud, Janet; Bartnik, Ewa; Rath, Johannes; Druml, Christiane; Friedrich, Bärbel; Carvalho, Ana Sofia; Lanzerath, Dirk; Saint‐Raymond, Agnès

doi:10.1007/s11248-017-0028-z

Cited by 35 publications

(13 citation statements)

References 8 publications

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“…National and international life sciences communities recognize the need for broader conversations about responsibility as well (c.f., The National Academies of Sciences, Engineering and Medicine [NASEM], 2016; Chneiweiss et al, 2017). Importantly, and as Hartley et al (2016) have noted, a much broader community of people, organizations, experts, and interest groups will need to be involved in resolving questions like the above when approaching new and emerging gene-editing techniques through RRI.…”

Section: Discussion: the Need For New Molecular Characterization And mentioning

confidence: 99%

Revisiting Risk Governance of GM Plants: The Need to Consider New and Emerging Gene-Editing Techniques

et al. 2018

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New and emerging gene-editing techniques make it possible to target specific genes in species with greater speed and specificity than previously possible. Of major relevance for plant breeding, regulators and scientists are discussing how to regulate products developed using these gene-editing techniques. Such discussions include whether to adopt or adapt the current framework for GMO risk governance in evaluating the impacts of gene-edited plants, and derived products, on the environment, human and animal health and society. Product classification or definition is one of several aspects of the current framework being criticized. Further, knowledge gaps related to risk assessments of gene-edited organisms—for example of target and off-target effects of intervention in plant genomes—are also of concern. Resolving these and related aspects of the current framework will involve addressing many subjective, value-laden positions, for example how to specify protection goals through ecosystem service approaches. A process informed by responsible research and innovation practices, involving a broader community of people, organizations, experts, and interest groups, could help scientists, regulators, and other stakeholders address these complex, value-laden concerns related to gene-editing of plants with and for society.

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Section: Discussion: the Need For New Molecular Characterization And mentioning

confidence: 99%

Revisiting Risk Governance of GM Plants: The Need to Consider New and Emerging Gene-Editing Techniques

et al. 2018

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“…Some research groups and institutes do indeed seek to engage people in their locality on their genome editing research. The need for a responsible innovation approach to genome editing has been recognised by research scientists, including the setting up of a European Steering Committee to address these issues (Chneiweiss et al 2017). In the UK, lay members are appointed to some scientific and ethical advisory committees, such as in the field of animal research, both at national and local level, where genome editing developments may be considered.…”

Section: Genome Editing As a Challenge To Responsible Research And Inmentioning

confidence: 99%

Genome Editing and Responsible Innovation, Can They Be Reconciled?

Bruce

2019

J Agric Environ Ethics

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Genome editing is revolutionising the field of genetics, which includes novel applications to food animals. Responsible research and innovation (RRI) has been advocated as a way of ensuring that a wider-range of stakeholders and publics are able to engage with new and emerging technologies to inform decision making from their perspectives and values. We posit that genome editing is now proceeding at such a fast rate, and in so many different directions, such as to overwhelm attempts to achieving a more reflective pace. An alternative location for reflection is during the much slower process of taking products from the lab to market. We suggest emphasising Responsible Innovation, putting the 'I' back into RRI, and encouraging companies to embrace an RRI approach. We review some previous attempts at developing industry-relevant frameworks for RRI. We then describe two examples of genome editing in livestock; hornless cattle and disease resistant pigs, and reflect on the sorts of questions that could be considered in these two genome editing examples. This paper seeks to take forward the discussion on RRI by extending it to bringing products to market in the context of genome edited livestock.

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“…Possible adverse long-term effects of artificial genetic modifications can be attributed to this category as well. With regard to genome editing the fairly unpredictable long-term effects of so called gene drives are just one example (Champer et al, 2016, p. 156–57; Chneiweiss et al, 2017, p. 712).…”

Section: Normative Criteriamentioning

confidence: 99%

Normative Criteria and Their Inclusion in a Regulatory Framework for New Plant Varieties Derived From Genome Editing

Hamburger

2018

Front. Bioeng. Biotechnol.

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Any legal regulation has to take into account fundamental interests and concerns, whether of private or public nature. This applies in particular to the politically and socially sensitive question of regulating plant biotechnology. With the advent of new breeding techniques, such as genome editing, new challenges are arising for legislators around the world. However, in coping with them not only the technical particularities of the new breeding techniques must be taken into account but also the diverse and sometimes conflicting interests of the various stakeholders. In order to be able to draft a suitable regulatory regime for these new techniques, the different interests and concerns at play are identified. Subsequently, a determination is made on how these interests relate to each other, before regulatory concepts to reconcile the conflicting demands are presented. The examined normative criteria, which can have an impact on regulatory decisions regarding genome edited plants and products derived from them, include: industry interests, farmer interests, public opinion, consumer rights and interests, human health and food safety, food security, environmental protection, consistency, and coherence of the regulatory framework and ethical or religious convictions. Since those interests differ from country to country depending on the respective political, economic, and social circumstances, the respective legislator has the task of identifying these normative criteria and must find a suitable balance between them. To this end, a concept is developed on how the different interests can be related to each other and how to deal with conflicting and irreconcilable demands. Additionally, a legislator may have recourse to a number of further analyzed regulatory measures. An approval or notification procedure can be used for a risk assessment or a socio-economic evaluation. Coexistence measures and labeling provisions are able to reconcile interests that are at odds with each other and the precautionary principle can justify certain safeguard measures. As a result, the individual country-specific regulatory outcomes regarding genome edited plants are likely to be as manifold as the interests and regulatory measures at hand.

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Fostering responsible research with genome editing technologies: a European perspective

Cited by 35 publications

References 8 publications

Revisiting Risk Governance of GM Plants: The Need to Consider New and Emerging Gene-Editing Techniques

Revisiting Risk Governance of GM Plants: The Need to Consider New and Emerging Gene-Editing Techniques

Genome Editing and Responsible Innovation, Can They Be Reconciled?

Normative Criteria and Their Inclusion in a Regulatory Framework for New Plant Varieties Derived From Genome Editing

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