Governing Gene Drive Technologies: A Qualitative Interview Study

Abstract

Background

Gene drive technologies (GDTs) bias the inheritance of a genetic element within a population of non-human organisms, promoting its progressive spread across this population. If successful, GDTs may be used to counter intractable problems such as vector-borne diseases. A key issue in the debate on GDTs relates to what governance is appropriate for these technologies. While governance mechanisms for GDTs are to a significant extent proposed and shaped by professional experts, the perspectives of these experts have not been explored in depth.

Methods

A total of 33 GDT experts from different professional disciplines were interviewed to identify, better understand, and juxtapose their perspectives on GDT governance. The pseudonymized transcripts were analyzed thematically.

Results

Three main themes were identified: (1) engagement of communities, stakeholders, and publics; (2) power dynamics, and (3) decision-making. There was broad consensus amongst respondents that it is important to engage communities, stakeholders, and publics. Nonetheless, respondents had diverging views on the reasons for doing so and the timing and design of engagement. Respondents also outlined complexities and challenges related to engagement. Moreover, they brought up the power dynamics that are present in GDT research. Respondents stressed the importance of preventing the recurrence of historical injustices and reflected on dilemmas regarding whether and to what extent (foreign) researchers can legitimately make demands regarding local governance. Finally, respondents had diverging views on whether decisions about GDTs should be made in the same way as decisions about other environmental interventions, and on the decision-making model that should be used to decide about GDT deployment.

Conclusions

The insights obtained in this interview study give rise to recommendations for the design and evaluation of GDT governance. Moreover, these insights point to unresolved normative questions that need to be addressed to move from general commitments to concrete obligations.

Keywords:

• Ethics
• qualitative research
• gene editing
• gene drives
• governance

Acknowledgements

We are grateful to all participants for their insights and contribution to this study. Moreover, we are grateful to Isabelle Pirson for her help in analyzing a part of the interviews.

Conflicts of interest

Annelien Bredenoord is a member of the Dutch Senate. She also serves as a member of the Ethics Committee of the ISSCR and the Ethics Advisory Board of IQVIA. Nienke de Graeff, Karin Jongsma and Jeantine Lunshof have no conflicts of interest to declare in relation to this research.

Ethics approval

Participants were informed about the study and agreed to participate via e-mail. Prior to the start of the interview, participants were verbally informed about the interview study, its recording and the pseudonimized analysis of interview data. Each participant gave verbal consent to the interview, which was recorded. The research protocol was submitted to the research ethics committee of the University Medical Center Utrecht for review prior to the initiation of research. The research ethics committee determined that this study was exempt from the Medical Research Involving Humans Act (research proposal no. 18/618).

Notes

1 Organisms whose genomes have been genetically altered with a gene drive to spread a desired gene alteration through a population. GDTs could only be used in organisms that have an inheritance pattern that can be biased, which typically means that they reproduce sexually (Alphey et al. 2020).

2 Technology governance may be defined as the "process of exercising political, economic and administrative authority in the development, diffusion and operation of technology in societies" (Organization for Economic Co-operation and Development (OECD)) 2021). Governance thus encompasses a broad range of mechanisms to steer technology development, including but not limited to regulation (Rudenko, Palmer, and Oye 2018; Organization for Economic Co-operation and Development (OECD)) 2021).

3 At the same time, it should be noted that the expertise relevant to GDT governance is not limited to professional expertise on GDTs, but importantly also includes what has been called the ‘experiential expertise’ (Harris et al. 2016) of community members living near potential GDT trial sites. Indeed, professional experts on GDTs may be laypersons on other topics of relevance to GDT governance (Nowotny 2003), such as expertise of the local environment and social-cultural context and having personal knowledge of the illness or problem that the release of GDT organisms would address (Teem et al. 2019; Bartumeus et al. 2019).

4 The findings related to the substantive ethical questions, concerns, and implications of GDTs − i.e. those questions, concerns, and implications that relate to “what is right in terms of duties, rights, and values (..) independent of any decision-making procedure” (Sollie 2009) (155) have been reported elsewhere (De Graeff, Jongsma, and Bredenoord 2021). A detailed description of the methodology of the study, in line with the consolidated criteria for reporting qualitative studies (COREQ), has also been provided in that publication.

5 The terms ‘communities’, ‘stakeholders’, and ‘public(s)’ were defined and used in different ways by the respondents of this study, frequently without explication of or differentiation between these categories. Generally speaking, respondents used the terms ‘communities’ and ‘stakeholders’ roughly in line with the way in which these terms were defined in a foundational report on GDTs written by the National Academies of Sciences, Engineering and Medicine (NASEM). According to this report, communities are “group[s] of people who live near enough to a potential field trial or release site that they have tangible and immediate interest in the gene drive project” (NASEM 2016, 180), and stakeholders are “person[s] with a professional or personal interests sufficient to justify engagement” (including communities) (NASEM 2016, 185). Correspondingly, we use these terms in this way in this manuscript. The term ‘publics’ was used in at least two significantly different ways by respondents. One the one hand, some respondents used this term to refer to what others called communities. On the other hand, other respondents used this term in line with the NASEM definition: “groups who lack the direct connection to a project that stakeholders and communities have but nonetheless have interests, concerns, hopes, fears, and values that can contribute to democratic decision making.” (NASEM 2016, 184). Where the term is used in the text of this manuscript, we use the term pubic(s) in the second sense.

6 It should be acknowledged that concepts used to divide the world also oversimplify it (Schneider 2017). Where we use the terms ‘global North’ and ‘global South’, one may also read ‘Minority World’ and ‘Majority World’ – terms that do more justice to the fact that the largest share of the world population is located in the global South.

7 I.e. approaches in which people would have a direct say in whether GDTs are deployed or not, for instance through voting.

Additional information

Funding

This work was supported by the division of Applied and Engineering Sciences of Dutch Research Council (NWO) under grant number 15804 of the research program ‘Biotechnology and Safety’ commissioned by the Dutch Ministry of Infrastructure and Water Management.