Enabling conditions.

There were three enabling conditions that facilitated the ED team’s capacity to “do” CE in a robust way: (1) support from sponsors; (2) regulatory approvals; and (3) an independent risk assessment. Although the funders did not impose specific requirements for CE on the ED Program, the need for, and importance of, CE in the ED Program was consistently and continually encouraged, supported, and reinforced by the Senior Program Officers from the BMGF and the Foundation for the National Institutes of Health (FNIH) who were responsible for managing the BMGF’s investments in the ED Program. The funders recognized that supporting CE should be a priority, based on prior examples of field trials of other modified-mosquito technologies that had failed because of inadequate or inappropriate public engagement processes.

We all knew, the applicants knew, everyone in the program knew how important this was going to be because we all had heard stories about similar types of technology that were inhibited, were stopped, because the public engagement process was not conducted appropriately… (IV3-24, Funder)

The Wolbachia technology did not fit neatly into any of the existing regulatory and risk assessment pathways in Australia. The lack of clarity about the appropriate regulatory review processes might have made it easier for the ED Program to deploy Wolbachia mosquitoes with minimal regulatory scrutiny. But, instead, the ED Program used the opportunity to engage regulators—an external stakeholder—to clarify an appropriate regulatory pathway and review process for the open-release studies. Additionally, the ED Program’s leadership chose to obtain an independent, comprehensive, expert risk assessment from a respected organization in Australia [27, 28].

Okay, the mosquito feeds on humans so humans are going to be a part of the mix. And that immediately made it very different to a process for releasing a new species into Australia, because in the context of biological control, you’re usually releasing something which is going to feed on a plant or another insect, not a mosquito that’s going to feed on humans. So, the risk assessment processes that you go through for the introduction of a new species into Australia is completely silent on pretty well anything other than environmental impact risk. … I said to [the ED PI], “well this has got to be bigger than that. We really do need to look at this as an all hazards risk assessment and we need to work out what all those hazards are and categorize them.” We just had this huge brainstorming exercise that delivered well over 100 potential hazards. … There were political issues. There were social issues. There were economic issues and there were regulatory issues. And so, we thought well okay, we need a way of tackling this. And again, there’s no blueprint. Nobody has done this in Australia as far as Australian legislation was concerned. (IB2-22: Independent Risk Analyst)

Internal leadership.

The championing of CE by the ED Program’s senior leadership team, including its Principal Investigator, established CE as a high priority and sent a strong signal to the ED team that CE was to be taken very seriously.

But I think amongst some of the scientists involved there was a view that what science does is so self-evidently a public good that you really don’t need to pay much attention to these issues. . . Equally, and I think this is really important, there were signs of a very different attitude …I don’t think there’s any doubt that [the PI], who was the leading light in this, or a leading light. It was very obvious to me early on that he certainly was well aware of the need to genuinely consider the social aspects. Not simply as a PR exercise. (IB2-18 ED Social Scientist)

Leadership on CE was manifested in three key program decisions: (1) CE would be an integral component of the ED Program; (2) sufficient human and financial resources would be invested in CE; and (3) sufficient time would be dedicated to CE before, during, and after the planned open-release trials. These decisions set the stage for the success of the ED Program’s approach to CE. Table 1 presents eight additional specific features of the ED Program leadership that had a formative role in the design and execution of their CE strategy.

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Table 1. Demonstrations of leadership by PI and senior program management.

https://doi.org/10.1371/journal.pntd.0003713.t001

Core commitments and guiding values.

Our analysis of interviews with internal and external stakeholders identified a clear set of core commitments and guiding values. Although these were never formalized by the ED program, they were explicitly and implicitly evident in the ED Program’s approach to CE, and in the experiences of both internal and external stakeholders. The central idea anchoring the ED Program’s approach was that throughout the entire duration of the project—including the planning and conduct of any open-release trials—CE had to be "meaningful" to stakeholders themselves and not simply useful to the investigators. That CE had to be meaningful to stakeholders was embodied and manifested in nine core commitments and guiding values that: (1) served as the ethical foundation for shaping the ED team’s approach to CE; (2) informed how the ED team would interact with stakeholders; and (3) provided practical guidance in terms of designing and conducting specific CE activities and practices. Table 2 presents an in-depth overview of these core commitments and guiding values.

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Table 2. Core commitments and guiding values.

https://doi.org/10.1371/journal.pntd.0003713.t002

Formative research.

In response to the funders’ requirement to address the social dimensions of the research in the initial grant application, the ED Program’s senior leadership specified that extensive formative social science research would be conducted in advance of initiating engagement activities in the host communities and in advance of any open-release trials. They engaged a local social scientist to design and manage a program of research with four goals: (1) to identify and understand stakeholders’ perspectives towards the proposed Wolbachia technology; (2) to understand stakeholders’ perspectives on the history of biological control in the region, and the current sociopolitical context; (3) to gain an understanding of stakeholders’ knowledge of dengue-transmitting mosquitoes and their behaviour; and (4) to identify what these stakeholders wanted to learn more about, and believed others would want to learn more about, and how they wanted to be engaged—including opportunities for becoming involved in the project [21, 22]. From the initiation of the formative research program up to, and beyond, the initial open-release trials, the social scientists engaged stakeholders—including residents of the host communities—using in-depth interviews, focus groups, and written surveys [21].

…[we wanted] to find out how people wanted to be engaged. What was the methodology that they were most comfortable with? How would they want us to interact with them? What level of engagement were they most comfortable with? Do they really want to participate, or do they just want to be informed? (IB2-18 Social Scientist)

The results of this formative research helped the ED team know “what they were up against” and helped identify and clarify what they needed to incorporate into their approach to CE and the design of the open-release trials. For example, the research revealed salient understandings and assumptions of stakeholders regarding dengue, such as the persistent misconception that local “swamp mosquitoes” were dengue transmitters, and concerns about the possibility of another “cane toad disaster” based on stakeholders’ previous experience with biological control that lead to undesirable outcomes in the region [15,16]. The ED team also identified that stakeholders wanted opportunities to become involved in the project as well as opportunities to engage with other stakeholders to learn about their perspectives towards Wolbachia [15]. Through these formative research activities the ED Program began to refine and operationalize its core commitments and guiding values, which shaped all of their subsequent interactions and relationships with stakeholders.

Building the CE team.

A dedicated CE team was an integral dimension of the ED Program’s operations. As described above, at the outset of the project, a social scientist was hired who had the expertise to take primary responsibility for designing and conducting the formative research and to guide the translation of the insights gained into a broader engagement plan to be used within the host communities. As the formative research began to take the ED Program increasingly into public view, and as the science progressed towards preparations for open-release studies, dedicated CE officers were hired to work in each host community. Often, the CE officers were residents of the host communities already and their familiarity with the local settings facilitated their engagement with residents.

Alongside the dedicated CE officers, as the planning of specific CE activities was initiated, there was growing recognition that “everyone” on the ED team “does CE” to some extent. This included senior ED Program leadership, field technicians, entomologists, other scientists, as well as staff involved in project communications. For example, scientists were paired with a CE officer to give presentations and answer questions from the public as part of town halls and other public events. Field technicians played a significant role as part of the “public face of the trial” because of their day-to-day interactions with residents who agreed to participate in entomological activities. And the communications team facilitated the development of public relations materials for use in CE—including sharing what was learned through CE within the host communities on the ED Program’s website for wider distribution to other stakeholders. Investment in CE training for ED staff was a key operational priority.

Integrating CE into internal program management.

The senior leadership of the ED Program recognized CE as a central management issue and ensured that it was incorporated into their day-to-day management priorities. Two main practices were involved. The first entailed having CE Officers provide updates during weekly program meetings, including feedback they had received from field technicians and any relevant insights gained through their interactions with stakeholders.

. . . having the community engagement person in the room as part of these weekly planning meetings that we had, so that there was the rapid feedback. What we were hearing from the communities via our community engagement person was integrated into our operations: Were we releasing too many mosquitoes in some areas of the community? Was there this informal chatter amongst the community that maybe we were getting to the point where people might not be all that happy to participate. . . . So having that rapid turnaround of feedback … was operationally very reassuring to know that we weren’t getting off track with our relationship … we want people out there measuring, listening, and bringing those feelings back into the project in a timely fashion. (IM1-09 Senior leadership)

The second practice entailed each CE officer maintaining a database tracking their interactions with stakeholders. This record-keeping facilitated the ED Program’s commitment to listen and be responsive. For example, if a resident declined participation in the release activities, this was noted in the database. When subsequent release activities were being planned this documentation allowed the ED team to avoid re-contacting this household for permission (recognition that ‘no’ meant ‘no’). Instead, the team would reach out and inform the resident of a new upcoming release, acknowledge their prior response, and seek their perspective on this latest release. Although the databases held a valuable dataset and helped the ED team fulfill their core commitments, the CE team members who used the databases reported that they could likely serve other useful purposes as well, but had not yet been employed more systematically across the program.

Discerning the community of stakeholders.

The ED team adopted an inclusive view of stakeholders (what we have referred to in our sampling strategy as external stakeholders)—i.e. the broad range of individuals, groups, and organizations they believed could be “affected” by their activities at all levels—local, state, and national—and committed to “reaching everyone”. As one ED team member described, “lines and lines” of public officials, individuals, community groups, and organizations were generated and plans put in place to engage them. Discerning the community of stakeholders was not a linear process, but rather a complex and recursive set of activities. Identifying potential stakeholders often began through interactions with public officials because they were seen to be legitimate representatives of relevant constituencies, and provided reliable introductions to other “well connected and respected” local leaders and those with “standing” in the community. As part of their commitment to inclusivity, the ED team consistently reached out to individuals and groups whom they, or others, believed might support the ED Program as well as those who might oppose it. The ED team also made efforts to identify and tap into existing social networks as ways to improve the “reach” of their engagement efforts and to acknowledge and respect the social structures that already existed in the host communities.

My feeling is quite often when anybody walks into a community, it doesn’t matter if it’s dengue work or. . . whatever you’re doing, there are already incredible networks that exist within a community. And if you bypass them and think you know better by coming in your way, then you are potentially really putting the community aside. And there are already, also, really good people within the community building those networks. So, it also is another way of respecting the social structures that already exist and talking to them and connecting to their networks as well.” (IB2-15 CE Officer)

Establishing and maintaining a presence in the community.

Establishing and maintaining a presence in the community reflected the ED Program’s ongoing commitment to “put themselves into the community” and to be transparent about their work. The goal was to make the ED Program visible and familiar and therefore further facilitate their commitment to make themselves available to stakeholders:

. . . I think it’s also being available for people to come and talk to you. It comes in many different forms, from essentially sitting on the side of the street somewhere so if people walk past they can come and talk to you and ask you questions. It’s having information around, and it’s making connections with different people within the community. . . By you being known to them, you’re bringing the community to you. (IC1-01 CE Officer)

Specific practices included traditional public relations strategies such as disseminating information about the program through pamphlets and posters in public places. They also employed branding practices such as ensuring staff uniforms and vehicles were marked with the ED logo. Other examples included renting a store-front in the Cairns city centre and having various members of the ED team, including the PI, “walk the streets” to interact with residents. Having ED team members accessible in these community settings and at times that were convenient for local residents increased the frequency and richness of interactions and contributed to the team’s commitments to listen and to be responsive to stakeholders’ concerns.

Socializing the technology and the research process.

The ED team made extensive efforts to socialize the Wolbachia technology and their proposed research strategy. This process involved introducing the scientific concepts underlying the technology, explaining what they hoped to achieve through the program, and eliciting host community input on these aims as well as feedback about their CE practices. Numerous individual and group-based activities were undertaken including formal meetings with public officials and local business leaders, town halls, presentations and meetings with community groups, community organizations and local business groups including residents’ associations, the local boating association, Meals on Wheels, the State Emergency Service, and the local Cane Growers Association. Other activities included presentations at area elementary schools, distributing newsletters to interested residents, hosting booths and installments at local community events and festivals, as well as regular “door knocks” at the homes of residents in the release areas—particularly during the open-release trials.

Each of these activities enabled the ED Program to operationalize several core commitments and guiding values including making themselves available to stakeholders, listening and responding to stakeholders’ concerns, and facilitating dialogue.

… if somebody says “you’re releasing a lot of mosquitoes” or “there’s too many mosquitoes around my house. I don’t want to be involved any more”. We follow up with a call. We say “when are you being bitten?” If they’re being bitten at night time, they’re not dengue mosquitoes. They’re not mosquitoes we’re releasing. So we tend to put our trap in the house. …we’ll provide that information back to the resident and say “hey, we’ve done some trapping. Yeah, the mosquito numbers are high but they’re mosquitoes that bite you at night. They’re not the ones we’re releasing.” So we try to educate them that it’s not just our mosquitoes, there’s more than one species. (IM1-10 Senior Leadership)

The ED team also chose to undertake several experiments—“direct experiments”—in response to questions raised by community members about the safety of the technology that were not originally part of the ED Program’s research plan:

We undertook certain research even though we felt as scientists that a lot of the concerns, when you looked at the scientific literature and what we knew about the bacterium, they weren’t really big problems in our mind but mindful of the community felt that they were issues… For example, could Wolbachia be transferred to people? So we did a bunch of experiments around that and showed that well no, it couldn’t. We already felt comfortable about that as scientists because lots of mosquitoes have Wolbachia that bite people all the time and we see no untoward effect from that. But we wanted to do the actual research to show the people in the community that there wasn’t a problem there and we ended up using that to show regulators as well subsequently. (IM1-08 Senior Leadership)

The results of these experiments were shared with the communities during their engagement activities.

Apprehension/opposition.

Several internal and external stakeholders recounted their own, and others’ apprehension and opposition to the Wolbachia technology, a perspective that was identified predominantly, though not exclusively, in the initial phases of engagement.

I wanted an ultimate feeling of safety, that it wasn’t another bad introduction. If you remember, the cane toad was introduced at Gordonvale and has been an environmental disaster. I said sometimes the scientists get it wrong, so I wanted to be sure. (IC2-12 Local Resident)

The reasons reported for apprehension and opposition were diverse and included unfamiliarity with the technology, difficulty grasping the logic of releasing more (Wolbachia-infected) mosquitoes to reduce the overall mosquito population, concerns over potential detrimental effects on both human and environmental health, doubts about whether scientists should be “messing with the balance of nature”, and concerns related to previous experiences with biological control strategies in the region.

What they talked about was bacterial cures and that sort of thing. People became a little bit apprehensive about that, a little concerned, because we had never heard of this sort of thing before. The reception was a little vague, no one really knew much about it IC1-05, Local Resident).

Some residents who refused to permit releases of mosquitoes on their property expressed frustration that the ED team’s policy of not releasing on adjacent properties, and even placing traps on their own properties in an effort to limit their exposure, ultimately meant that they were “just going to release them anyway”, and proceed with the program, despite their individual objections.

From apprehension to support from stakeholders: How CE was meaningful to stakeholders.

Although some individuals experienced some apprehension, and some residents refused to grant permission for releases on their property, these attitudes primarily reflect resistance to, or discomfort with, the concept of biological control, or the seeming paradox of releasing mosquitoes to control dengue, a mosquito-borne disease, or with the perceived inevitability of the program proceeding, even in the face of individual refusals to cooperate. We encountered no complaints from external stakeholders about the manner in which they were engaged. In fact, external stakeholders often described their experience of the intensive personal engagement with the ED program as instrumental in acknowledging and addressing their concerns, and in winning their confidence and support for the ED program. In their accounts of their experiences with the ED Program, stakeholders believed that they were listened to, that their concerns were taken seriously, and that they were respected as people. External stakeholders also indicated that they valued how ED team members made themselves readily available to them, as well as how they were transparent and honest about their work.

Upon going onto Google and seeing that Wolbachia was a derivative from the tsetse fly, I had concerns that there were enough safeguards in the program, that we wouldn’t go from being sore and sick from dengue to being zombies from Wolbachia. The JCU team then invited me up to see the research facilities in Cairns, and I went there and they allayed all my fears and questions about introducing this. Once I understood what was being proposed and what was going to go on, I supported it and encouraged it, and wherever possible I went with them to public consultation meetings and encouraged people not to have any great fears because I’d seen what they were doing”. (IC2-12 Local Resident)

And another

The group that was working with us here, they were absolutely brilliant in the way they went about it. They consulted to a degree that I have never seen before or since with the community. They came to the major organizations in our community, they came to the residents’ association. I believe they went to the school … We have a Festival of the Knob, they set up booths there and they set it up on consecutive years. They came to the State Emergency Service and updated us on everything. (IC1-06 Local Resident)

Toleration, collaboration and cooperation: Stakeholder investment in the ED program.

Although our study was not designed to provide quantitative estimates of the levels of investment by stakeholders, our analysis suggests that the majority of residents in the host communities were “tolerators” of the ED Program—i.e., they agreed that the trials should proceed, they were content with the level and quality of engagement, but showed little interest in taking on any active role beyond regular interactions with the ED team. Our analysis suggests that an attitude of toleration towards the ED Program simply reflects the limits of people’s willingness to invest time and energy in activities that fall outside their normal scope of activities.

And despite extensive investments in time on “education” and communications, there was also some predictable lack of understanding about the technology itself, and the logic of population replacement as a strategy to reduce dengue transmission:

Some people are very supportive but I don’t know if they understand what we’re doing as well, and that’s something that is a difficult one because without that level of understanding you always question. Can they really support it without getting it? You can have really good conversations with people and tell them all about it and they’ll be like yeah, yeah, and then at the end they’re like good luck killing the mosquitoes, I hope you get rid of them. You think, oh, you didn’t understand it. (IC1-01 CE Officer)

Several institutional and organizational stakeholders entered into formal collaborations with the ED team and several individual stakeholders were also willing to actively cooperate with the ED team to perform tasks such as “door-knocking”, which helped to facilitate the work of the ED Program. Queensland Health (QH) and James Cook University (JCU) were the two primary institutions that agreed to collaborate with the ED team. QH and JCU are prominent and respected institutions in the region. They facilitated the entry of the ED team into the host communities through their endorsement of the ED Program, introductions to community leaders, and insight into the host communities.

Individual stakeholders who were willing to cooperate with the ED team included local and national politicians, local community and business leaders, members of community-based organizations, and individual residents. Stakeholders who explicitly cooperated with the ED team also facilitated access to their social networks and thereby assisted the ED team to fulfill their commitment to “reach everyone” and their efforts to socialize the technology. Cooperators participated in community events, spread the word about the ED Program within their social networks, distributed public relations materials, and assisted with enrollment activities. Cooperation was also expressed through the willingness of individuals to allow entomological and release activities to occur in their homes and on their properties. The willingness to cooperate is reflected in the following account.

They took the time to explain it in a way that was very clear to me. And, they explained what they were trying to achieve, where they thought they were at, and what the plan was going forward. And, because of that reason, I could see that our SES [State Emergency Service] group could certainly provide some assistance to them, and I was so enthusiastic about the project that I was able to talk my team into helping them out pretty easily. (IC1-06 Local Resident)