Ethics and Public Engagement [This document summarizes the main points and structure on ethics and engagement needed for the overall framework for field-testing transgenic mosquitoes for disease vector control. This draft is for internal discussion and development purposes and should not be distributed. The final product will be embedded within a larger framework that includes sections on the efficacy, environmental and health risks and of the regulatory issues arising in connection with strategies that utilize transgenic mosquitoes for disease control. There will need to be text developed that both transitions to and from those additional section, and that discusses the place of the topics outlined below in relation to the larger themes of the document.] The Role of Ethics and Public Engagement in Science and Technology Scientists have long appreciated the importance of dialog with and outreach to the broader public in order to realize the envisioned results for their research. However, events and developments of over last three decades have led to a renewed interest in the ways and means for interaction between scientists and a number of distinct publics with different attitudes and interests in regard to scientific work. Important episodes that have marked key transitions in the way that scientific research groups interact with various segments of the lay public include: Nuremburg trials of doctors who had conducted experiments on human beings incarcerated in Nazi concentration camps Publication of Rachel Carson’s Silent Spring, which first brought unwanted environmental impacts of chemical technology into public awareness Television coverage of the “Space Race” between the United States and the Soviet Union, which attracted many youth into careers in science Publicity of the Tuskegee Syphilis Study (1932-1972) in which American doctors continued to observe the progress of the disease among 399 African-Americans for decades after penicillin had be validated as an effective treatment Diamond v. Chakrabarty (1980), in which the United States Supreme Court held that novel organisms can be patented Debates over the safety of nuclear reactors, culminating in the accident at the Chernobyl reactor in 1986 Creation of the Ethical, Legal and Social Issues (ELSI) track to support social science and humanities research on the broader significance of the Human Genome Initiative The announcement in 1997 that a group at the Roslyn Institute in the UK had successfully cloned an adult sheep Creation of the IPCC to develop and promote scientific consensus on the need for policy response to address climate change Some of these events have cast science and technology in a heroic light, while others, notably the Nazi and Tuskegee experiments have portrayed people scientific and technical walks of life as lacking in moral sensibility or fellow-feeling. Others simply testify to the way that developments in science and technology can grip the public’s attention, occasionally sparking reactions and consequences that the scientists involved had never imagined. The social phenomenon of public reaction to scientific developments has itself been the subject of numerous historical, philosophical and sociological studies. Ulrich Beck has argued that general public literacy in scientific matters has the ironic effect of creating a more sophisticated understanding of the way that advances in the sciences are accompanied by both benefits and risks. As a result, citizens have become more cognizant of scientific or technical breakthroughs as potentially controversial. This awareness has been accompanied by the rise of numerous civil society organizations dedicated to promoting specific causes such as consumer rights, women’s issues or environmental protection. The upshot is a greater willingness for citizens to both desire involvement in promoting those scientific activities that they see as consistent with their values (such as poverty alleviation or protection of wildlife), and to oppose technologies that they perceive to be inimical to those values. Resistance to agricultural and food applications of biotechnology as well as to nanotechnologies is seen as symptomatic of this new style of risk politics. At the same time, scientists themselves have become cognizant of new ways that involving non-scientists in their work can be beneficial. On the one hand, exceedingly complex or “wicked” problems may simply not be amenable to traditional applied or problem-solving research methods (Rittel and Weber, 1973; Batie, 2008). Effective methods for addressing issues in water quality, biodiversity preservation and public health are coming to be conceptualized as requiring strategies for dealing with ambiguity in problem definition, conflicting values among stakeholders, uncertainty and feedback loops that make conventional controlled experiments impossible. Such strategies may require planned activities that engage non-scientists in collaborative research and problem-solving activities, rather than treating them as subjects. In addition, stories of scientists such as Nancy Wexler and Jane Goodall have inspired many to envision a new era of science in which many people can become enrolled in cooperative projects as “co-producers” of new knowledge (Haraway, 1989; Wexler, 2004). In this connection, attempts to extend the “open source” model of software design and development into other areas of science are seen as ways to make science more democratic and more responsive to the needs and interests of those who felt excluded from many developments in 20th century science (Weber, 2004). For example, speakers at a symposium on “Outlaw Biology” at UCLA in January of 2010 proposed that the widespread availability and relatively low cost of materials for research in synthetic biology will herald an era in which the tools and techniques of high science can be turned toward achieving ends unimagined by those in university science departments, and of little interest to profit-seeking investors or corporations. Scientists undertaking work on the cutting edge of discovery or technological capability thus have both “positive” and “negative” motivations for paying attention to the reaction and receptiveness of the broader public. On the positive side, engagement with people not generally considered to be part of the research community can both enrich the research process and provide access to information and perspectives that would have otherwise been unavailable to people within a research group. It can also be instrumental for achieving broader impacts that researchers themselves seek. On the negative side, research that comes under the scrutiny of advocacy groups can become the target of organized opposition that has the potential to frustrate not only the application of science, but even the research process itself. It will not be possible to avoid such opposition in every case. Sometimes opponents of science and technology are simply pursuing interests that are genuinely contrary to the advancement of a given technical project. However, engagement with advocates can reduce the chance that opposition is based on a misunderstanding of the science or of its technical goals, and can, in a more positive spirit, sometimes result in changes or modifications to a research effort that researchers themselves view as beneficial. In addition, informal interactions with the public that create opportunities for improving science (or challenges that threaten to undo it) may overlap significantly with activities that are designed to manage environmental or public health risks, or that are required by regulations. Most obviously, research sponsored under the auspices of all major global funding agencies is required to submit protocols for human subjects, biosafety and the use of animals in research. In fact, these requirements are sometimes characterized as “ethics” requirements. Events such as the Nuremberg doctor trials and the Tuskegee Syphilis study were instrumental both in bringing about the current cultural climate for conducting research as well as regulatory requirements for human subjects approval. There is thus significant overlap between regulatory compliance and the opportunities and challenges associated with more fully realizing the beneficial potential of research, while also discharging broader responsibilities and dealing effectively with the potential for resistance to or misunderstanding of a scientific research project. However, in this section of the framework, emphasis will be placed on the realization of potential and broader (but not mandatory) ethical responsibilities. Regulatory requirements are dealt with in the appropriate section. In short, new challenges and opportunities of engagement await scientists in the 21st century. It is especially important for scientists conducting studies that are likely to attract significant coverage from the media to consider how their work might be affected by engagement and interaction with members of the public who have no training in their disciplines or methods. Stories may be disseminated either through traditional media such as newspapers, television and radio, or through new outlets on the Internet and emerging social media. Ordinary word of mouth can also create a widely shared impression of one’s research goals, intended applications and methods, especially at within specific village or urban locales. Such representations of science can create opportunities to obtain key informants, participants and partners, but they can also create suspicion, distrust and antagonism to a specific scientific research project. Ethics and Engagement Activities Given this background and rationale, useful ethics and engagement activities involve three distinct types of inquiry and project governance activity. First, conduct of research brings researchers into direct contact with a number of people, including but not limited those who are research subjects or whose cooperation is necessary for successful completion of research tasks. In classic bio-medical research, these individuals include those classified as “human subjects”. A research subject can be defined as any object or phenomenon that is observed for the purposed of research. Research involving human subjects thus involves observation of or collection of data that is from elicited from human beings. However, there may be many individuals who are directly affected by the conduct of research who are not involved in data collection or observation that is part of the research process. This will include those residing in the vicinity of a research project whose daily activities and/or livelihood will be affected by activities material to the research. The 1975 episode with male sterile mosquito research in India provides a vivid example where researchers had ethical responsibilities to people living within a research area, despite the fact that these people were not, in any traditional sense, subjects of observation for the purpose of the research at hand. Second, a much larger community of people may take an interest in the conduct or outcome of research, even if they are not directly affected by research activity. In traditional biomedical research, for example, people who are afflicted with a particular disease (along with friends and family) have an obvious interest in the outcome of research or clinical trials, even if they are uninvolved with trials. Such groups are likely to be strongly supportive of research intended to develop therapies for their condition. In a similar vein, people who take an interest in causes such as protecting vulnerable groups or endangered species may take an interest in a wide range of research activities, though they may not be unilaterally supportive of research goals or procedures. Desowitz also recounts an episode in which a civil society group called the Rural Advancement Fund International (now known as the ETC Group) protested a genetics-based public health research project because they feared that the interests of an indigenous Trobirands Islands village were not being adequately respected. In Desowitz’ account, the episode erupted into an international incident, with researchers carrying genetic samples being arrested when they attempted to move these samples across international borders, (Desowitz, 2002). Although the nature of responsibilities to such groups is quite different than to people who are directly affected by the conduct research, it is clear that an effective plan for engaging a wide spectrum of interested parties may be critical to the success of research, especially for projects that can be expected to attract a significant amount of attention in the press, or monitoring from civil society organizations. Third, conduct of research intended to benefit the public good is guided, if only implicitly, by an understanding or conception of the public good, and of general strategies that might be pursued to serve it. Scientists who are involved in work of this sort will typically engage in conversations and even debates over alternative ways to conceptualize the public good or social goals that will be served by the research. In some cases the deliberations that occur in connection with such conversations can be quite extensive, while in other cases the relevant notion of the public good will be relatively obvious and non-controversial. In such cases, deliberative or thoughtful inquiry into the social and ethical goals and rationale for the project or for various elements and strategies that arise within the project may be both minimal and informal. However, given the long history of debate over strategies for abating the human toll of infectious diseases, the role of these strategies in larger economic and social development, and disagreements about which approaches are most likely to be fruitful, it is doubtful that the goals or rationale for projects to investigate the viability of transgenic insects for vector control will be non-controversial. Indeed, scientists involved in the main research programs currently underway to investigate these strategies have already been deeply involved in discussions about the overall wisdom of this approach. It is important to recognize that these discussions are in fact an important component of ethics and engagement activities, and it will likely prove fruitful for projects involving field trials to include these critical and justificatory activities dedicated toward articulating and explaining the ethical purpose and rationale of the project as a formal element of project activities. The framework for conducting field trials of transgenic mosquitoes should include somewhat structured and planned elements for both conducting and documenting each of these three components for ethics and engagement. The outline for a broad structure for helping research teams to both discharge ethical responsibilities and also conduct public engagement activities that will improve the prospects of public receptivity follows below. It is important to bear three points in mind. First, although there are points of overlap between ethics and engagement and the regulatory requirements for research, the outline that follows below is not intended to substitute for or serve regulatory compliance. Co-relatively, one should not assume that regulatory compliance implies that ethical and engagement responsibilities have been adequately addressed. Second, the focus of activity should be on reflection, substantive interaction and participation both among researchers and with outside parties, and finally iterative integration of findings from ethics and engagement activities into the planning and conduct of research. As such, the outline is to be interpreted as a description of processes and goals, rather than as a prescriptive formula to be followed slavishly. These two points suggest the third: a number of researchers have noted that taking a regulatory compliance attitude toward ethics has not only created extra bureaucratic hurdles that hamper effective research, it can also run counter to the very goals that attention to ethics and engagement is intended to serve. When “research ethics” becomes an activity of ticking of boxes for compliance or slavish adherence to rules, the substantive goals of ethical responsiveness may well be sidelined and subverted by researchers who resent and resist a phenomenon known as “ethics creep,” (Hagerty, 2004; Rollin, 2008). Structure for Ethics and Engagement The basic organizational structure for the ethics and public engagement component of the framework document proposes elements keyed to each of the three types of ethical and engagement response described briefly in the preceding section and described in more detail below. An organized effort to address and complete each and all of these tasks is required for responsible implementation of research involving transgenic insects. First, the research will need to address a set of tasks that arise in virtue of its potential for direct effects in immediate proximity to the site at which field studies are conducted. These tasks overlap with regulatory requirements for securing appropriate forms of informed consent, but also include involving and empowering local populations in key elements of research planning and implementation, as well as addressing both real and perceived issues that may arise in connection with the project, including intellectual property or other broader socio-economic impact. (Note that substantive environmental and public health risks are addressed elsewhere in the framework document). Second, there will be tasks of stakeholder involvement with groups not immediately affected by the research, groups that will include members of civil society organizations, the press and the general public. (Note that interaction with government bodies is addressed in the regulatory section of the framework document). Third, there are reflective tasks associated with broader ethical issues that will contribute both to broader management goals and to effective learning and evaluation of the research. The plan for addressing each of these three task orientations envisions ongoing, planned project activities, as illustrated by the iterative arrow loops in Figure 1. Each of these activities should be understood as iterative and repetitive during the entire research period. That is, these are not tasks that can be executed and finished with once and for all. Rather each group of tasks is to be understood as an ongoing component of the research activity, and the research plan for any project involving transgenic insects should include a programmatic discussion of how tasks in each of these three areas will be discharged by members of the research team on an ongoing basis throughout all phases of the research activity. Human Subjects/ Community Consent Stakeholder & 3rd Party Engagement Broader Ethical Reflection Figure 1: The Three Task Functions One useful way to operationalize the three task activities for planning purpsoes is to focus on who will need to be involved in completing them. All three types of ethics and engagement activities involve the entire research team and will almost certainly involve officers from the sponsoring organizations as well. Discharge of ethics and engagement responsibilities among those directly affected cannot be accomplished without understanding the work as involving all people within the local areas contiguous to the field sites at which research is to be undertaken. These are tasks that arise “on the ground” where the research is being conducted. As noted below, this may not imply contact with literally every individual in the contiguous area, but it must be understood to require that mechanisms of representation be inclusive all those who will be effected by the research activity. In contrast, tasks that have been characterized in terms of stakeholder involvement will potentially include people and organizations from distant locations. Indeed, the potential geographical scope of stakeholders relevant to this research is global, as will become clear below. Thus while the term “stakeholder” might in some cases be taken to mean local people directly affected by the performance of the research, for present purposes the tasks of stakeholder involvement are understood to be those that involve interested parties who would normally be directly affected either by serving as research subjects or by being in immediate proximity to research activities. These tasks concern the negotiation of competing visions of the environmental and developmental goals, standards and metrics for the research. There may, of course, be some area of overlap between the ethics of environment and development, on the one hand, and ethics issues that arise on the ground, on the other. What is more, one should expect that some external stakeholders will take themselves to represent the interests of local people in the human subjects group. Thus, thinking through the relationships between the first and second groups of ethics and engagement tasks provides an example of something that falls into the category of “broader ethical concerns.” This task group will be primarily be internal to the project staff, understood to include permanent advisory committees and consultants, as well as other scientists whose opinions, views and reflections might be sought on an advisory basis. As such, the group focused on broader ethical questions need not exclude involvement of local representatives or people from stakeholder groups, either by invitation or permanent appointment to an advisory/consulting group. Figure 2 thus fleshes out some of the specific topics and issues that will need to be accomplished within each of these three task groups. The next three sections include a more detailed and substantive discussion of each of these three areas. However, all three of these task activities need to structured by a set of activities that include the following: Ongoing Literature and Methodology Development: Whether it be human subjects and informed consent or engaging with NGOs or the press, there are now developed scholarly literatures on these tasks that at least someone within any large scale project of this sort should be aware of. Task Planning and Implementation: Based on this literature, those charged with executing the activities will undertake the activities specific to a given task. This may involve consultations, negotiations and quasi legal activities in the case of human subjects; workshops, notifications and consultations in the case of stakeholder engagement; or committee meetings and seminars in the case of broader issues. Figure 2: Task Focus and Group Function Engagement Focus Groups & organizations with a focus on development, civil society or environmental concerns. Engagement Functions Communication of project goals and activities; elicitation of concerns; identification of response and negotiation with respect to 3rd party concerns. Engagement Focus People and organizations within the primary area of geographic activity and impact. Engagement Functions Identification of local institutions; enrollment into project; elicitation of concerns (general and project-related); negotiation and amelioration. Engagement Focus Membership (broadly conceived) of the project team. Engagement Functions Integrate project functions, especially engagement activities; question assumptions & power relationships; redefine membership & goals; adapt to new circumstances.  Measurement, Documentation and Reporting: The need for clear records is clear with respect to human subjects, but we should stress that all three of these areas should have at least minimal mechanisms to document and report on activities. In some cases, it may be that the best reporting will take the form of peer-reviewed articles on the ethics and engagement activities. Evaluation. Both internal and external evaluations of how well each of the three tasks are being performed should be part of the plan. Iteration. Evaluation should lead back to methods development and planning. Repeat as needed. Ethics, Engagement and the Direct Effects of Research As defined above, a “direct affect” from the research presumes physical proximity to the research activity. People who are directly affected will be in immediate physical contact with the research team, their buildings and vehicles and with any materials or substances that are released (intentionally or not) the environment. This, of course, includes people who see, hear or are bitten by mosquitoes, or who have contact with other animals exposed to mosquito bites in the field testing arena. There may be some ambiguity in determining who has the potential to be directly affected in this sense, as there will be movement through the locale and complex opportunities for animal-to-animal, person-to-person and animal-to-person contact. Persons at some distance from a locale may suffer affronts of an economic, spiritual or cultural nature, and they may come into contact with items (including foods) produced near the field testing site. What is more, scientists involved in the work are themselves directly affected, and some may move rapidly around the globe or, alternatively, have relatively little involvement at the field-testing site. As such, answering the question of who is directly affected is itself a key ethics activity for participants in the project. A framework for approaching this and other questions can be derived from recent trends in research ethics. Human Subjects Research In contemporary science, research involving human subjects entails both ethical and regulatory requirements. Beginning with the shocking revelations of cruel and inhumane experiments done in Nazi concentration camps, there has been a growing trend toward formal procedures to ensure that people directly affected by the conduct of research have been consulted, and when appropriate, that their cooperation and willingness to assume risks has been voluntarily obtained. The Belmont Report codified a set of ethical principles for the use of human subjects in biomedical and behavioral research, (U.S. Department of Health, Education and Welfare, 1979). It provided the baseline for implementation of United States Public Law 93-348, the National Research Act of 1974, and in that capacity The Belmont Report has implications for mandatory regulatory compliance for research institutions in the United States. As other sections of the framework document indicate, similar regulatory provisions obtain in most countries, and apply generally to research conducted under World Health Organization auspices, in any case. However, provisions of the Belmont Report have purely ethical significance, irrespective of regulatory guidelines. Two points are especially worth emphasizing: the criterion of informed consent, and the use of institutional committees for assuring compliance with ethical guidelines. The committee approach is important because it provides a deliberative model for addressing ethical issues that arise in connection with research. Rather than proposing strict rules or criteria that must be followed and then providing a mechanism for compliance, the committee approach mandates that ethical issues are considered before research is actually undertaken. Research projects that fail to engage in the deliberative review of the committee process are deemed to be unethical even if the actual substance of the research itself involves no ethical or regulatory violations. This means that the guiding ethical philosophy is procedural: it is following the procedure for deliberation, review, approval and subsequent monitoring by the committee that provides assurance of compliance with research ethics, rather than consistency with a standard such as “do no harm” or “insure that benefits outweigh costs.” This principle of procedural justification has become virtually standard in research ethics, even though it is far from universally understood by the research community. “Informed consent” can be interpreted as a general philosophy for guiding the deliberations of the committee process. Succinctly, informed consent requires that subjects who will be observed in a research process are a) fully and explicitly advised of all risks, costs or inconveniences they may bear as a result of participating as a research subject; and b) have voluntarily agreed to accept or bear those risks and costs. Both criteria are, on occasion, ambiguous and difficult to interpret. There can be disagreement about the risks and costs of participation in research, and there can be difficulties in communicating these risks in a manner that can be meaningfully understood by potential subjects of research. There can also be disagreement about what circumstances actually constitute voluntary consent. Seriously ill individuals hoping to receive treatment may be particularly vulnerable to coercive or manipulative attempts to secure agreement. In addition, the general philosophy of informed consent can be inherently difficult to apply in the case of human subjects who lack the competence to make an informed decision due to youth, deterioration of their mental capacity or the need for rapid response during situations when an individual may have lapsed or impaired consciousness, (Faden and Beauchamp, 1986). In part because of these issues, committees generally augment a strict interpretation of informed consent with criteria that focus on the level of risk that human subjects will bear. In general, research design should minimize risk to human subjects, exposing research subjects to the chance of harmful or unwanted outcomes only when doing so is necessary for achieving research outcomes. In addition, the research should be designed so that subjects can expect to receive benefits commensurate with the risks they bear. In the case of biomedical research, these criteria often involve patients who are suffering from a medical condition that the research is intended to alleviate or for which patients will at least receive palliative care that would otherwise be unavailable, (Weijer, 2000). In behavioral research, benefits to subjects may take the form of compensation for participation in the research in the form of cash payments or satisfaction of a programmatic requirement (such as academic credit), (Berg, 2003). Indeed, in purely therapeutic contexts (e.g. when physicians are suggesting interventions but are not collecting data for research), risk considerations may take precedence over informed consent, (Truog and coauthors, 1999). A committee charged with either ethical or regulatory review should include individuals familiar with the substantial body of literature on human subjects research. In addition to these issues that are inherent in any attempt to apply the general guidelines implied by the goal of informed consent, a number of researchers have noted that the overarching criteria can be especially tricky to interpret and apply in developing country settings. Western norms and cultural practices of individual decision making and personal autonomy may be poorly supported. Involvement of community leaders may be more appropriate, (Dialo and coauthors, 2005). Mechanisms for providing information on risk may need to be tailored to specific cultural practices and low levels of linguistic and mathematical literacy, (Schapiro and Meslin, 2001). Indeed, persons in field areas may have little basis for expecting or anticipating hazards from technically complex and uncertain activities, and thus may be unwary and ill prepared to participate in a conventional informed consent exercise. While research subjects and their kin in developed countries may expect to receive treatments and access to therapies developed on the basis of research through the established system of medical care, this may not be the case in developing countries. As such, mechanisms to ensure that subjects from developing countries who participate in research receive access to treatments and benefits from the research has been a particularly significant theme. This has been especially significant for drug trials and other forms of clinical research, (Emanuel and coauthors, 2005; Tindana, 2007). Outside of research ethics focused on clinical trials, there has long been recognition that criteria of informed consent may represent an inappropriate framework, especially for research conducted in developing countries. Not long after publication of the Belmont Report, researchers doing fieldwork in developing country settings stressed that the cumbersome approach to research protocols was ill-suited to field activities that involved long-term and very complex relationships between a field-researcher and members of the community in which ethnographic work is being attempted, (Wax, 1980). The stress that is laid on inclusive engagement with community stakeholders, on ensuring flexible and non-exploitive relationships with people living in the vicinity of fieldwork and the emphasis on ensuring that those who bear the physical risks of research receive benefits from the research suggest that the paradigm of informed consent may, indeed, not be the most relevant way to understand ethical responsibilities that researchers have with respect to those who are directly affected by their work. A host of other criteria may be proposed in both clinical and public health settings, (Emanuel and coauthors, 2000; Kass, 2001). Community Engagement and Authorization The above summary testifies to the potential for complexity and even contradictory indications in research ethics for field testing of genetically engineered mosquitoes. However, the complex interactions of different criteria for addressing ethical responsibilities do not undermine the importance of a committee process that is both flexible and open-ended. The literature of debate over informed consent and alternative approaches is thus one input into deliberations that should be undertaken by those individuals charged with ensuring that field testing meets high standards of research ethics. This material must be complemented with detailed knowledge of the local community, its institutions and common practices. In most cases, such information can only be gleaned from extended ethnographic work and ongoing relationships with individuals from different social classes, gender, occupation and social role. It is only in light of empirical findings that will be unique to each setting in which field-testing or public health interventions will be conducted that a useful committee process for ethics and engagement can be conducted. As noted above, the ethical significance of informed consent resides in its ability to guide deliberations. Specific procedures for securing informed consent are less relevant to the framework under review for two reasons. First, as already noted, the standard Western “consent form” is inappropriate in settings with low rates of literacy, weak traditions of individual decision making and vulnerability to exploitation. Second, as efforts move from the research stage into an active public health intervention other limitations in the dominant model of human subjects approval become apparent. Large scale public health interventions rarely achieve universal agreement. Controversy over the fluoridation of public water supplies, regulation of tobacco use and vaccination testifies to the fact that it is not unusual for public health interventions to be undertaken against the protest of at least some affected parties, (Cassiday, 2007; Powles, 2009). Thus although the tradition of informed consent expresses key desiderata for research ethics, a standard of community authorization may be more appropriate for research and intervention efforts involving transgenic mosquitoes. Where activities are conducted under the auspices of a responsive government and established traditions in public health law, community authorization may be understood to be co-extensive with securing the legal permission to proceed specified by regulatory guidelines. However, in some settings researchers may question whether regulatory statutes are adequate and whether public officials are either capable or willing to protect the public interest. In such settings, additional measures to secure community authorization become an ethical responsibility. These measures can be thought of as being guided by informed consent’s goal of protecting the interests of those who will be affected by research, but may need to create new mechanisms both for disseminating information about the potential risks and benefits of the project, and for achieving reasonable assurance that the community at large has agreed that the research and public health interventions should take place. With this thought in mind, framework documents for global public health research describe a practicum of community engagement that details a twelve point plan: Box 1. ‘Points to consider’ for effective community engagement (i) Rigorous site-selection procedures (ii) Early initiation of community engagement activities (iii) Characterize and build knowledge of the community, its diversity, and its changing needs (iv) Ensure the purpose and goals of the research are clear to the community (v) Provide information (vi) Establish relationships and commitments to build trust with relevant authorities in the community: formal, informal and traditional (vii) Understand community perceptions and attitudes about the proposed research (viii) Identify, mobilize, and develop relevant community assets and capacity (ix) Maximize opportunities for stewardship, ownership, and shared control by the community (x) Ensure adequate opportunities and respect for dissenting opinions (xi) Secure permission/authorization from the community (xii) Review, evaluate and if necessary, modify engagement strategies From Lavery and coauthors, 2009. Items 2 through eleven address specific needs for information or activities that will almost certainly need to be supervised by persons with training in appropriate field-disciplines in the social sciences. Furthermore, these individuals will need to budget a significant time commitment to in situ activities with local communities, and will these activities will require a significant budgetary commitment from the project. As such, the composition of the research team and committee process for addressing ethical responsibilities for engaging with local communities, gathering this information and integrating into the project’s own committee process. Depending on competencies of both project staff and locally affected parties, it may be appropriate to include representatives of affected groups within the project’s committee process, (Lavery and coauthors, 2010). Community authorization and informed consent share several key elements. Both are intended to empower people who will be affected by research project or a public health intervention. This means first that they are intended to make people aware that the activity is taking place, and that while they might expect to benefit from the activity, the activity is not without risk. Second, empowerment implies some potential for “exit”: for refusing to participate in the activity or to bear risk. It also implies “voice”: an opportunity to express concerns and to receive replies that are addressed specifically to these concerns. A reply might take the form of assurances or clarification of activities and/or risks, yet for the conditions of voice to be met fully, affected parties must accept the assurances offered as a satisfactory response to concerns. Response might also involve modifications to the plan that relieve concerns. Community authorization and informed consent are also similar in that when the specified conditions have been met, the scientific team has received permission to proceed with its planned activities. Community authorization also differs from informed consent in several key respects. First, the methods of informed consent that have dominated discussion of research ethics in the industrialized world assume that consent is given or withheld by individuals. When possible, the individual in question is the person who bears the risks, but in cases of children or people who are incapacitated, a third party is authorized to give or withhold consent on their behalf. Community authorization is a procedure intended to elicit agreement on behalf of a group, often a political community such as a neighborhood or township. Procedures for community authorization thus more typically rely on norms for group decision making such as voting, consensus or negotiations with leaders and representatives who are recognized as having the authority to speak on behalf of the community as a whole. Since norms for group decision making vary widely, it is especially critical that procedures for identifying leaders and representatives or for interacting with community groups are based on detailed knowledge of the locale, its traditions and its history of cooperation, exploitation and conflict resolution, (Christakas, 1992). Engagement Activities with Third Parties Once a determination of who counts as being directly affected has been made, virtually everyone else in the world is a de facto third party. Relevant third parties include those who have an interest in the conduct or outcome of the field testing activities. At a minimum this includes persons from the following groups: Persons associated with global or regional public health and international development organizations, including governments. Scientists and members of scientific organizations with disciplinary or trans-disciplinary links to research activities associated with field testing activities, including sciences dedicated to public health and infectious disease. Persons and organizations engaged in competing approaches to control of malaria and infectious disease. Members of organizations focused on promoting the interests and protecting the rights of poor and/or historically marginalized people. Members of organizations dedicated to the preservation of endangered species, genetic diversity and threatened ecosystems. Members of organizations with a history of monitoring the role of the sciences in debates over the use of biotechnology. Individuals and organizations with ties to national, regional and cultural groups active in the areas where field testing is occurring. Governments and international organizations, especially with the United Nations system. Some of these groups and the individuals involved with them have either formal or relatively well-established ways to express views on transgenic mosquito projects intended for controlling disease vectors and to interact with project staff. Others do not. In light of experiences with the global controversy over GMOs, it is wise from both an ethical and a strategic perspective for the framework to include mechanisms and procedures for engaging with these third parties in a systematic fashion. Interaction with third parties is ethically responsible because most if not all of the parties listed above can be said to have legitimate interests in the conduct and outcomes of transgenic mosquito field testing. Because their interests intersect and engage with the research in numerous ways, the project team has a prima facie responsibility to advise these groups of activities, to solicit their comments and advice, and to involve them in decision making about aspects of the research that are relevant to their interests. To say that this is a prima facie responsibility means that these duties of engagement might be overridden by more compelling concerns. Engagement with third parties could, in theory, become so consumptive of time and resources as to preclude progress on key research activities, or could hamper the project’s ability to discharge responsibilities to parties that are directly affected. Thus as is the case with responsibilities to those directly affected by research activities, interactions with third parties can be conceptualized as a procedural responsibility: The project team must develop and implement planned activities for considering the interests of third parties, for engaging with third parties in a respectful manner, and for determining when duties to consider the interests of third parties or to involve them in project decision-making or oversight are overridden by more compelling concerns. In addition to being an ethical responsibility, engagement with third parties may be of strategic importance to the project’s success. Third parties may have information or comments that can materially improve project activities. Their support and good wishes may contribute to a variety of activities ranging from securing funding or regulatory approvals to facilitating interactions with other scientists, suppliers, publication outlets and local officials. Strategically motivated interactions with third parties are an inherent part of science, (Latour, 1987; Collins and Pinch, 2002) and should not be regarded askance. Scientists are adept at some strategic interactions, especially those relating to their disciplinary colleagues, but are notoriously inept at others. According to Dan Charles history of agricultural biotechnology, many avoidable misunderstandings and much mistrust occurred because scientists in both public and private sector positions were insensitive to the fact that consumers and environmental advocates perceived themselves to have legitimate interests that were being neglected in the process of developing transgenic seeds and animal drugs, (Charles, 2001). From the perspective of strategic management, then, what is needed is a broadening of the perspective that scientists bring to their research, and a systematic effort to identify, understand and then interact with people holding perspectives on the research project that may seem initially to be unrelated to or at odds with that of the scientific team. The mechanisms for accomplishing this kind of broader outreach and engagement are still not well understood. One lesson that is now well established is that this kind of activity should not be conceptualized in terms of “public education”, or of simply telling informing third parties of things that the researchers know about transgenic mosquitoes and vector control. Communications launched with this so-called “deficit model” of public engagement have been shown not only to fail, but to substantially increase opposition and mistrust, (Wynne, 1996; Hensen and coauthors, 2003; Gjerris, 2008; Toumey, 2009). Rather, it is crucial to develop mechanisms of interaction with third parties that are based on what Roger Pielke, Jr. calls “the honest broker” approach. The keys to this approach are to first recognize that third party interests reflect values-based standpoints that inform the way that a scientific research project is going to be seen as either responsive to a problem, or alternatively as contributing to a problem. Second, it is critical to develop communication materials about the project that are framed in response to these values-based perspectives. Putatively “neutral” descriptions of projects may fail to provide information that allows third parties to gain a clear understanding of why the research is relevant to them. If such materials are disseminated to parties that are already suspicious or skeptical of a project, they can actually exacerbate feelings of mistrust. Finally, it is important to present a picture of the research that includes both strengths and weaknesses relative to the values-perspective that would motivate a third party to take an interest in it. While such a communications strategy should strive to be complete in its accounting of strengths and weaknesses, it should also be sensitive to the need for a concise treatment focused on the problem at hand, (Pielke, Jr. 2007). Thus, projects should include a general communications strategy based on Pielke Jr.’s principles. These communications should be disseminated through an array of media, including the Internet and through presentations at professional or public meetings relevant to key interests (e.g. environment, public health, poverty and development, science policy). It may be useful to sponsor public events such as conferences or workshops where third parties can learn about the goals and methods of transgenic mosquito research, and can interact with representatives from the research team. Other strategies for engagement with the public utilize universities, television and science museums, (Wilsdon and Willis, 2003). Once an engagement strategy has been launched in this manner, there should be opportunities for individuals to self-identify and interact with members of the project on various follow-up activities. These would include the submission of comments and questions, but might also involve more extended interactions or even collaborations in developing modifications or additions to the project that will either assure third parties that their issues are being given sufficient attention, or that will improve project activities in ways relevant to third party interests. It is crucial that third parties invited into engagements of this sort are not made to feel that they are being placated, simply tolerated or even worse, that the engagement is simply a stalling tactic with little genuine opportunity for third parties to have any substantive input, (see, for example, Griffiths and Steinbrecher, 2010). Just as discharging responsibilities for engagement with those directly affected by research, engagement with third parties will be more effective if researchers and/or consultants with specialized skills are part of the project team. However, it is important to stress that their efforts will have limited effectiveness unless key scientific staff are also involved in interactions with third parties. As such, there should be a component of the research activity that is designed and dedicated to third party engagement. It should be equipped with adequate personnel and budget, and this should include some time and energy commitments from leaders in the biological science component of the research. As with responsibilities to those directly affected by the research, there will need to be flexibility and responsiveness built into the plan for engagement with third parties, and this flexibility should extend (potentially, at least) into other phases of research management and activity. Broader Reflection on Social and Ethical Issues Virtually any scientific research project (if not any human activity) takes place in reference to assumptions about what would count as improvement or detriment to the human condition, what is worth doing in general and what are the most promising means to pursue at a given time and place. Many of the initiatives that have been launched under the aegis of “ethics and science” have been conceptualized as facilitating reflection and critical thinking about these assumptions, especially among the scientists, engineers and technical experts who are undertaking them, (Watson, 1990; Collins and coauthors, 1998; Roco, 2003). These reflective and critical activities augment what scientists would do as a matter of course or “over coffee,” as well as discussions that might be written into rationales for research in requests for funding. By providing explicit articulations of the considerations that guide scientific work and that relate it to social goals, and by presenting these rationales in public forums it is possible to more broadly disseminate this thinking and to demonstrate its role in the conduct of science. Canada has pioneered approaches to embed such activities within large-scale research projects dedicated to biological research, (Castle and Culver, 2006; Coward, 2006). The two previously described components of the framework are defined largely with in terms of engagements with individuals and groups that are not part of the project team. The third component is designed to both encourage and document reflective ethical engagement within and amongst members of the research team. It is especially appropriate for researchers working on transgenic mosquitos for vector control to engage in and support such reflective research in light of several points already mentioned above. First, research and interventions for control of malaria has a long history, and there is already a well-established record of conflicting views on the most appropriate strategy for addressing this persistent problem. Some authors express extreme skepticism about initiatives that propose “big science” approaches to malaria, (Packard, 2007). Parties involved in the research should be cognizant of this history, and should support additional efforts to reflect critically on the role of their own project in this enduring debate. Second, the use of transgenic approaches on animal species provides a second linkage of the project to research traditions that are involved in well-established debates, (Thompson, 2007). Finally, engagements with both directly affected people and with third parties will provide an opportunity for further learning about the way scientific research can be most effectively structured to both achieve substantive goals and to be responsive to broader public concerns. A reflective component will allow others to learn lessons from these activities that go above and beyond what would be required simply to discharge those responsibilities associated with engagement. While other activities dedicated to ethics and engagement are ongoing and will almost certainly require frequent and periodic management (as well as continuing activity), these more reflective activities may be more sporadic, and it may be fully appropriate to schedule them at longer time intervals or in conjunction with key milestones. They may include activities such as seminars or workshops with visitors not directly involved with the project, but should incorporate at least some public reporting on thinking within the project, including “lessons learned.” Such public reporting may take the form of peer-reviewed publications in appropriate ethics or policy outlets, and as such it may be appropriate to include professionals attuned to the production of such knowledge products within the project staff. Thus at a minimum, the plan for undertaking a reflective evaluation of broader goals requires two elements: Activities: A set of planned events in which members of the project team engage one another in discussion and debate over a project methods, goals and conduct. As noted, the effectiveness of activities can often be enhanced by selective involvement with individuals and groups who serve as facilitators or as “provocateurs” intended to stimulate discussion. Documentation: Planned methods to create a record group of deliberations. These should be periodically consulted within the group and will be of broader use if wider dissemination is achieved through public presentation or publication in appropriate forums. Broader reflections will, of course, overlap to some degree with activities undertaken in response to both direct and third party engagements. Identification of these three general areas within the overall framework is intended to help researchers planning field trials under the framework to develop a more complete and comprehensive plan for ethics and community engagement. It is not intended to suggest these three types of activities are unrelated to one another, or that specific project activities could not contribute to two or more of these ethical goals simultaneously. When Should Ethics and Engagement Take Place? The three components of the framework identify key tasks associated with the ethical conduct of science and with a public health intervention. The timing for tasks such as the securing permission and support from those that will be directly affected by the research may be implicit within the nature and goals of the activity: It will be crucial to organize and conduct these procedures in advance of actual impact on affected parties, but not so far in advance as to violate reasonable expectations of affected parties. Consent or agreement secured too far in advance will simply need to be renewed, as people do change their minds. Similarly, there will need to be planned efforts to revisit these tasks over the course of the project. The second and third activities are less clear in the timing needed. However, experience has shown that the need to begin these activities may arise well before field activities actually begin. The traditional model of engagement and outreach for scientific research that held sway for the first half of the 20th century would have envisioned little such activity at the stage of field testing for agricultural or public health intervention. On this view, the public did not need to be particularly aware of a research activity until their help or cooperation was needed in actually undertaking a large scale intervention. However, as cognizance of risks to human subjects grew and standards for procuring cooperation and consent began to develop, researchers recognized that there were key activities needed to inform and involve affected parties, even at this relatively preliminary stage of research. What is more, a few key episodes in field testing have demonstrated how inept public relations and engagement strategies can sabotage research efforts, sometimes having extremely long-lasting effects. While negative incidents should not overshadow the way that science and technological innovation are more typically associated with beneficial outcomes, a focus on several key episodes illustrates how the more typical course of events can go awry. One example of a field-testing debacle occurred during the early days of agricultural genetic engineering. A strain of bacteria had been modified in the laboratory to limit its ice-nucleating properties. It was hypothesized that use of this so-call “ice-minus” bacteria in conjunction with borderline freezing conditions could protect high value fruit crops. The planned field test became embroiled in legation, as it was the first experiment involving intentional release of a genetically engineered organism to come before the National Institutes of Health DNA Research Advisory Committee. The details of this regulatory debate are not germane in the present context, save for one important fact: Field trials were in fact conducted prior to regulatory approval, and this fact was widely reported in the press. Of almost equal importance were approved field trials in California that sparked protest demonstrations from residents of the counties in which the tests were conducted. Technicians conducting the trials wore full-body isolation suits, and photographs of these alien-like beings walking the fields with back-pack sprayers were also widely reprinted in the national media. Media scholars have argued that the combined coverage of legal wrong-doing, tests that were conducted in the face of local protest and the apparent precautions being taken to avoid exposure to a putatively risky substance combined to create a media event that helped solidify agricultural biotechnology as both potentially dangerous and as under the supervision and control of a scientific establishment unwilling to comply with commonsense precautions and regulatory oversight, (Jukes, 1988; Nelkin, 2002). The second example is more immediately relevant to field tests for transgenic mosquitoes. It involves an episode that occurred in conjunction with a field release of male-sterile mosquitoes as a component in research on malaria control in India. A cooperative project involving scientists from India and the United States, among others was conducting field trials with male sterile mosquitoes as basic research that could be adapted to a number of disease control situations. However, suspicions were raised both locally and in the national press about the nature and intent of this research, (Anonymous, 1975). The episode was recalled years later in connection with the expulsion of an American scientist from Pakistan, (Jayaraman, 1985), and is discussed at more length in Mark Kaplan’s personal history of WHO efforts to curtail chemical weapons, (Kaplan, 1999) It has been repeatedly cited by those who warn that field tests for transgenic mosquitoes must be accompanied by effective efforts to engage both local individuals in areas where field trials will be conducted and also activists self-identified as promoting pro-poor, pro-environmental and democratization of science initiatives, (Benedict and Robinson, 2003; Curtis, 2006; Knols and coauthors, 2007). Box 2: Male Sterile Mosquitoes in India Public health scientist Robert S. Desowitz summarized the episode in one of his books written for a popular audience and it is useful to consider his description at some length: On a morning in 1975, a van bearing the blue-and-white logo of the World Health Organization on the door—a snake caduceus through a global map—drives into the village center. The villagers, who have a fear and loathing of snakes, regard the serpent van suspiciously. They begin to be even more suspicious when a peculiar collection of men emerges from the van—a few undoubted Indians, some strange Orientals, and some very white white men. An angry murmur of astonishment passes through the gathered group of villages when these men remove large mesh-covered cages from the vehicle, open the cages—and out flies a cloud of mosquitoes. Without a word of explanation, the snake and mosquito men then return to their vehicle and drive away. Several weeks later, the snake van appears again in the village and once more the strange foreigners release a cloud of mosquitoes from the cages. The crowd reacts—chasing the men into the van, which makes a hurried escape. A month or so later the vehicle appears again. The villagers burn it, (Desowitz, 1991, p. 89). Desowitz writes that the villagers complained to Parliament, and that Parliamentarians accuse the American scientists of being agents for the CIA who were conducting an experiment in biological warfare. It was later revealed that suspicions of research on germ warfare were entirely unfounded. Scientists from the specific group involved in the episode recounted by Desowitz have always strenuously denied any such connection, (Powell and Jayaraman, 2002). These incidents illustrate why adequate plans for communication and engagement with broad publics even at the field testing stage. This brief history of unfortunate episodes testifies to the potential for misunderstandings that cause irreparable damage to specific research efforts. What is more, knowledge of these cases inclines some public advocates to be highly skeptical of the intentions and ability of scientific research efforts to respect and involve an appropriate cross-section of stakeholders, affected parties and representative members of the interested public through key phases of planning and executing field test activities. One basic motivation and rationale for engagement components of the framework is to complement and support those project activities that are dedicated to the anticipation and management of risks, on the one hand, or to regulatory compliance, on the other. At the same time, the history of field tests gone wrong shows why it is important to understand these components as having a purpose that is independent of risk management and regulatory compliance, and why it may be critical to involve third parties who cannot plausibly be thought to be at any personal risk, and whose participation would not be required by regulatory guidelines. Protecting the integrity of the test and the ability to work both locally and in a global culture of support for the project depends on a good faith effort to engage social and ethical issues. Conclusion In summation, teams should organize a set of events, procedures and activities that are intended to fulfill ethical responsibilities in three over-lapping areas. First, they should regard their research and public health implementation activities as entailing responsibilities to engage those directly affected so as to empower them to either give or withhold agreement for the activities to continue, and to identify elements that they believe to be important for allowing the research to continue. Second, they should interact with third parties who take an expressed interest in the activity and its outcomes in order to both ensure that the project is well understood and to avail the project team of information and insights that such interested parties might provide. Finally, they should plan and conduct ongoing events in which members of team will reflect on their own activities, and document these reflections for the purposes of learning and dissemination of ethical lessons. These activities are important, but should not be constructed or implemented so as to create barriers to project goals. 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