Biomedical research is increasingly globalized with ever more research conducted in low- and middle-income countries (LMICs). But the dominant paradigm remains essentially unchanged; the majority of funding coming from funding agencies and foundations in high-income countries (HIC) to support research programs and projects run by researchers in HIC institutions who conduct their research activities in LMIC settings [1]. The “background conditions”, of global inequality and injustice frame this research and raise a host of ethical concerns [2]. These conditions are further amplified by cultural and linguistic differences, a historical legacy of distrust and exploitation within the research enterprise, and concerns about scientific colonialism [3]. While these background conditions create significant challenges, they are challenges that need to be addressed and managed in the design and conduct of global biomedical research, which remains an important and fundamentally ethical pursuit, and essential to inform solutions to some of the world’s most pressing health problems.

One recurring theme in reporting about international biomedical research is that there is inadequate opportunity for research participants and affected communities to voice their concerns, and for researchers to acknowledge them and respond constructively [1–7]. Too often, these concerns go unaddressed and cause breakdowns in crucial relationships that, in turn, contribute to various types of failure, disappointment, or resentment, outcomes that perpetuate the historical injustices described above [8].

We argue that to address these problems, researchers, sponsors and funders need to invest in the human infrastructure of global health research: that web of relationships between researchers and the stakeholder community— the unique collection of diverse stakeholders who have interests in the conduct and/or outcomes of a given research project. Community Engagement (CE) is a promising strategy for cultivating this infrastructure. CE refers to a set of practices that help researchers establish and maintain relationships with the stakeholders to a research program [9]. While CE has become increasingly common in global health research, there is concern that the engagement is often not meaningful, particularly when it is mediated solely through Community Advisory Boards (CABs) [10–14]. To understand what makes CE meaningful, we have developed a framework to clarify what CE contributes to the ethical quality of research. Clarity about these ethical goals is critical to both improving CE practices, and to understanding when these practices are important to the ethical conduct of research.

To that end, we propose an ethical framework for CE. The framework is grounded in the insight that relationships between researchers and the community of stakeholders in a given global health research project are the foundation of meaningful engagement. We argue that it is primarily through these relationships that researchers are able to address three core ethical responsibilities: [1] identifying and managing non-obvious risks; [2] extending respect beyond the individual to the stakeholder community; and [3] building legitimacy for the research project. Although each of these ethical goals has received attention individually in the ethics of research, we propose that collectively they represent a coherent and comprehensive framework that clarifies the unique contributions of CE to global health research, and may serve as a useful reference for the on-going debate about how to evaluate the quality and impact of CE.

CE offers a promising solution to many seemingly intractable challenges in global health research by creating the infrastructure that allows researcher to engage with the social and political context of biomedical research. Despite this promise, there are concerns about what makes engagement meaningful [10–14]. We have responded to those concerns by presenting an ethical framework for CE. We argue that the ethical value of CE lies in its contribution to: identifying, and facilitating responsiveness to, non-obvious risks; extending respect beyond individual research participants to the community of stakeholders, whose interests may be affected; and to building the legitimacy of the research project. We argue further that these ethical goals are realized primarily through a human infrastructure of relationships between researchers and stakeholders. There is on-going uncertainty about when CE should be recommended or required for the ethical conduct of research, [10, 11] an issue for which there remains frustratingly little guidance, in particular, for research ethics committees. CE activities, being resource-intensive, may not be necessary or feasible for many research projects, and issues of scale and efficiency are yet to be worked out. Nonetheless, the framework presented here advances that conversation by identifying the kinds of circumstances in which CE is important for the ethical conduct of research.

More specifically, this framework advances the theory and practice of community engagement in three key ways. First, it improves mindfulness among funders, investigators, research ethics committees, and relevant regulatory authorities about what CE practices aim to accomplish ethically, by improving the specificity and precision of the stated ethical goals. There is no shortage of literature addressing ethical aspects and implications of CE. CE has received extensive attention in many fields—e.g., anthropology, sociology, social psychology, environmental management, forestry, global health, global development, community-based participatory research, feminist philosophy, public engagement for new technology assessment, public health practice, and social network theory, among many others. Despite this rich and extensive literature, however, the specific ethical contribution of CE remains unclear [11]. By distilling these insights, the current framework aims to improve the ability of teams to plan, implement and review CE. Second, our framework helps research funders justify the allocation of funds to CE in research proposals by clarifying the potential value of the investment. Currently, there is little, if any, public discussion about how, and to what extent, CE should be funded, and no publicly available data—to the best of our knowledge—about costs associated with successful CE practices in research. Clarifying the ethical value proposition for CE might help move this issue forward on the research policy agenda. Third, our framework can make a modest contribution towards improving partnerships with host communities, by providing those communities with greater specificity and precision about what CE practices aim to achieve.

While this framework focuses on the goals of CE, it also sheds light on the question of when CE is important to the ethical conduct of research. In particular, this framework suggests that CE should be strongly considered when the conduct and outcomes of the proposed research affect the interests of groups and individuals who are not direct research participants. The greater the reach of the research beyond research participants, the greater the need for CE. Research projects vary in the extent to which they might affect the interests of parties beyond research participants. Certain kinds of trials, such as cluster-randomized trials, or trials of new broad-based public health interventions (e.g., insect vector control strategies), [27] reach far into the community, beyond individual research participants, and thereby warrant special attention in the form of CE. Of course, the need for CE is often identified in retrospect, after unforeseen harms have occurred, but having a framework that conceptualizes the contributions of CE more clearly may also help clarify the appropriate context of application.

Although we focus, in this paper, on global health research, we believe that these ethical goals of CE apply in any geographic setting. The ethical goals reflect quite fundamental human concerns and, therefore, we expect that they would not be easily subverted by cultural or political considerations. Indeed, in our own work, we have studied cases of CE in Canada and Australia in which these goals would clearly have been applicable.

CE represents an important means of improving both the ethics and practice of global biomedical research. Our effort to clarify the ethical goals of CE and to explore its contribution to the ethical conduct of research represent a first step in improving the recognition that biomedical research programs are ultimately human endeavors, and that a strong human infrastructure is critical to both their ethical and practical success.