sk a clinical operations professional at a global sponsor company what community engagement means, and their answer will likely center on one word—recruitment—or on the related concepts of patient enrollment rates or site activation timelines. This is not wrong (community engagement does support recruitment), but this dramatically undersells what community engagement actually is and what it can do for a clinical trial from protocol conception through data lock to acceptance and implementation of trial outcomes.

Community engagement in clinical research is neither improvised, nor reactive, nor optional. It is planned, structured, and required—by ethics committees, by funders, and increasingly by communities themselves. It is, in a word, by design.

Community engagement, practiced well, is a Quality by Design discipline in clinical research. It must be architected into a clinical trial from the earliest stages of protocol development, not activated as an afterthought when recruitment falls short. And the global sponsor community—navigating new expectations under ICH E6(R3) and an evolving landscape of decentralized and participant-centered trials—has a great deal to learn from how it has been done in these settings for decades and from specific experiences.

Several years ago, we both worked in quality oversight and clinical operations roles supporting the BOHEMIA trial (Broad One Health Endectocide-based Malaria Intervention in Africa), a large-scale, decentralized, cluster-randomized clinical trial conducted first in Mozambique and then in Kenya.

We came to that work with nearly six decades of combined experience from two different professions: one a GCP quality professional focused on quality system design, risk-based oversight, and inspection readiness, and the other a clinical operations leader with extensive experience managing trials across CRO, biotech, and pharmaceutical settings.

In Mozambique, community engagement activities were embedded within broader demography, social science, and field implementation efforts, including engagement with community leaders, rumor identification and mitigation, and ongoing dialogue within participating communities; these activities, however, were not yet as visible to operational oversight teams as they later became during the Kenya implementation.

In the Kenya arm, we encountered something neither of us had seen operationalized in quite this way before: a community engagement function that was not peripheral to the trial but was woven into its fabric. This reframed how we each think about community engagement—and how our two disciplines (GCP/quality and clinical operations) must work together to realize its full value.

To expand beyond our experience, we conducted semistructured interviews with community engagement leaders from three research institutions across four countries: Noni Mumba, Head of Engagement at the KEMRI-Wellcome Trust Research Programme in Kilifi, Kenya; Simon Peter Asiimwe, the Public Engagement Specialist at the Infectious Diseases Institute (IDI) in Uganda; and Professor Richard Adegbola, Chair of Nigeria’s National Health Research Ethics Committee (NHREC), whose career arc—from 19 years conducting community engagement in Gambian villages as part of the UK Medical Research Council program, to funder, to industry, to national regulator—gives his observations a depth that is rare in any conversation about clinical research governance.

We do not claim to speak for community engagement practice across Africa. We speak only to what we observed, and what these three experienced practitioners described from their specific institutional contexts in Kenya, Uganda, Nigeria, and The Gambia.

What Community Engagement Is—and Is Not

Community engagement in clinical research is frequently defined by what it facilitates rather than by what it does. But Professor Adegbola drew a sharp distinction that the global research community often blurs:

“It is not the community engagement team that provides input; it is the community. Community engagement facilitates that input into the protocol and the ethical review process.”

This is more than semantics. It means that the community engagement function does not speak for communities; it creates the structured conditions under which communities can speak for themselves and ensures that those voices reach the people making decisions about protocol design, feasibility, and conduct. The distinction matters because it defines where accountability sits and challenges the common assumption that having a community liaison on staff satisfies the requirement. Just as quality cannot be delegated to a single function and declared resolved, community engagement cannot be delegated to a single liaison and declared complete. It requires a system, which means defined roles, documented processes, trained personnel, and feedback loops that reach decision-makers.

Noni Mumba described the primary role of community engagement at KEMRI as fundamentally about relationship building and trust, and explained why trust is not a soft or supplementary goal but is an operational prerequisite:

“In our context, research is not always a well-understood activity in many LMIC settings, compared to high-income countries that have been conducting research for many decades. In our settings, research is relatively new, and hence building trust in science is very important. The main role is trust: enabling community members to understand what researchers are doing, and enabling researchers to understand local culture, social norms, and lived experiences so that even as they develop their research protocols, they are informed about the population they are going to recruit from.”

A clinical operations professional directly translates this into study feasibility. Protocols written without that understanding of the community tend to generate start-up delays, consent challenges, and retention failures—problems that are far more expensive to fix than to prevent. For a GCP quality professional, protocol development is the earliest possible point at which critical-to-quality factors can be identified and designed into the trial instead of being discovered during monitoring.

Simon at IDI Uganda added the dimension of scope, noting that what he does is more accurately described as public engagement than community engagement because the relevant stakeholders extend well beyond the communities in which research takes place:

“Stakeholders are much more than the community. There is mainstream media engagement, stakeholders at district and national levels, academia, other research institutions, the Ministry of Health, international partners—and most importantly, the identification of stakeholders for a particular study.”

What does this look like on the ground, in practice? KEMRI-Wellcome Trust does not organize community engagement as an informal outreach activity but as a dedicated institutional function embedded within the research program itself. Community engagement personnel participate in protocol and participant-facing material review, liaise with study teams and community leadership structures, and contribute directly to study planning and implementation oversight.

In addition, community engagement personnel also participate in systematic stakeholder identification and mapping across multiple levels (national health authorities, district health management teams, local government administrators, cultural and religious leaders, community health workers, and community members); the formation and ongoing support of community advisory boards (CABs) with clearly defined roles, training, and terms of reference (e.g., CAB charters); development and distribution of culturally appropriate information, education, and communication (IEC) materials in appropriate languages, adapted for communities with varying literacy levels; and continuous feedback mechanisms that allow the research team to identify and respond to concerns throughout the life of the study, not only at the start.

This was directly operationalized in the Kenya arm of BOHEMIA. Community engagement liaisons worked alongside site staff to develop the educational and engagement strategy and materials collaboratively, not in isolation. Before any information reached the broader community, presentations were first shared with community leaders, whose questions were addressed and whose concerns were formally relayed back to the study team. Materials were then revised as needed before being presented to the community at large; community questions were similarly collected and transmitted back to the study team. This iterative, multi-directional process—resembling the functional equivalent of a community advisory structure even where no formal CAB charter existed—was not improvised. The engagement strategy and materials were shared with both the local and national institutional ethics committees as part of the regulatory process.

Simon described IDI’s approach to community engagement as governed by a suite of strategies and standard operating procedures (SOPs) covering community entry, CAB coordination, ethical social media engagement, and co-creation of communication materials. SOPs create institutional continuity so that knowledge does not walk out the door when a practitioner moves on, which a quality professional immediately recognizes as the difference between a function and a dependency on individuals, and an operations professional recognizes as the difference between a study that can be scaled and replicated and one that cannot.

Required, Not Optional: The Regulatory and Institutional Mandate

One of the most important findings, and one that will likely surprise sponsors whose experience is primarily in North American or European trial settings, is that in each country represented here, community engagement in clinical research is not a best practice. It is a requirement.

In Uganda, a public engagement strategy is mandatory for national ethics approval by the research institution research ethics committee and the Uganda National Council for Science and Technology (UNCST). UNCST together with research institutions hosts annual national cross-CAB meetings that convene representatives from research organizations across the country to review study performance and refine national guidance. A protocol that arrives without evidence of community engagement is not allowed to proceed.

At KEMRI in Kenya, community engagement is embedded at the institutional review board (IRB) level before a protocol even reaches the national ethics committee. Mumba detailed the sequencing clearly: The engagement strategy must be documented in the protocol itself, reviewed by the IRB, which includes engagement staff charged specifically with reviewing protocols for adequate community engagement, and approved at that level before national review begins. Without that documentation, the protocol does not advance. The national ethics committee has also tightened its own expectations in recent years, consistent with changes to global research ethics guidance including the revised Declaration of Helsinki.

“About five years ago, they may not have asked any questions if a protocol landed on their desk without community engagement. Now they would—because the global ethics guidance has changed and is requiring community engagement,” Mumba explained.

In Nigeria, Professor Adegbola described NHREC’s review of approximately 354 protocols in 2025, with review timelines now targeting 60 days. Protocols without evidence of community engagement or CAB formation trigger queries from the committee and can delay or block approval. As Professor Adegbola noted, the regulatory and ethical landscape globally is moving in one direction: toward mandatory community engagement, not away from it.

Funders have arrived at the same position. Both the UK’s National Institute for Health and Care Research (NIHR) and the Wellcome Trust treat community engagement as a funded line item, not an unfunded expectation. Mumba noted that without a community engagement component, funding applications to NIHR face a much harder time during funding assessments. This is not altruism; it reflects hard-won institutional learning that studies without community engagement are operationally fragile.

For global sponsors, the implication is practical and unambiguous: Community engagement must be in the budget, in the protocol, and in the timeline from day one. It is not a contingency. For those accustomed to ICH E6(R3)’s emphasis on sponsor oversight and risk-proportionate monitoring, the framing will be familiar: Community engagement is not a compliance checkbox; it is a foundational element of a quality management system for any trial conducted in these settings.