03 · What You Need to Know
Meaningful Engagement Starts Before Recruitment
Engagement Is a Process, Not a Permission Slip
Community engagement can include consultation, dialogue, collaboration, participation in research design, community advisory structures, formal authorization, and continuing communication. These activities do not all perform the same function.
CIOMS calls for potential participants and communities to be involved through an early and sustained participatory process covering research design and development, implementation, informed-consent planning, monitoring, and dissemination. The 2024 Declaration of Helsinki similarly states that meaningful engagement with potential and enrolled participants and their communities should occur before, during, and following medical research.
The emphasis on timing matters. If researchers first ask for community input after the important decisions have been made, the community is being asked to react to research rather than participate meaningfully in shaping it.
Community engagement
An ongoing process through which relevant communities and researchers exchange knowledge, priorities, concerns, and influence across appropriate stages of research.
Community permission
A specific authorization granted by a legitimate community authority where such authorization is required.
A project can require one, both, or neither in a particular form. Researchers should not describe obtaining permission from one leader as though it automatically constitutes broad community engagement.
Begin by Identifying Who Is Affected
The first practical task is not scheduling a town-hall meeting. It is identifying the relevant community or communities.
CIOMS uses a broad conception of community that can include people living in a geographic area, people with a shared interest or condition, and stakeholders who may affect or be affected by the research. The appropriate boundaries therefore depend on the study.
A hospital study may involve patients, caregivers, clinicians, and surrounding organizations. Research involving an Indigenous people may involve formal Indigenous governance and collective interests. A school-based project may implicate students, parents, teachers, administrators, and other groups in different ways.
The researchers should ask who will participate, who may experience consequences without participating, who controls relevant access or resources, and who possesses knowledge needed to understand the research setting.
Do Not Begin and End With the Most Visible Leaders
Formal and traditional leaders can be essential partners, particularly when they possess legitimate authority. But engagement should reflect the diversity relevant to the study.
CIOMS specifically calls for inclusion of diverse perspectives and warns against allowing people with greater authority to exert undue influence over others. A leadership structure dominated by one demographic or social group may need to be complemented by engagement with people whose experiences differ.
This is why researchers should first understand who has authority to speak for a community and avoid assuming that legitimate leadership automatically represents every perspective.
Ask About Priorities Before Explaining Your Solution
Researchers often approach communities with a carefully developed project and ask whether people support it. A stronger process can begin earlier by asking how the community understands the problem itself.
The 2024 Declaration of Helsinki states that researchers should enable participants and communities to share their priorities and values and participate in research design, implementation, and other relevant activities. The TRUST Code likewise states that the local relevance of research should be determined collaboratively with local partners.
This does not mean that every project must originate entirely from the community. It does mean that researchers should be prepared to discover that their question is less relevant locally than they assumed, that another outcome matters more, or that the proposed approach creates burdens they did not anticipate.
Explain What Is Still Open to Change
Honest engagement requires clarity about decision-making power. Some aspects of a project may still be negotiable. Others may be constrained by funding, law, scientific validity, prior approvals, or the purpose of the research.
Researchers should distinguish those categories rather than implying that everything is open for community decision when it is not.
A useful engagement conversation might identify which recruitment methods can change, whether data-collection procedures can be adapted, how results will be returned, what community priorities can influence, and which scientific requirements cannot reasonably be altered.
Transparency about limits is more respectful than offering influence that does not actually exist.
Engagement Should Be Able to Change Something
A useful test is counterfactual: what could happen differently because of this engagement?
Perhaps community input changes recruitment language, the consent process, the timing of data collection, compensation, privacy safeguards, an outcome measure, the composition of the research team, dissemination plans, or even the decision to conduct the research.
If researchers cannot identify any realistic decision that community input could affect, the activity may be communication or information-sharing rather than meaningful participation. Those activities can still be valuable, but they should be described accurately.
Discuss Risks That May Be Invisible to Outsiders
Researchers usually assess individual physical, psychological, social, economic, or privacy risks. Community members may identify another layer of consequences.
A research topic might reinforce stigma. Recruitment at a particular location could reveal sensitive information. Publishing the name of a small community might make anonymized participants identifiable. A seemingly modest incentive could carry unusual significance. A research question might reproduce an offensive historical framing.
These risks are difficult to evaluate without people who understand the setting.
Discuss Benefits Without Promising What the Research Cannot Deliver
Community engagement can create expectations. Researchers may be perceived as bringing healthcare, infrastructure, employment, political attention, educational opportunities, or other benefits beyond what the study can actually provide.
Researchers should explain realistically what participation and collaboration will and will not produce. The TRUST Code emphasizes fairness, respect, care, and honesty in international research partnerships and calls for research findings to be returned to local communities and participants in meaningful and understandable ways.
Engagement is weakened when enthusiasm is built through benefits that the project cannot deliver.
Discuss Data, Samples, and Future Use Early
Questions about data ownership, access, storage, secondary use, biological samples, intellectual property, and publication can become major sources of conflict when raised only after collection.
Where these issues are relevant, engagement should begin before participants contribute data or samples. International partnerships may also need explicit agreements about who will control research materials and how future decisions will be made.
The question of who should control data and samples collected through international research deserves particular attention when communities or local institutions have interests that extend beyond individual consent.
Plan How Results Will Return Before the Study Starts
Researchers frequently think about dissemination after analysis. Communities may reasonably want to know much earlier whether findings will be returned, in what form, in which language, and to whom.
The Declaration of Helsinki includes communities in engagement around understanding and disseminating results. The TRUST Code explicitly calls for feedback about research findings to be provided to local communities and participants in a meaningful, appropriate, and readily understandable way.
Planning this before research begins helps prevent returning research findings to communities from becoming an afterthought.
Agree on How Concerns Will Be Raised
Engagement should also create a route for problems to travel back to researchers. Community members need to know whom they can contact, how concerns will be handled, and whether complaints can be raised without jeopardizing services, relationships, or participation.
This becomes especially important where researchers hold more institutional, financial, or social power than the communities involved.
Watch Out
Do not make a public consultation the only route for criticism when participants may be uncomfortable disagreeing with leaders, researchers, employers, clinicians, or other influential people. Engagement mechanisms should allow concerns to emerge from less powerful voices too.
Budget for Engagement as Research Work
Meaningful engagement requires time, staff, communication, translation, accessible materials, travel or meeting arrangements, and sometimes appropriate compensation or reimbursement for community contributors. Treating these activities as free extras can shift the cost of research participation onto the very people researchers claim to be involving.
NIH community-engagement recommendations similarly emphasize defining responsibilities, maintaining collaboration, considering social and cultural context, and involving community members in protocol development and other stages of research.
Engagement Before Research Is the Beginning, Not the Entire Process
Early engagement cannot predict every issue. Risks can change, recruitment can reveal concerns, preliminary findings can affect community interests, and dissemination can create new questions.
The Declaration of Helsinki therefore describes engagement as occurring before, during, and after research. CIOMS likewise describes it as early and sustained.
A respectful pre-research process should establish how that continuing relationship will work rather than ending with a photograph of the launch meeting and a very optimistic caption.
