The Ethics of Being Left Out of Health Research: When Over-Protection Becomes Exclusion

Representation in health research extends far beyond scientific discovery — it directly shapes health-care planning, policy development, and resource allocation. When research fails to reflect the diversity of populations served, critical health needs can go unrecognized, contributing to inequities in prevention, diagnosis, and treatment. Yet the very bodies designed to protect research participants may, paradoxically, be contributing to this problem.

Research ethics boards (REBs) exist to ensure that research is conducted ethically and to protect participants from privacy breaches, coercion, and exploitation. However, in striving to achieve these goals, ethical board policies can produce an unintended consequence: over-protection that restricts the participation of people and communities historically excluded from research, including racialized communities, Indigenous people, and recent immigrants.

"An ethics process must not become so preoccupied with the potential harm of participation that it overlooks the certain harm of exclusion," write Sonia Anand, Associate Vice-President Global Health at McMaster University; Gina Ogilvie, Professor and Tier 1 Canada Research Chair in Global Control of HPV-Related Disease and Cancer (search)Search disease at the University of British Columbia; and Vanessa Watts, Associate Professor of Indigenous Studies and Sociology at McMaster University.

The Canadian Policy Framework

The Canadian Tri-Council Policy Statement (TCPS-2), which governs Canada's three largest public research funders, is explicit on this point. The statement asserts that "over-protectionist attitudes or practices of researchers or REBs, whether intentional or inadvertent, can exclude some members of society from participating in research," and that such exclusion "may constitute a failure to treat them justly."

The policy further states that researchers, institutions, and REBs "must navigate between the dangers of imposing unfair burdens on particular participants, groups and communities, and overprotecting them." The core message is clear: it is not protection at all costs, but protection balanced with justice. Ethics must recognize exclusion as harm, ensuring that caution does not erase participation.

Community-Based Research and Vulnerable Populations

This balance is particularly critical in community-based research with vulnerable populations. One example cited by the authors involves work with newcomers to Canada in Hamilton, Ontario, designed to overcome barriers to healthy active living, given that obesity (search)Search disease-related risks are shaped by the lived realities of migration, poverty, neighborhood design, and social exclusion.

The purpose of community-based research is to generate knowledge with communities, not merely about them, so that interventions can be relevant, usable, and fair. Yet this type of research can be hampered by over-protective REBs. Examples include restrictions on recruiting study participants in public spaces where newcomer families naturally gather, or requirements for separate approval for each poster placed in the community.

The rationale for such restrictions is to prevent coercion of vulnerable populations. But exclusion itself constitutes an ethical risk. "Regulations that make it so difficult to engage people that research cannot proceed don't protect the community — they lock the community out of participation," the authors note.

The Unseen Harms of Non-Participation

The harms of not conducting research are rarely given equal weight in ethics deliberations. While careful attention is paid to the possible discomfort of participation, non-participation also causes damage. When communities are excluded from research, there is no ability to document the burden of disease affecting that community. Researchers cannot demonstrate unmet need, measure inequity, or build the evidence that directs resources, services, and policy attention to those who need them most.

"In the absence of data, systems can always claim there is 'not enough evidence' when the very structures of oversight have helped prevent that evidence from being gathered," the authors warn.

Indigenous Peoples and Data Sovereignty

The issue is especially significant for Indigenous Peoples. Research involving First Nations, Inuit, and Métis people has historically been defined by non-Indigenous researchers, failed to reflect Indigenous world views, and failed to benefit Indigenous communities. Chapter 9 of the TCPS-2 was developed specifically to address this, emphasizing respectful relationships, collaboration, engagement, representation in planning and decision-making, and attention to the specific situation of the community involved.

The answer to a history of exploitative research is not exclusion from research, but better research: more respectful, participatory, accountable, and responsive to Indigenous priorities. Many Indigenous communities and organizations now maintain their own research ethics and governance infrastructures, including data governance protocols that reflect principles of Indigenous data sovereignty — emphasizing community and nation-based authority over when, how, and by whom data are accessed, shared, or withheld.

These infrastructures have expanded in response to increasing demand for Indigenous research following the release of the Truth and Reconciliation Commission's Calls to Action. Universities now have more Indigenous researchers, greater interest in Indigenous perspectives, and more frameworks attentive to ethics, consent, and privacy.

Pregnant Women and Clinical Research

Another example of over-protection is the exclusion of pregnant women from clinical research. While there may be valid reasons to exclude pregnant women from certain studies — such as trials of medication that could potentially harm a fetus — in many other cases, these exclusions leave clinicians and patients without evidence for the people who actually need care. Excluding a group to avoid risk may itself create long-term injustice by making the evidence base less applicable to them.

Toward a More Balanced Approach

What should change, the authors argue, is not the abandonment of ethics review, but a more careful balance between protection and the injustice of exclusion. REBs and administrators should ask, at the outset: what harms may follow if this research is not done, is delayed, or is made infeasible? Who loses if recruitment cannot happen in the spaces where people are? Whose voice disappears when the default answer is no?

"The people most often missing from decision-making are the newcomer parent, the Indigenous community member, the racialized participant, and the pregnant woman with no spare time to navigate institutional obstacles," the authors state. "These are not the people we should make hardest to reach. These are the people we should work hardest to include."

Engaging with communities of interest can help strike the right balance — whether through representation on REBs, representation on research teams, or opportunities for community representatives to speak directly to the urgency of the research. Ethical oversight must accomplish both goals: protect participants from harm and protect communities from being left out.