The ethics of being left out of health research

Beyond its importance for scientific discovery, representation in health research directly influences health-care planning, policy development and re

Without research that reflects the diversity of the populations served, important health needs may go unrecognized, contributing to inequities in prevention, diagnosis and treatment. Without research, major health issues faced by a given community cannot be known, nor can effective interventions be developed if the populations most affected are underrepresented in the evidence base

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

REBs often struggle to strike the right balance between protection and inclusion. When the pendulum swings too far towards protection, it can result in the very injustice it’s meant to prevent. The consequences can be profound: the people said to be protected are not heard, counted or represented in the evidence that shapes policy, care and re

The Canadian Tri-Council Policy Statement (TCPS-2) governing Canada’s three largest public research funders is clear 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.”

It also states that researchers, institutions and REBs “must navigate between the dangers of imposing unfair burdens on particular participants, groups and communities, and overprotecting them.”

It’s not protection at all costs, but protection balanced with justice. Ethics recognize exclusion as harm, so caution must not erase participation

Community-based research

This balance matters enormously in community-based research with vulnerable populations. One example from our work with newcomers to Canada in the Ontario city of Hamilton was designed precisely to overcome barriers to healthy active living, since obesity-related risks are shaped by the lived realities of migration, poverty, neighbourhood 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. But it’s the type of research that can be hampered by over-protective REBs. Examples include recruiting study participants in public spaces where newcomer families naturally gather, or requiring separate approval for each poster placed in the community

The rationale is to prevent coercion of vulnerable populations. But exclusion is also 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 harms of not doing research are rarely given equal weight in ethics deliberations. Careful attention is paid to the possible discomfort of participation, but non-participation also causes damage. When communities are excluded from research, there’s no ability to document the burden of disease on that community. We cannot demonstrate unmet need, measure inequity or build the evidence that directs re 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

Respect, welfare and justice

The Canadian Tri-Council Policy Statement is rooted in three interdependent principles: respect for persons, concern for welfare and justice

Concern for welfare requires researchers and REBs to protect participants from unnecessary risk and aim for the most favourable balance of risks and potential benefits. Justice requires that no segment of the population is unduly or overly burdened by research harms or denied the benefits of the knowledge generated from research

Those principles cannot be selectively applied. If welfare is interpreted so narrowly that entire populations are denied the benefits of inclusion in research, then welfare has been severed from justice

This is especially important for Indigenous Peoples. Research involving First Nations, Inuit and Métis people has too often been defined by non-Indigenous researchers, failed to reflect Indigenous world views and failed to benefit Indigenous Peoples or communities

This is why Chapter 9 of the statement was developed — the policy emphasizes respectful relationships, collaboration, engagement, representation in planning and decision-making and attention to the specific situation of the community involved

In other words, the answer to a history of exploitative research is not exclusion from research. It is better research: more respectful, participatory, accountable and more responsive to Indigenous priorities

The historical relationship between research institutions and Indigenous communities has often been extractive. Unsanctioned medical experiments and the removal of material culture are examples that rightly justify stricter guidelines for Indigenous-focused research. And yet, there is a danger in overstating harm through the blanket framing of Indigenous Peoples as inherently “vulnerable” when REBs assess proposed studies

Many Indigenous communities and organizations maintain their own research ethics and governance infrastructures, including data governance protocols that reflect principles of Indigenous data sovereignty. Indigenous researchers themselves must abide by these protocols. Indigenous data sovereignty emphasizes community and nation-based authority over when, how and by whom data are accessed, shared or withheld

These infrastructures have expanded in response to the increasing demand for Indigenous research following the release of the Truth and Reconciliation Commission’s Calls to Action. Universities now have more Indigenous researchers, more interest in Indigenous perspectives, more expectations of Indigenous participation and consultation, more calls for collaboration and co-creation, more frameworks attentive to ethics, consent and privacy

Vulnerability, where it exists, should not be understated — real risks remain and must be mitigated. However, REB ethical vigilance should not become automatic exclusion

Balancing protection and exclusion

Another example of over-protection is the exclusion of pregnant women from clinical research. There may be good reasons to exclude pregnant women from some studies, such as trials of medication that could potentially harm a fetus. But in many other cases, 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

What should change is not the abandonment of an 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. These are not the people we should make hardest to reach. These are the people we should work hardest to include

We must consider other ethical failures in addition to exploitation: the injustice of being excluded, including failure to measure the burden of disease affecting specific communities, and ensuring the safety and efficacy of treatments in that community

Unless exclusion itself is recognized as a form of ethical injury, REBs, institutions and funders risk sidelining the people research is most needed to serve

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 do both: protect participants from harm and protect communities from being left out