Canada relies on independent accreditation and oversight for nearly every system in health care responsible for protecting people – from hospitals, community clinics and care facilities to laboratories and public health programs. The principle is straightforward: when human welfare is at stake, independent oversight is non-negotiable.
But that principle vanishes when it comes to protecting Canadians who participate in human research. Research Ethics Boards (REBs) – the bodies responsible for the ethical review of research and ensuring that it safeguards the individuals in it – operate with no national standards, no oversight and no accreditation at all.
This is not a bureaucratic oversight. It is the structural flaw underlying many of the ethical failures we have witnessed in Canadian human research in recent years, including the Prince Albert School Study (PASS).
Yet, whenever a research scandal emerges – a study that harms its participants, an experimental intervention marketed as care or a consent process that misleads people about risks – public blame lands squarely on the REB. It is the most visible procedural checkpoint in a system that offers only the illusion of oversight, and therefore the easiest entity to criticize.
But the uncomfortable truth is this: REBs are being held responsible for failures they cannot prevent. They are being asked to carry duties that belong to an oversight system Canada has never meaningfully built.
REBs are essential, but their mandate is narrow.
They review protocols before research begins, but they rarely (if ever) have direct contact with the people enrolled in studies.
They technically have authority to monitor active research, but they are rarely given the resources to do so.
They can suspend research, but few have the independence or institutional protection needed to act when powerful interests are involved.
Most importantly, the quality, capacity and independence of REBs vary widely across the country.
Canada has:
- no mandatory national standards for REBs,
- no independent oversight, and
- no mechanism to ensure consistency or accountability.
In this environment, protection is not verified but presumed, which means responsibility almost exclusively defaults to REBs – committees that were never designed, resourced or empowered to carry such a burden alone.
This is why blaming REBs for systemic research failures misses the point. Canada’s response to research harms is reactive rather than proactive – we respond by faulting the REB, rather than by fixing the system – and a reactive posture cannot form the foundation of national protection, no matter how skilled or well-intentioned the people sitting on the ethics committees may be.
Real participant protection does not start at the REB deliberation table; it begins long before a protocol ever reaches it.
It depends on an institution’s entire ecosystem of oversight – the structures that determine:
- how researchers are trained and qualified,
- how conflicts of interest are identified and managed,
- how privacy and data protections are implemented,
- how contracts and indemnification are negotiated,
- how quality is assessed and improved, and
- whether the institution has the capacity and resources to conduct the research safely.
A responsible system recognizes that human research is inherently risky. Good intentions are not enough. Protection must be built into every layer of institutional practice from the moment a study is conceived – not just reviewed at a single meeting before it begins (as ethicist Michael McDonald observed in Is Anybody Minding the Store?).
Canada’s current governance structure lacks an integrated institutional framework to ensure research participant protection is consistent, proactive and accountable.
A Human Research Protection Program (HRPP) provides that framework. It ensures that ethics review, investigator qualifications, conflict-of-interest management, privacy protections, contracts, quality assurance and ongoing monitoring are aligned, coordinated and functioning long before an individual is approached for research participation.
Outside the research world, HRPPs may be unfamiliar. Inside it, they are recognized internationally as the backbone of research participant protection. In Canada, a standards-based HRPP accreditation program, grounded in multiple National Standards of Canada, is already in place. It offers the structure, independence and consistency our system has long needed, and it evaluates and strengthens the broader human research ecosystem.
The concept of HRPP accreditation is not new. Canada identified the need for system-level oversight more than two decades ago. However, we never developed a national mechanism to implement HRPP accreditation, leaving institutions without a coordinated framework for research participant protection.
In 2005, the National Council on Ethics in Human Research (NCEHR) published Options for the Development of an Accreditation System for Human Research Protection Programs, recommending that all institutions form HRPPs, that national standards be created and that a non-government body accredit them.
In 2008, the federally funded Sponsors’ Table Expert Committee reinforced these recommendations in its Moving Ahead report, adding costed implementation pathways. When no action followed, the Canadian 2012 report on Canada’s clinical trial infrastructure again urged the federal government to develop national standards and establish accreditation, echoing NCEHR’s earlier conclusions.
These Canadian analyses emerged in parallel with international developments, such as the creation of AAHRPP in the United States. Today’s National Standards of Canada and HRPP accreditation system operationalize precisely what NCEHR and the federal Expert Committee called for: independent verification, institutional accountability and protections built into the entire human research enterprise – not just its REBs.
HRPP accreditation does not replace REBs or second-guess their judgments. It strengthens the system around them.
It introduces elements Canada has been missing for decades:
- independent oversight,
- uniform national expectations,
- external validation of institutional practices,
- continuous quality improvement,
- transparent processes, and
- participant-centred accountability.
It also aligns Canada with global norms. Countries with mature human research ecosystems use HRPP accreditation to ensure that protections are real, consistent and demonstrable. Canada remains an outlier, attempting to modernize research without modernizing the protections that must accompany it.
Accreditation is not a barrier to research. It is the mechanism that makes research safer, more efficient, more consistent and globally competitive.
Accreditation is not foreign to Canada. We already use similar models to protect animal welfare in research through the Canadian Council on Animal Care, and to assess the quality and safety of hospitals, clinics and care facilities through Accreditation Canada. These systems work because they rely on independent, standards-based evaluation – the very element missing from human research.
Canada now needs to take the next step: adopt HRPP accreditation nationally so that participant protection is no longer left to chance or dependent on where the research is conducted.
If Canada wants fewer ethical failures, fewer damaging headlines and fewer harms to the people who participate in research, the solution is clear: build the system REBs have always needed, rather than blaming them for the one they were never given.
Researchers and institutions deserve the clarity that comes with national standards.
REBs deserve the infrastructure that allows them to focus on ethics rather than compensating for system-level gaps.
And research participants – the people who contribute their bodies, data and trust – deserve protections as strong, rigorous and credible as those we already require for animals in research.
Until Canada makes this shift, research participants will continue to bear the consequences of a governance structure that was never designed to protect them.
