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.
Janice, Thank you for this opinion piece. It is timely as the review and comment window for the Canadian human participants in research guidelines (HRSO 200.01) has just closed. That guideline lays out parameters for REBs, but what struck me when I read it was how high-level it remains and the leeway for interpretation. In addition, it maintains a focus on premarket risk. The complexity of modern drug trials, including adaptive designs, combination products (drug, biological, and/or medical devices), data systems and privacy protections, patient perceptions of risk and adversity, and the use of artificial intelligence in the administration and design. As regulatory bodies reform their approaches to accommodate the complexities of the modern health technology adoption cycle, the regulatory focus is shifting from exclusively pre-market risks to the alignment of pre-market and post-market risks. That is, they are adopting a systems approach. It is the right moment to ask whether the institutions that govern the REBs tasked with ensuring that patients get a fair shake in this risk landscape are sufficient. I think accreditation of HRPPs should go hand in hand with recognition of credentialed clinical trial professionals as a profession in Canada to ensure that appropriate subject-matter expertise drives decisions.
Thank you, Julie, for the thoughtful points raised in your comment, especially your emphasis on the need for subject matter expertise in the conduct and oversight of research. It is an important dimension of the conversation, and one that deserves deeper scrutiny in the Canadian context.
I agree with you that expertise matters, and that the individuals who conduct and oversee research require a high level of competency. Where I diverge slightly is on the idea that formal professionalization of clinical research roles, even if combined with accreditation, is the mechanism that will get us there. Canada already has a form of this model in place. Many of the professionals most involved in clinical trials, including physicians, nurses, pharmacists, and, in the broader human sciences, psychologists, are regulated by their respective professional orders and colleges. These bodies do have the authority to discipline their members when research is improperly conducted.
However, decades of experience have shown that professional regulation, even when it exists alongside institutional oversight, does not provide the type of proactive and systemic protection for participants that an accredited Human Research Protection Program can deliver.
Professional orders and colleges primarily intervene after a harm or deviation has occurred. Their inspections and investigations are usually confidential, and disciplinary actions, even when they occur, do not address the system level vulnerabilities that allow research misconduct or poor oversight to arise in the first place. For example, the Labrie decision in Quebec further clarified that disciplinary bodies are not positioned to reassess REB decisions or the ethical and methodological foundations of an REB-approved protocol. Their jurisdiction is limited, by design, to the professional conduct of individual members (see Labrie c. Médecins, 2002 QCTP 14 (CanLII), https://canlii.ca/t/1dm3x).
This is why HRPP accreditation represents a fundamentally different and far more promising approach.
Accreditation focuses on organizational responsibilities, institutional accountability, and system performance, rather than the actions of isolated professionals. It embeds ethics, quality, and participant protection into the operational fabric of research institutions. Training is a central component of HRPP accreditation, and this speaks directly to the point you raised.
A strong Human Research Protection (HRP) Training Program ensures that everyone involved in human research, including investigators, coordinators, data analysts, research administrators, REB members, and institutional leaders, understands their roles and responsibilities within an integrated protection system.
As indicated in the Human Research Standards Organization (HRSO) standard on the “Development of a Training Program for Human” (see https://hrso-onrh.org/wp-content/uploads/HRSO-100.02-2023-EN.pdf), an HRP Training Program must establish clear objectives for participant protection and research integrity while ensuring that all individuals involved in human research understand the ethical principles, historical context, diverse methodologies, and roles that collectively support a culture of ethical and responsible research.
In short, HRPP accreditation ensures that participant protection is not dependent on the professional background of any single actor. Instead, it embeds protections in a comprehensive and verifiable institutional system. It ensures consistency, quality, accountability, and transparency, which regulated professions and colleges alone cannot guarantee.
So while the expertise of clinical research professionals is unquestionably important, strengthening human research participant protections in Canada requires system level reforms, not only the creation of additional professional designations. Accreditation offers a preventive and proactive framework that professional orders and colleges, with their reactive mandate, cannot provide.
This is indeed the right moment to rethink how we protect research participants, but our solutions must align with the systemic nature of the challenges we face. In that light, HRPP accreditation represents a more effective, rigorous, proven, and future ready path, as demonstrated by its successful implementation in the United States since 2002 and its growing recognition internationally.
My reply to Mike Fraumeni’s question “Why isn’t the obvious as you are stating with implementing HRPP accreditation, happening? Is there some “bad apple” in the cogwheel, somewhere?”
That’s a fair question, and a common one. I don’t think there’s a single “bad apple” blocking progress. The reasons are more structural and cultural than individual.
I devote an entire chapter of my book, “Ethics on Trial” (Chapter 11), to this issue, because what tends to stall change is bureaucratic territorialism and a long-standing mindset that treats research participant protection as synonymous with REB review. Once protection is framed that narrowly, there is little perceived need to build or fund system-level oversight beyond the committee itself.
HRPP accreditation challenges that framing by shifting protection from a single review body to an institutional and governance responsibility. That kind of shift requires leadership and a willingness to rethink established roles – which is harder than identifying a bad actor, but ultimately where meaningful reform has to happen.
On the question of Clinical Trials Ontario: CTO’s REB qualification process and HRPP accreditation serve different functions and operate at different levels of the research ecosystem. CTO’s work focuses on coordinating and streamlining REB review – an approach that CTO is proposing to scale nationally through CanReview. This reflects a model in which the REB is treated as the primary locus of participant protection.
HRPP accreditation, by contrast, is a national, standards-based governance framework that evaluates whether an institution’s entire human research protection system – including governance, resources, training, conflicts of interest, privacy, contracts, monitoring, and REB review and support – is designed to protect participants consistently and accountably. It requires conformance with multiple National Standards of Canada across that full system.
In short, CTO facilitates REB-related processes, while HRPP accreditation evaluates institutional governance and system-wide research participant protection against national standards. They operate at different levels of the research ecosystem and serve different purposes. They are not interchangeable, and treating REB coordination as a substitute for system-level governance is precisely the gap my op-ed is trying to surface.
Great read Janice, could not agree more that participants in human research require more protection than is currently the case. Complexities exist. One of the links you made discusses professional guinea pigs and did a bit of research and found this which you may have noticed, but at any rate thought I’d mention:
“While it is easy to focus on the human subject protections in isolation, one particular phase at a time, or without addressing the sociopolitical context in which they are carried out, a more comprehensive approach might be needed if we are to address social justice issues in clinical trial research (Petryna 2009; Fisher 2008). A social justice approach cannot avoid the racialized, gendered, and class-based forms of inequality that compel mostly poor, desperate people to take risks while others more fortunate can just wait until the drug comes to market. Furthermore, tackling the politics of drug development from a social justice perspective requires asking who is benefiting, who is not, and how benefits could be distributed more equitably. These questions are difficult, but they are harder to avoid in the context of deepening social inequalities, where it is harder to pretend that the clinical trials research enterprise is a shared unmitigated social good. In turn, social inequality raises another challenge for social-justicebased redistributive policies. To succeed, they have to confront powerful economic actors that, thanks to decades of concentrated economic growth, have more access than ever to the economic and political resources to shut down any opposition.”
Source: Roberto Abadie. The Exploitation of Professional “Guinea Pigs” in the Gig Economy: The Difficult Road From Consent to Justice. Am J Bioeth . 2019 Sep;19(9):37-39.
Weblink to full article from Google Scholar:
https://scholar.google.ca/scholar?hl=en&as_sdt=0%2C5&q=abadie+2019+guinea
Thank you, Mike! I really appreciate this perspective. I agree completely that consent and formal protections, on their own, do not resolve the deeper social justice dimensions embedded in clinical trial participation.
My focus in this piece was deliberately narrow – on governance failures that allow protection to be presumed rather than demonstrated. I see system-level oversight, like HRPP accreditation, as a necessary but not sufficient foundation: it cannot resolve social inequality, but without it, existing inequities are far more likely to go unexamined and be exploited.
I’m glad you raised this, because it points to the next layer of the conversation – how we move from procedural protection toward a genuinely just research enterprise.
One step at a time. While governance alone cannot resolve the broader social justice concerns you rightly point to, one concrete thing Canada can do right now is adopt HRPP accreditation – a system that is already developed and operational, and that would move research participant protection from assumption to demonstration.
Ok, so why isn’t the obvious as you are stating with implementing HRPP accreditation, happening? Is there some “bad apple” in the cogwheel, somewhere?
At any rate, I asked AI Perplexity the question “What is the relationship between “clinical trials ontario” and “hrpp”? and take AI for what it is but below is the “answer” ;)
https://www.perplexity.ai/search/what-is-the-relationship-betwe-.mUTC3vdS42GecSCfzrk0w