When Streamlining Becomes Risky: Why WHO’s Guidance Needs a Canadian Reality Check 🇨🇦

In 2024, the World Health Organization released its "Guidance for Best Practices for Clinical Trials", calling for a global shift toward more streamlined, risk-based regulation. The intent was sound: remove unnecessary delays and inefficiencies that slow down life-saving research. But in countries like Canada, where regulatory and ethical “bureaucracy” is often the only structural protection for research participants, that message needs nuance - and caution.

Since the dismantling of the National Council on Ethics in Human Research (NCEHR) in 2010, research participant protection has relied on two things: Health Canada’s regulatory inspections (which cover only a small fraction of regulated clinical trials) and institutional Research Ethics Boards (REBs) operating under the Tri-Council Policy Statement (TCPS 2) without any meaningful oversight or accountability. These mechanisms are essential - but patchy and unevenly applied across the country.

If we dismantle or streamline what little "oversight" we have, we risk leaving research participants - especially children, marginalized populations, and those in vulnerable settings - completely exposed.

That’s why HRPP accreditation is so critical. It’s the missing piece that aligns institutions with Canadian national standards (such as those developed by Canadian stakeholders through HRSO/ONRH) and embeds research participant protection into the operational culture of research, aligning with the TCPS 2. Far from being an obstacle, accredited HRPPs make ethical oversight more efficient, consistent, and accountable.

The World Health Organization is correct in calling for smarter regulation. But in Canada, we must be vigilant: “less bureaucracy” cannot mean “less protection.” HRPP accreditation remains our most effective safeguard against system-level failure - and the human tragedies that follow.

The Two Ryans

Two little boys named Ryan. One unregistered clinical trial. A tragedy that never should have happened.

At a major Canadian pediatric hospital (CHEO), two children received overdoses of an experimental drug in a research study that was never registered with Health Canada. Ryan Lucio, just four years old, died after receiving 25 times the correct dose of interleukin-2. Ryan Carroll, 18 months old, barely survived after receiving a 22-times overdose months earlier.

As Ryan Carroll's mother opined: "What if her son's adverse reaction had been reported to Health Canada? Would the overdose that cost Ryan Lucio his life have been prevented?"

This case remains a chilling reminder of what happens when clinical research lacks objective oversight and accountability, and why HRPP accreditation matters. No one, especially children, should pay the price for systemic failure.

Stories like this are central to my upcoming book: "Ethics on Trial – Protecting Humans in Canada’s Broken Research System" - coming this September.

Read more about the two Ryans here 👉 https://www.cbc.ca/news/canada/ottawa/deadly-clinical-trial-wasn-t-approved-by-health-canada-1.384348

On Single REB Review

On February 5, our group sent a letter to CanReview expressing serious concerns about its plan to implement a single REB review model in Canada without a means to objectively and independently validate participating REBs.  We outlined key gaps in its proposed approach and offered a proven, long-standing solution to assess REB quality: Human Research Protection Program (HRPP) accreditation.

HRPP accreditation is an internationally recognized, evidence-based program that provides an objective assessment of REB quality. It is also the backbone of SMART IRB, the single REB system operating in the United States. Today, over 1,350 institutions are members of SMART IRB—demonstrating both its credibility and broad adoption. To date, we have received no response to our letter.  

Meanwhile, CanReview continues to move forward as though HRPP accreditation is not part of the conversation. CanReview does not have a mandate from Canadian stakeholders—no public consultation ever took place. Yet its unvalidated single REB model carries real consequences for research quality and research participant protection in our country.   In the interest of transparency and accountability, we are now making our letter public (see below).

Our goal is not to criticize, but to advocate for a system that puts research participant protection and research integrity first.   We encourage others in the research community to read our letter and speak up.

Ask CanReview why it is willfully ignoring HRPP accreditation—a solution with a 23-year track record of protecting research participants and upholding research quality and integrity! Time to put your oar in 🛶! Thank you.

The Deschamps Report

This month marks 30 years since the publication of the Deschamps Report (Report on Control Mechanisms for Clinical Research in Quebec).

The Deschamps Report was commissioned by the Quebec government following a significant ethical scandal in Quebec’s biomedical research sector—the “Affaire Poisson”. (Read more about this scandal and the significance of the Deschamps Report in my upcoming book → https://www.indigo.ca/en-ca/ethics-on-trial-protecting-humans-in-canadas-broken-research-system/9781459755970.html )

The Deschamps report provided a comprehensive evaluation of the ethical, legal, and operational frameworks governing clinical research. Most notably, it emphasized that research participant protection is a shared responsibility—a central theme that marked a significant evolution in our approach to ethical human research. It reframed human research participant protection not as a checklist or a gatekeeping function, but as a shared moral and structural commitment, requiring coordination, vigilance, and ethical integrity throughout the research lifecycle and across the entire research enterprise.

To our colleague Pierre Deschamps—thank you for reshaping the conversation. Your report’s insights continue to inform how we think about trust, transparency, and our shared duty to uphold human dignity in research. Your contribution remains profoundly relevant and has truly stood the test of time. Merci! ❤️

Assessing REB Quality

Saw a post yesterday where Western University’s director of research ethics and compliance touted "speed" as a key feature of CanReview’s proposed single REB review model. But since when has "speed" been a hallmark of rigorous research ethics review? How does this focus align with the primary role of an REB — which is safeguarding the rights, safety, and welfare of research participants?

The core mission of a Human Research Protection Program (HRPP) is protecting human research participants and ensuring responsible conduct of research through rigorous training, oversight, and accountability. Speed, efficiency, and harmonization are byproducts of HRPP accreditation.

In the U.S., the quality of an institution’s HRPP is the backbone of its single REB model – SMART IRB. The SMART IRB model reflects this priority, requiring institutions to undergo or initiate an assessment of their HRPP within five years before joining: “Within the 5 years prior to joining SMART IRB, the institution must have undergone or have initiated an assessment of the quality of its human research protection program (‘HRPP’).” HRPP accreditation is the most widely accepted assessment of HRPP quality - in Canada, this is performed by HRA Canada.

Single REB review must not be imposed on Canadians by a group unwilling to acknowledge the value of HRPP accreditation. Any discussion of single REB review in Canada must involve all stakeholders and be grounded in HRPP accreditation, just as SMART IRB requires. Let’s not reinvent the wheel — let’s ensure it’s moving forward responsibly based on a solid foundation.

Henri

Today, Henri would have been 95 years old.

Twenty years ago, his life was cut short while participating in a clinical study. Henri was what the drug industry calls a “normal healthy volunteer”—yet just 10 days into a bioequivalence trial at a test facility in Montreal, he suddenly collapsed and died.

His story is one of many that reveal the hidden human cost of research. It also inspired me to write "Ethics on Trial – Protecting Humans in Canada’s Broken Research System" (Dundurn Press, 2025).

Learn more about Henri and others whose experiences demand our attention: https://www.indigo.ca/en-ca/ethics-on-trial-protecting-humans-in-canadas-broken-research-system/9781459755970.html .

The Prince Albert School Study

The shocking revelations in CBC's investigation of the Prince Albert School Study (PASS) remind us that Canada needs to adopt HRA Canada's independent, objective accreditation program for human research. Without accreditation, human research ethics violations will continue unchecked.

This entire tragedy would have been prevented had the university developed a functional Human Research Protection Program. In an HRPP, the role of its leadership is clearly defined and monitored. The HRPP could have even been accredited which would have provided assurance by an independent third party that the HRPP was working properly.

A simple, cost-effective solution to prevent horribly harmful outcomes.

https://www.cbc.ca/news/canada/saskatchewan/ethics-research-canada-privately-funded-1.7393063