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.