Is industry shaping Canada’s research ethics ecosystem?

Health Canada is working to modernize Canada’s drug approval system, including reforms to its clinical trial requirements. Few would disagree with the goal of making research faster and more efficient.

Clinical trials are the process through which new medicines are tested before they can be approved for sale. In recent years, Canadian policymakers have placed growing emphasis on ensuring the country remains competitive in attracting clinical trials. In response, new initiatives aim to simplify oversight, including allowing a single research ethics board (REB) to approve a study across multiple jurisdictions.

Efficiency matters. But an important question arises: Who shapes the ethics review ecosystem – and whose interests does it ultimately serve?

Ethical oversight exists to ensure that protection of participants in research remains the system’s central priority as the interests of industry sponsors and research participants often diverge.

Much of the current discussion about clinical trial modernization focuses on the efficiency of REBs. Yet REBs are only one component of a much larger system of oversight. Just as aviation safety depends on the coordination of many systems – training, maintenance, regulation and oversight – protecting research participants depends on far more than the work of a single committee.

Research participant protection depends on institutional governance structures that oversee the entire research lifecycle – ethical reviews, investigator conduct, compliance, conflicts of interest, privacy protections, participant safety and the institutional resources and quality systems that support responsible research. When attention focuses narrowly on the speed of ethics review, it risks concentrating on the most visible checkpoint while leaving deeper governance gaps untouched.

Industry sponsors of clinical trials do not sit on REBs. But they do choose where their trials will take place – and consequently, which REBs will review those studies.

For many years, this dynamic was constrained because ethics review was largely tied to the institutions responsible for conducting the research. Sponsors could select research sites, but the ethics review was conducted by the REB accountable to the institution conducting the research.

As part of efforts to modernize and streamline clinical research, Canada is now moving toward multi-jurisdictional ethics review models in which a single REB can approve studies across multiple institutions. Initiatives such as CanReview are designed to streamline this process.

In principle, this approach could make it easier to launch clinical trials and reduce administrative coordination for researchers and sponsors, even though institutions hosting the research still retain ultimate responsibility for research participant protection.

But centralizing ethics review also reshapes the structure of the oversight system. When ethics review across multiple institutions – or even an entire country – is centralized, the selection of the reviewing REB becomes a central governance question and can carry broader consequences for the research ecosystem.

Over time, ethical review risks functioning more like a marketplace, where REBs compete for studies and industry sponsors select the pathway that moves their research forward most smoothly.

Ethics review was never intended to operate as a stand-alone process. In many countries, it functions within a broader governance framework known as a Human Research Protection Program (HRPP) – a system that provides institutional accountability, quality oversight and research participant protections across the research enterprise. Independent accreditation verifies that HRPPs are functioning as intended, creating the trust framework that allows institutions with equivalent governance systems to rely on one another’s ethics review.

If ethics review becomes centralized without strengthening these governance mechanisms, the independence of oversight could gradually weaken.

This governance structure helps ensure that ethics oversight remains anchored in institutional accountability rather than shaped primarily by the preferences of research sponsors.

Canada’s oversight model is different. While REBs play a central role, far less attention has been paid to the broader governance systems that support and oversee them.

If ethics review becomes centralized across jurisdictions without strengthening these governance mechanisms, the independence of oversight could gradually weaken – not because individual ethics board members intend it, but because the incentives shaping the system begin to shift.

This governance question is no longer theoretical.

Industry organizations such as Innovative Medicines Canada and many of its members have publicly endorsed efforts to streamline multi-jurisdictional ethics review in Canada. Industry participation in discussions about research efficiency is both expected and appropriate. Pharmaceutical companies are major drivers of clinical research and have legitimate interests in improving trial processes.

But when industry strongly supports changes to the architecture of ethics oversight, it raises a legitimate policy question: Is the system being designed primarily for efficiency or for research participant protection?

Those goals are not incompatible. But research participant protection must remain the system’s central priority.

Canada has an opportunity to modernize its clinical trial system in ways that improve efficiency while strengthening the governance structures that protect research participants. For modernization to succeed, Canada’s research governance framework must be strong enough to ensure that research ethics oversight remains independent – and that protecting research participants is its first obligation.