Canada’s oversight of human research ethics has come under scrutiny following revelations about a controversial brainwave study targeting Indigenous youth in Saskatchewan. The Prince Albert School Study (PASS), conducted between 2014 and 2016, promised extraordinary benefits such as enhanced intelligence, trauma recovery, and even the ability to levitate. However, experts have criticized the study as unethical, highlighting a glaring lack of protections for participants in privately funded clinical trials.
Janice Parente, a Quebec-based scientist and ethics expert, identified PASS as a troubling case. Despite receiving approval from two Canadian universities, the study lacked informed consent and used questionable methods. Participants, primarily Indigenous children and their guardians, were subjected to experiments in dark rooms, with promises of life-changing outcomes that lacked scientific backing. Parente, who is including this case in her upcoming book Ethics on Trial: Protecting Humans in Canada’s Broken Research System, was stunned by the federal government’s lack of jurisdiction over privately funded research, which constitutes roughly 85% of clinical trials in Canada.
The federal body responsible for research oversight, the Secretariat on the Responsible Conduct of Research, has authority only over publicly funded research. This regulatory void leaves participants in privately funded trials without recourse if their rights are violated. Parente argued that this lack of accountability represents a significant ethical failure. “Research participants are left unprotected,” she said, emphasizing the need for mandatory transparency and oversight.
PASS was funded by philanthropist Allan Markin and conducted by the Arizona-based Biocybernaut Institute. It was approved by the research ethics boards of the University of Regina and the University of Calgary, despite significant red flags. Both universities later acknowledged the study’s ethical shortcomings, yet no comprehensive investigation or accountability followed. Critics, including lawyer and ethicist Martin Letendre, have called Canada’s system a “wild West” where private studies operate without meaningful oversight.
Experts suggest Canada adopt a U.S.-style accreditation system, where independent third parties oversee research ethics. Such a model could ensure transparency and accountability, protecting participants from exploitation. As the debate continues, participants in the PASS study, like Alma Stonestand, are left searching for answers and justice. For many, the absence of recourse underscores the urgent need for systemic reform in Canada’s research ethics framework.