Ethical concerns over a study on Indigenous children have revealed “hugely problematic” holes in Canada’s research regulation framework and a lack of safety net for participants, it has been claimed.
The Prince Albert School Study, which ran from 2014 to 2016, tested the benefits of “brainwave training” on children aged between 12 and 15 and their parents in an area of Saskatchewan populated primarily by Indigenous peoples.
In the trial, students were placed in darkened rooms, sometimes for several hours a day, while listening to sounds generated by their own brainwaves and apparently learning to control them, reported.
The study was run by the Arizona-based Biocybernaut Institute, whose founder, James Hardt, has claimed that brainwave training can make participants cleverer, happier, and better able to overcome trauma. He has also reportedly claimed that it can help people levitate, walk on water and visit angels.
One of the principal investigators on the study was a professor at First Nations University, who submitted an?ethics application to the University of Regina, which reviews all ethics applications for First Nations University.?Regina’s research ethics board approved the study, while?another at the University of Calgary allowed researchers to examine data from it.
Udo Schuklenk, Ontario research chair in bioethics at Queen’s University, told Times Higher Education?that the study’s scientific rationale was highly questionable, and that its use of “marketing material” to attract participants had invalidated any informed consent.
“The fact that a dodgy research enterprise targeting vulnerable Indigenous people was approved by a properly constituted ethical review committee at Regina at the time raises questions about the extent to which potential research participants can trust that these institutions do their job reliably,” Professor Schuklenk said.
While all publicly funded research is overseen by the federal Secretariat on Responsible Conduct of Research, which can look into allegations of misconduct, has highlighted that the organisation has no responsibility for privately funded research.
Martin Letendre, a research ethicist and president of ethics review services company Veritas, said that this was “jaw-dropping” in a country where about three-quarters of studies are privately funded.
“When things go bad, there’s absolutely no safety net for research participants,” he said.
“This is the first example that illustrates that there is no protection for research participants and that the secretariat is not fulfilling its mandate as the research community thought.”
Bryn Williams-Jones, professor of public health at the University of Montreal, agreed that the system of oversight was “hugely problematic” and said greater centralisation was needed.
“It creates a breach in the governance system, it undermines trust, but it also leads to an imbalance because there’s no longer that check against the natural conflict of interest within institutions,” he told?THE.
“This story really scares me because it shows that what we imagined from start to finish being covered isn’t.”
Karen Wallace, the secretariat’s executive director, said that although it had no role in cases in privately funded research, it expected institutions to “respond appropriately”.
She also suggested that research subjects with grievances could seek legal redress. But Mr Letendre said that it was “absurd” to think that people could take on universities and private funders in court, particularly when they were from disadvantaged backgrounds.
Chris Yost, Regina’s vice-president of research, said that review processes had improved since the original approval in 2013.
“If the same proposal was brought forward today, the review process would be robust, particularly around data collection methods of a private company,” he said.
Calgary said that its involvement was confined to data entry, cleaning, analysis and reporting. “The ethics application stated that Calgary researchers would not have any direct contact with research participants and, to our knowledge, none occurred,” a spokesperson said.
Biocybernaut was approached for comment.
