'No consequences' for violating human rights in privately funded research in Canada, says ethics expert
Roughly 85 per cent of clinical trials in Canada are privately funded
When Janice Parente read a CBC story this past spring about a dubious brainwave study targeting primarily Indigenous kids in Saskatchewan, it immediately piqued her interest.
That's because the Quebec-based scientist and research ethics expert was putting the finishing touches on a book critiquing Canada's system of research oversight.
The Prince Albert School Study (PASS), which ran from 2014 to 2016, was conducted to test the benefits of brainwave training on 12- to 15-year-old children and their parents or guardians.
James Hardt, the American scientist leading the study, claims brainwave training can make participants smarter, happier and enable them to overcome trauma. He said it can also allow them to levitate, walk on water and visit angels.
Parente said the sheer volume of red flags in PASS took her breath away.
"It violated everything," she said, describing it as a "jackpot" of failure.
Knowing that PASS had been approved by two Canadian universities, Parente thought, "I could write a book just on this." Instead, she is adding a chapter on it in her forthcoming book, tentatively titled Ethics on Trial: Protecting Humans in Canada's Broken Research System.
But through her interactions with CBC, Parente made another discovery: the federal government body that oversees research ethics, the Secretariat on the Responsible Conduct of Research, does not have jurisdiction over privately funded clinical trials — which make up about 85 per cent of all such research in this country.
"I was shocked at this revelation," she said. "Everyone I have spoken to were just as shocked."
Martin Letendre, a Quebec-based lawyer and research ethicist, said this fact demonstrates that Canada's research ethics system is the "wild West."
"Clearly, it makes absolutely no sense," said Letendre, who is president of Veritas IRB, a private research ethics board founded by Parente. "It's going to come as a total shock to anyone in academia who is studying or experts on the governance of research in the country."
Parente says if she wasn't aware of the Secretariat's lack of jurisdiction in these cases, neither are the majority of people who volunteer to be part of research studies. She says that needs to be fixed.
"That should be on the informed consent form: 'This study is being funded by a private stakeholder and therefore, should anything happen to you, you're shit out of luck,'" she said.
Alma Stonestand and her daughter Chyna took part in the PASS in 2014.
"Somebody did wrong to us. To our children. And somebody needs to be held accountable for it," Stonestand told CBC earlier this month.
Parente said this revelation sends a chilling message to people like Stonestand who participate in privately funded research.
"You're not protected," said Parente.
A questionable study
PASS was a privately funded study run by Arizona-based Biocybernaut Institute. The company was testing its patented brainwave training program on students and their parents from schools with predominantly Indigenous students. The funding came from Allan Markin, a former Alberta oil executive, part-owner of the Calgary Flames and well-known philanthropist.
While Markin agreed to fund the Biocybernaut study, his lawyer pointed out to CBC that neither he nor his company, Pure North S'energy Foundation, were "involved in the direct supervision of Biocybernaut's work."
Biocybernaut promised the students that brainwave training would increase their happiness, joy and intelligence and help them recover from anxiety and trauma.
The students were recruited by Biocybernaut with the help of the Prince Albert school system. Participants were provided very few details about the research ahead of time.
Each student was flown, with a parent or guardian, to Victoria, B.C., for a week. They were placed alone in darkened rooms, sometimes for hours a day, while listening to sounds generated by their own brainwaves and learning to control them.
"Change your brainwaves, change your life," said the promotional brochure handed out at schools.
The study was approved by the University of Regina's research ethics board (REB). An REB at the University of Calgary gave approval for its researchers to examine data obtained from the project.
Experts consulted by CBC called the experiment weird, shocking, abusive and unethical, noting it lacked informed consent and that some of the research methods were risky and untested.
Reflecting on the fact that two universities approved the study, Ian Mosby, a medical historian at Toronto Metropolitan University, concluded "clearly a serious mistake was made."
Universities investigated themselves
When contacted by CBC earlier this year, the University of Regina's vice-president of research, Christopher Yost, wrote, "We are sorry for any role the U of R may have had in causing suffering or harm to children, parents or the Prince Albert School community in relation to this study."
He said after CBC brought the study to his attention, he asked for an informal review. As a result, the university has put new procedures in place to ensure proposed research is rigorously reviewed by appropriate experts and Indigenous community representatives.
CBC asked Yost if the review found how the REB failed and why. He didn't reply.
William Ghali, vice-president of research at the University of Calgary, told CBC the details in the PASS story "are distressing, and the criticisms and ethical questions raised are valid."
He said he launched an internal review earlier this year, when CBC began asking questions. It found the REB issued its approval after the data had already been gathered. It was merely authorizing researchers to analyze that data.
In an email, CBC pointed out that Stephen Hoption-Cann, a research ethics expert from the University of British Columbia's college of medicine, said despite that, the University of Calgary's REB was obligated to examine the study's ethics.
"You obviously can't take data or can't take specimens where you don't know whether that was collected in an ethical manner," said Hoption-Cann.
Ghali responded by saying, "it is not appropriate for us to declare, post hoc when hindsight provides more insight, that a review process has either 'passed' or 'failed.'"
Parente said both universities have displayed a lack of transparency.
"That is a sick system," said Parente. "They won't tell you what they did wrong. So there's nothing for these poor research participants who suffered in that study."
Alma Stonestand believes the universities are "just hoping that this will go away." She says that's not going to happen, adding no one has ever explained why the study was approved, or taken accountability for it.
"I don't like the feeling of being treated less than human," said Stonestand. "We're all just trying to figure out, where do we go from here? What do we do?"
A formal complaint
Parente reached out to CBC after reading the PASS story in June.
She's a noted expert in research ethics review. In 2017, Parente founded Human Research Accreditation Canada, an independent not-for-profit body that accredits research institutions like universities, ensuring they are accountable for following national standards. Two years later, she created the Human Research Standards Organization, which has developed a series of national standards for governing organizations conducting human research.
At CBC's request, she reviewed the documentation gathered during its investigation.
She and her colleagues were so alarmed that in July they filed a complaint with the Secretariat on the Responsible Conduct of Research, an arm of the three federal research funding agencies in Canada, known as the Tri-agencies.
Parente says that in order to receive money from the Tri-agencies, universities or other research organizations must sign the Tri-Council Policy Statement (TCPC) on the Ethical Conduct for Research Involving Humans, promising "research conducted under their auspices complies with this policy."
The statement adds, "failure to fulfill the requirements of the TCPS, by the researcher or the institution, may result in recourse by the agencies." Penalties could range from a sternly worded letter to public reprimand to loss of funding.
The Secretariat, Parente explained, is the enforcer. It has the power to order a university to conduct an investigation and it has the authority to review that investigation to make sure it was done properly.
"The Secretariat will make sure an investigation is done," she said.
The complaint Parente and her colleagues submitted raised the following allegations about PASS:
- The research ethics application failed to outline the purpose of the study, justify the methodology used or provide enough information to assess the study's risks.
- The research ethics application failed to justify conducting a study like this on children.
- The study pamphlet was more of a "sales brochure" promising to make participants smarter, happier and healthier without evidence, creating "undue influence on students and their parents."
- The consent form failed to outline what would happen during the research process or the risks participants faced.
- The Prince Albert school system was helping researchers recruit children for the study, which created a power imbalance.
The complainants concluded a lot of harm could have been prevented if the REBs had done their jobs and said no to this study.
"[The researchers] really exploited the hell out of that population," said Parente. "How come you see it, I see it and everyone in my world sees it, but the research ethics board didn't see it? It makes me so sad."
Universities only accountable to themselves
After learning of Parente's complaint, CBC reached out to the Secretariat to learn the status of its investigation. But there was no investigation.
The Secretariat told CBC it has no jurisdiction over privately funded studies.
"In the case of the Prince Albert School Study, this research was not funded by the federal research granting agencies and so is outside of the Secretariat's jurisdiction," said Karen Wallace, executive director of the Secretariat, in an email to CBC.
CBC pointed out to Wallace that the federal government's ethics website says its human research policies apply "to agency and non-agency funded research."
Wallace replied that the government hopes research institutions will follow the policy when it comes to privately funded studies, but its enforcement powers only apply to government-funded research.
She said if someone has a complaint about a privately funded study, they should complain to the organization that did the research. Failing that, they can take the research institution to court.
"While the Secretariat is unable to advise on recourse available to someone who has concerns about the institutional processes for research that is not funded by the Agencies, we expect that other avenues may be available, for example, via legal proceedings," said Wallace.
'Why does the Secretariat even exist?'
Parente said she knew Canada's system of research oversight was bad. She had no idea it was this bad.
She said this was shocking because she had always believed the Secretariat would ensure any violation of policy was investigated, regardless of funding source.
She said it's unbelievable that the Tri-agencies require universities to commit in writing to follow ethics rules, "but if they don't, there are no consequences."
Martin Letendre, who sat on the Tri-council's Panel on Responsible Conduct of Research from 2012 to 2014, points out that the vast majority of research conducted in Canada is privately funded, and therefore accountable to no one.
In a recent article, Megan Bettle, the executive director of clinical trials at the Canadian Institutes of Health Research — one of the Tri-agencies — said that while CIHR funds 150 clinical trials annually, industry sponsors between 750 and 1,000 trials every year.
That means up to 87 per cent of clinical trials in Canada are privately funded, and fall outside the Secretariat's purview.
"Why does the Secretariat even exist?" wondered Letendre. "What's the point if you're only looking at a tiny percentage?"
Canada should follow U.S. model, says expert
He said telling the participants in the PASS study to turn to the courts is especially infuriating. He points out the study application itself says participants had a low socioeconomic status.
Letendre points out even most wealthy people don't have the means to go after universities in court.
"Legal recourses and civil courts are not the solution to protect research participants," said Letendre. "It's absurd."
He said Canada should follow the American model of accreditation. In the U.S., universities must receive third-party accreditation in order to receive federal funding. This ensures an independent body can investigate allegations and impose sanctions if warranted.
He said if PASS had happened in the U.S., it would be investigated in a transparent manner.
"It would be discussed by the community. There would be actions to be taken," he said. "You would have policymakers who would be present and it would lead to actions."
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