The Canadian Cancer Trials Group (CCTG), based at Queen’s University, pictured, works with academic groups around the world.Andres Valenzuela/The Globe and Mail
A Canadian cancer research group is scrubbing gender-inclusive language from documents associated with U.S.-funded trials to comply with an executive order signed by President Donald Trump, in a move that critics say acquiesces to political overreach and undermines scientific integrity.
The Canadian Cancer Trials Group (CCTG), based at Queen’s University, works with academic groups around the world, and is the only non-American partner of the U.S. National Clinical Trials Network (NCTN). Six trials out of 170 will be affected.
In an April 7 memo obtained by The Globe and Mail and addressed to Canadian research ethics boards, research associates, investigators and other representatives, CCTG director of compliance Jessica Sleeth said the organization would be making changes to the group’s U.S.-funded trial protocols within the next two months because of Mr. Trump’s Jan. 20 order.
“To comply with the U.S. Executive Order Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, the U.S. National Cancer Institute (NCI) is requiring all Groups within the U.S. Clinical Trials Network (NCTN), including CCTG, to modify the language in their protocol and informed consent documents,” Ms. Sleeth wrote.
“Some examples of these changes are the replacement of the word ‘gender’ with the word ‘sex,’ the removal of the terms ‘intersex’ and ‘gender if different than birth,’ and other similar changes.”
Participants in the U.S.-funded trials will only have the option of self-identifying as male or female.
According to its website, the CCTG is made up of more than 85 member institutions, comprising more than 2,100 Canadian investigators, and it has facilitated more than 600 trials.
About 3,000 patient volunteers participate in CCTG-led trials each year to potentially receive better treatments that could also benefit others in the future.
The CCTG says that it does not have stable funding and must rely on grants and support from pharmaceutical companies. In 2019, it was awarded about $25-million over six years from the U.S. National Institutes of Health and the U.S. National Cancer Institute (NCI).
In an interview, CCTG chair Janet Dancey said her preference as a cancer researcher is always to lead trials that reflect the group’s diversity commitments and to understand the effects of cancer and its treatment across patients and for individuals. But, this is not the priority of the Trump administration.
“There are times you can’t do everything that you wish you could do in a trial, and so the aims are related to the primary objectives, where there can be benefits derived,” she said.
Dr. Dancey said health care teams will inform patient volunteers about the changes, and some may choose not to participate.
While the change won’t disrupt the primary objectives of these trials – such as testing a promising combination treatment for people with leukemia – Dr. Dancey said there will be discussions with network members about the path forward.
“There’s the additional issue of what else might come down as a directive, and what we will be doing,” she said.
The Canadian Institutes of Health Research has underscored the difference between sex and gender and explicitly advises research applicants to integrate both into research design and practice where appropriate. A 2016 article in the Journal of the American Medical Association noted the two are not mutually exclusive and can have an effect, for instance, on “how an individual selects, responds to, metabolizes, and adheres to a particular drug regimen.”
Françoise Baylis, a bioethicist and distinguished research professor emerita at Dalhousie University, called the NCI’s directive deeply offensive and factually incorrect.
“A lot of work has been done, over a very long time, to get people to understand the difference between sex and gender,” she said. “When you’re looking at biology and refusing to turn your attention to the ways in which people move through the world, you’re in fact entrenching a very peculiar and authoritarian way of understanding how people can be, and express themselves, in the world.”
Prof. Baylis said “bowing to political masters” will ultimately destroy knowledge production.
“This is a moment to stand up for what’s right, what you believe in and what you know, as opposed to the dictates of a country that right now is going through chaos and uncertainty,” she said. “If you acquiesce, you are, in fact, undermining trust in science. You’re contributing to that project, which is their project. It doesn’t have to be our project.”
Judy Illes, a professor of neurology and neuroethicist at the University of British Columbia, said the changes would reverse “decades of scientifically validated research that have demonstrated important differences in body and brain based on gender.
“They threaten to bring back discriminatory practices in health care for cancer-related and other medical conditions, and society at large.”
This is not the first instance of U.S. policies bleeding into Canada. Last month, the Canadian Association of University Teachers said that researchers working on projects funded wholly or in part by U.S. federal agencies were sent a lengthy questionnaire to determine how their work aligns with the Trump administration’s political agenda.
The CCTG’s decision is separate from this letter, though both developments are results of U.S. policies.
The researchers were asked to confirm that their research does not include climate or “environmental justice” elements; does not contain diversity, equity and inclusion elements; and does not ascribe to “gender ideology.”
David Robinson, executive director of the association, called on Canada’s institutions and federal government to push back against what he called a blatant attempt to interfere in academic research.
“The integrity and independence of research is necessary to protect the public interest,” he said in a March 17 statement. “We need to make it clear that there is no room for political interference in research in Canada.”
The same association expressed alarm over Conservative Leader Pierre Poilievre’s promise to “put an end to the imposition of woke ideology in the federal civil service and in the allocation of federal funds for university research,” as stated in the party’s Quebec platform released March 26.
“It’s worrying that a leader of a political party in Canada would try to dictate how research funds will be granted,” Mr. Robinson said. “This kind of American-style culture war has no place in Canada.”