The Canadian Cancer Trials Group (CCTG), a prominent research organization based at Queen’s University, is set to modify its trial protocols in response to an executive order issued by President Donald Trump. This executive order aims to change the way we refer to gender in federally funded clinical trials. Accordingly, CCTG has excised gender-inclusive language from the publicly available documentation for six U.S.-funded clinical trials.
As a result, CCTG is able to work with academic groups across the globe. So far, it is the only non-American partner in the U.S. National Clinical Trials Network (NCTN). Today, CCTG is made up of more than 85 member institutions and more than 2,100 Canadian investigators. As a vital part of the cancer research community, it helps support more than 600 active trials, recruiting nearly 3,000 patient volunteers each year.
In 2019, the CCTG won almost $25 million in funding. This funding from the U.S. National Institutes of Health and the National Cancer Institute (NCI) will continue for six years and significantly expand their research activities. The landscape has shifted dramatically with their recent directive from the NCI to make drastic changes in language. This has significant implications for the protocol and informed consent documents for some trials.
Here’s why each of these adjustments from the NCI’s rep, Jessica Sleeth, told us they made are important.
“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.”
The NCI now requires meaningful changes. They insist that we substitute the word “gender” for “sex,” remove “intersex,” and take out language such as “gender if different than birth.” These changes have sparked alarm among a broad cross section of the scientific community about how they would undermine research integrity and inclusivity.
Researcher and leading bioethicist Françoise Baylis, in 2015, warned against these dangerous changes.
“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.”
Baylis cautioned that if we bow to political pressure we will put the integrity of our scientific research at risk, saying,
“Bowing to political masters will ultimately destroy knowledge production.”
This sentiment echoes widespread concern from healthcare practitioners about the long-term impacts these changes will have on advancing healthcare practices. Judy Illes, a leading authority on ethics in cancer care, wrote about her worries. Perhaps most importantly, she is concerned about how all of these changes will impact marginalized communities.
“They threaten to bring back discriminatory practices in health care for cancer-related and other medical conditions, and society at large,” Illes remarked.
CCTG Chair Janet Dancey shared her personal commitment to enforce diversity standards in research. She underscored the importance of changing in the face of outside pressures. Her organization is still dedicated to staying true to its ethical standards.
“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,” Dancey stated.
Their plan is to ensure that patient volunteers who are actively involved in ongoing patient trials hear these important messages loud and clear. Other players might choose to drop out of participation altogether as a result of the changed protocols. Dancey has recognized that potential and pledged CCTG’s commitment to transparency during this transition.
CCTG looks forward to putting the changes into effect within the coming two months. They truly want to adhere to U.S. Department of State funding requirements, while remaining true to their values of inclusivity and respect for all participant identities.
Independent researcher David Robinson, an advocate for research independence, echoed the concerns, noting that when applying science to technology, it’s crucial that you maintain an unbiased approach. He stated,
“The integrity and independence of research is necessary to protect the public interest.”
Robinson called for a more explicit discussion of the political motivations behind Canadian research funding. He said any effort to control where and how research is done would trouble him greatly.
“We need to make it clear that there is no room for political interference in research in Canada,” Robinson asserted.
He said that this upending of science represents a metastasizing of societal divides between cultural values and scientific debate.
“This kind of American-style culture war has no place in Canada.”
As CCTG prepares for a new round of protocol amendments, it needs to be able to deftly juggle a variety of funding needs, all while maintaining a strong focus on inclusive language and diverse representation.
