Actions and Commitments

Call to Action # 65: Education for Reconciliation (62-65)

UofA: Indigenous researchers lead process to create new guidelines for including Indigenous people in Canadian clinical trials

June 26, 2023

Community engagement is key to overcoming distrust due to historical injustices, says Inuk researcher.

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INUK HEALTH RESEARCHER WAYNE CLARK IS TAKING A LEAD ROLE IN A NEW NATIONAL INITIATIVE TO ENSURE THAT FIRST NATIONS, MÉTIS AND INUIT COMMUNITIES AND INDIVIDUALS HAVE EQUITABLE ACCESS TO PARTICIPATE IN CLINICAL TRIALS — AND BENEFIT FROM THEM. (PHOTO: ATHABASCA UNIVERSITY)

NationTalk: University of Alberta Folio – Indigenous researchers at the University of Alberta are taking lead roles in a new national initiative to ensure First Nations, Métis and Inuit communities and individuals have equitable access to participate in — and benefit from — clinical trials.

“I feel that this consortium was deliberate in connecting with Indigenous researchers early on to guide the application process, recognizing that the inclusion of Indigenous perspectives and expertise meets a critical and long-neglected opportunity in clinical trials,” says Florence Glanfield, vice-provost of Indigenous Programming and Research and lead for U of A’s Braiding Past, Present and Future: University of Alberta Indigenous Strategic Plan, which, among other goals, seeks to develop research ethics principles in collaboration with Indigenous communities.

“In essence, ‘nothing about us, without us,’” she says.

Inuk health researcher Wayne Clark, executive director of the U of A’s Wâpanachakos Indigenous Health Program, was named Indigenous Peoples Champion and is a member of the operating committee of the Accelerating Clinical Trials (ACT) Canada Consortium, a $39-million plan announced in January by the Canadian Institutes of Health Research to expand clinical trial research in Canada.

Clark was also awarded $2.2 million over three years to co-chair the Indigenous research and community engagement component, along with Wanda Phillips-BeckIndigenous Research Chair in Nursing at the First Nations Health and Social Secretariat of Manitoba.

“Our approach will address a significant void in how clinical trials are conducted as they relate to Indigenous Peoples,” Clark explains in a YouTube video. “Developing best practices that can be used by each Indigenous group will help improve opportunities for input into trials while acknowledging past harms done to these groups in similar research.”

Clark, who is Inuk registered under the Nunavut Agreement, will carry out the work with Indigenous researchers, community members and allies from across the country who will engage with First Nations, Inuit and Métis peoples.

“The ACT award is a fantastic development for the University of Alberta and its leadership in bridging Indigenous expertise with western science in Indigenous-focused health research,” says Glanfield. A mathematics education professor and member of the Métis Nation of Alberta, Glanfield will serve on the ACT Consortium Indigenous Committee.

“The Truth and Reconciliation Commission Calls to Action and the United Nations Declaration on the Rights of Indigenous Peoples both seek to strengthen Indigenous sovereignty in Indigenous health and well-being, with the decision making of Indigenous peoples at the heart of these,” Glanfield says.

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U of A vice-provost Florence Glanfield, who will serve on the ACT Consortium Indigenous Committee, says the consortium recognizes that including Indigenous perspectives and expertise “meets a critical and long-neglected opportunity in clinical trials.” (Photo: John Ulan)
“It’s just better science”

Clinical trials are used to evaluate the safety and effectiveness of new treatments such as drugs, surgical techniques or behavioural interventions. Among Clark’s goals for the three-year project are to consult with Indigenous communities to learn what their research needs are, understand how they would like to be engaged in future research proposals, define full and informed consent, and set rules for how study results should be shared following First Nations’ principles of ownership, control, access and possession of data, known as OCAP.

The first and most important step is to carry out meaningful engagement with each of the communities, says Clark.  “We won’t know how clinical trials will look in the future until that’s done,” he explains. “We’ll identify the communities’ priorities, and then create a wise practices framework for each of the communities that can go forward as the new Canadian guideline.”

In the past, clinical trials were mainly carried out with white male participants. It wasn’t until 1997 that national guidelines specified that women should be included in clinical trials in Canada. Efforts to reflect ethnic diversity — including Indigeneity — have been equally slow, according to research team member Tracey Hillier, co-director of the Situated Knowledges: Indigenous Peoples and Place signature area at the University of Alberta and a member of the Qalipu First Nation.

Hillier says it is essential that trials develop a broader, more inclusive reach. “If we’re just researching one subset of our population, our results aren’t that generalizable,” points out Hillier, who was the first Indigenous associate dean for an MD program in Canada. “If we want to have meaningful results that can apply to a whole population, that whole population needs to be represented in the study.”

“It’s just better science.”

Overcoming a horrific history

While Indigenous peoples were often left out of scientific research in the past, there is also a legacy of abusive research practices within Indigenous communities carried out by governments and universities across Canada, including forced sterilization, attempts to eradicate traditional healing practices, nutritional experiments that withheld food from starving residential school students, and experimental tuberculosis vaccination of infants.

Such deficit-based research and unethical practices have created distrust of medical researchers within many Indigenous communities. Clark says historic wrongs must be acknowledged before a new shared approach to research can be built.

“We’re dealing with this at research institutions across the country,” he says. “It’s taken time to get to a point where we can actually do this work and do it together and march forward together.”

Glanfield points out that some Indigenous people were unwilling to take the vaccines offered during the COVID-19 pandemic because of the historic distrust in the medical system.

“Imagine how this work could change the future if we actually have Indigenous community members involved in the trials that lead to the development of vaccines,” she says. “How do we begin to change the narrative of what happened in residential schools, where Indigenous people were targeted as research subjects, kind of like rats? What if now we were involved in the process?”

“That contributes to braiding the past, present and future. We do want to benefit communities.”

Communities to set their own research priorities

Clark intends to follow the principles of the United Nations Declaration on the Rights of Indigenous Peoples, which state that Indigenous peoples have a right to equal access to the best health and medical services available, including being able to preserve and use traditional medicines, as well as the Calls to Action of the Truth and Reconciliation Commission, especially number 19 which calls for closing the gaps in Indigenous health outcomes.

“Anything that we do has to be identified and approved by the community,” Clark insists.

Hillier says this could mean, for example, ensuring full Indigenous participation in studies of particular interest to Indigenous communities, such as those related to diabetes or heart disease — chronic illnesses that affect Indigenous Canadians in disproportionate numbers, according to the Public Health Agency of Canada.

Tracey Hillier

If we want to have meaningful results that can apply to a whole population, that whole population needs to be represented in the study. It’s just better science.

Tracey Hillier
(Photo: Supplied)

It might also mean blending Indigenous and western research methods to investigate traditional healing practices, says Clark, as in a trial of a traditional First Nations antidiabetic plant with the James Bay Cree or in the integrated health-care delivery model of All Nations’ Healing Hospital in Fort Qu’Appelle, Saskatchewan.

Hillier says new funding mechanisms may be required to foster projects that are led by communities rather than driven by researchers. To overcome the wariness Indigenous Peoples feel, all research must be based on ethical relationships, she says.

“An ethical research relationship would include more meaningful engagement, looking at projects that are important to the community, and then sharing results back with them,” Hillier explains. “It means welcoming Indigenous Peoples into trials in a way that feels safer, respects different worldviews, collects data and shares it back in a way that the Indigenous community can help interpret.”

U of A pediatrics professor Lawrence Richer was also named to the operating and systems transformation committees of the ACT. Richer is the Alberta Health Services Chair in Health Informatics Research, vice-dean of clinical research for the Faculty of Medicine & Dentistry and director of the Northern Alberta Clinical Trials and Research Centre, overseeing all clinical trials at the university.

Hillier is delighted at the level of U of A leadership in the national clinical trials initiative. “I would love for us to become a national or international centre of excellence for engaging Indigenous communities in clinical trials,” she says, noting that Indigenous-focused research has attracted millions of dollars to the U of A.

“Over the decades, we have changed in terms of our understanding of ethics and what it means to work with community,” says Glanfield. “The U of A has continued to adjust some of those relationships in order to do research in a Good Way to benefit community.”

Clark sees the project having the potential to have a positive impact on the long-term health of Indigenous communities and individuals across the country. “My main goal is to elevate the involvement of elders, our own Ways of Knowing and our own self-determination, in order to make decisions and be empowered to participate in trials that we have a right to participate in,” says Clark.

“We need to build knowledge and make decisions about ourselves in our community that we haven’t been able to do in the past.”

BY GILLIAN RUTHERFORD

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