A Line in the Sand
The race to develop a vaccine for COVID-19 is raising new questions in research ethics. Dr. Charles Weijer is stepping up to answer them
By Ashley Rabinovitch
"Somebody once said that in a pandemic, everyone is a utilitarian,” mused Dr. Charles Weijer. “But I know that’s not true, because I’m not one. Lowering our ethical standards may be useful, but that doesn’t mean it’s right.”
“I’m deeply worried by the prospect that healthy volunteers could become seriously ill and die. We have yet to establish a safe dose of the virus or failsafe treatments if something goes wrong.” — Dr. Charles Weijer
For the past 15 years, Dr. Weijer has occupied a unique space as a joint appointee between Medicine at Schulich Medicine & Dentistry and Philosophy in the Faculty of Arts & Humanities. Trained as a physician and a philosopher, he describes himself first and foremost as an interdisciplinary researcher with a responsibility to respect the “singular and pivotal importance of human dignity” in every health research project he undertakes.
In March 2020, Dr. Weijer was on sabbatical in Spain when the World Health Organization (WHO) called upon him to weigh in on the ethics of human challenge studies for developing a COVID-19 vaccine. Unlike standard vaccine trials, which test vaccines on people who may then be exposed to the disease circulating naturally in the community, challenge trials intentionally infect healthy volunteers with the disease in order to test vaccines on a smaller population more quickly.
“When I first heard about human challenge studies back in 2012, my initial reaction was that the risk level was unacceptably high,” Dr. Weijer said.
His viewpoint changed through interactions with colleagues who employ challenge trials in their labs and devise strategies to protect research participants throughout the process. In challenge trials for diseases like influenza, cholera and malaria, for example, researchers typically use a genetically modified strain of the disease to maximize patient safety.
In 2013, Dr. Weijer joined a working group that clarified boundaries around challenge trials. At that time, the group unanimously agreed that the disease being tested could not be incurable or fatal. “We drew an ethical line in the sand,” he shared.
Alongside 13 other international experts on the WHO’s Working Group for Guidance on Human Challenge Studies, Dr. Weijer spent several months examining and re-examining that line in the sand.
“COVID-19 meets none of the ethical standards we had previously established,” he said. “I’m deeply worried by the prospect that healthy volunteers could become seriously ill and die. We have yet to establish a safe dose of the virus or failsafe treatments if something goes wrong.”
Ultimately, the working group produced a document that expresses cautious approval of challenge studies for COVID-19 as long as eight conditions are met, including restricting participation to healthy, consenting people between 18 and 30 years old.
Dr. Weijer’s primary contribution to the document was the concept that challenge studies should only accept participants who faced a substantial amount of exposure to COVID-19 in their everyday lives.
“It reduces the risk you can attribute to study participation,” he explained. “You’re changing when, not if, someone gets the virus.”
“It’s important to recognize, though, that these trials present ethical challenges like determining who should be considered a research participant and when to require informed consent.” — Dr. Charles Weijer
With a heated global race to produce a vaccine underway, Dr. Weijer can only speculate about whether or not human challenge trials will play a role in catalyzing vaccine development. As the dust settles, he will continue to advocate for clear ethical protections in any trials that move forward.
COVID-19 has consumed the majority of Dr. Weijer’s bandwidth this year, but the scope of his research extends far beyond the pandemic. In the course of his 25-year career, Dr. Weijer has invested much of his time and energy into exploring ethical questions related to randomized controlled trials, particularly cluster randomized trials (CRTs).
“The gap between medical evidence and practice is a major challenge for the health of Canadians, and CRTs play a significant role in bridging that gap,” he said. "It's important to recognize, though, that these trails present ethical challenges like determining who should be considered a research participant and when to require informed consent."
In 2012, he and his team of researchers, biostatisticians and philosophers garnered international recognition for creating the world’s first ethics guidance document for CRTs.
In 2017, Dr. Weijer and his team pivoted to developing a large-scale, comprehensive review of pragmatic research trials. In contrast to other types of randomized controlled trials, pragmatic trials evaluate treatments in real-world conditions in order to directly inform health care decisions around safety, effectiveness and cost.
“We’ve found that pragmatic trials raise ethical issues that no one has adequately addressed,” noted Dr. Weijer. His team’s ambitious review, which is still ongoing, explores questions of consent, risk disclosure, levels of oversight and a number of other factors to create an ethical framework for designing and conducting pragmatic research trials.
From human challenge trials to randomized controlled trials and beyond, Dr. Weijer has experienced his fair share of opposition to the ideals he defends. “There are always going to be scientists, policymakers and even ethicists who try to push against well-entrenched ethical standards,” he reflects. “My job is to hold the line and remind people of the obligation we have to safeguard vulnerable participants in our trials. We owe it to people to protect their welfare in a way that still makes room for scientific advancement.”