Hundreds of clinical and research cancer studies and trials take place around the province every year, and the Health Research Ethics Board of Alberta Cancer Committee (HREBA-CC), housed at Alberta Innovates – Health Solutions, has a part to play in every single one of them.
The ethics board, which provides scientific and ethical reviews of all cancer-related protocols in Alberta involving human participants, is made up of more than 30 volunteers, ranging from legal and privacy experts to psychologists and academic researchers to doctors, radiologists and statisticians.
“It’s very important work,” says committee chair Dale Dewhurst. “In terms of research trials being conducted in Alberta, we conduct ethical reviews by exploring the methodology and analyzing the risks and benefits of the research and ensuring that informed consent for participants is more easily understood.”
Dewhurst, who previously practised law and now teaches professional ethics at Athabasca University as an associate professor, first became a member of the board in 2005. He took over the role of chair almost two years ago.
He says besides weighing the cost-benefit factors for patient participants and ensuring they are clear on what is required, HREBA-CC has the final say on whether a trial is approved or not.
According to Dewhurst, the vast majority of the study applications the board receives are approved. Those that aren’t are most often missing information, need clarity or are awaiting funding. “We don’t see ourselves as a barrier for research,” says Dewhurst, noting there can also be privacy, legal and ethical reasons for refusing a study.
Patients must also be aware of what the study is asking of them and, on a practical side, be well enough to take part. “Some of the participants, their illnesses are very serious, and some of the side-effects can be very severe … they need to be exactly sure of what it is they are undertaking,” says Dewhurst.
Many of the studies approved by the committee are international drug trials – often undertaken at the province’s two largest cancer treatment centres: Calgary’s Tom Baker Cancer Centre and Edmonton’s Cross Cancer Institute – but the board has also looked at research involving radio therapy, cancer treatment devices and even the effects of an exercise regime on cancer patients, says Dewhurst.
The studies are initiated by pharmaceutical companies and researchers, including academics, doctors and other health-care professionals.
Each potential study is reviewed by at least two members of the board, who summarize the project and recommend its approval or denial. Their findings are then taken to the full board during twice monthly meetings, held simultaneously in Edmonton and Calgary via video conferencing. In total, the HREBA-CC discusses about 130 study applications annually at the full board level. Many more studies considered minimal risk are reviewed outside the full board meetings.
The committee, which is governed by Alberta’s Health Information Act, also monitors any adverse effects associated with approved studies and has the power to stop research and clinical trials. It was recently handed the responsibility of approving and monitoring pediatric cancer research.
Dewhurst says being a member of the volunteer board is fulfilling. “You know the damage that cancer can do to individuals and families, and you know the importance of increased research and treatment,” says Dewhurst. “The satisfaction comes from having the role to promote positive and clear research for participants for improving cancer treatment in the long term.”
Lauren Birks, who has her doctorate in public health and has studied maternal and baby care in Tanzania, took a role on the committee in February 2015. Like Dewhurst, she takes satisfaction in her role, saying it’s her way of contributing to a healthier community. “Research is a way of helping our caregivers and our society to move forward,” she says. “It’s an honour to participate in that process.”
As a community member, Birks represents the layperson and says she views her assigned studies through a unique lens due to her background in qualitative research, research, advocacy and capacity building.
“When I am reading protocols I [want] to make sure that, at the very minimum, no one is losing anything by participating, that it is indeed benefiting the community,” she says.
Dr. Naveen Basappa is another board member. He is a clinical researcher at the Cross Cancer Institute and has sat on the board as a scientific member for about two years. In addition to his research, Basappa, who was born and raised in Edmonton, works on the front lines of cancer care as a medical oncologist and has a keen interest in ethics, which he says he came by honestly.
“To say things are black and white is hard … there are a lot of greys these days. That’s why the ethics board is important,” he says, noting his father’s propensity for debate and asking tough questions got him interested in ethics.
That early interest in the importance of looking at an issue from many sides, coupled with his desire to ensure patient participants of studies are protected, ultimately compelled Basappa to volunteer his time on the board.
He is thrilled to be part of the collective that is the gatekeeper for cancer trials in Alberta, noting the makeup of the board, with its medical and law experts and laypeople, helps ensure the committee’s success.
“Sometimes you get so focused on what you do that you don’t see it from the other side,” he says, explaining that as a researcher, he understands how compelling it can be to further scientific and medical knowledge.
Basappa, a husband and father of two, says, for that reason, the board is a critical component of the tremendous research that is taking place in the province.
“As a researcher I want to further knowledge, ask questions, but on the flipside … people need to be protected. We have to have those checks and balances in place to ensure that,” he says, adding the recent death of several patients in a Phase 1 trial in France has reminded him of the importance of the ethics committee. “You can’t have clinical cancer research without the ethics board.”