Ensuring safety and ethical procedures of research that leads to medical innovation
That pill you’re about to swallow, that test you’re about to take, that medical procedure you’re about to undergo, that social program you’re about to enroll in—how do you know they’re safe and effective? Because every step in modern health care is based on scientific evidence gathered through rigorous research.
A reassuring answer—and most people wouldn’t ponder the matter beyond this point.
However, if you think a little more closely about that life-enhancing research, some troubling concerns come to mind. For instance, if a drug is tested on someone who’s already sick, how is that patient’s general well-being safeguarded?
What protection is afforded to vulnerable individuals, such as children who participate in research studies? Or people who are experiencing homelessness? Or those who have an intellectual disability or a mental illness?
What safety measures are in place when researchers venture into largely uncharted territory (such as AI) or onto new pathways in established fields (like immunology)?
The answers can be found in the efforts of expert groups that oversee the work of researchers, starting right from the moment an investigator has a good idea that they believe is worth looking into.
In spring 2023, Bessy Bitzas, Ph.D., leaves the Research Ethics Board (REB) after more than 15 years as a member, including the final 10 years as Chair. During that time, she played a significant role in guiding the Board, which helps to ensure that research in the Lady Davis Institute (LDI) at the JGH—and throughout CIUSSS West-Central Montreal—is conducted in ways that are safe and ethically sound for the participants.
Shortly before her departure, Ms. Bitzas reflected on her years of service with the Board. Read this interview in JGH News and find out more about Dr. Bitzas, who in February was named the CIUSSS’s Associate Director of Nursing.
At CIUSSS West-Central Montreal, that supervisory role is played by the Research Ethics Board (REB). While the REB’s activities may be largely unfamiliar to the public, its efforts are essential in ensuring that every aspect of research meets the highest standards.
“Studies aren’t carried out purely for scientific curiosity,” says To Nhu Nguyen, the CIUSSS’s Director of Academic Affairs and Research Ethics. “That means we need to protect the participants, of course, but also ask ourselves whether the knowledge we gain from the research will benefit the public and individual end-users.”
Every year, the Board approves approximately 250 projects, a number that’s been steadily rising in such fields as cancer care, cardiology, psychiatry and nursing.
In addition to reviewing new projects, the Board re-reviews all studies at the one-year mark to make sure they do not deviate from ethical standards. Similarly, if a project is considered to be a high risk to its participants, or has undergone major changes while the work was in progress, it is carefully scrutinized.
As well, the Board has the authority to halt any project that does not appear to be stringently protecting its research subjects. No work can resume until the Board agrees that the problems have been rectified.
The Board itself is composed of independent appointees in a wide range of fields: science members (to verify the soundness of the project’s methodology), a legal expert, an ethicist and a community representative (to advocate for the public, which is served by the CIUSSS). A representative from the pharmacology sector is also included in all meetings of the medical-biomedical branch of the REB, given the frequent use of drugs in clinical trials.
Bessy Bitzas, Ph.D., who recently stepped down as the Chair of the Board’s medical/biomedical committee, says ad hoc advisors are also brought in to lend additional expertise—many of them drawn from the CIUSSS’s vast pool of scientists. For instance, for help on the rare studies in our CIUSSS involving babies, the REB might reach out to the JGH Neonatology Department.
One of the board’s key ethical considerations when reviewing a proposal is that participants give fully informed consent to take part in a CIUSSS-led research study. Forms—some as long as 30 pages—are carefully prepared, in which all of the potential risks are spelled out.
Céline Gélinas, Ph.D., a Senior Researcher at the JGH Centre for Nursing Research since 2007, has worked closely with the Research Ethics Board when developing her studies on pain management in the Medical Surgical Intensive Care Unit (MSICU). Dr. Gélinas began her nursing career as an ICU bedside nurse, and was concerned with the challenges of pain management in patients who are on a ventilator or in a coma.
Her research supports ICU care teams with evidence-based tools. Implementing research in the MSICU has its own complex ethical considerations. Some patients, because of their critical illness, may be temporarily unable to consent to participating in a study. In such situations, someone qualified to consent for their care (such as a family member) can provide consent on their behalf. The researcher team has to follow up with these patients regularly to determine if they regain the ability to consent for themselves, so that they can pursue their participation in the study.
Similarly, Dr. Bitzas says, if a drug being tested for an effect will not have an impact on the progression of the patient’s disease and will not provide any measurable benefit to the patient, this fact must be made clear, so not to raise false expectations.
Dr. Bitzas emphasizes that the Board’s role is not to act as a roadblock, but to work with researchers. “There was once a perception that there are so many boxes to tick, and that these become barriers to our process,” she says, “but if a project is submitted by the deadline, researchers can expect a response from the Board within one week of our committee meeting.
“What follows is usually a back-and-forth process, but the pace is set by the research groups. Once they’ve amended their protocol as we’ve requested, they can proceed.
“Yes, we’re there to protect the rights of the participants, and it does take some finesse to ensure that the researchers are not discouraged. But our goal is to support and guide researchers. Ultimately, we aren’t looking for ‘perfect’ projects—only ones that don’t have glaring ethical problems.”
It isn’t only junior researchers who need the REB’s guidance, notes Dr. Brett Thombs, an LDI investigator who develops protocols for his research into the psychological effects of an autoimmune skin disease, scleroderma. “Many of our scientists work on ground-breaking research. When we’re pushing the envelope, it’s great to be able to work closely with the REB to develop our study designs.
“In our area of research, because it involves a rare condition, local studies may be too small to be useful to us,” Dr. Thombs explains. “In those instances, we have to gather personal information from study participants around the world, without infringing on their privacy. The REB helps us to accomplish that ethically.”
If the research proceeds as hoped, the eventual result can be a product or procedure that’s transferred from the lab bench to the bedside to enhance the quality of care, so that individuals benefit from improved health. “That’s why I’m so intent on sensitizing people to what happens in this process,” Ms. Nguyen says. “Without the Research Ethics Board, there simply wouldn’t be any research in our CIUSSS.”
*Now that Bessy Bitzas, Ph.D., is stepping down as Chair of the Research Ethics Board’s Medical-Biomedical Committee, the Board is seeking a new leader dedicated to championing safe and conscientious research in CIUSSS West-Central Montreal.
