June 2023Research at the Lady Davis Institute

Watchful eyes for inquiring minds: Inside the Research Ethics Board

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.

Céline Gélinas, Ph.D., a Senior Researcher at the JGH Nursing Research Centre , has worked closely with the Research Ethics Board when developing her studies on pain in the Medical Surgical Intensive Care Unit.

Céline Gélinas, Ph.D., a Senior Researcher at the JGH Nursing Research Centre , has worked closely with the Research Ethics Board when developing her studies on pain in the Medical Surgical Intensive Care Unit.

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.

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.

To Nhu Nguyen

To Nhu Nguyen

“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.

More about Dr. Bessy Bitzas

More about Dr. Bessy Bitzas, who in February was named the CIUSSS’s Associate Director of Nursing, can be found in this accompanying article.

Now that Dr. Bitzas 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.

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.

Dr. Brett Thombs

Dr. Brett Thombs

“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 investigator in the Lady Davis Institute, 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.”

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