In recent months, research ethics reviews in Canada have come under the media spotlight, with claims the process is exploitative and calls for innovation or reform.
We have seen advances intended to improve research ethics reviews in this country, including the recently announced CanReview collaboration to establish a single, streamlined Canada-wide research ethics review system.
In much of this conversation, however, one voice has been missing. What do patients and people who are called on to participate in research think about research ethics reviews?
This article is co-written by a number of members of the Clinical Trials Ontario (CTO) College of Lived Experience, a group of 24 people from across Ontario who represent a range of ages, health care and disease/condition, research ethics and trial participation experiences.
We sat down virtually to discuss patient and public perceptions related to research ethics reviews.
Paramount is recognizing the vital role of research ethics reviews in protecting the welfare and safety of research participants. However, there seem to be different approaches to research ethics boards interpreting legislation and their role in it, and this can impact the time it takes to review a study. One College member notes: “If you’ve been on a research team doing a multi-site study or trial, then you’ve been part of conversations about which research ethics board will be the first one to target to get the study reviewed and approved the fastest.” But are safety and speed necessarily at odds, or can we find a better way to make sure ethics reviews are both rigorous and efficient?
Most people in Canada are likely unaware that often duplicative research ethics review processes at different sites or in different jurisdictions in Canada are done for a single clinical trial. For College members, this feels like unnecessary bureaucracy that hinders advancements in medicine by bogging down and limiting access to clinical trials and the lifesaving or life-prolonging treatments that often come with them.
In fact, some of us count on clinical trials to keep us alive – and we don’t have time for bureaucracy. As taxpayers, some of us think about duplicative processes as research waste, and the need to better use resources that are already stretched thin. For others, this calls into question the safety of that trial: “Are ethics different across the country? When a trial has significant risks, do these different ethics reviews and processes not raise a worrisome concern that a trial participant on one coast is safer than a trial participant on the other?”
For others, it raises the concern as to whether interpretation of ethics around one clinical trial is so different from one research ethics board to another: “Why does every site or region need to do their own ethics review? Are we so different as people living in different parts of Canada that the approach to research ethics review should be so different?”
Clinical trials for innovative rare disease therapies can carry more risks and thus may be interpreted as needing greater protections. Here, some of us wonder: “Does the ethics review take into consideration that risk is interpreted differently when there are significant unmet needs and often no other options?” Perhaps a streamlined review would offer more consistency on the perception and evaluation of risk versus benefit for special populations (e.g., rare diseases, pregnant people, pediatric populations, etc.).
We’re also concerned about equity related to research in Canada. Variation in research ethics review may cause inequities for individuals hoping to access innovative therapies. For example, when studies come to some jurisdictions in Canada, but not others, or when studies open at some sites long after opening and recruiting participants at other sites, access to critical treatments is lost or delayed for the people in those areas.
We are all too aware of the current geo-political climate, and Canada’s need to be competitive. While we know research ethics review differences are not the same as interprovincial trade barriers, we draw a parallel to them. In a time of need, we must find ways to change systems and processes so that we can be more collaborative and move Canadian products – including therapies – across the country.
Not being able to solve research ethics review barriers or inequities may mean some clinical trials will not happen in Canada or if they do, only at select sites. While our group is small, some of us have direct experiences with this being the case – where sponsors have chosen not to open studies because they feel the barriers and challenges to study startups are too onerous to overcome. This can be devastating for people who have few treatment options, or no treatment options at all outside of clinical trials.
We aren’t suggesting that research ethics reviews should go away, that research ethics boards be dismantled, or that trials shouldn’t be done safely and with great care and regulation. We recognize that many of the issues we highlight above have been talked about for years, and even decades – but it’s time to act.
The time is right for research ethics reviews to change and adopt a Canada-wide approach – and to better take into account perspectives of those who ultimately benefit from access to clinical trials.
Most chronic disease is preventable and reversible yet that is not are priority. When we are talking about ethics we need to see how are healthcare system allows this travesty.
I would like to thank Sophie Craig, Natalie del Signore, Heather Douglas, Donna Lillie, Maureen Smith, and Murray Walz for sharing their perspective and for their involvement in these important discussions. Patient engagement in research ethics reform is essential, but it must be grounded in transparency, balance, and integrity.
That’s precisely what concerns me about this article and the role played by Clinical Trials Ontario (CTO) in moderating the conversation. Rather than clarifying foundational concepts, like the ethical distinction between clinical care and research, CTO appears to have guided the discussion toward endorsing its single-REB model, without addressing some critical risks.
One of those is therapeutic misconception, a concept at the heart of research ethics. Therapeutic misconception occurs when research participants believe that the primary purpose of a clinical trial is to treat them personally, rather than to produce generalizable knowledge. This misunderstanding is especially common and concerning in trials involving rare or serious conditions, where hope for treatment understandably runs high.
But even when a trial may offer some benefit, it is not designed as a form of individualized therapy. The Tri-Council Policy Statement (TCPS 2) makes this very clear: “The purpose of a clinical trial is to evaluate an experimental therapy or intervention, not to provide therapy.” Clinician-researchers — and in the context of advocacy organizations like CTO — have a duty to ensure this distinction is clearly communicated, so that patients can make informed decisions about their participation.
That context was unfortunately missing from the article. Instead, what comes through is a narrative that may unintentionally conflate the goals of clinical research with those of clinical care. This not only risks reinforcing therapeutic misconception, but also places undue weight on the idea that faster research ethics review is equivalent to better access to treatment, when in fact, such access is far from guaranteed, and may come with significant risks.
Separately, CTO’s CanReview model raises serious concerns. By centralizing the REB review process without requiring independent oversight, such as Human Research Protection Program (HRPP) accreditation, it introduces a model of delegated responsibility with retained liability. In such a system, institutions are held accountable for ethics decisions made by an REB they didn’t select and cannot independently evaluate (see for more details: https://www.linkedin.com/pulse/when-oversight-delegated-liability-remains-legal-look-martin-letendre-pzz7e/?trackingId=SU5zAeekQiS4%2Bx8J2c%2B4gA%3D%3D). That’s a deeply problematic structure, particularly when participant protection is at stake.
Efficiency in research is important, but it cannot come at the expense of rigour, independence, or ethical integrity. A truly trustworthy system is one that is not just fast or centralized, but also independently verified, transparently governed, and clear about what research participation actually means.