Written by: Sophie Craig, Natalie del Signore, Heather Douglas, Donna Lillie, Maureen Smith, Murray Walz, and Dawn Richards.
In recent months, research ethics review in Canada has come into the media spotlight, from a number of angles. Some have said Canada’s system is exploitative. Some have called for innovation or reform. We are already seeing advances intended to improve research ethics review 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, one voice has been missing. What do patients and people who are called on to participate in research think about research ethics review?
This article is co-written by a number of members of the Clinical Trials Ontario (CTO) College of Lived Experience or simply, members of the College. The College is a group of 24 people from different places in Ontario who represent a range of ages, health care, disease/condition, and trial participation experiences. These individuals all have an interest in research and advise CTO and other research organizations on various topics, projects, and initiatives with a goal of improving clinical trials.
College members have different experiences relating to the research ethics review process. Their experiences range from one member having been involved with the Panel on Research Ethics, two members being on the CanReview leadership team, others being part of preparing or contributing to research ethics applications as members of research teams, to others having general awareness of research ethics reviews and boards by being part of the clinical research space. We sat down virtually to discuss patient and public perceptions related to research ethics review.
Paramount is recognizing the vital role of research ethics review 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 of us 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.” One important question we find ourselves asking is, 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 are done for a single clinical trial that is being run at different sites or in different jurisdictions in Canada. What feels like unnecessary bureaucracy hinders advancements in medicine by bogging down and limiting access to clinical trials and the life-saving 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 what feels like bureaucracy. As taxpayers, some of us think about duplicative processes as research waste, and the need to better use resources in systems 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 or not 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.
Lastly, we’re 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 are finding 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 in Canada 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 review should go away, that research ethics boards be dismantled, or that trials shouldn’t be done safely and with great care and regulation. We’re recognizing that many of the issues we highlight above have been talked about for years, and even decades – it’s time to act. We’re suggesting the time is right for research ethics review 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.
We aren’t suggesting that research ethics review should go away, that research ethics boards be dismantled, or that trials shouldn’t be done safely and with great care and regulation. We’re recognizing that many of the issues we highlight above have been talked about for years, and even decades – it’s time to act. We’re suggesting the time is right for research ethics review 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.